Home Prevention I take rigevidon and my periods don’t stop. Rigevidon - official instructions for use

Prevention

I take rigevidon and my periods don’t stop. Rigevidon - official instructions for use

Light yellow, round, biconvex, film-coated tablets, marked “P9” on one side and “RG” on the other.

1 tablet contains the active ingredient: ethinyl estradiol 20 mcg, desogestrel 150 mcg. Excipients: quinoline yellow dye (E104), α-tocopherol, magnesium stearate, colloidal silicon dioxide, stearic acid, povidone, potato starch, lactose monohydrate.

Pharmacological action

A monophasic hormonal contraceptive for oral administration containing a combination of estrogen (ethinyl estradiol) and a progestin (desogestrel). The main contraceptive effect is to inhibit gonadotropins and suppress ovulation. In addition, by increasing the viscosity of the cervical fluid, the movement of sperm through the cervical canal slows down, and changes in the condition of the endometrium prevent the implantation of a fertilized egg.

Ethinyl estradiol is a synthetic analogue of the follicular hormone estradiol. Desogestrel has a pronounced gestagenic and antiestrogenic effect, similar to endogenous progesterone, and weak androgenic and anabolic activity. The drug has a beneficial effect on lipid metabolism: increases plasma HDL levels without affecting LDL levels.

When taking the drug, the loss of menstrual blood is significantly reduced (with initial menorrhagia), the menstrual cycle is normalized, and a beneficial effect on skin, especially in the presence of acne vulgaris.

Indications for use

oral contraception;
functional disorders menstrual cycle;
premenstrual syndrome.

Directions for use and doses

The drug is prescribed orally. Taking pills starts on the 1st day of the menstrual cycle. Prescribe 1 tablet for 21 days, if possible at the same time of day. After taking the last tablet from the package, take a 7-day break, during which menstrual-like bleeding occurs due to drug withdrawal. The next day after a 7-day break (4 weeks after taking the first tablet, on the same day of the week), resume taking the drug from the next package, also containing 21 tablets, even if the bleeding has not stopped. This pill regimen is followed as long as there is a need for contraception. If you follow the rules of administration, the contraceptive effect remains during the 7-day break.

Start taking the drug

First dose of the drug
The first tablet should be taken on the first day of the menstrual cycle. In this case there is no need to use additional methods contraception. You can start taking pills from the 2-5th day of menstruation, but in this case, in the first cycle of using the drug, you must use additional methods of contraception in the first 7 days of taking the pills. If more than 5 days have passed since the start of menstruation, you should delay starting the drug until your next menstruation.
Taking the drug after childbirth
Women who are not breastfeeding can start taking the pill no earlier than 21 days after giving birth, after consulting with their doctor. In this case, there is no need to use other methods of contraception. If there has already been sexual contact after childbirth, then taking the pills should be postponed until the first menstruation. If a decision is made to take the drug later than 21 days after birth, then additional methods of contraception must be used in the first 7 days.
Taking the drug after an abortion
After an abortion, in the absence of contraindications, you should start taking pills from the first day after surgery, and in this case there is no need to use additional methods of contraception.
Switching from another oral contraceptive
After using another hormonal oral contraceptive containing 30 mcg ethinyl estradiol, according to a 21-day regimen, it is recommended to take the first Novinet tablet the day after completing the course of the previous drug. There is no need to take a 7-day break or wait for the start of menstruation. There is no need to use additional methods of contraception. When switching from a drug containing 28 tablets, the next day after the tablets in the package run out, you should start a new package of Novinet.
Transition after oral hormonal drugs containing only progestogen ("mini-pill")
The first Novinet tablet should be taken on the 1st day of the cycle. There is no need to use additional methods of contraception. If menstruation does not occur while taking the mini-pill, then after excluding pregnancy, you can start taking Novinet on any day of the cycle, but in this case, in the first 7 days it is necessary to use additional methods of contraception (using a cervical cap with spermicidal gel, a condom, or abstinence from sexual intercourse). Application calendar method in these cases it is not recommended.

Delay of the menstrual cycle

If there is a need to delay menstruation, you must continue taking the tablets from the new package, without a 7-day break, according to the usual regimen. When menstruation is delayed, breakthrough or spotting bleeding may occur, but this does not reduce the contraceptive effect of the drug. Regular use of Novinet can be resumed after the usual 7-day break.

Missed pills

If a woman forgot to take the pill on time, and after missing it, no more than 12 hours, you need to take the forgotten pill, and then continue taking it at the usual time. If there is a gap between taking pills more than 12 hours- this is considered a missed pill; the reliability of contraception in this cycle is not guaranteed and the use of additional methods of contraception is recommended.

If you miss one tablet per first or second week of the cycle, you must take 2 tablets the next day and then continue regular use, using additional methods of contraception until the end of the cycle.

If you miss a pill third week of the cycle you need to take the forgotten pill, continue taking it regularly and not take a 7-day break. It is important to remember that due to the minimum dose of estrogen, the risk of ovulation and/or spotting increases if you miss a pill and therefore the use of additional methods of contraception is recommended.

Vomiting or nausea

If vomiting or diarrhea occurs after taking the drug, then absorption of the drug may be inadequate. If the symptoms stop within 12 hours, then you need to take one more tablet. After this, you should continue taking the tablets as usual. If vomiting or diarrhea continues for more than 12 hours, then it is necessary to use additional methods of contraception during vomiting or diarrhea and for the next 7 days.

Side effect

Side effects requiring discontinuation of the drug:

From the outside cordially- vascular system: arterial hypertension; rarely - arterial and venous thromboembolism (including myocardial infarction, stroke, deep vein thrombosis of the lower extremities, thromboembolism pulmonary artery); very rarely - arterial or venous thromboembolism of the hepatic, mesenteric, renal, retinal arteries and veins.
From the senses: hearing loss due to otosclerosis.
Others: hemolytic-uremic syndrome, porphyria; rarely - exacerbation of reactive systemic lupus erythematosus; very rarely - Sydenham's chorea (passing after discontinuation of the drug).

Other side effects are more common, but less severe:

The advisability of continuing to use the drug is decided individually after consultation with a doctor, based on the benefit/risk ratio.

From the reproductive system: acyclic bleeding/ bloody issues from the vagina, amenorrhea after drug withdrawal, changes in the state of vaginal mucus, development inflammatory processes vagina, candidiasis, tension, pain, breast enlargement, galactorrhea.
From the digestive system: nausea, vomiting, Crohn's disease, ulcerative colitis, occurrence or exacerbation of jaundice and/or itching associated with cholestasis, cholelithiasis.
Dermatological reactions: Erythema nodosum, exudative erythema, rash, chloasma.
From the side of the central nervous system: headache, migraine, mood lability, depression.
From the side of the organ of vision: increased sensitivity of the cornea (when wearing contact lenses).
From the side of metabolism: fluid retention in the body, change (increase) in body weight, decreased tolerance to carbohydrates.
Others: allergic reactions.

Contraindications

the presence of severe and/or multiple risk factors for venous or arterial thrombosis (including severe or moderate arterial hypertension with blood pressure ≥ 160/100 mm Hg);
presence or indication in history of precursors of thrombosis (including transient ischemic attack, angina pectoris);
migraine with focal neurological symptoms, incl. in the anamnesis;
venous or arterial thrombosis/thromboembolism (including myocardial infarction, stroke, deep vein thrombosis of the leg, pulmonary embolism) currently or in history;
a history of venous thromboembolism;
diabetes mellitus (with angiopathy);
pancreatitis (including a history), accompanied by severe hypertriglyceridemia;
dyslipidemia;
severe liver diseases, cholestatic jaundice (including during pregnancy), hepatitis, incl. history (before normalization of functional and laboratory parameters and within 3 months after their normalization);
jaundice when taking GCS;
gallstone disease currently or in history;
Gilbert's syndrome, Dubin-Johnson syndrome, Rotor syndrome;
liver tumors (including history);
severe itching, otosclerosis or its progression during a previous pregnancy or taking corticosteroids;
hormone dependent malignant neoplasms genitals and mammary glands (including if they are suspected);
vaginal bleeding of unknown etiology;
smoking over the age of 35 (more than 15 cigarettes per day);
pregnancy or suspicion of it;
lactation period;
hypersensitivity to the components of the drug.

Carefully the drug should be prescribed for conditions that increase the risk of developing venous or arterial thrombosis/thromboembolism: age over 35 years, smoking, family history, obesity (body mass index more than 30 kg/m2), dyslipoproteinemia, arterial hypertension, migraine, epilepsy, valvular defects heart, atrial fibrillation, prolonged immobilization, extensive surgical intervention, surgery on the lower extremities, severe trauma, varicose veins and superficial thrombophlebitis, postpartum period, the presence of severe depression (including a history), changes in biochemical parameters (activated protein C resistance, hyperhomocysteinemia, antithrombin III deficiency, protein C or S deficiency, antiphospholipid antibodies, including antibodies to cardiolipin, incl. including lupus anticoagulant), diabetes mellitus not complicated by vascular disorders, SLE, Crohn's disease, ulcerative colitis, sickle cell anemia, hypertriglyceridemia (including family history), acute and chronic diseases liver.

Use of Novinet during pregnancy and breastfeeding

Novinet is contraindicated for use during pregnancy and lactation (breastfeeding).

Use for liver and kidney dysfunctions

Novinet is contraindicated in cases of severe liver disease (including a history of liver disease).
With caution and only after a thorough assessment of the benefits and risks of use, Novinet should be prescribed for renal failure (including a history of it).

special instructions

Before starting to use the drug, it is necessary to conduct a general medical examination (detailed family and personal history, blood pressure measurement, laboratory research) and gynecological examination (including examination of the mammary glands, pelvic organs, cytological analysis of a cervical smear). Such examinations during the period of taking the drug are carried out regularly, every 6 months.

The drug is a reliable contraceptive: the Pearl index (an indicator of the number of pregnancies occurring during the use of a contraceptive method in 100 women over 1 year) when used correctly is about 0.05.

In each case, before prescribing hormonal contraceptives, the benefits or possible negative effects of their use are individually assessed. This issue should be discussed with the patient, who, after receiving the necessary information, will accept final decision about the preference for hormonal or any other method of contraception.

The woman's health condition must be carefully monitored. If any of the following conditions/diseases appear or worsen while taking the drug, you must stop taking the drug and switch to another, non-hormonal method of contraception:

diseases of the hemostatic system;
conditions/diseases predisposing to the development of cardiovascular and renal failure;
epilepsy;
migraine;
the risk of developing an estrogen-dependent tumor or estrogen-dependent gynecological diseases;
diabetes mellitus not complicated by vascular disorders;
severe depression (if depression is associated with a violation of tryptophan metabolism, then vitamin B 6 can be used for correction);
sickle cell anemia, because in some cases (for example, infections, hypoxia), estrogen-containing drugs for this pathology can provoke thromboembolism;
appearance of deviations in laboratory tests assessment of liver function.

Thromboembolic diseases

Epidemiological studies have shown that there is a connection between taking oral hormonal contraceptives and an increased risk of developing arterial and venous thromboembolic diseases (including myocardial infarction, stroke, deep vein thrombosis of the lower extremities, pulmonary embolism). An increased risk of venous thromboembolic diseases has been proven, but it is significantly less than during pregnancy (60 cases per 100 thousand pregnancies). When using oral contraceptive drugs very rarely, arterial or venous thromboembolism of the hepatic, mesenteric, renal or retinal vessels is observed.

The risk of arterial or venous thromboembolic disease increases:

with age;
when smoking (heavy smoking and age over 35 years are risk factors);
if there is a family history of thromboembolic diseases (for example, parents, brother or sister). If you suspect genetic predisposition, it is necessary to consult a specialist before using the drug;
for obesity (body mass index more than 30 kg/m2);
with dislipoproteinemia;
at arterial hypertension;
for diseases of the heart valves complicated by hemodynamic disorders;
with atrial fibrillation;
with diabetes mellitus complicated by vascular lesions;
with prolonged immobilization, after major surgery, after surgery on the lower extremities, after severe trauma.

In these cases, it is assumed to temporarily stop using the drug (no later than 4 weeks before surgery, and resume no earlier than 2 weeks after remobilization).

Women after childbirth have an increased risk of venous thromboembolic disease.

It should be taken into account that diabetes mellitus, systemic lupus erythematosus, hemolytic-uremic syndrome, Crohn's disease, ulcerative colitis, sickle cell anemia increase the risk of developing venous thromboembolic diseases.

It should be taken into account that resistance to activated protein C, hyperhomocysteinemia, protein C and S deficiency, antithrombin III deficiency, and the presence of antiphospholipid antibodies increase the risk of developing arterial or venous thromboembolic diseases.

When assessing the benefit/risk ratio of taking the drug, it should be taken into account that targeted treatment of this condition reduces the risk of thromboembolism. Symptoms of thromboembolism are:

sudden chest pain that radiates to the left arm;
sudden shortness of breath;
any unusually severe headache that continues for a long time or appears for the first time, especially when combined with sudden complete or partial loss of vision or diplopia, aphasia, dizziness, collapse, focal epilepsy, weakness or severe numbness of half the body, motor disorders, severe unilateral pain in the calf muscle, acute abdomen.

Tumor diseases

Some studies have reported an increased incidence of cervical cancer in women who took hormonal contraceptives for a long time, but the results of the studies are inconsistent. Sexual behavior, infection with the human papillomavirus and other factors play a significant role in the development of cervical cancer.

A meta-analysis of 54 epidemiological studies found that there is a relative increase in the risk of breast cancer among women taking oral hormonal contraceptives, but the higher detection rate of breast cancer may have been associated with more regular medical screening. Breast cancer is rare among women under 40, whether they are taking hormonal birth control or not, and increases with age. Taking pills can be considered one of many risk factors. However, the woman should be made aware of the possible risk of developing breast cancer based on an assessment of the benefit-risk ratio (protection against ovarian and endometrial cancer).

There are few reports of the development of benign or malignant liver tumors in women taking hormonal contraceptives for a long time. This should be kept in mind when differentially assessing abdominal pain, which may be associated with an increase in liver size or intraperitoneal bleeding.

Chloasma

Chloasma can develop in women with a history of this disease during pregnancy. Those women who are at risk of developing chloasma should avoid contact with sunlight or ultraviolet radiation while taking Novinet.

Efficiency

The effectiveness of the drug may decrease in the following cases: missed pills, vomiting and diarrhea, simultaneous use of other drugs that reduce the effectiveness birth control pills.

If the patient is concomitantly taking another drug that may reduce the effectiveness of birth control pills, additional methods of contraception should be used.

The effectiveness of the drug may decrease if, after several months of their use, irregular, spotting or breakthrough bleeding appears, in such cases it is advisable to continue taking the tablets until they run out in the next package. If at the end of the second cycle menstrual-like bleeding does not begin or acyclic bleeding does not stop, stop taking the pills and resume it only after pregnancy has been ruled out.

Changes in laboratory parameters

Under the influence of oral contraceptive pills - due to the estrogen component - the level of some laboratory parameters may change (functional indicators of the liver, kidneys, adrenal glands, thyroid gland, hemostasis indicators, levels of lipoproteins and transport proteins).

Additional Information

After suffering an acute viral hepatitis the drug should be taken after normalization of liver function (not earlier than 6 months).

For diarrhea or intestinal disorders, vomiting, the contraceptive effect may be reduced. Without stopping the drug, it is necessary to use additional non-hormonal methods of contraception.

Women who smoke have an increased risk of developing vascular diseases with serious consequences (myocardial infarction, stroke). The risk depends on age (especially in women over 35 years of age) and on the number of cigarettes smoked.

The woman should be warned that the drug does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Impact on the ability to drive vehicles and operate machinery

No studies have been conducted to study the effect of Novineta on the abilities necessary to drive a car and operate machinery.

Overdose

Symptoms: nausea, vomiting, and in girls - bleeding from the vagina.

Treatment: In the first 2-3 hours after taking the drug in a high dose, gastric lavage is recommended. There is no specific antidote, treatment is symptomatic.

Drug interactions

Medicines that induce liver enzymes, such as hydantoin, barbiturates, primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, felbamate, griseofulvin, and St. John's wort preparations reduce the effectiveness of oral contraceptives and increase the risk of breakthrough bleeding. The maximum level of induction is usually achieved no earlier than 2-3 weeks, but can last up to 4 weeks after discontinuation of the drug.

Ampicillin and tetracycline reduce the effectiveness of Novinet (the mechanism of interaction has not been established). If necessary joint reception, it is recommended to use an additional barrier method of contraception throughout the entire course of treatment and for 7 days (for rifampicin - within 28 days) after discontinuation of the drug.

Oral contraceptives may decrease carbohydrate tolerance and increase the need for insulin or oral antidiabetic agents.

One of the most popular oral contraceptives is Novinet. It is quite inexpensive in price (which also matters) and at the same time of high quality, so it is accessible even to women with little income.

Description of the drug

What is Novinet? This is a microdosed single-phase oral contraceptive. The active ingredients of Novinet are ethinyl estradiol and desogestrel. Their content in the drug is the highest: in 1 tablet of Novinet there are 20 mcg of ethinyl estradiol and 150 mcg of desogestrel. Magnesium stearate, potato starch, stearic acid, lactose, α-tocopherol, quinoline yellow dye (E104), colloidal silicon dioxide, povidone are used as excipients.

To make it convenient for a woman to take the pills, they are numbered on the packaging and marked with arrows.

If you have an ovarian cyst, Novinet can be used, but regular supervision by a specialist is required.

It is recommended to start taking Novinet for the first time on the first day. Then you will no longer need to use other means of contraception - a cap, a condom, a ring. You can also start taking pills on the second or third day of your period. But then you will need to take care of additional methods of protection against pregnancy, since a 100% result is obtained only by taking pills from the beginning of monthly discharge.

After an abortion, Novinet is prescribed to be taken on the day of surgery. This will allow you, even during the first month after an abortion, to have a calm sexual life and not use protection.

A woman who has given birth can start taking Novinet no earlier than three weeks after giving birth. (But only those who are not breastfeeding can protect themselves from pregnancy with this remedy.) In this case, you don’t have to use protection. If a woman has had sexual intercourse after childbirth, then taking a contraceptive should be postponed until her first menstruation. Before that, during the first week of taking the pills, use a condom or other methods of protection against pregnancy.

Contraindications

It is not recommended to use Novinet in the presence of severe or multiple factors venous thrombosis, with high blood pressure more than 160/100 mm Hg, with frequent migraines, myocardial infarction, thrombophlebitis, varicose veins, with diabetes mellitus, cholelithiasis, liver diseases, Gilbert, Dubin-Johnson, Rotor syndromes, otorosclerosis, vaginal bleeding of unknown etiology, with malignant neoplasms of the mammary glands or genital organs, as well as if they are suspected. The drug should not be used while smoking (if you smoke more than 15 cigarettes per day) or during lactation.

The instructions recommend that Novinet is contraindicated during pregnancy or suspected pregnancy.

Side effects

Among the side effects that may cause taking of this medicine, arterial hypertension, hearing loss, headache, migraine, mood swings, nausea, vomiting. Bloody vaginal discharge, candidiasis, pain and enlargement of the mammary glands are also possible; amenorrhea often occurs after discontinuation of the drug.

special instructions

The instructions for use of the drug also contain recommendations on the use of a contraceptive in cases where it is necessary to postpone menstruation or in case of missing pills.

To remember to take your pills, set a reminder on your mobile phone.

With the help of Novinet, you can shift the date of menstruation. To do this, after taking 21 tablets, you do not need to take a seven-day break, but should immediately start taking tablets from the next package.

If you forget to take your medicine at the usual time, but less than 12 hours have passed since then, you should take the missed pill as soon as possible and continue taking the medicine at the usual time. If the missed period is more than 12 hours, you will need to take care of additional contraception until the end of the cycle.

Storage conditions

The drug should be stored in a cool, dry place. Novinet is available from the pharmacy without a doctor's prescription.

You can find out detailed information about the drug Novinet by consulting your gynecologist or specialists at the Medep Family Medicine Center.

In this article you can find instructions for use medicinal product Novinet. Reviews of site visitors - consumers of this medicine, as well as the opinions of specialist doctors on the use of Novinet in their practice are presented. We kindly ask you to actively add your reviews about the drug: whether the medicine helped or did not help get rid of the disease, what complications and side effects were observed, perhaps not stated by the manufacturer in the annotation. Analogues of Novinet in the presence of existing structural analogues. Use for contraception in women, including during pregnancy and breastfeeding. Side effect of the drug.

Novinet- a monophasic hormonal contraceptive drug for oral administration containing a combination of estrogen (ethinyl estradiol) and gestagen (desogestrel). The main contraceptive effect is to inhibit gonadotropins and suppress ovulation. In addition, by increasing the viscosity of the cervical fluid, the movement of sperm through the cervical canal slows down, and changes in the condition of the endometrium prevent the implantation of a fertilized egg.

Ethinyl estradiol is a synthetic analogue of the follicular hormone estradiol.

Desogestrel has a pronounced gestagenic and antiestrogenic effect, similar to endogenous progesterone, and weak androgenic and anabolic activity.

The drug has a beneficial effect on lipid metabolism: it increases the HDL content in plasma without affecting the LDL content.

When taking the drug, the loss of menstrual blood is significantly reduced (in case of initial menorrhagia), the menstrual cycle is normalized, and a beneficial effect on the skin is noted, especially in the presence of acne vulgaris (pimples).

Pharmacokinetics

Desogestrel

Desogestrel is quickly and almost completely absorbed from the gastrointestinal tract and metabolized into 3-keto-desogestrel, which is a biologically active metabolite of desogestrel. Metabolites are excreted in urine and feces (in a ratio of 4:6).

Ethinyl estradiol

Ethinyl estradiol is quickly and completely absorbed from the gastrointestinal tract. About 40% is excreted in urine and about 60% in feces.

Indications

contraception;
acne (pimples).

Release forms

Film-coated tablets.

Instructions for use and dosage regimen

The drug is prescribed orally.

Taking pills starts on the 1st day of the menstrual cycle. Prescribe 1 tablet per day for 21 days, if possible at the same time of day. After taking the last tablet from the package, take a 7-day break, during which menstrual-like bleeding occurs due to drug withdrawal. The next day after a 7-day break (4 weeks after taking the first tablet, on the same day of the week), resume taking the drug from the next package, also containing 21 tablets, even if the bleeding has not stopped. This pill regimen is followed as long as there is a need for contraception. If you follow the rules of administration, the contraceptive effect remains during the 7-day break.

First dose of the drug

The first tablet should be taken on the first day of the menstrual cycle. In this case, it is not necessary to use additional methods of contraception. You can start taking pills from the 2-5th day of menstruation, but in this case, in the first cycle of using the drug, you must use additional methods of contraception in the first 7 days of taking the pills.

If more than 5 days have passed since the start of menstruation, you should delay starting the drug until your next menstruation.

Taking the drug after childbirth

Women who are not breastfeeding can start taking the pill no earlier than 21 days after giving birth, after consulting with their doctor. In this case, there is no need to use other methods of contraception. If there has already been sexual contact after childbirth, then taking the pills should be postponed until the first menstruation. If a decision is made to take the drug later than 21 days after birth, then additional methods of contraception must be used in the first 7 days.

Taking the drug after an abortion

After an abortion, in the absence of contraindications, you should start taking pills from the first day after surgery, and in this case there is no need to use additional methods of contraception.

Switching from another oral contraceptive

After using another hormonal oral contraceptive containing 30 mcg ethinyl estradiol, according to a 21-day regimen, it is recommended to take the first Novinet tablet the day after completing the course of the previous drug. There is no need to take a 7-day break or wait for the start of menstruation. There is no need to use additional methods of contraception.

When switching from a drug containing 28 tablets, the next day after the tablets in the package run out, you should start a new package of Novinet.

Switching to Novinet after using oral hormonal drugs containing only progestogen ("mini-pill")

The first Novinet tablet should be taken on the 1st day of the cycle. There is no need to use additional methods of contraception.

If menstruation does not occur while taking the mini-pill, then after excluding pregnancy, you can start taking Novinet on any day of the cycle, but in this case, in the first 7 days it is necessary to use additional methods of contraception (using a cervical cap with spermicidal gel, a condom, or abstinence from sexual intercourse). The use of the calendar method in these cases is not recommended.

Delay of the menstrual cycle

Missed pills

If a woman forgot to take a pill on time, and no more than 12 hours have passed since the omission, she needs to take the forgotten pill, and then continue taking it at the usual time. If more than 12 hours have passed between taking pills, this is considered a missed pill; the reliability of contraception in this cycle is not guaranteed and the use of additional methods of contraception is recommended.

If you miss one tablet in the first or second week of the cycle, you must take 2 tablets the next day and then continue regular use, using additional methods of contraception until the end of the cycle.

If you miss a pill in the third week of the cycle, you should take the forgotten pill, continue taking it regularly and not take a 7-day break. It is important to remember that due to the minimum dose of estrogen, the risk of ovulation and/or spotting increases if you miss a pill and therefore the use of additional methods of contraception is recommended.

Vomiting/nausea

Side effect

arterial hypertension;
arterial and venous thromboembolism (including myocardial infarction, stroke, deep vein thrombosis of the lower extremities, pulmonary embolism);
hearing loss due to otosclerosis;
hemolytic-uremic syndrome;
porphyria;
exacerbation of reactive systemic lupus erythematosus;
acyclic bleeding/bloody discharge from the vagina;
amenorrhea after drug withdrawal;
change in the state of vaginal mucus;
development of inflammatory processes in the vagina;
candidiasis;
tension, pain, enlargement of the mammary glands (breast engorgement);
galactorrhea;
nausea, vomiting;
Crohn's disease;
ulcerative colitis;
erythema nodosum;
exudative erythema;
headache;
migraine;
mood lability;
depression;
increased sensitivity of the cornea (when wearing contact lenses);
fluid retention in the body;
change (increase) in body weight;
allergic reactions.

Contraindications

the presence of severe and/or multiple risk factors for venous or arterial thrombosis (including severe or moderate arterial hypertension with blood pressure ≥ 160/100 mm Hg);
presence or indication in history of precursors of thrombosis (including transient ischemic attack, angina pectoris);
migraine with focal neurological symptoms, incl. in the anamnesis;
venous or arterial thrombosis/thromboembolism (including myocardial infarction, stroke, deep vein thrombosis of the leg, pulmonary embolism) currently or in history;
a history of venous thromboembolism;
diabetes mellitus (with angiopathy);
pancreatitis (including a history), accompanied by severe hypertriglyceridemia;
dyslipidemia;
severe liver diseases, cholestatic jaundice (including during pregnancy), hepatitis, incl. history (before normalization of functional and laboratory parameters and within 3 months after their normalization);
jaundice when taking glucocorticosteroids;
gallstone disease currently or in history;
Gilbert's syndrome, Dubin-Johnson syndrome, Rotor syndrome;
liver tumors (including history);
severe itching, otosclerosis or its progression during a previous pregnancy or taking corticosteroids;
hormone-dependent malignant neoplasms of the genital organs and mammary glands (including if they are suspected);
vaginal bleeding of unknown etiology;
smoking over the age of 35 (more than 15 cigarettes per day);
pregnancy or suspicion of it;
lactation period;
hypersensitivity to the components of the drug.

Use during pregnancy and breastfeeding

Novinet is contraindicated for use during pregnancy and lactation (breastfeeding).

special instructions

Before starting to use the drug, it is necessary to conduct a general medical examination (detailed family and personal history, blood pressure measurement, laboratory tests) and gynecological examination (including examination of the mammary glands, pelvic organs, cytological analysis of a cervical smear). Such examinations during the period of taking the drug are carried out regularly, every 6 months.

In each case, before prescribing hormonal contraceptives, the benefits or possible negative effects of their use are individually assessed. This issue must be discussed with the patient, who, after receiving the necessary information, will make the final decision on the preference for hormonal or any other method of contraception.

diseases of the hemostatic system;
conditions/diseases predisposing to the development of cardiovascular and renal failure;
epilepsy;
migraine;
the risk of developing an estrogen-dependent tumor or estrogen-dependent gynecological diseases;
diabetes mellitus not complicated by vascular disorders;
severe depression (if depression is associated with impaired tryptophan metabolism, then vitamin B6 can be used for correction);
sickle cell anemia, because in some cases (for example, infections, hypoxia), estrogen-containing drugs for this pathology can provoke thromboembolism;
the appearance of abnormalities in laboratory tests assessing liver function.

Thromboembolic diseases

Epidemiological studies have shown that there is a connection between taking oral hormonal contraceptives and an increased risk of developing arterial and venous thromboembolic diseases (including myocardial infarction, stroke, deep vein thrombosis of the lower extremities, pulmonary embolism). An increased risk of venous thromboembolic diseases has been proven, but it is significantly less than during pregnancy (60 cases per 100 thousand pregnancies). When using oral contraceptives, arterial or venous thromboembolism of the hepatic, mesenteric, renal or retinal vessels is very rarely observed.

The risk of arterial or venous thromboembolic disease increases:

with age;
when smoking (heavy smoking and age over 35 years are risk factors);
if there is a family history of thromboembolic diseases (for example, parents, brother or sister). If a genetic predisposition is suspected, it is necessary to consult a specialist before using the drug;
for obesity (body mass index more than 30 kg/m2);
with dislipoproteinemia;
with arterial hypertension;
for diseases of the heart valves complicated by hemodynamic disorders;
with atrial fibrillation;
with diabetes mellitus complicated by vascular lesions;
with prolonged immobilization, after major surgery, after surgery on the lower extremities, after severe trauma.

In these cases, it is assumed to temporarily stop using the drug (no later than 4 weeks before surgery, and resume no earlier than 2 weeks after remobilization).

Women after childbirth have an increased risk of venous thromboembolic disease.

It should be taken into account that resistance to activated protein C, hyperhomocysteinemia, protein C and S deficiency, antithrombin 3 deficiency, and the presence of antiphospholipid antibodies increase the risk of developing arterial or venous thromboembolic diseases.

sudden chest pain that radiates to the left arm;
sudden shortness of breath;
any unusually severe headache that continues for a long time or appears for the first time, especially when combined with sudden complete or partial loss of vision or diplopia, aphasia, dizziness, collapse, focal epilepsy, weakness or severe numbness of half the body, movement disorders, severe unilateral pain in the calf muscle, acute abdomen.

Tumor diseases

Chloasma

Efficiency

The effectiveness of the drug may be reduced in the following cases: missed pills, vomiting and diarrhea, simultaneous use of other drugs that reduce the effectiveness of birth control pills.

If the patient is concomitantly taking another drug that may reduce the effectiveness of birth control pills, additional methods of contraception should be used.

Changes in laboratory parameters

Under the influence of oral contraceptive pills - due to the estrogen component - the level of some laboratory parameters (functional indicators of the liver, kidneys, adrenal glands, thyroid gland, hemostasis indicators, levels of lipoproteins and transport proteins) may change.

Additional Information

With diarrhea or intestinal disorders, vomiting, the contraceptive effect may be reduced. Without stopping the drug, it is necessary to use additional non-hormonal methods of contraception.

The woman should be warned that the drug does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Impact on the ability to drive vehicles and operate machinery

No studies have been conducted to study the effect of Novineta on the abilities necessary to drive a car and operate machinery.

Drug interactions

Ampicillin and tetracycline reduce the effectiveness of Novinet (the mechanism of interaction has not been established). If co-administration is necessary, it is recommended to use an additional barrier method of contraception throughout the course of treatment and for 7 days (for rifampicin - within 28 days) after discontinuation of the drug.

Oral contraceptives may decrease carbohydrate tolerance and increase the need for insulin or oral antidiabetic agents.

Analogues of the drug Novinet

Structural analogues of the active substance:

Marvelon;
Mercilon;
Regulon;
Tri-Mercy.

If there are no analogues of the drug for the active substance, you can follow the links below to the diseases for which the corresponding drug helps, and look at the available analogues for the therapeutic effect.

Compound

Each tablet contains:

Active ingredients: desogestrel - 0.15 mg, ethinyl estradiol - 0.02 mg Excipients: lactose monohydrate, potato starch, povidone K-30, stearic acid, colloidal silicon dioxide anhydrous, magnesium stearate, all-rac-α-tocopherol, quinoline yellow 3 (E 104)

Film casing: propylene glycol, macrogol 6000, hypromellose

Description

Light yellow, round, biconvex, film-coated tablets, marked “P9” on one side and “RG” on the other.

Pharmacotherapeutic group

Sex hormones and modulators of the reproductive system. Fixed combinations of progestogens and estrogens.

CodeATX: G03AA09.

Pharmacological properties

Pharmacodynamics

The contraceptive effect of combined oral contraceptives is based on the interaction various factors, the most important of which seem to be suppression of ovulation and changes in cervical mucus secretion. In addition to protection against pregnancy, combined oral contraceptives have other positive properties that, along with negative properties (see sections "Precautions", "Side effects"), can be useful when choosing a method of birth control. When taking the drug, the menstrual cycle becomes more regular, and menstruation is often less painful and the amount of blood loss is less.

The latter makes it possible to reduce the incidence of iron deficiency anemia. In addition, when taking higher-dose combined oral contraceptives (0.05 mg ethinyl estradiol), there was a decrease in the risk of developing fibrocystic tumors of the mammary glands, ovarian cysts, and inflammatory diseases pelvic organs, ectopic pregnancy, as well as endometrial and ovarian cancer. The applicability of this observation to low-dose combined oral contraceptives requires confirmation.

Children and teenagers

There are no clinical data on the effectiveness and safety of the drug when used in adolescents under 18 years of age.

Pharmacokinetics

Desogestrel

Suction

After oral administration, desogestrel is rapidly and completely absorbed and metabolized to etonogestrel. The maximum concentration of the drug in plasma is achieved 1.5 hours after taking the drug. Bioavailability is 62-81%.

Distribution

Etonogestrel binds to serum albumin and sex hormone binding globulin (SHBG). Only 2-4% of the total drug concentration in serum is present in unbound form, 40-70% of the drug is specifically bound to SHBG. The increase in SHBG levels caused by ethinyl estradiol affects the distribution among serum proteins, causing an increase in the SHBG-bound fraction of the hormone and a decrease in the level of the albumin-bound fraction. The volume of distribution is 5 l/kg.

Metabolism

Etonogestrel is completely metabolized through known mechanisms of steroid hormone metabolism. Clearance from blood plasma is about 2 ml/min per 1 kg of body weight. No interactions of etonogestrel with ethinyl estradiol were detected when taken together.

Removal

The decrease in serum etonogestrel levels is biphasic. The terminal phase of elimination is described by the half-life, which is approximately 30 hours. Desogestrel and its metabolites are excreted in urine and bile in a ratio of about 6:4.

Equilibrium state

The pharmacokinetics of etonogestrel depends on the concentration of SHBG in the blood serum, which increases 3 times when taking ethinyl estradiol. When taking the drug daily, the state of equilibrium drug concentration is achieved in the second half of the cycle, when the concentration of etonogestrel increases by 2-3 times.

Ethinyl estradiol

Suction

After oral administration, ethinyl estradiol is rapidly and completely absorbed. Peak plasma concentrations are achieved within 1-2 hours. Absolute bioavailability as a result of first pass conjugation and first pass metabolism is approximately 60%.

Distribution

Ethinyl estradiol binds strongly, but not specifically, to serum albumin (approximately 98.5%) and causes an increase in serum concentrations of SHBG. Its volume of distribution is 5 l/kg.

Metabolism

Ethinyl estradiol undergoes presystemic conjugation in the mucous membrane of the small intestine and in the liver. Ethinyl estradiol is initially metabolized by aromatic hydroxylation to form wide range hydroxylated and methylated metabolites, present as free metabolites and conjugates with glucuronides and sulfates. The clearance rate is about 5 ml/min per 1 kg of body weight.

Removal

The decrease in the concentration of ethinyl estradiol in the blood serum is biphasic, the distribution in the final phase is characterized by a half-life of about 24 hours. Ethinyl estradiol is not excreted unchanged; its metabolites are excreted in urine and bile in a ratio of 4:6. The half-life of metabolites is approximately 1 day.

Equilibrium state

An equilibrium state is achieved after 3-4 days of administration; when the concentration of the drug in the blood serum is approximately 30-40% higher than the concentration observed with a single dose of the drug.

Indications for use

Oral contraception.

Before prescribing Novinet, a woman’s individual risk factors should be assessed, especially those related to venous thromboembolic complications (VTE), and the risk of venous thromboembolic complications when taking Novinet should be compared with the risk when taking other combined hormonal contraceptives (CHCs) (see sections “Contraindications” " and "Precautions").

Contraindications

Combined hormonal contraceptives(CHC) should not be used if the conditions listed below are present. If such a condition occurs while taking CHCs, the contraceptives should be stopped immediately.

Presence or risk of venous thromboembolic complications (VTE) Venous thromboembolic complications (VTE) - the presence of venous thromboembolism currently (on anticoagulants) or in history (for example, deep vein thrombosis [DVT] or pulmonary embolism [PE]). Established family history or acquired predisposition to the development of venous thromboembolic complications, for example, resistance to APS (including factor V Leiden), antithrombin III deficiency, protein C or protein S deficiency. Major surgery with prolonged immobilization (see section "Precautions") High risk of venous thromboembolic complications due to multiple risk factors (see section "Precautions") Presence of a risk of developing arterial thromboembolic complications (ATE) Arterial thromboembolic complications - the presence of current or previous arterial thromboembolism (for example, myocardial infarction) her conditions (for example, angina pectoris). Violation cerebral circulation- current or history of stroke or pre-existing conditions (eg, transient ischemic attack [TIA]). Established family history or acquired predisposition to arterial thromboembolism, for example, hyperhomocysteinemia and antibodies to phospholipids (anticardiolipin antibodies, lupus anticoagulant). A history of migraine with focal neurological symptoms. High risk of developing arterial thromboembolism due to multiple risk factors (see section “Precautions”) or the presence of one serious risk factor from the following: diabetes mellitus with vascular manifestations severe form of hypertension severe form of dyslipoproteinemia. Pancreatitis associated with severe hypertriglyceridemia, current or history. A history or current history of severe liver disease with altered laboratory parameters of liver function. History or current presence of liver tumors (benign or malignant). Known or suspected malignancy dependent on sex steroids (for example, neoplasm of the genital organs or mammary glands). Endometrial hyperplasia. Bleeding from the vagina of unknown etiology. Hypersensitivity to the active substances or to any of the excipients listed in the “Composition” section.

Novinet is contraindicated for combined use with medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir (see sections “Interaction with other medicinal products” and “Precautions”).

Use during pregnancy and breastfeeding

Pregnancy

The drug Novinet is contraindicated during pregnancy. Before starting to take Novinet, pregnancy should be excluded. If pregnancy occurs while using Novinet, it should be discontinued immediately.

According to the results of epidemiological studies, the incidence of congenital anomalies in women who took oral contraceptives before pregnancy, does not exceed the normal level, in addition, in the case of taking oral contraceptives for early stages pregnancy, no teratogenic effect was observed from their use.

When re-prescribing Novinet, the increased risk of developing VTE in the postpartum period should be taken into account (see sections “Dosage and Administration” and “Precautions”).

Breast-feeding

Taking oral contraceptives can reduce the level of breast milk production and change its composition, moreover, this group The drug passes into breast milk (however, there is no evidence of undesirable effects on the baby’s health); therefore, the use of this drug in nursing women is not recommended.

Small amounts of steroid hormones and/or their metabolites may pass into breast milk, but there is no evidence of undesirable effects on the baby's health.

Directions for use and doses

Children and teenagers

The safety and effectiveness of desogestrel in adolescents under 18 years of age has not been established. No data.

Mode of application

For oral administration.

The first tablet should be taken on the first day of menstruation, then take one tablet a day without a break for 21 days, preferably at the same time. After which they take a 7-day break from taking the pills, during which withdrawal bleeding is observed. The next day after a 7-day break (four weeks after taking the first tablet, on the same day of the week), resume taking the drug from the next package containing 21 tablets, even if the bleeding has not stopped. This pill regimen is followed as long as there is a need for contraception. If the rules of administration are followed, the contraceptive effect also remains during the 7-day break.

Start taking Novinet

If earlier hormonal did not use contraceptives (in the last month)

The first tablet of Novinet should be taken on the first day of the menstrual cycle; in this case, the use of additional methods of contraception is not required. Taking pills can also be started from the 2-5th day of menstruation, but in this case, in the first cycle of using the drug, additional methods of contraception should be used in the first 7 days of taking the pills.

If more than 5 days have passed since the start of menstruation, the start of taking Novinet should be postponed until the start of the next menstruation.

When switching from combined hormonal contraceptives (combined oral contraceptives (COCs), vaginal ring, or transdermal patch)

It is preferable for a woman to start taking Novinet the day after taking the last active tablet of the previous combined oral contraceptive (COC, the last tablet containing the active substance), but no later than the next day after the usual pill break or inactive tablets of the previous COC. When replacing a vaginal ring or transdermal patch, it is advisable to start taking Novinet on the day the previous product was removed; in such cases, taking Novinet should begin no later than the day of the planned replacement procedure. At proper use previous method of contraception, as well as if the absence of pregnancy is confirmed, a change in the method of contraception can be carried out on any day of the cycle.

When switching from other progestogen-only medications (mini-pills [progesterone-only pills], injections, implants) or from a progestogen-releasing intrauterine system

A woman taking “mini-pills” (preparations containing only progesterone) can start taking Novinet on any day (using an implant or intrauterine system - on the day of their removal, using injection forms- on the day when the next injection is due), however, in all these cases, it is recommended to use an additional method of contraception during the first 7 days of taking the pills.

After an abortion in the 1st trimester

You can start taking the pills immediately after spontaneous termination of pregnancy or abortion. In this case, the use of additional methods of contraception is not required.

After childbirth or abortion in the second trimester

Non-breastfeeding women should start taking oral contraceptives 21-28 days after childbirth or second trimester abortion. The use of additional methods of contraception in this case is not required.

If taking Novinet was started later, additional methods of contraception should be used in the first seven days of use.

If there has already been sexual contact after childbirth, taking the pills should be postponed until the first menstruation.

Note: Breastfeeding women should avoid taking combined oral contraceptives as their use may cause a decrease in breast milk production (see section "Use during pregnancy and breastfeeding").

Taking missed pills

less than 12 hours, the contraceptive effect of the drug is not reduced. It is necessary to take the missed tablet as soon as possible; the remaining tablets should be taken as usual.

If it has passed since you missed the pill more than 12 hours, the contraceptive effect of the drug may be reduced. If you miss taking pills, the following basic principles should be followed:

Taking the drug should not be interrupted for more than 7 days. To achieve a sufficient level of suppression of the hypothalamic-pituitary-ovarian system, 7 days of continuous use of the drug are required.

With this in mind, in daily practice you should do the following:

Week 1

You should take the last missed tablet as soon as possible, even if this means taking two tablets at the same time. After this, you must continue taking the pills at the usual time of day. An additional barrier method of contraception (eg, a condom) should be used for the first 7 days. If sexual intercourse has taken place within the previous 7 days, the possibility of pregnancy must be taken into account. The more pills were missed, and the closer the missed pills were to the pill break, the higher the risk of pregnancy.

Week 2

You should take the last missed tablet as soon as possible, even if this means taking two tablets at the same time. After this, you must continue taking the pills at the usual time of day. Provided the pills have been taken in the correct order during the 7 days preceding the missed pill, there is no need for additional methods of contraception. However, otherwise, or if 1 or more tablets have been missed, it is recommended to use an additional method of contraception for 7 days.

Week 3

The risk of a decrease in the contraceptive effect, due to the upcoming break in taking the drug, is inevitable. However, this risk can be reduced by adjusting the drug regimen. Therefore, provided that the pills have been taken in the correct order during the 7 days preceding the missed pill, there is no need for additional methods of contraception. Otherwise, you should follow the first of the two strategies described below, as well as use an alternative method of contraception for the next 7 days.

1. You should take the last missed pill as soon as possible, even if this means taking two pills at the same time. After this, you need to continue taking the pills at the usual time of day. It is necessary to start taking tablets from a new package immediately after taking the last tablet from the currently taken package, that is, there should be no break in taking between packages. It is unlikely that a woman will have menstrual bleeding after finishing the second pack of tablets, but spotting or breakthrough bleeding may occur while taking the tablets.

2. In addition, the woman may be advised to stop taking pills from the current package. In this case, you should take a break from taking pills for up to 7 days, including those days when taking pills was missed, after which you should start taking pills from the next package.

If you miss taking pills, or if there is no menstrual bleeding between doses, you should exclude the possibility of pregnancy.

In case of severe gastrointestinal disorders absorption may be incomplete, in which case additional methods of contraception should be used.

In case of vomiting that occurs within 3-4 hours after taking the pill, you should follow the recommendations for skipping a pill given in the section “Taking missed pills.” If a woman does not want to change her usual regimen of taking the drug, she should take additional tablet(s) from a different package.

How to shift or delay the menstrual cycle

Delay of the menstrual cycle is not an indication for the use of this drug. However, if in exceptional cases a delay in the menstrual cycle is required, the woman should start taking Novinet from a new package without a 7-day break in use. The delay can last as long as the woman wishes, until the tablets from the second package run out. Against the background of delayed menstruation, a woman may experience spotting or breakthrough bleeding. In the future, after a planned 7-day break, regular use of Novinet can be continued.

To reschedule menstruation to a different day of the week from the usual dosage schedule, a woman is recommended to reduce the duration of the break by the desired number of days. The shorter the break, the higher the risk that “withdrawal” bleeding will not develop, and while taking the next package, “spotting” and “breakthrough” bleeding will be observed (during the period of delayed menstruation).

Side effect

Description of individual adverse reactions

An increased risk of arterial and venous thrombotic and thromboembolic complications, including myocardial infarction, stroke, transient ischemic attacks, venous thrombosis and pulmonary embolism, has been observed in women using combined oral contraceptives. For more information, see the Precautions section.

In addition, other adverse events, such as arterial hypertension, hormone-dependent tumors (for example, liver tumors, breast tumors), chloasma, were observed when taking combined oral contraceptives, which are described in detail in the "Precautions" section.

As with any COC, there may be a change in the nature of menstrual bleeding, especially in the first month of use. Changes in bleeding frequency (complete disappearance, decrease or increase in frequency), intensity (decrease or increase) or duration may occur.

Possible adverse effects reported in women taking COCs containing 150 micrograms of desogestrel and 20 micrograms of ethinyl estradiol (as in Novinet), as well as adverse events common to COCs, are listed in the table below1. All adverse events are classified by organ system and frequency of development; very common (≥ 1/10), frequent (≥ 1/100 -

Class of organ systems	Often	Infrequently	Rarely
Immune system disorders			Hypersensitivity
Metabolic and nutritional disorders		Fluid retention
Mental disorders	Depressed mood Mood changes	Decreased libido	Increase libido
Nervous system disorders	Headache	Migraine
Visual disorders			Contact lens intolerance
Vascular disorders			Venous thromboembolic complications (VTE) Arterial thromboembolic complications (ATE)
Violations by gastrointestinal tract	NauseaStomach pain	Vomiting, Diarrhea,
Skin and subcutaneous tissue disorders		RashHives	Erythema nodosum Erythema multiforme
Disorders of the genital organs and breast	Pain in the mammary glands Pain in the mammary glands	Breast enlargement	Vaginal discharge Breast discharge
General and administration site disorders	Weight gain		Weight loss

1The most appropriate MedDRA term is provided to describe specific adverse reactions. Synonyms or associated conditions are not listed, but should be taken into account.

Interactions

Breakthrough bleeding and/or contraceptive failure may result from the interaction of other medicines(inducing microsomal enzymes) with oral contraceptives.

Overdose

No serious side effects have been reported following an overdose of oral contraceptives. Possible symptoms in in this case There may be: nausea, vomiting, as well as slight bleeding from the vagina in young girls. Thus, an overdose of the drug does not require treatment. However, if an overdose is detected within 2-3 hours, or if a large number of tablets are taken, gastric lavage can be performed. There is no specific antidote; symptomatic therapy should be carried out.

Interaction with other drugs

Note: to identify possible drug interactions and related recommendations, information from the Instructions for Medical Use should be taken into account concomitant medications.

Pharmacodynamic interactions

Concomitant use with medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir, with or without ribavirin, may increase the risk of increased ALT activity (see sections "Contraindications" and "Precautions"). Therefore, patients taking Novinet should switch to an alternative method of contraception (for example, contraceptives containing only progestogen or non-hormonal methods) before starting therapy according to the regimen combination drugs. Taking Novinet can be resumed 2 weeks after completion of therapy according to the combination drug regimen.

Pharmacokinetic interactions

Effect of other drugs on Novinet

There may be an interaction with drugs that induce microsomal enzymes, which may result in an increase in the clearance of sex hormones, which, in turn, can lead to breakthrough bleeding and/or failure of the contraceptive effect.

Tactics

Enzyme induction can be observed after just a few days of administration. Maximum enzyme induction is usually observed within a few weeks. After discontinuation of the drug, enzyme induction may persist for up to 4 weeks.

Short-term treatment

Women receiving treatment with microsomal enzyme inducing drugs are advised to temporarily use a barrier method of contraception or another method of contraception in addition to COCs. A barrier method of contraception should be used during the entire period of concomitant therapy and for another 28 days after its discontinuation. If the use of an inducer drug continues after taking the last COC tablet from the current package, you should start taking tablets from a new package, allowing a break in use.

Long-term treatment

Women receiving long-term therapy with drugs that induce the liver enzyme system are recommended to use another non-hormonal reliable method of contraception.

The following interactions are described in the literature:

Substances leading to an increase in the clearance of COCs (reduction in the effectiveness of COCs due to the induction of microsomal enzymes), for example:

Barbiturates, bosentan, carbamazepine, phenytoin, primidone, rifampicin, rifabutin and the HIV drug ritonavir, nevirapine and efavirenz and possibly also felbamate, griseofulvin oxcarbazepine, topiramate and preparations containing St. John's wort (Hypericum perforatum) .

Substances that have a variable effect on COC clearance:

When co-administered with COCs, many combinations of HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors, including combinations with hepatitis C virus protease inhibitors, may increase or decrease the concentration of estrogens or progestins in the blood plasma. The effect of these changes may in some cases be clinically significant.

Therefore, information from the Instructions for Medical Use of concomitant medications intended for the treatment of HIV infection/hepatitis C should be taken into account to identify possible drug interactions and related recommendations. If in any doubt, women receiving protease inhibitors or non-nucleoside reverse transcriptase inhibitors should use additional barrier method of contraception.

Effect of Novinet on other drugs

Oral contraceptives may affect the metabolism of other active ingredients. Therefore, their concentrations in plasma and tissues can either increase (for example, cyclosporine) or decrease (for example, lamotrigine).

Other interactions

Laboratory research

Taking steroid contraceptives may affect the results of certain laboratory tests, including biochemical indicators of liver, thyroid, adrenal and kidney function, as well as serum concentrations of plasma transport proteins, such as corticosteroid binding globulin and lipid/lipoprotein fractions, indicators carbohydrate metabolism, blood clotting and fibrinolysis. Changes usually do not go beyond normal laboratory values.

Precautionary measures

Warnings

If any of the following conditions or risk factors are present, the rationale for using Novinet should be discussed with the woman.

If these conditions or risk factors worsen or occur, the woman is advised to contact her doctor and discuss with him the possibility of stopping taking Novinet.

Circulatory disorders

Risk of venous thromboembolic complications (VTE)

The use of combined hormonal contraceptives (CHCs) increases the risk of venous thromboembolic complications (VTE) in patients taking them compared with those not taking these drugs.

Drugs containing levonorgestrel, norgestimate, or norethisterone are associated with the lowest risk of VTE. Other drugs, such as Novinet, may double the risk of VTE. The decision to use a drug that is not one of the drugs with the lowest risk of VTE should be made only after a conversation with the woman. It is necessary to ensure that she understands the risk of VTE while taking Novinet, as well as the impact of her existing risk factors on it, and that the greatest risk of developing VTE is observed in the first year of use of the drug. In addition, there is evidence that the risk increases when combined hormonal contraceptives are resumed after a break of 4 weeks or more.

Approximately 2 out of 10,000 women who are not pregnant and not taking combined hormonal contraceptives develop VTE over the course of a year. However, a woman's individual risk may be much higher given her risk factors (see below).

It is estimated that of 10,000 women who use desogestrel-containing COCs, 9 to 12 will develop VTE within a year (compared with approximately 6 cases among women using levonorgestrel-containing COCs).

In both cases, the number of VTEs per year is less than the number expected during pregnancy or the postpartum period;

VTE may end fatal in 1-2% of cases.

In very rare cases, thrombosis of other vessels (for example, hepatic, mesenteric, renal or retinal veins and arteries) has been reported in patients taking CHCs.

Risk factors for the development of venous thromboembolic complications (VTE)

The risk of developing venous thromboembolic complications with CHC use may be significantly increased in women with additional risk factors, in particular those with multiple risk factors (see table).

Novinet is contraindicated in women with multiple risk factors that place her at high risk of developing venous thrombosis (see section “Contraindications”). If a woman has more than one risk factor, a situation may arise in which the risk increases to a greater extent than simply summing up individual factors: in this case, the overall risk of developing VTE should be taken into account. If the benefit/risk ratio during the assessment turns out to be unfavorable, the use of CHCs should be abandoned (see section “Contraindications”).

Table: Risk factors for the development of venous thromboembolic complications (VTE)

Risk factor	Note
	As BMI increases, the risk increases significantly. It is very important to consider the presence of other risk factors.
Prolonged immobilization, major surgery, any lower extremity or pelvic surgery, neurosurgery, or major trauma. Note: Temporary immobilization, including air travel over 4 hours, may also be a risk factor for VTE, especially in women with additional risk factors.	In such situations, it is recommended to stop using the patch/tablet/ring (in the case of elective surgery, at least four weeks in advance) and not restart it until two weeks after full recovery mobility. To avoid unwanted pregnancy, resort to another method of contraception. If taking Novinet has not been stopped in advance, consider the possibility of antithrombotic therapy.
A burdened family history (cases of venous thromboembolic complications in close relatives - brother, sister, parent, especially in relatively at a young age, i.e. up to 50 years).
Any medical conditions associated with VTE.	Cancer, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) and sickle cell anemia.
With age	Especially after 35 years

There is no consensus on the possible role varicose veins veins and thrombophlebitis of superficial veins in the development or progression of venous thrombosis.

The increased risk of thromboembolism during pregnancy and especially in the first 6 weeks should be taken into account postpartum period(for information on pregnancy and lactation, see the section “Use during pregnancy and breastfeeding”).

Symptoms of venous thromboembolic complications (VTE)

Symptoms of deep vein thrombosis (DVT) may include:

Unilateral swelling lower limb and/or feet, or swelling along the vein of the lower limb; pain or tenderness in the lower extremity that is felt when standing or while walking; increased temperature of the affected lower limb; redness of the skin or change in skin color of the lower limb.

Symptoms of pulmonary embolism (PE) may include:

Sudden onset of causeless shortness of breath or rapid breathing; sudden cough without obvious reason, possibly with blood; sharp chest pain; lightheadedness or dizziness; fast or irregular heartbeat.

Some of the symptoms reported (eg, shortness of breath, cough) are nonspecific and may be mistaken for more common or less severe conditions (eg, infectious diseases respiratory tract).

Other signs of blocked blood vessels may include sudden pain, swelling, and mild blueness of the limb.

In the case of ocular embolism, symptoms may vary from blurred vision (without pain) until (with progression) its loss. In some cases, complete loss of vision can develop almost immediately.

Risk of developing arterial thromboembolic complications (ATE)

The results of epidemiological studies have linked the use of CHCs with an increased risk of developing arterial thromboembolic complications (myocardial infarction) or cerebrovascular accidents (for example, transient cerebrovascular accident, stroke). Cases of arterial thromboembolism can be fatal.

Risk factors for the development of arterial thromboembolic complications (ATE)

The risk of developing arterial thromboembolic complications or cerebrovascular accidents when using combined hormonal contraceptives (CHCs) increases in women with risk factors (see table). Novinet is contraindicated in women with one serious risk factor or multiple risk factors for the development of ATE, which place her at high risk of developing arterial thromboembolism (see section “Contraindications”). If a woman has more than one risk factor, a situation may arise in which the risk increases to a greater extent than if the individual factors were simply added together: in this case, the overall risk should be taken into account. If the benefit/risk ratio during the assessment turns out to be unfavorable, the use of CHCs should be abandoned (see section “Contraindications”).

Table: Risk factors for the development of arterial thromboembolic complications (ATE)

Risk factor	Note
With age	Especially after 35 years
Smoking	Women wishing to use CHCs are advised to quit smoking. Women over 35 years of age who have not quit smoking are strongly advised to choose other methods of contraception.
Arterial hypertension
Obesity (body mass index exceeds 30 kg/m2)	As BMI increases, the risk increases significantly. This is especially important for women with additional risk factors.
Compounded family history (cases of arterial thromboembolism in close relatives - brother, sister, parent, especially at a relatively early age, i.e. before 50 years)	If a hereditary predisposition is suspected, the woman should be referred for specialist consultation before deciding to use any CHC.
Migraine	An increase in the frequency or severity of migraine during the use of CHCs (which may be a harbinger of cerebrovascular accident) may lead to immediate discontinuation of the drug.
Any conditions associated with adverse vascular events.	Diabetes mellitus, hyperhomocysteinemia, heart disease and atrial fibrillation, dyslipoproteinemia and systemic lupus erythematosus.

Symptoms of arterial thromboembolic complications (ATE)

Women should be informed that if symptoms occur they should seek emergency medical attention and report medical worker on the use of CGC.

Symptoms of a cerebrovascular accident may include:

sudden weakness or numbness of the face, arm, or leg, especially on one side of the body; sudden difficulty walking, dizziness, loss of balance or coordination; sudden confusion, difficulty speaking or understanding; sudden loss of vision in one or both eyes; sudden, severe or prolonged headache for no known reason; loss of consciousness or fainting with or without convulsions.

The temporary nature of symptoms suggests a transient ischemic attack (TIA).

Symptoms of myocardial infarction (MI) may include:

Pain, discomfort, pressure, heaviness, a feeling of tightness or fullness in the chest, arm or chest; discomfort radiating to the back, lower jaw, throat, hand, stomach; feeling of fullness, indigestion, or suffocation; sweating, nausea, vomiting, or dizziness; extreme weakness, anxiety, or shortness of breath; fast or irregular heartbeat. Tumors

Epidemiological studies indicate that long-term use of oral contraceptives is a risk factor for the development of cervical cancer in women infected with human papillomavirus (HPV). However, there is still no consensus on the extent to which the data are susceptible to bias (for example, differences in the number of sexual partners or the use of barrier contraceptive methods).

According to the results of a meta-analysis 54 international studies, in women taking combined oral contraceptives, the relative risk of developing breast cancer is slightly increased (RR = 1.24). Over the course of 10 years after stopping CHC use, the additional risk gradually disappears. Since breast cancer is rare in women under 40 years of age, the additional number of cases of breast cancer diagnosed in patients taking chronic and recent CHC users relative to the total risk of developing breast cancer is small. These studies did not provide evidence of causality. The reasons for the noted increase in risk may be due to more early diagnosis breast cancer in patients taking COCs, the biological effects of COC drugs, or a combination of both factors. Malignant neoplasms of the breast in patients who had ever taken COCs were, as a rule, less advanced clinically than in women who had never taken COCs.

In women taking COC drugs, in rare cases, benign and, even more rarely, malignant tumors liver. In some cases, such tumors led to life-threatening intra-abdominal bleeding.

In women taking combined oral contraceptives, if severe pain in the upper abdomen, liver enlargement, or signs of intra-abdominal bleeding, within differential diagnosis a liver tumor should be suspected.

Other conditions

In women with hypertriglyceridemia or a family history of hypertriglyceridemia, the possible increased risk of pancreatitis should be considered when taking COCs.

Although many women taking COCs have experienced slight increase blood pressure, clinical significant increase rarely noted. There was no relationship between COC use and clinically manifested hypertension. However, in the case of ongoing clinically significant arterial hypertension while taking COCs, it is advisable to stop taking the COC and begin treatment for arterial hypertension. If necessary, taking COCs can be resumed if normal blood pressure values have been achieved with antihypertensive therapy.

The following conditions have been reported to develop or worsen during pregnancy and COC use (however, the relationship with COC use has not been convincingly proven): jaundice and/or itching associated with cholestasis; formation of gallstones; porphyria; systemic lupus erythematosus; hemolytic-uremic syndrome; chorea; herpes during pregnancy; hearing loss due to otosclerosis, angioedema(including hereditary).

Acute or chronic liver dysfunction may require discontinuation of combined oral contraceptives until liver function tests return to normal. Recurrence of cholestatic jaundice, which first occurred during pregnancy or during previous use of sex steroid hormones, requires discontinuation of COC use.

Although combined oral contraceptives may affect peripheral insulin resistance and glucose tolerance, evidence supports the need to change the treatment regimen in patients diabetes mellitus There are no patients taking CHCs. However, women with diabetes taking CHCs should be under close medical supervision.

CHC use has been associated with an increased likelihood of developing nonspecific ulcerative colitis and Crohn's disease.

Chloasma can sometimes develop (especially in women with a history of chloasma during pregnancy). Patients prone to chloasma should avoid exposure to sun rays or ultraviolet radiation while taking CHCs.

When choosing your contraceptive method(s), you should take all of the information above into account.

Medical examination/consultation

Before starting or re-prescribing Novinet, a thorough medical history (including family history) should be taken and pregnancy should be excluded. Blood pressure should be measured, a physical examination should be performed, guided by information on contraindications (see section "Contraindications") and special instructions and precautions (see section "Precautions"). It is important to draw a woman’s attention to the risk of venous and arterial thrombosis, including the risk from the use of Novinet in comparison with other CHCs, to the symptoms of VTE and ATE, as well as to established risk factors and actions taken in case of suspected thrombosis.

It is important that the woman read the patient information leaflet carefully and follow the recommendations contained therein. The frequency and type of inspections should be based on practical recommendations with their adaptation individually for each woman.

The woman should be warned that hormonal contraceptives do not protect against HIV infections(AIDS) and other sexually transmitted diseases.

Decreased contraceptive effectiveness

The effectiveness of CHCs may be reduced if pills are missed (see section “Dosage and Administration”), gastrointestinal disorders (see section “Dosage and Administration”), or with concomitant use of other drugs (see section “Dosage and Administration”) Interaction with other drugs").

Due to the risk of reducing the concentration of the drug Novinet in plasma, as well as reducing its clinical effects, it should be avoided in combination with herbal preparations containing St. John's wort (Hypericum perforatum) (see section “Interaction with other drugs”).

Menstrual cycle control

While taking any CHCs, irregular bleeding may occur (“spotting” or “breakthrough” bleeding), especially during the first months of use. Therefore, assessing any irregular bleeding is only meaningful after an adaptation period of approximately three cycles.

If irregular bleeding recurs or develops after previous regular cycles, you should pay attention to non-hormonal causes of these conditions and exclude malignant neoplasms or pregnancy. A diagnostic curettage may be performed.

Some women may not develop withdrawal bleeding during a break from oral contraceptives. If CHCs are taken as directed in the Dosage and Administration section, it is unlikely that the woman will become pregnant. However, if before the first absence of withdrawal bleeding, CHCs were not taken in accordance with the instructions, or there are no two withdrawal bleedings in a row, then pregnancy should be excluded before continuing to take the CHC.

Increased ALT activity

In clinical trials in patients treated with medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin for the treatment of hepatitis C virus infections, ALT elevations greater than 5 times the upper limit of normal and occurring more frequently in women using ethinyl estradiol-containing drugs, such as combined hormonal contraceptives (CHCs) (see sections “Contraindications” and “Interaction with other drugs”).

Novinet contains lactose. This drug should not be taken by patients with such rare hereditary diseases, such as galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome.

Impact on the ability to drive vehicles and operate machinery

Do not use after the expiration date stated on the package.

Vacation conditions

On prescription.

Manufacturer information

JSC "Gedeon Richter"

1103 Budapest, st. Dymroyi, 19-21, Hungary.

Company representing the interests of the manufacturer and applicant

Oral contraceptives with microdosed hormonal components, the so-called mini-pills, are a new generation of contraceptives that do not cause serious physiological disturbances in the body of women. One of these drugs, Novinet, has many positive reviews. Active substances its composition not only has a contraceptive effect, but also eliminates many negative symptoms associated with hormonal cycle disorders.

What is Novinet

This is a medicinal hormone-containing drug, produced in the form of tablets. It is the means of choice when a woman intends to use OC protection against unwanted pregnancy. A gynecologist has the right to prescribe Novinet birth control pills after deciphering the results of tests for sex hormones and a medical examination. Independently choosing and taking a remedy at random can lead to serious health complications.

How Novinet works

Synthetic analogues of the drug’s hormones prevent the release of their own gonadotropins and prevent ovulation. Under the influence of these substances, cervical mucus becomes thicker, which creates an additional contraceptive effect. The mild effect on the body allows Novinet to be used for fibroids, endometriosis and other pathologies. While a woman is taking Novinet, her periods are anovulatory, since the eggs do not mature.

Pregnancy while taking Novinet occurs in extremely rare cases and is usually associated with improper use of the medication. A delay in menstruation when taking Novinet occurs either when hormonal imbalances, or in case of an unauthorized change in the intake regimen. There is no need to worry about possible infertility while using the drug. Pregnancy after Novinet for most women usually occurs in the first months, as soon as taking the drug is stopped.

How to switch to OK Novinet from other birth control pills correctly

if the course of another OC is 21 tablets, start taking Novinet after a 7-day break;
if OK provides 28 tablets, you can switch to Novinet from the next day.

Release forms and composition

Novinet is available in tablets, the composition of which includes:

150 mcg of desogestrel;
20 mcg ethinyl estradiol.

The first component has a progestogenic effect, the second has an estrogenic effect. The minimum content of components negates the occurrence of unwanted reactions that are typical for potent drugs: headaches, weakness, swelling, worsening mood.

All Novinet tablets have the same dosage - it is a monophasic drug. Its convenience is that in case of confusion there are no consequences or risks. Numbering is present only to record the duration of admission. The packaging of the product contains 1 or 3 blisters of 21 tablets.

Indications for use

The main indication for use of the drug is protection against unwanted pregnancy. Taking into account the individual hormonal background of a woman, the doctor may prescribe Novinet for endometriosis, fibroids, polycystic disease and other estrogen-dependent pathologies. In addition, this remedy is used to correct disorders such as: acne, menstrual irregularities, severe PMS, painful periods.

Novinet is prescribed mainly to young people under 35 years of age, girls and women.

Contraindications for use

Hormones in the drug can cause health problems in women with heart problems and others. internal organs, vascular system, blood clotting. Contraindications to the use of Novinet tablets:

risk of vascular thrombosis;
neurological symptoms, including migraine;
thromboembolism;
diabetes;
pancreatitis;
cholecystitis, cholelithiasis, liver failure;
dysfunction of hematopoiesis;
oncological neoplasms;
age over 35 years;
vaginal and internal bleeding;
pregnancy and breastfeeding;
allergy to the components contained.

Directions for use and doses

Novinet packages include instructions for use. According to her, you need to start taking pills from the first day of your cycle. You need to drink 1 tablet per day. Preferably at the same time of day. After drinking 21 pieces, you need to take a 7-day break and start a new course. During the pause, spotting similar to menstruation should appear.

Side effects

If Novinet is prescribed and taken correctly, there are no side effects in most women it is not observed. However, not everyone follows the rules prescribed by the instructions. Existing hidden diseases can also have an impact. Possible side effects of the drug:

thick mucous discharge from the vagina;
dizziness;
nausea;
fluid retention in the body;
depressed mood;
pain in the stomach, abdominal cavity.

In some cases, an increase negative symptoms indicates that the drug is not suitable for a woman.

Overdose

vomit;
diarrhea;
severe headache;
vaginal bleeding.

If the tablets are taken in increased doses regularly, the following reactions are possible:

severe rashes on the skin;
nausea;
visual impairment;
swelling;
physical weakness;
increased blood pressure;
mood swings.

If any of the above signs appear, you should urgently contact a specialist for advice.

What to do if you miss a dose of Novinet

If the absence is no more than 12 hours, nothing needs to be changed: on the day following the day of the violation, the pills are taken as usual. The contraceptive effect is completely preserved. If the gap is more than half a day, the mechanism is as follows:

In the period from days 1 to 14: after the break, you need to take 2 tablets at once, and take the next ones as usual.
In the period from 15 to 21 days: the next dose is not increased, but the 7-day break is canceled, immediately starting the next course.

In cases where 2 or more tablets are missed, take them again from the first number; the current package is not used. To be on the safe side, they are protected for 1 week using barrier methods.

Use in old age

With the onset of 35 years, harbingers of menopause appear, hormonal levels change, and estrogen production gradually decreases. Novinet is not prescribed to women over 40 years of age, as such drugs can cause unwanted deviations in work endocrine system, cause cardiac and vascular disorders, accelerate subsequent aging. For middle and older age, the gynecologist prescribes other drugs that are more appropriate hormonal status I'll give.

Pharmacological action

Indications for use

Directions for use and doses

Side effect

Contraindications

Use of Novinet during pregnancy and breastfeeding

Use for liver and kidney dysfunctions

special instructions

Overdose

Drug interactions

Description of the drug

Contraindications

Side effects

special instructions

Storage conditions

Compound

Description

Pharmacotherapeutic group

Indications for use

Contraindications

Directions for use and doses

Side effect

Overdose

Interaction with other drugs

Precautionary measures

Vacation conditions

What is Novinet

How Novinet works

How to switch to OK Novinet from other birth control pills correctly

Release forms and composition

Indications for use

Contraindications for use

Directions for use and doses

Side effects

Overdose

What to do if you miss a dose of Novinet

Use in old age

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