Novinet: clear instructions. Instructions for use of Novinet

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

1 tablet contains active substance: 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 day after the tablets in the package run out, you should start new packaging 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 bloody discharge 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 of cardio-vascular system: arterial hypertension; rarely - arterial and venous thromboembolism (including myocardial infarction, stroke, deep vein thrombosis lower limbs, 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 discharge from the vagina, amenorrhea after discontinuation of the drug, changes in the state of vaginal mucus, development inflammatory processes vagina, candidiasis, tension, pain, breast enlargement, galactorrhea.
From the outside digestive system: nausea, vomiting, Crohn's disease, ulcerative colitis, the 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 arterial hypertension or medium degree severity 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;
cholelithiasis 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, major surgery, surgery on the lower extremities, severe trauma, varicose veins veins and superficial thrombophlebitis, postpartum period, presence of severe depression (including a history), changes biochemical parameters(activated protein C resistance, hyperhomocysteinemia, antithrombin III deficiency, protein C or S deficiency, antiphospholipid antibodies, including antibodies to cardiolipin, including lupus anticoagulant), diabetes mellitus, uncomplicated 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 serious illnesses liver (including history).
Novinet should be prescribed with caution and only after a thorough assessment of the benefits and risks of use. renal failure(including in medical history).

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 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 that occurred during the use of a contraceptive method in 100 women over 1 year) with correct use 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 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.

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;
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;
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). Proven increased risk venous thromboembolic diseases, 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 vessels or retinal vessels.

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;
at arterial hypertension;
for diseases of the heart valves complicated by hemodynamic disorders;
with atrial fibrillation;
at diabetes mellitus complicated by vascular lesions;
with prolonged immobilization, after a major surgical intervention, 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 this state 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 appearing 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 calf muscle, acute stomach.

Tumor diseases

Some studies have reported an increased incidence of cervical cancer in women who took hormonal hormones for a long time. contraception, but research results are contradictory. 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 was a relative increase in the risk of breast cancer among women taking oral hormonal contraceptives, but the higher incidence of breast cancer may have been associated with more regular use. medical examination. Breast cancer is rare among women under 40, whether they take 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 tumor liver 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 if following cases: missed pills, vomiting and diarrhea, simultaneous use of other drugs that reduce 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 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, St. John's wort preparations reduce the effectiveness of liver enzymes. 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 co-administration is necessary, 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.

There are more and more birth control pills, and making a choice from such a variety is becoming increasingly difficult. Every woman should understand that self-prescribing hormonal contraceptives is dangerous, as is being treated with unknown pills.

The best solution would be to contact a gynecologist who can select the appropriate remedy. It could be Novinet.

How does this work? medicinal product? What contraindications does it have? Are there many side reactions? - Let's find out in this article.

pharmachologic effect

Birth control pills Novinet provide contraceptive effect by suppressing the secretion of luteotropin and follitropin by the pituitary gland.

The mucous secretion of the vagina becomes more viscous, making it difficult for sperm to overcome it.

The advantage of the drug Novinet is that it contains a minimum of ethinyl estradiol.

This allows you to avoid the development of many adverse reactions in the form of:

Pain in the mammary glands;
Weight gain, etc.

Photos of adverse reactions:

Weight gain

Desogestrel reduces the amount bleeding, has a beneficial effect on the condition of the skin layer, normalizes the menstrual cycle.

It also prevents genital diseases and oncology.

Desogestrel is excreted in the urine, and ethinyl estradiol is excreted in urine and feces.

Composition and release form

The drug Novinet is produced in tablets with a concentration of ethinyl estradiol 20 mcg and desogestrel - 150 mcg.

One package contains 21 tablets

Used as auxiliary components:

A-tocopherol;
Magnesium stearate;
Povidone;
Colloidal silicon dioxide;
Potato starch;
Stearic acid;
Lactose monohydrate;
Hypromellose;
Macrogol-6000;
Propylene glycol.

Indications for use

The drug Novinet is intended to protect against unwanted pregnancy.

Birth control pills are also used for endometriosis of the uterus.

They are effective for uterine fibroids if they are small in size. Otherwise, the use of hormones is prohibited.

For ovarian cysts, the drug Novinet is also used.

Photo gallery of testimony:

Ovarian cyst Pregnancy

Contraindications

The drug Novinet has some contraindications for use:

Intolerance to the components of the drug;
Venous/arterial thrombosis;
Venous/arterial thromboembolism;
Focal migraine;
Diabetes mellitus with vascular complications;
Pancreatitis;
Severe liver diseases;
Liver oncology;
Tumors of different locations, depending on hormones;
Vaginal bleeding of unknown origin;
Otosclerosis;
Smoking;
Women over 35 years of age;
Carrying a child;
Lactation period.

Side effects

The active ingredient in Novinet birth control pills can cause adverse reactions as:

Bloody discharge between periods;
Amenorrhea after finishing treatment;
Thrush;
Changes in vaginal secretion;
Inflammation of the inner vaginal wall;
Discomfortable sensations in the mammary glands;
Nausea/vomiting;
Cholestatic jaundice;
Itching;
Erythema nodosum/exudative form;
Chloasma;
Skin rashes;
Headaches;
Mood variability;
Migraine;
Depressive state;
Edema;
Increased sensitivity to carbohydrates;
Weight gain;
Hypertension;
Porphyria.

Drug interactions

It is not advisable to simultaneously take Novinet birth control pills with medications that are liver enzyme inducers. They reduce the effectiveness of the contraceptive.

Simultaneous use of the drug Novinet with antibiotics requires the use of barrier contraception

There is poor compatibility between Novinet birth control pills and:

Tricyclic antidepressants;
Anticoagulants;
Beta blockers;
Bromocriptine;
Hepatoxic agents.

Alcohol compatibility

It is not advisable to combine Novinet birth control pills with alcohol, as this reduces contraceptive effectiveness.

Video on the topic:

Dosage and overdose

If you do not use the drug Novinet correctly, overdose symptoms may develop in the form of nausea, vomiting and bleeding.

Instructions for use

The method of using Novinet is no different from other oral contraceptive pills.

No.	Category	How to take the medicine?
1	General	The tablets are taken orally. Every day one piece at the same hours. It is advisable to start the course on the first day of your period. After 21 tablets, a break of 7 days is taken, and from 8 a new package is started.
2	Abortion/miscarriage	Should be taken immediately.
3	Switching from another contraceptive	Start on the day you intend to take or use a contraceptive.
4	To delay menstruation	Drink two packs without interruption.
5	If you missed a pill	Consume within 12 hours.
6	Is it possible during menopause?	If menopause has already occurred, there is no point in this. But, when menopause is just approaching, birth control pills will help relieve symptoms, although the dose of estrogen is minimal. High concentrations of estrogen increase the risk of uterine cancer.

Shelf life and storage of the drug

It must be stored in the temperature conditions of a living room. The period of use cannot exceed 3 years.

special instructions

For what age is the drug suitable? Basically, this is a period from 20 to 35 years, but it is possible to take it even older, in this matter it all depends on the individual characteristics of the body.

Therefore, when choosing a contraceptive, consultation with a gynecologist is necessary. But it is also important to note that the drug Novinet can be used by both women who have given birth and those who have not yet given birth.

If a woman is breastfeeding, birth control pills can only be taken 6 months after giving birth

If vomiting or diarrhea occurs after taking a contraceptive or a pill is missed, you need to resort to barrier contraceptives or other non-hormonal means of protection.

The description states that the drug Novinet does not protect against sexually transmitted infections.

Price

In pharmacies, Novinet birth control pills cost about 360 rubles for 21 pieces.

Conditions for dispensing from pharmacies

The drug Novinet from the manufacturer Gedeon Richter is sold on a prescription basis.

Useful video:

Analogues substitutes

Birth control pills Novinet have enough analogues.

Novinet is a combined hormonal contraceptive pill.

Taking pills has a systemic effect on reproductive system women, inhibits ovulation, prevents the penetration of sperm through the cervical mucus. The tablets have the ability to suppress the pituitary secretion of luteotropin and follitropin, thereby making vaginal secretions more viscous.

The active components of the drug are synthetic hormones - ethinyl estradiol and progestogen, which suppress ovulation.

Clinical and pharmacological group

Monophasic oral contraceptive.

Conditions for dispensing from pharmacies

Dispensed with a doctor's prescription.

Prices

How much does Novinet cost in pharmacies? average price is at the level of 500 rubles.

Release form and composition

The drug Novinet is available in dosage form enteric film-coated tablets for oral (inside) use. They are light yellow in color, round in shape and have a biconvex surface.

The basis of the drug is 20 mcg ethinyl estradiol and 150 mcg desogestrel.
The auxiliary components of Novinet include: E 104 (quinoline yellow dye), α-tocopherol, magnesium stearate, povidone, colloidal silicon dioxide, potato starch, stearic acid, lactose monohydrate.
Composition p/o: hypromellose, macrogol 6000, propylene glycol.

The tablets are packaged in blister packs of 21 pieces. The cardboard pack contains 1 or 3 blisters with the appropriate number of tablets, as well as instructions for use of the drug.

Pharmacological effect

Novinet is a hormonal contraceptive that contains two hormones: estrogen and gestagen. The contraceptive effect of the drug is based on the inhibition of gonadotropins and suppression of the ovulation process. Due to the increased viscosity of the cervical fluid, the movement of sperm through cervical canal slows down, and the altered state of the endometrium prevents the implantation of a fertilized egg.

Desogestrel, which is part of Novinet tablets, has a pronounced antiestrogenic and gestagenic effect, weak anabolic and androgenic activity. Ethinyl estradiol is a synthetic analogue of follicular estradiol. Reviews from doctors about Novinet are mostly positive, since the drug contains a small amount of hormones. In this regard, Novinet is widely used in gynecological practice.

During the period of taking Novinet, menstrual blood loss is greatly reduced, and the menstrual cycle returns to normal. In addition, according to doctors, Novinet has a beneficial effect on the skin, especially if it is prone to acne vulgaris.

Indications for use

Novinet tablets are prescribed to prevent unwanted pregnancy (contraception).

Contraindications

Taking Novinet tablets is contraindicated in a significant number of different pathological and physiological conditions of the body, which include:

Venous thromboembolism (presence of anamnestic data);
Dyslipidemia;
(with angiopathy);
Jaundice during therapy with glucocorticosteroids;
Gilbert, Dubin-Johnson, Rotor syndromes;
Vaginal bleeding of unknown origin;
Otosclerosis or its progression, severe itching during a previous pregnancy or during glucocorticosteroid therapy;
Smoking over 35 years of age (more than 15 cigarettes per day);
Pregnancy (confirmed or suspected) and lactation period;
Multiple and/or severe factors that increase the risk of developing venous or arterial thrombosis, including severe or moderate arterial hypertension with blood pressure from 160/100 mmHg;
Precursors of thrombosis, including transient ischemic attack, angina (currently or in the presence of anamnestic data);
Thrombosis/thromboembolism (venous or arterial), including myocardial infarction, deep vein thrombosis of the leg, stroke, pulmonary embolism (currently or if there is anamnestic data);
Pancreatitis occurring with severe hypertriglyceridemia (including in the presence of anamnestic data);
Severe liver diseases, cholestatic jaundice (including that developed during pregnancy), hepatitis (including in the presence of anamnestic data; the drug can be taken 3 months after normalization of laboratory and functional parameters);
Gallstone disease (currently or if there is anamnestic data);
Malignant hormone-dependent neoplasms of the mammary glands and genital organs (confirmed or suspected);
Liver tumors (including in the presence of anamnestic data);
Migraine occurring with focal neurological symptoms (including in the presence of anamnestic data);
Hypersensitivity to the components of the drug.

Novinet is prescribed with caution in the following conditions and/or diseases that increase the likelihood of arterial or venous thrombosis/thromboembolism: if indicated in the family history);

Severe injuries;
Sickle cell anemia;
Varicose veins and superficial thrombophlebitis;
Severe depression (including in the presence of anamnestic data);
Ulcerative colitis;
Prolonged immobilization;
Complicated family history;
Obesity (with a body mass index of more than 30 kg/m2);
Dyslipoproteinemia;
Extensive surgical interventions, surgical interventions on the lower extremities;
Arterial hypertension;
Migraine;
Epilepsy;
Valvular heart defects;
Atrial fibrillation;
Hypertriglyceridemia (including
Systemic lupus erythematosus;
Diabetes mellitus not complicated by vascular disorders;
Crohn's disease;
Liver diseases (acute and chronic);
Smoking;
Changes in biochemical parameters (antiphospholipid antibodies, including antibodies to cardiolipin, hyperhomocysteinemia, activated protein C resistance, antithrombin III deficiency, protein C or S deficiency, lupus anticoagulant);
Postpartum period;
Age from 35 years.

Dosage and method of administration

The instructions for use indicate that Novinet is prescribed orally.

Taking pills starts on the 1st day of the menstrual cycle. Prescribe 1 tablet/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 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.

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.

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-pills”):

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:

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.

Vomiting/diarrhea:

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 1 more tablet. additionally. After this, you should continue taking the tablets as usual. If symptoms continue 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.

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; contraceptive reliability 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 need to 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.

Side effects

Side effects of Novinet appear:

Nervous system: headache, mood instability, depression, migraine;
Organ of vision: in patients with contact lenses– increased sensitivity of the cornea;
Dermatological reactions: rash, erythema nodosum, chloasma, exudative erythema;
Metabolism: increased body weight, fluid retention in the body, decreased tolerance to carbohydrates;
Digestive system: nausea, vomiting, ulcerative colitis, Crohn's disease, exacerbation or development of jaundice and/or itching caused by cholestasis, cholelithiasis;
Reproductive system: amenorrhea during drug withdrawal, vaginal spotting or acyclic bleeding, changes in the state of vaginal mucus, candidiasis, development of vaginal inflammation, galactorrhea, pain, tension, enlarged mammary glands;
Other: development of allergic reactions.

The use of the drug may cause side effects that require immediate discontinuation of the drug:

Sense organs: hearing loss caused by otosclerosis;
Cardiovascular system: arterial hypertension; rarely - venous and arterial thromboembolism (including pulmonary embolism, stroke, myocardial infarction, deep vein thrombosis of the legs); very rarely - venous or arterial thromboembolism of the renal, hepatic, mesenteric, retinal veins and arteries;
Other: porphyria, hemolytic-uremic syndrome; rarely - exacerbation of reactive systemic lupus erythematosus; very rarely - transient Sydenham chorea.

Overdose

In case of overdose, symptoms may occur the following symptoms: nausea, vomiting, in girls – bleeding from the vagina.

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.

The woman's health condition must be carefully monitored. If a condition/disease appears or worsens while taking the drug, you must stop taking the drug and switch to another, non-hormonal method of contraception.

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.

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, and sickle cell anemia increase the risk of developing venous thromboembolic 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.

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.

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.

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.

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

With diarrhea or intestinal disorders, vomiting, the contraceptive effect may be reduced. While continuing to take 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.

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

Drug interactions

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

Medicines that induce liver enzymes, such as hydantoin, barbiturates, primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, felbamate, griseofulvin, 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.

Novinet is a monophasic drug, that is, all tablets in the blister contain the same dose of hormones. Each Novinet tablet contains 20 mcg (0.02 mg) ethinyl estradiol and 150 mg desogestrel.

One Novinet cardboard box contains one or three blisters of tablets. One blister contains 21 tablets (for 3 weeks of use).

ATTENTION: The drug has contraindications. Do not start using this drug without preliminary consultation with a doctor.

Advantages of Novinet

Novinet is a birth control pill. latest generation. The hormone content in Novinet tablets is so low that taking the drug causes virtually no side effects.

Regular use of Novinet for at least 3 months reduces the symptoms of premenstrual syndrome (PMS), eliminates chest pain shortly before menstruation,. Novinet can be recommended for girls who have an irregular menstrual cycle.

Long-term use of Novinet reduces the risk of hormonal disorders (mastopathy), oncological diseases(ovarian cancer, uterine cancer).

Admission rules

The first tablet can be taken on day 1 of the menstrual cycle (that is, on the first day of menstruation). In this case, the tablets begin to act immediately and you do not have to use additional funds contraception.
If you start taking Novinet from the 2-5th day of your period, then contraceptive effect will occur only after 7 days of daily use. Condoms should be used for the first 7 days.
It is recommended to take Novinet tablets at the same time every day (no matter what time of day). This way the effect of the tablets will be the highest.
All Novinet tablets contain the same dose of hormones, so if you mix up the tablets, nothing bad will happen. The main thing is to drink one tablet once a day.
After you take the last 21 tablets in the blister, take a week break. During these seven days off the pills, you may experience menstrual-like bleeding (periods).
During the 7-day break from taking Novinet, there is no need to take additional protection. This only applies if you start taking the pills again after the week-long break.
Regardless of whether you had menstruation during the break, you should take the first tablet from the new blister on day 8.

How to switch to Novinet from another OK?

You can switch to Novinet from another oral contraceptive. If the package of previous oral contraceptives contained 21 tablets, then take the first Novinet tablet on the 8th day after a week's break.

If one blister of previous oral contraceptives contained 28 tablets, then start taking Novinet the next day after finishing all the tablets in the previous blister.

How to switch to Novinet from a hormonal patch (Evra) or a vaginal ring?

You can switch to Novinet from other hormonal contraceptives. To do this, take the first Novinet tablet on the day you removed it. vaginal ring or, or on the day when you were scheduled to have a new ring inserted, or a new patch to be applied.

How to switch to Novinet from an intrauterine device (IUD)?

You can take your first Novinet tablet on the day you remove intrauterine device. During the next week after starting Novinet, it is recommended to use additional methods of contraception to avoid pregnancy.

How to start taking Novinet after an abortion?

If you have an abortion before 12 weeks of pregnancy, the first Novinet tablet should be taken on the day of the abortion. If you plan to start taking Novinet later (not on the day of your abortion) and you have already had unprotected sex, then you should only start taking the pills if you are sure that you are not pregnant again.

In case of abortion at a period of more than 12 weeks, the first Novinet tablet can be taken 21-28 days after the abortion. If you start taking Novinet later than this period, you will need to use additional contraception for another 7 days. If you have unprotected sex in the days after an abortion, you can start taking Novinet only when you are sure that you are not pregnant.

How to start taking Novinet after childbirth?

After giving birth, you can start taking Novinet in the first month (if you are not breastfeeding), or when you stop breastfeeding. If you are not breastfeeding, then the first Novinet tablet should be taken 21-28 days after birth. If, after giving birth, before starting to take Novinet, you had unprotected sex, then you are allowed to start taking Novinet when you are sure that pregnancy has not occurred.

What to do if you miss a Novinet tablet?

If the delay in taking Novinet lasted less than 12 hours (and less than 36 hours have passed since taking the previous pill), then the effect of the pills is preserved. Take the missed pill as soon as possible. There is no need for additional protection.

If you are more than 12 hours late, the effectiveness of the pills is reduced. Pay attention to the number of the missed pill - it will tell you what to do next:

1 to 7 tablets: Take the missed tablet as soon as possible, even if you have to take 2 tablets at the same time. In the next 7 days, it is recommended to use additional protection methods (condoms).
8 to 14 tablets: Take the missed tablet as soon as possible, even if you need to take two tablets at the same time. You do not have to use additional contraception if you have taken all your pills on time for the previous 7 days. Otherwise, you should take additional precautions for another week after taking Novinet to avoid pregnancy.
15 to 21 tablets: Take the missed Novinet tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets as usual, but after finishing one blister, immediately start taking the next one. This way you skip the week between packs. If you took all Novinet tablets on time during the previous 7 days before the missed period, then there is no need for additional protection. Otherwise, it is recommended to use additional contraception for a week after the missed date.

What should I do if I missed several Novinet tablets?

If you miss 2 Novinet tablets in a row, pay attention to which tablets you missed. If these are tablets of the first or second week of taking (from 1 to 14), then take 2 tablets as soon as you remember about the omission and 2 more tablets the next day. Then take one tablet per day as usual until the pack runs out. Use additional contraception for another 7 days after resuming taking the pills.

If you missed two tablets in a row in the 3rd week of taking it (from 15 to 21), then there are two options: 1. continue taking Novinet one tablet per day until the package runs out and then, without taking a 7-day break, start new packaging. At the same time, use additional contraception for another 7 days after the missed period.
2. throw away the current (unfinished) package and start taking a new package with the first tablet (one tablet per day, as usual). In this case, you need to use additional contraception for another 7 days after the missed date.

If you miss 3 Novinet tablets in a row, throw away the current pack of tablets and start a new pack with the first tablet. Use additional contraception for another 7 days. You will have an increased risk of pregnancy, so if your period does not come during the next break, contact your gynecologist.

If you are not sure what to do in your situation, use additional contraception until you talk to your doctor. In any case, if you miss two or more tablets, be sure to use additional protection (using condoms) for at least 7 days.

1-2 days after missing the pills, you may experience spotting or breakthrough bleeding, similar to your period. This is not dangerous and is associated with Novinet passes. Continue taking the pills according to the instructions and the discharge will stop.

What reduces the contraceptive effect of Novinet?

The contraceptive effect of Novinet can be reduced by vomiting, diarrhea, taking large doses of alcohol, or taking certain medications. Read more about this here:

How to delay menstruation with Novinet?

If you need to postpone your period, then after finishing one blister of Novinet, start a new blister the next day without taking a week's break. Menstruation will be delayed by 2-4 weeks. BUT: bloody spotting may appear in the middle of the next package. It's not scary.

Please note: you can postpone your periods only if you have taken Novinet for at least one month before the postponed menstruation.

What to do if brown discharge appears while taking Novinet?

Spotting and spotting when taking Novinet is sometimes normal. For example, such discharge does not cause concern if you have just started taking pills (on the first or second package), in the middle of the package and in the first few days after starting the next pack of Novinet.

If before the appearance brown discharge If you were late or missed taking pills, the contraceptive effect of Novinet may be reduced, which means you should use condoms in case of sexual intercourse.

What to do if you don’t have your period while taking Novinet?

If in the previous month you missed taking Novinet and had unprotected sex, then stop taking the pills. Do not start taking Novinet until you are sure that you are not pregnant.

If in the previous month you took the pills according to the rules, did not skip, or were not sexually active, then start taking a new blister on the 8th day, even if your period did not come. If there is no menstruation during the next week's break, it is recommended to visit a gynecologist.

What should I do if I become pregnant while taking Novinet?

It is not dangerous for the unborn child. If you find yourself pregnant, stop taking the pills immediately and consult your doctor. As a rule, taking Novinet does not affect the development of the fetus, so there is no need to have an abortion. If you plan to continue your pregnancy, start taking it as soon as possible.

Taking Novinet before surgery

If you are having surgery, you should stop taking Novinet at least 4 weeks before. surgical intervention. If the operation is urgent, tell your doctor that you are taking birth control pills.

Novinet thickens the blood, promoting the formation of blood clots (thrombi). If your doctor knows you are taking birth control pills, he will prescribe you blood thinners.

You can resume taking Novinet 14 days after you are able to walk independently after surgery.

How often should you visit a gynecologist while taking Novinet?

Even if nothing bothers you, visit your gynecologist at least once a year.

Monophasic hormonal contraceptive drug for oral administration.
Drug: NOVINET®

Active substance of the drug: desogestrel, ethinylestradiol
ATX coding: G03AA09
KFG: Monophasic oral contraceptive
Registration number: P No. 014994/01-2003
Registration date: 05/23/03
Owner reg. cert.: GEDEON RICHTER Ltd. (Hungary)

The film-coated tablets are pale yellow, biconvex, disc-shaped, marked “P9” on one side and “RG” on the other side.
1 tab.
ethinylestradiol
20 mcg
desogestrel
150 mcg

Excipients: quinoline yellow (E104), -tocopherol, magnesium stearate, anhydrous colloidal silicon dioxide, stearic acid, povidone, potato starch, lactose monohydrate.

Shell composition: propylene glycol, macrogol 6000, hypromellose.

21 pcs. - blisters (1) - cardboard boxes.
21 pcs. - blisters (3) - cardboard boxes.

The description of the drug is based on the officially approved instructions for use.

Pharmacological action Novinet

A monophasic hormonal contraceptive for oral administration containing a combination of estrogen (ethinyl estradiol) and a progestin (desogestrel). Inhibits pituitary secretion gonadotropic hormones. The contraceptive effect is due to the effect on the hypothalamic-pituitary-ovarian system.

Desogestrel is a synthetic gestagen that, when taken orally, inhibits the synthesis of LH and FSH in the pituitary gland and, by preventing follicle maturation, effectively blocks ovulation. It has an antiestrogenic, weak androgenic (anabolic) effect, and does not have an estrogenic effect.

Ethinyl estradiol is a synthetic analogue of the follicular hormone estradiol, involved together with the hormone corpus luteum in the formation of the menstrual cycle. Prevents the maturation of an egg capable of fertilization.

The contraceptive effect is due, on the one hand, to a decrease in the susceptibility of the endometrium to the blastocyte, and on the other hand, to an increase in the viscosity of mucus in the cervix, which prevents the advancement of sperm.

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. Regular use of the drug normalizes the menstrual cycle and helps prevent the development of a number of gynecological diseases, including cancer.

It has a beneficial effect on the skin, significantly improves the condition of the skin with acne vulgaris.

Pharmacokinetics of the drug.

Desogestrel

Suction

Desogestrel is quickly and almost completely absorbed from the gastrointestinal tract and is immediately metabolized in the liver and intestinal wall into 3-keto-desogestrel, which is a biologically active metabolite of desogestrel.

Cmax is reached after 1.5 hours and is 2 ng/ml. Bioavailability - 62-81%.

Distribution

3-keto-desogestrel binds to plasma proteins, mainly albumin and sex hormone binding globulin (SHBG).

Vd is 5 l/kg. Css is established by the second half of the menstrual cycle, when the level of 3-keto-desogestrel increases 2-3 times.

Metabolism

The products of further metabolism of ketodesogestrel are pharmacologically inactive; some of them are converted by conjugation into polar metabolites, primarily sulfates and glucuronides.

Removal

T1/2 is 38 hours. Metabolites are excreted in urine and feces (in a ratio of 6:4).

Ethinyl estradiol

Suction

Ethinyl estradiol is quickly and completely absorbed from the gastrointestinal tract. Cmax is reached 1-2 hours after taking the drug and is 80 pg/ml. The bioavailability of the drug due to presystemic conjugation and the “first pass” effect through the liver is about 60%.

Distribution

Ethinyl estradiol is almost completely bound to plasma proteins, mainly albumin.

Vd is 5 l/kg. Css is established by the 3-4th day of administration, while the level of ethinyl estradiol in the serum is 30-40% higher than after a single dose of the drug.

Metabolism

Presystemic conjugation of ethinyl estradiol is significant. Ethinyl estradiol and its metabolites in the form of sulfates and glucuronides are excreted into bile and enter the enterohepatic circulation. Clearance from blood plasma is about 5 ml/min/kg body weight.

Removal

T1/2 of ethinyl estradiol averages about 26 hours. About 40% is excreted in the urine and about 60% in feces.

Indications for use:

Oral contraception.

Dosage and method of administration of the drug.

The tablets are taken orally, at the same time of day, without chewing and with a small amount of liquid.

The drug is prescribed 1 tablet/day (if possible at the same time of day), starting from the 1st day of the menstrual cycle for 21 days. This is followed by a 7-day break, during which menstrual-like bleeding occurs. On the eighth day, resume taking tablets from the next package (even if the bleeding has not stopped yet). If the rules of administration are followed, the contraceptive effect is maintained during the 7-day break.

If the first tablet is taken on day 1 of the menstrual cycle, then additional methods of contraception are not required. You can start taking pills from the 2-5th day of menstruation, but in this case, in the first cycle, 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.

After childbirth, non-breastfeeding women can be prescribed the drug after 21 days. In this case, there is no need to use other methods of contraception. If the drug is prescribed later than 21 days after birth, then additional methods of contraception must be used in the first 7 days of administration. If in postpartum period sexual intercourse preceded oral contraception, then taking pills must wait until the first menstruation appears. For women who continue breastfeeding, the use of combined oral contraceptives is not recommended, as taking the drug may reduce milk production.

When switching to Novinet after taking another estrogen-progestogen hormonal contraceptive(calculated for 21 or 28 days of use), the first Novinet tablet should be taken the next day after completing the course of the previous drug. There is no need to use additional methods of contraception.

When switching to Novinet after taking a hormonal contraceptive containing only gestagen, the first Novinet tablet should be taken on the first day of the menstrual cycle; there is no need to use additional methods of contraception. If menstruation does not occur while taking the previous drug, you can start taking Novinet on any day of the cycle, but in this case, additional methods of contraception must be used in the first 7 days of use.

As additional methods of contraception, it is recommended to use a cervical cap with spermicidal gel, a condom, or abstain from sexual intercourse. The use of the calendar method as an additional method of contraception is less reliable.

If it is necessary to delay menstruation, taking the pills should be continued without a 7-day break. In this case, intermenstrual bleeding may appear, but this does not reduce the contraceptive effect of the drug. Regular use of Novinet can be resumed after the usual 7-day break.

If you miss taking the drug, if from the moment last appointment no more than 12 hours have passed, then you need to take the missed tablet and then continue taking it at the usual time. If more than 12 hours have passed since the last pill was taken, then the reliability of contraception in this cycle is not guaranteed and the use of additional methods of contraception is recommended.

If you miss 1 tab. in the first or second week of the cycle you need to 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 1 tab. in the third week of the cycle, in addition to the listed measures, a 7-day break is excluded.

Due to the intake of a smaller dose of estrogen into the body due to missing a pill(s), the likelihood of ovulation and/or spotting increases, so in such cases the use of additional methods of contraception is recommended.

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 1 additional tablet from another package. After this, you should continue taking the tablets as usual. If symptoms continue for more than 12 hours, then it is necessary to use additional methods of contraception in the next 7 days.

Side effects of Novinet:

Severe side effects, which are extremely rare, requiring discontinuation of the drug

From the cardiovascular system: myocardial infarction, stroke, deep vein thrombosis of the lower extremities, pulmonary embolism, increased blood pressure.

From the digestive system: cholestatic jaundice, cholelithiasis.

Other: exacerbation of systemic lupus erythematosus; in some cases - Sydenham's chorea, which disappears after discontinuation of the drug.

Other side effects are more common, but do not require discontinuation of the drug

From the reproductive system: intermenstrual bleeding, amenorrhea after discontinuation of the drug, changes in the nature of vaginal mucus, vaginal candidiasis, changes in the size of uterine fibroids, worsening of endometriosis, tension, pain, enlarged mammary glands, milk secretion, changes in libido.

From the digestive system: nausea, vomiting, gastralgia, hepatocellular adenoma.

Dermatological reactions: erythema nodosum, rash, generalized itching, chloasma (with long-term use).

From the central nervous system: headache, migraine, mood lability, depression, hearing loss.

From the organ of vision: swelling of the eyelids, conjunctivitis, blurred vision, flickering before the eyes, increased sensitivity of the cornea (when wearing contact lenses).

Metabolism: fluid retention in the body, changes in body weight, decreased tolerance to carbohydrates.

From the laboratory parameters: the estrogenic component of Novinet tablets can change some indicators of the function of the liver, kidneys, adrenal glands, thyroid gland, the level of blood coagulation factors and fibrinolysis, lipoproteins and transport proteins.

Contraindications to the drug:

Pregnancy or suspicion of it;

Arterial hypertension is severe or moderate;

Familial forms of hyperlipidemia;

Thromboembolism (including a history) or predisposition to it (myocardial infarction, cerebrovascular diseases (ischemic and hemorrhagic stroke), severe form of atherosclerosis);

IHD, decompensated heart defects, myocarditis;

Diabetic angiopathy (including retinopathy);

Severe liver diseases (including a history), cholestatic jaundice, hepatitis (before normalization of laboratory parameters and in the first 6 months after their normalization), jaundice during pregnancy or while taking corticosteroids, Dubin-Johnson syndrome, Rotor syndrome, cholelithiasis disease, liver tumor, porphyria;

Estrogen-dependent tumors or suspicion of them, breast and endometrial cancer, endometrial hyperplasia, endometriosis, breast fibroadenoma;

Genital bleeding of unknown etiology;

Systemic lupus erythematosus (including history);

Genital herpes, pregnancy herpes;

Severe skin itching;

Otosclerosis (aggravated during a previous pregnancy or while taking corticosteroids);

Hypersensitivity to the components of the drug.

With caution and only after a thorough assessment of the benefits and risks of use, the drug should be prescribed for diseases of the hemostatic system, heart failure (including a history), renal failure (including a history), epilepsy, migraine, and at risk of developing estrogen-dependent tumor, diabetes mellitus, sickle cell anemia (during infections or hypoxic conditions, taking an estrogen-containing drug can provoke thromboembolism), with severe depression (including a history).

Use during pregnancy and lactation.

Novinet is contraindicated for use during pregnancy. Taking Novinet should be stopped 3 months before the planned pregnancy. If pregnancy occurs, the drug should be discontinued.

Epidemiological studies have shown that among children, born by women who took hormonal contraceptives before pregnancy, the incidence of malformations does not increase. In cases of taking the drug for early stages No teratogenic effects were detected during pregnancy.

The use of Novinet is contraindicated during lactation (breastfeeding), because the drug reduces secretion breast milk, changes its composition. Besides, active substances excreted in small quantities in breast milk.

Special instructions for the use of Novinet.

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). A similar study during the period of taking the drug is carried out regularly, every 6 months.

The effectiveness of the drug Novinet is reduced if pills are missed, with vomiting and diarrhea, as well as with simultaneous administration with other drugs.

The effectiveness of Novinet may decrease if intermenstrual bleeding appears after several months of its use. If menstrual-like bleeding does not appear during the break, taking the pills can be continued only after pregnancy has been ruled out.

The risk of arterial or venous thromboembolic diseases increases with age, with smoking, with a family history of thromboembolic diseases, with obesity (body mass index above 30 kg/m2), with dyslipoproteinemia, with arterial hypertension, with heart valve defects, with atrial fibrillation , with diabetes mellitus, with prolonged immobilization.

If depression is associated with impaired tryptophan metabolism, then vitamin B6 can be used to correct it.

In the presence of resistance to activated protein C, hyperchromocysteinemia, deficiency of proteins C, S, deficiency of antithrombin III, the presence of antiphospholipid antibodies (anticardiolipins, lupus anticoagulants), the risk of developing thromboembolic diseases increases. Targeted treatment of the above conditions reduces the risk of blood clots.

Pregnancy poses a greater risk of blood clots than taking hormonal contraceptives.

Taking Novinet should be stopped immediately in the following cases:

New onset of severe headache or worsening of regular migraines;

Acute deterioration of visual acuity;

Suspicion of myocardial infarction or thrombosis;

A sharp increase in blood pressure;

The appearance of jaundice or hepatitis without jaundice, intense generalized itching;

The occurrence of epilepsy or increased frequency of epileptic seizures;

4 weeks before the planned surgical intervention and in case of prolonged immobilization (taking Novinet can be resumed after 2 weeks from the moment of remobilization);

Development of pregnancy.

Impact on the ability to drive vehicles and operate machinery

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

Drug overdose:

Symptoms: metrorrhagia. Taking the drug in high doses was not accompanied by the appearance of severe symptoms.

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.

Interaction of Novinet with other drugs.

With simultaneous use of Novinet with antispasmodics, phenobarbital derivatives, antibiotics (tetracycline, ampicillin, rifampicin, isoniazid, neomycin, penicillin, chloramphenicol), carbamazepine, phenylbutazone, analgesics, anxiolytics, activated carbon, sulfonamides, nitrofurans, antimigraine drugs, griseofulvin, laxatives and some medicinal plants(for example, St. John's wort) it is possible to change the nature of menstruation and reduce the contraceptive effect of Novinet.

Novinet, when used simultaneously, reduces the effectiveness of oral anticoagulants, anxiolytics (diazepam), tricyclic antidepressants, guanethidine, theophylline, caffeine, vitamins, clofibrate, glucocorticosteroids, paracetamol.

When Novinet is used simultaneously with oral hypoglycemic drugs or insulin, the condition may be impaired. carbohydrate metabolism, because Novinet may reduce carbohydrate tolerance and increase the need for insulin or oral hypoglycemic agents, which may require dose adjustment.

Terms of sale in pharmacies.

The drug is available with a prescription.

Terms of storage conditions for the drug Novinet.

The drug should be stored out of the reach of children at a temperature of 15° to 30°C. Shelf life - 3 years.