Novinet for what day can you not use protection? Contraceptive pills Novinet: instructions for use. Problems caused due to metabolic failure


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. The active substances in its composition not only have a contraceptive effect, but also eliminate 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 due to hormonal imbalances or due to an unauthorized change in the dosage 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 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.

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After removing the IUD, removing the implant or vaginal ring, the drug should also be used from the next day.

There is no need to be afraid to suddenly switch to Novinet; mini-pills do not cause a hormonal shock to the body, like many medications of previous generations.

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 composition of the drug can cause health problems in women who have problems with the heart and other internal organs, the vascular system, and 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.

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In case of delay, you should not stop taking the drug yourself. Only a doctor can find out what caused the possible failure. The gynecologist must also decide whether to stop or continue taking it.

If a woman started taking Novinet not during her period, but in the middle of her cycle, it’s not a big deal, the course should be completed according to the instructions. If you want to postpone your period, you can start a new package without interruption.

Side effects

When Novinet is prescribed and taken correctly, most women do not experience any side effects. 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, the increase in negative symptoms indicates that the drug is not suitable for the 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:

  1. In the period from days 1 to 14: after the break, you need to take 2 tablets at once, then take the next ones as usual.
  2. 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 provoke unwanted deviations in the functioning of the endocrine system, cause cardiac and vascular disorders, and accelerate subsequent aging. For middle and older age, the gynecologist prescribes other drugs that are more appropriate to the hormonal status of women.

Novinet is a combined oral contraceptive intended to protect against unwanted pregnancy. The drug contains the following combination of hormones, 0.02 mg of ethinyl estradiol and 0.15 mg of desogestrel in each tablet of the drug.

In order to start protection with combined oral contraceptives, you must consult a doctor. Firstly, any drug has contraindications, so it is necessary to conduct an examination in order to identify diseases, the presence of which is an obstacle to taking the drug. The desire of many women is to choose the lowest dosage drug. However, such desires may not at all correspond to the state of the body. Here, a lot depends on the initial hormonal status of your body. Low-dose drugs are not suitable for those who already have a high initial status, and vice versa. Thus, it is clear that before starting to take oral contraceptives, it is necessary to consult not only a gynecologist, but also a therapist and an endocrinologist. Thus, the most highly dosed drugs containing 35 mcg of ethinyl estradiol, medium-dose drugs include drugs containing 30 mcg, and low-dose drugs contain 20 mcg. Novinet belongs to the last group of drugs.

Taking Novinet should be started on the first day of menstrual flow. The drug must be taken one tablet per day, at the same time of day. The course of taking the drug is 21 days, after which a seven-day break is taken, during which a menstrual-like reaction should appear. If a woman continues to decide to protect herself from unwanted pregnancy with the help of this drug, then on the eighth day she should start taking pills from a new package. It is necessary to start taking a new pack on the eighth day even if menstruation has not stopped. For the woman’s convenience, the tablet number and arrow are indicated on the blister.
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The contraceptive effect of using Novinet, if the start of use coincides with the first day of menstruation, is achieved by the end of the first week of taking the drug. That is, after the end of menstruation, usually on the seventh day, you can have sexual intercourse without resorting to additional contraception. The contraceptive effect, provided the drug is taken correctly, persists throughout the entire period of use of the drug, including during the seven-day break.

If you miss a contraceptive pill, if vomiting or diarrhea follows after taking the pill, taking the drug coincides with taking antibiotics, the contraceptive effect may be significantly reduced, so it is recommended to use an additional non-hormonal method of contraception for two weeks after that.

After finishing taking the drug, fertility is restored on average within two to three months, but much depends on the individual characteristics of the body.

Three months after starting to take the drug, it is advisable to visit the doctor again in order to assess the effect of hormonal substances on the woman’s body and the woman’s general health. If a woman does not experience any side effects when taking the drug, she can visit a gynecologist once every six months. If changes occur in the body or side effects occur, you should consult a doctor immediately.


Additionally

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)

Novinet release form, drug packaging and composition.

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 the pituitary secretion of 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, which participates together with the corpus luteum hormone 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 the postpartum period sexual intercourse preceded oral contraception, then taking the pills should 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-progestin 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 a dose of the drug, if no more than 12 hours have passed since the last dose, 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 to women who took hormonal contraceptives before pregnancy, the incidence of malformations does not increase. In cases of taking the drug in the early stages of pregnancy, no teratogenic effect was detected.

The use of Novinet is contraindicated during lactation (breastfeeding), because the drug reduces the secretion of breast milk and changes its composition. In addition, the active substances are 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 tablets are missed, with vomiting and diarrhea, as well as when taken simultaneously 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, anti-migraine drugs, zeofulvin, laxatives and Some medicinal plants (for example, St. John's wort) may 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 control of carbohydrate metabolism may be impaired, 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.

Estrogen-progestogen, contraceptive .

Pharmacodynamics and pharmacokinetics

The drug contains synthetic estrogenic And progestational components , which are more active than natural sex hormones .

The effect is achieved primarily by preventing the release of pituitary hormones follitropin And luteotropin , which interferes with the process ovulation . Its intensification is facilitated by the increased viscosity of the mucus in the cervical canal and, consequently, its relative impassability for sperm.

A distinctive feature of Novinet tablets is that estrogenic component is present in them in minimal concentration, which reduces the risk of estrogen-dependent side effects (pain in the mammary glands, thromboembolic complications, nausea, weight gain, etc.).

Desogestrel represents gestagen II generation. The substance has a beneficial effect on lipid metabolism, maintaining cholesterol balance and normalizing lipid profile parameters.

In addition, against the background of the use of tablets:

  • blood loss is reduced;
  • skin condition improves;
  • the cycle of menstrual days is normalized;
  • the risk of developing gynecological diseases (including diseases of a tumor nature) is reduced.

Ethinyl estradiol And desogestrel absorbed in the proximal small intestine. Absorption is fast and almost 100%. Main product of metabolism desogestrel is 3-keto-desogestrel, its other metabolites are pharmacologically inactive.

Bioavailability ethinyl estradiol - 60%. For desogestrel this figure varies from 62 to 81%. Both substances have a high degree of binding to plasma proteins (more than 90%). Their concentration in the blood reaches maximum values ​​1-1.5 hours after taking the tablet.

The components of the drug are well distributed in tissues and organs, while ethinylestradiol characterized by the ability to accumulate in adipose tissue. Approximately a tenth of the dose taken passes into the milk of a nursing woman.

T1/2 - on average 24 hours, desogestrel - on average 30 hours.

Metabolic products desogestrel excreted by the kidneys. Metabolic products ethinyl estradiol eliminated in urine and bile.

Indications for use

Prevention from pregnancy.

Contraindications

Contraindications to the use of tablets are:

  • increased sensitivity to its constituent substances;
  • thrombosis/thromboembolism of veins/arteries ;
  • presence of precursors ;
  • with manifestations of focal neurological symptoms;
  • complicated by vascular pathologies ;
  • increased risk veins/arteries;
  • with severe hypertriglyceridemia;
  • serious liver pathologies (taking pills is contraindicated until the functional parameters of the organ return to normal);
  • tumor lesion of the liver ;
  • hormone-dependent tumors (identified or suspected);
  • vaginal bleeding, the nature of which cannot be determined;
  • otosclerosis ;
  • smoking;
  • age over 35 years;
  • pregnancy;
  • breast-feeding.

Side effects

Side effects of Novinet appear:

  • acyclic vaginal discharge;
  • after stopping the pills;
  • changes in the state of mucus in the vagina;
  • development of inflammatory processes in the vagina;
  • soreness, tension and enlargement of the mammary glands, secretion of milk from them;
  • nausea;
  • vomiting;
  • jaundice and/or itching associated with cholestasis;
  • ulcerative colitis ;
  • erythema nodosum or exudative ;
  • chloasma ;
  • skin rashes;
  • headaches;
  • mood swings;
  • migraine ;
  • depression ;
  • increased sensitivity of the cornea to contact lenses;
  • fluid retention in the body;
  • decreased tolerance to carbohydrates;
  • change in body weight towards its increase;
  • hypersensitivity reactions.

If the above symptoms appear, the question of the advisability of further taking the drug is decided on an individual basis.

Severe side effects of Novinet, which require immediate discontinuation of the drug:

  • acute blockage of veins/arteries by blood clots (rarely - , DVT, PE, etc.; extremely rarely - acute blockage of large retinal and mesenteric vessels, veins and arteries of the liver, kidneys);
  • otosclerosis and, as a consequence, hearing loss;
  • exacerbation of Libman-Sachs disease (rarely);
  • Sydenham's chorea (develops extremely rarely, symptoms disappear after stopping taking the pills);
  • porphyria .

Novinet tablets: instructions for use

Novinet is taken orally, one per day, with liquid. Reception begins no later than the 5th day of the menstrual cycle. The tablets are taken without breaks or breaks for a full three weeks, at the same time. From 22 to 28 days they take a break.

If the first tablet is taken between days 2 and 5 of the cycle, additional measures to protect against pregnancy are taken during the first 7 days of the course.

On day 29 (the day of the week corresponds to the day of the week when the first tablet was taken), the drug is resumed using a new pack.

If you strictly follow the recommendations described in the instructions for use of Novinet, the contraceptive effect remains between 22 and 29 days of the cycle.

How to take pills after childbirth/abortion

In the absence of lactation, Novinet can be taken from the first day of the first independent menstruation. Before starting treatment, you must consult a doctor. Additional contraception is not needed.

If there is sexual intercourse after childbirth, taking the drug is postponed until the next menstruation. If the decision to take pills is made later than 3 weeks after birth, the use of additional protective measures is indicated in the first 7 days of the course.

After an induced abortion or spontaneous termination of pregnancy, pills are started immediately without the use of other means of contraception.

Switching to Novinet from other contraceptives

After taking other COCs, the first pill is taken the next day after completing the course of the previous contraceptive (they do not take a break, there is no need to wait for the next menstruation). When switching from containing only progestogen Novinet medications are started from the first day of the cycle.

The use of additional protective measures in all the described cases is not necessary.

Additional precautions mean the use of barrier contraceptives or refusal of sexual relations during the entire “dangerous” period. It is not recommended to resort to the calendar method of contraception.

Delay of menstruation

If it is necessary to delay the start of the cycle, contraceptive pills are taken according to the usual regimen for the required time, without taking a break. In this case, spotting/breakthrough vaginal bleeding is possible, which does not affect the effectiveness of the product. Regular use is resumed after a standard break of 7 days.

Skipping a pill

The full contraceptive effect is maintained provided that the drug is taken regularly, in which the maximum delay in taking the pill does not exceed 12 hours. If the forgotten tablet is taken within 36 hours after the previous one, Novinet continues to be taken according to the standard regimen.

A missed pill is considered a situation when more than 12 hours have passed since the last dose of the drug.

If a pill is missed in the first 14 days of the cycle, the next day at the usual time you need to take a double dose of the drug at once. In the future, it is taken as usual.

If the omission occurred between days 15 and 21 of the cycle, you must take the missed dose of the drug and continue further administration without a seven-day break.

If you miss a pill, the risk of spotting and/or ovulation increases, which is associated with the minimum content in the drug. In this regard, additional contraception is required (until the new cycle).

In case of vomiting and/or diarrhea, the absorption of the drug may not be complete. If the symptoms disappear within 12 hours, it is recommended to additionally take a second tablet (further administration according to the usual regimen); if symptoms persist longer, throughout the entire period of illness, as well as throughout the next week, additional contraception is necessary.

Overdose

Signs of a drug overdose are nausea and vomiting; spotting (when taken by girls).

If an overdose is noticed in a timely manner, perform gastric lavage in the first hours after taking the tablets. Treatment is symptomatic, there is no antidote.

Interaction

The effectiveness of COCs for oral administration is reduced in combination with liver enzyme-inducing drugs: Hypericum perforatum drugs, , , barbiturates , Hydantoin , , Felbamate , , Oxcarbazepine .

In addition, these drugs increase the risk of breakthrough bleeding.

The level of induction reaches a maximum within 14-20 days, but can also persist for up to 4 weeks after discontinuation of the drug.

If necessary, use Novinet in combination with And During the entire course of treatment and for another week after its completion, additional contraception is necessary (these drugs reduce the effectiveness of the drug).

Upon admission Rifampicin additional precautions are required for 4 weeks after stopping treatment with the drug

COCs reduce carbohydrate tolerance and increase the need for oral or oral antidiabetic agents.

The contraceptive effect is reduced when:

  • vomiting/diarrhea;
  • skipping a pill;
  • simultaneous use with drugs that reduce the effectiveness of COCs.

The effectiveness of the tablets may decrease in cases where, after several cycles of their use, a woman experiences irregular, breakthrough or spotting discharge. In such situations, it is considered advisable to continue taking the drug until the end of the tablets in the next package.

If there is withdrawal bleeding at the end of cycle 2 acyclic secretions withdrawal bleeding has not stopped or started, the drug should be discontinued. It is resumed only after pregnancy has been ruled out.

Pills do not protect against STD And AIDS .

The estrogenic component of the drug can change certain laboratory parameters, including, but not limited to, indicators of hemostasis, the functional state of the adrenal glands, kidneys, thyroid gland, liver, the level of transport proteins and the level of lipoproteins.

During pregnancy

During pregnancy, taking Novinet tablets is contraindicated.

COCs suppress lactation; in addition, a small amount of their constituent substances passes into milk. Therefore, during breastfeeding, these drugs cannot be considered the means of choice.

During lactation, taking tablets is allowed from the sixth month.

Novinet: instructions for use and reviews

Novinet is a monophasic oral contraceptive.

Release form and composition

Dosage form – film-coated tablets: round, biconvex, light yellow in color, marked “RG” on one side, “P9” on the other (21 pieces in blisters, 1 or 3 blisters in a cardboard pack).

  • Ethinyl estradiol – 20 mcg;
  • Desogestrel – 150 mcg.

Auxiliary components: alpha-tocopherol, colloidal silicon dioxide, magnesium stearate, stearic acid, potato starch, povidone, lactose monohydrate, quinoline yellow dye (E104).

Film shell composition: hypromellose, macrogol 6000, propylene glycol.

Pharmacological properties

Pharmacodynamics

Novinet belongs to combined oral contraceptives. Its main contraceptive effect is to reduce the production of gonadotropins and suppress ovulation. Also, when used, the viscosity of the cervical mucus increases, which makes it difficult for sperm to move through the cervical canal, and the condition of the endometrium changes, as a result of which the fertilized egg does not implant into the uterine wall.

Ethinyl estradiol is a synthetic analogue of endogenous estradiol. Desogestrel is characterized by a pronounced gestagenic and antiestrogenic effect, reminiscent of that of endogenous progesterone, as well as minor anabolic and androgenic activity. Novinet has a beneficial effect on lipid metabolism: it increases the content of high-density lipoproteins in the blood plasma, without changing the concentration of low-density lipoproteins. During the use of the drug, there is a significant decrease in the amount of blood lost monthly during menstruation (with the initial diagnosis of menorrhagia), normalization of the menstrual cycle, and improvement in skin condition (especially in the presence of acne vulgaris).

Pharmacokinetics

When taken orally, desogestrel is almost completely and rapidly absorbed from the gastrointestinal tract. The biologically active metabolite of this compound is 3-keto-desogestrel. The average maximum level of desogestrel in the blood serum is 2 ng/ml and is recorded 1.5 hours after taking the tablet. The bioavailability of the substance is 62–81%.

3-keto-desogestrel binds to plasma proteins, mainly sex hormone-binding globulin and albumin. The volume of distribution is 1.5 l/kg.

In addition to 3-keto-desogestrel, which is formed in the intestinal wall and liver, other metabolites of desogestrel are known: 3β-OH-desogestrel, 3α-OH-desogestrel and 3α-OH-5α-H-desogestrel, which are first-phase metabolites. They are not characterized by pharmacological activity and partially, through conjugation (the second stage of metabolization), pass into the form of polar metabolites (glucuronates and sulfates). Clearance from blood plasma is approximately 2 ml/min per 1 kg of body weight.

The average half-life of 3-keto-desogestrel is 30 hours. Metabolites are excreted through the intestines and kidneys in a ratio of 6:4. A stable concentration of desogestrel in the body is observed in the second half of the cycle. During this period, the level of this substance increases 2-3 times.

Ethinyl estradiol is absorbed from the gastrointestinal tract quite quickly and completely. On average, the maximum concentration in the blood serum is 80 pg/ml and is achieved 1-2 hours after taking the tablet. Due to the “first pass” effect and presystemic conjugation, the bioavailability of the substance reaches 60%.

Ethinyl estradiol is 100% bound to plasma proteins, mainly albumin. The volume of distribution is 5 l/kg.

Presystemic conjugation of this compound is very significant. After passing through the intestinal wall (first phase of metabolism), ethinyl estradiol participates in the process of conjugation in the liver (second phase of metabolism). The substance and its conjugates, formed in the first phase of metabolism (glucuronides and sulfates), are excreted into bile and become elements of the enterohepatic circulation. The clearance of ethinyl estradiol from blood plasma is approximately 5 ml/min per 1 kg of body weight. Its average half-life is approximately 24 hours. About 60% of the substance is excreted through the intestines and about 40% through the kidneys.

A stable level of ethinyl estradiol in the body is established on the 3-4th day after starting Novinet. At the same time, the content of the substance in the blood serum is 30-40% higher than after taking a single dose.

Indications for use

The use of Novinet is indicated for women for oral contraception.

Contraindications

  • Angina pectoris, transient ischemic attack and other precursors of thrombosis (including when indicated in the anamnesis);
  • Moderate or severe arterial hypertension (blood pressure (BP) 160/100 mmHg or more) and other multiple and/or severe risk factors for arterial or venous thrombosis;
  • Migraine with focal neurological symptoms, including medical history;
  • History of venous thromboembolism;
  • Myocardial infarction, deep vein thrombosis of the leg, stroke, pulmonary embolism and other forms of venous or arterial thrombosis or thromboembolism, currently and in history;
  • Dyslipidemia;
  • Diabetes mellitus (with angiopathy);
  • Gallstone disease, including medical history;
  • Liver neoplasms, including medical history;
  • Severe liver diseases, cholestatic jaundice (including during pregnancy), hepatitis, including a history (before normalization of laboratory and functional parameters and within 3 months after it);
  • Pancreatitis (including medical history), occurring with severe hypertriglyceridemia;
  • Jaundice due to glucocorticosteroids (GCS);
  • Dubin-Johnson syndrome, Gilbert's syndrome, Rotor syndrome;
  • Severe skin itching, otosclerosis and its progression while taking GCS or during a previous pregnancy;
  • Vaginal bleeding of unknown origin;
  • Hormone-dependent malignant tumors of the mammary glands and genital organs or suspicions of them;
  • Breast-feeding;
  • The period of pregnancy, including suspicion of it;
  • Smoking more than 15 cigarettes per day over the age of 35;
  • Hypersensitivity to the components of the drug.

Caution should be exercised in women with conditions that increase the risk of developing arterial or venous thrombosis and thromboembolism: obesity (body weight index exceeds 30 kg/m2), smoking, age over 35 years, family history, dyslipoproteinemia, migraine, arterial hypertension, epilepsy, atrial fibrillation, valvular heart defects, ulcerative colitis, Crohn's disease, sickle cell anemia, chronic and acute liver pathologies, hypertriglyceridemia (including family history), prolonged immobilization, major surgery, surgery on the lower extremities, superficial thrombophlebitis, varicose veins, severe trauma, postpartum period, severe depression (including history), systemic lupus erythematosus (SLE), diabetes mellitus (without vascular complications), changes in biochemical parameters, including hyperhomocysteinemia, activated protein C resistance, antithrombin III and protein S or C deficiency , antiphospholipid antibodies, including antibodies to cardiolipin, lupus anticoagulant.

Instructions for use of Novinet: method and dosage

Novinet is taken for 21 days, starting from the first day of menstrual bleeding, 1 tablet orally at the same time of day. After taking all the tablets from the blister, take a 7-day break, during which menstrual-like bleeding occurs. Taking tablets from the next blister should be started the next day after the break, even if bleeding continues. This drug regimen provides contraceptive effect as long as it is needed.

If a woman starts taking the first pill on the first day of the menstrual cycle, additional contraceptive measures are not required. When starting use from the second to fifth day of menstruation in the first cycle, it is necessary to use barrier methods of contraception for the first 7 days. If more than 5 days have passed since the start of menstruation, you should not start taking pills in this cycle.

After childbirth, taking the drug can be started no earlier than 21 days without additional contraceptive measures, subject to prior consultation with a doctor and the absence of breastfeeding. If a woman had sexual contact during this period, the start of therapy should be postponed until the start of her first menstruation. If use is started more than 21 days after birth, barrier contraceptives should be used simultaneously for the first 7 days.

In the absence of contraindications, taking pills after an abortion should be started on the day of surgery without using additional contraceptive measures.

When switching from an oral hormonal contraceptive containing ethinyl estradiol 30 mcg and taken on a 21-day schedule, Novinet should be taken the next day after taking the last tablet of the previous contraceptive without a seven-day break and the use of additional contraception.

When switching from products containing 28 tablets, use of Novinet begins the next day after taking the last tablet from the package of the previous contraceptive.

After previous use of oral hormonal mini-pills containing only progestogen, it is recommended to start switching to Novinet on the 1st day of the cycle without the use of additional methods of contraception.

If there is no menstruation while taking the mini-pill, it is necessary to exclude the presence of pregnancy and only then switch to taking Novinet on any day of the menstrual cycle using additional methods of contraception during the first 7 days. As additional methods of contraception during this period, it is recommended to use a condom, a cervical cap with spermicidal gel, or sexual abstinence. It is not recommended to use the calendar method of protection during the first 7 days of taking the drug.

If a woman wants to postpone the onset of menstruation, then taking tablets from the next blister must be started immediately, according to the usual regimen, without taking a 7-day break. During this period, breakthrough or spotting bleeding may occur, which does not reduce the contraceptive effect of the drug. After the prescribed 7-day break, regular use of the drug is restored.

If you accidentally miss a dose at the scheduled time, you should take the pill as soon as you remember. If the delay period is less than 12 hours, the contraceptive effect of the drug is not impaired, further use can be continued as usual. A delay of more than 12 hours is considered a missed pill and violates the reliability of contraception in this cycle (the use of additional methods of contraception is required).

If one pill is missed during the first two weeks of the cycle, the next day you must take 2 tablets and continue taking it using additional methods of contraception until the end of the cycle.

If a pill is missed in the third week of the cycle, you should take it and continue taking Novinet without a 7-day break in this cycle. Since the estrogen content is minimal, if you miss the next dose, the risk of spotting and/or ovulation increases, so the use of additional methods of contraception is mandatory.

If vomiting or diarrhea occurs immediately after taking another Novinet tablet, the absorption process may be incomplete. If the stomach upset subsides within 12 hours, you should take an additional tablet and continue your usual contraceptive regimen. If the duration of vomiting or diarrhea exceeds 12 hours, the woman must use barrier methods of contraception during the period of illness and for the next 7 days.

Side effects

  • 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;
  • Nervous system: headache, mood instability, depression, migraine;
  • Digestive system: nausea, vomiting, ulcerative colitis, Crohn's disease, exacerbation or development of jaundice and/or itching caused by cholestasis, cholelithiasis;
  • Metabolism: increased body weight, fluid retention in the body, decreased tolerance to carbohydrates;
  • Organ of vision: in patients with contact lenses – increased sensitivity of the cornea;
  • Dermatological reactions: rash, erythema nodosum, chloasma, exudative erythema;
  • Other: development of allergic reactions.

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

  • 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;
  • Sense organs: hearing loss caused by otosclerosis;
  • Other: porphyria, hemolytic-uremic syndrome; rarely - exacerbation of reactive systemic lupus erythematosus; very rarely - transient Sydenham chorea.

Overdose

According to the instructions, Novinet in high doses can cause symptoms such as nausea and vomiting, as well as spotting from the vagina in girls. The drug does not have a specific antidote, so symptomatic treatment is prescribed. If signs of overdose are observed in the first 2-3 hours after taking the tablets, gastric lavage may be effective.

special instructions

Novinet is a reliable means of hormonal contraception.

The use of the drug should begin after a complete general medical and gynecological examination, including a detailed personal and family history, laboratory tests, blood pressure measurement, examination of the pelvic organs, mammary glands, and cytological analysis of a cervical smear. The gynecologist’s conclusion on the possibility of using the drug is made based on the data obtained. Having informed the patient about the possible negative effects and benefits of hormonal contraception, the doctor gives her the right to make the final decision.

The use of the drug should be carried out with regular (once every 6 months) examination by a gynecologist and careful individual monitoring of health status. A woman should know that the reason for immediate discontinuation of the drug is the appearance of one of the following abnormalities:

  • Diseases or conditions that contribute to the development of renal, cardiovascular failure;
  • Abnormalities in laboratory tests assessing liver function;
  • Pathologies of the hemostatic system;
  • Migraine;
  • Epilepsy;
  • Threat of developing estrogen-dependent gynecological diseases or estrogen-dependent neoplasms;
  • Severe depression (it is recommended to take vitamin B6 to correct the condition associated with the pathology of tryptophan metabolism);
  • Diabetes mellitus without vascular complications;
  • Sickle cell anemia.

While taking oral hormonal contraceptives, the risk of developing venous and arterial thromboembolic pathologies increases, especially in older women or with a family history of thromboembolic diseases (parents, sister, brother). The risk increases with heavy smoking, dyslipoproteinemia, obesity, diabetes mellitus with vascular lesions, heart valve disease with hemodynamic disturbances, arterial hypertension, atrial fibrillation, during prolonged immobilization associated with major surgery (including surgery on the lower extremities) or after severe trauma. .

The use of the contraceptive should be stopped 4 weeks before planned surgery and resumed 2 weeks after remobilization.

After childbirth, the likelihood of venous thromboembolic disease increases.

Diabetes mellitus, hemolytic-uremic syndrome, systemic lupus erythematosus, Crohn's disease, sickle cell anemia, ulcerative colitis increase the risk of developing venous thromboembolic diseases.

With a deficiency of proteins C and S, resistance to activated protein C, hyperhomocysteinemia, the presence of antiphospholipid antibodies, and a lack of antithrombin III, the likelihood of developing venous or arterial thromboembolic pathologies increases.

Targeted therapy of the above conditions helps reduce the risk of thromboembolism with characteristic symptoms such as sudden chest pain radiating to the left arm, sudden shortness of breath, unusually severe headache that continues for a long time (especially if the headache appears for the first time in combination with dizziness, weakness, acute abdomen, partial or complete loss of vision, diplopia, aphasia, focal epilepsy, collapse, movement disorders, numbness of half the body, severe unilateral pain in the calf muscle).

Taking a contraceptive can be regarded as one of many risk factors for developing breast cancer.

Long-term use of the drug may result in the development of benign or malignant liver tumors. This should be taken into account in the differential diagnostic assessment of abdominal pain, which may be associated with intraperitoneal bleeding or an increase in liver size.

Women who have a history of this pathology during pregnancy are at risk of developing chloasma, so they are advised to avoid direct sunlight or ultraviolet radiation.

The effectiveness of oral contraception may be affected by the simultaneous use of other drugs, in which case the use of additional barrier contraceptive methods is required.

The effect of the drug is reduced due to irregular, spotting or breakthrough bleeding that appears after several months of contraception. In this case, it is necessary to continue taking the pills until the end of the next cycle and in the absence of menstrual-like bleeding during the 7-day break or continuation of acyclic bleeding, stop taking the pills until pregnancy is ruled out.

In addition, skipping a pill, vomiting or diarrhea can interfere with the effect of the drug.

The action of the tablets can cause changes in laboratory parameters of kidney function, adrenal glands, liver, thyroid gland, levels of transport proteins and lipoproteins, and hemostasis indicators.

After acute viral hepatitis, use of the drug can be started after complete restoration of liver function (6 months or more).

Novinet does not protect against sexually transmitted diseases, including HIV infection (AIDS).

The effect of the drug on the ability to drive vehicles and machines has not been studied.

For impaired renal function

In case of renal failure (including a history), Novinet is prescribed with caution and only after a careful assessment of the balance of harm and benefit.

For liver dysfunction

The drug should not be prescribed for hepatitis (including a history of hepatitis, until laboratory and functional parameters are normalized and for 3 months after their normalization), cholestatic jaundice (including those accompanying pregnancy) and severe liver dysfunction. The contraceptive is used with caution in acute and chronic liver diseases.

Use in old age

Since Novinet is a contraceptive drug, it is not used in elderly patients.

Drug interactions

Concomitant use of Novinet with drugs that induce liver enzymes (barbiturates, hydantoin, primidone, rifampicin, carbamazepine, oxcarbazepine, felbamate, St. John's wort, topiramate, griseofulvin) reduces the effectiveness of contraception and increases the risk of breakthrough bleeding. It should be borne in mind that the maximum degree of induction of any of these drugs is achieved after 2-3 weeks of use, but can last up to 4 weeks after discontinuation of the drug.

Since tetracycline and ampicillin reduce the effectiveness of the drug, it is necessary to use additional barrier methods of contraception when combined with Novinet during the entire period of therapy and 7 (for rifampicin - 28) days after their discontinuation.

There may be a decrease in carbohydrate tolerance and an increased need for oral antidiabetic agents or insulin.

Analogs

Analogues of Novinet are: Marvelon, Regulon, Mercilon, Tri-Mercy.

Terms and conditions of storage

Store at 15-30 °C. Keep away from children.

Shelf life – 3 years.

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