Novynette 63 tablets — Made in Hungary — Free Delivery

Pharmacological properties

Pharmacodynamics. Novynette  is a combined hormonal contraceptive preparation for oral use, the action of which is associated with inhibition of the effect of gonadotropins and suppression of ovulation, as well as a decrease in the penetration of sperm through cervical mucus and implantation of a fertilized egg.

Ethinylestradiol is a synthetic estrogen.

Desogestrel is a synthetic progestogen, which, after ingestion, strongly inhibits ovulation, exhibits a pronounced progestogenic and antiestrogenic effect, does not exhibit estrogenic activity and has weak androgenic and anabolic activity.

Pharmacokinetics

Desogestrel

Suction. Desogestrel is rapidly and almost completely absorbed with further transformation into 3-keto-desogestrel (etonogestrel), which is a biologically active metabolite of desogestrel. Cmax of the preparation in blood plasma (2 ng / ml) is achieved 1.5 hours after administration (tmax). Bioavailability is 62–81%.

Distribution. In the body, 3-keto-desogestrel binds to plasma proteins, mainly albumin and globulins, which bind sex hormones (globulin-binding sex hormones - SHBG). Only 2–4% of the total amount of desogestrel in blood plasma is detected in the form of free steroids, and 40–70% are specifically associated with SHBG. An increase in the concentration of SHBG caused by ethinyl estradiol affects the distribution of plasma proteins, which leads to an increase in the SHBG-bound fraction and a decrease in the fraction associated with albumin.

The volume of distribution is 1.5 l / kg.

Biotransformation. Etonogestrel is completely degraded by known steroid metabolic pathways. The rate of elimination of metabolites from blood plasma is approximately 2 ml / min / kg. Interactions of etonogestrel with ethinyl estradiol have not been observed. In addition to 3-keto-desogestrel (which is formed in the liver and intestinal wall), there are other metabolites: 3α-OH-desogestrel, 3β-OH-desogestrel, 3α-OH-5α-H-desogestrel (phase I metabolites). These metabolites lack pharmacological activity; by conjugation, they are partially converted (the second phase of metabolism) into polar metabolites, sulfates and glucuronides. Excretion. T 1/2 of 3-keto-desogestrel - an average of 30 hours. Metabolites are excreted in the urine and feces in a ratio of 6: 4. Equilibrium state. The pharmacokinetics of etonogestrel is affected by the content of SHBG in the blood plasma, which increases 3 times when ethinyl estradiol is taken. The equilibrium concentration is established in the second half of the cycle, at which time the level of ketodesogestrel increases 2-3 times.

Ethinylestradiol

Suction. Ethinylestradiol is rapidly and almost completely absorbed. Cmax in blood plasma is 80 pg / ml and is reached 1-2 hours after oral administration (tmax). Due to presystemic conjugation and the first pass effect, bioavailability is about 60%.

Distribution. Ethinylestradiol almost completely binds to plasma proteins, mainly albumin, and activates SHBG in blood plasma. The volume of distribution is 5 l / kg.

Biotransformation. Ethinylestradiol undergoes presystemic conjugation in the mucous membrane of the small intestine and liver. Ethinylestradiol is mainly metabolized by aromatic hydroxylation, but many other hydroxylated and methylated metabolites are formed, which are detected as free metabolites, as well as conjugated sulfates and glucuronides. The metabolic clearance rate is about 5 ml / min / kg.

Excretion. T1 / 2 of ethinylestradiol - an average of 24 hours. Approximately 40% is excreted in the urine and 60% in the feces.

Equilibrium state. The equilibrium concentration is established on the 3-4th day, while the level of ethinyl estradiol in the blood plasma is 30-40% higher than after a single dose.

Indications

Oral contraception.

Application

The tablets must be taken in the order indicated on the blister pack. taking the preparation begins from the 1st day of the menstrual cycle and take 1 tablet per day for 21 days, if possible at the same time of day. after taking the last pill, a 7-day break is taken, during which menstrual bleeding occurs as a result of preparation withdrawal. the next day after a 7-day break (4 weeks after taking the first pill, on the same day of the week), resume taking from the next package, which contains 21 pills, even if the bleeding has not stopped. thus, the pills continue to be taken as long as there is a need for contraception. subject to the rules of admission, the contraceptive effect of the preparation persists for a 7-day break.

The first dose of Novynette . The first tablet should be taken on the 1st day of the menstrual cycle. In this case, additional methods of contraception are not required.

Taking pills can be started from the 2nd to 5th day of menstruation, but in this case, in the first cycle, additional (barrier) methods of contraception should be used in the first 7 days of taking the pills. If more than 5 days have passed since the onset of menstruation, it is necessary to postpone the start of taking the preparation until the next menstruation.

Taking the preparation after an abortion in the first trimester. The preparation should be taken from the 1st day after an abortion or miscarriage, in this case there is no need for additional methods of contraception.

Taking the preparation after childbirth or abortion in the II trimester. Women who are not breastfeeding should start taking pills 21-28 days after childbirth or abortion in the second trimester. In this case, there is no need for other methods of contraception.

If taking Novynette  tablets is started later, then in the first 7 days it is necessary to use additional (barrier) methods of contraception.

If after childbirth there has already been sexual intercourse, taking the preparation should be postponed until the next menstruation.

Note: Women who are breastfeeding should not take combined oral contraceptives (COCs), as this can lead to a decrease in the amount of breast milk (see SPECIAL INSTRUCTIONS).

Switching to Novynette   from another oral contraceptive. When a woman is transferred to Novynette  from another oral contraceptive, which is used in a 21- or 22-day regimen, all pills from the previous package of the contraceptive preparation  should be taken.

The first Novynette  tablet is recommended to be taken the next day, that is, you should not take a break or wait for the onset of menstruation. There is no need to use additional methods of contraception.

When switching to taking Novynette  from other contraceptive pills that are used according to a 28-day regimen, the first Novynette  tablet should be taken after taking the last active (hormone-containing) tablet from the previous package, you should not take a break or wait for the onset of menstruation. In this case, there is no need to use additional methods of contraception.

When switching to Novynette  from a hormonal preparation containing only a progestogen (mini-pills, injection or implant), or from an intrauterine system (IUD) that releases a progestogen, the first Novynette 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-pili, you can start taking Novynette on any day of the cycle, but in the first 7 days it is imperative to use additional methods of contraception.

You can start using Novynette on the day the implant or IUD is removed, in case of an injection - instead of the next injection. In these cases, a woman should use an additional barrier method of contraception during the first 7 days of taking the pills.

As additional methods of contraception in these cases, it is recommended to use non-hormonal methods (cervical cap with spermicidal gel, condom) or refrain from sexual intercourse. In this case, it is not recommended to use the calendar method.

Delayed onset of menstruation. If there is a need to delay menstruation, you must continue taking Novynette tablets from a new package without a 7-day break in the usual way. The delay can be continued until the end of taking the pills from the second package. When menstruation is delayed, breakthrough and spotting bleeding may appear, which is not evidence of a decrease in the contraceptive effect of the preparation. Regular use of Novynette can be resumed after the usual 7-day break.

Missed pills. If more than 12 hours have passed after skipping the pill, the contraceptive effect of the preparation does not decrease. A woman should immediately take a forgotten pill, and then continue taking the preparation at the usual time.

If more than 12 hours have passed after skipping the pill, the contraceptive effect of the preparation may decrease. If you miss taking a pill, you must take into account 2 basic rules:

1. Do not stop taking the tablets for more than 7 days.

2. To achieve sufficient suppression of the hypothalamic-pituitary-ovarian system, 7 days of continuous administration of the preparation are required.

In accordance with this, when taking pills, the following recommendations should be followed.

1st week. A woman should immediately take the missed pill, even if it means taking 2 pills at the same time. Then it is necessary to continue taking the preparation regularly at the usual time of the day. In this case, for the next 7 days, you must use a barrier method of contraception, such as a condom. If there was sexual intercourse in the previous 7 days, the possibility of pregnancy should be taken into account. The more pills are missed and the closer they are to the break, the higher the risk of pregnancy.

2nd week. A woman should immediately take the missed pill, even if it means taking 2 pills at the same time. Then you should continue to take the preparation regularly at the usual time of the day. Provided that the tablets are used correctly within 7 days before the missed tablet, there is no need for additional contraceptive measures, but if more than 1 tablet is missed, an additional method of contraception should be used within 7 days.

3rd week. The risk of reduced contraceptive performance is very high given the proximity of the pill break. However, this can be prevented by adjusting the pill regimen. So, there is no need for additional contraceptive measures if one of the following two options is used, provided that all pills are taken correctly within 7 days before the missed pill. Otherwise, the woman is recommended to be guided by the first option and at the same time use an additional method of contraception for 7 days.

1. You should immediately take the missed pill, even if it means taking 2 pills at the same time. Then it is necessary to continue taking the preparation regularly at the usual time of the day. Start a new package immediately after taking the last tablet from the current package, that is, do not take a break between packages. It is unlikely that menstrual bleeding will occur before the second pack of pills is finished, but breakthrough bleeding or spotting may occur while taking the pills.

2. You can stop taking pills from the current package. In this case, the woman should take a 7-day break, including days when she forgot to take the pills, and then start a new pack.

If a woman has forgotten to take the pills, and bleeding did not occur during the first normal break in taking them, the possibility of pregnancy should be taken into account.

Measures for vomiting and diarrhea. If vomiting or diarrhea appears after taking the preparation, the absorption of the preparation may be incomplete. If the symptoms have stopped within 12 hours, you should additionally take another 1 tablet from the backup package, and then continue taking the tablets from the old package as usual. If the symptoms continue for more than 12 hours, then it is necessary to use additional methods of contraception until the normalization of the function of the stomach and intestines, as well as in the next 7 days.

Contraindications

Kpc is not used in the conditions indicated below. if such a situation arises for the first time while taking an oral contraceptive, its use should be discontinued.

Established or possible pregnancy. Moderate or severe hypertension. Hyperlipoproteinemia. Presence or indication of a history of venous thromboembolism (VTE) (eg deep vein thrombosis, pulmonary embolism). The presence or indication of a history of arterial thromboembolism (eg myocardial infarction, cerebrovascular disorders), or a condition preceding it (eg angina pectoris, transient ischemic attack). The presence of severe or multiple risk factors for arterial or venous thrombosis (see SPECIAL INSTRUCTIONS). Hereditary or acquired tendency to arterial or venous thrombosis, for example, resistance to activated protein C, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia, and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant). Diabetes mellitus with vascular complications. Pancreatitis at present or in history, accompanied by severe hypertriglyceridemia. Severe liver disease, cholestatic jaundice or hepatitis, including a history (in the absence of normalization of liver function tests and within 3 months after their normalization), a history of jaundice during pregnancy, jaundice due to steroid use, Rotor syndrome, Dubin-Johnson syndrome, hepatocellular tumors and porphyria.

Cholelithiasis. Liver tumors, including a history (benign or malignant). Identified or suspected estrogen-dependent tumors (eg, genitals and mammary glands), endometrial hyperplasia. Vaginal bleeding of unknown etiology. Migraine with focal neurological symptoms. Systemic lupus erythematosus, including a history. Severe itching, herpes of pregnant women, the appearance or progression of otosclerosis during a previous pregnancy or when taking steroids. Hypersensitivity to active ingredients or any of the excipients of the preparation.

Side effects

Severe adverse reactions requiring discontinuation of the preparation. there is a link between taking oral contraceptives and an increased risk of venous and arterial thrombotic and thromboembolic diseases, including myocardial infarction, stroke, deep vein thrombosis, pulmonary embolism. these side reactions are rare.

Thrombosis of other veins or arteries, including hepatic, mesenteric, renal and retinal, has been reported very rarely. There is no consensus on the effect of taking oral contraceptives on the incidence of these adverse reactions.

If hypertension occurs, the preparation should be discontinued immediately.

The use of estrogen-containing PDAs can cause the growth of tumors dependent on sex steroid hormones, so the use of such preparations in women with such tumors is contraindicated.

A possible increase in the risk of developing breast cancer should be discussed with the patient and the benefit / risk ratio from taking COCs should be discussed, given that they have been proven to reduce the risk of developing other types of cancer, such as ovarian and endometrial cancer.

The use of oral contraceptives can lead to the development of cholestatic jaundice or cholelithiasis.

Women with a family history of hypertriglyceridemia or such a disease are at increased risk of developing pancreatitis when using COCs.

In acute and chronic disorders of liver function, the preparation should be discontinued until the results of liver function tests are normalized.

Cholestatic jaundice, which developed early in pregnancy or with previous use of sex steroid hormones, requires discontinuation of birth control pills.

Although birth control pills can affect insulin resistance and glucose tolerance in peripheral tissues, there is no indication to change the dosage regimen for diabetic patients taking birth control pills. However, such patients should be closely monitored while taking birth control pills.

Sometimes chloasma may appear, especially in women who have a history of this disease during pregnancy. Those women who are at risk of chloasma should avoid direct sunlight or ultraviolet radiation while taking the pills.

Very rarely, the use of oral contraceptives can activate reactive systemic lupus erythematosus.

Another rare complication that develops as a result of taking oral contraceptives is Sydenham's chorea, which disappears after the preparation is discontinued.

Other, less severe adverse reactions that develop when taking Novynette. On the part of the reproductive system: intermenstrual bleeding, amenorrhea after discontinuation of the preparation, changes in the state of vaginal mucus, an increase in the size of uterine fibroids, worsening of the course of endometriosis and some vaginal infections, such as candidiasis.

From the mammary glands: engorgement, pain, enlargement, secretion.

From the gastrointestinal tract: nausea, vomiting.

On the part of the skin: erythema nodosum, rash, chloasma.

From the side of the organ of vision: increased sensitivity of the cornea when wearing contact lenses.

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

From the side of metabolism: fluid retention in the body, increase / decrease in body weight, decrease in glucose tolerance.

The occurrence or worsening of the course during pregnancy or the use of PDAs has been reported for the following conditions, however, their relationship with the use of birth control pills has not been proven: jaundice and / or itching due to cholestasis; the formation of gallstones; porphyria, systemic lupus erythematosus, hemolytic uremic syndrome, Sydenham's chorea, herpes of pregnancy, hearing loss associated with otosclerosis, Crohn's disease, ulcerative colitis, epilepsy, uterine myoma.

Adverse reactions arising from the use of the preparation Novynette

From the immune system: hypersensitivity.

From the side of metabolism: fluid retention in the body.

Mental disorders: depression, mood lability, decreased / increased libido.

From the nervous system: headache, nervousness, dizziness, migraine.

From the side of the organ of vision: intolerance to contact lenses.

On the part of the organ of hearing and balance: otosclerosis.

From the vascular system: hypertension, thrombosis, embolism.

From the digestive system: nausea, abdominal pain, vomiting, diarrhea.

Skin and subcutaneous tissue disorders: acne, rash, urticaria, erythema nodosum, erythema multiforme, alopecia.

From the reproductive system and mammary glands: breakthrough bleeding, spotting, breast tenderness, engorgement, dysmenorrhea, premenstrual syndrome, amenorrhea, breast enlargement, vaginal discharge, mammary glands.

Systemic disorders and complications at the injection site: increase / decrease in body weight.

Some of the adverse reactions that develop in women when using PDAs are described in detail in the SPECIAL INSTRUCTIONS section. These include: venous thromboembolic disorders; arterial thromboembolic disorders; AG; hormone-dependent tumors (eg liver tumors, breast cancer); chloasma.

Special instructions

Relative contraindications. if any of the following conditions develops while taking the preparation, it is necessary to weigh the benefits of taking an oral contraceptive and the possible risk in each individual case, and also discuss them with the patient before deciding on the use of the preparation.

The health status of a woman must be carefully monitored. If any of the following conditions deteriorate, worsen, or appear while taking the pills, you should consult your doctor. The doctor decides to stop using the PDA and recommends other, non-hormonal methods of contraception.

Blood clotting disorder.

Other conditions that lead to an increased risk of developing diseases of the circulatory system, such as latent or overt heart failure, renal failure, or a history of these diseases.

Epilepsy, including a history.

Migraine headaches, including a history.

History of cholelithiasis.

The presence of risk factors for the appearance of estrogen-dependent tumors, estrogen-sensitive disorders, such as uterine fibroids or endometriosis.

Diabetes.

Severe depression, including a history. If depression is associated with impaired tryptophan metabolism, then vitamin B6 can be used for correction.

Sickle cell anemia, since in some cases, for example, infections, hypoxia, estrogen-containing preparations in this pathology can provoke thromboembolism.

In case of deviations in the results of liver tests, taking the tablets should be discontinued.

Thromboembolic diseases. It is known that there is a connection between the use of oral contraceptives and an increased risk of developing arterial and venous thromboembolic diseases, including myocardial infarction, stroke, deep vein thrombosis, pulmonary embolism. However, these phenomena are rare.

An increase in the risk of developing VTE with the use of oral contraceptives has been proven. However, it develops much less frequently than during pregnancy, when its frequency is estimated at 60 cases per 100,000 pregnancies. It is known that the risk of developing VTE in women taking oral contraceptives containing desogestrel and gestodene (so-called third-generation pills) is higher than in women who take pills containing levonorgestrel (so-called second-generation pills).

The incidence of VTE in healthy non-pregnant women who do not take oral hormonal contraceptives is 5-10 cases per 100,000 people per year. The risk of VTE is especially high in the first year of contraception among women who have never used COC before. 1-2% of VTE cases are fatal. The incidence in women taking second- and third-generation pills is approximately 15 cases per 100,000 people per year and 25 cases per 100,000 people per year, respectively. The risk of VTE increases with age and with other risk factors such as obesity.

It is known that women who take PDAs containing ethinyl estradiol, more often at a dose of 30 mcg, and a progestin, such as desogestrel, have a higher risk of developing VTE compared with women who take PDAs containing ethinyl estradiol at a dose of less than 50 mcg and the progestin levonorgestrel.

For preparations containing ethinylestradiol 30 mcg in combination with desogestrel or gestodene compared with preparations containing ethinyl estradiol at a dose of less than 50 mcg and levonorgestrel, the overall relative risk of developing VTE is estimated at 1.5-2. The incidence of VTE with oral contraceptives containing levonorgestrel with ethinyl estradiol in an amount of less than 50 mcg is approximately 20 cases per 100,000 patient-years of use. For Novynette, the incidence is approximately 30–40 per 100,000 patient-years of use: there is an additional 10–20 cases per 100,000 patient-years of use. The proportion of the relative risk for additional cases is higher in women who take COCs for the first year, in which the risk of developing VTE is highest for all COCs.

There is evidence of very rare cases of arterial or venous thrombosis of the liver, mesentery, kidney or retina.

The risk of developing arterial thromboembolism and / or VTE is increased:

• with age;
• when smoking (heavy smoking and age increase the risk, especially in women over 35);
• if you have a family history of thromboembolic diseases (for example, arterial thrombosis or VTE in a brother or sister, or parents at a young age). If you suspect a genetic predisposition, you should consult a specialist before using the preparation;
• with obesity (body mass index over 30 kg / m2);
• with dyslipoproteinemia;
• with hypertension;
• with migraine;
• with diseases of the heart valves;
• with atrial fibrillation;
• with diabetes;
• with prolonged immobilization, after extensive surgery, surgery on the lower extremities, severe trauma. In these cases, it is recommended to temporarily discontinue the use of oral contraceptives (no later than 4 weeks before surgery) and resume their use no earlier than 2 weeks after complete remobilization).

There is no consensus on the possible connection between varicose veins and superficial thrombophlebitis with VTE.

In the postpartum period, the increased risk of VTE should be considered (see Use during pregnancy and lactation).

Other diseases that may be accompanied by adverse reactions from the circulatory system include: diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis), and sickle cell anemia.

If the frequency or severity of migraine increases with the use of oral contraceptives (which may be a harbinger or cerebrovascular phenomenon), the preparationshould be discontinued immediately.

Hereditary or acquired factors that may indicate venous or arterial thrombosis include resistance to activated protein C, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).

When assessing the benefit / risk ratio of taking the preparation, it should be borne in mind that adequate elimination of this condition reduces the risk of thrombosis, and the risks associated with pregnancy are higher than the risks associated with the use of oral contraceptives.

Symptoms indicating the development of thrombosis are:

• sudden intense chest pain radiating to the left arm;
• sudden shortness of breath, sudden cough;
• any unusual, intense, prolonged headache, especially if it occurs for the first time and is more severe than usual, or in combination with the following symptoms: sudden complete or partial loss of vision or diplopia, aphasia, vertigo, severe dizziness, collapse, possibly with focal epilepsy, weakness or severe numbness of half of the body, movement disorders, intense one-sided pain in the gastrocnemius muscle and acute abdomen.

Oncological diseases. Hormonal contraceptives containing estrogen stimulate the growth of hormone-dependent tumors. Therefore, the use of hormonal contraceptives in patients with such tumors is contraindicated. A number of studies have been conducted with the participation of women taking oral contraceptives to investigate the incidence of ovarian, endometrial, cervical and breast cancer. According to the results obtained, oral contraceptives provide good protection against the development of both ovarian cancer and endometrial cancer.

Some studies have reported an increased risk of cervical cancer in women who have taken hormonal contraceptives for a long time, but research results are highly controversial. In the development of cervical cancer, sexual behavior (for example, the difference in the number of sexual partners or the use of barrier contraceptives) and other factors (for example, infection with the human papillomavirus (HPV)) play a significant role.

Studies have shown that the relative risk of developing breast cancer is higher in women taking oral hormonal contraceptives.

The additional risk gradually disappears within 10 years after the termination of the use of the PDA. Breast cancer is rare in women under the age of 40, and the additional incidence of breast cancer in women currently or recently taking COCs is small compared to the overall risk. There was no evidence of a causal relationship in these studies. Higher rates of breast cancer detection may be associated with earlier detection of breast cancer in women taking COCs, the biological effect of such contraceptives, or a combination of both. Breast cancer in women who have ever used such contraceptives is usually clinically less severe than in women who have never used such contraceptives.

The risk increases with age. The incidence of breast cancer in women taking the pill is low, and taking the pill can be considered one of many risk factors. Nevertheless, a woman should be informed about the risk of developing breast cancer, and the decision to take the preparation should be made based on an assessment of the benefit / risk ratio (CPC provide good protection against ovarian and endometrial cancer).

There are few reports of the development of benign or malignant liver tumors in women taking oral contraceptives for a long time. This should be borne in mind in the differential diagnostic assessment of abdominal pain, which may be associated with an increase in the size of the liver or intra-abdominal bleeding.

Other conditions. Women with a family history of hypertriglyceridemia or such a disease are at increased risk of pancreatitis when using COCs.

Although many women taking COCs have a slight increase in blood pressure, a clinically significant increase in this indicator is very rare. The connection between the reception of the PDA and the AG has not been established. However, with the development of persistent clinically significant hypertension in women taking COCs, it is advisable to stop taking COCs and start treatment for hypertension. If it is possible to achieve normal blood pressure with the help of antihypertensive therapy, then you can resume taking the PDA (if it is considered appropriate).

It was reported that the following conditions occurred or worsened during pregnancy or when taking PDAs, however, their relationship with taking birth control pills has not been proven: jaundice and / or itching due to cholestasis; the formation of gallstones; porphyria, systemic lupus erythematosus, hemolytic uremic syndrome, Sydenham's chorea, herpes of pregnancy, hearing loss associated with otosclerosis, hereditary angioedema.

Acute or chronic abnormalities in liver function may require discontinuation of COCs until liver function indicators return to normal. Recurrence of cholestatic jaundice that occurs during pregnancy or previous use of sex steroid hormones requires discontinuation of COCs.

Although COCs can affect peripheral insulin resistance and glucose tolerance, there is no evidence of the need to change the dosage regimen for patients with diabetes mellitus and taking COCs. Nevertheless, while taking a PDA, it is necessary to carefully monitor the condition of patients with diabetes mellitus.

The development of Crohn's disease and ulcerative colitis is associated with the use of PDAs.

Novynette contains lactose. Patients with rare hereditary galactose intolerance, lactase deficiency or malabsorption of glucose-galactose should take this into account.

The above information should be taken into account when choosing the method (s) of contraception.

Medical checkup. Before starting to use or re-prescribing an oral contraceptive, it is necessary to carefully study the family and personal history of the patient, conduct a physical and gynecological examination, including measuring blood pressure, laboratory tests, examination of the mammary glands, pelvic organs, cytological analysis of a cervical smear. Such a survey should be carried out regularly. Pregnancy should be excluded.

Periodic medical examination is also important given the contraindications and risk factors that may be identified during the initial period of oral contraceptive use.

It should be warned that oral contraceptives do not protect against HIV / AIDS and other sexually transmitted diseases.

Changes in laboratory parameters. Under the influence of oral contraceptive pills, due to the content of the estrogenic component, some laboratory parameters may change, including the functional parameters of the liver, kidneys, adrenal glands, thyroid gland, coagulation and hemostasis indicators, the levels of lipoproteins and transport proteins in the blood plasma.

Chloasma. Chloasma can develop, especially in women with a history of pregnant chloasma. Women who are at risk of chloasma should avoid direct sunlight or ultraviolet radiation while taking COCs.

Decreased efficiency. The effectiveness of the PDA may decrease in cases of missed tablets, vomiting, or the simultaneous use of other preparations.

Missed pills. If the patient has forgotten to take a pill at the usual time, this should be done within 12 hours. The next pills should be taken at the usual time. In such cases, there is no need for additional contraceptive measures.

If one or more tablets are not taken within 12 hours, the contraceptive effect of the preparation will be reduced. The woman should take the last missed pill, even if it means taking 2 pills in one day, and continue to take the pills at the usual time. In such cases, additional contraceptive methods will be required over the next 7 days.

Vomiting and diarrhea. If vomiting or diarrhea occurs after taking the preparation, its absorption may be reduced. If the symptoms have stopped within 12 hours, you should additionally take another 1 tablet from the backup package, and then continue taking the tablets from the old package as usual. If symptoms persist for more than 12 hours, additional contraceptive methods must be used until the function of the stomach and intestines normalizes and for the next 7 days.

Simultaneous use of preparations. If the patient is taking other preparations that can reduce the contraceptive effect of Novynette   tablets, an additional method of contraception should be used while taking this preparation.

When taking Novynette   tablets, you should not take herbal preparations containing St. John's wort (Hypericum perforatum), due to a possible decrease in the concentration of active substances in the blood plasma and a decrease in the clinical effect of Novynette tablets (see INTERACTIONS).

The contraceptive effect may decrease if, after several months of taking Novynette , irregular, spotting or breakthrough bleeding appears. If withdrawal bleeding does not occur or bleeding disorders occur, then pregnancy is unlikely and you should continue taking the pills until the end of the next package. If at the end of the second cycle, withdrawal bleeding does not occur or bleeding disorders persist, you should stop taking the pills and resume it only after excluding pregnancy.

Insufficient cycle control. In the case of taking any PDA, irregular bleeding (spotting or breakthrough bleeding) may occur, especially during the first months of using the preparation. In this regard, the assessment of any irregular bleeding is significant only after an adaptation period of approximately 3 cycles. With persistent irregular bleeding or their appearance with regular cycles, non-hormonal causes should be considered and appropriate diagnostic measures should be taken to exclude a malignant tumor or pregnancy, including diagnostic curettage.

In some women, after a break in taking the preparation, withdrawal bleeding may not occur. If the PDA was used according to the section APPLICATION, then pregnancy is unlikely. However, if the instructions in the APPLICATION section before the first absence of withdrawal bleeding were not followed, or if there are no consecutive 2 withdrawal bleeding, then pregnancy should be excluded before continuing to take the PDA.

Use during pregnancy and lactation. Novynette  is contraindicated during pregnancy. Before you start taking Novynette , you must exclude pregnancy. If you become pregnant while taking Novynette , the preparation should be canceled immediately.

It is known that the incidence of congenital malformations in children whose mothers used oral contraceptives before pregnancy does not increase, and no teratogenic or mutagenic effect has been revealed when taking pills in the early stages of pregnancy.

Oral contraceptives can reduce the amount of breast milk and change its composition, in addition, they are excreted in breast milk (there is no evidence of undesirable effects on the health of the newborn), therefore their use during breastfeeding is not recommended.

Children. Novynette  is not intended for use in children.

The ability to influence the reaction rate when driving and working with other mechanisms. The effect of Novynette  on the ability to drive vehicles and work with other mechanisms has not been identified, but the possibility of adverse reactions such as headache and dizziness should be considered (see SIDE EFFECTS).

Interactions

Preparation interactions can lead to breakthrough bleeding and / or a decrease in the effectiveness of contraceptive action. this has been found for preparation sthat induce microsomal enzymes, which leads to increased clearance of sex hormones (eg hydantoin, barbiturates, primidone, carbamazepine, rifampicin, rifabutin and oxcarbazepine, possibly topiramate, felbamate, ritonavir, griseofulvin, and preparations). the maximum level of induction is usually achieved no earlier than 2-3 weeks after the start of treatment, but can continue up to 4 weeks after discontinuation of the preparation. when using preparations that induce microsomal enzymes, a barrier method of contraception should be used in addition to PDA during the entire course of treatment and for 28 days after stopping their use.

It has also been found that antibiotics, such as ampicillin and tetracycline, reduce the contraceptive effect, but the mechanism of interaction has not been elucidated. Women who are taking any of these preparations need to additionally use a barrier or other method of contraception.

Women who receive antibiotics (except for rifampicin and griseofulvin) must additionally use a barrier method of contraception during the entire course of treatment and for 7 days after stopping the antibiotic.

If the duration of the concomitant medication is longer than the number of birth control pills in the pack, start the next pack without interruption.

Experts recommend increasing the dose of steroid contraceptive for women receiving long-term treatment with preparations that induce liver enzymes. If a high dose of contraceptive is not recommended, or insufficient, or dangerous (for example, leads to irregular bleeding), it is recommended to use another method of contraception.

Herbal preparations containing St. John's wort (Hypericum perforatum) can lead to a loss of contraceptive action with the preservation of such an effect for at least 2 weeks after stopping treatment with St. John's wort.

Oral contraceptives can decrease glucose tolerance and increase the need for insulin or oral antidiabetic preparations.

Oral contraceptives can interfere with the metabolism of other medicines. Accordingly, their concentrations in blood plasma and tissues may increase (for example, cyclosporine) or decrease (for example, lamotrigine).

Overdose

After taking oral contraceptives at a high dose, there were no serious adverse reactions. symptoms that may occur in this case: nausea, vomiting, in young girls - slight vaginal bleeding. however, if an overdose is detected within the first 2-3 hours or a large number of tablets have been taken, gastric lavage should be performed. there is no antidote, symptomatic treatment should be used.

Storage conditions

At a temperature not higher than 30 ° C.