New contraceptive effect. Use in old age

Film-coated tablets light yellow color, round, biconvex, marked “P9” on one side and “RG” on the other.

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

Pharmacological action

Monophasic hormonal contraceptive This is an oral preparation containing a combination of estrogen (ethinyl estradiol) and a progestin (desogestrel). Basics contraceptive effect consists of inhibiting gonadotropins and suppressing ovulation. In addition, by increasing the viscosity of the cervical fluid, the movement of sperm through cervical canal, and changes in the condition of the endometrium prevent the implantation of a fertilized egg.

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

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

Indications for use

oral contraception;
functional disorders of the menstrual cycle;
premenstrual syndrome.

Directions for use and doses

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

Start taking the drug

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

Delay of the menstrual cycle

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

Missed pills

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

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

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

Vomiting or nausea

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

Side effect

Side effects requiring discontinuation of the drug:

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

Other side effects are more common, but less severe:

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

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

Contraindications

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

Carefully the drug should be prescribed for conditions that increase the risk of developing venous or arterial thrombosis/thromboembolism: age over 35 years, smoking, family history, obesity (body mass index more than 30 kg/m2), dyslipoproteinemia, arterial hypertension, migraine, epilepsy, valve defects heart, atrial fibrillation, prolonged immobilization, extensive surgical intervention, surgery on the lower extremities, severe trauma, varicose veins veins and superficial thrombophlebitis, postpartum period, presence of severe depression (including a history), changes biochemical parameters(activated protein C resistance, hyperhomocysteinemia, antithrombin III deficiency, protein C or S deficiency, antiphospholipid antibodies, including antibodies to cardiolipin, including lupus anticoagulant), diabetes mellitus, uncomplicated vascular disorders, SLE, Crohn's disease, ulcerative colitis, sickle cell anemia, hypertriglyceridemia (including family history), acute and chronic liver diseases.

Use of Novinet during pregnancy and breastfeeding

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

Use for liver and kidney dysfunctions

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

special instructions

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

The drug is a reliable contraceptive: the Pearl index (an indicator of the number of pregnancies that occurred during the use of a contraceptive method in 100 women over 1 year) with correct use is about 0.05.

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

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

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

Thromboembolic diseases

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

The risk of arterial or venous thromboembolic disease increases:

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

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

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

It should be borne in mind that diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, Crohn's disease, ulcerative colitis, sickle cell anemia increase the risk of developing venous thromboembolic disease.

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

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

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

Tumor diseases

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

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

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

Chloasma

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

Efficiency

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

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

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

Changes in laboratory parameters

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

Additional Information

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

For diarrhea or intestinal disorders, vomiting, the contraceptive effect may be reduced. While continuing to take the drug, it is necessary to use additional non-hormonal methods of contraception.

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

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

Impact on the ability to drive vehicles and operate machinery

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

Overdose

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

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

Drug interactions

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

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

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

The choice of contraceptive method for women after 45 years of age, i.e., in the so-called “transition” period, is often quite difficult task due to the peculiarities of this age period associated with the inevitable processes of gradual decline of ovarian function, the presence of a number of gynecological and extragenital diseases, the appearance of vegetative-vascular and other early symptoms menopause. Despite the fact that in this age period Fertility is declining; births in women over 45 are not that uncommon. According to statistics, in countries Western Europe up to 30% of women aged 45-54 years have a regular menstrual cycle and are able to conceive. Moreover, against the background of a regular rhythm of menstruation, the frequency ovulatory cycles reaches 70-95%, and with oligomenorrhea - up to 34%. By this age, many women are already deciding on the number of children in the family; Situations such as remarriage, accidents with children and the need for childbirth occur quite rarely. In most cases, the onset of pregnancy makes one think about abortion.

Abortions in premenopausal women are much more often accompanied by various complications; the frequency of the latter is two to three times higher than that in women reproductive age. Often after an abortion, inflammatory diseases of the genital organs, complications associated with the presence of uterine fibroids, endometriosis, and exacerbation of extragenital pathology occur. It has been proven that abortion performed in the “transition” period often provokes severe course climacteric syndrome and is the background for the development hyperplastic processes in target organs - the uterus and mammary glands.

When choosing a method of contraception in this age period, in addition to the need reliable prevention abortion, the question arises of how to avoid influencing the metabolic processes that have undergone (or are undergoing) age-related changes on the background high sensitivity female body to exogenous influences. Prevention and treatment initial symptoms climacteric syndrome and, if possible, slowing down the aging process are among the main objectives of contraception at this age.

Of course, hormonal contraceptives (HCs) are the most promising in this regard, but before the advent of modern hormonal drugs, including microdosing formulations and releasing systems, the use of HA has been associated with a number of problems.

Over the 40-year period of its development, hormonal contraception has established itself not only as one of the most effective ways pregnancy prevention, but also as new, promising direction medicine. Oral contraceptives (OCs) are widely used throughout the world. IN last years More and more new combined oral contraceptives (COCs) are being developed. At the end of the 80s. OCs with higher gestagen selectivity for progesterone receptors were synthesized - these are desogestrel, norgestemate and gestodene.

Recent studies have shown that modern microdosing drugs latest generation do not have or have a minimal metabolic effect on the female body. Because of this, they can be used by non-smoking women after 40 years of age in the absence of risk factors associated with hypercoagulability (WHO, 1996). Such risk factors when using any types of hormonal contraception These include, first of all, cardiovascular diseases, liver diseases, heavy smoking in combination with taking COCs.

It should be remembered that hormonal contraceptives are contraindicated if there is a history of thromboembolism, cardiovascular pathology, severe diabetes mellitus, or malignant neoplasms of the reproductive system.

In the absence of the listed contraindications, microdosed drugs can be used quite widely. They are not only highly reliable, but also have a protective effect, including symptoms of menopausal syndrome, which are quickly relieved.

Known positive influence estrogen on brain function and emotional condition in women in perimenopause. In addition, numerous studies have confirmed the positive effects of oral contraceptives on cognitive processes, improving memory and mood. It has been found that the estrogen component of OCs reduces the concentration of monoamine oxidase (MAO), which leads to an increase in serotonin levels, as well as brain excitability and thereby improves mood.

We studied the effectiveness and feasibility of using the microdose combined oral contraceptive (COC) Novinet in premenopausal women.

Microdosed COC containing 20 mcg ethinyl estradiol and 0.150 mg desogestrel. The drug contains a third generation progestogen, which is a derivative of levonorgestrel, desogestrel, which has high selectivity for progesterone receptors and high progestogenic activity.

A distinctive feature of the drug is the minimal content of the estrogen component, which significantly reduces the risk of developing estrogen-dependent side effects. Under the influence of the drug, the release of FSH and LH is mainly prevented, which interferes with the ovulation process. The effect is enhanced by increasing viscosity cervical mucus, which makes it difficult for sperm to penetrate the uterine cavity.

We observed 35 somatically healthy women aged 44 to 47 years ( average age 45.4+0.4 years), with no contraindications to hormonal contraception. In addition to the general clinical study, we measured blood pressure(BP) and body weight, blood test for hemostasis and lipid spectrum, extended colposcopy, cytological examination smears from the surface of the cervix and cervical canal, ultrasonography pelvic organs.

Dynamic monitoring of patients was carried out every three, six and 12 months from the moment they started using contraception. No menstrual cycle irregularities were detected; only in six (17.1%) patients the cycle duration was reduced to 21 days, which is apparently due to hormonal changes organism.

During treatment, not a single case of pregnancy was registered, i.e., the contraceptive effectiveness of the drug was 100%. Novinet had a regulating effect on the menstrual cycle, which was expressed in establishing a cycle duration of 25-27 days in all patients. Average duration the menstrual cycle was 27.5 + 0.3 days. Menstrual-like reactions lasted 3.4+0.3 days, scanty menstrual-like discharge was observed in three (8.6%) women. Eight women dated adverse reactions: in the form of intermenstrual bleeding (two cases), engorgement of the mammary glands (six cases).

All adverse reactions disappeared during the first two to three months of using COCs and did not require therapeutic measures.

Four women who experienced physical discomfort (weakness) experienced emotional discomfort ( Bad mood) before contraception was prescribed significant improvement condition in the second month after starting contraception. It should be noted that in four patients with premenstrual syndrome after three months of using Novinet, a positive effect was also observed.

There were no significant changes in body weight while taking the drug.

The initial blood lipid parameters of the patients before using Novinet were normal. After 12 months, there was a trend towards an increase in HDL, which has anti-atherogenic potential, and a decrease in LDL, which has atherogenic potential.

The studies also showed that there was no negative dynamics changes in the blood coagulation system.

Studies of the condition of the cervix when using the complex are the most informative methods studies did not reveal any pathological changes.

Thus, the results of the study indicate that the modern microdosed COC Novinet is highly effective contraceptive, is well tolerated by premenopausal women, does not have a significant effect on blood pressure, body weight, blood lipid spectrum and hemostasis, and also allows achieving therapeutic effect in patients with premenstrual syndrome and women experiencing emotional discomfort due to age-related (hormonal) changes in the body.

Based on materials from the magazine “Attending Doctor”

Novinet (ethinyl estradiol + desogestrel) is a combined tablet contraceptive from the Hungarian pharmaceutical company GEDEON RICHTER. According to statistics, about 40% of women do not use pharmacological agents contraception. Meanwhile, from the point of view of embryology, human life begins with the fusion of the germ cells of a woman and a man, resulting in the formation of a nucleus containing unique genetic material. And this new human body genetically can in no way be considered an alien (i.e. maternal) part of the body. Thus, abortion should be considered the deliberate taking of the life of a new biological individual. Combined pill contraceptives have been used for several decades. Progestogens of the first two generations do not have the proper level of selectivity of action. In addition, they are characterized by a number of undesirable side reactions, incl. arterial hypertension, deterioration of lipid profile and insulin resistance. Desogestrel does not have the above disadvantages. This substance is one of the components of the drug Novinet. The estrogenic component in the drug is ethinyl estradiol. Desogestrel is a 3rd generation progestogen. It has high (more than 80% bioavailability). It undergoes metabolic transformations in the liver with the formation of an active derivative - 3-ketodesogestrel. Greatest degree Desogestrel exhibits selectivity to progesterone receptors, which determines its powerful gestagenic effect.

At the same time, its androgenic and estrogenic effect is practically not manifested. Among all currently known progestogens, desogestrel has the highest selectivity index. New improves lipid profile: increases the level of “good” cholesterol in the blood - lipoproteins high density without affecting the level of low-density lipoproteins. When using Novinet, blood loss during menstruation is significantly reduced, and the condition of the skin improves, especially in the presence of acne. The effectiveness of Novinet as a contraceptive is associated with its ability to suppress the functioning of the ovaries, including inhibiting the formation of follicles. From this point of view, Novinet is one of the best contraceptives. The incidence of side effects when taking this contraceptive is relatively low. This usually happens during the first three months of pharmacotherapy, when the body adapts to functioning in new conditions. Wherein side effects do not pose any threat to the health and well-being of the patient and almost completely disappear by the fourth cycle of contraceptive pharmacotherapy. A side effect characteristic of tablet contraceptives - weight gain - in the case of Novinet appears much less frequently. The drug has very little effect on hemodynamics in the peripheral vascular bed, and therefore does not have a pronounced effect on blood pressure levels.

Pharmacology

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

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

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

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

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

Pharmacokinetics

Desogestrel

Suction

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

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).

V d is 1.5 l/kg. C ss is established by the second half of the menstrual cycle, when the level of 3-keto-desogestrel increases 2-3 times.

Metabolism

In addition to 3-keto-desogestrel (which is formed in the liver and in the intestinal wall), other metabolites are formed: 3α-OH-desogestrel, 3β-OH-desogestrel, 3α-OH-5α-H-desogestrel (first phase metabolites). These metabolites do not have pharmacological activity and partially, by conjugation (the second phase of metabolism), are converted into polar metabolites - sulfates and glucuronates. Clearance from blood plasma is about 2 ml/min/kg body weight.

Removal

T1/2 is 30 hours. Metabolites are excreted in the urine and feces (in a ratio of 4:6).

Ethinyl estradiol

Suction

Ethinyl estradiol is quickly and completely absorbed from the gastrointestinal tract. Cmax is achieved 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 completely bound to plasma proteins, mainly albumin.

Vd is 5 l/kg. C ss 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. Bypassing the intestinal wall (first phase of metabolism), it undergoes conjugation in the liver (second phase of metabolism). Ethinyl estradiol and its conjugates of the first phase of metabolism (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 24 hours. About 40% is excreted in the urine and about 60% in feces.

Release form

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

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

Compound film shell: propylene glycol, macrogol 6000, hypromellose.

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

Dosage

The drug is prescribed orally.

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

First dose of the drug

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

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

Taking the drug after childbirth

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

Taking the drug after an abortion

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

Switching from another oral contraceptive

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

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

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

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

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

Delay of the menstrual cycle

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

Missed pills

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

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

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

Vomiting/diarrhea

Overdose

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

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

Interaction

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

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

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

Side effects

Side effects requiring discontinuation of the drug

From the cardiovascular system: arterial hypertension; rarely - arterial and venous thromboembolism (including myocardial infarction, stroke, deep vein thrombosis of the lower extremities, pulmonary embolism); very rarely - arterial or venous thromboembolism of the hepatic, mesenteric, renal, retinal arteries and veins.

From the senses: hearing loss caused by otosclerosis.

Other: hemolytic-uremic syndrome, porphyria; rarely - exacerbation of reactive systemic lupus erythematosus; very rarely - Sydenham's chorea (passing after discontinuation of the drug).

Other side effects are more common but less severe. The advisability of continuing to use the drug is decided individually after consultation with a doctor, based on the benefit/risk ratio.

From the reproductive system: acyclic bleeding/bloody discharge from the vagina, amenorrhea after discontinuation of the drug, changes in the state of vaginal mucus, the development of inflammatory processes in the vagina, candidiasis, tension, pain, enlarged mammary glands, galactorrhea.

From the digestive system: nausea, vomiting, Crohn's disease, ulcerative colitis, the occurrence or exacerbation of jaundice and/or itching associated with cholestasis, cholelithiasis.

Dermatological reactions: erythema nodosum, exudative erythema, rash, chloasma.

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

On the part of the organ of vision: increased sensitivity of the cornea (when wearing contact lenses).

Metabolism: fluid retention in the body, change (increase) in body weight, decreased tolerance to carbohydrates.

Other: allergic reactions.

Indications

Contraception.

Contraindications

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

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

Application features

Use during pregnancy and breastfeeding

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

Use for liver dysfunction

Contraindicated in severe liver diseases, cholestatic jaundice (including during pregnancy), hepatitis, incl. history (before normalization of functional and laboratory parameters and within 3 months after their normalization). The drug should be used with caution in acute and chronic diseases liver.

Use for renal impairment

With caution and only after a thorough assessment of the benefits and risks of use, the drug should be prescribed for renal failure (including a history),

special instructions

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

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

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

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

Thromboembolic diseases

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

The risk of arterial or venous thromboembolic disease increases:

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

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

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

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

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

Tumor diseases

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

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

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

Efficiency

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

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

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

Changes in laboratory parameters

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

Additional Information

After acute viral hepatitis, the drug should be taken after normalization of liver function (no earlier than 6 months).

With diarrhea or intestinal disorders, vomiting, the contraceptive effect may be reduced. While continuing to take the drug, it is necessary to use additional non-hormonal methods of contraception.

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

Impact on the ability to drive vehicles and operate machinery

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

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

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

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

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

Shell composition: propylene glycol, macrogol 6000, hypromellose.

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

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

Pharmacological action Novinet

A monophasic hormonal contraceptive for oral administration containing a combination of estrogen (ethinyl estradiol) and a progestin (desogestrel). Inhibits 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, involved together with the hormone corpus luteum in the formation of the menstrual cycle. Prevents the maturation of an egg capable of fertilization.

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

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

When taking the drug, the loss of menstrual blood is significantly reduced. Regular use of the drug normalizes the menstrual cycle and helps prevent the development of a number of gynecological diseases, including cancer.

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

Pharmacokinetics of the drug.

Desogestrel

Suction

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

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

Distribution

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

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

Metabolism

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

Removal

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

Ethinyl estradiol

Suction

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

Distribution

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

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

Metabolism

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

Removal

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

Indications for use:

Oral contraception.

Dosage and method of administration of the drug.

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

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

If the first tablet is taken on day 1 of the menstrual cycle, then additional methods of contraception are not required. You can start taking pills from the 2-5th day of menstruation, but in this case, in the first cycle, additional methods of contraception should be used in the first 7 days of taking the pills.

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

After childbirth, non-breastfeeding women can be prescribed the drug after 21 days. In this case, there is no need to use other methods of contraception. If the drug is prescribed later than 21 days after birth, then additional methods of contraception must be used in the first 7 days of administration. If in postpartum period sexual contact preceded oral contraception, then you need to wait until your first menstruation to take the pills. 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).

On the metabolic side: fluid retention in the body, changes in body weight, decreased tolerance to carbohydrates.

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

Contraindications to the drug:

Pregnancy or suspicion of it;

Arterial hypertension is severe or moderate;

Familial forms of hyperlipidemia;

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

IHD, decompensated heart defects, myocarditis;

Diabetic angiopathy (including retinopathy);

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

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

Genital bleeding of unknown etiology;

Systemic lupus erythematosus (including history);

Genital herpes, pregnancy herpes;

Severe skin itching;

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

Hypersensitivity to the components of the drug.

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

Use during pregnancy and lactation.

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

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

The use of Novinet is contraindicated during lactation (breastfeeding), because the drug reduces secretion breast milk, changes its composition. 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 pills are missed, with vomiting and diarrhea, as well as with simultaneous administration with other medicines.

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

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 a violation of 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 thrombosis.

Pregnancy represents greater risk thrombus formation rather than taking hormonal contraceptives.

Reception of Novinet should be stopped immediately in the following cases:

The onset of a severe headache for the first time or an increase in common migraines;

Acute deterioration in 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 an increase in epileptic seizures;

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

Development of pregnancy.

Impact on the ability to drive vehicles and operate machinery

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

Drug overdose:

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

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

Interaction of Novinet with other drugs.

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

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

When Novinet is used simultaneously with oral hypoglycemic drugs or insulin, the 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.

If you have any difficulties or problems, you can contact a certified specialist who will definitely help!

"Novineta" are the following diseases and violations:

Migraine accompanied by neurological symptoms;

Diabetes mellitus with angiopathy;

Cardiovascular diseases and venous thromboembolism;

Hepatitis, severe diseases and liver tumors;

Cholestatic jaundice, including those caused by taking glucocorticosteroid drugs;

Pancreatitis;

Dyslipidemia;

Cholelithiasis;

Otosclerosis or severe itching observed during a previous pregnancy or taking glucocorticosteroids;

Malignant neoplasms of the mammary glands and genital organs, accompanied by hormonal disorders;

Rotor, Dubin-Johnson or Gilbert syndrome;

Vaginal bleeding of unknown origin.

In addition, Novinet is contraindicated during pregnancy or suspected pregnancy, during breastfeeding and during hypersensitivity to the components. Also, this hormonal contraceptive is not prescribed to women over 35 years of age who have a nicotine addiction.

Side effects of Novinet

Side effects of Novinet are divided into two main groups. The first includes adverse reactions, the occurrence of which requires immediate discontinuation of the drug, and the second includes less serious negative effects.

Side effects due to which the use of Novinet should be discontinued include:

Arterial hypertension, arterial and venous thromboembolism;

Exacerbation of otosclerosis leading to hearing loss;

Hemolytic-uremic syndrome;

Porphyria.

Less severe side effects of Novinet may appear as:

Nausea, vomiting, ulcerative colitis, jaundice, itching, cholelithiasis;

Headache and migraine;

Depression, sudden mood changes;

Vaginal bleeding;

Development of inflammatory processes in the vagina;

Amenorrhea;

Enlarged mammary glands;

Galactorrhea;

Candidiasis;

Development of erythema, chloasma or rash;

Increased body weight and fluid retention in the body.

In women using contact lenses, Novinet may cause increased sensitivity of the cornea. In patients with hypersensitivity to artificially synthesized estrogen and gestagen, the drug can provoke the development allergic reactions.

Tip 2: "Novinet": instructions for use, reviews of the drug

"Novinet" is a monophasic oral contraceptive. The drug suppresses ovulation by changing the endometrium, as a result of which the mucus produced by the cervix thickens, and it becomes impermeable to sperm.

Instructions for use of "Novinet"

"Novinet" is used to prevent unwanted messages. The drug is started on the first day of menstruation and continues to drink one tablet daily for 21 days. At the end of the course, you need to take a week break, after which the course of taking Novinet is resumed. During week break must begin menstrual bleeding. The drug continues to be taken regardless of whether menstruation has ended or not. After Novinet they start drinking from the first day after the operation.

"Novinet" contains the hormones estrogen ethinyl estradiol and progestogen desogestrel.

Take the drug at the same time of day, do not allow a break of more than 12 hours. In this case, they take two "Novineta" at once and use other methods of contraception during the week. If the drug was missed on the first day of menstruation, the course begins on the second or fifth day. However, in this case, the drug exhibits a low contraceptive effect, so additional methods of protection against should be used within a week.

In addition to the contraceptive effect, the drug has therapeutic effect: it evens out the menstrual cycle, reduces blood loss, reduces inflammatory processes in the female genitals. According to reviews, after using Novinet, the condition of the skin improves, the risk of developing tumors in the breast is reduced.