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 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 organism 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. Desogestrel exhibits the greatest degree of selectivity towards 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. Novine improves the lipid profile: it increases the level of “good” cholesterol in the blood - high-density lipoproteins, 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 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. At the same time, side effects do not pose any threat to the health and well-being of the patient and disappear almost completely 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, and weak androgenic and anabolic activity.
The drug has a beneficial effect on lipid metabolism: it increases the HDL content in plasma without affecting the LDL content.
When taking the drug, the loss of menstrual blood is significantly reduced (in case of initial menorrhagia), the menstrual cycle is normalized, and a beneficial effect on the skin is noted, especially in the presence of acne vulgaris.
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).
Vd 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 are partially converted, through conjugation (the second phase of metabolism), 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.
Film shell composition: 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. Prescribe 1 tablet/day for 21 days, if possible at the same time of day. After taking the last tablet from the package, take a 7-day break, during which menstrual-like bleeding occurs due to drug withdrawal. The next day after a 7-day break (4 weeks after taking the first tablet, on the same day of the week), resume taking the drug from the next package, also containing 21 tablets, even if the bleeding has not stopped. This pill regimen is followed as long as there is a need for contraception. If you follow the rules of administration, the contraceptive effect remains during the 7-day break.
First dose of the drug
The first tablet should be taken on the first day of the menstrual cycle. In this case, it is not necessary to use additional methods of contraception. You can start taking pills from the 2-5th day of menstruation, but in this case, in the first cycle of using the drug, you must use additional methods of contraception in the first 7 days of taking the pills.
If more than 5 days have passed since the start of menstruation, you should delay starting the drug until your next menstruation.
Taking the drug after 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
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.
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
Medicines that induce liver enzymes, such as hydantoin, barbiturates, primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, felbamate, griseofulvin, St. John's wort preparations, reduce the effectiveness of oral contraceptives and increase the risk of breakthrough bleeding. The maximum level of induction is usually achieved no earlier than 2-3 weeks, but can last up to 4 weeks after discontinuation of the drug.
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.
Features of application
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 prescribed with caution for acute and chronic liver diseases.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.
The woman's health condition must be carefully monitored. If any of the following conditions/diseases appear or worsen while taking the drug, you must stop taking the drug and switch to another, non-hormonal method of contraception:
- diseases of the hemostatic system;
- conditions/diseases predisposing to the development of cardiovascular and renal failure;
- epilepsy;
- migraine;
- the risk of developing an estrogen-dependent tumor or estrogen-dependent gynecological diseases;
- diabetes mellitus not complicated by vascular disorders;
- severe depression (if depression is associated with a violation of tryptophan metabolism, then vitamin B 6 can be used for correction);
- sickle cell anemia, because in some cases (for example, infections, hypoxia), estrogen-containing drugs for this pathology can provoke thromboembolism;
- 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.
It should be taken into account that resistance to activated protein C, hyperhomocysteinemia, protein C and S deficiency, antithrombin III deficiency, and the presence of antiphospholipid antibodies increase the risk of developing arterial or venous thromboembolic diseases.
When assessing the benefit/risk ratio of taking the drug, it should be taken into account that targeted treatment of this condition reduces the risk of thromboembolism. Symptoms of thromboembolism are:
- sudden chest pain that radiates to the left arm;
- sudden shortness of breath;
- any unusually severe headache that continues for a long time or appears for the first time, especially when combined with sudden complete or partial loss of vision or diplopia, aphasia, dizziness, collapse, focal epilepsy, weakness or severe numbness of half the body, movement disorders, severe unilateral pain in the calf muscle, acute abdomen.
Tumor diseases
Some studies have reported an increased incidence of cervical cancer in women who took hormonal contraceptives for a long time, but the results of the studies are inconsistent. Sexual behavior, infection with the human papillomavirus and other factors play a significant role in the development of cervical cancer.
A meta-analysis of 54 epidemiological studies found that there is a relative increase in the risk of breast cancer among women taking oral hormonal contraceptives, but the higher detection rate of breast cancer may have been associated with more regular medical screening. Breast cancer is rare among women under 40, whether they 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.
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.
The auxiliary components of Novinet include: E 104 (quinoline yellow dye), α-tocopherol, magnesium stearate, povidone, colloidal silicon dioxide, potato starch, stearic acid, lactose monohydrate.
Composition p/o: hypromellose, macrogol 6000, propylene glycol.
Release form
Tablets po (20 + 150) mcg. Packaged in blisters, packaging No. 21 or No. 63.
pharmachologic effect
Estrogen-progestogen, contraceptive .
Pharmacodynamics and pharmacokinetics
The drug contains synthetic estrogenic And progestational components , which are more active than natural sex hormones .
The effect is achieved primarily by preventing the release of pituitary hormones follitropin And luteotropin , which interferes with the process ovulation . Its intensification is facilitated by the increased viscosity of the mucus in the cervical canal and, consequently, its relative impassability for sperm.
A distinctive feature of Novinet tablets is that estrogenic component is present in them in minimal concentration, which reduces the risk of estrogen-dependent side effects (pain in the mammary glands, thromboembolic complications, nausea, weight gain, etc.).
Desogestrel represents gestagen II generation. The substance has a beneficial effect on lipid metabolism, maintaining cholesterol balance and normalizing lipid profile parameters.
In addition, against the background of the use of tablets:
- blood loss is reduced;
- skin condition improves;
- the cycle of menstrual days is normalized;
- the risk of developing gynecological diseases (including diseases of a tumor nature) is reduced.
Ethinyl estradiol And desogestrel absorbed in the proximal small intestine. Absorption is fast and almost 100%. Main product of metabolism desogestrel is 3-keto-desogestrel, its other metabolites are pharmacologically inactive.
Bioavailability ethinyl estradiol - 60%. For desogestrel this figure varies from 62 to 81%. Both substances have a high degree of binding to plasma proteins (more than 90%). Their concentration in the blood reaches maximum values 1-1.5 hours after taking the tablet.
The components of the drug are well distributed in tissues and organs, while ethinylestradiol characterized by the ability to accumulate in adipose tissue. About a tenth of the dose taken passes into the milk of a nursing woman.
T1/2 - on average 24 hours, desogestrel - on average 30 hours.
Metabolic products desogestrel excreted by the kidneys. Metabolic products ethinyl estradiol eliminated in urine and bile.
Indications for use
Prevention from pregnancy.
Contraindications
Contraindications to the use of tablets are:
- increased sensitivity to its constituent substances;
- thrombosis/thromboembolism of veins/arteries ;
- presence of precursors ;
- with manifestations of focal neurological symptoms;
- complicated by vascular pathologies ;
- increased risk veins/arteries;
- with severe hypertriglyceridemia;
- serious liver pathologies (taking pills is contraindicated until the functional parameters of the organ return to normal);
- tumor lesion of the liver ;
- hormone-dependent tumors (identified or suspected);
- vaginal bleeding, the nature of which cannot be determined;
- otosclerosis ;
- smoking;
- age over 35 years;
- pregnancy;
- breast-feeding.
Side effects
Side effects of Novinet appear:
- acyclic vaginal discharge;
- after stopping the pills;
- changes in the state of mucus in the vagina;
- development of inflammatory processes in the vagina;
- soreness, tension and enlargement of the mammary glands, secretion of milk from them;
- nausea;
- vomiting;
- jaundice and/or itching associated with cholestasis;
- ulcerative colitis ;
- erythema nodosum or exudative ;
- chloasma ;
- skin rashes;
- headaches;
- mood swings;
- migraine ;
- depression ;
- increased sensitivity of the cornea to contact lenses;
- fluid retention in the body;
- decreased tolerance to carbohydrates;
- change in body weight towards its increase;
- hypersensitivity reactions.
If the above symptoms appear, the question of the advisability of further taking the drug is decided on an individual basis.
Severe side effects of Novinet, which require immediate discontinuation of the drug:
- acute blockage of veins/arteries by blood clots (rarely - , DVT, PE, etc.; extremely rarely - acute blockage of large retinal and mesenteric vessels, veins and arteries of the liver, kidneys);
- otosclerosis and, as a consequence, hearing loss;
- exacerbation of Libman-Sachs disease (rarely);
- Sydenham's chorea (develops extremely rarely, symptoms disappear after stopping taking the pills);
- porphyria .
Novinet tablets: instructions for use
Novinet should be used with caution in combination with:
- tricyclic antidepressants ;
- indanedionic anticoagulants or coumarin series ;
- β-adrenergic receptor blockers ;
- hepatotoxic agents (in particular with Dantrolene ).
Terms of sale
On prescription.
Storage conditions
At temperatures between 15 and 30°C. Keep away from children.
Best before date
special instructions
After viral hepatitis It is necessary to start taking the pills after the indicators of the functional state of the liver return to normal (not earlier than six months after the illness).
The contraceptive effect is reduced when:
- vomiting/diarrhea;
- skipping a pill;
- simultaneous use with drugs that reduce the effectiveness of COCs.
The effectiveness of the tablets may decrease in cases where, after several cycles of their use, a woman experiences irregular, breakthrough or spotting discharge. In such situations, it is considered advisable to continue taking the drug until the end of the tablets in the next package.
If there is withdrawal bleeding at the end of cycle 2 acyclic secretions withdrawal bleeding has not stopped or started, the drug should be discontinued. It is resumed only after pregnancy has been ruled out.
Pills do not protect against STD And AIDS .
The estrogenic component of the drug can change certain laboratory parameters, including, but not limited to, indicators of hemostasis, the functional state of the adrenal glands, kidneys, thyroid gland, liver, the level of transport proteins and the level of lipoproteins.
During pregnancy, taking Novinet tablets is contraindicated.
COCs suppress lactation; in addition, a small amount of their constituent substances passes into milk. Therefore, during breastfeeding, these drugs cannot be considered the means of choice.
During lactation, taking tablets is allowed from the sixth month.
Novinet is a hormonal contraceptive drug. Instructions for use classify these tablets as microdosed contraceptives.
Release form and composition
Novinet is produced in the dosage form of tablets, film-coated enteric coating for oral (inside) use. They are light yellow in color, round in shape and have a biconvex surface. The tablet contains 2 main active ingredients:
- Desogestrel – 150 mcg.
- Ethinyl estradiol – 20 mcg.
The composition also includes auxiliary components.
Novinet tablets are packaged in blister packs of 21 pieces. The cardboard pack contains 1 or 3 blisters with the appropriate number of tablets, as well as instructions for use of the drug.
Indications for use
What does Novinet help with? According to the instructions, Novinet tablets are used:
- for the treatment of functional disorders of the menstrual cycle;
- with premenstrual syndrome;
- as a means of oral contraception.
Instructions for use
The drug is prescribed orally.
Taking pills starts on the 1st day of the menstrual cycle. Prescribe 1 tablet per day for 21 days, if possible at the same time of day. After taking the last tablet from the package, take a 7-day break, during which menstrual-like bleeding occurs due to drug withdrawal.
The next day after a 7-day break (4 weeks after taking the first tablet, on the same day of the week), resume taking the drug from the next package, also containing 21 tablets, even if the bleeding has not stopped.
This pill regimen is followed as long as there is a need for contraception. If you follow the rules of administration, the contraceptive effect remains during the 7-day break.
First dose of the drug
The first tablet should be taken on the first day of the menstrual cycle. In this case, it is not necessary to use additional methods of contraception. You can start taking pills from the 2-5th day of menstruation, but in this case, in the first cycle of using the drug, you must use additional methods of contraception in the first 7 days of taking the pills.
If more than 5 days have passed since the start of menstruation, you should delay starting the drug until your next menstruation.
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.
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.
Missed pills
If a woman forgot to take a pill on time, and no more than 12 hours have passed since the omission, she needs to take the forgotten pill, and then continue taking it at the usual time. If more than 12 hours have passed between taking pills, this is considered a missed pill, the reliability of contraception in this cycle is not guaranteed and the use of additional methods of contraception is recommended.
If you miss one tablet in the first or second week of the cycle, you must take 2 tablets the next day and then continue regular use, using additional methods of contraception until the end of the cycle.
If you miss a pill in the third week of the cycle, you should take the forgotten pill, continue taking it regularly and not take a 7-day break. It is important to remember that due to the minimum dose of estrogen, the risk of ovulation and/or spotting increases if you miss a pill and therefore the use of additional methods of contraception is recommended.
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.
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.
Switching from another oral contraceptive
After using another hormonal oral contraceptive containing 30 mcg ethinyl estradiol, according to a 21-day regimen, it is recommended to take the first Novinet tablet the day after completing the course of the previous drug. There is no need to take a 7-day break or wait for the start of menstruation. There is no need to use additional methods of contraception.
When switching from a drug containing 28 tablets, the next day after the tablets in the package run out, you should start a new package of Novinet.
Switching to Novinet after using oral hormonal drugs containing only progestogen ("mini-pill")
The first Novinet tablet should be taken on the 1st day of the cycle. There is no need to use additional methods of contraception.
If menstruation does not occur while taking the “mini-pill”, then after excluding pregnancy, you can start taking Novinet on any day of the cycle, but in this case, in the first 7 days it is necessary to use additional methods of contraception (using a cervical cap with spermicidal gel, a condom, or abstinence from sexual intercourse). The use of the calendar method in these cases is not recommended.
Also read the instructions for using the contraceptive drug.
pharmachologic effect
Novinet is a monophasic hormonal contraceptive drug for oral administration. The medication contains a combination of estrogen (ethinyl estradiol) and gestagen (desogestrel). The main contraceptive effect is to inhibit gonadotropins and suppress ovulation.
By increasing the viscosity of the cervical fluid, the movement of sperm through the cervical canal slows down, and changes in the condition of the endometrium prevent the implantation of a fertilized egg.
Ethinyl estradiol is a synthetic analogue of the follicular hormone estradiol.
Desogestrel has a pronounced gestagenic and antiestrogenic effect, similar to endogenous progesterone, and weak androgenic and anabolic activity. The drug has a beneficial effect on lipid metabolism: it increases the HDL content in plasma without affecting the LDL content.
When taking the drug, the loss of menstrual blood is significantly reduced (in case of initial menorrhagia), the menstrual cycle is normalized, and a beneficial effect on the skin is noted, especially in the presence of acne vulgaris.
Contraindications
Contraindications to the use of tablets are:
- increased risk of vein/artery thrombosis;
- age over 35 years;
- serious liver pathologies (taking pills is contraindicated until the functional parameters of the organ return to normal);
- vaginal bleeding, the nature of which cannot be determined;
- presence of precursors of thromboembolism;
- breast-feeding;
- migraine with manifestations of focal neurological symptoms;
- pancreatitis with severe hypertriglyceridemia;
- increased sensitivity to its constituent substances;
- thrombosis/thromboembolism of veins/arteries;
- smoking;
- diabetes mellitus complicated by vascular pathologies;
- hormone-dependent tumors (identified or suspected);
- pregnancy;
- otosclerosis;
- tumor lesion of the liver.
Side effects
- Development of allergic reactions;
- Nervous system: headache, mood instability, depression, migraine;
- Dermatological reactions: rash, erythema nodosum, chloasma, exudative erythema;
- Metabolism: increased body weight, fluid retention in the body, decreased tolerance to carbohydrates;
- Organ of vision: in patients with contact lenses – increased sensitivity of the cornea;
- Digestive system: nausea, vomiting, ulcerative colitis, Crohn's disease, exacerbation or development of jaundice and/or itching caused by cholestasis, cholelithiasis;
- Reproductive system: amenorrhea during drug withdrawal, vaginal spotting or acyclic bleeding, changes in the state of vaginal mucus, candidiasis, development of vaginal inflammation, galactorrhea, pain, tension, enlarged mammary glands.
The use of the drug may cause side effects that require immediate discontinuation:
- Porphyria, hemolytic-uremic syndrome; rarely - exacerbation of reactive systemic lupus erythematosus; very rarely - transient Sydenham chorea.
- Sense organs: hearing loss caused by otosclerosis.
- Cardiovascular system: arterial hypertension; rarely - venous and arterial thromboembolism (including pulmonary embolism, stroke, myocardial infarction, deep vein thrombosis of the legs); very rarely - venous or arterial thromboembolism of the renal, hepatic, mesenteric, retinal veins and arteries.
Children, pregnancy and breastfeeding
The drug is contraindicated for use during pregnancy and breastfeeding. Novinet is contraindicated in children.
special instructions
Before you start taking Novinet tablets, you should carefully read the instructions for the drug. Before starting to take the drug, you must undergo a thorough examination by a doctor using laboratory research techniques aimed at identifying possible contraindications. There are a number of special instructions regarding the use of the drug, which include:
- The effect of the drug on the functional activity of the cerebral cortex, the speed of psychomotor reactions and the ability to concentrate has not been studied.
- To date, there have been reports of a possible risk of developing cervical and breast cancer while taking the drug.
- The drug may interact with drugs from other pharmacological groups, so if they are used, you should warn your doctor.
- The drug is a fairly reliable method of contraception, the Pearl index (index of the risk of pregnancy while using the drug) is about 0.05.
- Before starting to use the drug, the benefits and risks of using it as a contraceptive are assessed together with your doctor.
- The active ingredients of Novinet tablets can affect the results of various laboratory tests.
- While using the drug, it is necessary to carefully monitor the woman’s health; if the slightest sign of side effects appears, especially with regard to the development of thrombosis, she should immediately consult a doctor.
- Overweight women who smoke have a significantly increased risk of developing side effects and complications from the cardiovascular system.
Drug interactions
If it is necessary to use Novinet in combination with Tetracycline and Ampicillin during the entire course of treatment and for another week after its completion, additional contraception is required (these drugs reduce the effectiveness of the drug).
- In addition, these drugs increase the risk of breakthrough bleeding.
- COCs reduce carbohydrate tolerance and increase the need for oral antidiabetic agents or insulin.
- When taking Rifampicin, additional precautions are required for 4 weeks after stopping treatment with the drug.
- The level of induction reaches a maximum within 14-20 days, but can also persist for up to 4 weeks after discontinuation of the drug.
- The effectiveness of COCs for oral administration is reduced in combination with drugs that induce liver enzymes: drugs Hypericum perforatum, Carbamazepine, Griseofulvin, barbiturates, Hydantoin, Rifampicin, Primidon, Felbamate, Topiramate, Oxcarbazepine.
Novinet should be used with caution in combination with:
- bromocriptine;
- hepatotoxic agents (in particular, with Dantrolene);
- β-adrenergic receptor blockers;
- anticoagulants of the indanedione or coumarin series;
- tricyclic antidepressants.
Analogues of the drug Novinet
Analogues are determined by structure:
- Tri-Mercy.
- Marvelon.
- Regulon.
- Mercilon.
Vacation conditions and price
The average cost of Novinet (tablets No. 21) in Moscow is 455 rubles. In the pharmacy chain, tablets are available with a prescription. It is not recommended to take them on your own without appropriate examination and a doctor’s prescription.
The shelf life of the tablets is 3 years from the date of manufacture. The instructions for use of Novinet require storage in the original packaging, in a dark, dry place, out of reach of children, at an air temperature of +15 to +30° C.
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According to statistics, women with a regular sexual partner prefer oral contraceptives to protect against unwanted pregnancy. Today, the pharmacological industry offers a wide selection of drugs in this group. It is quite difficult to understand this diversity.
The answer is actually very simple - the leading gynecologist should prescribe oral contraceptives, only in this case can you protect yourself from unwanted side effects of the hormonal drug.
Novinet birth control pills are a monophasic, microdosed, hormonal contraceptive. Novinet contains 2 synthetic hormones - progestogen and estrogen. The contraceptive effect is achieved by suppressing ovulation and changing the endometrium. Cervical mucus becomes more viscous, which leaves virtually no chance for sperm to penetrate the egg. This method of contraception underlies most drugs of the same group.
Novinet: instructions for use
Instructions for use recommend starting taking Novinet on the first day of menstrual bleeding. You must continue taking it for 21 days, 1 tablet at the same time. For convenience, the blister of tablets has marks in the form of numbers.
After the package is finished, that is, all the tablets have been taken, the woman should take a week break. For example, taking the drug ended on Wednesday, therefore, a week later, on Wednesday, you begin taking pills from the next package. During this break, the woman begins to have menstrual bleeding, usually on the 2nd day after completing the dose. It is necessary to start a new monthly course regardless of whether menstruation has ended or not.
If you missed taking a pill on the 1st day of menstruation, you can start taking the pill on the 2nd or 5th day. But then it is necessary to use barrier methods of contraception for 14 days, since the contraceptive effect may decrease.
Novinet is also prescribed after abortion. In this case, the drug should be taken on the day after the operation. And take it at the same time for the period recommended by the doctor.
Like any drug, Novinet has its own indications and contraindications. The list of the latter is quite wide. The drug should not be taken if there is an increased concentration of cholesterol in the blood or thromboembolism, even if such a pathology was observed in relatives. The list of contraindications includes jaundice, endometrial hyperplasia, cholelithiasis, vaginal bleeding of unknown etiology, the presence of hormone-dependent tumors and individual hypersensitivity to the components of the drug.
It is also not recommended to take the drug while breastfeeding a child, as it can reduce the production of human milk. Novinet is prescribed with great caution to women with heart defects, epilepsy, diabetes and varicose veins.
Novinet: reviews from doctors
In most cases, doctors speak positively about this drug, and this is due to microdosing. Novinet, along with other low-dose drugs, is widely used in gynecology. In addition to the contraceptive effect, there is also a therapeutic effect. Taking Novinet regulates the menstrual cycle, reduces blood loss during menstruation, and also affects the inflammatory processes of the female genital area. Moreover, taking the drug reduces the likelihood of an ectopic pregnancy and the appearance of tumor processes in the breast, ovaries and endometrium.
Novinet: side effects
According to reviews from women, Novinet can cause depression and migraines. Also, changes in mood, moodiness and tearfulness may occur from the nervous system. Sometimes, Novinet causes nausea and even vomiting, which indicates individual intolerance to the drug. Sometimes it can provoke an exacerbation of cholelithiasis.
While taking the drug, spotting and even bloody vaginal discharge may occur.
Some women indicate water retention in the body, which provokes weight gain. Allergic reactions and erythema were also noted - the occurrence of such symptoms requires stopping the drug - this is one of the options for individual intolerance.
On the part of the cardiovascular system, complications such as hypertension can form; extremely rarely, the drug is able to create all the conditions for the formation of a heart attack.
Only a leading gynecologist who has been observing you for at least a couple of years should prescribe oral contraceptives. It is difficult to do without appropriate tests. A correctly selected drug can not only protect against unwanted pregnancy, but also have a positive effect on health - the number of days of menstruation, which ceases to be painful, decreases, breast enlargement, etc.
Today, oral contraception is the most popular among women. Firstly, it has a fairly high contraceptive effectiveness, secondly, it eliminates discomfort, unlike the use of mechanical ones, and thirdly, it allows women to control the entire situation. Each lady sees her own additional advantages in this contraceptive method.
However, they are not without their disadvantages, but, according to most women, they still have more advantages. Now all that remains is to choose the most optimal tablets that are quite effective and do not cause side effects. Their choice is so large that sometimes gynecologists cannot immediately navigate. Today we will talk about Novinet tablets. Reviews from doctors about this drug are mixed, but most experts still claim its high degree of protection.
How does Novinet work?
These tablets consist of synthetic analogues of natural and progestogen. Scientists have proven that it is synthetic hormones that have a stronger effect. This drug blocks the production of certain hormones responsible for ovulation. As a result, the egg does not mature, and fertilization does not occur. Under the influence of the tablets, cervical mucus thickens, which interferes with the progress of sperm.
Those suffering from dysmenorrhea and severe premenstrual syndrome are advised to take the drug "Novinet". Reviews from doctors in such cases are only positive. Special benefits: restoration of the menstrual cycle (if it is irregular), reduction of pain during menstruation, regulation of heavy bleeding and relief from acne.
If we compare this contraceptive with other OCs, then the drug “Novinet” among this abundance is considered one of the most harmless and safe. The tablets contain a minimal level of estrogen, which can significantly reduce the risk of many side effects - especially weight gain.
Side effects caused by Novinet tablets
Reviews from gynecologists about the drug indicate the following adverse reactions: diarrhea, nausea, dizziness, headaches, changes in libido, jaundice, increased blood pressure, swelling of the mammary glands, decreased or increased body weight.
Other manifestations are possible: fatigue, amenorrhea, candidiasis, hair loss, erythema nodosum, thrombosis, hypertension, vaginal mycosis, skin pigmentation. Some manifestations disappear on their own after three months of regular use of the tablets.
Novinet tablets: how to take
Thanks to the convenient packaging, which indicates how to take the drug correctly, a woman can easily control her contraceptive intake. The first tablet is taken on the day of the menstrual cycle. The next one is accepted at the same hours as the first one. The course lasts 21 days, then there is a seven-day break, during which period menstruation begins.
After seven days we start drinking a new pack - 21 days. If your period has not ended and the week has passed, still start drinking Novinet. Reviews from doctors regarding the duration of use agree - it is not recommended to use it for more than two years.
It is necessary to take a break for at least six months so that the functioning of the ovaries is restored. You should stop taking it if:
- Pregnancy occurred while taking it.
- The next menstruation did not come.
- Hepatitis or jaundice has developed.
- Vision has decreased.
- Severe headaches began.
- Epileptic seizures appeared (increased).
- Hypertension developed.
- An operation is planned.
If you were unable to take the next dose or you simply forgot, take the pill as soon as you remember about it and then everything else according to the schedule. If you have not taken the drug for about a month, then you need to start the course of treatment again, just keep in mind that the effect of the pill is significantly reduced.
Contraindications for Novinet tablets
