Compound
The basis of the drug is 20 mcg ethinyl estradiol and 150 mcg desogestrel .
The auxiliary components of Novinet include: E 104 (quinoline yellow dye), α-tocopherol, magnesium stearate, povidone, colloidal silicon dioxide, potato starch, stearic acid, lactose monohydrate.
Composition p/o: hypromellose, macrogol 6000, propylene glycol.
Pharmacodynamics and pharmacokinetics
The drug contains synthetic estrogen and progestogen components , which are more active than natural sex hormones .
The effect is achieved primarily by preventing the release of the pituitary hormones follitropin and luteotropin , which interferes with the 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 the estrogen component is present in them in a minimal concentration, which reduces the risk of estrogen-dependent side effects (pain in the mammary glands, thromboembolic complications, nausea, weight gain, etc.).
Desogestrel is progestogen . 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 are absorbed in the proximal small intestine. Absorption is fast and almost 100%. The main product of desogestrel is 3-keto-desogestrel; its other metabolites are pharmacologically inactive.
Bioavailability of ethinyl estradiol is 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 ethinyl estradiol is characterized by the ability to accumulate in adipose tissue. Approximately a tenth of the dose taken passes into the milk of a nursing woman.
T1/2 - on average 24 hours, desogestrel - on average 30 hours.
Metabolic products of desogestrel are excreted by the kidneys. Metabolic products of ethinyl estradiol are eliminated in urine and bile.
Pharmacological properties of the drug Novinet
Novinet is a combined hormonal contraceptive drug for systemic use, the action of which is associated with inhibition of the effect of gonadotropins and suppression of ovulation, as well as a decrease in the penetration of sperm through the cervical mucus and implantation of a fertilized egg. The effect of the drug is due to the properties of its components: synthetic estrogen - ethinyl estradiol and synthetic progestogen - desogestrel, which, when administered orally, have a pronounced inhibitory effect on ovulation. Desogestrel is rapidly absorbed and almost completely metabolized to 3-keto-desogestrel, which is a biologically active metabolite of desogestrel. The average maximum concentration of the drug in the blood serum (2 ng/ml) is achieved 1.5 hours after administration. Bioavailability - 62–81%. In the body, 3-keto-desogestrel binds to blood plasma proteins, mainly albumin and sex hormone binding globulin (SHBG). The volume of distribution is 1.5 l/kg. In addition to 3-keto-desogestrel (which is formed in the liver and in the intestinal wall), there are other metabolites: 3α-OH-desogestrel, 3β-OH-desogestrel, 3α-OH-5α-H-desogestrel (first phase metabolites). These metabolites have no pharmacological activity; by conjugation they are partially converted (the second phase of metabolism) into polar metabolites, sulfates and glucuronates. Blood plasma clearance is about 2 ml/min per 1 kg of body weight. The half-life of 3-keto-desogestrel is on average 30 hours. Metabolites are excreted in urine and feces in a ratio of 6:4. The equilibrium concentration is established in the second half of the cycle, at which time the level of keto-desogestrel increases 2-3 times. Ethinyl estradiol is rapidly and completely absorbed. The average maximum serum concentration is 80 pg/ml and is achieved 1–2 hours after oral administration. Due to presystemic conjugation and the first-pass effect, bioavailability is approximately 60%. Ethinyl estradiol is completely bound to plasma proteins, mainly albumin. Causes an increase in sex hormone binding globulin (SHBG) levels. The volume of distribution is 5 l/kg. Presystemic conjugation of ethinyl estradiol is significant. Penetrating through the intestinal wall (first phase of metabolism), it undergoes conjugation in the liver (second phase of metabolism). Ethinyl estradiol and its conjugates (sulfates and glucuronides) are excreted in the bile and enter the enterohepatic circulation. Blood plasma clearance is about 5 ml/min/kg body weight. The half-life of ethinyl estradiol is on average 24 hours. Approximately 40% is excreted in the urine and 60% in the feces. The equilibrium concentration is established on the 3rd–4th day, while the level of ethinyl estradiol in the blood serum is 30–40% higher than after a single dose.
Contraindications
Contraindications to the use of tablets are:
- increased sensitivity to its constituent substances;
- thrombosis/thromboembolism of veins/arteries;
- the presence of precursors of thromboembolism ;
- migraine with manifestations of focal neurological symptoms;
- diabetes mellitus complicated by vascular pathologies ;
- increased risk vein/artery thrombosis
- pancreatitis 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.
Contraindications to the use of the drug Novinet
Absolute contraindications: pregnancy or suspicion of it, hypertension (arterial hypertension) of moderate or severe degree, lipid metabolism disorders, the presence or history of arterial thromboembolic diseases (myocardial infarction, ischemic stroke), the risk of arterial or venous thromboembolism, the presence of venous thromboembolism in a personal or family history, diabetic angiopathy, the presence or indication in anamnesis of severe liver disease, cholestatic jaundice, hepatitis, jaundice during pregnancy, when using steroid drugs, with Dubin-Johnson syndrome or Rotor syndrome, with liver tumors, porphyria; hepatitis (within 3 months from the moment of normalization of laboratory parameters), cholelithiasis, the presence of estrogen-dependent tumors or suspicion of them, endometrial hyperplasia, genital bleeding of unknown etiology; presence or history of systemic lupus erythematosus, previously noted pruritus, genital herpes, otosclerosis, or progression of otosclerosis during a previous pregnancy or while taking steroids; hypersensitivity to the components of the drug. Relative contraindications (in the presence of any of the following conditions, the benefits or possible negative effects of taking oral contraceptives are assessed individually): disorders of the blood coagulation system, all diseases in which there is a possibility of circulatory disorders: heart failure, renal failure, as well as a history of these diseases ; epilepsy or a history of it; migraine or a history of it; history of cholelithiasis; the risk of developing an estrogen-dependent tumor or estrogen-dependent gynecological diseases; diabetes; presence of severe depression, including a history of depression; sickle cell anemia.
Side effects
Side effects of Novinet appear:
- acyclic vaginal discharge;
- amenorrhea after stopping the pills;
- candidiasis;
- 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:
- hypertension;
- acute blockage of veins/arteries with blood clots (rarely - myocardial infarction , DVT, PE, stroke , etc.; extremely rarely - acute blockage of large retinal and mesenteric vessels, veins and arteries of the liver, kidneys);
- otosclerosis and, as a result, hearing loss;
- GUS;
- exacerbation of Libman-Sachs disease (rare);
- Sydenham's chorea (develops extremely rarely, symptoms disappear after stopping taking the pills);
- porphyria.
Novynette®
If any of the following conditions/diseases/risk factors are present, a careful assessment of the benefit-risk ratio of using COCs should be carried out. This issue should be discussed with the woman before starting the drug. In case of exacerbation of diseases, deterioration of condition, or the appearance of the first symptoms of conditions/diseases or risk factors, a woman should immediately consult a doctor to decide whether to stop taking the drug.
Risk of developing VTE and ATE
Epidemiological studies have established an association between the use of COCs and an increased risk of arterial and venous thrombosis and thromboembolism, such as myocardial infarction, stroke, DVT and PE. These diseases are extremely rare.
The use of any COC is associated with an increased risk of developing VTE, manifested as DVT and/or PE. The greatest risk of developing VTE is observed in the first year of COC use. An increased risk of developing this complication is also observed when COC use is resumed after a break of 4 weeks or more.
Some epidemiological studies suggest that women taking low-dose COCs containing third-generation progestogens, including desogestrel, have an increased risk of developing VTE compared with women taking drugs containing the progestogen levonorgestrel, norgestimate or norethisterone. These studies demonstrated an approximately twofold increase in the risk of developing VTE. The annual incidence of VTE in women taking COCs containing desogestrel ranges from 9 to 12 cases per 10,000 women; in women who do not use COCs, the incidence of VTE is 2 cases per 10,000 women. The incidence of VTE with COC use is lower than the incidence of VTE during pregnancy (up to 20 cases per 10,000 women) and the postpartum period (40 to 65 cases per 10,000 women). VTE can be fatal in 1-2% of cases.
It is extremely rare that when taking COCs, thrombosis occurs in other blood vessels (for example, in the veins and arteries of the liver, mesentery, kidneys, brain or retina).
Symptoms of VTE and ATE may include:
sudden pain and/or swelling of the lower extremity, sudden intense chest pain, with or without radiation to the left arm, sudden shortness of breath, sudden cough, unusual severe and prolonged headache, sudden partial or complete loss of vision, diplopia, speech impairment or aphasia, dizziness, collapse with or without a convulsive attack, weakness or severe numbness that suddenly appears on one side of the body, movement disorders, “acute abdomen.”
The risk of developing VTE increases with the presence of the following risk factors:
- age;
— obesity (BMI more than 30 kg/m2);
- a family history of venous or arterial thrombosis, or thromboembolism in brothers, sisters or parents under the age of 50 years (if a hereditary predisposition is suspected, you should consult a specialist before starting to take COCs);
- prolonged immobilization, major surgery, any operation on the lower extremities or pelvis, neurosurgery, major trauma. In these cases, you should stop taking the COC (at least 4 weeks before planned surgery) and resume it only 2 weeks after the woman has fully recovered her mobility;
— temporary immobilization, including air travel lasting more than 4 hours, is also a factor in the development of VTE, especially in women with other risk factors. The possible role of varicose veins and superficial thrombophlebitis in the development of VTE remains controversial.
The risk of developing ATE increases with the presence of the following risk factors:
- age;
- smoking (the risk increases to a greater extent in women over 35 years of age);
- dislipoproteinemia;
— obesity (BMI more than 30 kg/m2);
- arterial hypertension;
- migraine;
- heart valve disease;
- atrial fibrillation;
- a family history of venous or arterial thrombosis, or thromboembolism in brothers, sisters or parents under the age of 50 years (if a hereditary predisposition is suspected, you should consult a specialist before starting to take COCs).
It is necessary to take into account the increased risk of thromboembolism in the postpartum period.
Other conditions/diseases that cause circulatory problems
: diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel disease (eg, Crohn's disease or ulcerative colitis) and sickle cell anemia.
An increase in the frequency or intensity of migraine (may be a prodromal symptom of cerebrovascular accident) while taking a COC is grounds for immediate discontinuation of its use.
Biochemical factors that may indicate hereditary or acquired predisposition to VTE or ATE include activated protein C resistance, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).
When assessing the benefit/risk ratio, it should be taken into account that therapy for these conditions/diseases can reduce the associated risk of thrombosis.
Tumors
The most important risk factor for the development of cervical cancer (CC) is persistent human papillomavirus (HPV) infection. Epidemiological studies show an increased risk of developing cervical cancer in women infected with HPV and long-term users of COCs (> 5 years), however, there are still contradictions regarding the degree of influence of various factors on these data, in particular cervical screening examinations or characteristics of a woman’s sexual behavior (number of sexual partners and the use of barrier methods of contraception), as well as the cause-and-effect relationship of these factors.
A meta-analysis of the results of 54 epidemiological studies revealed a slight increase (1.24) in the risk of developing breast cancer (BC) in women using COCs. The increased risk gradually decreases over 10 years after discontinuation of COCs. Due to the fact that breast cancer is rare in women under 40 years of age, the increase in the incidence of breast cancer in women who are currently taking COCs or have recently taken it is insignificant in relation to the overall risk of developing this disease. Its connection with COC use has not been proven. The observed increase in risk may also be a consequence of earlier diagnosis of breast cancer in women taking COCs (they are diagnosed with earlier clinical forms of breast cancer than women not taking COCs), the biological effects of COCs, or a combination of both of these factors.
Very rarely, when using COCs, cases of the development of benign, and even more rarely, malignant liver tumors were observed. In some cases, these tumors have resulted in life-threatening intra-abdominal bleeding. In case of severe abdominal pain, liver enlargement or signs of intra-abdominal bleeding, this should be taken into account when making a differential diagnosis.
Other states
— Depressed mood and depression are known adverse reactions when using hormonal contraceptives (see section “Side effects”). Depression can be a serious disorder and is a known risk factor for suicidal behavior and suicide. Women should be advised to contact their doctor if mood changes or depressive symptoms occur, including soon after starting treatment.
- Women with hypertriglyceridemia or a corresponding family history have an increased risk of developing pancreatitis when taking COCs.
- Many women taking COCs experienced a slight increase in blood pressure, but clinically significant increases in blood pressure were rare. The connection between taking COCs and arterial hypertension has not been established. However, if persistent arterial hypertension develops while taking COCs, then it is advisable to stop taking COCs and prescribe antihypertensive therapy. If blood pressure is adequately controlled with antihypertensive drugs, it is possible to resume taking COCs.
— During pregnancy and during the use of COCs, the development or worsening of the following conditions was noted, although their relationship with the use of contraceptives has not been definitively established: jaundice and/or itching caused by cholestasis, formation of gallstones, porphyria, systemic lupus erythematosus, hemolytic uremic syndrome, Sydenham's chorea (minor chorea), gestational herpes, hearing loss due to otosclerosis, hereditary angioedema.
— Acute or chronic liver dysfunction may warrant discontinuation of COCs until liver function tests return to normal. Recurrence of cholestatic jaundice, previously observed during pregnancy or when using sex hormones, requires discontinuation of COCs.
— Despite the fact that COCs can have an effect on insulin resistance and glucose tolerance, there is usually no need to adjust the dose of hypoglycemic drugs in patients with diabetes mellitus taking COCs. However, patients with diabetes mellitus should be under close medical supervision while taking COCs. Worsening of endogenous depression, epilepsy, Crohn's disease and ulcerative colitis has been reported with the use of COCs.
- Sometimes, when taking COCs, pigmentation of the facial skin (chloasma) may occur, especially if it occurred earlier during pregnancy. Women with a predisposition to chloasma should avoid direct sunlight and ultraviolet radiation from other sources when taking COCs.
— 1 tablet of Novinet® contains 67.665 mg of lactose monohydrate. The drug is contraindicated for women with rare hereditary diseases associated with lactase deficiency, lactose intolerance, glucose-galactose malabsorption, and those on a lactose-free diet.
All of the above information should be taken into account when choosing a contraceptive method.
Medical examinations/consultations
Before prescribing or resuming the use of the drug Novinet®, you should carefully familiarize yourself with the woman’s life history (including family history), conduct a thorough general medical examination (including measuring blood pressure, determining BMI) and gynecological examination (with mandatory examination of the mammary glands and cytological examination of the cervical epithelium), exclude pregnancy. The volume of additional studies and the frequency of control examinations are determined individually; control examinations should be carried out at least once every 6 months. It is important to draw a woman's attention to information about venous and arterial thrombosis, including the risk of using Novinet® compared to other COCs, symptoms and known risk factors for the development of VTE and ATE, and what to do if thrombosis is suspected.
The woman should be advised that oral contraceptives do not protect against HIV (AIDS) and other sexually transmitted infections.
Reduced efficiency
The effectiveness of Novinet® may be reduced in case of missed tablets (see section “Dosage and Administration”), gastrointestinal disorders (see section “Dosage and Administration”), or in the case of concomitant therapy, which reduces the concentration of etonogestrel, the active metabolite. desogestrel in blood plasma (see section “Interaction with other drugs”).
Insufficient cycle control
When taking COCs, especially in the first months of use, irregular spotting or heavy bleeding may occur, so assessment of irregular bleeding should be carried out only after the end of the adaptation period of three months.
If irregular bleeding persists or appears after previous regular cycles, possible non-hormonal causes of cycle disruption should be taken into account and appropriate studies should be carried out to exclude malignant neoplasms or pregnancy. Diagnostic curettage of the cavity and cervical canal of the uterus may be required.
Some women may not experience menstrual bleeding during the interval between taking the drug. If the COC was taken as recommended above, there is little chance that the woman is pregnant. Otherwise, or if there is no bleeding twice in a row, the possibility of pregnancy should be excluded before continuing to use the COC.
Laboratory research
Oral contraceptives may affect the results of some laboratory tests, including biochemical indicators of liver, thyroid, adrenal and kidney function, the content of transport proteins in plasma, for example, corticosteroid binding globulin (CBG) and lipid/lipoprotein fractions, parameters of carbohydrate metabolism, coagulation parameters and fibrinolysis. Usually these changes are within normal laboratory values.
Increased ALT activity
In clinical studies of patients receiving hepatitis C therapy with drugs containing ombitasvir/paritaprevir/ritonavir and dasabuvir (with or without ribavirin), increases in ALT levels greater than 5 times the upper limit of normal were significantly more common in women using ethinyl estradiol-containing drugs such as COCs. Women taking Novinet® should switch to an alternative method of contraception (progestogens only or non-hormonal methods of contraception). Taking Novinet® should be discontinued before starting antiviral therapy and can be resumed 2 weeks after completion of therapy with a combination of antiviral drugs.
Novinet tablets: instructions for use
contraceptive pills are taken orally, one per day, with liquid. Reception begins no later than the 5th day of the menstrual cycle. The tablets are taken without breaks or breaks for a full three weeks, at the same time. From 22 to 28 days they take a break.
If the first tablet is taken between days 2 and 5 of the cycle, additional measures to protect against pregnancy are taken during the first 7 days of the course.
On day 29 (the day of the week corresponds to the day of the week when the first tablet was taken), the drug is resumed using a new pack.
If you strictly follow the recommendations described in the instructions for use of Novinet, the contraceptive effect remains between 22 and 29 days of the cycle.
How to take pills after childbirth/abortion
In the absence of lactation, Novinet can be taken from the first day of the first independent menstruation. Before starting treatment, you must consult a doctor. Additional contraception is not needed.
If there is sexual intercourse after childbirth, taking the drug is postponed until the next menstruation. If the decision to take pills is made later than 3 weeks after birth, the use of additional protective measures is indicated in the first 7 days of the course.
After an induced abortion or spontaneous termination of pregnancy, pills are started immediately without the use of other means of contraception.
Switching to Novinet from other contraceptives
After taking other COCs, the first pill is taken the next day after completing the course of the previous contraceptive (they do not take a break, there is no need to wait for the next menstruation). When switching from progestogen products, Novinet should be taken from the first day of the cycle.
The use of additional protective measures in all the described cases is not necessary.
Additional protective measures mean the use of barrier contraceptives or refusal of sexual relations during the entire “dangerous” period. It is not recommended to resort to the calendar method of contraception.
Delay of menstruation
If it is necessary to delay the start of the cycle, contraceptive pills are taken according to the usual regimen for the required time, without taking a break. In this case, spotting/breakthrough vaginal bleeding is possible, which does not affect the effectiveness of the product. Regular use is resumed after a standard break of 7 days.
Skipping a pill
The full contraceptive effect is maintained provided that the drug is taken regularly, in which the maximum delay in taking the pill does not exceed 12 hours. If the forgotten tablet is taken within 36 hours after the previous one, Novinet continues to be taken according to the standard regimen.
A missed pill is considered a situation when more than 12 hours have passed since the last dose of the drug.
If a pill is missed in the first 14 days of the cycle, the next day at the usual time you need to take a double dose of the drug at once. In the future, it is taken as usual.
If the omission occurred between days 15 and 21 of the cycle, you must take the missed dose of the drug and continue further administration without a seven-day break.
If you miss a pill, the risk of spotting and/or ovulation increases, which is associated with the minimal estrogen in the drug. In this regard, additional contraception is required (until the new cycle).
In case of vomiting and/or diarrhea, the absorption of the drug may not be complete. If the symptoms disappear within 12 hours, it is recommended to additionally take a second tablet (further administration according to the usual regimen); if symptoms persist longer, throughout the entire period of illness, as well as throughout the next week, additional contraception is necessary.
Novinet
Combined oral contraceptive based on ethinyl estradiol and desogestrel. The effect is achieved by preventing the process of ovulation and increasing the viscosity of cervical mucus. A distinctive feature of the drug, its manufacturers call the minimum content of the estrogen component - and this guarantees a low risk of developing such side effects as nausea, pain in the mammary glands, weight gain, and thromboembolic complications.
Side effects when taking Novinet may be the following:
- nausea, vomiting, headache;
- tension and engorgement of the mammary glands;
- changes in weight and libido;
- mood swings, irritability, depression;
- discomfort when wearing contact lenses;
- the appearance of pigment spots on the skin;
- increased blood pressure;
- hair loss;
- diarrhea.
It must be emphasized that side effects occur extremely rarely and, with strict adherence to the dosage regimen, they usually go away on their own after 2-3 months of constant use.
Contraindications to the use of Novinet may include:
- liver diseases, liver tumors;
- congenital hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndromes);
- cholelithiasis, cholecystitis, chronic colitis;
- severe cardiovascular and cerebrovascular changes;
- thromboembolism and predisposition to them;
- malignant tumors, primarily breast or endometrial cancer;
- hyperlipoproteinemia;
- severe form of hypertension;
- severe diabetes mellitus with vascular complications;
- sickle cell anemia, chronic hemolytic anemia;
- vaginal bleeding of unknown etiology;
- migraine, otosclerosis;
- history of idiopathic jaundice in pregnancy.
Particular care is required in the following cases:
- diabetes mellitus;
- heart diseases of non-ischemic etiology, hypertension;
- renal dysfunction;
- thrombophlebitis, otosclerosis, multiple sclerosis, epilepsy;
- intermittent porphyria;
- bronchial asthma.
Novinet is not recommended for smoking women over 35 years of age.
If you are prescribed medication, be sure to tell your doctor that you are taking Novinet. The fact is that in combination with a number of drugs, the contraceptive effect of Novinet can be reduced. These are primarily: rifampicin, phenobarbital derivatives, anticonvulsants (phenytoin, carbamazepine), dihydroergotamine, some tranquilizers, phenylbutazone, ketoconazole, as well as broad-spectrum antibiotics (tetracycline, chloramphenicol, ampicillin, neomycin), anticoagulants (coumarin or indandione derivatives), tricyclic antidepressants, beta blockers, oral antidiabetic drugs, insulin, bromocriptine, hepatotoxic drugs.
Reception scheme
The first Novinet tablet is taken on the first day of menstruation. Then take one tablet every day, preferably at the same time for 21 days - until the tablets in the package run out. This is followed by a week-long break, during which menstrual-like bleeding occurs. On the eighth day, you begin taking pills from a new package - this is actually the first day of the new menstrual cycle.
To make it easier for a woman to navigate the days of her cycle and control her intake of Novinet, all tablets are numbered and connected to each other by arrows.
If another combined oral contraceptive was used in the previous menstrual cycle, then the first Novinet tablet is taken on the day when the first tablet from the new package of the previous drug should have been taken.
After childbirth, in the absence of breastfeeding, the first Novinet tablet is taken on the 21st day. The drug is not recommended for breastfeeding.
After an abortion, the first pill can be taken on the same day or the next day.
What to do if you forget to take your pill?
If the delay in administration is no more than 12 hours, the contraceptive effect is not reduced. You need to take the pill as soon as possible and then proceed according to your usual schedule. Additional contraceptive measures are not required.
If the delay is more than 12 hours, then the reliability of contraception in this cycle is not guaranteed. Actions in such a case depend on which week of admission the delay occurred.
If you miss one tablet in the first or second week of your cycle, you should take two tablets the next day and then continue taking them regularly.
If you miss two tablets in a row in the first or second week of the cycle, you must take two tablets in the next two days, then continue taking them regularly according to your usual schedule. Additionally, barrier methods of protection should be used until the end of the cycle.
If you miss a pill in the third week of your cycle, you need to take two pills the next day. Then take the drug according to your usual schedule, but do not take a week break - the first tablet from the new package is taken the next day after all the tablets from this package have been taken.
Important points
Before you start taking Novinet, you need to undergo a medical examination and rule out pregnancy. Subsequently, it is necessary to visit a doctor every six months.
After viral hepatitis, the use of hormonal oral contraceptives is recommended no earlier than six months later. In this case, a medical examination should include an analysis of the state of liver function.
If you experience severe abdominal pain, you should consult a doctor. You may need to stop using Novinet.
If during the week when the drug is not taken there is no menstrual-like bleeding, you need to take a pregnancy test.
If you take the drug for three months or more, but bleeding occurs irregularly and sporadically, you should consult a doctor.
In case of vomiting or diarrhea, the tablets should be taken as usual. Additionally, barrier methods of protection should be used.
When planning a pregnancy, taking Novinet should be stopped at least three months before the expected date of conception.
In cases of severe headaches, vision problems, increased blood pressure and severe periodic pain in the legs, the drug should be stopped.
During surgery and prolonged forced immobilization, the drug should be discontinued. In the case of elective surgery, this must be done six weeks in advance.
Interaction
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 , Primidone , Felbamate , Topiramate , Oxcarbazepine .
In addition, these drugs increase the risk of breakthrough bleeding.
The level of induction reaches a maximum within 14-20 days, but can also persist for up to 4 weeks after discontinuation of the drug.
If 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).
When taking Rifampicin, additional precautions are required for 4 weeks after stopping treatment with the drug.
COCs reduce carbohydrate tolerance and increase the need for oral antidiabetic agents or insulin .
Novinet should be used with caution in combination with:
- tricyclic antidepressants;
- anticoagulants of the indanedione or coumarin series ;
- β-adrenergic receptor blockers;
- bromocriptine;
- hepatotoxic agents (in particular, with Dantrolene ).
special instructions
After viral hepatitis, it is necessary to start taking pills after the indicators of the functional state of the liver return to normal (no 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 at the end of cycle 2, withdrawal bleeding, acyclic discharge has not stopped or withdrawal bleeding has not begun, the drug should be stopped. It is resumed only after pregnancy has been ruled out.
The pills do not protect against STDs 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.
Special instructions for the use of the drug Novinet
Before prescribing the drug, you should collect a detailed family and personal history, conduct a general and gynecological examination (measurement of blood pressure, laboratory tests, examination of the mammary glands and pelvic organs, cytological examination of smears) to exclude diseases, the risk of which increases with the use of oral contraceptives. Examinations must be repeated periodically. When deciding whether to prescribe oral contraceptives, one should evaluate the ratio of potential risks and benefits of their use, in particular, oncoprotective properties against ovarian and endometrial cancer. If liver function test results change, the drug should be discontinued. If any of the above conditions occur or progress while using the drug, it must be stopped and switched to using a non-hormonal method of contraception. Taking oral contraceptives may be accompanied by changes in some laboratory test parameters (functional tests of the liver, kidneys, adrenal glands, thyroid gland, blood coagulation and fibrinolytic activity, levels of lipoproteins and transport proteins). The risk of developing arterial or venous thromboembolic complications increases with age, smoking (heavy smoking is considered an increased risk factor in women over 35 years of age), the presence of thromboembolic diseases in personal and family history (parents, brother or sister), and obesity (index body weight 30 kg/m2), dyslipoproteinemia, hypertension (arterial hypertension), heart valve diseases, atrial fibrillation, diabetes mellitus, prolonged immobilization, after extensive surgical interventions, interventions on the lower extremities, severe injuries. It is recommended to stop taking the drug 4 weeks before surgery and resume 2 weeks after remobilization. The risk of developing thromboembolic complications is increased in diabetes mellitus, systemic lupus erythematosus, hemolytic-uremic syndrome, Crohn's disease, ulcerative colitis, and sickle cell anemia. If a dose is missed, but no more than 12 hours have passed since the missed dose, you should take the missed tablet and then continue taking the drug at the usual time. If more than 12 hours have passed since the missed period, the reliability of contraception in this cycle is not guaranteed, the use of additional methods of contraception is recommended. If a dose is missed in the 1st or 2nd week of the cycle, you must take 2 tablets the next day, and then continue taking the drug regularly, using additional methods of contraception until the end of the cycle. If a dose is missed in the 3rd week of the cycle, you should take the missed tablet and continue taking the drug regularly without a 7-day break. Due to the minimal dose of estrogen, the risk of ovulation and/or spotting if a dose is missed is increased, so the use of additional methods of contraception is recommended. If vomiting or diarrhea was noted after taking the drug, absorption of its components may be incomplete. If these symptoms disappear within 12 hours, you must take 1 additional tablet. After this, taking the drug should continue as usual. If vomiting and diarrhea continue for more than 12 hours, additional methods of contraception must be used that day and for the next 7 days. The appearance of irregular, spotting or breakthrough bleeding after several months of using the drug may indicate a decrease in its effectiveness. If menstrual-like bleeding does not begin at the end of the second cycle, taking the pills should be stopped and resumed only after possible pregnancy has been ruled out. The drug did not have a teratogenic effect when taken accidentally at the beginning of pregnancy. The use of combined oral contraceptives during breastfeeding is not recommended as they can reduce the secretion of breast milk.
Analogs
Level 4 ATC code matches:
Ovidon
Rigevidon
Non-Ovlon
Mercilon
Yarina Plus
Yarina
Miniziston 20 fem
Microgynon
Janine
Lindineth
Cyclo-Proginova
Regulon
Logest
Midiana
Belara
Femoden
Jess Plus
Jess
Zoely
Analogues of Novinet: Marvelon , Regulon , Mercilon , Tri-Mercy .
Which is better - Janine or Novinet?
The composition of Janine of ethinyl estradiol as active substances (Novinet tablets contain this component in the amount of 0.02 mg) and 2 mg of dienogest . The latter is a testosterone and is characterized by antiandrogenic activity .
Thus, Janine contains more hormones and is more suitable for women who have an excess of male hormones.
Reviews about Novinet
Reviews about birth control pills Novinet are mostly positive: the majority of women who have taken the drug note its main advantages as high efficiency, ease of use and affordable price.
However, there is a certain percentage of patients who are dissatisfied with the drug. Negative reviews about Novinet are mainly due to the fact that the tablets provoke side effects (in particular, they reduce libido) and provoke hormonal imbalance in the body.
As for pregnancy after Novinet, reviews differ here - some women write that they took the drug in small courses in order to stimulate pregnancy, and became pregnant already in the first or second cycle, while others complain that after taking the drug, their periods disappeared for quite some time. a long period, and the eggs did not mature for a year or more.
Analyzing doctors' reviews of Novinet, we can conclude that the reaction to taking COCs is always unpredictable and very individual, so opinions about these drugs are often opposite.
Due to the minimal concentration of hormones in the drug, doctors recommend taking it to young women who have not given birth. But for women with children, the dose of active substances may be insufficient.
Another positive aspect of using Novinet is its ability to stop the growth of fibroids . For fibroids, the drug is prescribed if the size of the node is small, as well as in situations where it is necessary to preserve the woman’s reproductive function.
Novineta price
The price of Novinet in pharmacies depends on the number of tablets in the package.
The price for Novinet birth control pills in Ukraine ranges from 220 UAH for package No. 21 and from 750 UAH for package No. 63.
You can buy package No. 21 in Russian pharmacies for 280-460 rubles, the cost of package No. 63 varies from 1100 to 2500 rubles.
- Online pharmacies in RussiaRussia
- Online pharmacies in KazakhstanKazakhstan
ZdravCity
- Novinet tablets p.p.o.
63 pcs. JSC Gedeon Richter RUB 1,198 order - Novinet tablets 21 pcs. JSC Gedeon Richter
481 rub. order
Pharmacy Dialogue
- Novinet (tab.p.pl/rev. No. 21) Gedeon-Richter
485 rub. order
- Novinet (tab.p.pl/rev. No. 21x3)Gedeon-Richter
RUB 1,223 order
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