Composition, form of production and packaging
The tablets covered with a film cover of light pink color, round, biconcave; the color of the kernel is white or almost white.
1 tab.
ethinylestradiol 30 Ојg
Chlormadinone acetate 2 mg
Excipients: povidone K30 - 4.5 mg, corn starch - 9 mg, lactose monohydrate - 68.97 mg, magnesium stearate - 0.5 mg.
The composition of the film membrane: hypromellose 6 mPa В· s - 1.115 mg, lactose monohydrate - 0.575 mg, macrogol 6000 - 0.279 mg, propylene glycol 0.093 mg, talc 0.371 mg, titanium dioxide 0.557 mg, iron oxide red 0.01 mg.
21 pcs. - blisters (1) - packs of cardboard.
21 pcs. - blisters (3) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2017.
PHARMACHOLOGIC EFFECT
Combined contraceptive for oral administration.
Prolonged use of the drug Belara В® leads to a decrease in the secretion of FSH and LH and, consequently, to suppression of ovulation. Simultaneously, proliferation of the endometrium and its secretory transformation prevent the implantation of a fertilized egg, the viscosity of the mucous secretion of the cervix increases, which is accompanied by difficulty in passage of spermatozoa through the cervical canal and a violation of their mobility.
The chloromadinone acetate-gestagen, which has antiandrogenic properties, is part of the drug. Its action is based on the ability to replace androgens at specific receptors, excluding and weakening the effect of endogenous and exogenous androgens. The Perl index is 0.291-0.698, depending on how thoroughly a woman observes the regimen of taking the drug.
To completely suppress ovulation requires 1.7 mg of chloromadinone acetate daily. The required dose per cycle is 25 mg.
PHARMACOKINETICS
Chlormadinone acetate
Suction
After ingestion of chloromadinone, acetate is quickly and completely absorbed. C max is achieved in 1-2 hours.
Distribution
More than 95% of chloromadinone acetate binds to human plasma proteins, mainly albumin.
Metabolism
Various processes of reduction, oxidation and binding with glucuronides and sulfates lead to the formation of a variety of metabolites. The main metabolites in blood plasma are 3-alpha and 3-beta-hydroxy-chloromadinone acetate with T 1/2 , not significantly different from nonmetabolized chloromadinone acetate. 3-hydroxy metabolites have anti-androgenic activity similar to that of chloromadinone acetate itself. In the urine, metabolites are mainly contained in the form of conjugates.After enzymatic digestion, the main metabolite becomes 2-alpha-hydroxy-chloromadinone acetate, 3-hydroxy metabolites and dihydroximetabolites are also formed.
Excretion
The mean T 1/2 of chloromidinone acetate from the blood plasma is approximately 34 hours (after a single dose) and about 36-39 hours (with repeated use). When using chloromadinone inside, acetate and its metabolites are excreted in approximately equal amounts by the kidneys and through the intestine.
Ethinylestradiol
Suction
Ethinylestradiol is rapidly and almost completely absorbed after ingestion, reaching C max in the blood plasma after 1.5 hours. Due to presystemic binding and metabolism in the liver, absolute bioavailability is about 40% and is subject to strong individual variability (20-65%).
Distribution
The information available in the literature on the concentration of ethinylestradiol in blood plasma varies greatly. About 98% of ethinyl estradiol binds to blood plasma proteins, almost exclusively with albumin.
Metabolism
Like natural estrogens, ethinyl estradiol is biotransformed through hydroxylation of the aromatic ring (the mediator is the cytochrome P450 system). The main metabolite is 2-hydroxy-ethinyl estradiol, which is transformed to other metabolites and conjugates. Ethinyl estradiol undergoes presystemic binding, both in the mucosa of the small intestine and in the liver. In the urine are found, mainly, glucuronides, and in bile and blood plasma - sulfates.
Excretion
The average T 1/2 of ethinylestradiol from the blood plasma is approximately 12-14 hours. Ethinyl estradiol is excreted by the kidneys and through the intestine in a ratio of 2: 3. Ethyl estradiol sulphate, excreted with bile after hydrolysis by intestinal bacteria, undergoes intestinal hepatic recirculation.
INDICATIONS
- oral contraception.
DOSING MODE
The drug should be taken orally. The tablet, indicated by the corresponding day of the week, should be removed from the blister pack and swallowed whole, if necessary, with a small amount of water. One tablet should be taken every day at the same time (preferably in the evening) for 21 consecutive days, then a 7-day break in taking the tablets should be done; in two to four days after taking the last pill there will be a bleeding "cancellation", similar to menstrual bleeding. After the end of the 7-day break, you should start taking Belara В® from the following package, regardless of whether bleeding has stopped or not.
If hormonal contraceptives were not previously used (during the last menstrual cycle), the first tablet should be taken on the first day of the natural cycle of a woman, i.e. on the 1st day of the next menstrual bleeding. If the first tablet is taken on the 1st day of menstrual bleeding, the contraceptive effect of the drug begins on the first day of admission and continues for a 7-day break in taking the tablets.
The first tablet can also be taken on the 2nd-5th day of menstrual bleeding, regardless of whether bleeding has stopped or not. In this case, during the first 7 days of admission, additional barrier methods of contraception should be used.
If menstrual bleeding began more than 5 days ago, a woman should be advised to wait for the next menstrual bleeding to begin taking Belara В® .
When switching from another hormonal contraceptive containing 21 or 22 active tablets, you should end up taking all the pills of the old package. The first tablet of the preparation Belara В® should be taken the next day. There should not be a break in taking the pills, and the patient should not wait for the next menstrual cycle.Additional contraceptive measures are not required.
When switching from contraceptives containing only gestagen (mini-pili), the first tablet of the preparation Belara В® should be taken the next day after the last tablet containing only gestagen. During the first 7 days, additional barrier methods of contraception must be used.
When switching from a hormonal injectable contraceptive or a contraceptive implant , the preparation of Belara В® can be started on the day of removal of the implant or on the day of the initially scheduled injection. During the first 7 days, additional barrier methods of contraception must be used.
After a spontaneous or medical abortion in the first trimester of pregnancy , you can start taking Belara В® immediately after the abortion. In this case, there is no need for additional contraceptive measures.
After delivery, spontaneous or medical abortion in the second trimester of pregnancy , it is recommended to start taking the drug Belara В® on the 21-28th day after the birth, if the woman does not breast-feed, or after the abortion in the second trimester of pregnancy. In this case, there is no need for additional barrier methods of contraception.
If the drug was started more than 28 days after childbirth or abortion, additional barrier methods of contraception should be used within the first 7 days.
If a woman has already had sexual intercourse, you should exclude the presence of pregnancy or wait for the start of the next menstrual cycle before you start taking the drug.
After discontinuation of the preparation, the current cycle may extend for about one week.
Irregular intake of tablets
If the patient forgot to take the pill at the set time, but took it within the next 12 hours , no additional contraceptive measures are required. The patient should continue taking the drug as usual.
If the patient forgot to take the pill at the set time, but took it after 12 hours , the contraceptive protection may be reduced. In case of missing the tablet, you should act on the basis of the following two basic rules:
1) never take pills for more than 7 days;
2) 7 days of continuous reception of tablets is necessary to achieve adequate suppression of the regulation of the hypothalamic-pituitary-ovarian system.
The last missed tablet should be taken immediately, even if it means taking 2 tablets at a time. The following tablets should be taken as usual. In the next 7 days, barrier methods of contraception, for example, condoms, need to be used additionally. If the taking of tablets was missed during the first week of the cycle, and within 7 days before the missed tablets there was a sexual intercourse (including a seven-day break in taking the tablets), the probability of developing a pregnancy should be taken into account. The more pills were missed, and the closer they were to the usual pause in taking pills, the higher the probability of pregnancy.
If you miss tablets at the 2 nd and 3 rd week of taking the drug, you should immediately take the missed tablet, even if it means taking two pills at the same time. The next tablet is taken as usual. During the next 7 days, additional contraceptive methods, such as condoms, should be used.
If less than 7 tablets remain in the used pack, immediately after the end of taking the tablets from the used pack, you should start taking the tablets from a new package of the preparation Belara В® , i.e. there should not be a break between the two packages. Probably, the usual bleeding of "cancellation" does not occur until the tablets from the second package run out; However, during the reception of tablets from a new package, there may be a "breakthrough" bleeding or "smearing" bloody discharge from the vagina. If the bleeding "cancellation" does not occur after the end of taking the tablets from the second package, then you should make a pregnancy test.
If there is vomiting or severe diarrhea within 4 hours after taking the pill, the absorption of the drug may be incomplete and the reliability of contraception can not be guaranteed. In this case, follow the recommendations given in the section "Irregular tablets". You should continue taking the drug Belara В® .
To delay bleeding , a woman should continue taking the tablets from the next package of the Belara В® preparation without taking a break. Continue taking the tablets at will, as long as the tablets from the second package do not run out. During the reception of tablets from the second package may appear minor bloody discharge or "breakthrough" bleeding. After an ordinary 7-day break in taking the tablets, you should resume regular use of the drug Belara В® . To move the onset of bleeding to another day of the week, different from the day the bleeding started according to the current scheme, a woman can be recommended to reduce the next 7-day break for the desired number of days. The shorter the break in taking the tablets, the higher the likelihood of bleeding from the "cancellation" and "breakthrough" bleeding or minor bleeding during taking the tablets from the next package (as well as delaying the bleeding).
SIDE EFFECT
When taking the drug Belara В® the most common adverse reactions (more than 20% of cases) are "breakthrough" bleeding, spotting from the vagina, headache and discomfort in the mammary glands. The frequency of acyclic bleeding usually decreases as the duration of administration of the drug Belara В® increases.
Frequency of occurrence of adverse reactions is determined as follows: very often (? 1/10), often (? 1/100, <1/10), infrequently (? 1/1000, <1/100), rarely (? 1 / 10,000 , <1/1000), very rarely (<1/10 000).
There may be adverse reactions from the following organs and systems.
From the immune system: infrequently - hypersensitivity to the components of the drug, including allergic reactions from the skin.
From the side of metabolism: infrequently - changes in lipid composition of blood, including hypertriglyceridemia; rarely - increased appetite.
From the side of the psyche: often - a depressed mood, nervousness, irritability; infrequently - decreased libido.
From the nervous system: often - dizziness, migraine (and / or its enhancement).
From the side of the organ of vision: often - visual disturbances; rarely - conjunctivitis, intolerance of contact lenses.
From the side of the hearing organ: rarely - an unexpected loss of hearing, noise in the ears.
From the cardiovascular system: rarely - arterial hypertension, arterial hypotension, cardiovascular collapse, varicose veins, thrombosis of veins.
From the side of the digestive system: very often - nausea; often - vomiting; infrequently - pain in the abdomen, flatulence, diarrhea.
From the skin and subcutaneous tissue: often - acne; infrequently - disorders of pigmentation, chloasma, hair loss, dry skin, hyperhidrosis; rarely - hives, eczema, erythema, skin itching, psoriasis, hypertrichosis; very rarely erythema nodosum.
From the osteomuscular system: often - a sense of heaviness in the lower limbs; infrequently - back pain, muscle disorders.
On the part of the reproductive system: very often - increased mucosal discharge from the vagina, dysmenorrhea, amenorrhea; often - pain in the lower abdomen;infrequently - galactorrhea, fibroadenoma of the breast, vaginal candidiasis; rarely - breast enlargement, vulvovaginitis, menorrhagia, premenstrual syndrome.
General disorders: often - fatigue, swelling, weight gain.
When using combined oral contraceptives, including Belarus, the following undesirable effects were also noted:
- increased risk of venous and arterial thromboembolism (eg, venous thrombosis, pulmonary embolism, stroke, myocardial infarction); risk may be exacerbated by additional factors;
- increased risk of bile duct disease;
- In rare cases, an increased risk of developing benign liver tumors (and even less often - malignant neoplasms of the liver); Single cases can lead to life-threatening intra-abdominal bleeding;
- exacerbation of chronic inflammatory bowel diseases (Crohn's disease, ulcerative colitis).
CONTRAINDICATIONS
Acceptance of the drug Belara В® is contraindicated in the following diseases / conditions:
- Thrombosis (venous and arterial) and thromboembolism at present or in the anamnesis (for example, deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders);
- presence of the first signs of thrombosis, thrombophlebitis or symptoms of embolism (eg, transient ischemic attacks, angina pectoris);
- planned surgical intervention (at least 4 weeks before it) and the period of immobilization, for example, after trauma (including after the application of plaster bandages);
- diabetes mellitus with vascular complications;
- diabetes mellitus, not amenable to adequate control;
- uncontrolled arterial hypertension or significant increase in blood pressure (over 140/90 mm Hg);
- hereditary or acquired predisposition to the development of venous or arterial thrombosis: increased resistance of the organism to activated protein C (APC-resistance); deficiency of antithrombin III, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant);
- acute or chronic liver disease of severe degree (before the normalization of liver function);
- generalized pruritus, cholestasis, especially during the previous pregnancy or the reception of sex hormones in the anamnesis;
- Dubin-Johnson syndrome, Rotor syndrome, violation of bile flow;
- the presence of liver tumors at present or in the anamnesis;
- severe pain in epigastrium, enlarged liver or symptoms of intra-abdominal bleeding;
- the newly discovered porphyria or its relapse (all three forms, especially acquired porphyria);
- presence of hormone-dependent malignant diseases, incl. in the anamnesis (for example, a mammary gland or a uterus), or suspicion on them;
- pronounced violations of lipid metabolism;
- pancreatitis currently or in history, in combination with severe forms of hypertriglyceridemia;
- first arising seizures of migraine pain or frequent severe headaches;
- Migraine in combination with local neurologic symptoms (associated migraine);
- Acute sensory disorders, for example, visual or hearing impairment;
- motor disorders (in particular, paresis);
- an increase in the number of epileptic seizures;
- severe depression;
- worsening of the course of otosclerosis during previous pregnancies;
- amenorrhea of ​​unclear etiology;
- Endometrial hyperplasia;
bleeding from the vagina of an unclear etiology;
- Pregnancy or suspicion of it;
- lactation period (breastfeeding);
- smoking over the age of 35;
- lactose intolerance, lactase deficiency, glucose-galactose malabsorption;
- the availability of express or multiple factors, arterial or venous thrombosis (increasing age, smoking, particularly over the age of 35 years, obesity> 30 kg / m 2 ; dislipoproteinemia, the presence of a family history of venous or arterial insufficiency relatives 1st line of kinship; disease heart valves, atrial fibrillation, bacterial endocarditis, and any operation on the lower extremities, extensive trauma);
- Hypersensitivity to the components of the drug.
With caution (only after the evaluation of the potential risk and anticipated benefits, as well as a thorough medical control) should be administered the drug Belara В®under the following conditions / diseases / risk factor current or history of epilepsy, multiple sclerosis; convulsions (tetany); migraine without focal neurological symptoms; bronchial asthma; cardiac or renal failure; chorea; diabetes with uncomplicated; acute and chronic pulmonary disease, and moderate hepatic (standard indicators of liver function tests); abnormal lipid metabolism, dislipoproteinemia; autoimmune diseases (including NCR); obesity (BMI <30 kg / m 2); controlled hypertension; endometriosis; varicose veins, phlebitis of superficial veins of the lower extremities; violation of blood coagulation; breast; uterine fibroids; herpes gestationis; depression; chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis).
PREGNANCY AND LACTATION
Application Belara preparation В® pregnancy contraindicated. Before you start to use the drug Belara В® , it is necessary to exclude pregnancy. If pregnancy occurs during use of Belarus, the drug should be discontinued immediately. Existing epidemiological data do not contain information about the development of a teratogenic or embryotoxic effect in women who have accidentally taken during pregnancy drugs containing estrogen and progestin in the same combination as in the preparation Belara В® .
Application Belara preparation В®in breast-feeding period is contraindicated because the drug reduces the quantity of milk produced and changes its composition.Small amounts included in the contraceptive hormones and / or its metabolites are excreted in breast milk and may affect the baby.
APPLICATION FOR FUNCTIONS OF THE LIVER
Precautions should be used drug Belara В® in renal failure.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Use of the drug contraindicated with acute or chronic liver disease, severe (before normalization of liver function), in the presence of liver tumors currently or history.
Precautions should be used drug for acute and chronic liver disease of mild to moderate severity (standard indicators of liver function tests).
SPECIAL INSTRUCTIONS
Smoking increases the risk of developing severe adverse reactions of the cardiovascular system in the application of the CPC. The risk increases with age and depends on the number of cigarettes smoked. The risk is more pronounced in women over the age of 35 years. Female smokers over the age of 35 years should use other methods of contraception.
In the application of the CPC is increased risk of serious disease: myocardial infarction, thromboembolism, stroke, and liver tumors. Other risk factors such as hypertension, hyperlipidemia, obesity and diabetes distinctly increase the risk of morbidity and mortality.
If one of the above diseases / risk factors must weigh the potential benefits from the destination Belara preparation В®against the risks, and this should be discussed with the woman before taking her medication. If these diseases or risk factors will begin to appear or progress during treatment, consult your doctor. The doctor must decide whether to stop taking this drug.
Thromboembolism and other vascular diseases
Epidemiological studies show that there is a correlation between the reception PDAs and increased risk of diseases caused by arterial or venous thromboembolism, such as myocardial infarction, cerebral stroke, deep vein thrombosis or pulmonary embolism. These complications are rare.
Receiving CCP leads to an increased risk of venous thromboembolism (VTE). The risk of VTE is highest during the first year of admission. This risk is less than during pregnancy, when the VTE incidence is 60 cases per 100,000 pregnancies. VTE leads to death in 1-2% of cases. No assessment of the risk of developing VTE when receiving data Belara drug В® compared to other PDAs.
The risk of developing venous thromboembolic complications when taking the CPC increases:
- age;
- the presence of thromboembolism in relatives (eg venous thromboembolism in siblings, sisters or parents at a relatively young age). If it is assumed the presence of a genetic predisposition, it is recommended to send a woman to consult a specialist before prescribing the drug Belara В® ;
- during prolonged immobilization;
- obesity (BMI> 30 kg / m 2 ).
The risk of developing arterial thromboembolic events when receiving CCP increases:
- age;
- smokers;
- when dislipoproteinemia;
- obesity (BMI> 30 kg / m 2 );
- arterial hypertension;
- with heart defects;
- atrial fibrillation;
- in the presence of relatives thromboembolism (arterial thromboembolism in siblings, sisters or parents at a relatively young age). If it is assumed the presence of a genetic predisposition, it is recommended to send a woman to consult a specialist before prescribing the drug Belara В® .
Other diseases affecting blood circulation, are diabetes, lupus, hemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn's disease and ulcerative colitis), sickle-cell anemia. In assessing the risk / benefit ratio should be remembered that adequate treatment of the above diseases may reduce the risk of thrombosis. It is necessary to take into account the increased risk of thromboembolic complications in the postpartum period.
There is no consensus as to whether a relationship exists between thrombophlebitis of superficial veins and / or varicose veins and the etiology of venous thromboembolism. With the development of venous or arterial thrombosis following symptoms may occur:
- pain in the lower extremities and / or swelling;
- sudden severe pain in the chest, radiating or without irradiation to the left arm;
- sudden shortness of breath, coughing for no apparent reason;
- sudden severe prolonged headache;
- partial or complete loss of vision;
- diplopia / speech disorders or aphasia;
- dizziness, fainting, in some cases accompanied by focal epileptic seizures;
- sudden weakness or dysesthesia (sensitivity violation) on one side or in one part of the body;
- motor disturbances;
- acute abdominal pain.
Women taking the drug Belara В® , should be informed of the fact that the appearance of symptoms that resemble the symptoms of thrombosis, you should consult your doctor. Preparation Belara В® must be canceled with suspected thrombosis or confirmation of diagnosis.
Increased or increase the severity of migraine attacks during reception Belara preparation В® (which may indicate the prodromal phase disturbances of cerebral blood flow) is an indication for immediate lifting of the drug Belara В® .
Tumors
Some epidemiological studies suggest that prolonged use of PDAs is a risk factor for cervical cancer in women infected with human papillomavirus (HPV). However, it is still controversial question of the degree of influence on the results of the observations of other confounding factors (eg, the number of sexual partners or use barrier methods of contraception).
The relative risk (RR = 1.24) of developing breast cancer in women who take the PDA, only slightly higher. During the 10 years after stopping the CCP's risk level gradually decreases and returns to age. However, not established a causal relationship between the disease and drug intake. Observed an increased risk may be due to the fact that women taking the CPC, breast cancer is diagnosed at an earlier stage than those who did not apply, as well as the biological effects of a PDA or a combination of both.
In rare cases, after receiving the CPC recorded cases of benign liver tumors, even more rarely malignant tumor recorded. In some cases, these tumors are the causes of life-threatening intra-abdominal haemorrhage. In case of severe abdominal pain that does not go by yourself, hepatomegaly or signs of intra-abdominal bleeding, it is necessary to take into account the possibility of a liver tumor and stop the drug Belara В® .
other diseases
Many women taking oral contraceptives, there is a slight increase in blood pressure; but clinically significant increase is rare. The relationship between the administration of oral contraceptives and clinical manifestation of hypertension has not been confirmed to date. When you are receiving the drug Belara В® there is a clinically significant increase in blood pressure, the drug should be discontinued and treat hypertension. As soon as the blood pressure parameters return to normal in the background of antihypertensive therapy, taking medication Belara В® can continue.
Women with a history of herpes pregnant while taking the PDA can be a relapse. Women with a history of hypertriglyceridemia or a family history per se increases the risk of developing pancreatitis while taking the drug Belara В® . Acute or chronic disorders of the liver may require discontinuation Belara В® to normalization of liver function. Recurrence of cholestatic jaundice which occurred first during pregnancy or previous use of sex hormones, requires the removal of the drug Belara В® .
PDAs may have effects on the resistance of peripheral tissues to insulin or glucose tolerance. Therefore, patients with diabetes during reception Belara preparationВ®must be under constant supervision.
In rare cases it can develop chloasma, especially among women who have had chloasma pregnant. Women are at risk of developing chloasma should avoid exposure to sunlight and ultraviolet radiation while taking the drug Belara В® .
Patients with a rare congenital disorders - galactose intolerance, lactase deficiency lapp (lactase deficiency in some nations North) or malabsorption syndrome glucose-galactose - drug application Belara В® is contraindicated.
Medical examination
Prior to the appointment of the drug Belara В®necessary to carry out a medical examination and to collect comprehensive data on the health of the woman and her relatives to identify contraindications and risk factors. Medical examination should be performed 1 time per 6 months while receiving the drug Belara В® . Regular medical examination is also necessary due to the fact that diseases are contraindications (e.g., transient ischemic attack) or risk factors (e.g., venous thrombosis or arterial personal or family history), may first occur in patients receiving the drug Belara В® .
Medical examination should include measurement of blood pressure, breast examination, abdominal and pelvic organs, including cytological examination of cervical epithelium and conducting appropriate laboratory tests.
A woman should be warned that the use of oral contraceptives, including and drug Belara В® , it does not protect against infection with HIV (AIDS) or other diseases, sexually transmitted diseases.
Laboratory parameters
during reception Belara preparation В®changes may occur some laboratory parameters, including the functional activity of the liver, thyroid, adrenals, concentration-related proteins in the plasma (e.g., binding globulin sex hormones, lipoproteins), carbohydrate metabolism, coagulation and fibrinolysis. The nature and extent of changes in part determined by the nature and dose of hormones taken.
Insufficient efficiency
of missed pills, vomiting and diarrhea, prolonged concomitant use of certain drugs or, in very rare cases, metabolic disorders may reduce the effectiveness of contraception.
Effects on the menstrual cycle
Bleeding "breakthrough" or acyclic spotting
All oral contraceptives may cause irregular vaginal bleeding (bleeding "breakthrough" or acyclic bleeding), especially during the first few cycles in patients receiving the drug. Therefore, a medical examination on the irregular cycles should only be done after a period of adjustment, which usually lasts for 3 cycles. If during reception Belara preparation В® appearance extraordinary bleeding continues or first appeared in women with a regular cycle, it is necessary to conduct examination to exclude pregnancy or organic pathology. After excluding pregnancy and organic pathology reception Belara drug В® can continue or switch to other medications.
Acyclic bleeding can be a sign of lack of contraceptive effectiveness.
No bleeding "cancel"
After 21 days after taking the drug typically occurs bleeding "cancel". Sometimes, especially in the first few months of taking the drug, bleeding "cancel" can be absent. However, this does not indicate a lack of contraceptive effect. If the bleeding does not occur after drug administration for one cycle, with the proviso that was not missed no reception Belara preparation В® , the period after completion of dosing did not exceed 7 days, there was no vomiting or diarrhea, pregnancy is unlikely. After excluding an organic pathology of pregnancy and reception preparation Belara В®It can be continued. If you are taking the drug Belara В® instructions are not carried out before the first absence of bleeding, "cancel", or bleeding of "lifting" was absent for two consecutive cycles, pregnancy must be excluded for the presence of a decision on the continuation of treatment.
Simultaneously with the reception of the preparation Belara В® should not take herbal remedies containing St. John's wort (Hypericum perforatum).
Impact on the ability to drive vehicles and manage mechanisms
The drug has no negative effect on the ability to drive vehicles and mechanisms.
OVERDOSE
If overdose is not observed any severe toxic reactions.
Symptoms at random receiving a large number of tablets may be nausea, vomiting, bleeding from the vagina.
Treatment: symptomatic therapy if necessary. No specific antidote. In rare cases, it requires monitoring of indicators of water-electrolyte metabolism and
