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Each film-coated tablet contains:Active ingredients: dienogest - 2 mg, ethinyl estradiol - 0.03 mg.Excipients: lactose monohydrate - 57.17 mg, corn starch - 12 mg, povidone 30LP - 3 mg, sodium starch glycolate - 5 mg, magnesium stearate - 0.8 mg.Film casing: aquapolish white 014.17 MS (hypromellose - 48%, hydroxypropylcellulose - 12%, talc - 20%, seed cotton - 5% hydrogenated oil, 15% titanium dioxide).
Round biconvex tablets, film-coated white.Pharmacotherapeutic group:Combined contraceptive (gestagen + estrogen).ATH code:G03 AA
The drug Bonade is a low-dose monophasic oral combination estrogen-progestin contraceptive drug.The contraceptive effect of the drug Bonade is based on the combined action of various factors, the most important of which is the suppression of ovulation and the increase in the viscosity of the cervical secretions.The progestogenic component of the drug Bonade, dienogest, is a derivative of nortestosterone and has antiandrogenic effects. Dienogest also has a beneficial effect on the lipid profile, increasing the high-density lipoprotein content.In women taking combined oral contraceptives (COCs), the cycle becomes more regular, less frequent painful menstruation, decreases the intensity and duration of bleeding.
Absorption. After ingestion, dienogest is rapidly and almost completely absorbed. The maximum plasma concentration (51 ng / ml) is reached 2.4 ± 1.4 hours after a single dose. Bioavailability in combination with ethinyl estradiol is about 96%.Distribution. Dienogest binds to serum albumin (90%) and does not bind to specific transport proteins — the sex hormone-binding globulin (SHBG) and the corticosteroid-binding globulin (KSG). Any effect on the physiological transport of endogenous steroids is unlikely. An ethinyl estradiol-induced increase in the concentration of SHBG does not affect the binding of dienogest to serum proteins.Metabolism. Dienogest is metabolized mainly by hydroxylation, but also by hydrogenation, conjugation and aromatization with the formation of inactive metabolites. Total clearance after a single dose of 3.6 liters / hour.Inference. The half-life of dienogest (T1 / 2) is 8.5-10.8 hours. A minor amount of dienogest is excreted by the kidneys unchanged. Its metabolites are excreted by the kidneys and with bile in a ratio of 3: 1. The half-life of metabolites is 14.4 hours.Equilibrium concentration. Concentration of SHBG does not affect the pharmacokinetics of dienogest. After taking a daily dose, the concentration of the drug in the blood plasma increases by approximately 1–5 times, and equilibrium is reached after taking about 4 daily doses.Ethinyl Estradiol
Absorption. After oral administration, ethinyl estradiol is rapidly and completely absorbed. The maximum plasma concentration (67 ng / ml) is reached within 1.5-4 hours. During absorption and “first pass” through the liver, ethinyl estradiol is metabolized, resulting in an average oral bioavailability ofDistribution. Ethinyl estradiol is almost completely (98%), although not specific, bound by albumin. Ethinyl estradiol induces the synthesis of SHBG. The recorded volume of distribution of ethinyl estradiol is 2.8-8.6 l / kg.Metabolism. Ethinyl estradiol is subjected to presystemic conjugation in the small intestinal mucosa and in the liver. The main metabolic pathway is aromatic hydroxylation, followed by conjugation with glucuronic and / or sulfuric acids. The rate of metabolic clearance from blood plasma is 2.3-7 ml / min / kg.Inference. The concentration of ethinyl estradiol in the blood plasma decreases, and the decrease is biphasic The first phrase is characterized by a half-life of about 1 hour, the second - 10-20 hours. In unchanged form is not displayed. Ethinyl estradiol metabolites are excreted by the kidneys and liver in a ratio of 4: 6 with an elimination half-life of about 24 hours.Equilibrium concentration. Equilibrium concentration is reached during the second half of the treatment cycle, when the levels of the drug in the serum become two times higher compared to a single dose.
Contraception (prevention of unwanted pregnancy).Acne treatment of mild to moderate severity in women who need contraception, with the failure of other treatments (topical treatment or use of systemic antibiotics).
Bonade is contraindicated in the presence of any of the conditions / diseases listed below. If any of these conditions develop for the first time against the background of its intake, the drug should be immediately canceled.Thrombosis (venous and arterial) and thromboembolism currently or in history (including deep vein thrombosis, pulmonary thromboembolism, myocardial infarction)The states preceding thrombosis (including angina pectoris) at present or in historyCerebrovascular disease: stroke, transient ischemic attacks in the present and in historyMultiple or severe risk factors for venous or arterial thrombosis, including complicated lesions of the cardiac valve apparatus, atrial fibrillation, diseases of cerebral vessels or coronary arteries, severe dyslipoproteinemia, uncontrolled arterial hypertension, serious surgical intervention, long-term immobilization, uninterrupted arterial hypertension, operation, immobilization, unacceptable arterial hypertension, uninterrupted arterial hypertension, uninterrupted arterial hypertension and pelvic organs, neurosurgical interventions, smoking after the age of 35Congenital or acquired susceptibility to arterial or venous thrombosis (resistance to activated protein C (including Leiden factor 5), deficiency of antithrombin III, deficiency of protein C, deficiency of protein S, hyperhomocysteinemia, the presence of antibodies to phospholipids (anti-cardiolipin, lupocenter,Migraine with focal neurological symptoms now or in historyDiabetes with vascular complicationsPancreatitis with severe hypertriglyceridemia now or in historyHepatic failure and severe liver disease (before normalization of liver enzymes), including Rotor and Dubin-Johnson syndromesLiver tumors (benign or malignant) now or in historyIdentified hormone-dependent malignant neoplasms (including the genitals or mammary glands) or suspicion of themBleeding from the vagina of unknown originPregnancy or suspicion of itBreastfeeding periodHypersensitivity to any of the components of the drug BonadeGalactose intolerance, lactase deficiency or glucose-galactose maladsorption (the product contains lactose)Obesity (body mass index more than 30 kg / m2)Extensive injury .Bonade preparation is not intended for use in men.Carefully
The potential risk and the expected benefit of using COC in each individual case should be carefully weighed with the following diseases / conditions and risk factors:Risk factors for thrombosis and thromboembolism: smoking obesity (body mass index less than 30 kg / m 2) dyslipoproteinemia, arterial hypertension migraine without focal neurological symptoms uncomplicated valvular heart disease hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebral circulation at a young age in one of the closest relatives)Other diseases in which violations of the peripheral circulation can occur: diabetes mellitus cancer, systemic lupus erythematosus hemolytic uremic syndrome Crohns disease and ulcerative colitis sickle cell anemia phlebitis of superficial veinsHereditary angioedemaHypertriglyceridemiaDiseases that have first arisen or aggravated during pregnancy or against the background of previous intake of sex hormones (for example, jaundice, cholestasis, gallbladder disease, otosclerosis with impairment of hearing, porphyria, herpes during pregnancy, Sydengham chorea)Postpartum period.
Pregnancy. The drug Bonade can not be used during pregnancy. If pregnancy is detected during the use of the drug Bonade, it should be canceled immediately and consult a doctor. However, extensive epidemiological studies have not revealed an increased risk of developmental defects in children born to women who received sex hormones before pregnancy or when taking sex hormones through negligence in the early stages of pregnancy.Breastfeeding period. Taking COCs can reduce the amount of breast milk and alter its composition therefore, their use is not recommended until breastfeeding is stopped.
The drug Bonade is taken orally, one tablet per day, without chewing and squeezed with a small amount of water at the same time every day. Tablets are taken for 21 days without a break according to the scheme indicated on the blister. Each blister contains 21 pills. Each tablet is labeled with the day of the week in which it should be taken. Over the next 7 days do not take pills. During this period, menstrual bleeding should begin ("withdrawal bleeding"). It usually begins 2-3 days after taking the last pill of the drug Bonade.After a 7-day break, on the 8th day, they begin taking pills from a new package (if the package contains 21 tablets) or blisters (if the package contains 63 tablets), even if the bleeding has not yet stopped. This means that you will always start a new package (blister) on the same day of the week and that every month there will be a “withdrawal” bleeding around the same day of the month.How to start taking the drug Bonade
In the absence of taking any hormonal contraceptives in the previous month.Reception of the drug Bonade begins on the first day of the natural menstrual cycle (that is, on the first day of the menstrual bleeding). Take a pill labeled with the appropriate day of the week. For example, if menstruation begins on Friday, take a pill labeled with letters denoting Friday. Then, continue to take pills on the following days in the prescribed manner. It is also possible to start taking from the 2nd to the 5th day of the cycle, but in this case it is recommended to additionally use a barrier method of contraception (condom) during the first 7 days of taking the pills from the first package (blister).When switching from other COCs, a contraceptive vaginal ring or a contraceptive patch.You can start taking the drug Bonade the next day after taking the last tablet from the previous package of COCs (that is, without interruption in the reception). If the previous package also contained inactive tablets (without active substance), you can start using the drug Bonade the next day after taking the last active tablet. You can also start taking it later, but in no case no later than the next day, after the usual break in reception (7 days break for drugs containing 21 tablets) or after taking the last inactive tablet (for drugs containing 28 tablets per pack).In the case of using a contraceptive patch or a contraceptive vaginal ring, taking the drug Bonade should be started on the day of their removal, but no later than the day when a new ring should be inserted or a new patch should be pasted.When switching from oral contraceptives containing progestogen only ("mini-pili").You can stop taking “mini-drank” any day and start taking Bonade the next day, at the same time. During the first 7 days of taking the pills, you must also use an additional barrier method of contraception.When switching from an injection contraceptive, implant or intrauterine contraceptive device (intrauterine device), releasing progestogen.Start taking Bonade on the day when the next injection is to be given or on the day the implant or intrauterine contraceptive is removed. During the first 7 days of taking the pills, you must also use an additional barrier method of contraception.After childbirth
Immediately after giving birth, the doctor may recommend that you wait until the end of the first normal menstrual cycle before you begin taking the drug Bonade ®. Sometimes, on the advice of a doctor, you can start taking the drug earlier.After spontaneous miscarriage or abortion in the first trimester of pregnancy.Consult a doctor. It is usually recommended to start taking the drug immediately.If you miss taking the drug Bonade
- If the delay in taking the regular pill is less than 12 hours, the contraceptive effect of the drug Bonade is preserved. Take a pill as soon as you remember it. Take the next pill at the usual time.- If the delay in taking the pills is more than 12 hours, contraceptive protection can be reduced. The more pills in a row are missed, and the closer this pass to the beginning of the reception or to the end of the reception, the higher the risk of pregnancy.In this regard, you can follow the following rules:Missing more than one tablet from the packaging (blister).Missing one tablet in the 1st week of taking the drug.Take the missed pill as soon as possible as soon as you remember (even if it means taking two pills at the same time). Take the next pill at the usual time. Additionally, use a barrier method of contraception for the next 7 days. If sexual intercourse was within a week before the pill was missed, the likelihood of pregnancy should be considered. Consult a doctor immediately.Missing one tablet in the 2nd week of taking the drug.Take the missed pill as soon as possible as soon as you remember (even if it means taking two pills at the same time). Take the next pill at the usual time. If you took the pills correctly within 7 days preceding the first missed pill, the contraceptive effect of the drug Bonade remains, and you do not need to use additional contraceptive measures. Otherwise, as well as skipping two or more pills, you must additionally use barrier methods of contraception for 7 days.One pill is missed on the 3rd week of taking the drug.If during the 7 days preceding the first missed pill, all pills were taken correctly, there is no need to use additional contraceptive methods if you follow either of the following two options:1. Take the missed pill as soon as possible as soon as you remember (even if it means taking two pills at the same time). Take the next pill at the usual time. Start the next package (blister) immediately after taking the pills from the current package (blister), so there will be no break between the packages (blisters). Bleeding "cancellation" is unlikely until the tablets from the second package (blister) run out, but there may be "spotting" discharge or "breakthrough" uterine bleeding on the days of taking the drug.2. Stop taking the pills from the current package (blister), take a break of 7 days or less (including the day you miss the pill), and then start taking the pills from the new package (blister).If there is no expected menstrual bleeding after a break in taking the pills, you may be pregnant. Consult a doctor before you start taking pills from a new package (blister).In situations where you are advised to stop taking the drug bonade, or when its reliability can be reduced, you should refrain from sex or use non-hormonal contraceptive methods (for example, a condom or other barrier methods). Do not use rhythmic or temperature methods. These methods may be unreliable, because COC administration leads to changes in basal temperature and cervical mucus.In the event of discontinuation of the drug Bonade
You can stop taking the drug Bonade at any time. In case of discontinuation of reception due to the desire to become pregnant, it is usually recommended to wait until the first normal menstruation and only after that try to become pregnant. With this method it is easier to set the date of delivery.Recommendations for gastrointestinal disorders
In the event of vomiting or diarrhea, the active ingredients of the drug bonade may not be completely absorbed. If vomiting lasts 3–4 hours after taking a contraceptive pill, the result may be the same as skipping a pill. Do as recommended when you skip taking the pill. In case of severe diarrhea, consult your physician.Delayed onset of menstrual bleeding
You can delay the onset of menstrual bleeding if you start taking tablets from the next package (if the package contains 21 tablets) or blisters (if the package contains 63 tablets) right after the end of the current package (blister). You can take pills as long as you wish, or until the pills in the package (blister) run out. If you want the “cancel” bleeding to begin, simply stop taking the pills. While taking the tablets of the drug Bonade from the new package (blister), abundant or “spotting” spotting may appear. Take the pills from the next package (blister), start after the usual 7-day interval.Change the day of the onset of menstrual bleeding
If you take pills, strictly following all recommendations, menstrual bleeding occurs approximately on the same days every 4 weeks. If you want to change these days, simply shorten (but by no means extend) the next interval without taking pills. For example, bleeding begins on Fridays, and you want it to start on Tuesdays (3 days earlier), then you need to start taking pills from a new package (blister) 3 days earlier than usual. If the interval without taking the pill is too short, the bleeding may not occur at all at this interval. However, while taking pills from a new package (blister), copious or “spotting” spotting may appear.
Bonade preparation is indicated only after the onset of menarche.Elderly Patients
Not applicable. Bonade is not indicated after menopause.Patients with impaired liver function
Bonade is contraindicated in women with severe liver disease until liver function levels return to normal. See also the section "Contraindications".Patients with impaired renal function
Bonade has not been specifically studied in patients with impaired renal function. The available data do not imply a change in the dosage regimen in these patients.
When taking the drug Bonade, there may be irregular bleeding ("spotting" bleeding or "breakthrough" uterine bleeding), especially during the first months of use.Other adverse effects may be observed while taking the drug Bonade, although their appearance is not necessary in all patients.Serious adverse effects
See “Precautions” and “Special Instructions”. Please read these sections carefully and, in the event of undesirable effects, including serious reactions associated with the use of the drug, consult your doctor.The side effects detected during the administration of the active ingredients of the drug Bonade are shown with distribution by frequency of development and by organ system. The frequency of side effects was classified as follows: very often (> 1/10), often (> 1/100, <1/10) and infrequently (> 1/1000, <1/100), rarely (> 1/10000, < 1/1000), very rarely (<1/10000, including individual cases) and unspecified frequency.Infectious and parasitic diseases: infrequently - vaginitis, vulvovaginitis, vaginal candidiasis or other fungal vulvovaginal infections rarely, salpingo-oophoritis (adnexitis), urinary tract infections, mastitis, cervicitis, fungal infections, oral herpes, influenza, bronchitis, sinusitis, infections of the upper respiratory tract, viral infection.Benign, malignant and unspecified neoplasms (including cysts and polyps): infrequently - ovarian cysts rarely - cysts of the uterus, uterus myoma, breast lipoma, breast cysts, fibrocystic mastopathy.Violations of the blood and lymphatic system: rarely - anemia.Immune system disorders: rarely allergic reactions.Disorders of the endocrine system: rarely - virilism.Metabolic and nutritional disorders: infrequently - increased appetite rarely anorexia.Mental disorders: rarely - depression very rarely - changes in mood, unspecified frequency - decrease in mood, insomnia, sleep disturbances, aggression.Nervous system disorders: often - headache infrequently, headache, migraine rarely - ischemic stroke, cerebrovascular disorders, dystonia.Violations on the part of the organ of vision: rarely - dryness of the mucous membrane of the eyes, irritation of the mucous membrane of the eyes, oscillopsia unspecified frequency - intolerance to contact lenses (discomfort when wearing them).Disturbances of the organ of hearing and labyrinth disorders: rarely - sudden hearing loss, noise in the ears, dizziness, hearing loss.Cardiac disorders: rarely - cardiovascular disorders, tachycardia.Vascular abnormalities: infrequently - increase, decrease in blood pressure rarely - venous and arterial thrombosis and thromboembolism, thrombophlebitis, increased diastolic pressure, orthostatic circulatory dystonia, "hot flashes", varicose veins, venous diseases, pain along the veins.Disorders of the respiratory system, organs of the chest and mediastinum: rarely - bronchial asthma, hyperventilation.Disorders of the gastrointestinal tract: infrequently - abdominal pain, discomfort, bloating, nausea, vomiting, diarrhea rarely - gastritis, enteritis, dyspepsia.Disturbances of the skin and subcutaneous tissues: infrequently - acne, alopecia, rash, including macular rash, itching (including generalized itching) rarely - allergic dermatitis, atopic dermatitis, neurodermatitis, eczema, psoriasis, hyperhidrosis, chloasma, hyperpigmentation, seborrhea, dandruff, hirsutism, skin reaction - "cellulite", vascular "asterisks" unspecified frequency - urticaria, erythema nodosum, erythema multiforme.Disorders of the musculoskeletal and connective tissues: rarely - back pain, discomfort in the muscles and skeleton, myalgia, pain in the limbs.Disorders of the genital organs and the breast: often - pain in the mammary glands, a feeling of discomfort infrequently - change in the duration and volume of menstrual bleeding, including heavy menstrual bleeding, scarce menstrual bleeding and the absence of menstrual bleeding, acyclic bleeding, including vaginal bleeding and metrorrhagia, an increase in the size of the mammary glands, engorgement and a feeling of fullness in the mammary gland, swelling of the mammary gland, painful menstrual-like blood-smelling, discharge from the vagina, pain in the pelvic region rarely - cervical epithelial dysplasia, dyspareunia, galactorrhea unspecified frequency - discharge from the mammary glands, decreased libido, increased libido.Common disorders and disorders: infrequently - fatigue, asthenia, feeling unwell, changes in body weight (increase, decrease and fluctuations in body weight) rarely, chest pain, peripheral edema, flu-like symptoms, fever, irritability unspecified frequency - fluid retention.Impact on the results of laboratory and instrumental studies: rarely hypertriglyceridemia, hypercholesterolemia.The following serious adverse events have been reported in women who use COCs (which include Bonade):- Venous thromboembolic disorders.- Arterial thromboembolic disorders.- Stroke.- Increased blood pressure.- Hypertriglyceridemia.- Impaired glucose tolerance or effect on peripheral insulin resistance.- Liver tumors (benign and malignant).- Violation of the functional parameters of the liver.- Chloasma.- In women with hereditary angioedema, exogenous estrogens can cause or increase the symptoms of angioedema.- The onset or worsening of conditions for which the relationship with the use of COCs (which include the drug Bonade) is not indisputable: jaundice and / or itching associated with cholestasis the formation of gallstones porphyria systemic lupus erythematosus hemolytic uremic syndrome chorea herpes during a previous pregnancy hearing loss associated with otosclerosis Crohn's disease ulcerative colitis cervical cancer.- Visual impairment.- Dizziness.- Pancreatitis.- Cholecystitis.- The frequency of diagnosis of breast cancer in women who use COCs (which include the drug Bonade), is increased very slightly. Breast cancer is rarely observed in women under 40 years, the frequency excess is negligible relative to the overall risk of developing breast cancer. The causal relationship of breast cancer with the use of COC is not installed. See the “Contraindications” and “Special Instructions” section for more information.If you notice any unwanted effects that are not listed in the instructions, please inform your doctor.
There are no reports of serious adverse effects from overdose. Nausea, vomiting, and small vaginal bleeding or spotting may occur. There is no specific antidote symptomatic treatment should be carried out.
Some drugs can reduce the effectiveness of the drug Bonade. These include drugs used to treat:- epilepsy (for example, primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate) - it is necessary to use barrier methods of contraception during the whole cycle of therapy and another 28 days after its termination- tuberculosis (for example, rifampicin, rifabutin) and HIV infection (for example, ritonavir, nevirapine) - it is necessary to use barrier methods of contraception during the whole cycle of therapy and another 28 days after its termination- antibiotics for the treatment of some other infectious diseases (for example, penicillin, tetracyclines, griseofulvin) - it is necessary to use barrier methods of contraception during the whole cycle of therapy and another 7 days after its termination- medicines based on Hypericum perforatum (used to treat depressive conditions) - it is necessary to use barrier methods of contraception during the entire cycle of therapy and another 28 days after its termination.Bonade can affect the metabolism of other drugs, which leads to an increase (for example, cyclosporine) or a decrease (for example, lamotrigine) in plasma and tissue plasma concentrations.Some drugs can affect the metabolism of the active ingredients of the drug Bonade. These include:- antifungal drugs (for example, ketoconazole)- H2-blockers for the treatment of gastric ulcer and duodenal ulcer (for example, cimetidine)- some drugs for the treatment of hypertension (for example, verapamil, diltiazem)- antibiotics for the treatment of bacterial infections (macrolides, for example, erythromycin)- antidepressants- grapefruit juice.Always tell your healthcare provider which medicines (including herbal medicines) you are taking or have recently taken. Also, tell any doctor, including dentists who prescribe other drugs, and the pharmacist who is selling you the drug that you are taking Bonade.In some cases, the doctor may recommend that you additionally use a barrier method of contraception (condom).
If you have any of the conditions or risk factors listed below, you should carefully assess the potential risk and expected benefits of using the drug and discuss it with a woman before she decides to start taking the drug. In the event of an increase in the symptoms of an existing disease, an exacerbation of the disease or the appearance of the first signs of these conditions or risk factors when using this drug, it is necessary to consult with a physician who may decide whether to discontinue the drug.Thrombosis
Thrombosis is the formation of a blood clot (thrombus) that can clog a blood vessel. With the separation of a blood clot thromboembolism develops. Sometimes thrombosis develops in the deep veins of the lower extremities (deep vein thrombosis), heart vessels (myocardial infarction), brain (stroke), and extremely rarely - in vessels of other organs. The risk of deep vein thrombosis in women who take COCs is higher than those who do not take them, but not as high as during pregnancy.The results of epidemiological studies indicate a relationship between the use of COCs and an increased risk of thrombosis and thromboembolic diseases such as myocardial infarction, stroke, deep vein thrombosis and pulmonary embolism when taking COCs. These complications are rare.The risk of venous thromboembolism (VTE) is maximum in the first year of taking such drugs, mainly during the first 3 months. Increased risk is present after the initial use of the COC or when resuming use of the same or different COCs (after a break between taking the drug in 4 weeks or more).The overall risk of VTE in patients taking low-dose COCs (<50 μg of ethinyl estradiol) is two to three times higher than in non-pregnant patients who do not take COCs, however, this risk remains lower compared to the risk of VTE during pregnancy and childbirth .In very rare cases, venous or arterial thromboembolism can be fatal.VTE, manifested as deep vein thrombosis and / or pulmonary embolism, can occur with the use of any COC.Thrombosis in other blood vessels, such as the veins and arteries of the liver, mesentery, kidneys, brain or retina, is extremely rare with COCs.Symptoms of deep vein thrombosis (DVT) include the following: one-sided swelling of the lower limb or along the vein on the lower limb, pain or discomfort in the lower limb only in a vertical position or when walking, a local temperature increase in the affected lower limb, redness or change in skin color lower limb.The symptoms of pulmonary thromboembolism (pulmonary embolism) are as follows: difficulty breathing or rapid breathing sudden cough, incl. with hemoptysis acute pain in the chest, which may increase with a deep breath sense of anxiety severe dizziness rapid or irregular heartbeat. Some of these symptoms (eg, shortness of breath, cough) are nonspecific and may be misinterpreted as signs of other more common and less serious conditions / diseases (eg, respiratory tract infection).In the case of the above symptoms in women taking COCs, you should immediately consult with your doctor.The risk of VTE increases:- with age- when smoking (with intensive smoking and with increasing age, the risk is further increased, especially among women over 35 years old. Women over 35 should be strongly recommended to quit smoking if they want to take the drug Bonade)- with a family history (i.e. if there is a history of cases of venous thromboembolism at a relatively young age among parents or close relatives). If a hereditary predisposition is suspected, a woman should consult with a specialist before making a decision about any hormonal contraception- during prolonged immobilization, serious surgery, any operation on the lower limbs or an extensive injury. In these situations, it is necessary to discontinue use (in the case of a planned operation no less than 4 weeks), and not to resume it until two weeks after the full restoration of motor activity. If the use of the drug Bonade was not stopped in advance, the issue of antithrombotic therapy should be considered- air flight lasting more than 4 hours- with obesity (body mass index more than 30 kg / m 2).The risk of arterial thromboembolic complications or disorders of cerebral circulation increases:- with age- when smoking (with intensive smoking and with increasing age, the risk is further increased, especially among women over 35 years old. Women over 35 should be strongly recommended to quit smoking if they want to take the drug Bonade)- with dyslipoproteinemia- with arterial hypertension- with migraine- in diseases of the heart valves- with atrial fibrillation- with a family history (i.e., with a history of cases of arterial thrombosis at a relatively young age with parents or close relatives). If a hereditary predisposition is suspected, a woman should consult a specialist before making a decision on any hormonal contraception.Peripheral circulatory disorders can also occur in diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel disease (namely, Crohn’s disease or ulcerative colitis) and sickle cell anemia.You must consider the increased risk of thromboembolism in the postpartum period. The increase in the frequency or severity of migraine attacks during the use of the drug Bonade (which may be a precursor of cerebral circulation) is the reason for the immediate discontinuation of the drug.Concerning the potential role of varicose veins and surface thrombophlebitis in the development of VTE, there is no consensus.Tumors
The most important risk factor for cervical cancer is persistent papillomavirus infection. Some epidemiological studies suggest that long-term use of COCs may contribute to increasing this risk. However, there is still a discussion about how this result depends on other factors, such as screening studies of the cervix and freer sexual behavior and the rejection of barrier methods of contraception.A meta-analysis of the results of 54 epidemiological studies suggests a slightly increased relative risk of detecting breast cancer in women using COCs (relative risk 1.24). The increased risk gradually decreases over 10 years after discontinuing COC. Given the fact that breast cancer is rare in women younger than 40 years of age, the increase in the number of diagnosed breast cancer in women who take or have previously received COCs is small compared with the overall risk of breast cancer. These studies do not confirm the presence of a causal relationship. The reason for the observed increase in the number of breast cancer cases in women taking COCs may be earlier diagnosis, the biological effect of the drugs, or a combination of these factors. Breast cancer diagnosed in women who take or have previously taken COCs, is usually a less clinically advanced cancer than in patients who have never used them.Individual cases of benign liver tumors and, much less frequently, malignant liver tumors in women taking COCs were diagnosed. In rare cases, such tumors caused life-threatening intra-abdominal bleeding. In the event of severe pain in the upper abdominal cavity, an enlarged liver or signs of intra-abdominal bleeding in women taking COCs, it is necessary to consult a doctor immediately.Other states
In women with hypertriglyceridemia or having a family history of the disease, the risk of pancreatitis may be increased when taking COCs.Despite the fact that many women taking COCs, there was a slight increase in blood pressure, a clinically significant increase is rare. However, if a clinically significant increase in blood pressure (above 140/90 mm Hg) develops while taking COCs, the administration of the drug Bonade should be stopped and the treatment of arterial hypertension should be started. The drug can be continued if normal blood pressure values are achieved with the help of antihypertensive therapy.Discontinuation of COCs may be unavoidable in case of acute and chronic abnormalities of the liver, until all indicators of liver function return to normal. Relapses of cholestatic jaundice, which occurred for the first time during pregnancy or during the previous period of using COCs, also require discontinuation of the drug.The use of COCs (which include the drug Bonade) may cause the appearance or worsening of conditions for which the connection with the use of these drugs is not undeniable: jaundice and / or itching associated with cholestasis, the formation of gallstones, porphyria, systemic lupus erythematosus, hemolytic-uremic syndrome, Sydengham chorea, herpes during a previous pregnancy, hearing loss associated with otosclerosis.Despite the fact that COCs may affect peripheral insulin resistance and glucose tolerance, women with diabetes who take low-dose COCs do not usually need a dose adjustment or dosage regimen of hypoglycemic drugs. However, such women should be carefully monitored.Crohn's disease and ulcerative colitis may be associated with taking COCs.Chloasma (hyperpigmentation of the skin of the face) can sometimes appear, especially if it was observed during pregnancy. Women with a predisposition to chloasma while using COC should be wary of direct sunlight and exposure to other ultraviolet radiation.The disappearance of the symptoms of acne (acne) is usually marked after 3-4 months of therapy.Women should be warned that Bonade does not protect them from HIV infections and other sexually transmitted diseases.Reduced efficiency
The effectiveness of COCs may be reduced, for example, in the case of skipping pills, in the case of disorders of the gastrointestinal tract (vomiting, diarrhea) or the simultaneous use of other drugs.Cycle irregularity
Irregular bleeding ("spotting" or "breakthrough" bleeding) may appear during the intake of any COCOS, especially in the first months of taking the pills. Bleeding usually stops as the body adapts to the drug Bonade (usually after three cycles of taking pills). If the bleeding continues, and their severity increases, you should consult with a specialist.The absence of another bleeding "cancel"
In some women, “withdrawal” bleeding does not occur during a break in the pill. If the drug was taken in accordance with the instructions, the occurrence of pregnancy is unlikely. However, if the pills were taken irregularly, or the “withdrawal” bleeding did not occur twice in a row, then before continuing to use the drug, pregnancy should be excluded.Laboratory research
The use of COCs may affect laboratory results, including biochemical indicators of the performance of the liver, thyroid gland, adrenal glands and kidneys, the concentration of plasma proteins, such as corticosteroid-binding globulin, as well as the lipid / lipoprotein composition of the blood, carbohydrate metabolism and blood coagulation parameters. However, deviations usually remain within the range of normal laboratory values.Medical checkup
Before the first appointment or resumption of taking the drug Bonade, it is necessary to collect a detailed history and conduct a medical examination, taking into account contraindications, special instructions and precautions. The examination must be repeated regularly. Regular medical examinations are also necessary due to the presence of contraindications (for example, transient ischemic conditions, etc.) or risk factors (for example, the presence of venous or arterial thrombosis in the family history) that can occur for the first time only while taking COCs. The frequency and nature of such examinations should be based on approved practical methods adapted to the specific patient, but in general they should include, first of all, pregnancy should be excluded, the blood pressure indicators, the state of the mammary glands, abdominal organs and small pelvis should be checked, including cytological examination of the cervical epithelium, to exclude violations of the blood coagulation system.In the case of prolonged use of the drug, an examination should be carried out, at least 1 time in 6 months.Consult a doctor as soon as possible:In case of any health changes, especially any conditions listed in these instructions for use (see the section "Contraindications" and "With caution")With local compaction in the mammary glandIf you are going to use other drugs (see the section "Interaction with other drugs")If prolonged immobilization is expected (for example, a plaster is applied to the leg), hospitalization or surgery is planned (consult a doctor 4-6 weeks before it)If an unusually strong uterine bleeding occursIf you forgot to take a pill in the first week of taking the package (blister) and you had sexual intercourse a week beforeIf you have not had another “withdrawal” bleeding twice in a row, or you suspect that you are pregnant (do not start taking the next pack (blister) until you consult with your doctor).Influence on ability to drive vehicles and mechanismsCare must be taken when driving vehicles and practicing potentially hazardous activities, as dizziness may occur in rare cases when taking the drug Bonade.
Tablets, film coated 2 mg + 0.03 mg.On 21 tablets in the blister from PVC / PVDH / Al. On 1 or 3 blisters together with the instruction for application are placed in a cardboard pack.Shelf life - 3 years.Do not use after the expiration date printed on the package.Storage conditions
Store at a temperature not higher than 25 ° С.Keep out of the reach of children.Pharmacy sales conditions:
You don't need a prescription to buy Bonade.'
|The purpose of the medication||Contraception|