Bonade pills 2mg + 0.03mg, 21pcs

Composition

1 tablet contains:

active ingredients:

ethinyl estradiol 30 mcg,

dienogest 2 mg,

excipients:

lactose monohydrate – 57.17 mg,

corn starch-12 mg,

povidone 30 LP-3 mg,

sodium starch glycolate-5 mg,

magnesium stearate-0.8 mg.

:

aquapolish white 014.17 MS (hypromellose-48%, hydroxypropylcellulose-12%, talc-20%, hydrogenated cotton seed oil-5%, titanium dioxide-15%) – 9 mg

Pharmacological action

Bonade is a low-dose monophasic oral combined estrogen-progestogen contraceptive. The effect of Bonade is based on the combined action of various factors, the most important of which is the suppression of ovulation and an increase in the viscosity of cervical secretions.

The progestogenic component of Bonade, dienogest, is a derivative of nortestosterone and has an antiandrogenic effect. Dienogest also has a beneficial effect on the lipid profile, increasing the HDL content.

In women taking combined oral contraceptives (COCs), the cycle becomes more regular, painful menstruation is less frequent, and the intensity and duration of bleeding decreases.

Pharmacokinetics

Dienogest

Suction

After oral use, dienogest is rapidly and almost completely absorbed. Cmax in blood plasma (51 ng/ml) is reached in 2.4±1.4 hours after taking the drug. Bioavailability in combination with ethinyl estradiol is about 96%.

Distribution

Dienogest binds to serum albumin (90%) and does not bind to specific transport proteins-sex hormone-binding globulin (SHBG) and corticosteroid-binding globulin (CSG). Any effect on the physiological transport of endogenous steroids is unlikely. Ethinylestradiol-induced increase in SHBG concentrations does not affect the binding of dienogest to serum proteins.

The pharmacokinetics of dienogest are not affected by SHBG concentrations. After taking a daily dose, the concentration of the drug in the blood plasma increases approximately 1-5 times, and Css is reached in about 4 days.

Metabolism

Dienogest is primarily metabolized by hydroxylation, but also by hydrogenation, conjugation, and aromatization to form inactive metabolites.

Deduction

The total clearance after a single dose is 3.6 l/h.

T 1/2 of dienogest is 8.5-10.8 h. A small amount of dienogest is excreted unchanged by the kidneys. Metabolites are excreted by the kidneys and bile in a ratio of 3: 1. T 1/2 of metabolites is 14.4 hours.

Ethinyl Estradiol

Suction

After oral use, ethinyl estradiol is rapidly and completely absorbed. Cmax in blood plasma (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 of 44%.

Distribution

Ethinyl estradiol binds almost completely (98%), although not specifically, to albumin. Ethinyl estradiol induces SHBG synthesis. The recorded Vd of ethinyl estradiol is 2.8-8.6 l / kg.

Css is achieved during the second half of the treatment cycle, when the drug levels in the serum become 2 times higher compared to a single dose.

Metabolism

Ethinyl estradiol undergoes presystemic conjugation both in the mucosa of the small intestine and in the liver. The main route of metabolism is aromatic hydroxylation, followed by conjugation with glucuronic and / or sulfuric acids.

Deduction

The rate of metabolic clearance from blood plasma is 2.3-7 ml / min / kg. The concentration of ethinyl estradiol in blood plasma decreases, and the decrease is biphasic: the first phrase is characterized by a T 1/2 of about 1 hour, the second-10-20 hours.

It is not displayed unchanged. Metabolites of ethinyl estradiol are excreted by the kidneys and liver in a ratio of 4: 6, with a T 1/2 of about 24 hours.

Indications

Contraception.

Contraindications

Bonade should not be used in the presence of any of the conditions/diseases listed below. If any of these conditions develop for the first time during its use, the drug should be discontinued immediately.

• thrombosis (venous and arterial) and thromboembolism in the present or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke), cerebrovascular disorders;
• status, previous thrombosis (including transient ischemic attack, angina) at present or in history;
• migraine with focal neurological symptoms in the present or in the anamnesis;
• diabetes mellitus with vascular complications;
• severe or multiple risk factors for venous or arterial thrombosis, including the complicated lesions of valvular heart atrial fibrillation, vascular diseases of the brain or coronary arteries of the heart; uncontrolled hypertension, major surgery, prolonged immobilization, Smoking age 35 years;
• congenital or acquired predisposition for arterial or venous thrombosis (resistance to activated protein C, antithrombin III deficiency, deficiency of protein C, protein S deficiency, hyperhomocysteinemia, the presence of antibodies to phospholipids, lupus anticoagulant);
• pancreatitis with severe hypertriglyceridemia now or in history;
• liver failure and severe liver disease (up to normalization of liver enzymes);
• liver tumor (benign or malignant) at present or in history;
• identification of hormone-dependent malignant tumors (including genitalia or mammary glands) or suspicion of them;
• vaginal bleeding of unknown origin;
• pregnancy or suspicion of it;
• lactation (breastfeeding);
• hypersensitivity to any component of the drug;
• galactose intolerance, lapp lactase deficiency or malabsorption of glucose and galactose (product contains lactose);
• obesity (body mass index more than 30 kg/m 2);
• extensive trauma.

With caution

• The potential risk and expected benefit of using COCs should be carefully weighed on a case-by-case basis in the presence of the following diseases: /conditions and risk factors:
• risk factors for development of thrombosis and thromboembolism: Smoking; obesity (body mass index less than 30 kg/m 2); dislipoproteinemia, arterial hypertension; migraine without focal neurologic symptoms; uncomplicated cardiac valve diseases of the heart; hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at a young age in any of the next of kin);
• other diseases, which may include peripheral circulatory disorders: diabetes mellitus; SLE; hemolytic uremic syndrome; Crohn’s disease and ulcerative colitis; sickle cell anemia; phlebitis of superficial veins;
• hereditary angioedema;
• hypertriglyceridemia;
• disease, new-onset or aggravated during pregnancy or in the background of previous use of sex hormones (eg, jaundice, cholestasis, gallbladder disease, otosclerosis with hearing impairment, porphyria, herpes during pregnancy, chorea Sydenham);
• postpartum period.

Side effects

When using Bonade, irregular bleeding (spotting spotting or breakthrough uterine bleeding) may occur, especially during the first months of use.

Other undesirable effects may occur with the use of Bonade, although they are not necessarily present in all patients.

The following adverse reactions have been reported in women taking COCs, but the reactions described may not have been caused by these pills. The adverse reactions listed below usually occur during the first months of using birth control pills and tend to subside over time.

Side effects identified during the use of the active ingredients of the drug Bonade are given with a distribution by frequency of development and by organ systems.

Infectious and parasitic diseases: infrequently-vaginitis, vulvovaginitis, vaginal candidiasis or other fungal vulvovaginal infections; rarely-salpingoophoritis (adnexitis), urinary tract infections, cystitis, mastitis, cervicitis, fungal infections, oral herpetic lesions, flu, bronchitis, sinusitis, upper respiratory tract infections, viral infection.

Benign, malignant and unspecified neoplasms (including cysts and polyps): infrequently – ovarian cysts; rarely – uterine appendage cysts, uterine fibroids, breast lipoma, breast cysts, fibrocystic mastopathy.

Allergic reactions: rarely-allergic dermatitis, atopic dermatitis, neurodermatitis, eczema; unspecified frequency-urticaria, erythema multiforme.

From the hematopoietic system: rarely-anemia.

From the endocrine system: rarely-virilism.

Psychiatric disorders: rarely-depression; very rarely-mood changes; unspecified frequency-decreased mood, insomnia, sleep disorders, aggression.

From the nervous system: often-headache; infrequently-dizziness, migraine; rarely-ischemic stroke, cerebrovascular disorders, dystonia.

From the side of the organ of vision: rarely-dryness of the eye mucosa, irritation of the eye mucosa, oscillopsia; unspecified frequency-intolerance to contact lenses (unpleasant sensations when wearing them).

Hearing disorders and labyrinthine disorders: rarely-sudden hearing loss, tinnitus, dizziness, hearing impairment.

From the cardiovascular system: rarely-cardiovascular disorders, tachycardia, thrombosis or pulmonary embolism, thrombophlebitis, increased diastolic blood pressure, orthostatic circulatory dystonia, hot flashes, varicose veins, venous diseases, pain along the veins; infrequently-increased or decreased blood pressure.

From the respiratory system: rarely-bronchial asthma, hyperventilation.

From the digestive system: infrequently-abdominal pain, including pain in the upper and lower abdomen, discomfort, bloating, nausea, vomiting, diarrhea; rarely – gastritis, enteritis, dyspepsia.

From the skin and subcutaneous tissues: infrequently-pruritus (including generalized pruritus), acne, alopecia, rash, including macular rash; rarely-psoriasis, hyperhidrosis, chloasma, hyperpigmentation, seborrhea, dandruff, hirsutism, cellulite, vascular asterisks; unspecified frequency – erythema nodosum.

From the musculoskeletal system: rarely-back pain, discomfort in the muscles and skeleton, myalgia, pain in the extremities.

From the genitals and breast: often – pain in the mammary glands, a feeling of discomfort; infrequently – changes in the duration and volume of menstrual – like bleeding, including heavy menstrual – like bleeding, scanty menstrual-like spotting and the absence of menstrual-like spotting, 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, breast edema breast cancer, painful menstrual-like spotting, vaginal discharge, pelvic pain; rarely-cervical epithelial dysplasia, dyspareunia, galactorrhea; unspecified frequency-discharge from the mammary glands, decreased libido, increased libido.

General disorders and disorders: infrequently-increased appetite, fatigue, asthenia, poor health, changes in body weight (increase, decrease and fluctuations in body weight); rarely-anorexia, chest pain, peripheral edema, flu-like phenomena, fever, irritability; unspecified frequency-fluid retention.

From the laboratory parameters: rarely-hypertriglyceridemia, hypercholesterolemia.

Women with oestrogen-dependent hereditary angioedema may develop or worsen symptoms of angioedema. Since breast cancer rarely occurs in women under the age of 40, the overall risk of developing breast cancer is very low. The relationship with the use of PDAs is not known.

If there are undesirable effects that are not specified in the instructions, the woman should inform the doctor about this.

Interaction

The drug Bonade can affect the metabolism of other drugs, which leads to an increase (for example, cyclosporine) or a decrease (for example, lamotrigine) in their concentration in blood plasma and tissues.

Medications that may reduce the effectiveness of Bonade

These include medications used to treat:

– epilepsy (for example, primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate) – it is necessary to use barrier methods of contraception during the entire cycle of therapy and for another 28 days after its end;

– tuberculosis (for example, rifampicin, rifabutin) and HIV infections (e. g. ritonavir, nevirapine) – requires the use of barrier methods of contraception during the entire cycle of therapy and for 28 days after its completion;

– antibiotics to treat certain other infectious diseases (e. g., penicillin, tetracycline, griseofulvin) – requires the use of barrier methods of contraception during the entire cycle of treatment and 7 days after its completion;

– medicines based on St. John’s wort (used to treat depression) – it is necessary to use barrier methods of contraception during the entire cycle of therapy, and a further 28 days thereafter.

Drugs that may affect the metabolism of the active components of Bonade

These include:

– antifungal agents (e. g. ketoconazole);

– histamine H 2-receptors for the treatment of gastric ulcer and duodenal ulcer (eg, cimetidine);

– certain drugs for the treatment of hypertension (e. g., verapamil, diltiazem);

– antibiotics to treat bacterial infections (macrolides, such as erythromycin);

antidepressant;

– grapefruit juice.

A woman should inform the attending physician about what medications (including herbal medicines)she is taking. she accepts or has recently accepted. Please inform any doctor (including dentist) who prescribes other medications, as well as the pharmacist, that the woman is taking Bonade.

In some cases, your doctor may recommend that you additionally use a barrier method of contraception (a condom).

How to take, course of use and dosage

The drug Bonade is taken orally 1 tablet a day, without chewing and with a small amount of water, at the same time every day. Tablets are taken for 21 days without interruption according to the scheme indicated on the blister. Each blister contains 21 tablets. Each tablet is marked with the day of the week on which it should be taken. No pills are taken for the next 7 days. During this period, menstrual-like bleeding (withdrawal bleeding) should begin. It usually begins 2-3 days after taking the last pill of Bonade.

After a 7-day break, on the 8th day, start taking tablets from a new package (if the package contains 21 tablets) or a blister (if the package contains 63 tablets), even if the bleeding has not stopped yet. This means that a woman will always start a new pack (blister) on the same day of the week and that every month withdrawal bleeding will occur on approximately the same day of the month.

Initiation of the use of Bonade

In the absence of taking any hormonal contraceptives in the previous month, the use of Bonade should begin on the 1st day of the natural menstrual cycle (i. e., on the 1st day of menstrual bleeding). Take a pill marked with the corresponding day of the week. For example, if your period starts on a Friday, take a pill marked with letters indicating Friday. Then, you should continue to take the pills in the following days in accordance with the established procedure. It is also acceptable to start using from the 2nd-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 using tablets from the first package (blister).

If you switch from other PDAs, a contraceptive vaginal ring, or a contraceptive patch, you can start taking Bonade the day after taking the last pill from the previous pack of PDAs (i. e., without interruption). If the previous package also contained inactive tablets (without the Active ingredient), you can start using Bonade the day after taking the last active tablet. You can also start using it later, but in no case later than the next day, after the usual break in use (a break of 7 days for drugs containing 21 tablets) or after taking the last inactive tablet (for drugs containing 28 tablets in a package).

If a contraceptive patch or a contraceptive vaginal ring is used, Bonade should be started on the day they are removed, but not later than the day when a new ring is inserted or a new patch is applied.

If you switch from progestogen-only oral contraceptives (mini-pili), you can stop taking mini-pili on any given day and start using Bonade the next day, at the same time. During the first 7 days of use of tablets, it is also necessary to use an additional barrier method of contraception.

When switching from an injectable contraceptive, implant, or intrauterine device (intrauterine device) that releases progestogen, you should start using Bonade on the day when the next injection is to be made or on the day when the implant or intrauterine device is removed. During the first 7 days of use of tablets, it is also necessary to use an additional barrier method of contraception.

Immediately after delivery, your doctor may recommend that you wait until the end of your first normal menstrual cycle before starting Bonade. Sometimes, on the recommendation of a doctor, you can start using the drug earlier.

After a spontaneous miscarriage or abortion in the first trimester of pregnancy, you should consult your doctor. It is usually recommended to start using the drug immediately.

Taking missed pills

If the delay in taking the next pill is less than 12 hours, the contraceptive effect of Bonade remains. The patient should take the pill as soon as she remembers it. The next tablet should be taken at the usual time.

If the delay in taking pills is more than 12 hours, the contraceptive protection may be reduced. The more consecutive pills missed, and the closer this skip is to the start or end of the intake, the higher the risk of pregnancy.

In this regard, you can follow the following rules::

– if you missed more than 1 tablet from the package (blister), you should consult your doctor;

– if you missed 1 tablet in the first week of using the drug, you should take the missed tablet as soon as possible, as soon as the patient remembers (even if this means taking two tablets at the same time). The next tablet should be taken at the usual time. It is necessary to additionally use a barrier method of contraception for the next 7 days. If sexual intercourse took place within a week before skipping the pill, the probability of pregnancy should be taken into account. You should consult your doctor immediately;

– if you miss 1 tablet in the second week of taking the drug, you should take the missed tablet as soon as possible, as soon as the patient remembers (even if this means taking 2 tablets at the same time). The next tablet should be taken at the usual time. If the woman took the pills correctly during the 7 days preceding the first missed pill, the contraceptive effect of Bonade is preserved, and the woman does not need to use additional contraceptive measures. Otherwise, and if you pass 2 or more pills, you must also use a barrier method of contraception for 7 days;

– if 1 tablet is missed in the third week of taking the drug, but during the 7 days preceding the first missed tablet, all the pills are taken correctly, no need to use additional contraceptive methods, if a woman will adhere to any of the following two options:

1. You should take the missed pill as soon as possible, as soon as the patient remembers (even if this means taking 2 tablets at the same time). The next tablet should be taken at the usual time. The next package (blister) should be started immediately after the end of taking tablets from the current package( blister), so there will be no break between packages (blisters). Withdrawal bleeding is unlikely until you run out of pills from the second package (blister), but there may be spotting or breakthrough uterine bleeding on the days of taking the drug.

2. You should stop using tablets from the current package (blister), take a break for 7 or less days (including the day you missed the pill), and then start taking tablets from the new package (blister).

The absence of the expected menstrual-like bleeding after a break in the use of tablets may mean that the woman is pregnant. In this case, the woman should consult a doctor before she starts using tablets from a new package (blister).

Using this scheme, a woman can always start using tablets from the next package (blister) on the day of the week when she usually does it.

In situations where it is recommended to stop taking Bonade, or when its reliability may be reduced, you should refrain from sexual contact or use non-hormonal contraceptive methods (for example, a condom or other barrier methods). Do not use rhythmic or temperature methods. These methods can be unreliable, as taking COCs leads to changes in basal temperature and cervical mucus.

Discontinuation of the drug

You can stop taking Bonade at any time. If you stop using it due to the desire to get pregnant, it is usually recommended to wait for the first normal menstruation and only then try to get pregnant. Using this method, it is easier to set the date of delivery.

Recommendations for gastrointestinal disorders

In case of vomiting or diarrhea, the active ingredients of Bonade may not be completely absorbed. If vomiting continues for 3-4 hours after taking a contraceptive pill, the result may be the same as if you missed taking the pill. You should do as recommended if you miss taking the pill. In case of severe diarrhea, consult your doctor.

Delaying the onset of menstrual-like bleeding

You can delay the onset of menstrual-like bleeding if you start taking pills from the next package (if the package contains 21 tablets) or a blister (if the package contains 63 tablets) immediately after the end of the current package (blister). You can take the pills for as long as necessary, or until the pills in the package (blister) run out. If it is necessary for the withdrawal bleeding to start, you should stop taking the pills. During the use of Bonade tablets from a new package (blister), heavy or smearing spotting may appear. The use of tablets from the next package (blister) should begin after the usual 7-day interval.

Changing the day of onset of menstrual-like bleeding

If a woman takes pills, strictly following all the recommendations, menstrual-like bleeding occurs approximately on the same days every 4 weeks. If you need to change these days, you should shorten (but never extend) the next interval without taking pills. For example, if the bleeding starts on Fridays, but it is necessary that it starts on Tuesdays (3 days earlier), then you should start using tablets from a new package (blister) 3 days earlier than usual. If the interval without taking pills is too short, bleeding may not occur at all during this interval. However, during the use of tablets from a new package (blister), heavy or smearing spotting may appear.

Special patient groups

For children and adolescents, Bonade is indicated only after the onset of menarche.

Bonade is not indicated after menopause.

The drug is contraindicated in women with severe liver diseases until liver function indicators return to normal.

Bonade has not been specifically studied in women with impaired renal function. The available data do not suggest a change in the dosage regimen in such patients.

Overdose

No serious side effects of overdose have been reported.

Symptoms: Nausea, vomiting, and small vaginal bleeding or spotting may occur.

Treatment: There is no specific antidote, and symptomatic treatment should be performed.

Special instructions

If you have any of the following conditions or risk factors, you should carefully evaluate the potential risk and expected benefit of therapy and discuss it with the woman before she decides to start taking the drug. If the symptoms of an existing medical condition increase, the disease worsens, or the first signs of these conditions or risk factors appear when using this drug, you should consult your doctor, who can decide whether to discontinue the drug.

Thrombosis

The risk of deep vein thrombosis in women taking COCs is higher than in 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 developing venous thromboembolism (VTE) is maximal in the first year of using such drugs, mainly during the first 3 months. There is an increased risk when using a PDA for the first time or when using the same or different PDA again (after a break between taking the drug of 4 weeks or more).

Overall risk of VTE in patients taking low-dose COCs (

In very rare cases, venous or arterial thromboembolism can be fatal.

VTE, which manifests as deep vein thrombosis and / or pulmonary embolism, can occur with any PDA.

Very rarely, when using a PDA, thrombosis occurs in other blood vessels, such as the veins and arteries of the liver, mesentery, kidneys, brain, or retina.

Symptoms of deep vein thrombosis (DVT): unilateral swelling of the lower limb or along a vein in the lower limb, pain or discomfort in the lower limb only when standing upright or walking, local fever in the affected lower limb, redness or discoloration of the skin on the lower limb.

Symptoms of pulmonary embolism (PE): difficulty or rapid breathing; sudden coughing, including coughing up blood; acute chest pain, which may increase with deep breathing; anxiety; severe dizziness; rapid or irregular heartbeat. Some of these symptoms (for example, shortness of breath, cough) are non – specific and can be misinterpreted as signs of other more or less severe events (for example, respiratory tract infection).

If any of the symptoms listed above occur in women taking COCs, you should consult your doctor immediately.

The risk of developing thrombosis (venous and/or arterial) and thromboembolism increases:

– with increasing age;

– in smokers (with an increase in the number of cigarettes or an increase in age, the risk increases, especially in women over 35 years of age). When using the drug Bonade, smoking should be stopped, especially if the age of the woman exceeds 35 years;

– if a family history indicates the presence of venous or arterial thromboembolism ever in close relatives or parents at a relatively young age.In the case of hereditary or acquired predisposition, the woman should be assessed appropriately skilled for the solution of the question about the possibility of taking the drug Bonade;

– when overweight (a body mass index more than 30 kg/m 2);

– if dyslipoproteinemia;

– hypertension;

– migraine;

– in diseases of valvular heart;

– atrial fibrillation;

– systemic lupus erythematosus;

– diabetes;

-with sickle-cell anaemia;

– during prolonged immobilization, major surgery, any surgery on the lower limbs or major trauma. In these situations, it is necessary to stop using the drug (in the case of planned surgery, at least 4 weeks before it) and not resume taking the drug for 2 weeks after the end of immobilization.

Tumors

A link between PDA use and breast cancer has not been proven, although it is slightly more common in women who take PDA than in women of the same age who do not use PDA.

Perhaps these differences are caused by the fact that when using the drug, women are observed by specialists and therefore breast cancer is detected at an early stage more often.

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 an increase in this risk. However, there is still ongoing debate about how much this outcome depends on other factors, such as cervical screening studies and freer sexual behavior and the rejection of barrier methods of contraception.

A meta-analysis of the results of 54 epidemiological studies indicates a slightly increased relative risk of breast cancer detection in women using COCs (relative risk 1.24). The increased risk gradually decreases within 10 years after the use of COCs is discontinued. Given the fact that breast cancer is rare in women younger than 40, the increase in the number of diagnosed breast cancers in women who take or have previously taken COCs is small compared to the overall risk of breast cancer. These studies do not confirm the existence of a causal relationship. The reason for the observed increase in breast cancer detection in women taking COCs may be an 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 less clinically advanced than in patients who have never used them.

Isolated cases of benign liver tumors and, significantly less frequently, malignant liver tumors have been diagnosed in women taking COCs. In rare cases, such tumors have caused life-threatening intra-abdominal bleeding. If you experience severe upper abdominal pain, enlarged liver, or signs of intra-abdominal bleeding in women taking COCs, you should consult your doctor immediately.

Other states

Women who suffer from hypertriglyceridemia or have a family history of this condition may have an increased risk of pancreatitis when using COCs.

Although many women taking COCs have experienced a slight increase in blood pressure, clinically significant increases are rare. However, if a clinically significant increase in blood pressure develops while taking COCs, the doctor should be advised to stop taking COCs as a precaution and start treatment for hypertension. The use of the drug can be continued if normal blood pressure values are achieved with the help of antihypertensive therapy.

Withdrawal of COC may be unavoidable in acute and chronic liver function disorders until all liver function parameters return to normal. Relapses of cholestatic jaundice that occurred for the first time during pregnancy or during the previous period of PDA use also require discontinuation of the drug.

Although COCs may have an effect on peripheral insulin resistance and glucose tolerance, there is no evidence that women with diabetes and those using low-dose oral contraceptives (including those with low-dose oral contraceptives) should be able to control the risk of diabetes.

Crohn’s disease and ulcerative colitis may be associated with the use of COCs. Sometimes chloasma (hyperpigmentation of the facial skin) may appear, especially if it was observed during pregnancy. Women with a predisposition to chloasma should avoid direct sunlight and exposure to other ultraviolet radiation while using COCs.

Reduced efficiency

The effectiveness of COCs may decrease, for example, in the case of skipping taking pills, in the case of disorders of the gastrointestinal tract, or the simultaneous use of other medications.

Cycle irregularity

Irregular bleeding (spotting or breakthrough bleeding) may occur during the use of any PDA, especially in the first months of taking the pill. Bleeding usually stops as the body adapts to the drug Bonade (usually after 3 cycles of taking tablets). If the bleeding continues and its severity increases, you should consult a specialist.

No regular withdrawal bleeding

Some women do not experience withdrawal bleeding during the pill break. If the drug was taken in accordance with the instructions, pregnancy is unlikely to occur. However, if the pills were taken irregularly, or withdrawal bleeding did not occur twice in a row, then pregnancy should be excluded before continuing to use the drug.

Laboratory tests

The use of PDA can have an impact on laboratory results, including biochemical indicators of liver, thyroid, adrenal, and kidney performance, plasma protein concentrations such as corticosteroid-binding globulin, as well as blood lipid/lipoprotein composition, carbohydrate metabolism, and blood coagulation parameters. However, deviations usually remain within the range of normal laboratory values.

Medical examination

Before the first appointment or resumption of taking Bonade, it is necessary to collect a detailed medical history and conduct a medical examination, taking into account contraindications, special instructions and precautions. The examination should be repeated regularly. Regular medical examination is also necessary because of contraindications (for example, transient ischemic conditions, etc. ) or risk factors (for example, a family history of venous or arterial thrombosis) that may occur for the first time only during the use of COCs. The frequency and nature of such examinations should be based on approved practical methods adapted to the individual patient, but in general they should include, first of all, blood pressure measurement, determination of the condition of the mammary glands, abdominal and pelvic organs, including the study of cervical mucus and cytological examination of vaginal smears. In case of long-term use of the drug, the examination should be carried out at least once every 6 months.

A woman should consult a doctor as soon as possible:

– if you have any health changes, especially any of the conditions listed in the instructions for use;

– when a local lump in the breast;

– the appointment of other drugs;

– if it is expected prolonged immobilization (e. g., the imposition of a plaster bandage on the lower extremity), planned hospitalization or surgery (it is necessary to consult with your doctor 4-6 weeks before);

– in the event of unusually heavy uterine bleeding;

– if a woman forgot to take the pill in the first week of packing (blister) and had intercourse in the week before;

if twice in a row was not a regular withdrawal bleeding or suspected pregnancy (you should not start taking the next pack (blister) before consulting a doctor).

A woman should be warned that the drug Bonade does not protect against HIV infection and other sexually transmitted diseases.

Influence on the ability to drive motor vehicles and manage mechanisms

Caution should be exercised when driving vehicles and engaging in potentially dangerous activities, as dizziness may occur in rare cases while taking Bonade.

Form of production

Film-coated tablets

Storage conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C.

Shelf

life is 2 years.

Active ingredient

Ethinyl Estradiol, Dienogest

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as prescribed by a doctor, For women of childbearing age

Indications

Seborrhea, Contraception, Acne