Ethinyl Estradiol, Dienogest

Brand Haupt Pharma Münster GmbH

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Available since: 2019-09-19

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Clinical Pharmacology

PHARMACOTHERAPY GROUP

Combined contraceptive (gestagen + estrogen).

ATX code: G03 AA

PHARMACOLOGICAL PROPERTIES

Pharmacodynamics

Drug BONADE^® - low-dose monophasic oral combined estrogen-progestin contraceptive drug.

Contraceptive effect of the drug BONADE^® based on the joint action of various factors, the most important of which is the suppression of ovulation and the increase in the viscosity of the cervical secretions.

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 content of high-density lipoproteins.

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

Pharmacokinetics

Dienogest

Absorption. After oral administration, 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.

Derivation. The half-life of dienogest (T_1/2) 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 the daily dose, the concentration of the drug in the blood plasma increases by approximately 1-5 times, and equilibrium is achieved 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 of 44%.

Distribution. 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 both in the mucous membrane of the small intestine and in the liver. The main metabolic pathway is aromatic hydroxylation, followed by conjugation with glucuronic and / or sulfuric acid. The rate of metabolic clearance from blood plasma is 2.3-7 ml / min / kg.

Derivation. 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.

Indications

Contraception (prevention of unwanted pregnancy).
Acne treatment of mild to moderate severity in women who need contraception, with the ineffectiveness of other treatments (topical treatment or use of systemic antibiotics).

Composition

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 coating: aquapolish white 014.17 MS (hypromellose - 48%, hydroxypropylcellulose - 12%, talc - 20%, seed cotton - 5% hydrogenated oil, 15% titanium dioxide).

Ethinyl Estradiol, Dienogest is marketed under different brands and generic names, and comes in different dosage forms:

Brand name	Manufacturer	Country	Dosage form
Bonade	Haupt Pharma Münster GmbH	Czech	pills
Siluet	Gedeon Richter	Hungary	pills
Janin	Bayer Pharma AG	Germany	dragee

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Dosage and Administration

When and how to take the drug BONADE^®

Drug BONADE^® taken orally, one tablet per day, without chewing and squeezing a small amount of water at the same time every day. pills 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 tablet of the BONADE drug.^®.

After a 7-day break, on the 8th day, start taking the pills from the new package (if the package contains 21 pills) or blisters (if the package contains 63 pills), 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 the “cancellation” bleeding will occur approximately on 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.

Taking the drug BONADE^® begin on the first day of the natural menstrual cycle (i.e., 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 the COC (i.e., without interruption in the intake). If the previous package also contained inactive pills (without active substance), you can begin to use the drug BONADE^® the day after taking the last active pill. 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 pills) or after taking the last inactive tablet (for drugs containing 28 pills per pack).

In case of using a contraceptive patch or a contraceptive vaginal ring, take BONADE^® should begin on the day they are removed, but no later than the day when a new ring is to be inserted or a new adhesive is pasted.

When switching from oral contraceptives containing progestogen only ("mini-pili").

You can stop taking “mini-drank” any day and start taking the drug 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 the drug BONADE^® on the day when the next injection is to be done 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 starting the BONADE drug.^®. 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 next pill is less than 12 hours, the contraceptive effect of the drug BONADA^®preserved. Take the 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 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).

Consult a doctor.

Missed one tablet in 1^th 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.

One tablet missed in 2^th 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 BONADA^®persists, 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.

Missing one tablet for 3^her 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:

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 pack (blister) immediately after taking the pills from the current pack (blister), so there will be no break between the packs (blisters). Bleeding "cancellation" is unlikely until the pills from the second package (blister) run out, but there may be "spotting" discharge or "breakthrough" uterine bleeding on the days of taking the drug.
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, it is necessary to refrain from sexual intercourse 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 case of discontinuation of the drug BONADE^®

You can stop taking the drug BONADE^® Anytime. In case of discontinuation due to the desire to become pregnant, it is usually recommended to wait for the first normal menstruation and only after that try to become pregnant. Using this method is easier to set the date of delivery.

Recommendations for gastrointestinal disorders

In the event of vomiting or diarrhea, the active ingredients of the preparation 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 pills from the next package (if the package contains 21 pills) or blisters (if the package contains 63 pills) immediately after the current package (blister) is over. You can take the 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 pills of the drug BONADE^® abundant or “spotting” spotting may appear from the new package (blister). 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.

Adverse reactions

When taking the drug BONADE^®irregular bleeding can occur ("spotting" bleeding or "breakthrough" uterine bleeding), especially during the first months of use.

Against the background of the drug BONADA^®other undesirable effects may occur, although their appearance is not necessary in all patients.

Serious adverse effects

See “Precautions” and “Special Instructions”. Please read these sections carefully and, in case of undesirable effects, including serious reactions associated with the use of the drug, consult your doctor.

Side effects identified during the administration of active ingredients of the drug BONADE^®are given with the distribution of the frequency of development and organ systems. The frequency of side effects was classified as follows: very often (> 1/10), often (> 1 / 100.1 / 1000.1 / 10000,

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, herpetic oral cavity disease, influenza, bronchitis, sinusitis, upper respiratory infections, viral infection.

Benign, malignant and unspecified neoplasms (including cysts and polyps): infrequently - ovarian cysts; rarely - cysts of the uterus, uterine myoma, breast lipoma, breast cysts, fibrocystic mastopathy.

Violations of the blood and lymphatic system: rarely - anemia.

Immune system disorders: rarely allergic reactions.

Endocrine disorders: 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 - dizziness, 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.

Heart 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: rarely - abdominal pain, discomfort, bloating, nausea, vomiting, diarrhea; rarely - gastritis, enteritis, dyspepsia.

Violations of the skin and subcutaneous tissues: rarely - 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 "stars"; 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 breast: often - pain in the mammary glands, discomfort; infrequently - changes in the duration and volume of menstrual bleeding, including heavy menstrual bleeding, scanty menstrual bleeding and the absence of menstrual bleeding, acyclic bleeding, incl. 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 bleeding, vaginal discharge, 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 using COCs (which include the drug 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).

- Impaired liver function.

- Chloasma.

- In women with hereditary angioedema, exogenous estrogens can cause or exacerbate the symptoms of angioedema.

- The onset or deterioration of conditions for which communication with the use of COCs (to which 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 apply COCs (which include the drug BONADE^®), raised 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. For more information, see “Contraindications” and “Special Instructions”.

If you notice any unwanted effects that are not listed in the instructions, please inform your doctor.

Drug BONADE^® 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 embolism, myocardial infarction);
The states preceding thrombosis (including angina) are currently or in history;
Cerebrovascular disease: stroke, transient ischemic attacks in the present and in history;
Multiple or severe risk factors for venous or arterial thrombosis, including complicated lesions of the valvular apparatus of the heart, atrial fibrillation, vascular diseases of the brain or coronary arteries, severe dyslipoproteinemia, uncontrolled arterial hypertension, serious surgical intervention, prolonged immobilization, unsupervised arterial hypertension; and pelvic organs, neurosurgical interventions, smoking after the age of 35;
Congenital 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, lupus antioxidant).
Migraine with focal neurological symptoms now or in history;
Diabetes with vascular complications;
Pancreatitis with severe hypertriglyceridemia now or in history;
Liver failure and severe liver disease (before normalization of liver enzymes), including Rotor and Dubin-Johnson syndromes;
Liver tumors (benign or malignant) now or in history;
Identified hormone-dependent malignant neoplasms (including the genital organs or mammary glands) or suspicion of them;
Bleeding from the vagina of unknown origin;
Pregnancy or suspicion of it;
Breastfeeding period;
Hypersensitivity to any of the components of the drug BONADE^®;
Galactose intolerance, lactase deficiency or glucose-galactose maladsorption (the product contains lactose);
Obesity (body mass index more than 30 kg / m²);
Extensive injury.

Drug BONADE^® not intended for use in men.

Carefully

The potential risk and expected benefit of using COC should be carefully weighed.in each individual case with the following diseases / conditions and risk factors:

Risk factors for thrombosis and thromboembolism: smoking; obesity (body mass index less than 30 kg / m²); 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 there may be violations of peripheral circulation: diabetes mellitus; cancer, systemic lupus erythematosus; hemolytic uremic syndrome; Crohn's disease and ulcerative colitis; sickle cell anemia; phlebitis of the superficial veins;
Hereditary angioedema;
Hypertriglyceridemia;
Diseases that first arose or worsened 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.

Drug interactions

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.

Drug BONADE^® may affect the metabolism of other drugs, which leads to an increase (for example, cyclosporine) or a decrease (for example, lamotrigine) of their concentration in blood plasma and tissues.

Some drugs can affect the metabolism of the active ingredients of the drug BONADE^®. These include:

- antifungal drugs (for example, ketoconazole);

- N₂-blockers for the treatment of gastric ulcer and duodenal ulcer (eg, 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, as well as the pharmacist who is selling you the drug, that you are taking the drug BONADA^®.

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

Pregnancy and Lactation

Pregnancy. Drug BONADE^®Do not use 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 change its composition; therefore, their use is not recommended until breastfeeding is stopped.

Special instructions

If you have any of the conditions or risk factors listed below, you should carefully evaluate 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, you should consult with your doctor, who may decide 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 the resumption of 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 g="" 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="" the="" vte="" during="" pregnancy="" and="" childbirth="" p="">

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

VTE, which is 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.

Symptoms of pulmonary thromboembolism (pulmonary embolism) are as follows: difficulty breathing or rapid breathing; sudden cough, incl. with hemoptysis; acute chest pain, which may worsen with a deep breath; sense of anxiety; severe dizziness; rapid or irregular heartbeat. Some of these symptoms (for example, shortness of breath, cough) are nonspecific and may be misinterpreted as signs of other more common and less serious conditions / diseases (for example, an infection of the respiratory tract).

In the event 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 in women over 35 years old. Women over 35 should be strongly advised to stop smoking if they want to take the drug BONADE^®);
with a family history (i.e., with 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;
with prolonged immobilization, serious surgery, any operation on the lower limbs or extensive trauma. 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^® has not been terminated in advance, should consider antithrombotic therapy;
air flight lasting more than 4 hours;
with obesity (body mass index more than 30 kg / m²).

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 in women over 35 years old. Women over 35 should be strongly advised to stop smoking if they want to take the drug BONADE^®);
with dyslipoproteinemia;
with hypertension;
with migraine;
with valvular heart disease;
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 about 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.

It is necessary to take into account the increased risk of thromboembolism in the postpartum period.

Increase in the frequency or severity of migraine attacks during the use of the drug BONADE^® (which may be a precursor of the cerebral circulation) is the reason for the immediate abolition of the drug.

Concerning the potential role of varicose veins and superficial thrombophlebitis in the development of VTE, there is no consensus.

Tumors

The most important risk factor for cervical cancer is persistent human papillomavirus infection. Some epidemiological studies indicate 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). Increased risk gradually decreases over 10