Bonade pills №21

Indications

- contraception.

Dosing regimen

Drug bonade^® taken orally on 1 tab. / day, not liquid and squeezed with 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 pill 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 a woman will always start a new package (blister) on the same day of the week and that every month the withdrawal will bleed around the same day of the month.

Starting the drug Bonade^®

In the absence of taking any hormonal contraceptives in the previous month use of the drug Bonade^® should begin on the 1st day of the natural menstrual cycle (i.e., on the 1st day of 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 the pills on the following days in the prescribed manner. It is also permissible to begin use from 2-5 days of the cycle, but in this case it is recommended to additionally apply a barrier method of contraception (condom) during the first 7 days of using the pills from the first package (blister).

When transferring from other PDAs, contraceptive vaginal ring or contraceptive patch you can start taking the drug Bonade^® the next day after taking the last pill from the previous package of the PDA (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 the application later, but in no case no later than the next day, after the usual interruption in use (a break of 7 days for preparations containing 21 tablets) or after taking the last inactive pill (for preparations containing 28 pills per pack).

In case of using a contraceptive patch or a contraceptive vaginal ring, taking the drug 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 only gestagen (mini-pili) You can stop taking a mini-drink on any given day and start using the drug Bonade.^® the next day, at the same time. During the first 7 days of pill use, you must also use an additional barrier method of contraception.

When switching from an injection contraceptive, implant or intrauterine contraceptive device (intrauterine device), releasing the gestagen, start using the drug Bonade^® should be 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 pill use, you must also use an additional barrier method of contraception.

Right away after childbirth the doctor may recommend to wait until the end of the first normal menstrual cycle before starting the use of the drug Bonade^®. Sometimes, according to the recommendation of the doctor, you can start using the drug earlier.

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

Acceptance of missed pills

If the delay in taking the next pill less than 12 hours, contraceptive effect of the drug Bonade^® preserved. The patient should take a pill as soon as she remembers. The following pill should be taken at the usual time.

If the delay in taking the pills was more than 12 hours, contraceptive protection can be reduced. The more pills in a row are missed, and the closer this pass is 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:

- if more than 1 pill out of the package (blister) is missed, you should consult with your doctor;

- if 1 pill is missed first week use of the drug, you should take the missed pill as soon as possible, as soon as the patient remembers (even if it means taking two pills at the same time). The following pill should be taken at the usual time. You must additionally use a barrier method of contraception over the next 7 days. If sexual intercourse was within a week before the pill was missed, the likelihood of pregnancy should be considered. It should immediately consult a doctor;

- if 1 pill is missed second week taking the drug, you should take the missed pill as soon as possible, as soon as the patient remembers (even if it means taking 2 pills at the same time). The following pill should be taken at the usual time. If a woman took the pills correctly within 7 days preceding the first missed pill, the contraceptive effect of the drug Bonade^® preserved, and the woman does not need the use of additional contraceptive measures. Otherwise, as well as skipping 2 or more pills, you must additionally use barrier methods of contraception for 7 days;

- if 1 pill is missed on third week taking the drug, but within 7 days preceding the first missed pill, all pills were taken correctly, there is no need to use additional contraceptive methods, if the woman adheres to either of the two following options:

1. You should take the missed pill as soon as possible, as soon as the patient remembers (even if it means taking 2 pills at the same time). The following pill should be taken at the usual time. The next package (blister) should be started immediately after taking the pills from the current package (blister), so there will not be a break between the packages (blisters). Withdrawal bleeding is unlikely until the pills from the second package (blister) run out, but there may be spotting or breakthrough uterine bleeding on the days of taking the drug.

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

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

Using this scheme, a woman can always start applying the pills 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 the drug Bonade^®, or when its reliability can be reduced, you should refrain from sex or use non-hormonal contraceptive methods (for example, condoms or other barrier methods). Do not use rhythmic or temperature methods. These methods may be unreliable, because taking CPC leads to changes in basal temperature and cervical mucus.

Discontinuation

You can stop taking the drug Bonade^® Anytime. In case of termination of use 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. You should do as recommended when you skip taking the pill. In the case of severe diarrhea, you should consult your doctor.

Delayed onset of menstrual bleeding

You can delay the onset of menstrual bleeding if you start taking pills from the following package (if the package contains 21 tablets) or blisters (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 withdrawal bleeding to begin, you should stop taking the pills. During the use of pills of the drug Bonade^® from the new packaging (blister) may appear copious or spotting bleeding. The use of pills from the next package (blister) should begin after the usual 7-day interval.

Change the day of the onset of menstrual bleeding

If a woman takes the pill, strictly following all the recommendations, menstrual bleeding occurs approximately on the same days every 4 weeks. If it is necessary to change these days, one should shorten (but in no case extend) the next interval without taking pills. For example, bleeding begins on Fridays, but it is necessary that it starts on Tuesdays (3 days earlier), then you should start using 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, during the use of pills from a new package (blister), copious or spotting may appear.

Special patient groups

Children and teenagers drug bonade^® shown only after the onset of menarche.

Drug bonade^® not shown after menopause.

The drug is contraindicated women with severe liver disease until the liver function returns to normal.

Drug bonade^® not specifically studied women with impaired renal function. Available data do not imply a change in dosing regimen in these patients.

Side effect

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

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

The following adverse reactions have been reported in women taking CPA, however, it is possible that the reactions described were not caused by these pills. The undesirable reactions listed below usually occur during the first months of use of the contraceptive pill and, as a rule, weaken over time.

Side effects identified during the use 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, <1/10), infrequently (> 1/1000, <1/100), rarely (> 1/10 000, <1/1000), very rarely (<1/10 000, 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, cystitis, mastitis, cervicitis, fungal infections, herpetic oral cavity disease, influenza, bronchitis, sinusitis, upper respiratory tract infections, 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.

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

From the hemopoietic system: rarely - anemia.

On the part of the endocrine system: rarely - virilism.

Mental disorders: rarely, depression; very rarely - mood changes; unspecified frequency - decrease in mood, insomnia, sleep disturbances, aggression.

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

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).

On the part of the organ of hearing and labyrinth disorders: rarely, sudden hearing loss, tinnitus, dizziness, hearing loss.

Since the cardiovascular system: rarely - cardiovascular disorders, tachycardia, thrombosis or pulmonary embolism, thrombophlebitis, increased diastolic blood pressure, orthostatic circulatory dystonia, hot flashes, varicose veins, venous disease, pain along the veins; infrequently - increase, decrease in blood pressure.

On the part of the respiratory system: rarely - 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 .

Skin and Subcutaneous Tissues: infrequently - itching (including generalized itching), acne, alopecia, rash, including macular rash; rarely - psoriasis, hyperhidrosis, chloasma, hyperpigmentation, seborrhea, dandruff, hirsutism, cellulitis, spider veins; unspecified frequency - erythema nodosum.

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

From the genital and breast organs: often - pain in the mammary glands, 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, vaginal discharge, pain in the pelvic area 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, feeling unwell, changes in body weight (increase, decrease and fluctuations in body weight); rarely - anorexia, chest pain, peripheral edema, flu-like symptoms, fever, irritability; unspecified frequency - fluid retention.

From the laboratory indicators: rarely - hypertriglyceridemia, hypercholesterolemia.

In women with estrogen-dependent hereditary angioedema, symptoms of angioedema may be provoked or worsen. In women using PDA, there is a slight increase in the rate of breast cancer detection. Since breast cancer rarely occurs in women under 40 years of age, then given the overall risk of developing breast cancer, the additional number of cases of the disease is very small. Communication using the PDA is not known.

If unwanted effects occur, which are not indicated in the instructions, the woman should be informed about this by the doctor.

Contraindications

Drug bonade^® should not be applied 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 use, the drug should be immediately canceled.

- Thrombosis (venous and arterial) and thromboembolism at present or in history (includingdeep vein thrombosis, pulmonary embolism, myocardial infarction, stroke), cerebrovascular disorders;

- conditions preceding thrombosis (including transient ischemic attacks, angina pectoris) now or in history;

- migraine with focal neurological symptoms at present or in history;

- diabetes with vascular complications;

- multiple or pronounced risk factors of venous or arterial thrombosis, including complicated lesions of the valvular apparatus of the heart, atrial fibrillation, diseases of cerebral vessels or coronary arteries of the heart; uncontrolled arterial hypertension, serious surgical intervention, prolonged immobilization, smoking after the age of 35;

- congenital or acquired predisposition to arterial or venous thrombosis (resistance to activated protein C, deficiency of antithrombin III, deficiency of protein C, deficiency of protein S, hyperhomocysteinemia, the presence of antibodies to phospholipids, lupus anticoagulant);

- pancreatitis with severe hypertriglyceridemia now or in history;

- liver failure and severe liver disease (until normalization of liver enzymes);

- liver tumors (benign or malignant) now or in history;

- identified hormone-dependent malignant neoplasms (including genitals or mammary glands) or suspicion of them;

- bleeding from the vagina of unknown origin;

- pregnancy or suspicion of it;

- lactation period (breastfeeding);

- Hypersensitivity to any of the components of the drug;

- intolerance to galactose, lactase deficiency lapp or impaired absorption of glucose and galactose (the product contains lactose);

- obesity (BMI over 30 kg / m²);

- extensive injury.

Carefully

The potential risk and the expected benefit of using a PDA in each individual case should be carefully weighed in the presence of the following diseases / conditions and risk factors:

- risk factors for thrombosis and thromboembolism: smoking; obesity (BMI 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 the peripheral circulation: diabetes mellitus; SLE; hemolytic uremic syndrome; Crohn's disease and ulcerative colitis; sickle cell anemia; phlebitis of superficial veins;

- hereditary angioedema;

- hypertriglyceridemia;

- Diseases that first arose or aggravated during pregnancy or against the background of previous use of sex hormones (for example, jaundice, cholestasis , gallbladder disease, otosclerosis with impairment of hearing, porphyria, herpes during pregnancy, Sydenhem's chorea);

- postpartum period.

Use during pregnancy and lactation

Drug bonade^® can not be used during pregnancy.

Application for violations of the liver

The drug is contraindicated for use in liver failure, severe liver disease (before normalization of liver enzymes), liver tumors (benign or malignant) now or in history.

Application for violations of kidney function

Drug bonade^® not specifically studied in women with impaired renal function. Available data do not imply a change in dosing regimen in these patients.

Use in children

Children and teenagers drug bonade^® shown only after the onset of menarche.

Use in elderly patients

Drug bonade^® not shown after menopause.

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 therapy 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

The risk of deep vein thrombosis in women who take PDA 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 PDA and an increased risk of thrombosis and thromboembolic diseases, such as myocardial infarction, stroke, deep vein thrombosis and pulmonary embolism when taking PDA. These complications are rare.

The risk of venous thromboembolism (VTE) is maximum in the first year of use of such drugs, mainly during the first 3 months.Increased risk exists when the initial use of PDA or the resumption of use of the same or different PDAs (after a break between taking the drug in 4 weeks or more).

The overall risk of VTE in patients taking low-dose PDA (<50 μg of ethinyl estradiol) is 2-3 times higher than in non-pregnant patients who do not take PDA, 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, which is manifested in the form of deep vein thrombosis and / or pulmonary embolism, can occur with the use of any PDA.

Thrombosis in other blood vessels, such as the veins and arteries of the liver, mesentery, kidneys, brain, or retina, is extremely rare when using PDA.

Symptoms of deep vein thrombosis (DVT): 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, local temperature increase in the affected lower limb, redness or change in skin color on the lower limb .

Symptoms of pulmonary thromboembolism (pulmonary embolism): difficulty 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 (for example, shortness of breath, cough) are nonspecific and may be misinterpreted as signs of other more or less serious events (for example, an infection of the respiratory tract).

In the event of the symptoms listed above for women taking PDA, you should immediately consult with your doctor.

The risk of 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). When using the drug Bonade^® Smoking should be stopped, especially if the woman is over 35 years old;

- when indicating in the family history of 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 examined by an appropriate specialist to decide on the possibility of taking the drug Bonade^®;

- with overweight (BMI more than 30 kg / m²);

- with dyslipoproteinemia;

- with arterial hypertension;

- with migraine;

- in diseases of the valvular apparatus of the heart;

- with atrial fibrillation;

- with systemic lupus erythematosus;

- with diabetes;

- in sickle cell anemia;

- 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, at least 4 weeks before it) and not to resume taking the drug within 2 weeks after the end of immobilization.

Tumors

The relationship between taking CPC and breast cancer has not been proven, although in women who take PDA, it is detected more often than in women of the same age who do not use PDA.

Perhaps these differences are due to 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 show that long-term use of PDA 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 CCP (relative risk 1.24). The increased risk gradually decreases within 10 years after the cessation of the use of PDAs. Considering the fact that breast cancer is rare in women under the age of 40 years, an increase in the number of diagnosed breast cancer in women who take or have previously taken a PDA 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 incidence of breast cancer in women taking CPC may be earlier diagnostics, the biological effect of drugs, or a combination of these factors. Breast cancer, diagnosed in women who take or have previously taken CPC, usually is a less clinically advanced cancer than in patients who have never used them.

Individual cases of benign tumors of the liver and, much less often, malignant tumors of the liver in women taking CPC were diagnosed. In rare cases, such tumors caused life-threatening intra-abdominal bleeding. In case of severe pain in the upper abdominal cavity, an enlarged liver or signs of intra-abdominal bleeding in women taking PDA, you should immediately consult with your doctor.

Other states

In women with hypertriglyceridemia or having an indication of this disease in the family history, the risk of pancreatitis may be increased when using PDA.

Despite the fact that many women taking CPC, there was a slight increase in blood pressure, a clinically significant increase is rare. However, if a clinically significant increase in blood pressure develops while taking CPC, then as a precautionary measure, it is better to recommend to the doctor to stop taking CPC and begin treatment of arterial hypertension. The use of the drug can be continued if normal blood pressure values ​​are achieved using antihypertensive therapy.

Cancellation of the PDA may be unavoidable with acute and chronic abnormal liver function, until all indicators of liver function return to normal. Relapses of cholestatic jaundice, which arose for the first time during pregnancy or during the period before which CPC was used, also require discontinuation of the drug.

Although PDAs may affect peripheral insulin resistance and glucose tolerance, there is no evidence that women with diabetes mellitus and who use low-dose oral contraceptive drugs (containing <0.05 mg of ethinyl estradiol) should change the dosage regimen. However, for women with diabetes who are taking low-dose oral contraceptive drugs, proper monitoring should be established.

Crohn's disease and ulcerative colitis may be associated with the use of PDAs. 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 PDA should avoid direct sunlight and exposure to other ultraviolet radiation.

Reduced efficiency

The effectiveness of PDA may decrease, for example, in the case of missing pills, in the case of disorders of the gastrointestinal tract or the simultaneous use of other drugs.

Cycle irregularity

During the application of any PDA, irregular bleeding (spotting or breakthrough bleeding) may appear, especially in the first months of taking the pills. Bleeding usually stops as the body adapts to Bonade.^® (about