Gestarella pill №21

Indications

- oral contraception.

Dosage and administration

Drug Gestarella ^® take in a certain order, indicated on the package, every day at about the same time. pills are taken orally with a small amount of water. For 21 days, take one pill daily.

Taking the pills from the next pack should be started the next day after a 7-day break, during which menstrual-like bleeding occurs. Bleeding usually starts 2-3 days after taking the last pill and may not end before taking the pills from a new pack.

How to start taking the drug Gestarella^®

If in the previous month hormonal contraception was not carried out.

Taking the pills should begin on the first day of the natural menstrual cycle (ie, on the first day of the menstrual bleeding). You can also begin reception from 2 to 5 days of the menstrual cycle, but it is necessary to use a barrier method of contraception during the first 7 days of the first cycle.

Transfer from another combined oral contraceptive, vaginal ring, or transdermal patch

Taking the drug Gestarella^® it is best to start immediately the next day after taking the last active pill (last pill,containing the active substance) of the previous contraceptive drug, but in no case later than the next day after the usual 7-day break in taking the pills (for drugs with 21 pills per pack) or after taking the placebo pills of the previous contraceptive drug (for drugs with 28 pills packaged). In the case of using a transdermal patch, a woman should start taking the drug the day after it is removed, but in no case no later than the day when it is necessary to introduce a new ring or stick the next patch.

Transition from contraceptives containing only progestogens ("mini-pili", injections, implant), or the intrauterine system (IUD), releasing progestogen

Switching from “mini-pili” is possible at any time, from an implant or an IUD on the day of their removal, from injections on the day when the next injection is to be given, but in all these cases it is necessary to use an additional barrier method of contraception during the first 7 days of administration drug Gestarella^®.

Use after abortion in the first trimester of pregnancy

A woman can start taking the drug immediately. In this case, the use of additional contraceptive methods is not required.

Use after childbirth or abortion in the II trimester of pregnancy

The drug is started after delivery, in the absence of breastfeeding of the child, or abortion in the second trimester of pregnancy. Taking the drug Gestarella^® should begin between 21 and 28 days after birth or abortion during the second trimester. If a woman starts taking it later, it is necessary to apply an additional barrier method of contraception during the first 7 days of taking the pills. However, if sexual contact was before taking the drug, it is necessary to exclude pregnancy before using the contraceptive drug, or the woman should wait for her first menstrual bleeding.

Usually, the first menstrual cycle after the end of taking the drug is extended by 1 week. If within 2-3 months the normal cycle is not restored, it is necessary to consult a doctor.

Acceptance of missed pills

If you are late in taking the pill less than 12 hours, contraceptive protection is not violated. The pill must be taken immediately, as soon as the woman remembers the missed pill, the next pill should be taken at the usual time. If you are late in taking the pill more than 12 hours, contraceptive protection can be reduced. In this case, you must follow the following basic rules and take appropriate measures:

1. Taking pills should never be interrupted for more than 7 days.

2. To achieve the necessary inhibition of the hypothalamic-pituitary-ovarian system requires a 7-day period of continuous taking pills.

In accordance with the above rules, the following is recommended.

The first week of taking the drug

A woman should take the last missed pill as soon as she remembers, even if it means taking two pills at the same time. After that, pills should be taken at the usual time. Additionally, over the next 7 days, you should use a barrier method of contraception, for example, a condom. If a woman had sex in the previous 7 days, it is necessary to take into account the possibility of pregnancy. The greater the number of missed pills and the closer the pass to a break in taking the drug, the higher the risk of pregnancy.

Second week of taking the drug

A woman should take the last missed pill as soon as she remembers, even if it means taking two pills at the same time. After that, pills should be taken at the usual time. If the pill is taken regularly for 7 days before the first missed pill, no additional contraceptive measures are required. If the woman took the pills irregularly or missed more than one pill, additional contraceptive measures should be taken within 7 days.

Third week of taking the drug

Due to the upcoming break in the pill there is a high risk of reducing the reliability of contraception. However, despite this, by adjusting the dosage regimen, a decrease in contraceptive protection can be prevented. When one of the following two guidelines is followed, there is no need for other contraceptive measures, provided that the woman has taken the pills correctly for 7 days before the first missed pill.Otherwise, the woman should adhere to the first recommendation and take other additional contraceptive measures within 7 days.

1. A woman should take the last missed pill as soon as she remembers, even if it means taking two pills at the same time. After that, pills should be taken at the usual time. A woman should start taking from the next package immediately after taking the pills from the previous package. Thus, the break between the packages will be absent. Withdrawal bleeding is unlikely until the second pack is complete, but there may be scant spotting or profuse bleeding from the vagina.

2. A woman may also stop taking pills from the current pack. In this case, you need to take a break for 7 days, including the days of skipping, then start taking pills from a new package.

If a woman has forgotten to take pills and there is no withdrawal bleeding during the break in taking the pills, it is necessary to exclude pregnancy.

Reception in case of gastrointestinal disturbances

If a woman has vomiting or diarrhea within 4 hours after taking the pills, absorption may not be complete and additional contraceptive measures should be taken. In these cases, you should focus on the recommendations when skipping the pill.

Change the day of the beginning of the menstrual cycle

If a woman wants to delay the day of the onset of menstrual bleeding, she should start taking Gestarella^® from the next package without interruption. It is possible to continue taking the drug from the new package as long as the woman wants (up to the end of the pills in the package). Breakthrough bleeding or spotting may occur during this period. After a 7-day break, a woman should resume regular intake.

If a woman wants to postpone the onset of bleeding to another day of the week, then the closest break in taking the pill should be reduced to as many days as she wants. The shorter this interval, the higher the risk of bleeding withdrawal and the appearance of breakthrough bleeding and spotting during the reception of the second package (as well as in the case of transfer of onset of bleeding).

Adverse effects

The most frequently recorded adverse events (HP) in clinical studies and postmarketing observations with PDA are bloody discharge / bleeding. Women taking CPC showed an increased risk of arterial and venous thrombotic and thromboembolic events, including myocardial infarction, stroke, transient ischemic attack, venous thrombosis and pulmonary thromboembolism.

Undesirable reactions are divided into groups according to the terminology of MedDRA (Medical vocabulary of terminology of regulatory activities). The incidence of side effects was determined in accordance with the WHO classification: very often (≥ 10%); often (≥ 1% and <10%); infrequently (≥ 0.1% and <1%); rarely (≥ 0.01% and <0.1%); very rarely (<0.01%); unknown frequency (it is not possible to determine the frequency of occurrence of side effects from the available data).

On the part of the immune system: rarely, hypersensitivity reactions; unknown frequency - exacerbation of systemic lupus erythematosus.

Metabolism and nutrition: often - weight gain, fluid retention; rarely, weight loss; unknown frequency - exacerbation of porphyria.

Mental Disorders: often - depressed mood, mood changes; infrequently - decreased libido; rarely - increased libido; unknown frequency - nervousness, depression.

From the nervous system: often - headache, migraine; unknown frequency - dizziness, exacerbation of chorea.

On the part of the organ of vision: rarely - intolerance to contact lenses (discomfort when wearing them); unknown frequency - optic neuritis.

From the side of the vessels: rarely - venous thromboembolism, arterial thromboembolism.

From the digestive tract: often - nausea, vomiting; infrequently - abdominal pain, diarrhea; very rarely - pancreatitis; unknown frequency - bloating, colitis.

Liver and biliary tract: rarely - cholelithiasis.

Skin and Subcutaneous Tissues: infrequently - skin rash, incl. urtikarnaya; rarely, erythema nodosum, erythema multiforme; unknown frequency - acne, hirsutism, alopecia.

From the genital and breast organs: often - a feeling of tension, tenderness of the mammary glands, vaginal discharge; infrequently - an increase in the mammary glands; rarely - discharge from the mammary glands; unknown frequency - painful menstrual bleeding, vaginitis, vulvovaginal candidiasis, chest pain.

Laboratory and instrumental data: infrequently - hyperlipidemia.

The following serious adverse events have been reported in women using PDAs. Additional information on possible side effects is presented in the section "Special Instructions":

- venous thromboembolic disorders;

- arterial thromboembolic disorders;

- cerebrovascular disorders;

- increase in blood pressure;

- hypertriglyceridemia;

- decrease in glucose tolerance or effect on peripheral insulin resistance;

- liver tumors (benign and malignant);

- violation of the functional parameters of the liver;

- chloasma.

The onset or worsening of conditions for which communication with the use of PDA has not been proven: jaundice and / or itching associated with cholestasis ; the formation of gallstones; hemolytic uremic syndrome; herpes pregnant; hearing loss associated with otosclerosis; Crohn's disease; ulcerative colitis; cervical cancer.

Contraindications

Drug Gestarella^® 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 reception, the drug should be immediately canceled.

- thrombosis (venous and arterial) and thromboembolism at present or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction);

- conditions preceding thrombosis (including angina);

- cerebrovascular disease: stroke, transient ischemic attacks in the present and in history;

- multiple or pronounced risk factors of venous or arterial thrombosis, including complicated valvular lesions of the heart, atrial fibrillation, diseases of cerebral vessels or coronary
heart arteries, severe dyslipoproteinemia, uncontrolled
arterial hypertension, serious surgical intervention, prolonged immobilization, air flight lasting more than 4 hours, surgery on the lower
limbs 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 V), deficiency of antithrombin III, deficiency of protein C, deficiency of protein S, hyperhomocysteinemia, the presence of antibodies to phospholipids
(anticardiolipin, lupus anticoagulant));

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

- diabetes with vascular complications;

- pancreatitis with severe hypertriglyceridemia now or in history;

- liver failure and severe liver diseases, including and Dubin-Johnson and Rotor syndromes (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;

- children and adolescents (before menarche) age;

- bleeding from the vagina of unknown origin;

- obesity (BMI over 30 kg / m²);

- extensive injury;

- pregnancy or suspicion of it;

- breastfeeding period;

- galactose intolerance, lactase deficiency or glucose-galactose malabsorption, fructose intolerance or sucrase-isomaltase deficiency (the preparation contains lactose monohydrate and sucrose);

- hypersensitivity to any of the components of the drug Gestarella^®.

Carefully

The potential risk and the expected benefit of using combined oral contraceptives (PDC) 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 / m²arterial dyslipoproteinemia
hypertension, air flight lasting more than 4 hours, migraine without focal neurological symptoms, uncomplicated valvular heart disease, hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebral circulation at a young age in any of the close relatives);

- other diseases in which there may be violations of the peripheral blood circulation: diabetes mellitus, cancer, systemic lupus erythematosus, 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 intake of sex hormones (for example, jaundice, cholestasis, gallbladder diseases,
otosclerosis with impairment of hearing, porphyria, herpes during
pregnancy chorea Sydenham);

- depression;

- epilepsy;

- postpartum period.

Use during pregnancy and lactation

Pregnancy

Drug Gestarella^® Do not use during pregnancy. If pregnancy is detected during the use of the drug Gestarella^®, 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 CCP can reduce the amount of breast milk and change its composition, therefore, the use of the drug Gestarella^® contraindicated during breastfeeding.

Application for violations of kidney function

With caution in renal impairment.

Use in children

Contraindicated in children and adolescents (before menarche) age.

special instructions

If there is any of the conditions or risk factors listed below, the possibility of using the drug
Gestarella^® should be discussed previously with a woman. In case of deterioration or the first appearance of any of
conditions or risk factors should recommend that a woman contact her doctor to decide whether to continue or stop taking the drug.

Due to the fact that the contraceptive effect of the drug Gestarella^® mainly manifested by the 14th day from the start of the intake, then in the first 2 weeks of taking the drug, it is recommended to additionally use non-hormonal (barrier) methods of contraception.

Diseases of the cardiovascular system

Risk of venous thromboembolism (VTE)

The use of any PDA increases the risk of VTE compared with women who do not take these drugs. Before starting the use of the drug Gestarella^® It should be discussed with a woman a higher (almost 2 times) risk of developing VTE compared with other PDAs containing levonorgestrel, norgestimate or norethisterone. This risk is highest in the first year of taking the drug or when it resumes after a break of 4 weeks or more.

The results of an epidemiological study showed that among women who do not take the CCP and are not pregnant, VTE occurs in about 2 out of 10,000 during the year. However, for some women, the risk may be significantly higher, depending on their main risk factors (see below). According to experts, during the year, VTE occurs in 9-12 out of 10,000 women who take PDA containing gestodene. In both cases, the number of VTE per year is less than the number of expected VTE during pregnancy or in the postpartum period.

Risk factors for thromboembolic complications

The risk of venous and arterial thromboembolic complications in women taking CPC may increase significantly with additional risk factors, especially if the risk factors are multiple (see table 1 and table 2).

Drug Gestarella^® contraindicated if the woman has multiple risk factors for VTE or ATE. If a woman has more than one risk factor, it is possible that the risk of developing thromboembolic complications will be greater than the simple sum of individual factors. If the balance between benefits and risks is negative, prescribe Gestarella^® it does not follow.

Risk factors for VTE

Table No. 1. VTE risk factors

There is no consensus on the possible role of varicose veins and thrombophlebitis in the development or progression of venous thrombosis.

The increased risk of thromboembolism during the first 6 weeks of the postpartum period should be considered.

Symptoms of VTE (deep vein thrombosis (DVT) and pulmonary thromboembolism (PE))

If there are symptoms of VTE, a woman should immediately seek emergency medical care and inform the doctor that she is taking CPC.

Symptoms of DVT may include:

- unilateral edema of the lower limb and / or foot or along the vein in the lower limb;

- pain in the lower limbs or soreness when touched, which can only be felt when standing or walking;

- increased skin temperature of the affected lower limb;

- redness or paleness of the skin of the lower limb.

Symptoms of pulmonary embolism may include:

- sudden unexplained shortness of breath or rapid breathing;

- sudden cough, which may be accompanied by hemoptysis;

- acute chest pain;

- severe dizziness;

- frequent or irregular heartbeat.

Some of these symptoms (for example, shortness of breath or cough) are non-specific and may be incorrectly regarded as manifestations of more frequent and less severe conditions (for example, infections of the respiratory tract).

Other signs of vessel occlusion may include: sudden pain, swelling, and mild limb cyanosis.

With ocular occlusion, the symptoms can range from a painless blurred vision that can progress to loss of vision. Sometimes the loss of vision can be acute.

Risk of arterial thromboembolism (ATE)

Epidemiological studies associate the use of PDA with an increased risk of ATE (myocardial infarction) or cerebrovascular diseases (for example, transient ischemic attack (TIA), stroke). Arterial thromboembolic events can be fatal.

ATE risk factors

Table 2. Risk factors for ATE

Symptoms of ATE

If there are symptoms of ATE, a woman should immediately seek emergency medical care and inform the doctor that she is taking CPC.

Symptoms of cerebrovascular diseases may include:

- sudden numbness or weakness of the muscles of the face, arm or leg, especially on one side of the body;

- sudden difficulties in movement, dizziness, loss of balance or coordination;

- sudden confusion, problems with speech or understanding;

- sudden, severe or prolonged headache without a specific reason;

- Fainting or fainting with or without convulsions.

Temporary symptoms indicate an event called a transient ischemic attack (TIA).

Symptoms of myocardial infarction (MI) may include:

- pain, discomfort, pressure, heaviness, feeling of compression or distension in the chest or behind the sternum, radiating to the back, neck, jaw, upper limb, epigastric region;

- feeling of fullness in the stomach, indigestion or choking;

- sweating, nausea, vomiting and dizziness;

- extreme weakness, anxiety or shortness of breath;

- frequent or irregular heartbeat.

There is evidence of an increase in the incidence of venous and arterial thrombosis and thromboembolism when taking CPC.

However, the incidence of venous thromboembolism (VTE), which develops when taking PDA, is less than the frequency of VTE that occurs during pregnancy (6 cases per 10,000 pregnant women per year).

In women taking CPC, extremely rare cases of thrombosis of other blood vessels are described, for example, hepatic, mesenteric, renal arteries and veins, the central vein of the retina and its branches. Communication with the reception of the CCP has not been proven.

Tumors

One of the significant risk factors for cervical cancer is persistent HPV infection. There are reports of an increased risk of developing cervical cancer with prolonged use of CPC. However, the connection with the admission of the PDA is not proven. This increase may be associated with the identification of cervical pathology during the mandatory examination before the appointment of the CPC or the characteristics of sexual behavior (more rare).
use of barrier methods of contraception).

It was also found that there is a slightly increased relative risk of developing breast cancer diagnosed in women who used CCP, but the connection with their use has not been proven. The observed increase in risk may be due not only to an earlier diagnosis of breast cancer in women using PDA, but also to the biological effects of sex hormones or a combination of these two factors. Breast cancer in women who have taken or taken CRP in the past is usually detected at clinically less severe stages than women who have never taken these drugs.

In rare cases, against the background of the use of PDA, the development of liver tumors was observed. This should be considered when carrying out a differential diagnosis in the event of severe pain in the abdomen, enlarged liver or signs of intra-abdominal bleeding.

Other states

Women with hypertriglyceridemia (or in the presence of this condition in the family history) may increase the risk of developing pancreatitis while taking the drug Gestarella^®.

Although a slight increase in blood pressure (not higher than 160/100 mm Hg) was described in many women taking CPC, a clinically significant increase in blood pressure was rarely observed. However, while taking Gestarella^® A persistent, clinically significant increase in blood pressure (BP ≥ 160/100 mm Hg) is developing, these drugs should be canceled and treatment of hypertension should be initiated.Taking the drug Gestarella^® can be continued if normal blood pressure values ​​are achieved with the help of antihypertensive therapy.

Conditions such as jaundice and / or itching associated with cholestasis, the formation of gallstones, porphyria, systemic lupus erythematosus,