Model pro pills 3mg + 0.03mg №21

Indications

- contraception.

Dosing regimen

The drug is taken orally. pills should be taken in the order indicated on the packaging, every day at about the same time, with a small amount of water. Should take 1 tab. continuously for 21 days. Taking the pills from the next pack begins after a 7-day break, during which menstrual bleeding is usually observed (withdrawal bleeding). As a rule, it starts 2-3 days after taking the last pill and may not end before taking the pills from a new package.

Start taking the drug Modell Pro

In the absence of taking any hormonal contraceptives in the previous month, use of the drug Modelle Pro should be started on the 1st day of the menstrual cycle (ie, on the 1st day of menstrual bleeding). It is allowed to start taking on the 2-5th day of the menstrual cycle, but in this case it is recommended to additionally use a barrier method of contraception during the first 7 days of taking the pills from the first package.

Transition from other combined hormonal contraceptive drugs (PDA, vaginal ring or contraceptive patch)

It is preferable to start taking the drug Modell Pro the next day after taking the last pill from the previous package, but in no case no later than the next day after the usual 7-day break.Acceptance of the drug Modelle Pro should be started on the day of removal of the vaginal ring or patch, but no later than the day when a new patch is to be inserted or a new patch is pasted.

Transition from contraceptives containing progestogens only ("mini-pili", injection forms, implant or intrauterine system (IUD) with controlled release of progestogen)

You can switch from “mini-drank” to taking the drug Modell Pro on any day (without a break), from the implant or IUD - on the day of their removal, from the injection contraceptive - on the day when the next injection should be made. In all cases, you must use an additional barrier method of contraception during the first 7 days of taking pills.

After abortion in the first trimester of pregnancy You can start taking the drug immediately - on the day of the abortion. Subject to this condition, the woman does not need additional methods of contraception.

After childbirth or abortion in the II trimester of pregnancy

It is recommended to start taking the drug on the 21-28 day after birth (in the absence of breastfeeding) or abortion in the second trimester of pregnancy. If reception is started later, you must use an additional barrier method of contraception during the first 7 days of taking the pills. If sexual intercourse has occurred, then before taking the drug Modell Pro, pregnancy should be excluded or it is necessary to wait for the first menstruation.

Acceptance of missed pills

If the delay in taking the drug was less than 12 hours, contraceptive protection is not reduced. You should take a pill as soon as possible, the next pill is taken at the usual time. If the delay in taking the drug was more than 12 hours, contraceptive protection can be reduced. The more pills missed and the closer the pass to the 7-day break in taking pills, the greater the likelihood of pregnancy. In this case, you can follow the following two basic rules:

- The drug should never be interrupted for more than 4 days;

- to achieve adequate suppression of the hypothalamic-pituitary-ovarian system requires 7 days of continuous administration of tablets.

Accordingly, if the delay in taking the pills was more than 12 hours (the interval from the moment of taking the last pill is more than 36 hours), the woman should follow the recommendations given below.

The first week of the drug

You must take the last missed pill as soon as possible as soon as the woman remembers this (even if you need to take two pills at the same time). The next pill is taken at the usual time. Additionally, you should use a barrier method of contraception (for example, a condom) for the next 7 days. If sexual intercourse took place during the week before the pill was missed, the likelihood of pregnancy should be considered.

The second week of the drug

You must take the last missed pill as soon as possible as soon as the woman remembers this (even if you need to take two pills at the same time). The next pill is taken at the usual time.Provided that the woman took the pills correctly within 7 days preceding the first missed pill, there is no need to use additional contraceptive measures. Otherwise, as well as skipping two or more pills, you must additionally use barrier methods of contraception (for example, a condom) for 7 days.

The third week of the drug

The risk of pregnancy increases due to the upcoming break in taking pills. It should strictly adhere to one of the following two options. At the same time, if during the 7 days preceding the first missed pill, all pills were taken correctly, there is no need to use additional contraceptive methods. Otherwise, you must use the first of the following schemes and additionally use a barrier method of contraception (for example, a condom) within 7 days.

1. You must take the last missed pill as soon as possible, as soon as the woman remembers this (even if you need to take two pills at the same time). The following pills are taken at the usual time until the pills in the current packaging run out. The next package should start immediately without a break. Withdrawal bleeding is unlikely until the second pack ends, but there may be spotting and breakthrough bleeding while taking the pills.

2. You can also stop taking the pills from the current package, thus starting the 7-day break (including the day you miss the pills), and then start taking the pills from the new package.

If a woman misses taking pills, and then during a break in reception she has no withdrawal bleeding, it is necessary to exclude pregnancy.

Recommendations in case of disorders of the gastrointestinal tract

In the event of severe gastrointestinal disorders (vomiting, diarrhea), absorption may be incomplete, therefore additional contraceptive methods should be used. If vomiting occurs within 4 hours after taking the pill, you should follow the recommendations when skipping pills.

Change the day of the beginning of the menstrual cycle

In order to delay the onset of menstruation, it is necessary to continue the further intake of pills from the new package Modell Pro without a 7-day break. pills from the new packaging can be taken as long as necessary, including until the packaging is over. While taking the drug from the second package, spotting blood from the vagina or breakthrough uterine bleeding is possible. Regular intake of Modell Pro from regular packaging should be resumed after the usual 7-day break. In order to postpone the onset of menstruation to another day of the week, a woman should reduce the closest interruption in taking the pills for the desired number of days. The shorter the interval, the higher the risk that she will not have withdrawal bleeding, and later there will be spotting and breakthrough bleeding while taking the second package (just like when she would like to delay the onset of menstruation).

Additional information for specific patient categories

The efficacy and safety of the drug as a contraceptive studied in women of reproductive age. It is assumed that the efficacy and safety of the drug in postpubertal under the age of 18 similar to those in women after 18 years. Drug use before the menarche not shown.

After menopause drug Modelle Pro is not shown.

The use of the drug is contraindicated in the presence or in the history severe liver disease (before normalization of liver function tests), the presence or current history of benign or malignant liver tumors.

The drug is contraindicated in acute renal failure and severe renal failure.

Side effect

The frequency of adverse reactions that were identified during the use of the drug, is determined as follows: often (≥1 / 100- <1/10); infrequently (≥1 / 1000- <1/100); rarely (≥1 / 10 000- <1/1000).

On the part of the immune system: rarely - asthma, hypersensitivity reactions.

From the nervous system: often - a headache.

Mental disorders: often - depressive state; Infrequently - a change in libido.

From the organ of hearing: rarely - hearing loss.

Since the cardiovascular system: often - migraine; infrequently - increase in blood pressure, decrease in blood pressure; rarely - thromboembolism.

From the digestive system: often nausea; infrequently - vomiting, diarrhea.

Skin and Subcutaneous Tissues: infrequently - acne, eczema, itching; rarely, erythema nodosum, erythema multiforme.

On the part of the reproductive system and the breast: often - violations of the menstrual cycle, acyclic bleeding, tenderness of the mammary glands, hypersensitivity of the mammary gland, leucorrhea, vulvovaginal candidiasis; infrequently - an increase in the mammary gland, vaginitis; rarely - discharge from the mammary glands.

Other: infrequently - fluid retention, change in body weight.

The following serious adverse events have been reported in women taking CPC: venous thromboembolism; arterial thromboembolism; increased blood pressure; liver tumors; the emergence or worsening of conditions whose connection with the admission of CPC is not definitively established (Crohn’s disease, ulcerative colitis, epilepsy, migraine, uterine fibroids, porphyria, SLE, herpes during a previous pregnancy, Sydenhem’s chorea, hemolytic uremic syndrome, cholestatic jaundice); chloasma

In women with hereditary angioedema, the use of estrogen may cause or aggravate its symptoms.

Contraindications

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

- conditions preceding thrombosis (including transient ischemic attacks, atrial fibrillation, 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 for venous or arterial thrombosis (including complicated lesions of the cardiac valve apparatus, atrial fibrillation, vascular diseases of the brain or coronary arteries; uncontrolled arterial hypertension, prolonged immobilization, extensive surgical intervention, surgery on the lower extremities, extensive injuries, smoking over the age of 35, obesity with a BMI> 30 kg / m²);

- pancreatitis with severe hypertriglyceridemia now or in history;

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

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

- acute renal failure and severe renal failure;

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

- bleeding from the vagina of unknown origin;

- pregnancy or suspicion of it;

- lactation period (breastfeeding);

- hereditary lactose intolerance , lactase deficiency or glucose-galactose malabsorption syndrome;

- hypersensitivity to the drug.

If any of the above diseases or conditions develop for the first time while taking the drug, it should be immediately canceled.

Carefully

The ratio of the potential risk and the expected benefit of using the drug Modelle Pro in each individual case should be assessed with the following diseases / conditions and risk factors:

- risk factors for thrombosis and thromboembolism: smoking, obesity (BMI <30 kg / m²), dyslipoproteinemia, controlled arterial hypertension, migraine without focal neurological symptoms, uncomplicated valvular heart disease, hereditary predisposition to thrombosis (thrombosis, myocardial infarction or impaired cerebral circulation at a young age in someone from close relatives);

- other diseases in which disorders of the peripheral circulation can be noted: diabetes mellitus without diabetic angiopathy, SLE, hemolytic uremic syndrome, Crohn's disease and ulcerative colitis, sickle cell anemia, phlebitis of superficial veins;

- hereditary angioedema;

- hypertriglyceridemia;

- liver disease, not related to contraindications;

- Diseases that first arose or aggravated during pregnancy or against the background of previous intake of sex hormones (for example, jaundice and / or itching associated with cholestasis , cholelithiasis, otosclerosis with impaired hearing, porphyria, pregnant herpes, Sydenhem chorea);

- postpartum period.

Use during pregnancy and lactation

Pregnancy

If pregnancy is detected while taking Modell Pro, the drug should be immediately canceled.Extensive epidemiological studies have not revealed an increased risk of developmental defects in children born to women who received sex hormones before pregnancy, or teratogenic effects in cases where sex hormones were taken by negligence in the early stages of pregnancy. In animal studies, the effects of drospirenone and ethinyl estradiol have been associated with their pharmacological action. In particular, in reproductive toxicity studies in animals, an embryotoxic and fetotoxic effect was detected, but these effects were considered to be related to the specifics of a particular animal species. At exposure levels in animals exceeding the corresponding levels in women taking drospirenone and ethinyl estradiol, an effect was observed on the differentiation of the sex of rat embryos, which was absent in small monkeys. According to the data obtained in animal studies, the possibility of the development of undesirable effects caused by the hormonal activity of the active substances in humans cannot be excluded. However, the cumulative experience of the use of PDA during pregnancy did not provide evidence of the development of undesirable effects in humans. Data on the results of taking the drug Modelle Pro during pregnancy is limited, which does not allow to draw any conclusions about the negative impact of the drug on pregnancy, the health of the fetus and newborn. There are currently no significant epidemiological data available.

Lactation period

The drug is contraindicated during breastfeeding. It can reduce the amount of breast milk and change its composition, therefore, the use of the drug is not recommended until the cessation of breastfeeding. A small amount of sex hormones and / or their metabolites can be excreted in breast milk, but there is no evidence of their negative impact on the health of the child.

Application for violations of the liver

The use of the drug is contraindicated in the presence or in the history severe liver disease (before normalization of liver function tests), the presence or current history of benign or malignant liver tumors.

Application for violations of kidney function

The drug is contraindicated in acute renal failure and severe renal failure.

Use in children

It is assumed that the efficacy and safety of the drug in postpubertal under the age of 18 similar to those in women after 18 years. Drug use before the menarche not shown.

Use in elderly patients

After menopause drug Modelle Pro is not shown.

special instructions

Before starting or resuming use of the drug, Modell Pro, it is necessary to familiarize with the history of life, family history of a woman, conduct a thorough general medical (including measurement of blood pressure, heart rate, BMI) and gynecological examination, including the examination of the mammary glands and cytological examination of scraping from the cervix (test on ), exclude pregnancy.The amount of additional research and the frequency of control examinations are determined individually. Usually, control examinations should be carried out at least 1 time in 6 months.

A woman should be informed that Modell Pro does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

If any of the conditions, diseases, and risk factors listed below are present, then the potential risk and the expected benefits of using a PDA in each individual case should be carefully weighed and discussed with the woman before she decides to start taking the drug. When weighting, amplification, or at the first manifestation of risk factors may require the abolition of the drug.

Diseases of the cardiovascular system

The results of epidemiological studies indicate a relationship between the use of CPC and an increase in the incidence of venous and arterial thrombosis and thromboembolism, such as deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disease. These diseases are rare. The risk of venous thromboembolism (VTE) is maximum in the first year of taking such drugs. Increased risk is present after the initial use of PDA or the resumption of the use of the same or different PDAs (after a break between taking the drug in 4 weeks or more). Data from a large prospective study involving 3 groups of patients show that this increased risk is predominantly present during the first 3 months.

The overall risk of VTE in patients taking low-dose PDA (containing <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. VTE can be fatal (1-2% of cases).

VTE, which is manifested as deep vein thrombosis or pulmonary thromboembolism, can develop with the use of any PDA.

Thrombosis of other blood vessels, for example, hepatic, mesenteric, renal, cerebral veins and retinal arteries or vessels, occurs extremely rarely with CPK. There is no consensus regarding the relationship between the occurrence of these events and the use of PDAs.

Symptoms of deep vein thrombosis (DVT) include: 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 limbs.

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 symptoms of other more or less serious events (for example, an infection of the respiratory tract).

Arterial thromboembolism can lead to stroke, vascular occlusion, or myocardial infarction. Symptoms of a stroke: sudden weakness or loss of sensitivity of the face, limbs, especially on one side of the body, sudden confusion, problems with speech and understanding; sudden one or two-sided vision loss; sudden gait disturbance, dizziness, loss of balance or coordination of movements; sudden, severe or prolonged headache for no apparent reason; loss of consciousness or fainting with or without epileptic seizures. Other signs of vascular occlusion: sudden pain, swelling and weak blue in the limbs, symptom puncture "acute" abdomen.

Symptoms of myocardial infarction include: pain; the discomfort; feeling of pressure, heaviness; feeling of squeezing or bursting in the chest, in the hand or behind the sternum; discomfort in the left half of the chest radiating to the back, cheekbone, larynx, arm, epigastric region; cold sweat, nausea, vomiting, or dizziness, marked weakness, anxiety, or shortness of breath; rapid or irregular heartbeat.

Arterial thromboembolism can be fatal.

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

- with 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 old);

- for obesity (BMI> less than 30 kg / m²);

- in the presence of a burdened family history (for example, venous or arterial thromboembolism ever with close relatives or parents at a relatively young age).In the case of hereditary or acquired predisposition, a woman should be referred to the appropriate specialist to decide on the possibility of using a PDA;

- With prolonged immobilization, serious surgery, any operation on the lower limbs or extensive trauma. In these situations, it is desirable to discontinue the use of PDA (in the case of the planned operation, at least 4 weeks before it) and not to resume reception within 2 weeks after the end of immobilization;

- with dyslipoproteinemia;

- with arterial hypertension;

- with migraine;

- in diseases of the heart valves;

- with atrial fibrillation.

The question of the possible role of varicose veins and superficial thrombophlebitis in the development of venous thromboembolism remains controversial. You should consider the increased risk of thromboembolism in the postpartum period.

Peripheral circulatory disorders can also occur in diabetes mellitus, SLE, hemolytic-uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis), and sickle cell anemia.

An increase in the frequency and severity of migraine attacks during the use of PDA (which may precede cerebrovascular disorders) should be the basis for the immediate cessation of these drugs.

To biochemical indices indicating hereditary or acquired susceptibility to venous or arterial thrombosis,include: resistance to activated protein C, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, the presence of antibodies to phospholipids (antibodies to cardiolipin, lupus anticoagulant).

When assessing the risk / benefit ratio, it should be borne in mind that adequate treatment of the corresponding condition can reduce the associated risk of thrombosis. It should also be borne in mind that the risk of thrombosis and thromboembolism during pregnancy is higher than when taking low-dose CPC (containing less than 50 μg of ethinyl estradiol).

Drugs containing levonorgestrel, norgestimate or norethindrone have a low risk of developing venous thromboembolism. For drugs that include drospirenone, the risk of thromboembolic complications is 2 times higher, and therefore A woman should be warned about this increased risk before prescribing the drug Modell Pro.

Tumors

The most important risk factor for cervical cancer is persistent HPV infection. There are reports of some increase in the risk of developing cervical cancer with prolonged use of PDA. However, the connection with the admission of the PDA is not proven. Conflicting data remain on the extent to which these data are associated with screening for the identification of cervical pathology or sexual behavior (more rare use of barrier methods of contraception).

A meta-analysis of 54 epidemiological studies has shown that there is a slightly increased relative risk of developing breast cancer diagnosed in women taking CPC at the present time (relative risk 1.24). The increased risk gradually disappears within 10 years after discontinuation of these drugs. Due to the fact that breast cancer is rarely observed in women under 40 years of age, an increase in the number of breast cancer diagnoses in women who are currently taking or are taking CCP is insignificant relative to the overall risk of the disease. The relationship between the development of breast cancer and the intake of PDA has not been proven. The observed increase in risk may also be the result of careful observation and earlier diagnosis of breast cancer in women using CPC. Women who have ever used CCP, are detected earlier stages of breast cancer than women who have never used them.

In rare cases, against the background of the use of PDA, the development of benign, and in extremely rare cases, malignant tumors of the liver, which in some cases led to life-threatening intra-abdominal bleeding, was observed. In the event of severe pain in the abdomen, enlarged liver or signs of intra-abdominal bleeding, this should be considered when conducting a differential diagnosis.

Other states

Clinical studies have shown no effect of drospirenone on serum potassium concentration in patients with mild to moderate renal insufficiency.Theoretically, there is a risk of hyperkalemia in patients with impaired renal function and the initial potassium content at the level of VGN or against the background of medication, leading to a delay of potassium in the body.

Women with hypertriglyceridemia (or in the presence of this condition in the family history) may increase the risk of developing pancreatitis while receiving PDA. Despite the fact that a slight increase in blood pressure has been described in many women taking CPC, clinically significant hypertension was rarely observed. However, if a persistent, clinically significant increase in blood pressure develops during CPA use, these drugs should be canceled and treatment of hypertension should begin. Reception of PDA can be continued if normal blood pressure values ​​are achieved with the help of antihypertensive therapy.

The following conditions have been reported to develop or worsen both during pregnancy and when taking PDA, but their relationship with taking PDA has not been proven: jaundice and / or itching associated with cholestasis; the formation of gallstones; porphyria; SLE; hemolytic uremic syndrome; Chorea Sydenham; herpes pregnant; hearing loss associated with otosclerosis. Also described are cases of Crohn's disease or ulcerative colitis with PDA use.

In women with hereditary forms of angioedema, exogenous estrogens can cause or worsen the symptoms of angioedema.

In acute or chronic liver dysfunction, it may be necessary to discontinue the drug until liver function indicators return to normal.Recurrent cholestatic jaundice, which develops for the first time during pregnancy or a previous intake of sex hormones, requires the discontinuation of PDA.

Although KPC may affect insulin resistance and glucose tolerance, there is no need to change the therapeutic regimen in diabetic patients using low-dose KPC (containing less than 50 μg of ethinyl estradiol a). However, women with diabetes mellitus need careful control of the concentration of glucose in the blood during the use of the drug.

With the use of the drug may develop chloasma, especially in women with a history of pregnant chloasma. Women with a tendency to chloasma while taking a PDA should avoid prolonged exposure to the sun and exposure to ultraviolet radiation.

The effectiveness of PDA can be reduced by skipping tablets, vomiting and diarrhea, or as a result of drug interactions.

Effect on the menstrual cycle

Irregular (acyclic) bleeding (spotting or breakthrough bleeding) may occur on the background of PDA use, especially during the first months of use. Therefore, the assessment of any irregular bleeding should be carried out only after an adaptation period of approximately 3 cycles.

If irregular bleeding recurs or develops after previous regular cycles, a thorough examination should be performed to rule out malignant tumors or pregnancy.

Some women may not develop withdrawal bleeding during a break in the pill.If taking the PDA was carried out in accordance with the instructions, then pregnancy is unlikely. However, if before taking CPC was performed irregularly or if there are no two withdrawal bleeding in a row, then pregnancy should be excluded before continuing to take the drug.

Impact on laboratory test scores

Acceptance of PDA may affect the results of some laboratory tests, including indicators of liver function, kidney, thyroid, adrenal glands, the content of transport proteins in the blood plasma, carbohydrate metabolism, coagulation parameters and fibrinolysis. Changes usually do not go beyond the normal range. Drospirenone increases plasma renin and aldosterone activity, which