MODELL® PIUR (MODELLE® PURE)

If any of the conditions, diseases and risk factors identified below are present, careful consideration should be given to the potential risk and expected benefits of using CPC in each individual case and to discuss it with a woman before she decides to start taking the drug. In case of weighting, strengthening or the first manifestation of any of these conditions, diseases or risk factors, a woman should consult with her doctor who can decide whether to cancel the drug.

Diseases of the cardiovascular system

There is evidence of an increase in the incidence of venous and arterial thrombosis and thromboembolism (such as deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke) with PDA. These diseases are rare.

The risk of developing venous thromboembolism is maximal in the first year of taking such drugs. The risk of developing thrombosis (venous and / or arterial) and thromboembolism increases:

- with age;

- smokers (with an increase in the number of cigarettes or an increase in age, the risk further increases, especially in women over 35 years of age);

in the presence of:

- a burdened family history (for example, venous or arterial thromboembolism ever at close relatives or parents at a relatively young age). In the case of hereditary predisposition, a woman should be examined by an appropriate specialist to decide whether to accept the CCP;

- obesity (body mass index more than 30 kg / m²);

- dyslipoproteinemia;

- arterial hypertension;

- migraine;

- heart valve diseases;

- atrial fibrillation;

- prolonged immobilization, serious surgical intervention, any foot surgery or extensive trauma. In these situations, it is desirable to stop using the PDA (in the case of a planned operation, at least four weeks before it) and not to resume reception within two weeks after the end of immobilization.

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. Violations of peripheral circulation can also occur in diabetes mellitus, systemic lupus erythematosus, tetany,hemolytic uremic syndrome, chronic inflammatory bowel diseases (Crohn's disease or ulcerative colitis) and sickle cell anemia.

An increase in the frequency and severity of migraine during the use of CPC (which may precede cerebrovascular disorders) may be the reason for the immediate discontinuation of these drugs.

Tumors

An important risk factor for cervical cancer is the persistence of papillomavirus. The results of some epidemiological studies indicate an additional increase in this risk with prolonged use of CPC, however, this statement remains contradictory, since it has not been fully established whether the results of studies take into account co-occurring risk factors, for example screening of the cervix and sexual behavior, including a more rare application barrier methods of contraception. The relationship between CPC and breast cancer has not been proven. There is a slightly increased relative risk of developing breast cancer diagnosed in women currently taking CPC.Increased risk gradually disappears within 10 years after discontinuation of these drugs. The observed increase in risk may be the result of careful monitoring and earlier diagnosis of breast cancer in women using CPC. Women who have ever used CPC have earlier stages of breast cancer and are less clinically active than women who have never used them.

In isolated cases, against the backdrop of the use of CPC, there was a development of benign, and extremely rare, malignant liver tumors, which in some cases led to life-threatening intraabdominal hemorrhage. In the case of severe pain in the abdominal region, an increase in the liver, or signs of intra-abdominal bleeding in differential diagnosis, the possibility of a liver tumor in patients taking CPC should be considered.

Other states

Women with hypertriglyceridemia (or having this condition in a family history) may have an increased risk of developing pancreatitis while taking CPC.

Despite the fact that a small increase in blood pressure was described in many women taking combined oral contraceptives, clinically significant increases were rarely noted.Nevertheless, if a persistent, clinically significant increase in blood pressure develops during the administration of the PDA, these drugs should be discontinued and begin treatment of hypertension. 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 the PDA, but their relationship with the use of CPC has not been proven: jaundice and / or pruritus associated with cholestasis; formation of stones in the gallbladder; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; chorea; herpes pregnant; hearing loss associated with otosclerosis. Also described are cases of Crohn's disease and ulcerative colitis in the background of the use of CPC.

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

Acute or chronic liver dysfunction may require the withdrawal of CPC until the liver function returns to normal. Recurrent cholestatic jaundice, which develops for the first time during pregnancy or previous reception of sex hormones, requires discontinuation of the PDA.

Although the CCP can influence insulin resistance and glucose tolerance, there is no need to change the therapeutic regimen in patients with diabetes mellitus, using low-dose PDA (<0.05 mg ethinylestradiol). Nevertheless, women with diabetes should be carefully observed during the reception of the CCP.

Sometimes chloasma can develop, especially in women with a history of pregnancy chloasma. Women with a tendency to chloasma during the reception of CPC should avoid prolonged exposure to the sun and exposure to ultraviolet radiation.

Treatment (contraception) should be immediately discontinued if pregnancy occurs, the development of migraine headaches (if they were not before), the appearance of early signs of phlebitis or phlebothrombosis (unusual pain or swelling of veins), with the appearance of jaundice, visual disturbances, cerebrovascular disorders, stabbing pain of unknown etiology when breathing or coughing, pain and feeling of tightness in the chest, with the increase in blood pressure.

Admission is also terminated 3 months before the planned pregnancy, 6 weeks before the planned surgical intervention and with prolonged immobilization.With diarrhea and vomiting, the contraceptive effect is reduced, therefore, while continuing to take MODEL® PYUR, additional non-hormonal methods of contraception should be used.

Laboratory Tests

Receiving CCP can affect pas results of some laboratory tests including liver function, kidney, thyroid, adrenals, transport protein content in the plasma, carbohydrate metabolism, coagulation parameters and fibrinolysis.

Laboratory staff should be warned about taking oral contraceptives.

It is possible to change the results of skin allergic tests, decrease the concentration of LH and FSH.

Due to the fact that the contraceptive effect is fully manifested by the 14th day from the beginning of admission, in the first 2 weeks it is recommended to additionally use non-hormonal (barrier) methods of contraception. The MODEL® PYUR preparation has no influence on the course of puberty during the period of normal menstrual cycle formation. The appointment after childbirth is recommended not earlier than the first normal after the birth of menstruation. In cases of acyclic bleeding in the first 3 weeks of hormonal contraception, it is possiblecontinued use of the drug, as a rule, bloody discharge ceases on their own. If there is no bleeding during the 7-day interval between taking the drug, taking the pills should be stopped before pregnancy is excluded.

Effects on the menstrual cycle

On the background of taking CPC, irregular (acyclic) bloody discharge / bleeding from the vagina (spotting spotting or breakthrough bleeding) can occur, especially during the first months of use. Therefore, any irregular bleeding should be assessed after an adaptation period of approximately three cycles.

If irregular bleeding recurs or develops after previous regular cycles, a thorough examination should be conducted to exclude malignant neoplasms or pregnancy.

Some women may not develop withdrawal bleeding during a break in taking pills. If combined oral contraceptives are taken according to recommendations, it is unlikely that a woman is pregnant. However, with irregular use of CPC and the absence of two consecutive bleeding cancellations, taking the drug can not be continued until the pregnancy is excluded.

Medical examinations

Before starting or resuming the use of MODEL® PYUR, a woman needs a thorough general medical check-up including blood pressure measurement, heart rate, body mass index, and gynecological examination, including breast examination and cervical scraping (Papanicolaou test), to exclude pregnancy. The volume of additional studies and the frequency of follow-up visits are determined individually. Usually, follow-up examinations should be conducted at least 2 times a year.

A woman should be warned that preparations such as MODELL® PYUR do not protect against HIV infection (AIDS) and other sexually transmitted diseases.