Index of drugs

Oral contraception.

Each blister contains 28 tables. area: 21 tabl. pink, each containing 3 mg drospirenone and 0.02 mg ethinyl estradiol; 7 tables white (placebo), which do not contain active substances. The drug contains lactose.

Monophasic, combined oral contraceptive. The main mechanism of the contraceptive effect of the preparation is inhibition of ovulation and induction of changes in the endometrium. At therapeutic doses, drospirenone also shows antiandrogenic activity and low antimineralocorticoid activity. It has no estrogenic, glucocorticoid and anti-glycocorticoid properties (the pharmacological profile of drospirenone is very similar to that of natural progesterone). Drospirenone is rapidly and almost completely absorbed after oral administration, reaching C_max after 1-2 h. Bioavailability is 76-85%, food does not affect bioavailability. It binds to albumin, is not associated with SGBH and CBG. It is rapidly metabolised, metabolites are excreted in faeces and urine. T_0,5 in the elimination phase is approx. 31 h. Ethinyl estradiol is rapidly and completely absorbed after oral administration, reaching C_max after 1-2 h. Is subject to the first-pass effect, which is characterized by high individual variability. Bioavailability is about 45%. It is 98% bound to plasma proteins and induces hepatic synthesis of SHBG and CBG. It is completely metabolized, metabolites are excreted in the bile and urine. T_0,5 in the elimination phase, it is about 20 hours.

Hypersensitivity to the active substances or auxiliary substances of the preparation. Current or past venous thrombosis (deep vein thrombosis, pulmonary embolism). Current or past arterial thrombosis (eg myocardial infarction) or prodromal conditions (e.g. angina pectoris, transient ischemic attack). Current or past cerebrovascular incident. The presence of severe or complex risk factors for arterial thrombosis: diabetes with vascular lesions, severe hypertension, severe dyslipoproteinaemia. Inherited or acquired predisposition to venous or arterial thrombosis: resistance to activated C protein (APC), deficiency of antithrombin III, protein C deficiency, protein S deficiency, hyperhemocysteinemia, presence of anti-phospholipid antibodies (anticardiolipid, lupus anticoagulant). Current or previous pancreatitis, if progressing with severe hypertriglyceridemia. Current or past severe liver disease, until the liver parameters return to normal. Severe or acute renal failure. Current or past liver tumors (benign or malignant). Suspicion of the presence or presence of malignant tumors dependent on sex hormones (e.g., genital or breast cancer). Bleeding from the genital tract of undetermined etiology. Migraine with focal neurological symptoms in an interview.

Before starting treatment (or before re-applying it after a break), pregnancy should be excluded, a full medical history (including family history), blood pressure measurement and physical examination should be performed to exclude contraindications and conditions requiring special care. Checks should be repeated regularly during the use of the preparation, in accordance with the applicable guidelines. If irregular menstrual bleeding persists or occurs in a woman who has had regular menstrual cycles, non-hormonal etiology should be considered and appropriate diagnostics should be performed to rule out malignant tumors or pregnancy. Particularly cautiously use in patients with risk factors for venous or arterial thromboembolic events, such as: advanced age, positive family history, puerperal period, long-term immobilization, surgery, lower limb surgery or severe trauma (discontinuation of the preparation is recommended for at least 4 weeks). before the planned surgery and re-application only after 2 weeksfrom returning to full mobility; if not withdrawn in advance, anticoagulation should be considered), obesity (body mass index> 30 kg / m²), smoking, dyslipoproteinaemia, hypertension, migraine, heart valve defects, atrial fibrillation. There are discrepancies in the role of varicose veins and thrombophlebitis of superficial veins in the initial stage or progression of venous thrombosis. The presence of one serious or several risk factors for venous or arterial disease may be a contraindication to the use of the preparation. In such cases, the possibility of anticoagulant treatment should be considered. Caution should also be exercised in the presence of other diseases that lead to circulatory disorders such as diabetes, systemic lupus erythematosus, haemolytic-uremic syndrome, chronic inflammatory bowel disease and sickle cell anemia. Due to the risk of pancreatitis, caution should be used in patients with hypertriglyceridemia or a positive family history of hypertriglyceridemia. Exercise caution in patients with: congenital angioedema, endogenous depression, epilepsy, Crohn's disease, ulcerative colitis, jaundice and / or pruritus associated with cholestasis, cholelithiasis, porphyria, systemic lupus erythematosus, haemolytic-uremic syndrome, Sydenham's chorea, herpes of pregnant women, hearing loss associated with otosclerosis, because the above diseases can get worse when using hormonal contraceptives. In patients with renal insufficiency or whose potassium levels before starting the use of the product were at the upper limit of normal, especially when concomitant use of potassium sparing diuretics, it is recommended to check the concentration of potassium during the first cycle of treatment with the product. Patients with diabetes should be closely monitored, especially at the beginning of the treatment, due to the risk of drug effects on peripheral insulin resistance and Glucose tolerance. Women with a tendency to chloasma should avoid exposure to sunlight or UV radiation when using the product. The preparation should be discontinued if thrombosis is suspected or diagnosed, the incidence or severity of migraine pain, acute or chronic hepatic impairment (until hepatic parameters return to normal), recurrent cholestatic jaundice and / or pruritus associated with cholestasis. In case of clinically significant hypertension during the use of the preparation or hypertension not responding to the pharmacological treatment, the preparation should be set; in justified cases, it can be returned to the use of the preparation when antihypertensive therapy leads to normalization of the pressure. In case of severe pain in the epigastric region, enlargement of the liver or symptoms of abdominal bleeding, differential diagnosis should take into account the possibility of liver cancer. Patients with rare hereditary lactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption using a lactose-free diet should take into account the lactose content of the preparation.

The use of the preparation is not indicated in pregnant women. Do not use until breastfeeding (the drug may reduce the amount and change the composition of the food, steroids and their metabolites may pass into the milk and affect the child).

Common: menstrual disorders, intermenstrual bleeding, breast pain, headache, depressive mood, migraine, nausea, vaginal discharge, vaginal candidiasis. Uncommon: libido changes, hypertension, hypotension, vomiting, acne, eczema, pruritus, vaginitis, fluid retention, body weight changes. Rarely: hypersensitivity, asthma, breast discharge, hearing loss, thromboembolic disease, erythema nodosum, erythema multiforme. In women taking combined oral contraceptives, the following serious adverse reactions have been reported: venous and arterial thromboembolic events (deep vein thrombosis, pulmonary embolism, myocardial infarction, transient ischemic attack), the occurrence of thrombosis in the mesenteric and hepatic arteries, renal, cerebral or retinal), hypertension, liver cancer (they can lead to life-threatening bleeding into the abdomen), chloasma, acute or chronic liver problems (requiring in some cases discontinuation of a combined oral contraceptive until liver function returns to standard).There are unclear data regarding the association of combined oral contraceptives with the following diseases: Crohn's disease, ulcerative colitis, epilepsy, migraine, endomeriosis, uterine fibroids, porphyria, systemic lupus erythematosus, herpes simplex, Sydenham chorea, hemolytic syndrome urea, cholestatic jaundice. In women with an inborn propensity to exogenous angioneurotic edema, estrogens may induce or worsen symptoms of angioedema. Several epidemiological studies have shown an increased risk of cervical cancer in long-term users of contraceptive pills - it is not known to what extent these effects affect, for example, sexual behavior and human papillomavirus (HPV) infection. Breast cancer is diagnosed more frequently (however, the causal relationship with the use of combined oral contraceptives is unknown).

Oral: The tablets should be taken in the order indicated on the pack, every day, at about the same time of the day, with a small amount of liquid if necessary. Take 1 tabl. daily for 28 consecutive days: 21 pink tablets, then 7 white tablets. Each subsequent pack should be started the Next day after taking the last white tablet from the previous pack. The withdrawal bleed usually begins 2-3 days after starting the placebo pill and may not end until the next packet begins.Beginning of the preparation. If during the last month the patient did not use any hormonal contraceptive method, the preparation should be started on day 1 of the cycle (ie on day 1 of menstrual bleeding). If you have previously taken another combined oral contraceptive, you should take your tablets the day after taking the last tablet containing the active ingredients of the previous combined pill, but no later than the day after the end of the break or after taking the placebo tablets of the previous combined pill. If the patient uses a therapeutic vaginal system or a patch, the preparation should be started preferably on the day of removal, but no later than on the day when the next system should be used. If the patient had previously used a progestogen-only contraceptive (mini-tablet, injection, implant or intra-progestin-releasing intrauterine therapy), taking the preparation instead of the minitabletka can be started on any day of the cycle, in the case of the implant and system - on the day of the implant or system removal, in the case of injections - on the day on which the next injection was to be made; in all these cases, a mechanical contraceptive method should be used for the first 7 days of the preparation. In the event of a miscarriage in the first trimester of pregnancy, the preparation can be immediately started; no other methods of contraception are necessary. In the event of delivery or miscarriage in the second trimester of pregnancy, the preparation may be started 21-28 days after delivery or after a miscarriage; if the patient starts using the product later, additional mechanical contraceptive methods should be used for the first 7 days. Patients who have had an intercourse before taking the preparation should exclude pregnancy or wait for the first menstrual bleeding.Proceeding if you miss a tablet. If you have missed the tablet from the last row of the blister (white), ignore it because these are placebo tablets. Nevertheless, it should be removed from the blister in order to avoid the accidental prolongation of the use of placebo tablets. The information described below applies only to the case of omission of tablets containing active substances (tablets from the 1st to 3rd row in the blister, in pink). If less than 12 hours have passed since the tablet was missed, the contraceptive effectiveness is maintained; omit the tablet should be taken as soon as possible, and the next - at the usual time. If more than 12 hours have elapsed since the tablet was missed, the effectiveness may be reduced, then proceed as follows. You must never stop taking tablets for more than 7 days.It is necessary 7 days of uninterrupted taking of tablets to maintain the proper degree of inhibition of the hypothalamo-pituitary-ovary axis. If you miss a tablet in the first week, take it as soon as possible, even if it means taking two tablets at the same time, take your next tablet at the usual time. For the next 7 days, additional mechanical contraception should be used. If there has been sexual intercourse during the 7 days preceding the omission of the tablet, there is a possibility of pregnancy. The more tablets are missed and the less time has passed since the placebo tablets were taken, the greater the risk of getting pregnant. If you miss a tablet in the second week, take it as soon as possible, even if it means taking two tablets at the same time, take your next tablet at the usual time. If the preparation was taken correctly within 7 days before skipping the tablet, no additional contraceptive methods are required. If, however, more than one tablet has been omitted, barrier methods of contraception should be used for 7 days. If you miss the tablet in the third week, there are two options for the procedure. If the preparation was used correctly for 7 days before skipping the tablet, one of the following recommendations may be chosen without the need for any additional contraceptive methods, otherwise recommendation 1 should be used and the contraceptive barrier method should be used for 7 days. 1. - If you forget to take the missed tablet as soon as possible, even if it means taking two tablets at the same time, take your next tablet at the usual time, until you stop taking the tablets containing the active ingredients. Discard 7 tablets from the last row (placebo tablets) and immediately start taking the tablets from the next pack (discontinuation bleeding will occur after completing the second pack, staining or intermenstrual bleeding may occur while taking the tablets). 2. - You can stop taking the tablets from the current packaging, start using placebo tablets from the last row for up to 7 days, including those in which you have missed taking tablets, and then start a new pack.Proceedings in the case of gastrointestinal disorders. In the event of vomiting or acute diarrhea within 3-4 hours after taking the tablet, an additional tablet should be taken within 12 hours of the usual admission schedule; if more than 12 hours have elapsed, proceed as if you missed the tablet. If the patient does not want to change the set dosing schedule, she should take an additional tablet from the next pack.Procedure to delay bleeding. To delay the withdrawal bleed, placebo tablets should be discarded and another container should be started. Bleeding time can be extended by taking further tablets, even until the end of the second pack. During the extended cycle, there may be some intermenstrual bleeding or spotting. Then, after the use of placebo tablets, the preparation should be resumed. To delay the withdrawal period to a different day of the week, you should shorten the period of taking placebo tablets for as many days as you intend to postpone the bleeding date. The shorter the break, the greater the risk that there will be no withdrawal bleeding, and there will be a small intermenstrual bleeding or spotting during the next package.