Index of drugs

Oral contraception.

1 tabl powl. contains 75 μg of desogestrel. The preparation contains lactose.

An oral contraceptive that only contains progestagen - desogestrel. The preparation is adapted for use during breastfeeding and for patients who can not or do not want to use estrogens. The contraceptive effect of the preparation is achieved mainly by inhibiting ovulation. Other activities include increasing the viscosity of cervical mucus. The use of the preparation leads to a decrease in the serum estradiol concentration to the level corresponding to the early vesicular phase. Following oral administration, desogestrel (DSG) is rapidly absorbed and metabolised to etonogestrel (ENG). At steady state, the maximum serum concentration occurs 1.8 h after taking the tablet, and the absolute bioavailability of ENG is about 70%. ENG in 95.5-99% binds to plasma proteins, mainly albumin and to a lesser extent to sex hormone binding protein (SHBG). DSG is metabolized by hydroxylation and dehydrogenation to the active metabolite ENG, which is metabolized by sulphate and glucuronide coupling. T_0,5 for ENG is about 30 h. Steady-state in plasma is achieved after 4-5 days. ENG and its metabolites are excreted as free steroids or in conjugate form, with urine and faeces (ratio of 1.5: 1). In patients during the lactation phase, ENG is excreted in breast milk in a milk / plasma ratio of 0.37-0.55.

Hypersensitivity to the active substance or to any of the excipients. Pregnancy or its suspicion. Active venous thromboembolism. Severe liver disease currently or in history until the results of liver function tests return to normal. Occurrence or suspicion of malignant tumors dependent on sex hormones. Bleeding from the vagina of unknown etiology.

When using combined oral contraceptives, the risk of breast cancer is slightly increased. This increased risk gradually disappears within 10 years after discontinuation of these preparations and is not related to the duration of their use but with the age of the patients. The risk for patients using contraceptives containing only progestin is probably similar, but the data are less clear. Since the biological effect of progestagens can not be ruled out with regard to liver cancer, individual benefit risk assessment should be performed in patients with liver cancer. If you have acute or chronic liver problems, please ask your specialist for tests and advice. Epidemiological studies show a connection between the use of combined oral contraceptives and the incidence of venous thromboembolism (VTE, deep vein thrombosis and pulmonary embolism). Although it is unknown whether this clinical relationship is associated with the use of desogestrel, as a contraceptive without an estrogen component, in the case of thrombosis should be discontinued. Discontinuation of the preparation should also be considered in the case of long-term immobilization of the patient due to surgery or disease. Patients with thromboembolic events should be informed about the possibility of their recurrence. Progestins may have an effect on peripheral insulin resistance and Glucose tolerance, but there are no data to support a change in the dosage regimen in diabetic patients - a diabetic patient should be carefully observed in the first months of use. If chronic hypertension develops during treatment, or if there is no appropriate response to treatment with antihypertensive medicinal products in the event of markedly elevated blood pressure, discontinuation of the preparation should be considered. Treatment with the preparation leads to a decrease in serum estradiol levels to the level corresponding to the early vesicular phase - it is not known if this has a clinically significant effect on bone mineral density.Prevention of ectopic pregnancies using traditional contraceptive pills (pills) containing only progestin is not as effective as the use of combined oral contraceptives. Although the preparation consistently inhibits ovulation, an ectopic pregnancy should be considered during differential diagnosis if the patient develops amenorrhea or abdominal pain. Patients prone to chloasma should avoid exposure to the sun or ultraviolet radiation. When using low-dose hormonal contraceptives, bubbles may occasionally get a larger volume than normal in the menstrual cycle. Usually, enlarged vesicles (functional cysts) disappear spontaneously. They are often asymptomatic but in some cases mild abdominal pain may occur. Surgical intervention is rarely required. There are no appropriate indications for use in children. The preparation contains lactose - should not be used in patients with rare hereditary problems of galactose intolerance, lactase deficiency (Lappa type) or malabsorption of glucose-galactose.

The preparation is contraindicated during pregnancy. Animal studies have shown that very high doses of progestogen substances can cause masculinization of female fetuses. Data on various combined oral contraceptives containing desogestrel do not indicate an increased risk of having a child with congenital malformations by patients using COCs before pregnancy or teratogenic effects of these preparations on the fetus if they are unintentionally used in early pregnancy. The preparation can be used during breastfeeding, however, the development and growth of breastfed infants should be carefully monitored. The preparation does not affect the production or quality (protein, lactose or fat content) of breast milk. Small amounts of etonogestrel are excreted in breast milk (0.01-0.05 μg / kg / day with an estimated milk intake of 150 ml / kg / day). Limited data are available from long-term follow-up among children whose mothers started using desogestrel during 4-8. weeks after delivery. The children were breastfed for 7 months and monitored for up to 1.5 or 2.5 years. Assessment of physical and psychomotor growth and development did not show any differences compared to breastfed infants whose mothers used the copper releasing IUD system.

Common: change of mood, decreased libido, headache, nausea, acne, breast pain, irregular menstruation, lack of menstruation, weight gain. Uncommon: vaginal infection, contact lens intolerance, vomiting, alopecia, dysmenorrhea, ovarian cyst, fatigue. Rarely: rash, urticaria, erythema nodosum. When using dezogestrel, mycotoxicity may occur. Ectopic pregnancy has been rarely reported. Chloasma may occur occasionally, especially in patients with chloasma during pregnancy. In patients using (combined) oral contraceptives, a number of (severe) side effects have been reported: venous thromboembolic events, arterial thromboembolic events, hormone-dependent tumors (eg liver cancer, breast cancer) and rheumatism. During and during the use of preparations containing steroidal sex hormones, the following symptoms have been reported, but their relationship to the use of progestagens has not been established: jaundice and / or pruritus associated with cholestasis; formation of gallstones, porphyria; systemic lupus erythematosus; haemolytic-uremic syndrome; Sydham's chorea; herpes of pregnant women; hearing loss associated with otosclerosis; angioedema (congenital).

Orally. The tablets must be used daily, with a small amount of liquid, at about the same time, so that the interval between tablets taken is always 24 h. The first tablet should be used on the first day of menstrual bleeding. Since then, one table should be used continuously every day, without paying attention to possible bleeding. The use of tablets from the new blister should be started the day after the end of the previous blister.Beginning of the preparation. No hormonal contraception last month: the use of tablets should start at 1.on the menstrual cycle of the woman (first day of menstrual bleeding). It is acceptable to start taking tablets from the 2nd to the 5th day of the cycle, but in this case, for the first 7 days of taking tablets during the first cycle, it is recommended to use a barrier method of contraception.After a miscarriage in the first trimester of pregnancy: immediate intake of tablets is recommended; it is not necessary to use an additional method of contraception.After delivery, after premature delivery or abortion in the second trimester of pregnancy: the use of the preparation can be started before the onset of menstruation. If more than 21 days have passed since birth, you must exclude pregnancy and use an additional method of contraception for the first week before starting treatment.Begin using the product when changing from other methods of contraception. Change from a combined hormonal contraceptive, vaginal therapeutic system or transdermal patch: the preparation should be started preferably the day after the last tablet (the last tablet containing active substances) of the previous combined oral contraceptive or on the day of removal of the intravaginal or patch system. In these cases, it is not necessary to use an additional method of contraception. A woman may begin the use of the preparation at the latest on the day following the usual discontinuation of the use of tablets, the transdermal patch, patches, the vaginal therapeutic system or the period of taking the placebo tablets of the previous combined contraceptive. During the first 7 days of taking tablets it is recommended to use an additional mechanical method of contraception.A change from a progestogen-only agent (mini-pills, injections, implants or from a progestin-releasing intrauterine therapy system): a woman can change the minipill on any day (in the case of an implant or an intrauterine system on the day of its removal, in the case of an injection on the day on which the Next injection is due).Proceeding in case of skipping tablets. If more than 36 hours have passed between two consecutive tablets, the contraceptive effectiveness may be impaired. If the delay in taking the tablet is less than 12 hours, the missed tablet should be taken as soon as she remembers and the next tablet at the usual time. If the delay is more than 12 hours, an additional method of contraception should be used for the next 7 days. If the tablet was skipped in the first week and there was sexual intercourse in the week preceding the missed tablets, then you should consider the possibility of getting pregnant.Proceedings in the case of gastrointestinal disorders. If severe gastrointestinal disturbances occur, absorption may not be complete and additional contraceptive measures should be taken. If vomiting occurs within 3-4 hours after taking the tablet, the absorption may not be complete. In this case, do the same as if you skipped the tablet. If the systematic use of the preparation has bleeding disorders (bleeding occurs very often or irregularly), a different method of contraception should be considered; if the symptoms persist, organic causes should be excluded.