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. It can be used during breastfeeding and in patients who can not or do not want to use estrogen. The contraceptive effect of the preparation is achieved mainly by inhibiting ovulation; another action is to increase the viscosity of the cervical mucus. The use of the preparation leads to a decrease in the serum estradiol concentration to the level corresponding to the early follicular 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 total bioavailability of the ENG is approximately 70%. ENG is 95.5-99% bound to plasma proteins, mainly albumin and to a lesser extent to sex hormone binding globulin (SHBG). DSG is metabolized by hydroxylation and reduction to the active metabolite ENG, which is converted to sulphates and conjugated glucuronides. 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 in the lactation phase, ENG is excreted in breast milk in a milk / serum ratio of 0.37-0.55.

Hypersensitivity to the active substance or to any of the excipients. Presence of venous thromboembolism. Occurrence, now or in the past, of severe liver disease until the liver function parameters return to normal. Presence or suspected hormone-dependent malignancies. Bleeding from the vagina of unknown cause.

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 similar, but less pronounced. The biological effect of progestagens on liver cancer can not be excluded - in patients with liver cancer, the benefits and risks of these hormones must be considered individually. In case of acute or chronic hepatic dysfunction, the patient should be referred for specialist examinations. If hypertension develops clinically significant during the use of the tablets or there are significant increases in blood pressure, which do not respond to the treatment of hypertension, it is recommended to discontinue the use of contraceptive pills. Epidemiological studies associate the use of oral combined contraceptives with an increased incidence of venous thromboembolism (deep vein thrombosis and pulmonary embolism). It is not known whether such a relationship exists for desogestrel used alone, and not in combination with estrogen. If thromboembolic disorders are diagnosed, the preparation should be discontinued. Discontinuation of tablets should also be considered in cases where it is necessary to immobilize after surgery or due to illness. Women who have had thromboembolism in the past should be informed about the risk of their recurrence. Progestins may affect insulin resistance and Glucose tolerance, but there is no evidence that it is necessary to change the current treatment of diabetes during their use; patients with diabetes should be under the constant care of a physician during the first months of application. The use of the preparation decreases the plasma estradiol concentration to the concentration found in the early follicular phase - it is not known if this has an effect on the bone mineral density.Conventional contraceptives containing only progestins do not protect as well as combined contraceptives before the onset of an ectopic pregnancy; Ovulations were observed during their use; Ectopic pregnancy should be considered during the differential diagnosis of menstrual arrest or abdominal pain in women. Women prone to chloasma should avoid solar radiation or ultraviolet radiation when using the preparation. If you have menstrual irregularities with regular use (bleeding is very frequent and irregular), another method of contraception should be considered. If these symptoms persist, the organic factor should be excluded. The efficacy of the preparation can be reduced due to the omission of the tablet, gastrointestinal disturbances and the simultaneous use of other drugs. In some women, when using contraceptives containing only progestagens, vaginal bleeding may be more frequent or longer lasting, while in others, it may be very rare or completely disappear. These changes are often the reason for the lack of acceptance of this method of contraception - the patient should be informed about the possibility of changing the profile of bleeding. The assessment of the bleeding profile should be carried out together with the study excluding the occurrence of malignancy or pregnancy. When contraceptives containing low doses of hormones are used, the ovarian follicles mature. Sometimes these bubbles are larger than those usually encountered during the menstrual cycle. As a rule, these enlarged vesicles (functional cysts) disappear spontaneously. Often their appearance is asymptomatic; in some cases, they can cause minor abdominal pain. They rarely require surgical intervention. 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 high doses of progestagens may cause masculinization of female fetuses. Data on various contraceptives containing desogestrel do not indicate an increased risk of having a child with congenital malformations by patients taking combined oral contraception before pregnancy, or teratogenic effects of these preparations if they are inadvertently used in early pregnancy. The preparation can be used during breastfeeding. The development and growth of breastfed infants should be closely monitored. The preparation does not affect the quantity or quality of milk produced (protein, lactose, fat concentration). Small amounts of etonogestrel are excreted in milk (0.01-0.05 μg / kg / day with milk consumption 150 ml / kg / day). There are limited long-term data on the observation of children whose mothers started using the preparation between 4 to 8 weeks after giving birth. They breastfed for 7 months, the observation lasted up to 1.5 years of the child or up to 2.5 years of the child. Assessment of growth, physical and psychomotor development does not show any differences compared to breast-fed infants whose mothers used copper-containing intrauterine therapy.

Common: variable mood, depressed mood, decreased libido, headache, nausea, acne, breast pain, irregular bleeding, no bleeding, weight gain. Uncommon: vaginitis, contact lens intolerance, vomiting, alopecia, painful bleeding, ovarian cysts, fatigue. Rarely: rash, urticaria, erythema nodosum. The appearance of discharge from the breast and in rare cases an ectopic pregnancy has been observed in women using the product. In addition, there may be (increase) angioedema and / or the severity of congenital angioedema. Many of the serious side effects associated with the use of combined oral contraceptives have been reported: venous thromboembolic events, arterial thromboembolic events, hormone-dependent tumors (eg liver cancer, breast cancer), chloasma (especially in patients who have had during pregnancy).The following symptoms were observed, both during pregnancy and during the use of sex steroids, but their relationship with the use of gestagens could not be determined: jaundice and / or pruritus caused by cholestasis; cholelithiasis; porphyria; systemic lupus erythematosus; haemolytic-uremic syndrome; Sydham's chorea; herpes; hearing loss due to otosclerosis; angioedema (congenital).

Orally. The tablets are taken once a day at the same time of the day with a small amount of liquid. The first tablet should be taken on the first day of the cycle, i.e. the first day of menstruation. The tablets should be taken for 28 days, taking them in the direction of the arrows on the package. Taking the tablets from the Next pack should be started immediately after the previous packaging is finished.Beginning of the preparation. No hormonal contraception last month: the first tablet should be taken on the first day of the cycle, i.e. the first day of menstruation. Taking tablets can also be started between day 2 and 5 of the cycle, but in this case an additional contraceptive (barrier) method should be used for the first 7 days of taking the tablets in the first cycle.After a miscarriage in the first trimester of pregnancy: it is recommended to take the tablets immediately after a miscarriage in the first trimester of pregnancy; no additional methods of contraception are needed.After delivery, about time or miscarriage in the second trimester of pregnancy: start taking tablets between the 21st and 28th day after giving birth or a second mornment. In case of later start of taking the tablets, an additional method of contraception (barrier method) should be used for the first 7 days of taking tablets. After the intercourse, pregnancy should be ruled out before taking the tablets or wait for the first menstrual period.Begin using the product when changing from other methods of contraception. Change from a combined contraceptive (combined birth control pills, contraceptive vaginal rings, contraceptive patches): take the tablets on the preparation the day after taking the last tablet containing the active substance of the previous preparation. If a contraceptive vaginal disc or a contraceptive patch is used, the preparation should be started on the day of removal. In this case, there is no need for an additional method of contraception. The preparation may also be started later, but no later than the first day following the discontinuation of the tablet of the previously used preparation, on the day of the next contraceptive vaginal disc or contraceptive patch or on the day after the last placebo tablet is used. In these cases, an additional method of contraception (barrier) should be used for the first 7 days of taking the preparation.A change from a contraceptive containing only progestogen (mini-pills, injections, implant or with progestin-releasing intrauterine therapy): you can stop taking a mini-tablet every day and start taking the tablets of the preparation (in the case of the implant or system on the day of removal, in the case of injection on the day when the next injection should be made). In all these cases, there is no need for an additional method of contraception.Proceeding if you forget to take your tablet. The contraceptive effectiveness may be reduced if there is a break longer than 36 h between taking two tablets. If the delay in taking tablets is less than 12 h, take the forgotten tablet as soon as possible and the rest as usual. If the delay is more than 12 hours, it should be done as in the previous situation, but at the same time use an additional method of contraception for the next 7 days. If the patient forgot to take the tablet in the first week of the use of the preparation, and during the week preceding forgetting had sexual intercourse, there is a risk of becoming pregnant.Proceedings in the case of gastrointestinal disorders. In case of severe gastrointestinal disturbances, the absorption of active substances could be incomplete. You should then use additional methods of contraception. If vomiting occurs within 3-4 hours after taking the tablet, the absorption of the contraceptive could be reduced - it should be done as if the tablet was forgotten.