Index of drugs

Progesterone deficiencies: treatment of dysmenorrhea, treatment of endometriosis, treatment of secondary menstrual periods, treatment of irregular menstrual cycles, treatment of abnormal uterine bleeding, premenstrual syndrome treatment, treatment of abortions endangering, treatment of habitual miscarriages, treatment of infertility associated with failure of corpus luteum.Hormone Replacement Therapy: counteracting the influence of unbalanced estrogen on the endometrium, administered as part of hormone replacement therapy in women with a preserved uterus, with disorders caused by natural or surgically induced menopause.

1 tabl powl. contains 10 mg of dydrogesterone. The preparation contains lactose.

Dydrogesterone is an orally active progestagen. It causes the secretory transformation of the endometrium in the uterus, previously treated with estrogen, thanks to which it protects against estrogen upregulation of the risk of endometrial hyperplasia and / or endometrial cancer. It does not exert estrogenic, androgenic, thermogenic, anabolic and corticosteroid effects. After oral administration, it is rapidly absorbed, reaching C_max after 0.5-2.5 h. The absolute bioavailability is 28%. Following oral administration, dydrogesterone is rapidly metabolised to 20α-dihydrodydrogesterone (DHD). C_max DHD reaches about 1.5 hours after taking the preparation. The DHD concentration in the blood is much higher than dydrogesterone. Dydrogesterone and DHD bind to plasma proteins at> 90%. Medium T_0,5 dydrogesterone and DHD is respectively: 5-7 h and 14-17 h. Approx. 63% of the dose is excreted in the urine. Within 72 hours, the drug is expelled completely. In urine, DHD is mainly present in a form conjugated to glucuronic acid.

Hypersensitivity to the active substance or to any of the excipients. Diagnosis or reasonable suspicion of progestogen-dependent cancers. Bleeding from the vagina with an undetermined cause. If estrogen is co-administered with dydrogesterone, contraindications for estrogen should be considered.

Before starting treatment with dydrogesterone, abnormal vaginal bleeding should be explained their aetiology. During the first months of treatment, bleeding and spotting may occur - it is only after a certain period of treatment or after the treatment has been discontinued that studies should be carried out to identify their cause. These tests may include performing a biopsy of the endometrium to exclude malignancy. The patient should be closely monitored if present, present in the past, aggravated during pregnancy or prior hormonal treatment, any of the following pathologies (during treatment with dydrogesterone may recur or worsen): porphyria, depression, abnormal values ​​of liver function tests due to acute or chronic liver disease. Dydrogesterone is not recommended before the first menstrual period. The safety and efficacy of dydrogesterone in adolescents aged 12-18 has not been established. The preparation contains lactose - it should not be given to patients with rare hereditary galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose.The following precautions are for the use of dydrogesterone in combination with estrogen during HRT. In cases of treatment of symptoms associated with menopause, HRT should be initiated only when these symptoms cause a deterioration of the quality of life. Risks and expected benefits associated with treatment should always be considered. Such assessment should be made at least once a year, and therapy should be continued, as long as the benefits outweigh the risks. Data on the risks associated with HRT in the treatment of premature menopause are limited. However, due to the low absolute risk in younger women, the benefit-risk ratio in this group of patients may be better than in older women. Before starting or re-using HRT, an accurate interview about the patient and her family should be carried out.It is advisable to perform a physical examination (including pelvic and breast organs) in order to identify contraindications or conditions requiring special care. During treatment, periodic examinations are recommended, the frequency of which should depend on individual needs. Diagnostic tests, including appropriate imaging examinations, eg mammography, should be performed in accordance with the currently valid screening principles, taking into account individual needs. In women with a preserved uterus, the risk of hyperplasia and development of endometrial cancer increases, when estrogens are used for a long time - cyclic addition of progestogen (eg dydrogesterone) for at least 12 days a month, in a 28-day cycle, or continuous estrogen therapy with progestogen can prevent this risk from increasing. Available data suggest an increased risk of breast cancer in women using HRT with estrogen with progestogen and probably also with estrogen alone, which depends on the duration of HRT; increased risk becomes apparent after 3 years of treatment. The increase in risk is evident within a few years of treatment, but the risk indicators return to baseline after a few (usually five) years after the end of treatment. HRT, especially involving the combined use of estrogens and progestagens, leads to an increase in the density of mammography images, which may make detection of breast cancer by radiological method difficult. Long-term (5-10 years) use of HRT by the combined method may slightly increase the risk of ovarian cancer. HRT is associated with a 1.3-3-fold increase in the risk of venous thromboembolism (VTE, i.e. deep vein thrombosis or pulmonary embolism). The probability of occurrence of ŻZZZ episode is the highest during the first year of using HRT. Patients with a history of thrombosis in a history of HRT are contraindicated. VTE risk factors include: estrogen use, older age, major surgery, prolonged immobilization, obesity (body mass index> 30 kg / m²), pregnancy, puerperium, systemic lupus erythematosus and cancer. There are no unambiguous findings regarding the potential impact of varicose veins on the occurrence of VTE episode. In all patients after a surgical operation, special attention should be paid to the prevention of VTE. In case of anticipated prolonged immobilisation after surgery, it is recommended to discontinue HRT 4 to 6 weeks earlier. Treatment can be resumed after the patient returns to full physical activity. Patients without a history of VTE who have experienced cases of early-onset thrombosis in relatives in the first line of blood can be offered screening after a precise presentation of their limitations (screening tests detect only a certain percentage of thrombotic disorders). HRT is contraindicated if thrombotic events that caused thrombosis are found among close family members or the disorder has been classified as severe (eg, antithrombin deficiency, protein S, protein C or a combination of these disorders). In women on chronic anticoagulant therapy, the benefit / risk ratio should be carefully considered before including HRT. In the event of VTE occurring after initiation of HRT treatment, the drug should be discontinued. The patient should be informed about the need to immediately contact a doctor after finding out the potential symptoms of VTE (eg painful swelling of the legs, sudden chest pain, shortness of breath). The studies did not confirm the protective effect of combined HRT (using estrogen and progestogen) and estrogen alone on reducing the risk of myocardial infarction in women with or without coexisting ischemic heart disease. In the combination of estrogen and progestogen combined therapy, the relative risk of ischemic heart disease when using HRT with estrogen in combination with progestogen is slightly increased. The initial absolute risk of ischemic heart disease is strongly dependent on age. The number of new cases of ischemic heart disease due to the use of estrogens with progestagens is very low in healthy women approaching menopause, but increases with age. Combination therapy with estrogen with progestogen and estrogen alone is associated with up to a 1.5-fold increase in the risk of ischemic stroke. The relative risk does not change with age or over time from menopause.However, as the initial risk of stroke is strongly dependent on age, the total risk of stroke in women using HRT will increase with age.

The drug can be used during pregnancy. So far, no data have been obtained indicating the harmful effect of using dydrogesterone during pregnancy. There are literature reports linking the use of some progestagens with an increased risk of hypospadias, however, clinical studies with a limited number of women treated with dydrogesterone in early pregnancy did not show any increased risk of hypospadias (so far no other epidemiological data on this topic is known). Progestogens and their metabolites penetrate in a small amount into breast milk, it is not known if there is a risk for the child - dydrogesterone should not be used during breastfeeding.

Common: migraines, headaches, nausea, menstrual disorders (such as: uterine haemorrhage, heavy bleeding, scanty menstruation, amenorrhea, dysmenorrhea, irregular menstruation), breast tenderness / tenderness. Uncommon: depressed mood, dizziness, vomiting, abnormal liver function (with jaundice, weakness or malaise and abdominal pain), allergic skin reactions (eg rash, pruritus, urticaria), weight gain. Rare: increase in the size of progestogen-dependent tumors (eg meningioma), haemolytic anemia, hypersensitivity reactions, drowsiness, angioneurotic edema, swelling of the breast, edema. On the basis of spontaneous reports and limited data from clinical trials, the safety profile in adolescents appears to be similar to that seen in adults. Adverse reactions associated with estrogen treatment with progestogen: breast cancer, hyperplasia of the endometrium, endometrial cancer, ovarian cancer; venous thromboembolism (VTE); myocardial infarction, ischemic heart disease, ischemic stroke.

Orally.Painful menstruation: 10 mg or 20 mg daily from the 5th to the 25th day of the cycle.endometriosis: 10 mg to 30 mg daily from the 5th to the 25th day of the cycle or on a continuous basis.Abnormal uterine bleeding: if treatment is started to stop bleeding, 20 mg or 30 mg of dydrogesterone per day for up to 10 days should be given. When administered continuously, 10 mg or 20 mg of dydrogesterone should be used daily during the second part of the menstrual cycle. The day of starting the treatment and the number of days in which the drug will be administered depend on the individual length of the menstrual cycle of each patient. The withdrawal bleeding occurs if the endometrial growth has previously been sufficiently stimulated by endogenous or exogenous estrogen.Secondary lack of menstruation: 10 mg or 20 mg dydrogesterone per day for 14 days of the second part of the assumed menstrual cycle in order to obtain the optimal secretory transformation of the endometrium, previously sufficiently stimulated by endogenous or exogenous estrogen.Premenstrual syndrome: 10 mg 2 times a day starting from the second half of the menstrual cycle to the first day of the Next cycle. The day of starting the treatment and the number of days in which the drug will be administered depend on the length of the menstrual cycle of the patient.Irregular cycles: 10 mg or 20 mg dydrogesterone daily starting from the second half of the menstrual cycle to the first day of the next cycle. The day of starting the treatment and the number of days in which the drug will be administered depend on the length of the menstrual cycle of the patient.Abortive threat: starting dose up to 40 mg in a single dose, followed by 20 mg or 30 mg per day until the symptoms disappear.Habitual miscarriage: 10 mg dydrogesterone 2 times a day for the 12th week of pregnancy.Infertility associated with failure of corpus luteum: 10 mg or 20 mg dydrogesterone daily starting from the second half of the menstrual cycle to the first day of the next cycle. Treatment should be continued for at least 3 consecutive cycles.Hormone Replacement Therapy. Continuous sequential therapy: estrogen is administered continuously and 1 tablet is added. 10 mg dydrogesterone per day during the last 14 days of each 28-day cycle, in a sequential manner. Cyclical therapy: estrogen is administered cyclically with intervals without taking the drug, usually for 21 days with 7 days off. 1 tabl Dydrogesterone 10 mg per day is added over the last 12-14 days of estrogen therapy.Depending on the clinical response, the dose may be increased to 20 mg dydrogesterone per day.Way of giving. When taking larger doses, tablets should be taken in equal doses distributed throughout the day.