Duphaston 10 mg 60 tablets

Duphaston

Composition:
Each tablet contains:
Dydrogesterone 10 mg
Excipients:
lactose monohydrate, hypromellose, corn starch, colloidal silicon dioxide, magnesium stearate.
Properties:
An analogue of natural progesterone. Dydrogesterone is very similar to natural progesterone in its molecular structure, chemical, and pharmacological properties. Since dydrogesterone is not a testosterone derivative, it does not have the side effects typical of most synthetic progestogens, the so-called "androgenic" progestogens. Dydrogesterone does not have estrogenic, androgenic, anabolic, glucocorticoid, or thermogenic activity. As the progestogen component of HRT during menopause, dydrogesterone helps maintain the beneficial effects of estrogens on blood lipid profiles. However, unlike estrogens, which typically negatively affect the blood coagulation system, dydrogesterone does not affect coagulation parameters. It does not adversely affect carbohydrate metabolism or liver function. When administered orally, dydrogesterone selectively affects the endometrium, thereby preventing the increased risk of endometrial hyperplasia and/or carcinogenesis in conditions of estrogen excess. It is indicated in all cases of endogenous progesterone deficiency.
Dydrogesterone has no contraceptive effect. Treatment with dydrogesterone achieves its therapeutic effect without suppressing ovulation or disrupting menstrual function. Dydrogesterone facilitates conception and maintenance of pregnancy during treatment.
Indications:
Progesterone deficiency: endometriosis; Infertility due to luteal insufficiency; threatened or habitual miscarriage (due to progesterone deficiency); premenstrual tension syndrome; dysmenorrhea, irregular menstrual cycle; secondary amenorrhea (in combination therapy with estrogens); dysfunctional uterine bleeding.
HRT: to neutralize the proliferative effect of estrogens on the endometrium in women with disorders due to natural or surgical menopause with an intact uterus.
Dosage and administration:
Oral. The dose and treatment regimen are determined individually, depending on the indication. The duration of therapy and dose can be adjusted based on the individual clinical response of the patient and the severity of the pathology.
Contraindications:
Hypersensitivity to dydrogesterone; diagnosed or suspected progestogen-dependent neoplasms (e.g., meningioma); vaginal bleeding of unknown etiology; Liver dysfunction due to acute or chronic liver disease, currently or in history (until liver function tests return to normal); malignant liver tumors, currently or in history; breastfeeding period; porphyria, currently or in history; age under 18 years.
When combined with estrogens (HRT): untreated endometrial hyperplasia; arterial and venous thrombosis, thromboembolism, currently or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, thrombophlebitis, cerebrovascular disorders of hemorrhagic and ischemic type); A known predisposition to venous or arterial thrombosis (activated protein C resistance, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).
Caution: depression, current or history; conditions that previously appeared or worsened during a previous pregnancy or previous use of sex hormones, such as cholestatic jaundice, herpes during pregnancy, severe pruritus, otosclerosis.
Precautions:
Before initiating treatment with dihydrosterone for abnormal uterine bleeding, it is necessary to determine the cause of the bleeding. With prolonged use of dihydrosterone, periodic gynecological examinations are recommended, the frequency of which is determined individually, but not less than once every 6 months. During the first months of treatment for abnormal uterine bleeding, "breakthrough" bleeding may occur. Bleeding or spotting. If breakthrough bleeding or spotting occurs after a period of taking dihydrosterone or continues after a course of treatment, consult your doctor for appropriate additional testing, including an endometrial biopsy if necessary to rule out endometrial neoplasms.
Side effects:
Hematopoietic system disorders: Rare - hemolytic anemia.
Nervous system disorders: Common - migraine/headache; Uncommon - dizziness; Rare - drowsiness.
Psychiatric disorders: Uncommon - depressive mood.
Gastrointestinal disorders: Common - nausea; Uncommon - vomiting.
Hepatobiliary disorders: Uncommon - liver dysfunction (with jaundice, asthenia or malaise, abdominal pain).
Allergic reactions: Uncommon - allergic dermatitis (e.g., rash, itching, urticaria); Rare - Quincke's edema, hypersensitivity reactions.
Reproductive system disorders: Common - menstrual cycle disorders (including metrorrhagia, menorrhagia, oligo-/amenorrhea, dysmenorrhea, and irregular menstrual cycle); Breast tenderness/soreness; rarely, breast swelling. 
Other: Uncommon: weight gain; rare: edema, enlargement of progestogen-dependent tumors (e.g., meningioma).
Storage:
At a temperature not exceeding 30°C. Store in a dry place.
Packaging:
A cardboard box contains 3 blisters of 20 tablets each, along with paper instructions.