2 mg estradiol for the first 14 days of a 28-day cycle; for the second 14 days, 2 mg estradiol and 10 mg dydrogesterone.

 

Hormone replacement therapy (HRT) for women with disorders due to naturally or surgically induced menopause (relief of climacteric symptoms, prevention of postmenopausal osteoporosis).

 

Known or suspected carcinoma of the breast, endometrial carcinoma or other hormone-dependent neoplasia. Acute or chronic liver disease. History of liver disease where the liver function tests have failed to return to normal. Acute venous thromboembolic disorders. Abnormal genital bleeding of unknown etiology.
Known or suspected pregnancy.
Hypersensitivity to one of the components of the product.

 

Physical examination and a complete medical and family history should be taken prior to the initiation of any (HRT) with special reference to blood pressure, palpation of the breasts and the abdomen, and a gynaecological examination.
Mammography is advisable.
Patients in the peri-menopausal phase should be advised to take non-hormonal contraceptive precautions. Special care should be taken in patients with a past history of deep venous thrombosis, thrombo-embolic disorders, cerebral vascular accident, uterine leiomyomata or endometriosis. Patients with or developing epilepsy, migraine, cardiac failure, hypertension, porphyria, hemoglobinopathies or otosclerosis should be carefully observed during treatment.

 

During the first few months of treatment with the combination breast tenderness may occur. Nausea, headache and edema occur rarely. Symptoms are normally transient. Breakthrough bleeding may occur. Furthermore, skin reactions have been reported.

 

One tablet, containing 2 mg estradiol, daily during 14 consecutive days per cycle of 28 days, and one tablet, containing 2 mg estradiol and 10 mg dydrogesterone, daily during the remaining 14 days has to be taken. Immediately after a 28-day cycle, the next treatment cycle is to be started. If the patient is still menstruating, it is recommended to begin treatment on the first day after onset of menstruation. In patients who had their last period more than approximately 12 months ago, treatment can be started at any time.

 

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