Hormone replacement therapy (HRT) for the treatment of:
173-estradiol, which is chemically and biologically identical to endogenous human E2, and the synthetic progestogen, DRSP. 173-estradiol provides hormone replacement during and after the climacteric. The addition of DRSP helps to provide bleeding control and opposes the development of endometrial hyperplasia caused by estrogens.
Each pack covers 28 days of treatment. Treatments continuous, which means that the next pack follows immediately without a break. The tablets are to be swallowed whole with some liquid irrespective of food intake.
The most commonly reported adverse drug reactions (ADRs) with Ethinylestradiol & Drospirenone are breast pain, female genital tract bleeding and gastrointestinal and abdominal pains. They occur in >6% of users.
Ethinylestradiol & Drospirenone must not be used during pregnancy and lactation. If pregnancy occurs during medication with Ethinylestradiol & Drospirenone, treatment must be discontinued immediately. Small amounts of DRSP are excreted with the milk.
Acute toxicity studies indicate that, even in the case of inadvertent intake of a multiple of the therapeutic dose, no acute toxicity risk is to be expected. In clinical studies up to 100 mg of DRSP and estrogen/ progestogen preparations containing 4 mg E2 were well tolerated.
Drugs for menopausal symptoms: Hormone replacement therapy
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.