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Indications - Hormone replacement therapy (HRT) for the treatment of: Climacteric syndrome in postmenopausal women including vasomotor symptoms (such.as hot flushes and sweating attacks), sleep disorders, depressed moods, nervousness and atrophic, urogenital conditions caused by deficient endogenous estrogen production due to natural menopause, hypogonadism, castration or primary ovarian failure in women with an intact uterus. Prevention of postmenopausal osteoporosis.

Dosage & Administration - Dosage How to start: Women who do not take estrogens or women who change from a continuous combination product may start treatment at any time. Women changing from a continuous sequential or cyclic HRT should complete the current cycle of therapy before initiating this therapy. Dosage: One tablet is taken daily. Missed tablets: In case a tablet is forgotten, it should be taken as soon as possible. If more than 24 hours have elapsed, no extra tablet needs to be taken. If several tablets are forgotten, bleeding may occur Administration 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 tablets should preferably be taken at the same time every day. For the treatment of postmenopausal symptoms, the lowest effective dose should be used. For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration should be used.

Side Effects - 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. Bleeding irregularities usually subside during continued treatment. The frequency of bleeding decreases with the duration of treatment. Serious adverse reactions are arterial and venous thromboembolic events as well as breast cancer

Contraindications - Hormone replacement therapy (HRT) should not be started in the presence of any of the conditions listed below. The product should be stopped immediately, if any of the conditions appear during HRT use. Undiagnosed abnormal genital bleeding Known or suspected cancer of the breast Known or suspected premalignant conditions or malignancies, if sex steroid-influenced The excess risk disappears within a few years after stopping HRT. HRT increases the density of mammographic images which may adversely affect the radiological detection of breast cancer in some cases. Endometrial cancer: Prolonged exposure to unopposed estrogens increases the risk of development of endometrial hyperplasia or carcinoma. The addition of DRSP opposes the development of endometrial hyperplasia caused by estrogens. Liver tumors: In rare cases benign, and even more rarely, malignant liver tumors have been observed after the use of hormonal substances such as those contained in HRT products. In isolated cases, these tumors led to life-threatening intra-abdominal hemorrhage.

Others - Pregnancy & Lactation 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.