Rozy 0.5 mg+0.25 mg Tablet

Rozy 0.5 mg+0.25 mg Tablet

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.

Pharmacology

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.

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.

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.

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.

Overdose Effects

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.

Therapeutic Class

Drugs for menopausal symptoms: Hormone replacement therapy

Storage Conditions

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.