Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
DYDROGESTERONE
Abbott Healthcare Products Ltd
10 Milligram
Film Coated Tablet
1985-01-28
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Duphaston 10 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg Dydrogesterone. Excipients: each tablet contains 111.1 mg of lactose monohydrate. For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Film coated tablet A round, biconvex, scored, white film-coated tablet, one side with inscription ‘155’ on either side of the score. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the management of conditions associated with progesterone insufficiency: dysmenorrhoea, endometriosis, infertility, irregular menstrual cycles. The drug may be used with an estrogen in the management of dysfunctional bleeding or secondary amenorrhoea, or in association with estrogen in hormone replacement therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Hormone replacement therapy: The standard dose is 10 mg Duphaston daily for the last 14 days of each 28-day estrogen treatment cycle. The dose may be increased to 10 mg twice daily if either early withdrawal bleeding occurs, or if endometrial biopsy reveals inadequate progestational response. In women who are not taking hormone replacement therapy, have established amenorrhoea or women who switch from a continuous combined hormone replacement therapy, treatment may be started on any convenient day. In women transferring from a cyclic or continuous sequential HRT regimen, treatment should begin the day following completion of the prior regimen. If the patient is menstruating, treatment is started within five days of the start of bleeding. For initiation and continuation of treatment of postmenopausal symptoms, the lowest e Read the complete document