País: Malàisia
Idioma: anglès
Font: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DYDROGESTERONE
ABBOTT LABORATORIES (M) SDN. BHD.
DYDROGESTERONE
20Tablet Tablets
Abbott Biologicals B.V.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ DUPHASTON® TABLET Dydrogesterone (10mg) 1 WHAT IS IN THIS LEAFLET 1. What Duphaston® is used for 2. How Duphaston® works 3. Before you use Duphaston® 4. How to use Duphaston® 5. While you are using it 6. Side effects 7. Storage and disposal of Duphaston® 8. Product description 9. Manufacturer and product registration holder 10. Date of revision WHAT DUPHASTON® IS USED FOR Duphaston® is used for problems you may get when your body does not produce enough progesterone: • painful periods • endometriosis, where tissue from the lining of the womb grows outside the womb. • unusual menstrual bleeding • periods that have stopped before the menopause • pre-menstrual syndrome (PMS) • irregular periods • to reduce the risk of miscarriage (threatened and recurrent) • infertility due to low levels of progesterone. • as part of Assisted Reproductive Technology (ART) treatment Duphaston® is also used to treat the symptoms of menopause in women with intact womb. HOW DUPHASTON® WORKS The body normally balances the amount of the natural hormone progesterone with estrogen (the other major female hormone). If your body does not produce enough progesterone, Duphaston® makes up for this and restores the balance. BEFORE YOU USE DUPHASTON® _- When you must not use it_ Do not take Duphaston® if: • if you are allergic (hypersensitive) to dydrogesterone or to any of the other ingredients of Duphaston®. • You have, or might have a tumour that is made worse by progesterone - such as a brain tumour called a ‘meningioma’ • You have vaginal bleeding and the cause is not known. If you are not sure, talk to your doctor or pharmacist before taking it. Duphaston® is not recommended for use in children below age 18 due to insufficient safety information _ _ _- Before you start to use it _ Talk to your doctor or pharmacist before taking Duphaston® if you suffer from any medical conditions or illnesses, in particular if you have: • depression • liver Llegiu el document complet
1. NAME OF THE MEDICINAL PRODUCT Duphaston 10 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg dydrogesterone. Excipient(s) with known effect: Each tablet contains 111.1 mg Lactose monohydrate. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM A round, biconvex, scored, white film-coated tablet, one side with inscription ‘155’ on either side of the score (size 7 mm). The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS PROGESTERONE DEFICIENCIES • Treatment of dysmenorrhoea • Treatment of endometriosis • Treatment of secondary amenorrhoea • Treatment of irregular cycles • Treatment of dysfunctional uterine bleeding • Treatment of pre-menstrual syndrome • Treatment of threatened abortion, associated with proven progesterone deficiency • Treatment of habitual abortion, associated with proven progesterone deficiency • Treatment of infertility due to luteal insufficiency • Luteal support as part of an Assisted Reproductive Technology (ART) treatment HORMONE REPLACEMENT THERAPY To counteract the effects of unopposed estrogen on the endometrium in hormone replacement therapy for women with disorders due to the natural or surgical induced menopause with an intact uterus. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Always take Duphaston exactly as your doctor has prescribed. If you have any questions, contact your doctor or pharmacist. If you forget to take your tablet(s), do not take a double dose to compensate for it. If you require further information, please ask your doctor or pharmacist for advice. For hormone replacement therapy: ■ In combination with continuous oestrogen therapy, take one tablet daily for 14 consecutive days of a 28 day cycle. ■ In combination with cyclical oestrogen therapy, take one tablet daily during the last 12 to 14 days of oestrogen therapy. ■ For doctors: If endometrial biopsies or ul Llegiu el document complet