מדינה: מלטה
שפה: אנגלית
מקור: Medicines Authority
ESTROGENS CONJUGATED
Pfizer Hellas S.A. 243 Messoghion Ave., Neo Psychiko 15451, Athens, Greece
G03CA57
ESTROGENS CONJUGATED 1.25 mg
COATED TABLET
ESTROGENS CONJUGATED 1.25 mg
POM
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
Withdrawn
2006-11-09
Page 1 of 12 PACKAGE LEAFLET: INFORMATION FOR THE USER PREMARIN ® 0.3 MG, 0.625 MG & 1.25 MG COATED TABLETS (CONJUGATED ESTROGENS) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. IN THIS LEAFLET: 1. What Premarin is and what it is used for 2. Before you take Premarin 3. How to take Premarin 4. Possible side effects 5. How to store Premarin 6. Further information 1. WHAT PREMARIN IS AND WHAT IT IS USED FOR? Premarin is a Hormone Replacement Therapy (HRT). It contains the female hormone estrogen. Premarin is used to treat some of the symptoms and conditions associated with the menopause. Premarin is used for: RELIEF OF SYMPTOMS OCCURRING AFTER MENOPAUSE During the menopause, the amount of the estrogen produced by a woman’s body drops. This can cause symptoms such as hot face, neck and chest ("hot flushes"). Premarin alleviates these symptoms after menopause. You will only be prescribed Premarin if your symptoms seriously hinder your daily life. PREVENTION OF OSTEOPOROSIS After the menopause some women may be at risk of developing fragile bones (osteoporosis). You should discuss all available treatment options with your doctor. If you are at an increased risk of fractures due to osteoporosis and other medicines are not suitable for you, you can use Premarin 0.625 mg or 1.25 mg Coated Tablets to prevent osteoporosis after menopause. Premarin is usually prescribed for women who have had their womb removed (hysterectomy). However, women who have not had this operation can still take Premarin and their doctor may prescribe a second type of tablet containing קרא את המסמך השלם
MT Submission/Approval: 29Oct2012 UK Ref No: PA 7_0 Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Premarin ® 1.25mg Coated Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1.25 mg Conjugated Estrogens. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Coated tablets Yellow oval biconvex sugar coated tablets marked with “1.25” in black ink. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Hormone replacement therapy for estrogen deficiency symptoms in postmenopausal women. - Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS: Premarin is an estrogen only HRT. TREATMENT OF POSTMENOPAUSAL SYMPTOMS Premarin 0.3-1.25mg daily is the usual starting dose for women without a uterus. Continuous administration is recommended. _ _ For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration (see also Section 4.4 Special warnings and precautions for use) should be used. Treatment to control menopausal symptoms should be initiated with Premarin 0.3mg. If symptoms are not adequately controlled, higher doses of Premarin may be prescribed. Once treatment is established the lowest effective dose necessary for the relief of symptoms should be used. Patients should be re-evaluated periodically to determine if treatment for symptoms is still necessary. TREATMENT OF OSTEOPOROSIS The minimum effective dose is 0.625mg daily for most patients. (See section 5.1 Pharmacodynamic properties)._ _ MT Submission/Approval: 29Oct2012 UK Ref No: PA 7_0 Page 2 קרא את המסמך השלם