Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
ESTROGENS CONJUGATED
Pfizer Healthcare Ireland
ESTROGENS CONJUGATED
0.625 Milligram
Coated Tablets
Product subject to prescription which may not be renewed (A)
Transfer Pending
0000-00-00
CT 4_0 1 of 11 2013-0002737 PACKAGE LEAFLET: INFORMATION FOR THE USER CATHATE 0.625 MG COATED TABLETS (CONJUGATED ESTROGENS) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET: 1. WHAT CATHATE IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CATHATE 3. HOW TO TAKE CATHATE 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE CATHATE 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT CATHATE IS AND WHAT IT IS USED FOR Cathate is a Hormone Replacement Therapy (HRT). It contains the female hormone estrogen. Cathate is used to treat some of the symptoms and conditions associated with the menopause. Cathate is usually prescribed for women who have had their womb removed (hysterectomy). However women who have not had this operation can still take Cathate and their doctor may prescribe a second type of tablet containing another hormone called a progestogen to be taken 12-14 days per month as well as the Cathate tablets. Cathate is used for: RELIEF OF SYMPTOMS OCCURING 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"). Cathate alleviates these symptoms after Przeczytaj cały dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cathate 0.625mg Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Cathate tablet contains 0.625 mg Conjugated Estrogens. Excipients: Contains Lactose Monohydrate 91.8mg and sucrose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Coated Tablet. A white, oval, coated tablet printed “0.625” in black. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cathate is indicated for hormone replacement therapy (HRT) for estrogen deficiency symptoms in menopausal and 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. _(See also section 4.4)_ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Cathate Tablets are an estrogen only HRT for oral use. POSOLOGY: ADULTS Cathate 0.625-1.25mg 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) should be used. Patients should be re-evaluated periodically to determine if treatment for symptoms is still necessary. VASOMOTOR SYMPTOMS: 0.625-1.25mg daily depending on the response of the individual. ATROPHIC VAGINITIS, KRAUROSIS VULVAE, ATROPHIC URETHRITIS: 0.625-1.25mg daily depending on the response of the individual. PROPHYLAXIS OF OSTEOPOROSIS: IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 01/11/2013_ _CRN 2134033_ _page number: 1_ The minimum effective dose is 0.625mg for most patients. CONCOMITANT PROGESTOGEN USE FOR WOMEN WITH Przeczytaj cały dokument