מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
Ferrous fumarate Ph.Eur.
Clonmel Healthcare Ltd
B03AA; B03AA02
Ferrous fumarate Ph.Eur.
140 mg/5ml
Oral suspension
Iron bivalent, oral preparations; ferrous fumarate
Marketed
1988-07-25
Page 1 of 4 PACKAGE LEAFLET: INFORMATION FOR THE USER GALFER 140 MG/5 ML ORAL SUSPENSION ferrous fumarate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. This medicine is available without prescription. However, you still need to take Galfer Oral Suspension carefully to get the best results from it. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need any more information or advice. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. • You must talk to a doctor if you do not feel better or if you feel worse after 28 days. WHAT IS IN THIS LEAFLET: 1. What Galfer Oral Suspension is and what it is used for 2. What you need to know before you take Galfer Oral Suspension 3. How to take Galfer Oral Suspension 4. Possible side effects 5. How to store Galfer Oral Suspension 6. Contents of the pack and other information 1. WHAT GALFER ORAL SUSPENSION IS AND WHAT IT IS USED FOR Galfer Oral Suspension contains ferrous fumarate which is used to replace low levels of iron in the blood. It is used to treat and prevent anaemia caused by iron deficiency. This product should only be used for the treatment of iron deficiency anaemia diagnosed by laboratory testing under the supervision of a doctor. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GALFER ORAL SUSPENSION DO NOT TAKE THE MEDICINE IF YOU OR YOUR CHILD HAVE…. • An ALLERGY to any of the ingredients listed in section 6. • Other PROBLEMS WITH IRON IN THE BLOOD (including conditions that lead to iron building up in soft tissues, or problems with red blood cells). • A STOMACH ULCER or other STOMACH OR BOWEL PROBLEM. • Had REPEATED BLOOD TRANSFUSIONS in the past. • ANAEMIA NOT RELATED TO LOW LEVELS OF IRON. • Are currently HAVING IRON INJECTIONS . • קרא את המסמך השלם
Health Products Regulatory Authority 01 July 2021 CRN00CDWF Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Galfer 140 mg/5ml Oral Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient: Each 5 ml contains 140 mg Ferrous Fumarate equivalent to 45 mg elemental iron. Excipient(s) with known effect Dose per 5 ml contains: Methyl parahydroxybenzoate 4.69 mg Ethyl parahydroxybenzoate 0.94 mg Propyl parahydroxybenzoate 0.63 mg Maltitol liquid 5 g Benzyl alcohol 0.65 micrograms Ethanol 0.117 micrograms Sodium benzoate 2.6 micrograms Lactose 0.023 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral suspension (oral liquid) This medicine is a brown liquid suspension with a chocolate/mint odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicine is indicated for the prevention and treatment of iron deficiency states. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology a) Prevention of iron deficiency: ADULTS, THE ELDERLY AND CHILDREN OVER 12 YEARS: Two 5 ml spoonfuls (10 ml) taken once daily. INFANTS AND YOUNG CHILDREN (UNDER 12 YEARS): 1-2 mg elemental Iron per kg body weight per day. Maximum dose not to exceed 15 mg Iron per day. Dosage of Galfer Oral Suspension to be determined by the physician. B) TREATMENT OF IRON DEFICIENCY: ADULTS, THE ELDERLY AND CHILDREN OVER 12 YEARS: Two 5 ml spoonfuls (10 ml) taken twice daily. INFANTS LESS THAN ONE MONTH OLD: 2-4 mg elemental iron per kg body weight per day. To be taken in divided doses. Maximum dose not to exceed 15 mg Iron per day. Dosage of Galfer Oral Suspension to be determined by the physician. Health Products Regulatory Authority 01 July 2021 CRN00CDWF Page 2 of 5 INFANTS OVER ONE MONTH OLD AND CHILDREN UNDER 12 YEARS: 3-6 mg elemental Iron per kg body weight per day. To be taken in divided doses. Dosage of Galfer Oral Suspension to be determined by the physician. Administration to infants and children should take place under medical supervision. Medical advice should be sought if s קרא את המסמך השלם