Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
IRON POLYMALTOSE, FOLIC ACID
Vifor France
B03AD02
IRON POLYMALTOSE, FOLIC ACID
100 Milligram
Tablets Chewable
Product not subject to medical prescription
Iron bivalent, oral preparations
Authorised
2002-04-22
PIL-YT260/IE/E05 Ferrum Fol 100 mg / 350 micrograms chewable tablets Ireland Page 1/5 Vifor (International) Inc. PIL-YT260/IE/E05 PACKAGE LEAFLET : INFORMATION FOR THE USER FERRUM FOL 100 MG / 350 MICROGRAMS CHEWABLE TABLETS FERRUM FOL 100 MG / 350 MICROGRAMS CHEWABLE TABLETS iron as iron(III)-hydroxide polymaltose complex / folic acid 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 Ferrum Fol chewable tablets is and what it is used for 2. What you need to know before you take Ferrum Fol chewable tablets 3. How to take Ferrum Fol chewable tablets 4. Possible side effects 5. How to store Ferrum Fol chewable tablets 6. Contents of the pack and other information PIL-YT260/IE/E05 Ferrum Fol 100 mg / 350 micrograms chewable tablets Ireland Page 2/5 Vifor (International) Inc. PIL-YT260/IE/E05 1. WHAT FERRUM FOL CHEWABLE TABLETS IS AND WHAT IT IS USED FOR It is used in women before and during pregnancy, and during breast-feeding to • treat iron deficiency • prevent iron and folic acid deficiency 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FERRUM FOL CHEWABLE TABLETS DO NOT TAKE FERRUM FOL CHEWABLE TABLETS if you are/have • ALLERGIC to iron(III)-hydroxide po Perskaitykite visą dokumentą
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ferrum Fol 100mg / 350 micrograms Chewable Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 100 mg of Iron in the form of iron polymaltose and 350 micrograms of Folic Acid. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Brown-white speckled chewable, round and flat tablets with score-line on one side. This 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 For prophylaxis of iron and folic acid deficiency during pregnancy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults only: 1 tablet a day throughout pregnancy. Tablets may be chewed. Route of administration: Oral. 4.3 CONTRAINDICATIONS 1. Use in patients with a known hypersensitivity to any of the active ingredients. 2. Use in patients with anaemia of undiagnosed aetiology. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE This product should be used with caution in patients with haemochromatosis and haemolytic anaemias. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION 1. The absorption of iron salts is decreased in the presence of antacids. 2. Iron chelates with tetracyclines, absorption of both agents may be impaired. 4.6 FERTILITY, PREGNANCY AND LACTATION No information submitted. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 15/07/2013_ _CRN 2134217_ _page number: 1_ 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES No information submitted. 4.8 UNDESIRABLE EFFECTS Side effects include nausea, diarrhoea, constipation may occur rarely. 4.9 OVERDOSE Symptoms of overdosage with iron salts include nausea and vomiti Perskaitykite visą dokumentą