Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Folic Acid
Clonmel Healthcare Ltd
B03BB; B03BB01
Folic Acid
400 microgram(s)
Tablet
Product subject to prescription which may be renewed (B)
Folic acid and derivatives; folic acid
Not marketed
1997-05-30
PACKAGE LEAFLET: INFORMATION FOR THE USER FOLIC ACID 400 MICROGRAM TABLETS FOLIC ACID 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 has told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need 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. WHAT IS IN THIS LEAFLET 1. What Folic Acid 400 microgram Tablets are and what they are used for 2. What you need to know before you take Folic Acid 400 microgram Tablets 3. How to take Folic Acid 400 microgram Tablets 4. Possible side effects 5. How to store Folic Acid 400 microgram Tablets 6. Contents of the pack and other information 1. WHAT FOLIC ACID 400 MICROGRAM TABLETS ARE AND WHAT THEY ARE USED FOR Folic Acid is a member of the vitamin B group. It is essential for good health. Folic acid is required for the manufacture of nucleic acids (such as DNA), the genetic material of cells. It is vital for the development and proper function of the central nervous system. Folic acid 400 microgram tablets are indicated for the prevention of first time neural tube defects in the foetus. The neural tube is part of the nervous system and is located within the spine. Neural tube defects cause stillbirth, neonatal death and severe disabilities such as Spina Bifida. It is for use by women who are planning a pregnancy. Studies have shown that over 70% of first time neural tube defects such as Spina Bifida can be prevented by taking folic acid (0.4mg) daily. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FOLIC ACID 400 MICROGRAM TABLETS DO NOT TAKE FOLIC ACID 400 MICROGRAM TABLETS - If you are allergic to folic acid or any of the other ingredients of this medicine (listed in section 6). Les hele dokumentet
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Folic Acid 400 microgram Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 400 micrograms folic acid. Excipient: Lactose monohydrate 50 mg per tablet. _For full list of excipients, see section 6.1_ 3 PHARMACEUTICAL FORM Tablet. Pale-yellow, circular, biconvex tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Folic Acid 400 microgram Tablets are indicated for the prevention of first occurrence neural tube defects (including Spina Bifida) in the foetus. For use by women who are planning a pregnancy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adult females One tablet (400 micrograms) daily. Supplementation should begin at least 14 weeks before the woman conceives and be continued for at least the first 12 weeks of pregnancy. Administration Route of administration: Oral. The tablets should be swallowed with water. 4.3 CONTRAINDICATIONS ○ Hypersensitivity to folic acid or any of the excipients. ○ Vitamin B 12 deficiency 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Caution is advised for patients under therapy for folate-dependent tumours when taking folic acid. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency of glucose-galactose I R I S H M E D I C I N E S B O A R D ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _1_ _9_ _/_ _0_ _5_ _/_ _2_ _0_ _1_ _0_ _C_ _R_ _N_ _ _ _2_ _0_ _8_ _3_ _0_ _0_ _6_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ malabsorption should not take this medicine. 4.5 Les hele dokumentet