Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Folic acid
Alissa Healthcare Research Limited
B03BB; B03BB01
Folic acid
400 microgram(s)
Tablet
Product not subject to medical prescription
Folic acid and derivatives; folic acid
Not marketed
2018-06-14
IE/H/0468/001/DC 1 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 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 Tablets are and what they are used for 2. What you need to know before you take Folic Acid Tablets 3. How to take Folic Acid Tablets 4. Possible side effects 4. How to store Folic Acid Tablets 6. Contents of the pack and other information 1. WHAT FOLIC ACID TABLETS ARE AND WHAT THEY ARE USED FOR Folic acid is a member of the Vitamin B group it is the active ingredient of Folic Acid Tablets. It is essential for good health and is present in fresh and processed foods. You should use this medicines if you are trying to become pregnant or think you are pregnant and also for the first three months of your pregnancy. Folic Acid is necessary for the development and growth of healthy cells and tissues. It is vital for the development and proper function of the central nervous system. Folic acid is used to help prevent babies being born with neural tube defects such as Spina Bifida. The neural tube is part of the nervous system and is located in the spine. The baby’s neural tube develops during the early stages of pregnancy and it is at this particular critical stage that neural tube defects such as Spina Bifida can occur. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FOLIC ACID TABLETS DO NOT TAKE FOLIC ACID TABLETS: - if you are allergic to folic acid or any of the other ingredients of this medicine (listed in section 6) Soma hati kamili
Health Products Regulatory Authority 21 July 2020 CRN009SPX Page 1 of 4 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 (as folic acid hydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Off white to yellowish, round, bevelled-edged, convex tablet, 7 mm in diameter. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Folic Acid is indicated for the prevention of first occurrence neural tube defects in the foetus. For use by women who are planning a pregnancy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adult females One tablet (0.4mg) daily. Supplementation should begin by taking one tablet (0.4 mg) daily prior to conception and be continued for at least the first 12 weeks of pregnancy. Method of administration Oral. The tablets should be swallowed with water. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Folic acid should not be given alone in the treatment of Addisonian pernicious anaemia and other vitamin B12 deficiency states, as this may precipitate the onset of subacute combined degeneration of the spinal cord. Patients with malignant disease, unless megaloblastic anaemia due to folic acid deficiency. Should not be taken by people with folate dependant tumours. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Folic acid should not be administered for treatment of pernicious anaemia or undiagnosed megaloblastic anaemia without sufficient amounts of cyanocobalamin (vitamin B12) as folic acid alone will not prevent and may precipitate development of subacute combined degeneration of the spinal cord. Therefore a full clinical diagnosis should be made before initiating treatment. Women with pre-existing diabetes, obesity, family history of neural tube defects, or previous pregnancy affected by neural tube defect have an increased risk of having a pregnancy affected b Soma hati kamili