Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
Folic acid
Clonmel Healthcare Ltd
B03BB; B03BB01
Folic acid
0.4 milligram(s)
Tablet
Product not subject to medical prescription
Folic acid and derivatives; folic acid
Marketed
1995-02-15
Package leaflet: Information for the user Clonfolic 0.4mg 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 Clonfolic 0.4 mg Tablets are and what they are used for 2. What you need to know before taking Clonfolic 0.4 mg Tablets 3. How to take Clonfolic 0.4 mg Tablets 4. Possible side effects 5. How to store Clonfolic 0.4 mg Tablets 6. Contents of the pack and other information 1. WHAT CLONFOLIC 0.4 mg TABLETS ARE AND WHAT THEY ARE USED FOR The name of your medicine is Clonfolic 0.4 mg Tablets. It contains folic acid which belongs to a group of vitamins called ‘B vitamins’. It is essential for good health. Folic acid is required for the manufacture of nucleic acids-the genetic material of cells. It is vital for the development and proper function of the central nervous system. Clonfolic is indicated for the prevention of first time neural tube defects* (including Spina Bifida) 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. Clonfolic is indicated for use by all females who are capable of conceiving, whether planning to do so or not. For advice on dosing when planning a pregnancy and in the first trimester of pregnancy see section 3. * 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 Baca dokumen lengkapnya
Health Products Regulatory Authority 18 October 2019 CRN008SK4 Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Clonfolic 0.4 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 0.40 mg (400 micrograms) folic acid. Excipient(s) with known effect Contains 50 mg lactose monohydrate per tablet. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Pale yellow, circular, biconvex tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Clonfolic is indicated for the prevention of first time neural tube defects (including Spina Bifida) 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. Clonfolic is indicated for use by all females who are capable of conceiving, whether planning to do so or not. For advice on dosing when planning a pregnancy and in the first trimester of pregnancy see Section 4.2. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adult females All females who are capable of conceiving should take ONE TABLET (0.4 MG) DAILY. If you are planning a pregnancy you should begin taking Clonfolic at least 14 weeks before you become pregnant and continue taking it for at least the first 12 weeks of pregnancy. Method of administration Oral. The tablets should be swallowed with water. 4.3 CONTRAINDICATIONS 1. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 2. 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. 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 by a neural tube defect and higher doses should be considered. Health Products Regulatory Authority 18 October 2019 CRN008SK4 Page 2 of 4 For women takin Baca dokumen lengkapnya