País: Reino Unido
Idioma: inglés
Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)
Folic acid
DE Pharmaceuticals
B03BB01
Folic acid
5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 09010200
CHANGE CONTROL : Version changes due to change in: Size/Layout Regulatory Non-Regulatory Changes in detail: • Regulatory text amends pg1/2 PACKAGE LEAFLET: INFORMATION FOR THE USER FOLIC ACID 5MG TABLETS 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. See section 4. 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 5. 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 The name of your medicine is Folic Acid Tablets, which contains folic acid, a vitamin essential in the production and maintenance of new cells. Folic Acid Tablets are used in the treatment and prevention of: • anaemia due to a lack of folic acid in adults and children • anaemia in pregnancy • anaemia, as a side effect from treatment with certain medicines • anaemia due to damaged red blood cells • anaemia in patients on kidney dialysis. Folic acid Tablets can also be given to some women before and during pregnancy to prevent spina bifida (an abnormality of the spine) in babies, which can be caused by deficiency of this vitamin. 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 to any of the other ingredients of this medicine (listed in section 6). • if you have cancer (unless you have anaemia due to a deficiency of folic acid) WARNINGS Leer el documento completo
OBJECT 1 FOLIC ACID 5MG TABLETS Summary of Product Characteristics Updated 09-Jul-2018 | Wockhardt UK Ltd • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Fertility, pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 1. Name of the medicinal product Folic Acid 5mg Tablets 2. Qualitative and quantitative composition Folic Acid 5mg Excipients with known effect Lactose For the full list of excipients see section 6.1. 3. Pharmaceutical form Tablet Plain yellow, biconvex tablet with break-line on one face and CP on the reverse. 4. Clinical particulars 4.1 Therapeutic indications Folic acid is indicated for the treatment of megaloblastic anaemia due to folic acid deficiency. It is also used for prophylaxis in chronic haemolytic states, in renal dialysis, and in drug induced folate deficiency. Folic acid is used for the prevention of recurrence of neural tube defects. 4.2 Posology and method of administration Posology _Adults_ IN FOLATE DEFICIENT MEGALOBLASTIC ANAEMIA: 5mg daily for 4 months Up to 15mg daily may be necessary for malabsorption states FOR PROPHYLAXIS IN CHR Leer el documento completo