Country: Իռլանդիա
language: անգլերեն
source: HPRA (Health Products Regulatory Authority)
FOLIC ACID
GR Lane Health Products Ltd
B03BB01
FOLIC ACID
400 Microgram
Tablets
Product not subject to medical prescription
folic acid
Not marketed
1997-07-25
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Preconceive 400 microgram Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 400 micrograms Folic Acid. For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Tablet Cream/yellow, circular, biconvex, uncoated tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the prevention of first occurrence of neural tube defect in all women who are planning a pregnancy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION All women planning a pregnancy should take 0.4 mg (400 mcg) folic acid daily before conception and until the end of the third month of pregnancy. Women who have not been taking folic acid supplements and who suspect that they are pregnant should begin to take Preconceive Tablets at once and continue until week 12 of pregnancy. 4.3 CONTRAINDICATIONS 1. Should not be taken by people having folate dependent tumours. 2. Vitamin B 12 deficiency. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Preconceive Tablets are not intended be given alone in the treatment of Addisonian pernicious anaemia or other B12 deficiency states, as the onset of sub-acute degeneration of the spinal cord might thereby be precipitated. Keep out of the sight and reach of children. Store in a cool dry place. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Folic acid reduces plasma phenytoin, phenobarbital and primidone concentrations. Consequently patients on anti epileptic therapy should have their dose adjusted at regular intervals and be supervised by the physician. 4.6 FERTILITY, PREGNANCY AND LACTATION While it is possible to produce toxicity with huge doses of folate in rats, by precipitation of folate in the renal tubes this effect is not relevant in the proposed dosages. It has been demonstrated in many studies that 4 mg of folic acid taken before and during the first trimester of pregnancy will prevent recurrence of neural tube defects. Folic acid is excreted in breast milk, however, problems in humans read_full_document