PRECONCEIVE

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

FOLIC ACID

Available from:

GR Lane Health Products Ltd

ATC code:

B03BB01

INN (International Name):

FOLIC ACID

Dosage:

400 Microgram

Pharmaceutical form:

Tablets

Prescription type:

Product not subject to medical prescription

Therapeutic area:

folic acid

Authorization status:

Not marketed

Authorization date:

1997-07-25

Summary of Product characteristics

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