PRECONCEIVE 400 MICROGRAMS TABLETS - summary of medicine characteristics

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Ingredient micrograms/tablet

Folic Acid 400

For a full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Tablet

Cream/yellow circular biconvex tablet

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

For oral use

Women who are planning a pregnancy or who are in the first three months of pregnancy: Swallow 1 tablet with water and food once a day, at about the same time each day. Continue until the end of the third month of pregnancy (first trimester).

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients

Should not be taken by people with folate dependant tumours

4.4 Special warnings and precautions for use

Folic acid should not be given alone in the treatment of Addisonian pernicious anæmia and other B12 deficiency states, as it may precipitate the onset of sub-acute combined degeneration of the spinal cord.

4.5 Interaction with other medicinal products and other forms of interaction

Interactions with anti-epileptics: Folic Acid reduces plasma phenytoin concentrations. Consequently, patients on anti-epileptic therapy should have their dose adjusted at regular intervals and be supervised by the physician.

4.6 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 4mg of Folic Acid taken before and during the first trimester of pregnancy will prevent recurrence of neural tube defects.

4.7 Effects on ability to drive and use machines

Preconceive Tablets have no influence on the ability to drive and use machines

4.8 Undesirable effects

No undesirable effects have been reported

4.9 Overdose

Overdose is not normally a problem. Any excess is excreted.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Folic Acid is essential in preventing megaloblastic aiuumia especially if it is deficient in poor nutritional states, pregnancy or anti-epileptic patients.

Folic Acid has been demonstrated to prevent recurrence of neural tube defects, as well as to prevent first occurrence neural tube defect when taken in different doses of 4mg and 0.4mg respectively.

5.2 Pharmacokinetic properties

None stated

5.3 Preclinical safety data

None stated

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Calcium Hydrogen Phosphate

Magnesium Stearate

Maize Starch

Microcrystalline Cellulose

Stearic Acid

6.2 Incompatibilities

Not applicable

6.3 Shelf life

2 years.

6.4 Special precautions for storage

Do not store above 25°C

6.5 Nature and contents of container

60 tablets packaged into PVDC/PVC with aluminium foil blister packs, with 20 tablets per foil blister and 3 blisters per carton.

60 and 90 tablets packaged into PVDC/PVC with aluminium foil blister packs, with 30 tablets per blister. There are two blisters per 60 tablet carton, and three blisters per 90 tablet carton.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

Any unused product or waste material should be disposed of in accordance with local requirements