FOLIC ACID TABLETS BP 5mg

Each tablet contains 5mg Folic Acid PhEur.

Yellow uncoated tablets.

Folic acid is a component of the B group of vitamins and is necessary for the normal production and maturation of red blood cells.

1. For the treatment of folate-deficient megaloblastic anaemia due to malnutrition, malabsorption syndromes (such as coeliac disease or sprue) and increased utilisation as in pregnancy. It should not be used alone in undiagnosed megaloblastic anaemia including in infancy, pernicious anaemia or macrocytic anaemia of unknown aetiology, unless administered with adequate amounts of hydroxocobalamin.

2. For the prophylaxis of drug induced folate deficiency e.g. caused by administration of phenytoin, phenobarbital and primidone. (See section 4.5).

3. For the prophylaxis against folate deficiency in chronic haemolytic states or in renal dialysis.

4. For the prevention of neural tube defects for woman planning a pregnancy and known to be at risk. (See section 4.6).

Adults (including the elderly):

In folate deficient megaloblastic anaemia: 5mg daily for 4 months; up to 15mg daily may be necessary for malabsorption states.

In drug induced folate deficiency: 5mg daily for 4 months; up to 15mg daily may be necessary for malabsorption states.

For prophylaxis in chronic haemolytic states or in renal dialysis: 5mg every 1-7 days depending on underlying disease.

Prevention of neural tube defects in women known to be at risk: 5mg daily started before conception and continued throughout the first trimester.

Pregnancy:

In established folate deficiency: 5mg daily continued to term.

Children:

For young children a more suitable dosage form should be used.

In folate deficient megaloblastic anaemia:

Child 1-18 years 5mg daily for 4 months; maintenance 5mg every 1-7 days.

In haemolytic anaemia; metabolic disorders:

Child 1-12 years 2.5mg-5mg once daily.

Child 12-18 years 5-10mg once daily.

Prophylaxis of folate deficiency in renal dialysis:

Child 1-12 years 250 microgram/kg (max 10mg) once daily.

Children 12-18 years 5-10mg once daily.

For oral administration.

• Long-term folate therapy is contraindicated in any patient with untreated cobalamin deficiency. This can be untreated pernicious anaemia or other cause of cobalamin deficiency, including lifelong vegetarians. In elderly people, a cobalamin absorption test should be done before long-term folate therapy. Folate given to such patients for 3 months or longer has precipitated cobalamin neuropathy. No harm results from short courses of folate

• Folic acid should never be given alone in the treatment of Addisonian pernicious anaemia and other vitamin B₁₂ deficiency states because it may precipitate the onset of subacute combined degeneration of the spinal cord

• Folic acid should not be used in malignant disease unless megaloblastic anaemia owing to folate deficiency is an important complication.

• Known hypersensitiviy to the active ingredient or any of the excipients.

• Patients with rare hereditary problems of galactose intolerance, the lapp lactase deficiency or glucose – galactose malabsorption should not take this medicine

• Caution should be exercised when administering folic acid to patients who may have folate dependent tumours.

• Antiepileptics – if folic acid supplements are given to treat folate deficiency, which can be caused by the use of antiepileptics (phenytoin, phenobarbital and primidone), the serum antiepileptic levels may fall, leading to decreased seizure control in some patients.

• Antibacterials – chloramphenicol and co-trimoxazole may interfere with folate metabolism.

• Sulfasalazine - can reduce the absorption of folic acid.

• Folic acid may interfere with the toxic and therapeutic effects of methotrexate.

Pregnancy

There are no known hazards to the use of folic acid in pregnancy, supplements of folic acid are often beneficial.

Non-drug - induced folic acid deficiency, or abnormal folate metabolism, is related to the occurrence of birth defects and some neural tube defects. Interference with folic acid metabolism or folate deficiency induced by drugs such as anticonvulsants and some antineoplastics early in pregnancy results in congenital anomalies. Lack of the vitamin or its metabolites may also be responsible for some cases of spontaneous abortion and intrauterine growth retardation.

Lactation

Folic acid is actively excreted in human breast milk. Accumulation of folate in milk takes precedence over maternal folate needs. Levels of folic acid are relatively low in colostrum but as lactation proceeds, concentrations of the vitamin rise. No adverse effects have been observed in breast fed infants whose mothers were receiving folic acid.

None known.

No special procedures or antidote are likely to be needed.

ATC Code BO3B B01

Folic acid is a member of the vitamin B group. It is used in the treatment and prevention of folate deficiency states.

Absorption – folic acid is rapidly absorbed from the gastrointestinal tract, mainly from the proximal part of the small intestine. Dietary folates are stated to have about half the bioavailability of crystalline folic acid. The naturally occurring folate polyglutamates are largely deconjugated and reduced by dihydrofolate reductase in the intestine to form 5-methyltetrahydrofolate (5MTHF). Folic acid given therapeutically enters the portal circulation largely unchanged, since it is a poor substrate for reduction by dihydrofolate reductases.

Distribution – via portal circulation. 5MTHF from naturally occurring folate is extensively plasma bound. The principal storage site of folate is in the liver; it is also actively concentrated in the CSF. Folate is distributed into breast milk.

Metabolism – therapeutically given folic acid is converted into the metabolically active form 5MTHF in the plasma and liver. There is an enterohepatic circulation for folate.

Elimination – Folate metabolites are eliminated in the urine and folate in excess of body requirements is excreted unchanged in the urine. Folic acid is removed by haemodialysis.

Not applicable.

Also contains: colloidal silica, lactose, maize starch, magnesium stearate, E460.

None known.

Shelf-life

Two years from the date of manufacture.

Shelf-life after dilution/reconstitution

Not applicable.

Shelf-life after first opening

Not applicable.

Store below 25°C in a dry place.

Protect from light.

The product containers are rigid injection moulded polypropylene or injection blow-moulded polyethylene containers and snap-on polyethylene lids; in case any supply difficulties should arise the alternative is amber glass containers with screw caps.

The product may also be supplied in blister packs and cartons:

a) Carton: Printed carton manufactured from white folding box board.

b) Blister pack: (i) 250µm white rigid PVC. (ii) Surface printed 20µm hard temper aluminium foil with 5-6g/M² PVC and PVdC compatible heat seal lacquer on the reverse side.

Blister pack sizes: 7s, 10s, 14s, 21s, 28s, 30s, 56s, 60s, 84s, 90s, 100s, 112s, 500s, 1000s

Securitainers pack sizes: 7s, 10s, 14s, 21s, 28s, 30s, 56s, 60s, 84s, 90s, 100s, 112s, 500s, 1000s

Product may also be supplied in bulk, for reassembly purposes only, in polybags contained in tins, skillets or polybuckets filled with suitable cushioning material.

Maximum size of bulk packs: 150,000

Not applicable.

Name or style and permanent address of registered place of business of the holder of the Marketing Authorisation:

Actavis UK Limited

(Trading style: Actavis)

Whiddon Valley

BARNSTAPLE

N Devon EX32 8NS

PL 0142/5522 R

15.1.87/16.1.92

10/02/2010