Folicap 0.5 Mg Or 2.5 Mg Soft Gelatin Capsules

Each soft gelatin capsule contains: Active Ingredient: Folic acid 0.5 mg or 2.5 mg.

Folic acid is necessary for the normal production and maturation of blood cells and is used in the treatment of nutritional megaloblastic anaemia e.g. megaloblastic anaemia following gastrectomy and the megaloblastic anaemia of pregnancy.

It is also used in:

  • Prevention of neural tube defects.
  • Prophylaxis in chronic haemolytic states.
  • As adjunct to methotrexate therapy.
  • Prophylaxis of folate deficiency in dialysis, pregnancy & other states.

Posology and method of administration

Treatment of folate deficient megaloblastic anemia: Two 2.5 mg FOLICAP Soft gelatin capsules daily for up to 4 months. The dose may be increased up to 6 capsules daily in malabsorption states.

Women at high risk of fetal neural tube defects: Two 2.5 mg FOLICAP Soft gelatin capsules daily starting before pregnancy and continued throughout the first trimester.

Prophylaxis of chronic hemolytic states: Two 2.5 mg FOLICAP Soft gelatin capsules every 1-7 days depending on the underlying disease.

As adjunct to methotrexate therapy: Two 2.5 mg FOLICAP Soft gelatin capsules once weekly.

Prophylaxis of folate deficiency (as in pregnancy): 1-2 FOLICAP Soft gelatin capsules 0.5 mg daily.

Prophylaxis of folate deficiency in dialysis: Two capsules FOLICAP Soft gelatin capsules 2.5 mg every 1 – 7 days.

Contraindications

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 B,, 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 hypersensitivity to folic acid or any of the excipients.

Special Warnings And Precautions For Use

Patients with vitamin B, deficiency should not be treated with folic acid unless administered with adequate amounts of hydroxocobalamin, as it can mask the condition but the subacute irreversible damage to the nervous system will continue. The deficiency can be due to undiagnosec megaloblastic anaemia including in infancy.

pernicious anaemia or macrolytic anaemia of unknown aethiology or other cause of cobalamin deficiency, including lifelong vegetarians.

Effects on ability to drive and use machines

No effect on concentration and co-ordination.

Pregnancy & Lactation

Pregnancy

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

No-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 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 precedence over maternal folate needs. Levels of folic acid are relatively low in colostrums 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.

Undesirable effects

Gastrointestinal disorders Rare (>1/10,000 til < 1/1,000): Anorexia, nausea, abdominal distension and flatulence.

Immune system disorders Rare (21/10,000 til < 1/1,000): Allergic reactions, comprising erythema, rash, pruritus, urticaria, dyspnoea, and anaphylactic reactions (including shock).

Overdose

There are no specific symptoms of overdosage and similarly no emergency treatment or antidotes, metabolism and excretion can be rapid.

Pharmacological properties

Pharmacodynamic properties

Folic acid is a member of the vitamin B group which is induced in the body to tetrahydrofolate, a co-enzyme active in several metabolic processes and produces a haemopoietic response in nutritional megaloblastic anaemias. Folic acid is rapidly absorbed and widely distributed in body tissues.

Pharmacokinetic properties

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, 5 MTHF 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 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.

Further Information

Composition

Each soft gelatin capsule contains:

  • Active Ingredient: Folic acid 0.5 mg or 2.5 mg.
  • Inactive Ingredients: Ethyl vanillin, Soyalecithin, Beeswax, Hydrogenated Soyabean Oil. Soyabean Oil.

Interaction With Other Medicinal Products And Other Forms Of Interaction

There is a specific interaction between phenytoin and folate such that chronic phenytoin use produces folate deficiency. Correction of the folate deficiency reduces plasma phenytoin with potential loss of seizure control. Similar but less marked relationship exist with all anti-convulsant treatments including sodium valproate, carbamazepine and the barbiturates.

Sulphasalazine and triamterene also inhibit absorption. Antibacterials, chloramphenicol and co-trimoxazole, may interfere with folate metabolism.

Folate supplements enhance the efficacy of lithium therapy. Methotrexate and trimethoprim are specific anti-folates and the folate deficiency caused by their prolonged use cannot be treated by folic acid.

Folinic acid should be used. Nitrous oxide anaesthesia may cause an acute folic acid deficiency. Both ethanol and aspirin increase folic elimination.

Packing

A carton box containing 24 capsules in aluminium/transparent PVC blisters, each of 12 soft gelatin capsules and insert leaflet.

Storage

Store at temperature not exceeding 30° C, in a dry place. Keep out of the reach of children.


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