For the use of registered Medical Practitioner or Laboratory or Pharmacy

PRIFOL

(Folic Acid Tablets BP 400 mcg)

COMPOSITION

Each uncoated tablet contains:

Folic Acid                    BP                   400 mcg

Excipients                                               q.s.

Colour: Approved colours to be used

PHARMACEUTICAL FORM

Tablets

PHARMACOLOICAL PROPERTIES

Pharmacodynamic:

Pharmacotherapeutic group: folic acid and derivatives

ATC code: BO3B B01

Mechanism of action: Folic acid is a member of the vitamin B group which is reduced 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.

It is used in the treatment and prevention of folate deficiency states.

Pharmacokinetics:

Absorption: Folic acid is rapidly absorbed in the jejunum, undergoing a reduction and methylation to form 5- methyltetrahydrofolate, which is the form present in portal circulation. Distribution: Its bioavailability after oral administration is high and ranges between 76% and 93%. Maximum plasmatic concentration is reached in one hour.

Elimination: There is an enterohepatic circulation of folates, and they are secreted in the urine as metabolites. Folates cross the placenta and are present in maternal milk. In conclusion, folic acid bonds extensively with plasmatic proteins, the liver being the main organ for storage.

INDICATION

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.
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.

DOSAGE AND ADMINISTRATION

Posology: 1 tablet daily, starting 1 month prior to conception and continue uninterrupted for 3 months after conception. The daily dose may be doubled, in case of insufficient intake of folates. This dosage is not adequate if the woman has previously given birth to babies with NTD (Neural Tube Defects).

Method of Administration: The product should be administered for oral use, before meals.

CONTRAINDICATIONS

Hypersensitivity to active substance or to any of the excipients.

Patients with cancer.

DRUG INTERACTIONS

Folic Acid may decrease the plasmatic concentrations of phenobarbital, phenytoin and primidon, by increasing their metabolism. Therefore, the concomitant use of Folic Acid with phenobarbital, phenytoin, or primidone is not recommended. If needed, a close monitoring of the plasmatic concentration of these antiepileptics should be made.

Methotrexate or sulphasalazine may decrease folic acid effect due to their antagonist property. Concurrent administration of chloramphenicol and folic acid may result in antagonism of haematopoietic response to folic acid.

ADVERSE EFFECTS

Allergic reactions (erythema, itching, urticaria) have been reported. Anaphylactic reaction, gastrointestinal disorders (nausea, abdominal disorders, flatulence), irritability and insomnia have been reported during treatment with folic acid in higher doses than that contained in Folic Acid.

WARNINGS AND PRECAUTIONS

Before starting a treatment with Folic Acid, the clinical conditions of the following kinds of patients should be evaluated carefully as they may require higher dosages of folic acid:

• women who have previously given birth to babies (or aborted a foetus) with a neural tube defect
• women under treatment with antiepileptics: carbamazepine or valproic acid;
• familial occurrence of neural tube defects;
• women treated with folic acid antagonists (methotrexate, sulphasalazine)
• pernicious anemia megaloblastic due to insufficient intake of folic acid

PREGNANCY AND LACTATION

Pregnancy: Folic Acid is indicated in the prevention of neural tube defects before and during pregnancy.

Breastfeeding: Folic acid is excreted in the breast milk.

OVERDOSAGE

Doses of folic acid up to 4-5 mg are well tolerated. Higher doses have shown to cause: mental, sleep and gastroenteric disorders. The doses of folic acid are very low; therefore the risk of toxicity due to overdose is very remote.

MODE OF ADMINISTRATION

For Oral Use

MODE OF SELLING

Prescription Only Medicine

SHELF LIFE

36 months from the date of manufacturing.

STORAGE CONDITIONS

Store at a temperature not exceeding 30⁰C. Protect from light and moisture.

Keep out of the reach of children.

PRESENTATION

30 Tablets packed in a jar and packed in a carton with package insert.

The Holder of Trademark and Marketing Authorization is Sterlist Pharma LTD, England.

Manufactured exclusively for Sterlist Pharma LTD, England.