FOLIC ACID 400 MICROGRAMSTABLETS - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Folic Acid 400 microgram Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 400 micrograms folic acid (as folic acid hydrate).

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Tablet.

Off white to yellowish, round, bevelled-edged, convex tablet, 7 mm in diameter.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Folic Acid is indicated for the prevention of first occurrence neural tube defects in the foetus.

For use by women who are planning a pregnancy.

4.2 Posology and method of administration

Posology

Adult females

One tablet (0.4mg) daily.

Supplementation should begin by taking one tablet (0.4 mg) daily prior to conception and be continued for at least the first 12 weeks of pregnancy.

Method of administration

Oral.

The tablets should be swallowed with water.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Folic acid should not be given alone in the treatment of Addisonian pernicious anaemia and other vitamin B12 deficiency states, as this may precipitate the onset of subacute combined degeneration of the spinal cord. Patients with malignant disease, unless megaloblastic anaemia due to folic acid deficiency. Should not be taken by people with folate dependant tumours.

4.4 Special warnings and precautions for use

Folic acid should not be administered for treatment of pernicious anaemia or undiagnosed megaloblastic anaemia without sufficient amounts of cyanocobalamin (vitamin B12) as folic acid alone will not prevent and may precipitate development of subacute combined degeneration of the spinal cord. Therefore a full clinical diagnosis should be made before initiating treatment.

Women with pre-existing diabetes, obesity, family history of neural tube defects, or previous pregnancy affected by neural tube defect have an increased risk of having a pregnancy affected by a neural tube defect and higher doses should be considered.

4.5 Interaction with other medicinal products and other forms of interaction

Folic acid status may be affected by a number of drugs:

Antiepileptics: Folic acid can reduce plasma concentrations of anticonvulsants, particularly phenytoin, phenobarbital and primidone and therefore patients on antiepileptic therapy may need to have their dose adjusted at regular intervals and should be under the supervision of a physician while taking folic acid supplements

Antibacterials: chloramphenicol and co-trimoxazole may interfere with folate metabolism

Sulfasalazine: can reduce the absorption of folic acid

Preparations containing folic acid or its derivatives may decrease the effectiveness of methotrexate.

Patients with hypersensitivity to folic acid have been demonstrated to have antibodies that cross react with other folic acid analogues, including methotrexate, folinic acid and aminopterin.

4.6 Fertility, pregnancy and lactation

Pregnancy

Folic acid is indicated for use during pregnancy. In normal use, the recommended dose of 400 pg of folic acid per day is not associated with deleterious effects during pregnancy and lactation.

Breast-feeding

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.

4.7 Effects on ability to drive and use machines

Folic Acid Tablets have no influence on the ability to drive and use machines.

4.8 Undesirable effects

Folic acid is generally well tolerated.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme.

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

Overdose is not normally a problem. Folic acid is stored in the liver and cerebrospinal fluid. Any excess to requirement is excreted in the urine.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Folic acid and derivatives. ATC code: BO3B

B01

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 defects when taken in different doses of 4 mg and 0.4 mg respectively.

Folic acid is a member of the vitamin B group. Folic acid is reduced in the body to tetrahydrofolate, which is a coenzyme for various metabolic processes including the synthesis of purine and pyrimidine nucleotides, and hence in the synthesis of DNA; it is also involved in some amino-acid conversions, and in the formation and utilisation of formate.

5.2 Pharmacokinetic properties

Absorption

Folic acid is absorbed mainly from the proximal part of the small intestine. The naturally occurring folate polyglutamates are largely deconjugated and reduced prior to absorption. It is the 5-methyltetrahy­drofolate, which appears in the portal circulation, where it is extensively bound to plasma proteins.

Distribution

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

Elimination

There is an enterohepatic circulation for folate; about 4 to 5 micrograms is excreted in the urine daily. Administration of larger doses of folic acid leads to proportionately more of the vitamin being excreted in the urine. Folic acid 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.

5.3 Preclinical safety data

Folic Acid is a drug on which extensive clinical experience has been obtained. Folic acid is not mutagenic. Massive doses in rats and in rabbits (100mg/kg upwards) produced precipitation of folate crystals in the neural tubules, particularly the proximal tubules and in the ascending limb of the Loop of Henle. Tubular necrosis is followed by recovery.

6.1

Hydroxypropyl­cellulose Croscarmellose sodium Cellulose, microcrystalline Silica, colloidal anhydrous Stearic acid

6.2

Not applicable.

6.3

3 years

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container

White Al/PVC/PVDC blisters in packs of 30, 60 and 90 tablets.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

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

7 MARKETING AUTHORISATION HOLDER

Alissa Healthcare Research Limited

Unit 5

Fulcrum 1

Solent Way

Whiteley, Fareham

Hampshire

United Kingdom

PO15 7FE

8 MARKETING AUTHORISATION NUMBER(S)

PL 30322/0024

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THEAUTHORISATION

04/05/2018