Folic Acid Tablets Bp 5mg
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Folic Acid 5 mg Tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg folic acid For excipients, see 6.1.
3. PHARMACEUTICAL FORM
Tablets.
The tablets are yellow, biconvex, engraved APS over 0406 : plain.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Folic acid tablets are indicated for treatment of megaloblastic anaemia due to folic acid deficiency. They are also indicated for use as a supplement to folate deficiency, and for the prevention of recurrent neural tube defects.
4.2 Posology and method of administration
For oral administration.
Adults and children over 1 year Initially 5 mg daily for 4 months.
Daily maintenance dose 5 mg every 1-7 days depending on the underlying disease.
Prevention of recurrent neural tube defects: 5 mg daily.
Children (up to 1 year)
500 mcg/kg daily.
The Elderly
The normal adult dose is appropriate.
4.3 Contraindications
Folic acid is contra-indicated in the treatment of pernicious anaemia and other vitamin B12-deficiency states without adequate amounts of cyanocobalamin.
4.4 Special warnings and special precautions for use
Folic acid should not be used in malignant disease unless folate deficiency is an important complication.
4.5 Interactions with other medicinal products and other forms of interaction
Folic acid occasionally reduces the plasma level of phenytoin and phenobarbital.
4.6 Pregnancy and lactation
Folic acid should be used when it is indicated that dietary supplementation is necessary in pregnancy and lactation.
4.7 Effects on ability to drive and use machines
None stated.
4.8 Undesirable effects
Folic acid is usually well tolerated though anorexia, nausea and flatulence have been reported.
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 at: www.mhra.gov.uk/yellowcard.
4.9 Overdose
Treatment should be by gastric lavage.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
ATC Code: BO3B B01 Folic acid and derivatives.
Folic acid is a member of the B group of vitamins, it is necessary for the normal production and maturation of red blood cells.
5.2 Pharmacokinetic properties
Absorption of folic acid is through the duodenum and upper small intestine which are both rich in dihydrofolate reductase. The reduced folate is rapidly transported to tissues and to liver storage, from where up to 200 mg each day is provided for recirculation to tissues by an enterohepatic cycle of the vitamin.
5.3 Preclinical safety data
Preclinical information has not been included because the safety profile of Folic acid has been established after many years of clinical use. Please refer to section 4.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Lactose Dextrin Maize Starch
Magnesium Stearate (E572).
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
Not applicable.
6.4 Special precautions for storage
Store in the original package. Do not store above 25°C.
6.5 Nature and contents of container
HDPE or polypropylene containers with caps or child resistant closures in packs of 1000 tablets.
Amber glass bottles with plastic screw caps in packs of 1000 and 10 x 50 tablets.
PVdC coated PVC film with hard temper aluminium foil (blister pack). Pack sizes 7, 10, 14, 21, 28, 30, 56, 60, 84, 90, 100, 110, 112, 120, 150, 160 and 168.
Not all pack sizes may be marketed.
6.6 Instructions for use/handling
Not applicable.
7 MARKETING AUTHORISATION HOLDER
TEVA UK Ltd, Eastbourne, BN22 9AG ENGLAND.
MARKETING AUTHORISATION NUMBER
8.
PL 0289/5094R
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
08/06/99
10 DATE OF REVISION OF THE TEXT
07/07/2015