Folic Acid Tablets Bp 5mg
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
FOLIC ACID TABLETS BP 5mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5mg Folic Acid.
Excipient with known effect:
44.45mg lactose monohydrate per tablet.
For the full list of excipients, see Section 6.1.
3. PHARMACEUTICAL FORM Yellow uncoated tablets.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
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).
4.2 Posology and Method of Administration
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.
4.3 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 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 hypersensitivity to the active ingredient or any of the excipients.
4.4 Special warnings and precautions for use
• Patients with vitamin Bi2 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 undiagnosed megaloblastic anaemia including in infancy, pernicious anaemia or macrocytic anaemia of unknown aethiology or other cause of cobalamin deficiency, including lifelong vegetarians.
• Caution should be exercised when administering folic acid to patients who may have folate dependent tumours.
• This product is not intended for healthy pregnant women where lower doses are recommended, but for pregnant women with folic acid deficiency or women at risk for the reoccurrence of neural tube defects.
• This product contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the lapp lactase deficiency or glucose -galactose malabsorption should not take this medicine
4.5 Interactions with other medicinal products and other forms of interactions
• 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.
4.6 Pregnancy and lactation
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
Accumulation of folate Levels of folic acid are concentrations of the in breast fed infants
Folic acid is actively excreted in human breast milk. in milk takes precedence over maternal folate needs. relatively low in colostrum but as lactation proceeds, vitamin rise. No adverse effects have been observed whose mothers were receiving folic acid.
4.7. Effects on Ability to Drive and Use Machines
None known.
4.8 Undesirable effects
|
Gastrointestinal disorders Rare (>1/10,000 til <1/1,000) |
Anorexia, nausea, abdominal distension and flatulence |
|
Immune system disorders Rare (>1/10,000 til <1/1,000) |
Allergic reactions, comprising erythema, rash, pruritus, urticaria, dyspnoea, and anaphylactic reactions (including shock). |
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
4.9. Overdose
No special procedures or antidote are likely to be needed.
5.1 Pharmacodynamic properties 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.
5.2 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. 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.
5.3. Pre-clinical Safety Data
Not applicable.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Also contains:
Colloidal silica Lactose monohydrate Maize starch Magnesium stearate E460
6.2. Incompatibilities
None known.
6.3. Shelf-Life
Shelf-life
Two years from the date of manufacture.
Shelf-life after dilution/reconstitution Not applicable.
Shelf-life after first opening Not applicable.
6.4. Special Precautions for Storage
Store below 25°C in a dry place. Protect from light.
6.5. Nature and Content of Container
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) 250pm white rigid PVC. (ii) Surface printed 20pm 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
6.6. Instructions for Use, Handling and Disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Actavis UK Limited (Trading style: Actavis) Whiddon Valley BARNSTAPLE N Devon EX32 8NS
8. MARKETING AUTHORISATION NUMBER(S)
PL 0142/5522R
9. DATE OF FIRST AUTHORISATION/RENEWAL OF
AUTHORISATION
16.1.92
10 DATE OF REVISION OF THE TEXT
30/03/2015