Folic Acid 5mg Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Folic Acid 5 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Folic Acid 5 mg Excipients with known effect:
Each tablet contains 50.4mg lactose and 2.8mg sucrose For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablets
Plain yellow, round uncoated tablets.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Folic acid is necessary for the normal production and maturation of blood cells, and is
used in the treatment of nutritional megaloblastic anaemias eg. following gastrectomy
and the megaloblastic anaemia of pregnancy. It may also be used prophylactically in chronic haemolytic states or in renal dialysis.
4.2 Posology and method of administration
For oral use.
For nutritional megaloblastic anaemia in adults: 1 tablet daily for up to 4 months is usually sufficient. A dose of 15 mg (3 tablets) daily may be required where malabsorption exists.
A maintenance dose of 5 mg every 1 to 7 days may also be required.
In children over 1 year of age, the dose is as for adults.
Contraindications
4.3
Hypersensitivity to folic acid or any of the ingredients
Addisonian pernicious anaemia (Vitamin B12 deficiency), and malignant disease.
4.4 Special warnings and precautions for use
Should not be used in the treatment of pernicious anaemia or other vitamin B12 deficiency states until adequate amounts of hydroxocobalamin have been administered parenterally (may precipitate subacute combined degeneration of the spinal cord).
Caution has been expressed concerning the continuous use of high doses of 5mg per day; such dose levels have no value except in malabsorption, when regular doses with Folic Acid Tablets BP would be justified. The treatment of megaloblastic anaemias of malignant disease should be approached individually and folic acid tablets are unlikely to be the most suitable agent.
Patients with rare hereditary problems of fructose or galactose intolerance, the LAPP lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
4.5 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 exists with all anti-convulsant treatment including sodium valproate, primidone, carbamazepine and the barbiturates. Sulfasalazine and triamterene also inhibit absorption.
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 Tablets BP. Folinic acid should be used.
Nitrous oxide anaesthesia may cause an acute folic acid deficiency.
Both ethanol and aspirin increase folic elimination.
4.6 Fertility, pregnancy and lactation
Prophylactic administration during pregnancy is frequently recommended.
4.7 Effects on ability to drive and use machines
No effect on concentration or co-ordination.
4.8 Undesirable effects
Gastrointestinal disorders:
Rare (>1/10,000 to <1/1,000) : Anorexia, nausea, abdominal distension and
flatulence
Immune system disorders:
Rare (>1/10,000 to <1/1,000): Allergic reactions, comprising erythema, rash,
pruritis, 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 at: www.mhra.gov.uk/yellowcard.
4.9 Overdose
There are no specific symptoms of overdosage and similarly no emergency
treatment or antidotes. Metabolism and excretion can be rapid.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
B03B B01 - Folic Acid and Derivatives
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 (but see warning in section 4.4 regarding the need for concomitant use of hydroxo-cobalamin). Folic acid is rapidly absorbed and widely distributed in body tissues.
5.2 Pharmacokinetic properties
Folic acid is readily absorbed mainly from the small intestine. It rapidly appears in the blood and there is considerable plasma protein binding. Excretion is of the order of 4-5 pg daily in the urine, for subjects on normal diets.
5.3 Preclinical safety data
There is no preclinical safety data of relevance to the prescriber which is additional to that already included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Lactose
Pregelatinised Maize Starch
Sucrose
Stearic Acid
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
36 months.
6.4 Special precautions for storage
Tablet containers: Do not store above 25°C. Keep the container tightly closed. Blisters: Do not store above 25 °C. Store in the original package.
6.5 Nature and contents of container
HDPP tablet containers with LDPE lids containing 50, 100, 500 or 1000 tablets.
Al/PVC/PVDC blisters enclosed in an outer carton, containing 28 or 56 tablets.
Al/PVC/PVDC blisters enclosed in an outer carton - “Burgopackaging format, containing 28 tablets.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No specific instructions.
MARKETING AUTHORISATION HOLDER
7
Crescent Pharma Limited Units 3 & 4
Quidhampton Business Units
Polhampton Lane
Overton
Hants
RG25 3ED
8 MARKETING AUTHORISATION NUMBER(S)
PL 20416/0290
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
16/04/2015
10 DATE OF REVISION OF THE TEXT
16/04/2015