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Folic Acid Tablets Bp 5 Mg

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SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Folic Acid Tablets BP 5 mg

2    QUALITATIVE AND QUANTITATIVE    COMPOSITION

Folic Acid 5 mg For excipients, see 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 e.g. 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.

4.3    Contra-indications

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 interactions

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. Pregnancy and Lactation

Prophylactic administration during pregnancy is frequently recommended.

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 4-5pg 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 - “Burgopak” packaging format, containing 28 tablets.

Not all pack sizes may be marketed.

6.6.    Instruction for Use/Handling

No specific instructions.

7.    MARKETING AUTHORISATION HOLDER

Dalkeith Laboratories Ltd

2 Park Street

Woburn Bedfordshire MK17 9PG

8.    MARKETING AUTHORISATION NUMBER(S)

PL 17496/0017

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

14/03/2007

10    DATE OF REVISION OF THE TEXT

07/07/2015