FOLIC ACID TABLETS 5MG
Active substance: FOLIC ACID
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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Folic Acid Tablets BP 5mg.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Folic Acid BP 5.0mg
3
PHARMACEUTICAL FORM
Tablet.
4
4.1
CLINICAL PARTICULARS
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. megaloblastic anaemia 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 ADULTS: For nutritional megaloblastic anaemia a dose of 1 tablet daily for up to 4 months is normally sufficient but up to 15mg daily may be required where malabsorption exists. A maintenance dose of 5mg every 1 - 7 days may also be required. CHILDREN: In children over 1 year the dose is as for adults. (See BNF 25). Administration Oral
4.3
Contraindications Addisonian pernicious anaemia (vitamin B12 deficiency), malignant disease. Known hypersensitivity to folic acid or any of the excipients.
4.4
Special warnings and precautions for use Should not be used in the treatment of pernicious anaemia until adequate amounts of hydroxycobalamin have been administered parenterally. Caution has been expressed concerning the continuous use of high doses 5mg per day. Such dose levels have no value except in malabsorption, when regular doses with folic acid tablets BP be would be justified. The treatment of the megalublastic anaemias of malignant disease should be approached individually and folic acid tablets are unlikely to be the most suitable agent.
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 exist with all anti-convulsant treatment including sodium valproate, carbamazepine and the barbiturates, sulphasalazine and triamterene also inhibits absorption. Folate supplements enhances 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.
4.7
Effects on ability to drive and use machines No effect on concentration and co-ordination.
4.8
Undesirable effects Folic acid is normally well tolerated but nausea, anorexia, abdominal distention and allergic reactions may occasionally be seen.
4.9
Overdose There are no specific symptoms of overdosage and similarly no emergency treatment or antidotes, metabolisation and excretion can be rapid.
5
5.1
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties ATC Code: 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 need for concomitant use of hydroxycobalamin). 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 g daily in the urine for subjects on normal diets.
5.3
Preclinical safety data None stated.
6
6.1
PHARMACEUTICAL PARTICULARS
List of excipients Lactose granules (comprising Lactose BP, Potato Starch BP and Syrup BP.), Stearic acid BPC.
6.2
Incompatibilities None known.
6.3
Shelf life 36 months in tub presentation 24 months in blister presentation
6.4
Special precautions for storage Do not store above 25C.
6.5
Nature and contents of container The tablets are available in Securitainers or Tampertainers in packs of 10 50 tablets, 100, 500 and 1000 tablets. Specification for Securitainers and Tampertainers: High density polypropylene containers with low density polyethylene caps. The tablets are also available in blister packs of 28 tablets. Specification details of blister packs: - PVC (rigid, PVdC coated): - Aluminium foil (hard tempered): - Primer: - Heat seal lacquer:
286.6 microns 5% 30 2 microns 1 0.4 gsm 7 1.5 gsm
6.6
Special precautions for disposal Folic Acid Tablets BP 5mg are for oral administration only. Always read instructions on the label and the Patient Information Leaflet (PIL) enclosed. Keep all medicines out of the reach of children. Do not use after the expiry date.
7
MARKETING AUTHORISATION HOLDER
Intrapharm Laboratories Limited Kidwells Park House Kidwells Park Drive Maidenhead Berkshire SL6 8AQ United Kingdom
8
MARKETING AUTHORISATION NUMBER(S)
PL 17509/0050
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
15/03/2011
10
DATE OF REVISION OF THE TEXT
15/03/2011
1
NAME OF THE MEDICINAL PRODUCT
Folic Acid Tablets BP 5mg.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Folic Acid BP 5.0mg
3
PHARMACEUTICAL FORM
Tablet.
4
4.1
CLINICAL PARTICULARS
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. megaloblastic anaemia 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 ADULTS: For nutritional megaloblastic anaemia a dose of 1 tablet daily for up to 4 months is normally sufficient but up to 15mg daily may be required where malabsorption exists. A maintenance dose of 5mg every 1 - 7 days may also be required. CHILDREN: In children over 1 year the dose is as for adults. (See BNF 25). Administration Oral
4.3
Contraindications Addisonian pernicious anaemia (vitamin B12 deficiency), malignant disease. Known hypersensitivity to folic acid or any of the excipients.
4.4
Special warnings and precautions for use Should not be used in the treatment of pernicious anaemia until adequate amounts of hydroxycobalamin have been administered parenterally. Caution has been expressed concerning the continuous use of high doses 5mg per day. Such dose levels have no value except in malabsorption, when regular doses with folic acid tablets BP be would be justified. The treatment of the megalublastic anaemias of malignant disease should be approached individually and folic acid tablets are unlikely to be the most suitable agent.
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 exist with all anti-convulsant treatment including sodium valproate, carbamazepine and the barbiturates, sulphasalazine and triamterene also inhibits absorption. Folate supplements enhances 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.
4.7
Effects on ability to drive and use machines No effect on concentration and co-ordination.
4.8
Undesirable effects Folic acid is normally well tolerated but nausea, anorexia, abdominal distention and allergic reactions may occasionally be seen.
4.9
Overdose There are no specific symptoms of overdosage and similarly no emergency treatment or antidotes, metabolisation and excretion can be rapid.
5
5.1
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties ATC Code: 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 need for concomitant use of hydroxycobalamin). 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 g daily in the urine for subjects on normal diets.
5.3
Preclinical safety data None stated.
6
6.1
PHARMACEUTICAL PARTICULARS
List of excipients Lactose granules (comprising Lactose BP, Potato Starch BP and Syrup BP.), Stearic acid BPC.
6.2
Incompatibilities None known.
6.3
Shelf life 36 months in tub presentation 24 months in blister presentation
6.4
Special precautions for storage Do not store above 25C.
6.5
Nature and contents of container The tablets are available in Securitainers or Tampertainers in packs of 10 50 tablets, 100, 500 and 1000 tablets. Specification for Securitainers and Tampertainers: High density polypropylene containers with low density polyethylene caps. The tablets are also available in blister packs of 28 tablets. Specification details of blister packs: - PVC (rigid, PVdC coated): - Aluminium foil (hard tempered): - Primer: - Heat seal lacquer:
286.6 microns 5% 30 2 microns 1 0.4 gsm 7 1.5 gsm
6.6
Special precautions for disposal Folic Acid Tablets BP 5mg are for oral administration only. Always read instructions on the label and the Patient Information Leaflet (PIL) enclosed. Keep all medicines out of the reach of children. Do not use after the expiry date.
7
MARKETING AUTHORISATION HOLDER
Intrapharm Laboratories Limited Kidwells Park House Kidwells Park Drive Maidenhead Berkshire SL6 8AQ United Kingdom
8
MARKETING AUTHORISATION NUMBER(S)
PL 17509/0050
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
15/03/2011
10
DATE OF REVISION OF THE TEXT
15/03/2011
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
