FOLIC ACID / ACCORD Tablets (2019)
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Περιεχόμενα
Name of the medicinal product
FOLIC ACID TABLETS BP 5mg.
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.
Pharmaceutical form
Yellow uncoated tablets.
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. For the treatment of folate-deficient megaloblastic anaemia due to malnutrition, ...
Posology and method of administration
Posology 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: ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Long-term folate therapy is contraindicated in any patient with untreated cobalamin deficiency. This can be untreated ...
Special warnings and precautions for use
Patients with vitamin B<sub>12</sub> 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 ...
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 ...
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 ...
Effects on ability to drive and use machines
No effect on concentration and co-ordination.
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, ...
Overdose
No special procedures or antidote are likely to be needed.
Pharmacodynamic properties
Pharmacotherapeutic group: folic acid and derivatives ATC Code: BO3BB01 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 ...
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 ...
Preclinical safety data
Not applicable.
List of excipients
Also contains: Colloidal silica Lactose monohydrate Maize starch Magnesium stearate E460
Incompatibilities
None known.
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.
Special precautions for storage
Store below 25°C in a dry place. Protect from light.
Nature and contents 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 ...
Special precautions for disposal and other handling
Not applicable.
Marketing authorization holder
Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS
Marketing authorization number(s)
PL 0142/5522 R
Date of first authorization / renewal of the authorization
Date of first authorisation: 15.1.87 Date of latest renewal: 05.06.03
Date of revision of the text
07/06/2019
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