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SPC, UK: FOLIC ACID / ACCORD Tablets (2019)

Αναφορές

Βιβλιογραφική αναφορά

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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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