Folic acid

Shelf life

Unopened: 3 years

After first opening: Three months.

Folic Acid price

Average cost of Folic Acid 1 mg per unit in online pharmacies is from 0.21$ to 0.21$, per pack from 21$ to 21$.

Incompatibilities

None stated.

List of excipients

Mannitol (E421)

Glycerol (E422)

Methyl hydroxybenzoate (E218)

Ethyl hydroxybenzoate (E214)

Propyl hydroxybenzoate (E216)

Sodium dihydrogen phosphate dihydrate

Disodium hydrogen phosphate dodecahydrate

Disodium edetate

Strawberry flavour (contains phenylalanine, cherry juice concentrate and maltol)

Purified water

Preclinical safety data

Folic Acid is a drug on which extensive clinical experience has been obtained. Relevant information for the prescriber is provided elsewhere in the Summary of Product Characteristics.

Pharmacokinetic properties

About 70 - 80 % of a 2 mg oral solution of folic acid is absorbed. Larger doses are probably equally well absorbed. It is distributed into plasma and extracellular fluid. In plasma, folate is bound weakly to albumin (70 %). There is a further high affinity binder for folate but this has a very low capacity and is barely detectable in normal sera. About 70 % of small doses of folate (about 1 mg) are retained and the rest excreted into the urine. With larger doses most is excreted into the urine. With a 5 mg dose of folate, urinary excretion will be complete in about five hours. There is an enterohepatic circulation of folate. The retained folate is taken into cells and reduced by dihydrofolate to tetrahydrofolate. Folic acid is a relatively poor substrate for folate reduction, the normal substrate being dihydrofolate.

Folic acid itself does not occur in natural materials, it is entirely a pharmacological form of the compound. Once reduced, folate has additional glutamic acid residues added, a folate pentaglutamate being the dominant intracellular analogue. These polyglutamates are the active co-enzymes.

Date of revision of the text

04/05/2016

Marketing authorisation holder

Wockhardt UK Ltd

Ash Road North

Wrexham

LL13 9UF

U.K.

Special precautions for storage

Store in a refrigerator (2°C - 8°C)

Store in the original bottle and outer cardboard carton in order to protect from light.

Nature and contents of container

150 ml amber soda glass (type III) bottle fitted with a 28 mm white child resistant tamper evident screw cap, with expanded polyethylene (EPE) liner, and outer cardboard carton.

Marketing authorisation number(s)

PL 29831/0358

Special precautions for disposal and other handling

Not applicable.

Date of first authorisation/renewal of the authorisation

09/04/2010