Vitamin B1 Tablets 100mg
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vitamin B1 Tablets 100 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Thiamine Hydrochloride BP 100 mg
3 PHARMACEUTICAL FORM
Tablet
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Treatment of thiamine deficiency.
4.2 Posology and method of administration
Adults, the elderly and children over three years
Severe deficiency: Two to three tablets daily in single or divided doses.
Route of administration
Oral.
4.3 Contraindications
Known hypersensitivity to thiamine.
4.4 Special warnings and precautions for use
None.
4.5 Interaction with other medicinal products and other forms of interaction
None known.
4.6 Fertility, pregnancy and lactation
Thiamine hydrochloride is acceptable for use during pregnancy and lactation in normal doses.
4.7 Effects on ability to drive and use machines
None.
4.8 Undesirable effects
Hypersensitivity reactions have been reported (mainly after parenteral administration).
4.9 Overdose
Overdose with this preparation has not been reported.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Thiamine is an essential co-enzyme for carbohydrate metabolism.
5.2 Pharmacokinetic properties
Thiamine is well absorbed from the gastro-intestinal tract following oral administration, although the absorption of large doses is limited. It is widely distributed to most body tissues; and appears in breast milk. Thiamine is not stored to any appreciable extent in the body and amounts in excess of the body’s requirements are excreted in the urine as unchanged thiamine or metabolites.
5.3
Preclinical safety data
No relevant data.
PHARMACEUTICAL PARTICULARS
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6.1 List of excipients
Calcium Phosphate Lactose Maize Starch Potato Starch Stearic Acid Magnesium Stearate Feculose Solids
Feculose Maize Starch Sodium Starch Glycollate Nipa Esters Combination Mains Water
6.2 Incompatibilities
None known.
6.3 Shelf life
36 months.
6.4 Special precautions for storage
In well closed containers in a dry place protected from light.
6.5 Nature and contents of container
High density polyethylene pails.
Pack size: 1000 tablets.
6.6 Special precautions for disposal
None.
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MARKETING AUTHORISATION HOLDER
Nutrition Warehouse Limited Samuel Ryder House Townsend Drive Attleborough Fields Nuneaton Warwickshire CV11 6XW United Kingdom
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