Vitamin B1 Tablets 25mg
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vitamin B1 Tablets 25mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Thiamine Hydrochloride tablet 25mg
3 PHARMACEUTICAL FORM
Tablet.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Prevention and treatment of thiamine deficiency.
4.2 Posology and method of administration
Adults, the elderly and children over 3 years.
Mild and chronic deficiency: Half to one tablet daily in single dose.
Severe deficiency : Eight to twelve 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
4.6 Fertility, pregnancy and lactation
This is acceptable for use during pregnancy and lactation in normal doses.
4.7 Effects on ability to drive and use machines
None known
4.8 Undesirable effects
Hypersensitive reactions have been reported, (mainly after parenteral administration)
4.9 Overdose
Overdose with this substance has not been reported.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Thiamine is an essential coenzyme for carbohydrate metabolism.
5.2 Pharmacokinetic properties
Thiamine is well adsorbed from the gastrointestinal tract following oral administration although the adsorption of large doses is limited. It is widely distributed in body tissue 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 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
Yeast Dolomite Sago Flour Vegetable fatty acid Gum acacia
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 impact polystyrene white or polystyrene amber co-plastic bottles. Pack size 100 & 1000 tablets.
6.6 Special precautions for disposal
None.
7 MARKETING AUTHORISATION HOLDER
Nutrition Warehouse Ltd Head Office Address Samuel Ryder House Townsend Drive Nuneaton CV11 6XW
MARKETING AUTHORISATION NUMBER(S)
PL 14010/0005
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DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
1 October 1999
DATE OF REVISION OF THE TEXT November 1998
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