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VITAMIN B1 TABLETS 100MG

Active substance(s): THIAMINE HYDROCHLORIDE

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Transcript
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.

6

PHARMACEUTICAL PARTICULARS

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.

7

MARKETING AUTHORISATION HOLDER
Nutrition Warehouse Limited
Samuel Ryder House
Townsend Drive
Attleborough Fields
Nuneaton
Warwickshire
CV11 6XW
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 14010/0009

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
1st October 1999

10

DATE OF REVISION OF THE TEXT
October 2003

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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