THIAMINE HYDROCHLORIDE Tablets Ref.[7382] Active ingredients: Vitamin B1

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2015  Publisher: Athlone Pharmaceuticals Limited, Ballymurray, Co. Roscommon, Ireland

Therapeutic indications

For the treatment of thiamine deficiencies due to increased dietary requirements, reduced intakes, reduced absorption or increased excretion. Also for treatment of Wernicke-Korsakoff syndrome, beriberi and thiamine deficiency related to chronic alcoholism.

Situations often accompanied by marginal thiamine deficiency and requiring supplementation include but are not limited to:

  • Regular heavy drinking/chronic alcohol consumption.
  • High carbohydrate intakes.
  • Heavy physical exertion.
  • Compromised nutritional status.
  • High dose diuretics.
  • Type I and Type II diabetes mellitus.

Posology and method of administration

Posology

Treatment

Adults and adolescents from 12 years of age

Mild deficiency: 50-100mg per day.

Severe deficiency: 200-300mg per day in divided doses.

Not recommended for children under 12 years.

Route of Administration

Oral.

Overdose

Overdose with this route of administration is unlikely. A suspected overdose should be treated symptomatically.

Shelf life

Shelf life

Blister: 2 years.

Pot: 2 years – unopened.

After first opening the pot, medicinal product should be used within 100 days.

Special precautions for storage

Store below 25°C.

Store in the original package.

For storage conditions after first opening of pots, see section 6.3.

Nature and contents of container

Pot: Polypropylene snap Secure Pot with HDPE/LDPE closure.

Blister pack: 250μm PVC/PVDC (white opaque) with 40 gsm aluminium foil (20μm).

84 tablets in blisters and 100 tablets in pots packaging.

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

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