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

Contraindications

Known allergy or hypersensitivity to thiamine or to any of the excipients in Thiamine Hydrochloride 50mg Tablets (see section 6.1).

Special warnings and precautions for use

This product contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Interaction with other medicinal products and other forms of interaction

The thiamine antagonists thiosemicarbazone and 5-fluorouracil can neutralise the effect of thiamine. Patients using any of these treatments may need their thiamine dose adjusted.

Thiamine could give false positive results for urobilinogen determination by the Ehrlich’s reaction. High doses of thiamine may interfere with spectrophotometric assays of theophylline plasma concentration.

Pregnancy and lactation

This product is not intended for use in pregnant or lactating women.

Effects on ability to drive and use machines

No studies on the effect on the ability to drive and use machines have been performed.

However, patients should be cautioned to see how they react before driving or operating machinery.

Undesirable effects

Gastrointestinal disorders

Frequency not known (cannot be estimated from data): Mild gastrointestinal events such as nausea, vomiting, diarrhoea, and abdominal pain have been reported.

Immune system disorders

Frequency not known (cannot be estimated from data): Allergic and anaphylactic reactions, with symptoms of pruritus, urticaria, itching, hives, angioedema, abdominal pain, respiratory distress, tachycardia, palpitations, and shock have been reported in single cases.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme website www.mhra.gov.uk/yellowcard.

Incompatibilities

Not applicable.

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