Thiamine Hydrochloride 50mg Tablets

Product Description

Product Name Thiamine Hydrochloride 50mg Tablets

Product Description:

Qualitative and quantitative composition

Thiamine Hydrochloride 50mg Tablets are a thiamine (vitamin B1)-containing monovitamin product.

Each tablet contains thiamine hydrochloride, 50mg.

Excipient(s) with known effect:

This product contains lactose monohydrate

Pharmaceutical form

Tablet

Round, white or almost white, biconvex tablets embossed with

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

ïType 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

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 Ehrlichs reaction. High doses of thiamine may interfere with spectrophotometric assays of theophylline plasma concentration.

Fertility, 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:

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

Immune system disorders:

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. Frequency not known (cannot be estimated from data).

Pharmaceutical particulars

List of excipients

Lactose monohydrate

Microcrystalline Cellulose

Croscarmellose Sodium

Stearic Acid

Magnesium Stearate

Shelf life

Blister: 2 years

Bottle: 2 years

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.

ïPackaging: It can be customize as per requirement.