Thiamine 50mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Thiamine hydrochloride

Available from:

Zanza Specials International Ltd

ATC code:

A11DA01

INN (International Name):

Thiamine hydrochloride

Dosage:

50mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 09060206; GTIN: 5060033711668

Patient Information leaflet

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Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme
at
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on
the safety of this medicine.
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PATIENT INFORMATION LEAFLET
THIAMINE HYDROCHLORIDE 50mg & 100mg TABLETS
Read all of this leaflet carefully before you start taking this
medicine because it contains
important information for you. Always take this medicine exactly as
described in this leaflet
or as your doctor or pharmacist has told you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact a doctor if your symptoms worsen or do not
improve.
• If you get any side effects talk to your doctor or pharmacist.
This includes any possible
side

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Thiamine Hydrochloride 50mg Tablets
2
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, see section 4.4.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
Round, white or almost white, biconvex tablets embossed with “T50”
4
CLINICAL PARTICULARS
4.1
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
4.2
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
4.3
CONTRAINDICATIONS
Known allergy or hypersensitivity to thiamine or to any of the
excipients in
Thiamine Hydrochloride 50mg Tablets (see section 6.1).
4.4
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.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
The thiamine antagonists thiosemicarbazone and 5-fluorouracil can
neutralise
the effect of thiamine. Patients us