Thiamine 100mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Thiamine hydrochloride

Available from:

DE Pharmaceuticals

ATC code:

A11DA01

INN (International Name):

Thiamine hydrochloride

Dosage:

100mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 09060206

Patient Information leaflet

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 EFFECTS NOT LISTED IN THIS LEAFLET. SEE SECTION 4
1.
WHAT THIAMINE HYDROCHLORIDE TABLETS ARE AND WHAT THEY
ARE USED FOR
Thiamine Hydrochloride Tablets are vitamin tablets which contain
thiamine (vitamin B
1
). They are
used to treat thiamine deficiency (when your body does not have enough
of the vitamin).
Even though thiamine is found naturally in many foods (especially in
yeast, wholegrain cereals, meats
and beans), sometimes your body requires a supplement. This may be
because your diet does not
contain enough thiamine or you may not be absorbing it from your diet
effectively. You may also
have a special need for extra thiamine, especially if you are
excreting it quickly from your body (e.g.
in your urine). By taking Thiamine Hydrochloride Tablets, you can make
sure you have sufficient
thiamine in your diet.
2.
WHAT
YOU
NEED
TO
KNOW
BEFORE
YOU
TAKE
THIAMINE
HYDROCHLORIDE TABLETS
DO NOT TAKE THIAMINE HYDROCHLORIDE TABLETS IF YOU ARE:
•
Allergic (hypersensitive) to thiamine or any of the other ingredients
in this medicine (see
section 6, Contents of the pack and other information)
•
Under 12 years of age
OTHER MEDICINES AND THIAMINE HYDROCHLORIDE TABLETS:
Tell your doctor or pharmacist if you are taking any other medicines,
including those obtained without
a prescription, such as vitamins or herbal preparations which you have
bought yourself.
Certain medicines can reduce the effect of your thiamine tablets.
Tell your doctor i

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Thiamine Hydrochloride 100mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Thiamine Hydrochloride 100mg Tablets are a thiamine (vitamin B1)-
containing monovitamin product.
Each tablet contains thiamine hydrochloride, 100mg.
Excipient(s) with known effect:
This product contains lactose monohydrate, see section 4.4.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
Round, white or almost white, biconvex tablets embossed with
“T100”
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