Thiamine 50mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Thiamine hydrochloride

Available from:

NorthStar Healthcare Unlimited Company

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: 5051089990282

Patient Information leaflet

PARTICULARS TO APPEAR ON
{POT – OUTER }
1.
NAME OF THE MEDICINAL PRODUCT
Thiamine Hydrochloride 50mg Tablets
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains 50mg of the active substance thiamine
hydrochloride (vitamin B
1
)
3.
LIST OF EXCIPIENTS
Also contains lactose monohydrate
4.
PHARMACEUTICAL FORM AND CONTENTS
100 Tablets
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
For oral use
DOSAGE:
(Adults and children over 12 years of age)
Mild thiamine deficiency: 1-2 tablets once a day.
Severe thiamine deficiency: 2 tablets 2-3 times a day.
The tablets should be swallowed with water. Do not chew the tablets.
6.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF
THE SIGHT AND REACH OF CHILDREN
K
EEP OUT OF THE SIGHT AND REACH OF CHILDREN
.
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
If your condition does not improve, tell your doctor.
8.
EXPIRY DATE
EXP:
9.
SPECIAL STORAGE CONDITIONS
Store below 25ºC. Store in the original pack.
10.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
11.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
PL HOLDER:
Athlone Pharmaceuticals Limited,
Ballymurray, Co. Roscommon, Ireland.
12.
MARKETING AUTHORISATION NUMBER(S)
PL 30464/0136
13.
BATCH NUMBER<, DONATION AND PRODUCT CODES>
_ _
BN:
14.
GENERAL CLASSIFICATION FOR SUPPLY
_ _
P
15.
INSTRUCTIONS ON USE
READ THE PACKAGE LEAFLET CAREFULLY BEFORE USING THIS PRODUCT.
AFTER OPENING PLEASE USE IN 100 DAYS
USE BY DATE…………………..
16.
INFORMATION IN BRAILLE
Thiamine Hydrochloride #50mg Tablets
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

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