Thiamine 100mg tablets

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Thiamine hydrochloride

Dostępny od:

Zanza Specials International Ltd

Kod ATC:

A11DA01

INN (International Nazwa):

Thiamine hydrochloride

Dawkowanie:

100mg

Forma farmaceutyczna:

Oral tablet

Droga podania:

Oral

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 09060206; GTIN: 5060033711651

Ulotka dla pacjenta

Colours
CUSTOMER: SP
ORIGINATED BY: AWG (MAT)
PRODUCT: Thiamine Hydrochloride JNT Tablets
ITEM CODE: CP.VTB.JNT.T.SP.V5P1
DATE:
14/05/2020
REVISION:
ADDITION OF SUREPHARM SERVICES LTD AS BATCH RELEASE SITE
ARTWORK FOR SUBMISSION
Supersedes:
CP.VTB.JNT.T.SP.V4P1
DIMENSIONS: 297mm x 148mm
Pantone
280 C 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. 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 if you are taking the
following medicine because he/she may
need to adjust your thiamine dose:
• fluorouracil (used to treat certain cancers
and viral infections)
PREGNANCY, BREAST-FEEDING AND FERTILITY
Do not take Thiamine Hydrochloride Tablets
if you are pregnant or breast-feeding, think
you may be pregnant or are planning to
have a baby. Ask y

Charakterystyka produktu

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