Benerva 100mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Thiamine hydrochloride

Available from:

Teofarma S.r.l.

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; GTIN: 5010605116131

Patient Information leaflet

02420163P00310163L02-M045UBRUS
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This medicine is available without prescription.
However, you still need to take Benerva 100mg
tablets carefully to get the best results from it.
•
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 have any unusual effects after using this
product, tell your doctor or pharmacist.
IN THIS LEAFLET
1.
What are Benerva 100mg tablets and what are
they used for?
2.
Before you use Benerva 100mg tablets
3.
How to use Benerva 100mg tablets
4.
Possible side effects
5.
How to store Benerva 100mg tablets
6.
Further information
1.
WHAT ARE BENERVA
® 100MG TABLETS AND
WHAT ARE THEY USED FOR?
Benerva 100mg 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 Benerva 100mg tablets, you can make sure
you have sufficient thiamine in your diet.
2.
BEFORE YOU TAKE BENERVA
® 100MG
TABLETS
DO NOT TAKE BENERVA 100MG TABLETS IF YOU ARE:
•
Allergic (hypersensitive) to thiamine or any of the
other ingredients in the product (_see section 6,_
_Further Information_).
•
Under 12 years of age.
IMPORTANT INFORMATION ABOUT SOME OF THE
INGREDIENTS:
These tablets contain lactose and sucrose. If you
have been told by your doctor that you have an
intolerance to some sugars, speak to your doctor
before taking this medicine.
TAKING OTHER MEDICINES:
Tell your doctor or pharmacist if you are taking an

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Benerva 100mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Benerva 100mg Tablets are a thiamine (vitamin B1)-containing
monovitamin
product.
Each tablet contains thiamine hydrochloride, 100mg.
This product contains lactose and sucrose, see section 4.4.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
Round, white or almost white, biplanar tablets with bevelled edges
embossed ‘100
Benerva’ on one side.
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 Benerva
100mg 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.
This product contains sucrose. Patients with rare hereditary problems
of fructose
intolerance, glucose-galactose malabsorption or sucrase-isomaltase
insufficiency
should not take this medicine.
4.5
INTERACTION WITH OTHER MEDICINA