Vitamin B compound tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Nicotinamide; Riboflavin; Thiamine hydrochloride

Available from:

BR Pharmaceuticals Ltd

INN (International Name):

Nicotinamide; Riboflavin; Thiamine hydrochloride

Dosage:

15mg ; 1mg ; 1mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 09060207

Patient Information leaflet

CLIENT:
PROJECT:
ITEM(S):
Almus UK
11638 / UK
Vitamin B Compound
Tablets BPC
(nicotinamide, thiamine
hydrochloride and
riboflavin)
Carton artwork
COLOURS USED:
Checked by:
Paul Adams
Queries regarding this artwork,
please contact: Steve Hobbs or
Paul Adams
Date:
26.7.2018
PMS
2945
PMS
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CUTTER
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BARCODE 5055382301363
ALMUS CODE A0136a/2
REVISED ARTWORK FOR MHRA APPROVAL
VERSION: 2 (DALKEITH)
DRAFT ISSUE: 2
REASON FOR CHANGE: TEXT UPDATES
SUPPLIER ISSUE DATE: 26.7.2018
5 055382 301363
VITAMIN B
COMPOUND
TABLETS BPC
(nicotinamide,
thiamine and
riboflavin)
28
Tablets
Oral use
A0136a/2 L3874/2
ask your doctor or pharmacist. Carry on
taking them for as long as you have been
told unless you have any problems. In
that case, check with your doctor.
THE USUAL DOSES ARE AS FOLLOWS:
ADULTS, THE ELDERLY AND CHILDREN OVER
12 YEARS:
Take one to three tablets daily.
The tablets are not recommended for
children under 12 years.
IF YOU TAKE MORE TABLETS THAN YOU
SHOULD
If you have taken more tablets than
you should, speak to your doctor or
pharmacist straightaway. Take your
tablets or the pack with you.
IF YOU FORGET TO TAKE YOUR TABLETS
If you miss a dose don't worry. Miss this
dose and carry on with the normal routine.
Vitamin B Tablets are suitable for most
occur with these tablets.
doctor, pharmacist or nurse. This includes
directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
provide more information on the safety
of this medicine.
5. HOW TO STORE THESE TABLETS
Keep out of the sight and reach of children.
Do not store above 25°C. Store in the
original container. Keep container tightly
closed. Do not use the tablets after the
expiry date shown on the label.
Take any left over back to your
pharmacist to be destroyed.
6. FURTHER INFORMATION
INGREDIENTS
Each round, yellow tablet contains
15 mg nicotinamide, 1 mg

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Vitamin B Compound Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nicotinamide 15.0 mg
Thiamine Hydrochloride 1.0 mg
Riboflavin 1.0 mg.
Excipient with known effect:
Each tablet contains lactose 122.0 mg
For the full list of excipients see section 6.1
3
PHARMACEUTICAL FORM
Tablet.
Plain yellow, uncoated round tablet
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the prophylaxis of Vitamin B deficiencies; as a nutritional
supplement in
the elderly; and as an aid to convalescence after illness or surgery.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
Adults, the elderly and children over 12 years: One to three tablets
daily.
Not recommended for children under 12 years of age.
4.3
CONTRAINDICATIONS
Known hypersensitivity to any of the ingredients present.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
These tablets are not suitable for the treatment of symptomatic
Vitamin B
complex deficiencies.
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
None known.
4.6
FERTILITY, PREGNANCY AND LACTATION
Widespread use over the years has not shown any problems when used
during
pregnancy and breastfeeding.
4.7
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
No or negligible influence.
4.8
UNDESIRABLE EFFECTS
None known.
REPORTING OF SUSPECTED ADVERSE REACTIONS:
Reporting suspected adverse reactions after authorisation of the
medicinal product is
important. It allows continued monitoring of the benefit/risk balance
of the medicinal
product. Healthcare professionals are asked to report any suspected
adverse reactions
via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9
OVERDOSE
If large amounts are ingested accidentally, treat symptomatically.
5
PHARMACOLOGICAL PROPERTIES
5.1
PHARMACODYNAMIC PROPERTIES
A11E A – Vitamin B-Complex, Plain
Thiami