Vitamin B compound tablets

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Nicotinamide; Riboflavin; Thiamine hydrochloride

Beschikbaar vanaf:

Alliance Healthcare (Distribution) Ltd

INN (Algemene Internationale Benaming):

Nicotinamide; Riboflavin; Thiamine hydrochloride

Dosering:

15mg ; 1mg ; 1mg

farmaceutische vorm:

Oral tablet

Toedieningsweg:

Oral

klasse:

No Controlled Drug Status

Prescription-type:

Valid as a prescribable product

Product samenvatting:

BNF: 09060207

Productkenmerken

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