Vitamin B compound strong tablets

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiva substanser:

Nicotinamide; Pyridoxine hydrochloride; Riboflavin; Thiamine hydrochloride

Tillgänglig från:

Healthcare Pharma Ltd

INN (International namn):

Nicotinamide; Pyridoxine hydrochloride; Riboflavin; Thiamine hydrochloride

Dos:

20mg ; 2mg ; 2mg ; 5mg

Läkemedelsform:

Oral tablet

Klass:

No Controlled Drug Status

Receptbelagda typ:

Valid as a prescribable product

Produktsammanfattning:

BNF: 09060207; GTIN: 5060013770135

Bipacksedel

PKD22001

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Vitamin B Compound Strong Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains
20mg Nicotinamide,
2mg Pyridoxine Hydrochloride,
2mg Riboflavine and
4.85mg Thiamine Mononitrate.
Excipient with known effect: lactose.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Film-coated tablet (Tablets)
Brown coloured, circular, film coated tablets with debossed ‘BP’
on one side
and ‘2’ on other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of clinical and sub-clinical vitamin B deficiency
states
(manifestations
of
which
include
glossitis,
stomatitis,
cheilosis,
the
heart
manifestations
of
beriberi,
the
skin
manifestations
of
pellagra,
corneal
vascularisation and polyneuritis).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults (including elderly) and children over 3 years: One to two
tablets three
times daily.
_Paediatric population_
Should not be used in children under 3 years.
Method of administration
For oral administration.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
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
Pyridoxine may increase the peripheral metabolism of levodopa,
reducing therapeutic
efficacy of the latter drug. Therefore, patients with Parkinson's
disease who are
receiving treatment with plain levodopa should not take vitamin B
6
in doses which
greatly exceed the daily requirement. This does not apply when
levodopa is combined
with a peripheral decarboxylase inhibitor.
4.6
FERTILITY, PREGNANCY AND LACTATION
PREGNANCY:
There is limited amount of data from the use of the product in
pregnant
women. Animal studies are insufficient with respect to repro