Vitamin B compound strong tablets

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Nicotinamide; Pyridoxine hydrochloride; Riboflavin; Thiamine hydrochloride

זמין מ:

Genesis Pharmaceuticals Ltd

INN (שם בינלאומי):

Nicotinamide; Pyridoxine hydrochloride; Riboflavin; Thiamine hydrochloride

כמות:

20mg ; 2mg ; 2mg ; 5mg

טופס פרצבטיות:

Oral tablet

מסלול נתינה (של תרופות):

Oral

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 09060207; GTIN: 5060014442475

עלון מידע

PKD22001

מאפייני מוצר

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