Vitamin B compound strong tablets

国: イギリス

言語: 英語

ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)

有効成分:

Nicotinamide; Pyridoxine hydrochloride; Riboflavin; Thiamine hydrochloride

から入手可能:

Healthcare Pharma Ltd

INN（国際名）:

Nicotinamide; Pyridoxine hydrochloride; Riboflavin; Thiamine hydrochloride

投薬量:

20mg ; 2mg ; 2mg ; 5mg

医薬品形態:

Oral tablet

クラス:

No Controlled Drug Status

処方タイプ:

Valid as a prescribable product

製品概要:

BNF: 09060207; GTIN: 5060013770135

情報リーフレット

PKD22001

製品の特徴

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