Vitamin B compound tablets

Negara: Inggris

Bahasa: Inggris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Nicotinamide; Riboflavin; Thiamine hydrochloride

Tersedia dari:

Ennogen Healthcare Ltd

INN (Nama Internasional):

Nicotinamide; Riboflavin; Thiamine hydrochloride

Dosis:

15mg ; 1mg ; 1mg

Bentuk farmasi:

Oral tablet

Rute administrasi :

Oral

Kelas:

No Controlled Drug Status

Jenis Resep:

Valid as a prescribable product

Ringkasan produk:

BNF: 09060207

Selebaran informasi

Artwork No.
Customer
Description
Market
Language
Size
Min. Font Size
Page No.
Version No.
Date
Software
211117/3
Ennogen
Vitamin B Compound_label-leafle
UK
English
420 x 32mm
8 pt
1 of 1
1
21-11-17
Coreldraw 12
Packaging Development
Quality Assurance (QA)
Quality Control (QC)
Production
e-mail : [e-mail]
Ph : [phone]
Colours Used
PANTONE 185 C
PANTONE 137 C
Black
Keyline
Braille Text
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customer.
If you sign this proof you are signifying full approval of design and
text.
Read the leaflet carefully and keep it in
case you want to read it again.
Do not share medicines with other people.
If any of the side effects get serious, or if
you have any other questions, speak to
your doctor or pharmacist.
Patient Information Leaflet
(nicotinamide, thiamine
hydrochloride and riboflavin)
1. WHAT THESE TABLETS ARE AND WHAT
THEY ARE USED FOR
These tablets contain three vitamins
as the active ingredients. These are
nicotinamide, thiamine hydrochloride
and riboflavin (Vitamins B3, B1 and B2).
Vitamins are essential nutrients for the
body.
These tablets are used to prevent Vitamin
B deficiencies, as a nutritional supplement
in the elderly and to help your recovery
after illness or surgery.
2. BEFORE YOU TAKE THESE TABLETS
DO NOT TAKE THESE TABLETS IF:
• You know you are allergic to the active
ingredients or to any of the other
ingredients (these are listed in section 6)
You must be ESPECIALLY CAREFUL if:
You have an intolerance to some sugars.
These tablets contain small amounts of
lactose.
Discuss your t

Karakteristik produk

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