Vitamin B compound strong tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Nicotinamide; Pyridoxine hydrochloride; Riboflavin; Thiamine hydrochloride

Available from:

Accord-UK Ltd

INN (International Name):

Nicotinamide; Pyridoxine hydrochloride; Riboflavin; Thiamine hydrochloride

Dosage:

20mg ; 2mg ; 2mg ; 5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 09060207; GTIN: 5012617010605

Patient Information leaflet

148x210 Leaflet Reel Fed Profile (BST)
Dimensions:
Component:
Date Sent:
Technologist: TECHNICALLY APPROVED
Pharmacode:
JDE No.:
Vitamin B Compound Strong
28 x Film-coated Tablets (UK)
148x210 (Reel Fed)
50993872
Leaflet for Blisters
4517
T. Hull
04/09/2020
approved for print/date
PROOF ROUND
Technical
Approval
DATE SENT:
DATE RECEIVED:
Item number:
ORIGINATOR:
ORIGINATION DATE:
REVISION DATE:
REVISED BY:
DIMENSIONS:
MIN BODY TEXT SIZE:
SUPPLIER:
NON PRINTING COLOURS
COLOURS
1.
2.
3.
4.
5.
6.
1.
2.
3.
[e-mail]
M.Doak
18/09/2020
148x210mm
9pt
Accord Barnstaple
N/A
N/A
VITAMIN B 28 TABLETS PIL - UK
Black
Profile
BBBA9009
1
* Please note that ONLY Artwork Studio is permitted to make changes to
the above artwork.
No changes are permitted by any 3rd party other than added notes and
mark ups for required changes.
Version 7
12.02.2020
Cartons and label leaflets only
(labels only when specified)
German GTIN 14
(incorporating PZN): N/A
Vitamin B Compound Strong
Film-coated Tablets
READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as
described in this leaflet or as your
doctor or pharmacist has told you.
• Keep this leaflet. You may need to
read it again.
• Ask your pharmacist if you need
more information or advice.
• If you get any side effects, talk
to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
• You must talk to a doctor if you do not feel
better or if you feel worse.
• The full name of this medicine is Vitamin B
Compound Strong Film-coated Tablets but
within this leaflet it will be referred to as
Vitamin B Compound Strong Tablets.
WHAT IS IN THIS LEAFLET
1 WHAT VITAMIN B COMPOUND STRONG
TABLETS ARE AND WHAT THEY ARE USED FOR
2 WHAT YOU NEED TO KNOW BEFORE YOU
TAKE VITAMIN B COMPOUND STRONG
TABLETS
3 HOW TO TAKE VITAMIN B COMPOUND
STRONG TABLETS
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE VITAMIN B COMPOUND
STRO

Summary of Product characteristics

OBJECT 1
VITAMIN B COMPOUND STRONG TABLETS
Summary of Product Characteristics Updated 14-May-2020 | Accord-UK Ltd
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
VITAMIN B COMPOUND STRONG FILM-COATED TABLETS
2. Qualitative and quantitative composition
Each tablet contains 20mg Nicotinamide, 2mg Pyridoxine Hydrochloride,
2mg Riboflavine, 4.85mg
Thiamine Mononitrate.
Also contains lactose.
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Film-coated tablet (tablet).
Brown, circular, biconvex film-coated tablets with the identifying
letters “VB” embossed on one side.
4. Clinical particulars
4.1 Therapeutic indications
1) 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
_Adults (including elderly) and