Summary of Product Characteristics (SmPC) - Vigranon B syrup
1 NAME OF THE MEDICINAL PRODUCT
VIGRANON-B SYRUP
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml contains
Thiamine Hydrochloride 5.00 mg Riboflavin Sodium Phosphate 2.74 mg Nicotinamide 20.00 mg Pyridoxine Hydrochloride 2.00 mg Dexpanthenol 3.00 mg
3. PHARMACEUTICAL FORM
Oral Solution
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Oral prophylactic and therapeutic treatment of vitamin B complex deficiency.
4.2 Posology and method of administration
Prophylactic
Children
up to 1 year, One 5ml spoonful daily up to 12 years, One 5ml spoonful twice daily Adults and elderly
One 5ml spoonful three times daily
Therapeutic
Children
up to 1 year, One 5ml spoonful three times daily up to 12 years, Two 5ml spoonfuls three times daily Adults and elderly
Two to three 5ml spoonfuls three times daily
Or as prescribed by a doctor
4.3 Contraindications
Known sensitivity to any of the ingredients.
4.4 Special warnings and precautions for use
No special warnings.
4.5 Interactions with other medicinal products and other forms of interaction
The pyridoxine hydrochloride may reduce the effectiveness of levodopa.
4.6 Pregnancy and lactation
Considered safe in the recommended dose.
4.7 Effects on ability to drive and use machines
None stated
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, Website: www.mhra.gov.uk/yellowcard
4.9 Overdose
Not applicable.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Vitamin B Complex.
Thiamine Hydrochloride (Vit B1): A water soluble vitamin. It is a co-enzyme for carbohydrate metabolism.
Riboflavine Sodium Phosphate (Vit B2): A water soluble vitamin converted in the body to flavine mononucleotide and flavine adenine dinucleotide and then involved as co-enzymes in oxidative and reductive metabolic processes.
Nicotinamide: A water soluble vitamin considered part of the Vitamin B group. Converted to Nicotinamide Adenine Dinucleotide and Nicotinamide Adenine Dinucleotide Phosphate in the body, both of which are co-enzymes important in electron transfer in respiratory reactions.
Pyridoxine Hydrochloride (Vit B6): A water soluble vitamin. Involved in carbohydrate and fat metabolism, but also important in haemoglobin formation.
Pantothenol: The alcoholic analogue of D-pantothenic acid traditionally considered a B vitamin. It is a component of co-enzyme A, which is important in the metabolism of fat, carbohydrate and protein.
5.2 Pharmacokinetic properties
All the actives are water soluble vitamins. Quantities in excess of the bodies requirements are excreted either unchanged or as metabolites, mainly in the urine but to a lesser extent also in the faeces.
5.3 Preclinical Safety Data
None stated
6.1 List of excipients
Disodium Edetate
Sorbitol Solution (non-crystallising) Dilute Hydrochloric Acid
Methyl Hydroxybenzoate
Ethyl Hydroxybenzoate
Propyl Hydroxybenzoate
Butyl Hydroxybenzoate
Propylene Glycol
Soluble Orange Oil Flavour Purified Water
6.2 Incompatibilities
None known.
6.3 Shelf life
36 months.
6.4 Special precautions for storage
Store between 4°C and 25°C. Protect from light.
6.5 Nature and contents of container
150ml Glass bottle.
Cap White PP28 TE CR with EPE/PE/AL/PET Wad
6.6 Instructions for use/handling
None stated
7 MARKETING AUTHORISATION HOLDER
Wallace Manufacturing Chemists Ltd.
Wallace House
51-53 Stert Street
Abingdon
Oxfordshire OX14 3JF
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 0400/5049R
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
05 March 1998
10 DATE OF REVISION OF THE TEXT
06/07/2015