- 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 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
- Administrative data
- 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 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. 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 children over 3 years: One to two tablets three times daily.Children under 3 years: Not recommended.For oral administration.
Known hypersensitivity to any of the active constituents.
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 B6 in doses which greatly exceed the daily requirement. This does not apply when levodopa is combined with a peripheral decarboxylase inhibitor.
4.6 Pregnancy and lactation
The usual precautions should be observed when administering drugs during pregnancy, especially in the first trimester.In high doses, pyridoxine may interfere with prolactin release and should only be used with caution in nursing mothers.
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
Toxic effects are unlikely since any excess vitamin B is excreted. 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
Excess vitamin B is readily excreted, therefore no serious problems are anticipated for the administration of vitamin B in this form.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Nicotinamide is a vitaminPyridoxine hydrochloride is a vitamin (B6)Riboflavine is a vitamin (B2)Thiamine mononitrate is a vitamin (B1)The vitamin B-complex comprises a group of water-soluble factors more or less closely associated in their natural occurrence. It is known that nearly every vitamin of the B-complex forms part of a co-enzyme essential for the metabolism of protein, carbohydrate or fatty acid.
5.2 Pharmacokinetic properties
Nicotinamide is readily absorbed from the GI tract following oral administration and is widely distributed in the body tissues. Small amounts of nicotinamide are excreted unchanged in urine following therapeutic doses, however, the amount excreted unchanged is increased with larger doses. Pyridoxine is absorbed from the GI tract and is converted to the active form pyridoxal phosphate. It is excreted in the urine as 4-pyridoxic acid.Riboflavine is absorbed from the GI tract and in the circulation is bound to plasma proteins. Although widely distributed, little is stored in the body, and amounts in excess of requirements are excreted in the urine.Thiamine is absorbed from the GI tract and is widely distributed to most body tissues. It is not stored to any appreciable extent in the body and amounts in excess of requirements are excreted in the urine as unchanged thiamine or metabolites.
5.3 Preclinical safety data
6. Pharmaceutical particulars
6.1 List of excipients
Tablet core contains: Lactose monohydrateMagnesium stearateMaize starchPregelatinised maize starchStearic acidFilm-coat contains:Hypromellose Hydroxypropyl Cellulose Medium Chain Triglycerides Macrogol 3350 Titanium Dioxide (E171) Iron oxide Red (E172) Iron oxide Black (E172)
6.3 Shelf life
Shelf-lifeThree years from the date of manufacture.
Shelf-life after dilution/reconstitutionNot applicable.
Shelf-life after first openingNot applicable.
6.4 Special precautions for storage
Store below 25°C in a dry place.
6.5 Nature and contents of container
The product containers are rigid injection moulded polypropylene or injection blow-moulded polyethylene tablet containers with polyfoam wad or polyethylene ullage filler and snap-on polyethylene lids; in case any supply difficulties should arise the alternative is amber glass bottles with screw caps and polyfoam wad or cotton wool.The product may also be supplied in blister packs in cartons:a) Carton: Printed carton manufactured from white folding box board.b) Blister pack: (i) 250µm white rigid PVC. (ii) Surface printed 20µm hard temper aluminium foil with 5-7g/M² PVC and PVdC compatible heat seal lacquer on the reverse side.Pack sizes: 28, 30, 56, 60, 84, 90, 100, 112, 120, 168, 180, 250, 500, 1000.Product may also be supplied in bulk packs, for reassembly purposes only, in polybags contained in tins, skillets or polybuckets filled with suitable cushioning material. Bulk packs are included for temporary storage of the finished product before final packaging into the proposed marketing containers.Maximum size of bulk packs: 50,000.
6.6 Special precautions for disposal and other handling
7. Marketing authorisation holder
Name or style and permanent address of registered place of business of the holder of the Marketing Authorisation:Actavis UK Limited (Trading style: Actavis)Whiddon ValleyBARNSTAPLEN Devon EX32 8NS
8. Marketing authorisation number(s)
PL 0142/5538 R
9. Date of first authorisation/renewal of the authorisation
Granted: 19.9.86(Product Licence of Right: 31.5.73)(Renewed: 23.12.91, 26.4.99)
10. Date of revision of the text
Actavis UK Ltd
Whiddon Valley, Barnstaple, Devon, EX32 8NS, UK
+44 (0)1271 346 106
Medical Information e-mail
+44 (0)1271 311 200
Medical Information Direct Line
+44 (0)1271 385 257