Nicotinamide Tablets 100mg
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nicotinamide Tablets 100 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Nicotinamide BP 100 mg
3 PHARMACEUTICAL FORM
Tablet
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Treatment of nicotinic acid deficiency.
4.2 Posology and method of administration
Adults, the elderly and children over twelve years One to three tablets daily in divided doses.
Children under twelve years Not recommended.
Route of administration
4.3 Contraindications
None known
4.4 Special warnings and precautions for use
None
4.5 Interaction with other medicinal products and other forms of interaction
None known.
4.6 Fertility, pregnancy and lactation
Nicotinamide is acceptable for use in pregnancy and lactation at normal doses.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
None known.
4.9 Overdose
Overdose with nicotinamide does not appear to have been reported. Adverse effects of the related nicotinic acid are usually not serious and subside on withdrawal of the drug.
5.1 Pharmacodynamic properties
Nicotinamide is converted in the body to the enzymes nicotinamide adenine dinucleotide and nicotinamide adenine dinucleotide phosphate which are involved in electron transfer reactions in the respiratory chain.
5.2 Pharmacokinetic properties
Nicotinamide is readily absorbed from the gastro-intestinal tract following oral administration and widely distributed in the body tissues. The main route of metabolism is conversion to n-methylnicotinamide and the 2-pyridone and 4-pyridone derivatives; nicotinuric acid is also formed. Small amounts of nicotinamide are excreted unchanged in urine following therapeutic doses; however the amount excreted unchanged is increased with larger doses.
5.3 Preclinical safety data
No relevant data.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sago Flour Dolomite
Vegetable Fatty Acid Gum Acacia
Gum Acacia (as 10% mucilage)
6.2 Incompatibilities
None known.
Shelf life
6.3
36 months.
6.4 Special precautions for storage
In well closed containers, in a dry place protected from light.
6.5 Nature and contents of container
High impact polystyrene white or polystyrene amber co-plastic bottles. Pack size: 100 and 1000 tablets
6.6 Special precautions for disposal
None
7 MARKETING AUTHORISATION HOLDER
Nutrition Warehouse Limited Samuel Ryder House Townsend Drive Attleborough Fields Nuneaton Warwickshire CV11 6XW United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 14010/0006
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 1st October 1999
10 DATE OF REVISION OF THE TEXT
October 2003