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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