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NICOTINAMIDE TABLETS 100MG

Active substance(s): NICOTINAMIDE

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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

Oral.

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

PHARMACOLOGICAL PROPERTIES

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 4pyridone 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.

6.3

Shelf life
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

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
1st October 1999

10

DATE OF REVISION OF THE TEXT
October 2003

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