SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Hexopal 500mg Tablets

Inositol Nicotinate 500mg Tablets BP

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Inositol Nicotinate BP 500mg

3 PHARMACEUTICAL FORM

Tablet

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Hexopal is indicated for the symptomatic relief of severe intermittent claudication and Raynaud’s phenomenon.

4.2 Posology and method of administration

For oral administration

Adults (including the elderly): The usual dose is 3g daily (i.e. 2 tablets three times a day). The dose may be increased to 4g daily if necessary.

Children: Not recommended.

4.3 Contraindications

Use in patients who have suffered a recent myocardial infarction or are in the acute phase of a cerebrovascular accident.

Use in patients hypersensitive to the active ingredient.

4.4 Special warnings and precautions for use

This product should be used with caution in the presence of cerebrovascular insufficiency or unstable angina.

4.5 Interaction with other medicinal products and other forms of interaction

None

4.6 Pregnancy and lactation

There is no evidence of the safety of Hexopal in human pregnancy nor is there adequate evidence from animal work that it is free from hazard. The use of Hexopal in pregnancy should therefore be avoided unless there is no safer alternative.

4.7 Effects on ability to drive and use machines

None

4.8. Undesirable Effects

Side effects are uncommon, but may include flushing, dizziness, headache, nausea, vomiting, syncope, paraesthesia, rash, oedema, and postural hypotension.

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 at: www.mhra.gov.uk/yellowcard

4.9 Overdose

Despite extensive clinical experience in Britain since 1959, no case of poisoning or overdosage with Hexopal has been reported. In an emergency, it is suggested that the stomach be emptied by gastric lavage and the patient be treated symptomatically.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

The mode of action of inositol nicotinate in Raynaud’s phenomenon and in intermittent claudication remains to be determined. Inositol nicotinate does not appear to produce general peripheral vasodilation.

5.2 Pharmacokinetic properties

Radiolabelled tracer studies indicate that with orally administered inositol nicotinate very low concentrations of nicotinic acid are found in the plasma. These levels appear to be maintained for approximately 24 hours.

5.3 Preclinical safety data

There are no preclinical safety data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Pregelatinised starch, Maize starch, Purified talc, Magnesium stearate, Stearic acid, Sodium lauryl sulphate

6.2    Incompatibilities

None

6.3 Shelf life

60 months

6.4    Special precautions for storage

Store below 25°C

6.5    Nature and contents of container

Amber glass bottle with wadded white tinplate screws caps

Pack size: 100 and 500 tablets

200pm white opaque PVC/20pm aluminium blister packs Pack size: 100 tablets

6.6 Special precautions for disposal

None

7 MARKETING AUTHORISATION HOLDER

Genus Pharmaceuticals Limited T/A Genus Pharmaceuticals Linthwaite,

Huddersfield,

HD7 5QH, UK

MARKETING AUTHORISATION NUMBER(S)

PL 06831/0147

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

10/05/2005

DATE OF REVISION OF THE TEXT

13/11/2014