Hexopal 500mg Tablets

1. Name Of The Medicinal Product

Hexopal Tablets 500mg / Inositol Nicotinate Tablets BP 500mg.

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.

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 wadless polypropylene screws caps.

Pack size: 100 and 500 tablets.

200µm white opaque PVC/20µm aluminium blister pack.

Pack size: 100 tablets.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Genus Pharmaceuticals Limited (trading as Genus Pharmaceuticals)

Park View House

65 London Road

Newbury

Berkshire

RG14 1JN UK

8. Marketing Authorisation Number(S)

PL 06831/0147

9. Date Of First Authorisation/Renewal Of The Authorisation

10^th May 2005

10. Date Of Revision Of The Text

15 January 2008