Home | About the eMC | Help | Mobile
eMC - trusted, up to date and comprehensive information about medicines
Link to eMC medicine guides website
eMC homepage
Advanced search
Get Medicines Compendium UK app here

Genus Pharmaceuticals
Park View House, 65 London Road, Newbury, Berkshire, RG14 1JN
Telephone: +44 (0)1635 568 400
Fax: +44 (0)1635 568 401
Medical Information Direct Line: +44 (0)870 851 0207
Medical Information e-mail: genus@medinformation.co.uk
Customer Care direct line: +44 (0)1635 568 445
Medical Information Fax: +44 (0)1793 710 387

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Summary of Product Characteristics last updated on the eMC: 21/05/2008
SPC Hexopal 500mg Tablets


Go to top of the page
1. NAME OF THE MEDICINAL PRODUCT

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


Go to top of the page
2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Inositol Nicotinate BP 500mg.


Go to top of the page
3. PHARMACEUTICAL FORM

Tablet.


Go to top of the page
4. CLINICAL PARTICULARS

Go to top of the page
4.1 Therapeutic indications

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


Go to top of the page
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.


Go to top of the page
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.


Go to top of the page
4.4 Special warnings and precautions for use

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


Go to top of the page
4.5 Interaction with other medicinal products and other forms of interaction

None.


Go to top of the page
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.


Go to top of the page
4.7 Effects on ability to drive and use machines

None.


Go to top of the page
4.8 Undesirable effects

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


Go to top of the page
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.


Go to top of the page
5. PHARMACOLOGICAL PROPERTIES

Go to top of the page
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.


Go to top of the page
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.


Go to top of the page
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.


Go to top of the page
6. PHARMACEUTICAL PARTICULARS

Go to top of the page
6.1 List of excipients

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


Go to top of the page
6.2 Incompatibilities

None.


Go to top of the page
6.3 Shelf life

60 months.


Go to top of the page
6.4 Special precautions for storage

Store below 25°C.


Go to top of the page
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.


Go to top of the page
6.6 Special precautions for disposal and other handling

None.


Go to top of the page
7. MARKETING AUTHORISATION HOLDER

Genus Pharmaceuticals Limited (trading as Genus Pharmaceuticals)

Park View House

65 London Road

Newbury

Berkshire

RG14 1JN UK


Go to top of the page
8. MARKETING AUTHORISATION NUMBER(S)

PL 06831/0147


Go to top of the page
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

10th May 2005


Go to top of the page
10. DATE OF REVISION OF THE TEXT

15 January 2008



More information about this product

Link to this document from your website: http://www.medicines.org.uk/emc/medicine/16947/SPC/


Active Ingredients/Generics

 
  inositol nicotinate