SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Hexopal Forte 750mg Tablets Inositol Nicotinate 750mg Tablets BP

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains Inositol Nicotinate BP 750 mg.

For excipients, see 6.1.

3.    PHARMACEUTICAL FORM

Tablets

4.    CLINICAL PARTICULARS

4.1.    Therapeutic indications

Hexopal is indicated for the symptomatic relief of severe intermittent claudication and Raynauds phenomenon.

4.2.    Posology and method of administration

Adults: The usual dose is 3g daily (two Hexopal Forte Tablets twice daily). The dose of Hexopal may be increased up to 4g daily if necessary.

Oral administration.

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. Interactions 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 any 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.

PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties

In addition to a vasodilator effect, thought to be due to the slow release of nicotinic acid, Hexopal has been reported to reduce fibrinogen and blood viscosity and to have a beneficial effect on the fibrinolytic system and on blood lipids.

5.2. Pharmacokinetic properties

Pharmacokinetic Group: Peripheral Vasodilators, ATC CODE: CO4A C03 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

None.

6. PHARMACEUTICAL PARTICULARS 6.1. List of excipients

Pregelatinised starch, Talc, Magnesium stearate, Maize starch, Stearic acid and Sodium Lauryl Sulphate.

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

60 months.

6.4.    Special precautions for storage

The product should be stored below 25°C.

6.5.    Nature and contents of container

Amber glass bottles containing 100, 250 and 500 tablets.

250 pm clear PVC/20pm aluminium blister pack containing 112 tablets.

Not all pack sizes may be marketed.

6.6.    Instructions for use/handling

No special requirements.

7    MARKETING AUTHORISATION HOLDER

Genus Pharmaceuticals Limited T/A Genus Pharmaceuticals Linthwaite,

Huddersfield,

HD7 5QH, UK

8.    MARKETING AUTHORISATION NUMBER

PL 06831/0148

9.    DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION

10^th May 2005

10 DATE OF REVISION OF THE TEXT

13/11/2014