Summary of medicine characteristics - INOSITOL NICOTINATE 750 MG TABLETS BP, HEXOPAL FORTE 750 MG TABLETS
1 NAME OF THE MEDICINAL PRODUCT
1 NAME OF THE MEDICINAL PRODUCTHexopal 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.
Ingredients with specified warnings
This medicine contains less than 1mmol sodium (23mg) per dose, that is to say essentially ‘sodium-free’.
4.5 Interaction with other medicinal products and other forms of interaction
The risk of bleeding can be increased when concomitantly taken with warfarin.
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
Nicotinic acid can cause myalgia, the risk of myalgia due to intake of lipidlowering agents, especially statins, can be increased.
Uncommon side effects include flushing, dizziness, headache, nausea, vomiting, syncope, paraesthesia, rash, oedema, and postural hypotension.
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 or search for ‘MHRA Yellow Card’ in the Google Play or Apple App Store.
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
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
6.6. Instructions for use/handlingNo special requirements.
7 MARKETING AUTHORISATION HOLDER
7 MARKETING AUTHORISATION HOLDERGenus Pharmaceuticals Limited
T/A Genus Pharmaceuticals
Linthwaite,
Huddersfield,
HD7 5QH, UK
8. MARKETING AUTHORISATION NUMBER
PL 06831/0148