PACKAGE LEAFLET: INFORMATION FOR THE USER

HEXOPAL 500MG TABLETS

(inositol nicotinate)

Read all of this leaflet carefully before you start taking this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side-effects get serious, or if you notice any side-effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Hexopal 500mg Tablets are and what they are used for

2.    Before you use Hexopal 500mg Tablets

3.    How to use Hexopal 500mg Tablets

4.    Possible side-effects

5.    How to store Hexopal 500mg Tablets

6.    Further information

1. WHAT HEXOPAL 500MG TABLETS ARE AND WHAT THEY ARE USED FOR

Hexopal 500mg Tablets contain inositol nicotinate, which works by relaxing the blood vessels. Hexopal 500mg Tablets are used to treat intermittent claudication (pain in the legs whilst walking) and Raynaud’s phenomemon (fingers and toes which go white and bloodless in the cold).

2. BEFORE YOU USE HEXOPAL 500MG TABLETS Do not use Hexopal 500mg Tablets if you:

•    are allergic (hypersensitive) to inositol nicotinate or any of the other ingredients of Hexopal 500mg Tablets (see section 6 - Further information for details)

•    have recently had a heart attack or stroke

Take special care with Hexopal 500mg Tablets if you have:

•    poor circulation to the brain (cardiovascular insufficiency)

•    chest pains (unstable angina).

Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Hexopal should not usually be used during pregnancy. If you are pregnant or planning to become pregnant you should discuss your treatment with your doctor.

3. HOW TO USE HEXOPAL 500MG TABLETS

Always take Hexopal 500mg Tablets exactly as your doctor has told you to. You should check with your doctor or pharmacist if you are not sure.

Adults and the elderly

The usual dose is two tablets three times a day (3g inositol nicotinate daily). The maximum dose is 4g of inositol nicotinate daily. Swallow the tablets with a drink of water.

Children

Hexopal 500mg Tablets should not be used in children.

Please read the back of this leaflet.

’Trademark

GENUS PHARMACEUTICALS M869

G E N/H EX500/PI L/273_01

If you take more Hexopal 500mg Tablets than you should

An overdose of this medicine may be dangerous. If you have taken an overdose, tell your doctor or go to the nearest hospital casualty department immediately.

If you forget to take Hexopal 500mg Tablets

If you forget to take a dose at the right time, take it as soon as you remember then go on as before. Do not take a double dose to make up for a forgotten tablet.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE-EFFECTS

Like all medicines, Hexopal 500mg Tablets can cause side-effects, although not everybody gets them. Uncommon side-effects include:

•    headache

•    redness of the face

•    feeling sick (nausea)

•    vomiting

•    swelling (oedema)

•    dizziness and fainting caused by low blood pressure

•    pins and needles

•    rash.

If any of the side-effects get serious or if you notice any side-effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE HEXOPAL 500MG TABLETS Keep out of the sight and reach of children.

Do not use Hexopal 500mg Tablets after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month. Store below 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. FURTHER INFORMATION

The active substance in Hexopal 500mg Tablets is inositol nicotinate.

The other ingredients are pregelatinised starch, talc, magnesium stearate, maize starch, stearic acid and sodium lauryl sulphate.

What Hexopal 500mg Tablets look like and the contents of the pack

Hexopal 500mg Tablets are white or almost white round tablets with a breakline on one side and X^v on the other. They are supplied in cartons of 100 tablets.

P

PL 06831/0147 Hexopal 500mg Tablets Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Holder: Genus Pharmaceuticals, Linthwaite, Huddersfield, HD7 5QH, UK. Manufacturer: Clonmel Healthcare Ltd., Waterford Road, Clonmel, Tipperary, Ireland.

This leaflet was last revised in August 2014.

trademark    GENUS PHARMACEUTICALS

G E N/H EX500/PI L/273_01