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INFORMATION FOR THE USER

IKOREL 10mg and 20mg Tablets

nicorandil

sanoFi aventis

Is this leaflet hard to see or read?

Phone 01483 505515 for help

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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Ikorel is and what it is used for

2.    Before you take Ikorel

3.    How to take Ikorel

4.    Possible side effects

5.    How to store Ikorel

6.    Further information

1. What Ikorel is and what it I J is used for    I l

The name of your medicine is Ikorel 10mg or 20mg Tablets (called Ikorel in this leaflet). The active ingredient in this medicine is called nicorandil. This belongs to a group of medicines called ‘potassium channel activators’.

It works by increasing the blood flow through the blood vessels of the heart

Ikorel is used to stop and treat long-term chest pain (angina).

2. Before you take Ikorel

Do not take this medicine and tell your doctor if:

You are allergic (hypersensitive) to nicorandil or any of the other ingredients of Ikorel (listed in Section 6 below)

Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue You have low blood pressure (signs include feeling dizzy, light-headed or faint)

You have a heart problem where it is damaged and cannot pump enough blood around the body

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x You have heart failure (signs include

shortness of breath, swollen ankles and legs, and feeling tired)

Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Ikorel.

Take special care with Ikorel

Check with your doctor or pharmacist before taking your medicine if:

▲    You have been told by your doctor that you have a low blood volume or low systolic blood pressure

▲    You have recently had a heart attack

▲    You have a build up of fluid in the lungs (pulmonary oedema)

▲    You have mouth ulcers

▲    You have bowel disease as it may get worse with Ikorel.

When taking Ikorel there is an increased risk that you may develop ulceration in different parts of your body, including your eyes and the gastro-intestinal track (gut). In some cases ulcers in the gut can rupture to cause serious bleeding. If you notice any signs of ulceration, you should seek immediate medical advice, as you will need to stop taking Ikorel (see section 4 possible side effects).

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Ikorel.

ISfgJ Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Ikorel can affect the way some other medicines work. Also some medicines can affect the way Ikorel works.

In particular, do not take this medicine, and tell your doctor if you are taking:

•    Medicines for impotence such as sildenafil, tadalafil or vardenafil

Tell your doctor if you are taking any of the following:

•    Medicines that widen the blood vessels such as hydralazine, minoxidil or nitroprusside (vasodilators)

•    Medicines for high blood pressure

•    Medicines for depression

•    Medicines for inflammation (corticosteroids such as prednisolone)

•    Medicines that increase the amount of potassium in your blood

•    Aspirin, which can lead to an increased risk of intestinal bleeding

Taking Ikorel with food and drink

Do not drink alcohol while you are taking Ikorel.

Pregnancy and breast-feeding

Talk to your doctor before taking this medicine if you are pregnant, might become pregnant, or think you may be pregnant.

You should not breast-feed if you are taking Ikorel. This is because small amounts may pass into mothers’ milk. If you are breast-feeding or planning to breast-feed, talk to your doctor or pharmacist before taking this medicine.

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

Driving and using machines

You may feel dizzy while taking this medicine.

If this happens, do not drive or use any tools or machines.

3. How to take Ikorel

Always take Ikorel exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

You should not take the tablets, which are included in the pack to protect Ikorel tablets from moisture. If you do accidentally take any of these tablets, they should not harm you, but you should tell you doctor straight away.

Taking this medicine

•    Take this medicine by mouth

•    Swallow the tablets whole with a drink of water. Do not crush or chew the tablets

•    If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor

How much to take

•    The usual dose is 10mg or 20mg taken in the morning and evening.

•    Your doctor might increase this to 30mg twice a day if necessary.

•    If you have a tendency to get headaches, your doctor may start you on a lower dose of 5mg (half a 10mg tablet) twice a day.

Children

Ikorel is not recommended in children.

If you take more Ikorel than you should

If you take more tablets than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken. The following effects may happen: you may feel dizzy or weak or have difficulty in breathing or wheezing.

Turn

Over

Very rare

•    Ulcers of the genital tract

•    Skin ulcers, possibly on the hands, legs, or feet

•    Ulcers in the nasal passages

•    Ulcers around a stoma (in those with an artificial opening for waste removal such as a colostomy or ileostomy)

•    Weakness, fatigue and a slow heart beat due to high levels of potassium in the blood

•    Red, itchy, swollen, watery eyes or painful eyes with blurred vision due to ulcers in the eyes.

Tell your doctor as soon as possible if

you have any of the following side-effects:

Very Common (affects more than 1 in 10

people)

•    Headache. These are more common when you first start taking Ikorel

Common (affects less than 1 in 10 people)

•    Feeling dizzy or weak

•    Feeling sick or being sick

•    Flushing of the skin

Uncommon (affects less than 1 in 100 people)

•    Feeling dizzy, lightheaded or fainting (due to low blood pressure)

•    Mouth ulcers

•    Pain in your muscles

Rare (affects less than 1 in 1000 people)

•    Skin rashes

Very Rare (affects less than 1 in 10,000 people)

•    Stomach pain

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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. m h ra.gov, u k/ve11owca rd.

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

5. How to store Ikorel

Keep this medicine in a safe place where children cannot see or reach it.

Do not use Ikorel after the expiry date which is stated on the carton after ‘EXP’.

The expiry date refers to the last day of that month.

Do not store above 25°C. Keep the blister strip in the outer carton in order to protect from moisture.

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 to protect the environment.

6. Further information

What Ikorel Tablets contain

•    Each tablet contains 10mg or 20mg of the active substance, nicorandil.

•    The other ingredients are corn starch, croscarmellose sodium, stearic acid and mannitol.

What Ikorel Tablets look like and contents of the pack

Ikorel Tablets are off-white, round, scored with IK10 or IK20 engraved on the tablets.

Also included in the carton are tablets, which help to protect Ikorel Tablets from moisture. These are included in a blister labelled differently from the Ikorel Tablets.

They are supplied in cartons of 10, 20, 30, 40, 50, 60, 70, 80, 90 or 100 tablets.

Not all pack sizes may be marketed.

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Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sanofi-aventis

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

Tel: 01483 505515 Fax: 01483 535432 email:

uk-medicalinformation@sanofi-aventis.com

Manufacturer

Sanofi Winthrop Industrie

56 route de Choisy-au-Bac

60205 Compiegne Cedex - France

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

This leaflet was last revised in April 2014 © Sanofi-aventis, 1999 - 2014