PACKAGE LEAFLET: INFORMATION FORTHE USER

Nicorandil lOmg Tablets Nicorandil 20mg Tablets

Nicorandil

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, askyour 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 Nicorandil is and what it is used for

2.    Before you take Nicorandil

3.    How to take Nicorandil

4.    Possible side effects

5.    How to store Nicorandil

6.    Further information

1.    WHAT NICORANDIL IS AND WHAT IT IS USED FOR

Nicorandil belongs to a group of medicines called "potassium channel activators". Your doctor has prescribed Nicorandil to help relieve your angina.

Angina is a chest pain that occurs when the heart muscle does not receive enough blood to supply it with oxygen when it is working hard. Angina can be brought on by physical activity, sudden cold or stress.

Nicorandil relieves angina by widening the blood vessels that supply the heart muscle to increase the blood supply. Nicorandil also opens up blood vessels elsewhere in the body to reduce the amount of work the heart has to do to pump blood around the body.

2.    BEFORE YOU TAKE NICORANDIL

Do not take Nicorandil:

•    If you are allergic (hypersensitive) to nicorandil or any of the other ingredients in this medicine. (See section 6 of this leaflet for a list of ingredients). Signs of allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.

•    If you have any heart conditions such as a low blood output from the heart or if you have suffered from heart failure

•    If you have low blood pressure.

•    If you are using medicines for treating impotence such as sildenafil, tadalafil and vardenafil.

Take special care with Nicorandil

Tell your doctor before you take Nicorandil if you:

-    have severe mouth ulcerations.

-    are taking medicines to treat high blood pressure

-    are taking medicines to treat inflammation (corticosteroids).

Children and adolescents under the age of 18 years

Nicorandil is not recommended for use in children and adolescents under the age of 18 years.

Taking/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.

Nicorandil can affect the way some other medicines work and some medicines can affect the way nicorandil works.

Please tell your doctor if you are taking or have recently taken:

•    medicines for blood pressure or angina that work on blood vessels such as hydralazine and minoxidil

•    antidepressants such as amitryptiline, doxepin and imipramine

•    medicines used to treat impotence such as sildenafil, tadalafil and vardenafil (as these should not betaken whilstyouareon nicorandil - see Do not take Nicorandil above.

Taking Nicorandil with food and drink:

Alcohol may increase the blood pressure lowering effects of nicorandil. Discuss with your doctor if it is appropriate for you to have alcohol whilst taking this medicine but be aware that the combination may adversely affect your ability to drive and use machinery (see Driving and using machines below).

Pregnancy and breast-feeding:

Askyour doctor or pharmacist for advice before taking any medicine.

If you are pregnant or think you might be pregnant you should talk to your doctor before taking Nicorandil

Nicorandil may not be suitable for you if you are breast-feeding - seek advice from your doctor.

Driving and using machines:

You may feel dizzy and or light-headed whilst taking this medicine.This may be more likely if you are taking other medicines (especially those used to treat high blood pressure and some medicines for depression) and if you have been drinking alcohol. If you are affected you should not drive, use machinery or take part in any activities where these effects may put you or others at risk.

3. HOW TO TAKE NICORANDIL

Always take Nicorandil exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. You should continue to take your Nicorandil for as long as your doctor tells you to.

Tablets should be swallowed whole or halved with a glass of water at the same time each day.

Adults and the elderly:

Your doctor will usually start your treatment with a dose of 10 mg twice daily, to be taken in the morning and evening. Your doctor may increase

this dose if necessary. The usual maximum dose is 30 mg twice daily.

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

The same doses can be used in patients that are older than 70 years of age.

If you take more Nicorandil than you should:

If you take more Nicorandil tablets than you should contact your doctor or the nearest hospital emergency department. Symptoms of overdose are you may feel dizzy or weak or have difficulty breathing or experience wheezing.

If you forget to take a Nicorandil:

Do not worry if you have missed a dose. Take your next dose at the right time and then carry on as before. Do not take a double dose next time to make up for a forgotten dose.

If you stop taking Nicorandil:

As the treatment for angina is usually life-long, you should discuss with your doctor before stopping this medicinal product.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Nicorandil can cause side effects, although not everybody gets them.

If you experience the following, stop taking this medicine and tell your doctor immediately or go to the casualty department of your nearest hospital:

Uncommon (affects less than 1 in 100 people)

•    Red and lumpy skin rash, swollen eyelids, face, lips, mouth or tongue, itching, difficulty breathing or swallowing. This could be an allergic reaction (angioedema).

Very rare (affects less than 1 in 10.000 people)

•    Yellowing of your skin or eyes (which may be signs of liver problems).

Tell your doctor immediately if you have any of the following side effects:

Common (affects less than 1 in 10 people)

•    Increased or fast heart-beat.

Rare (affects less than 1 in 1000 people)

•    Blood in your stools or vomit, due to ulcers in the stomach or gut

•    Ulcers of the back passage, bleeding from the back passage.

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

•    Ulcers of the genital tract

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

•    Ulcers in the nasal passages

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

Tell your doctor as soon as possible if you have any of the following:

Very common (affects more than 1 in 10 people)

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

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 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.

Talk to your doctor or pharmacist if any of the side effects gets serious or lasts longer than a few days, or if you notice any side effects not listed in this leaflet

5.    HOWTO STORE NICORANDIL

Keep out of the reach and sight of children.

Do not use Nicorandil after the expiry date which is stated on the outer carton and the blister foil. The expiry date refers to the last day of that month. Do not store above 25°C. Store in the original package in order to protect from moisture. Do not swallow the drying agent which is contained in the strip. Use the blister strip within 30 days of opening. 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 Nicorandil contains:

•    The active substance is nicorandil. Two strengths of tablets are available. The strengths are 10 mg and 20 mg.

•    Other ingredients are maize starch, croscarmellose sodium, stearic acid and mannitol (E421).

What Nicorandil looks like and contents of the pack:

Nicorandil 10 mg tablets are white, round, scored on one side and embossed with '10' on the other side. Nicorandil 20 mg tablets are white, round, scored on one side and embossed with '20' on the other side. Nicorandil 10 mg tablets and 20 mg tablets are available in blister packs. Each blister contains 10 tablets.The blisters are packed in cartons of 60 tablets.

Marketing Authorisation Holder:

Rivopharm UK

6th floor, 28 Kingsway, London WC2B 6JR.

Manufacturer:

Laboratoires BTT

Zl de Krafft - 67150 ERSTEIN- France.

Distributed by:

Creo Pharma Ltd

Felsted Business Centre, Felsted, Essex CM6 3LY, UK.

This leaflet was last approved in May 2012

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