Ikorel 20mg Tablets
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NICORANDIL 10MG AND 20MG TABLETS
PATIENT INFORMATION LEAFLET
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 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
The name of your medicine is Nicorandil 10mg or 20mg Tablets (called nicorandil 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.
Nicorandil is used to stop and treat long-term chest pain (angina).
2. BEFORE YOU TAKE NICORANDIL
Do not take this medicine and tell your doctor if:
• You are allergic (hypersensitive) to nicorandil or any of the other ingredients of nicorandil (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.
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• 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.
• 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 nicorandil.
Take special care with nicorandil 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 nicorandil
When taking nicorandil 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 nicorandil (see section 4 possible side effects).
If you are not sure whether any of the above applies to you, talk to your doctor or pharmacist before taking nicorandil.
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 nicorandil can affect the way some other medicines work. Also some medicines can affect the way nicorandil 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 nicorandil with food and drink
Do not drink alcohol while you are taking nicorandil.
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 nicorandil. 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 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 not take the tablets, which are included in the pack to protect nicorandil 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
Nicorandil is not recommended in children.
If you take more nicorandil 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.
If you forget to take nicorandil
If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten tablet.
If you stop taking nicorandil
Keep taking nicorandil until your doctor tells you to stop. Do not stop taking nicorandil because you feel better. If you stop, your illness may get worse or come back.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, nicorandil can cause side effects, although not everybody gets them.
Stop taking nicorandil and see a doctor or go to a hospital straight away if you have the following side effects:
Uncommon
• 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
• Yellowing of your skin or eyes (which may be signs of liver problems).
Frequency unknown
• Gnawing or burning pain in the middle or upper stomach between meals, bloating, heartburn, vomiting, these can be signs of ulcers in the stomach or gut. Severe ulcers can cause blood in your stools, vomiting, weight loss and severe abdominal pain.
Tell a doctor straight away if any of the following side effects trouble you:
Common
• Increased or fast heart-beat.
Rare
• 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
• Ulcers of the genital tract.
• Skin ulcers possibly on 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 nicorandil.
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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.mhra.aov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE NICORANDIL
Keep this medicine in a safe place where children cannot see or reach it.
Do not use nicorandil 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 nicorandil 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.
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What nicorandil tablets look like and contents of the pack
Nicorandil 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 nicorandil tablets from moisture. These are included in a blister labelled differently from the nicorandil tablets.
They are supplied in cartons of 60 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sanofi-aventis
One Onslow Street
Guildford
Surrey
GU1 4YS
UK
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