Nicoril 20mg Tablets
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Nicoril 10mg Tablets Nicoril 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, 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 Nicoril is and what it is used for
2. Before you take Nicoril
3. How to take Nicoril
4. Possible side effects
5. How to store Nicoril
6. Further information
1. WHAT NICORIL IS AND WHAT IT IS USED FOR
Your doctor has prescribed Nicoril 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.
Nicoril relieves angina by widening the blood vessels that supply the heart muscle to increase the blood supply. Nicoril 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 NICORIL Do not take Nicoril:
- 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).
- 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 Nicoril
Tell your doctor before you take Nicoril if you:
- have severe mouth ulcerations.
- are taking medicines to treat high blood pressure.
Children and adolescents under the age of 18 years
Nicoril 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.
Nicoril can affect the way some other medicines work and some medicines can affect the way Nicoril 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
• alcohol
• medicines used to treat impotence such as sildenafil, tadalafil and vardenafil
• medicines for inflammation (corticosteroids such as prednisolone)
Taking Nicoril with food and drink:
Do not drink alcohol while you are taking this medicine.
Pregnancy and breast-feeding:
Ask your doctor or pharmacist for advice before taking any medicine.
If you are pregnant or think you might be pregnant you should not use Nicoril.
If you are breast-feeding you should not use Nicoril.
Driving and using machines:
You may feel dizzy while you are using this medicine. If you are affected do not drive or use machinery.
3. HOW TO TAKE NICORIL
Always take Nicoril 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 Nicoril for as long as your doctor tells you to.
Tablets should be swallowed 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. The same doses can be used in patients that are older than 70 years of age.
If you take more Nicoril than you should:
If you take more Nicoril 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 Nicoril:
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 Nicoril:
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, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Nicoril 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:
• A severe allergic reaction (rash, itching, swelling of the face, lips, mouth or throat that may cause difficulty in swallowing or breathing).
This is a serious but very rare side effect, which affects less than 1 patient out of 10000 patients. You may need urgent medical attention or hospitalisation.
The following side effects may also occur:
Very Common (affecting more than 1 in every 10 people)
• Headaches - these may occur in the first few days of treatment, but should disappear with time. If not, talk to your doctor.
Common (affecting up to 1 in 10 people)
• Feeling sick or vomiting
• Weakness or dizziness
• Flushing
Uncommon (affecting more than 1 in 1,000 patients but less than 1 in 100 patients)
• An increase in heart rate when taking high doses
• Low blood pressure when taking high does
Rare (affecting more than 1 in 10,000 patients but less than 1 in 1,000)
• Muscle pain
• Rashes
• Persistent mouth ulcers
• Yellowing of the skin
Very Rare (affecting fewer than 1 in 10,000 patients)
• Swelling of the skin similar to hives
• Ulcers including ulcers and bleeding of the back passage
If you experience any of the following tell your doctor immediately.
• Palpitations - sensations of fast or irregular heartbeat.
• Ulcers or pain of the back passage
• Bleeding or discharge of pus from the back passage or abnormal vaginal discharge
• Swelling, tenderness, irritation and itching on the skin around the back passage
• Vomiting blood, severe or lasting stomach pains or dark, tarry stools
• Swelling of the lips and tongue.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
5. HOW TO STORE NICORIL
Keep out of the reach and sight of children.
Do not use Nicoril 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 blister.
Use the blister 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 Nicoril 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, croscar-mellose sodium, stearic acid and mannitol (E421).
What Nicoril looks like and contents of the pack:
Nicoril 10 mg tablets are white, round, scored on one side and embossed with '10' on the other side.
Nicoril 20 mg tablets are white, round, scored on one side and embossed with '20' on the other side.
Nicoril is available in blister packs. Each blister contains 10 tablets. The blisters are packed in cartons of 60 tablets.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder Rivopharm UK Ltd
6th floor 28 Kingsway, London WC2B 6JR. Manufacturer
Laboratories BTT, Z.I. de Krafft, 67 150 ERSTEIN, France
Distributed by:
Creo Pharma Ltd Felsted Business Centre Felsted
Essex CM6 3LY, UK
This leaflet was approved in September 2012