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NICORIL 20MG TABLETS

Active substance(s): NICORANDIL

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Nicoril 10 mg Tablets
Nicoril 20 mg Tablets
nicorandil
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
 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 only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as yours.
 If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Nicoril is and what it is used for
2. What you need to know before you take Nicoril
3. How to take Nicoril
4. Possible side effects
5. How to store Nicoril
6. Contents of the pack and other information
1.
WHAT NICORIL IS AND WHAT IT IS USED FOR
Nicoril contains a medicine 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. It improves the blood and oxygen supply of your heart muscle and reduces its
workload.
Nicoril is used to prevent or attenuate painful, straining symptoms (angina pectoris) of your heart
disease. It is used in adult patients who do not tolerate or cannot take heart medicines called betablockers and/or calcium antagonists.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NICORIL
Do not take Nicoril:
- if you are allergic to nicorandil or any of the other ingredients of this medicine listed in
section 6).
- if you have low blood pressure (hypotension).
- if you have heart problems such as cardiogenic shock, or left ventricular failure with low
filling pressure or cardiac decompensation or shock.
- if you are taking medicines to treat erectile dysfunction such as sildenafil, tadalfil, vardenafil
(phosphodiesterase inhibitors) or medicines to treat pulmonary hypertension such as
riociguat (guanylate cyclase stimulators). This may seriously affect your blood pressure.
- if you have a low blood volume.
- if you have a build-up of fluid in the lungs (pulmonary oedema).
Warnings and precautions
Talk to your doctor or pharmacist before taking Nicoril.
Stop taking straight away nicorandil and talk to your doctor if you experience any of the
following:
- Nicorandil may cause injuries to your gastrointestinal tract such as ulcers. This can develop
problems such as bleeding, fistula, wholes, abscess, especially if you have diverticular disease
(a digestive condition affecting the large intestine).
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- If your eyes become red, itchy or swollen. You may have eye injuries, stop taking Nicoril and

contact your doctor immediately.

These side effects can occur at the beginning of treatment or latter in the treatment course.
The only possible treatment is to stop nicorandil. Do not take aspirin or any medicines for
inflammation (corticosteroids).
Talk to your doctor or pharmacist before taking Nicoril:
• If you have a low blood pressure.
• If you have low blood potassium level and your doctor has prescribed potassium
supplements, or if you are suffering from renal impairment or taking other medical
products that may increase potassium levels.
• If you have heart problems such as heart failure.
• If you have glucose 6 Phosphate Deshydrogenase deficiency.
Children
• Nicoril is not recommended in children .
Other medicines and Nicoril
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines. This is because Nicoril may affect the way some other medicines work. Also some
medicines may affect the way Nicoril works.
Do not take this medicine and talk to your doctor if you are taking the following:



Medicine for impotence such as sildenafil, tadalafil or vardenafil
Medicines to treat pulmonary hypertension such as riociguat.

Tell your doctor, if you are taking any of the following:
• Medicines to treat high blood pressure.
• Medicines that widen the blood vessels.
• Medicines that increase blood potassium levels.
• Dapoxetine, a medicine used to treat premature ejaculation.
• Medicines for inflammation (corticosteroids, non-inflammatory steroidal drugs such as
ibuprofen).
• Medicines for depression.
• Aspirin(acetylsalicylic acid).
Nicoril with alcohol
Nicorandil may lower your blood pressure. If you drink alcohol while you are treated with
Nicoril, your blood pressure may be decreased even further.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a
baby,ask your doctor or pharmacist for advice before taking this medicine.
You should avoid taking this medicine while you are pregnant.It is not known whether nicorandil
passes in human milk. You should not breast-feed while you are taking this medicine.
Driving and using machines
Nicoril may cause dizziness or weakness. If this happens, do not drive or use any tools or
machines.
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3.
HOW TO TAKE NICORIL
Always take this medicine exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.
The recommended dose is:
- The usual starting dose is 10 mg twice daily.
- In case you are particularly prone to headache, a lower dose of 5 mg twice daily might be
prescribed by your doctor, for the first few days (2 to 7 days).
- Your doctor may increase the dose up to 20 mg twice daily depending on your needs, response
to treatment and tolerance.
Preferably take one dose in the morning and one in the evening.
Swallow the tablet (oral use)
Do not take out or separate tablet from the blister strip until intake.
The tablet of 10 mg can be divided into equal doses.
For the tablet of 20 mg, the score line is only there to help you break the tablet if you have
difficulty swallowing it whole.
Do not swallow the drying agent which is the bigger tablet on one end of each blister strip. It is
included in the pack to protect Nicoril tablets from moisture. On the blister, it is clearly indicated
which tablet is the drying agent. If you do accidentally take any of these drying agent tablets, they
should not harm you but you should straight away talk to your doctor.
If you take more Nicoril than you should
If you take more Nicoril tablets than you should, or if a child has swallowed any of your tablets,
tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with
you. You may feel blood pressure lowering effect such as dizziness, feeling of weakness. You
may also feel your heart is beating irregularly and faster.
If you forget to take Nicoril
If you forget to take a dose, take it as soon as you remember, unless it is nearly time for your next
dose.
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4.
POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Talk straight away to your doctor if you experience any of the following:
- Nicorandil may cause injuries to your gastrointestinal tract such as ulcers in the mouth,
tongue, stomach, guts (small and large), back passage. This can develop problems such as
bleeding (blood in your stools or vomit), fistula (abnormal tube-like passage from one body
cavity to another or to the skin), wholes, abscess, weight loss. Ulcers can occur at other site
such as: skin, genital tract and nasal passages or around a stoma (in those with an artificial
opening for waste removal such as a colostomy or ileostomy).
- Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or
breathing.
Other side effects include:
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Very common (may affect more than 1 in 10 people)
Headache – This especially occurs during the first few days of treatment. Your doctor may
progressively increase the dose to reduce the frequency of headaches.
Common (may affect up to 1 in 10 people)

Dizziness

Very fast, uneven or forceful heart-beat (palpitations)

Flushing of the skin

Feeling sick (nausea)

Being sick (vomiting)

Feeling of weakness.
Uncommon (may affect up to 1 in 100 people)

Decrease in blood pressure..
Rare (may affect up to 1 in 1,000 people)

Rash

Itching

Aching muscles not caused by exercise (myalgia).
Very rare (may affect up to 1 in 10,000 people)

High potassium levels in the blood (hyperkalaemia)

Red, itchy, swollen or watery eyes (conjunctivitis)

Eye injuries

Cornea injuries

Yellowing of the skin and eyes, light coloured bowel motions, dark coloured urine – This
may be signs of liver problems

Stomach aches.
Not known (frequency cannot be estimated from the available data)
Double vision (diplopia).



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 Yellow
Card Scheme, Website: 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 NICORIL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
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.

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Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how
to throw away medicines you no longer use. These measures will help protect the environment.
6.

CONTENT OF THE PACK AND OTHER 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, croscarmellose 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.
Nicoril 10 mg: the blisters are packed in cartons of 20 and 60 tablets
Nicoril 20 mg: the blisters are packed in cartons of 60 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
Rivopharm UK Ltd
30th Floor, 40 Bank Street, Canary Wharf, London, E14 5NR, UK
Manufacturer
Laboratories BTT, Z.I. de Krafft, 67 150 ERSTEIN, France
This leaflet was lst revised in August 2015

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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