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IKOREL 10MG TABLETS

Active substance(s): NICORANDIL

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Ver11 – II CMC harmonisation exercise following Art 30 referral

PACKAGE LEAFLET: INFORMATION FOR THE USER

IKOREL 10mg and 20mg Tablets
nicorandil
Is this leaflet hard to see or read? Phone 08453 727101 for help.
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 Ikorel is and what it is used for
2. What you need to know before you take Ikorel
3. How to take Ikorel
4. Possible side effects
5. How to store Ikorel
6. Contents of the pack and other information

1.

What Ikorel is and what it is used for

Ikorel contains the active substance “nicorandil”. This belongs to a group of medicines called
‘potassium channel activators’.
Ikorel is used to prevent or reduce painful signs (“angina pectoris”) of your heart disease. It is used in
adults who cannot take heart medicines called “beta-blockers” or “calcium antagonists”.
Ikorel 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.

2.

What you need to know before you take Ikorel

Do not take Ikorel if:
 you are allergic to nicorandil or any of the other ingredients of Ikorel (listed in section 6)
 you have severe low blood pressure (“hypotension”)
 you have heart problems such as cardiogenic shock, or left ventricular failure with low filling
pressure or cardiac decompensation
 you are taking medicines to treat erectile dysfunction (such as sildenafil, tadalafil, vardenafil) or
medicines to treat “pulmonary hypertension” (such as riociguat). Your blood pressure may be
affected if these medicines are taken with Ikorel
 you have low blood volume
 you have a build-up of fluid in the lungs (“pulmonary oedema”).
Do not take Ikorel if any of the above apply to you. If you are not sure, talk to your doctor or
pharmacist before taking Ikorel.
Warnings and precautions

Ver11 – II CMC harmonisation exercise following Art 30 referral

Talk to your doctor straight away if you notice any of the following serious side effects during
treatment:
 red, itchy, swollen or watery eyes.
 ulcers in your mouth, stomach, guts (small and large) or back passage. These may cause blood in
your stools or vomit, a fistula (abnormal tube-like passage from one body cavity to another or to
the skin), a hole, abscess or weight loss. Ulcers may also develop on the skin, genital tract and
nasal passages or around a stoma (where there is an artificial opening for waste removal such as a
colostomy or ileostomy). These are more likely to happen if you have a problem with your large
intestine (‘diverticular disease’).
Talk to your doctor before taking medicines for inflammation (corticosteroids) or non-steroidal antiinflammatory medicines including aspirin, with Ikorel. If taken together, you may be more likely to
get ulcers or the other problems mentioned above.
These side effects can happen at the beginning of treatment or later in treatment. Talk to your doctor
straight away if you notice any of the signs above. See section 4 for a full list of side effects.
Talk to your doctor or pharmacist before taking Ikorel if:
 you have low blood pressure
 you have low blood potassium levels and are taking potassium supplements
 you have kidney problems or are taking other medicines that may increase potassium levels
 you have heart problems such as heart failure
 you have a genetic condition called “glucose-6-phosphate dehydrogenase deficiency”.
If any of the above apply (or you are not sure), talk to your doctor or pharmacist before taking Ikorel.
Children
Ikorel is not recommended for use in children.
Other medicines and Ikorel
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines. This is because Ikorel can affect the way some other medicines work. Also some
medicines may affect the way Ikorel works.
Do not take this medicine, and talk to your doctor if you are taking any of the following:
 medicines for erectile dysfunction such as sildenafil, tadalafil or vardenafil
 medicines to treat ‘pulmonary hypertension’ such as riociguat.
Do not take this medicine and talk to your doctor or pharmacist if any of the above apply to you.
Tell your doctor before taking Ikorel, 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 and non-steroidal anti-inflammatory drugs such as
ibuprofen. If taken with Ikorel you may be more likely to get ulcers
 medicines for depression
 aspirin (acetylsalicylic acid).
Tell your doctor before taking Ikorel, if you are taking any of the medicines above.
Ikorel with alcohol
Nicorandil may lower your blood pressure. If you drink alcohol while being treated with Ikorel, your
blood pressure may become even lower.

Ver11 – II CMC harmonisation exercise following Art 30 referral

Pregnancy and breast-feeding
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 if you are pregnant.
It is not known whether nicorandil passes into your breast-milk. You should not breast-feed while you
are taking this medicine.
Driving and using machines
Ikorel may make you feel dizzy or weak. If this happens, do not drive or use any tools or machines.

3.

How to take Ikorel

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist
if you are not sure.
How much to take
The recommended dose is:
- 10mg, twice a day.
- In case you get headaches, your doctor may give you a lower dose of 5mg, twice a day for the first
2 to 7 days.
- Your doctor may increase your dose up to 20mg, twice a day. This will depend on your needs,
response and tolerance to treatment.
Taking this medicine
- Take one dose in the morning and one in the evening.
- Swallow the tablet (oral use).
- Do not take the tablet out of the blister strip until you are about to take it.
- The tablet of 10mg can be divided into equal doses.
- For the tablet of 20mg, the score line is only there to help you break the tablet if you have
difficulty swallowing it whole.
A larger desiccant capsule corresponding to a ‘drying agent’ is clearly marked at one end of each
blister strip. It is to protect Ikorel tablets from moisture. Do not swallow this desiccant capsule. If you
do accidentally take a desiccant capsule, talk to your doctor straight away. They should not harm you.
If you take more Ikorel than you should
If you take more Ikorel than you should or a child swallows any of the tablets, talk to a doctor or go to
hospital straight away. Take the medicine pack with you. You may feel dizzy or weak – signs of low
blood pressure. You may also feel your heart beating irregularly and faster.
If you forget to take Ikorel
If you forget a dose, take it as soon as you remember. However, if it is nearly time for your next dose,
skip the missed 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 product, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Talk to your doctor straight away if you notice any of the following serious side effects:

Ver11 – II CMC harmonisation exercise following Art 30 referral




red, itchy, swollen or watery eyes, including problems with a part of the eye called the ‘cornea’
(very rare, may affect up to 1 in 10,000 people).
ulcers in your mouth, stomach, guts (small and large) or back passage (rare, may affect up to 1
in 1,000 people). These may cause blood in your stools or vomit, a fistula (abnormal tube-like
passage from one body cavity to another or to the skin), a hole, abscess or weight loss. Ulcers
may also develop on the skin, genital tract and nasal passages or around a stoma (where there is
an artificial opening for waste removal such as a colostomy or ileostomy). These are more likely
to happen if you have a problem with your large intestine (diverticular disease).

These side effects can happen at the beginning of treatment or later in treatment.
Talk to your doctor straight away if you notice any of the serious side effects above.
Other side effects
Tell your doctor or pharmacist if you notice any of the following side effects:
Very common: may affect more than 1 in 10 people
 Headache – especially during the first few days of treatment. Your doctor may start you on a low
dose and increase it slowly to reduce the frequency of headaches.
Common: may affect up to 1 in 10 people
 feeling dizzy
 flushing of the skin
 feeling sick (nausea)
 being sick (vomiting)
 feeling weak
 very fast, uneven or forceful heart-beat (palpitations).
Uncommon: may affect up to 1 in 100 people
 low blood pressure.
Rare: may affect up to 1 in 1,000 people
 rash
 itching
 aching muscles not caused by exercise.
Very rare: may affect up to 1 in 10,000 people
 stomach ache
 high potassium levels in the blood
 yellowing of the skin and eyes, light coloured bowel motions, dark coloured urine – these may be
signs of liver problems
 swelling of the face, lips, mouth, tongue or throat which may cause problems swallowing or
breathing.
Not known: it is not known how often these happen
 double vision.
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.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.

Ver11 – II CMC harmonisation exercise following Art 30 referral

5.

How to store Ikorel

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 after ‘EXP’. The expiry
date refers to the last day of that month.
Do not store above 25oC. Store in the original packaging in order to protect from moisture.
After opening, each blister strip should be used within 30 days at the above mentioned storage
conditions.
Medicines should not be thrown away via wastewater or household waste. Ask your pharmacist how
to throw away medicines you no longer use. These measures will help to protect the environment.

6.

Content of the pack and other information

What Ikorel contains
 For 10mg: The active substance is nicorandil. Each tablet contains 10mg of the active substance,
nicorandil. The other ingredients are maize starch, croscarmellose sodium, stearic acid (E570) and
mannitol (E421).
 For 20mg: The active substance is nicorandil. Each tablet contains 20mg of the active substance,
nicorandil. The other ingredients are maize starch, croscarmellose sodium, stearic acid (E570) and
mannitol (E421).
What Ikorel looks like and contents of the pack
 For 10mg: Ikorel is an off-white, round tablet with facetted edge, scored on one side, and with
inscription “IK10” on the other side.
The tablet can be divided into equal doses.
 For 20mg: Ikorel is an off-white, round tablet with facetted edge, scored on one side, and with
inscription “IK20” on the other side.
The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal
doses.
A larger desiccant capsule corresponding to a ‘drying agent’ is clearly marked at one end of each
blister strip. It is to protect Ikorel tablets from moisture.
The desiccant capsule must not be swallowed.
Pack sizes available are 30 or 60 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sanofi
One Onslow Street
Guildford
Surrey
GU1 4YS
UK
Manufacturer
Sanofi Winthrop Industrie
56 route de Choisy-au-Bac
60205 Compiegne
Cedex
France

Ver11 – II CMC harmonisation exercise following Art 30 referral

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 June 2017.

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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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