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IKOREL 10MG TABLETS

Active substance(s): NICORANDIL / NICORANDIL / NICORANDIL

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CONFIDENTIAL

Module 1 Page 1

1.
2.
3.
4.
5.
6.

What Ikorel is and what it is used for
What you need to know before you take Ikorel
How to take Ikorel
Possible side effects
How to store Ikorel
Contents of the pack and other information

What is in this leaflet

• 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.

Read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you.

Is this leaflet hard to see
or read?
Phone 01483 505515 for
help

IKOREL 10mg and 20mg Tablets
nicorandil

INFORMATION FOR THE USER

PACKAGE LEAFLET:

-1-

R775390

• 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:

2. What you need to know before
you take Ikorel

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.

1. What Ikorel is and what it
is used for

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 before taking medicines for
inflammation (corticosteroids) or non steroidal
anti-inflammatory medicines including aspirin,
with Ikorel. If taken together, you may be more
likely to get ulcers or the other problems
mentioned above.

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’).

Warnings and precautions

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.

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Module 1 Page 2

• 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.

Do not take this medicine, and talk to your
doctor if you are taking any of the following:

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.

Other medicines and Ikorel

Ikorel is not recommended for use in children.

Children

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.

-2-

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.

Pregnancy and breast-feeding

Nicorandil may lower your blood pressure. If
you drink alcohol while being treated with Ikorel,
your blood pressure may become even lower.

Ikorel with alcohol

Tell your doctor before taking Ikorel, if you are
taking any of the medicines above.

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-inflammatory steroidal 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
Driving and using machines

- 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.

Taking this medicine

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.

How much to take

Always take this medicine exactly as your doctor
has told you. Check with your doctor or pharmacist
if you are not sure.

3. How to take Ikorel

Ikorel may make you feel dizzy or weak. If this
happens, do not drive or use any tools or machines.

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

4. Possible side effects

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

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 forget to take Ikorel

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 take more Ikorel than you should

A larger tablet called 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 tablet. If you do accidentally take a
drying agent tablet, talk to your doctor straight
away. They should not harm you.

-3-

Talk to your doctor straight away if you notice
any of the following serious side effects:
• 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.

Serious side effects

feeling dizzy
flushing of the skin
feeling sick (nausea)
being sick (vomiting)
feeling weak.
very fast, uneven or forceful heart-beat
(palpitations)

Rare: may affect up to 1 in 1,000 people
• rash
• itching
• aching muscles not caused by exercise.

Uncommon: may affect up to 1 in 100 people
• low blood pressure.








Common: may affect up to 1 in 10 people

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.

Tell your doctor or pharmacist if you notice any
of the following side effects:

Other side effects

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Module 1 Page 4

Do not store above 25ºC. Keep the blister strip
in the outer carton in order to protect from
moisture.

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.

Keep this medicine out of the sight and reach
of children.

5. How to store Ikorel

By reporting side effects you can help provide
more information on the safety of this
medicine.

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.

Reporting of side effects

happen
• double vision.

Not known: it is not known how often these

• 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

Very rare: may affect up to 1 in 10,000 people

-4-

R775390

Ikorel 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 Ikorel tablets from moisture. These are
included in a blister labelled differently from
the Ikorel tablets.
They are supplied in cartons of 60 tablets.

What Ikorel tablets look like and
contents of the pack

• Each tablet contains 10mg or 20mg of the
active substance, nicorandil.
• The other ingredients are corn starch,
croscarmellose sodium, stearic acid and
mannitol.

What Ikorel tablets contain

6. Contents of the pack and other
information

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.

This leaflet was last revised in October 2015.

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.

Manufacturer
Sanofi Winthrop Industrie
56 route de Choisy-au-Bac
60205 Compiegne
Cedex
France

Marketing Authorisation Holder
Sanofi-aventis
One Onslow Street
Guildford
Surrey
GU1 4YS
UK

Marketing Authorisation Holder and
Manufacturer

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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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