NICORANDIL 10MG TABLETS

Active substance: NICORANDIL

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Nicorandil 10mg Tablets
Nicorandil 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 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
Nicorandil belongs to a group of medicines
called "potassium channel activators". Your
doctor has prescribed Nicorandil 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.
Nicorandil relieves angina by widening the
blood vessels that supply the heart muscle to
increase the blood supply. Nicorandil 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 NICORANDIL
Do not take Nicorandil:
• 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). Signs of allergic reaction include:
a rash, swallowing or breathing problems,
swelling of your lips, face, throat or tongue.
• 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 Nicorandil
Tell your doctor before you take Nicorandil if you:
- have severe mouth ulcerations.
- are taking medicines to treat high blood
pressure
- are taking medicines to treat inflammation
(corticosteroids).

Children and adolescents under the age of
18 years
Nicorandil 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.
Nicorandil can affect the way some other
medicines work and some medicines can affect
the way nicorandil 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
• medicines used to treat impotence such as
sildenafil, tadalafil and vardenafil (as these
should not be taken whilst you are on
nicorandil – see Do not take Nicorandil
above.
Taking Nicorandil with food and drink:
Alcohol may increase the blood pressure
lowering effects of nicorandil. Discuss with your
doctor if it is appropriate for you to have alcohol
whilst taking this medicine but be aware that the
combination may adversely affect your ability to
drive and use machinery (see Driving and using
machines below).

this dose if necessary. The usual maximum dose
is 30 mg twice daily.
If you have a tendency to get headaches, your
doctor may start you on a lower dose of 5 mg
(half a 10 mg tablet) twice a day.
The same doses can be used in patients that are
older than 70 years of age.
If you take more Nicorandil than you should:
If you take more Nicorandil 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 Nicorandil:
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 Nicorandil:
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, Nicorandil 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:

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 talk to your doctor before
taking Nicorandil
Nicorandil may not be suitable for you if you are
breast-feeding – seek advice from your doctor.

Uncommon (affects less than 1 in 100 people)
• Red and lumpy skin rash, swollen eyelids,
face, lips, mouth or tongue, itching, difficulty
breathing or swallowing. This could be an
allergic reaction (angioedema).

Driving and using machines:
You may feel dizzy and or light-headed whilst
taking this medicine. This may be more likely if
you are taking other medicines (especially those
used to treat high blood pressure and some
medicines for depression) and if you have been
drinking alcohol. If you are affected you should
not drive, use machinery or take part in any
activities where these effects may put you or
others at risk.

Tell your doctor immediately if you have any
of the following side effects:

3. HOW TO TAKE NICORANDIL

Very rare (affects less than 1 in 10,000 people)
• Ulcers of the genital tract
• Skin ulcers, possibly on the hands, legs or feet
• Ulcers in the nasal passages
• Ulcer around a stoma (in those with an
artificial opening for waste removal such a
colostomy or ileostomy).

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
continue to take your Nicorandil for as long as
your doctor tells you to.
Tablets should be swallowed whole or halved
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

Very rare (affects less than 1 in 10.000 people)
• Yellowing of your skin or eyes (which may be
signs of liver problems).

Common (affects less than 1 in 10 people)
• Increased or fast heart-beat.
Rare (affects less than 1 in 1000 people)
• Blood in your stools or vomit, due to ulcers in
the stomach or gut
• Ulcers of the back passage, bleeding from the
back passage.

Tell your doctor as soon as possible if you
have any of the following:
Very common (affects more than 1 in 10 people)
• Headache. These are more common when
you first start taking Nicorandil Tablets.

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 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.
Talk to your doctor or pharmacist if any of the
side effects gets serious or lasts longer than a
few days, or if you notice any side effects not
listed in this leaflet
5. HOW TO STORE NICORANDIL
Keep out of the reach and sight of children.
Do not use Nicorandil 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 strip. Use the blister
strip 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 Nicorandil 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 Nicorandil looks like and contents of
the pack:
Nicorandil 10 mg tablets are white, round,
scored on one side and embossed with '10' on
the other side. Nicorandil 20 mg tablets are
white, round, scored on one side and embossed
with '20' on the other side. Nicorandil 10 mg
tablets and 20 mg tablets are available in blister
packs. Each blister contains 10 tablets. The
blisters are packed in cartons of 60 tablets.
Marketing Authorisation Holder:
Rivopharm UK
6th floor, 28 Kingsway, London WC2B 6JR.
Manufacturer:
Laboratoires BTT
ZI de Krafft - 67150 ERSTEIN- France.
Distributed by:
Creo Pharma Ltd
Felsted Business Centre, Felsted, Essex CM6 3LY, UK.
This leaflet was last approved in
May 2012
Heading - 14pt
Body text - 9pt

PACKAGE LEAFLET: INFORMATION FOR THE USER

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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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