NICORANDIL 10 MG TABLETS

Active substance: NICORANDIL

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TEVA UK Ref:

231-30-12345-A LEA NICORANDIL 10mg & 20mg TABS TUK
NICORANDIL
10 mg AND 20 mg TABLETS
PACKAGE LEAFLET:
INFORMATION FOR THE USER

Version:

5

25 September 2014

Other medicines and Nicorandil
Tell your doctor or pharmacist if you are taking, have
recently taken or might any other medicines.

You must not take Nicorandil, and tell your doctor, if
you are taking medicines for impotence such as
Read all of this leaflet carefully before you start
sildenafil, tadalafil or vardenafil (phosphodiesterase
taking this medicine because it contains important
5 inhibitors). These medicines are also used for a rare
information for you.
progressive disease of the blood vessels in the lung
• Keep this leaflet. You may need to read it again.
(pulmonary arterial hypertension). The simultaneous
• If you have any further questions, ask your doctor or use of these medicines and Nicorandil can lead to a
pharmacist.
serious drop in blood pressure.
• This medicine has been prescribed for you only. Do
Tell your doctor if you are taking any of the following:
not pass it on to others. It may harm them, even if
• medicines that widen the blood vessels
their signs of illness are the same as yours.
(vasodilators)
• If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects • medicines used to treat high blood pressure
• medicines used to treat depression (tricyclic
not listed in this leaflet. See section 4.
antidepressants).
WHAT IS IN THIS LEAFLET:
If you take one of these medicines together with
Nicorandil your blood pressure could get too low.
1. What Nicorandil is and what it is used for
2. What you need to know before you take
If you take Nicorandil together with corticosteroids
Nicorandil
(medicines used to treat inflammation), perforations in
3. How to take Nicorandil
the stomach or gut can occur.
4. Possible side effects
Nicorandil with food, drink and alcohol
5. How to store Nicorandil
6. Contents of the pack and other information Do not drink alcohol while you are taking Nicorandil.
This is because Nicorandil may increase the effect of
What Nicorandil is and what it is alcohol.

1

used for

Nicorandil Tablets contain the active substance
nicorandil. This substance belongs to a group of
medicines called “potassium channel activators”. It
works by relaxing blood vessels and increasing the
blood flow and oxygen supply to the heart.

Pregnancy, breast-feeding and fertility
Ask your doctor or pharmacist for advice before taking
any medicine. Nicorandil should not be used during
pregnancy unless your doctor considers that it is
clearly necessary.
You should not use Nicorandil if you are
breast-feeding because it is not known whether
nicorandil is excreted into human breast milk.

Nicorandil is used
• to prevent chest pain (angina pectoris)
• for long-term treatment of chest pain (stable angina If you are pregnant or breast-feeding, think you may
pectoris).
be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this
2 What you need to know before medicine.

you take Nicorandil

Do not take Nicorandil
• if you are allergic (hypersensitive) to nicorandil or
any of the other ingredients of this medicine (listed
in section 6)
• if you have a condition called “cardiogenic shock”.
This is a severe drop in blood pressure, caused by
the fact that the heart cannot pump enough blood
around the body.
• if you have a heart failure and your left side of the
heart fails to pump blood effectively (left ventricular
failure with low filling pressures)
• if you have low blood pressure
• together with medicines for impotence (see also
"Other medicines and Nicorandil").
Warnings and precautions
Talk to your doctor or pharmacist before taking
Nicorandil.
Take special care with Nicorandil if you have
• ulcers in the stomach or gut
• skin ulcers
• mouth ulcers
• been told by your doctor that you have a low blood
volume or low systolic blood pressure
• an acute build up of fluid in the lungs (acute
pulmonary oedema)
• recently had a heart attack (acute myocardial
infarction).
Inform your doctor before treatment if any of the
above mentioned conditions apply to you.

Driving and using machines
Since Nicorandil lowers your blood pressure, you may
feel dizzy or light-headed while taking this medicine. If
this happens, do not drive or use any tools or
machines.
Nicorandil contains sodium starch glycolate (type A)
and mannitol.

3 How to take Nicorandil
Always take this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if you
are not sure.
Route and Method of administration
Take this medicine by mouth. Swallow the tablets
whole with a sufficient amount of water (e.g. one glass
of water). You can take the tablets with or without
food. Do not crush or chew the tablets.
Dosage
The usual dose is 10 mg or 20 mg taken in the morning
and in the evening (equivalent to a daily dose of 20 mg
to 40 mg of Nicorandil). Your doctor might increase this
to 30 mg twice a day, if necessary (equivalent to a
daily dose of 60 mg of nicorandil).
If you have a tendency to get headaches, your doctor
may start you on a lower dose of 5 mg twice a day
(equivalent to 10 mg of nicorandil).
Use in children and adolescents
Nicorandil is not recommended for use in children and
adolescents below 18 years due to insufficient data on
its safety and efficacy.

TEVA UK Ref:

231-30-12345-A LEA NICORANDIL 10mg & 20mg TABS TUK
Elderly patients
Elderly patients should take the lowest possible dose
that relieves the complaints.
Your doctor will decide how many tablets of Nicorandil
you will have to take per day. If you feel the effect of
your medicine is too weak or too strong, do not
change the dose yourself, but talk to your doctor.
If you take more Nicorandil than you should
If you take more 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. This is so the doctor
knows what you have or the child has taken. The
following effects may happen: your blood pressure
drops off and you may feel dizzy or weak, your heart
may beat faster than normal or you have difficulty in
breathing or wheezing.
If you forget to take Nicorandil
If you forget a dose, take it as soon as you remember
it. However, if it is nearly time for the next dose, skip
the missed dose. Do not take a double dose to make
up for a forgotten tablet.
If you stop taking Nicorandil
Keep taking Nicorandil until your doctor tells you to
stop. Do not stop taking Nicorandil because you feel
better. If you stop, your illness may get worse or come
back.
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.
Stop taking Nicorandil immediately and seek urgent
medical advice immediately if you have any of the
following side effects:

Version:

5

25 September 2014

Very rare: may affect up to 1 in 10,000 people
• stomach ache.
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.

5 How to store Nicorandil
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the label 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 throw away 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 Contents of the pack and other
information

What Nicorandil contains
• The active substance is nicorandil. Each Nicorandil
10 mg Tablet contains 10 mg nicorandil and each
Nicorandil 20 mg Tablet contains 20 mg nicorandil.
• The other ingredients are sodium starch glycolate
(type A), stearic acid, mannitol.
What Nicorandil looks like and contents of the pack
Nicorandil 10 mg Tablets are white to off-white round,
flat tablets with a break line on one side.
The tablets can be divided into equal halves.

Nicorandil 20 mg Tablets are white to off-white round
Rare: may affect up to 1 in 1,000 people
and flat.
• blood in your stools or vomit (due to ulcers in the
stomach or gut), mouth ulcers, tongue ulcers, ulcers Nicorandil is available in blisters of 20, 30 or 60 tablets.
of the anus, or bleeding from the anus.
Not all pack sizes may be marketed.
Very rare: may affect up to 1 in 10,000 people
• yellowing of your skin or eyes (which may be signs Marketing Authorisation Holder
of liver problems)
TEVA UK Limited, Eastbourne, BN22 9AG, UK
• red and lumpy skin rash, swollen eyelids, face, lips,
Manufacturer
mouth or tongue, itching, difficulty breathing or
Bluepharma Indústria Farmacêutica, S.A,
swallowing. This could be an allergic reaction
Cimo de Fala – S. Martinho do Bispo, 3045-016
(angioedema)
Coimbra, Portugal
• skin ulcers (possibly on the hands, legs, or feet),
ulcers of the genital tract, in the nasal passages, or This leaflet was last revised in 09/2014
around a stoma (in those with an artificial opening
PL 00289/1746
for the bowels such as a colostomy or ileostomy).
PL 00289/1747
In addition to the above, the following side effects
have also been reported:
Very common: may affect more than 1 in 10 people
• headache (this is more common when you first start
taking Nicorandil).
Common: may affect up to 1 in 10 people
• increased or fast heart-beat (palpitation)
• dizziness
• increased heartbeat
• flushing of the skin
• feeling sick or being sick
• feeling weak.
Uncommon: may affect up to 1 in 100 people
• decrease in blood pressure (feeling dizzy,
lightheaded or faint).
Rare: may affect up to 1 in 1,000 people
• skin rashes
• itching
• pain in your muscles.

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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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