NICORANDIL 20 MG TABLETS

Active substance: NICORANDIL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Nicorandil 20 mg 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 contains a substance called
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.
Nicorandil is used
- to prevent chest pain (angina pectoris)
- for long-term treatment of chest pain
(stable angina pectoris)
2. BEFORE YOU TAKE NICORANDIL
Do not take Nicorandil
- if you are allergic (hypersensitive) to
nicorandil or any of the other ingredients
of Nicorandil
- 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 "Taking other medicines")
Take special care with Nicorandil
- if you have ulcers in the stomach or gut
- if you have skin ulcers
- if you have mouth ulcers
- if you have been told by your doctor that
you have a low blood volume or low
systolic blood pressure
- if you have an acute build up of fluid in
the lungs (acute pulmonary oedema)
- if you have recently had a heart attack
(acute myocardial infarction )
Inform your doctor before treatment if any of
the above mentioned conditions apply to
you.
Taking 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.
You must not take Nicornadil, and tell your
doctor, if you are taking medicines for
impotence such as sildenafil, tadalafil or
vardenafil (phosphodiesterase 5 inhibitors).

These medicines are also used for a rare
progressive disease of the bloodvessels in
the lung (pulmonary arterial hypertension).
The simultaneous use of these medicines
and Nicornadil can lead to a serious drop in
blood pressure.
Tell your doctor if you are taking any of the
following:
- medicines that widen the blood vessels
(vasodilators)
- medicines used to treat high blood
pressure
- medicines used to treat depression
(tricyclic antidepressants)
If you take one of these medicines together
with Nicornadil your blood pressure could
get too low.
If you take Nicornadil together with corticosteroids (medicines used to treat inflammation), perforations in the stomach or gut can
occur.
Taking Nicorandil with food and drink
Do not drink alcohol while you are taking
Nicorandil. This is because Nicorandil may
increase the effect of alcohol.
Pregnancy and breast-feeding
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.
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.
3. HOW TO TAKE NICORANDIL
Always take Nicorandil exactly as your
doctor has told you. You should check with
your doctor or pharmacist if you are not
sure.
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 10mg or 20mg taken in
the morning and in the evening (equivalent
to a daily dose of 20 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 nicorandil twice a day (equivalent to
10 mg of nicorandil). Therefore you can get
Nicornadil 10 mg tablets, that can be divided
into equal halves with 5 mg nicorandil each.
Use in children
Nicorandil is not recommended for use in
children and adolescents below 18 years
due to insufficient data on safety and
efficacy.
continued overleaf

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 product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Nicorandil can cause
side effects, although not everybody gets
them.
Assessment of side effects is based on the
following frequency rates:
very common:
common:
uncommon:
rare:
very rare:

affects more than 1 user in 10
affects 1 to 10 users in 100
affects 1 to 10 users in 1,000
affects 1 to 10 users in
10,000
affects less than 1 user in
10,000

a) Stop taking Nicorandil immediately and
see a doctor or go to a hospital straight
away if you have the following side
effects:
Very rare
- Yellowing of your skin or eyes (which may
be signs of liver problems)
- Red and lumpy skin rash, swollen eyelids,
face, lips, mouth or tongue, itching,
difficulty breathing or swallowing. This
could be an allergic reaction
(angioedema).
b) Stop taking Nicorandil and see your
doctor if you develop ulcerations.
These ulcers cannot medicinally be
treated and they only respond if you
discontinue the treatment with
Nicorandil:
Rare
- Blood in your stools or vomit (due to
ulcers in the stomach or gut), mouth
ulcers, tongue ulcers, ulcers of the anus,
or bleeding from the anus
Very Rare
- Skin ulcers (possibly on the hands, legs,
or feet), ulcers of the genital tract, in the
nasal passages, or around a stoma (in
those with an artificial opening for the
bowels such as a colostomy or ileostomy)
c) Tell a doctor straight away if you have
any of the following side effects
Common
- Increased or fast heart-beat (Palpitation)

d) Tell your doctor as soon as possible if
you have any of the following side
effects:
Very common
- Headache. These are more common
when you first start taking Nicorandil.
Common
- Dizziness
- Increased heartbeat
- Flushing of the skin
- Feeling sick or being sick
- Feeling weak
Uncommon
- Decrease in blood pressure (feeling dizzy,
lightheaded or fainting)
Rare
- Skin rashes
- Itching
- Pain in your muscles
e) Other side effects
Very rare
- Belly ache
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.
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 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.
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. Each
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 tablets are white to off-white
round and flat
They are supplied in blisters of 20, 30 or 60
tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Teva UK Limited,Brampton Road,Hampden Park
Eastbourne,East Sussex,BN22 9AGT
Manufacturer
Bluepharma Indústria Farmacêutica, S.A
Cimo de Fala – S. Martinho do Bispo,
3045-016 Coimbra Portugal
This medicinal product is authorised in the
Member States of the EEA under the
following names
United Kingdom: Nicorandil 20 mg tablets
Spain: Nicorandil Petazone 20 mg comprimidos
Germany, Netherlands: Doranic 20 mg
Tabletten
Italy: Doranic 20 mg compresse
Portugal: Doranic 20 mg comprimidos
Denmark:Nicozone 20 mg tabletter
Ireland: Nicozone 20 mg tablets
This leaflet was last approved in 06/2011.

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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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