PLETAL 100 MG TABLETS

Active substance: CILOSTAZOL

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PLETAL® 100 mg Tablets

T04596

(cilostazol)

Patient Information Leaflet
This medicine is subject to additional
monitoring. This will allow quick identification of
new safety information. You can help by
reporting any side effects you may get. See the
end of section 4 for how to report side effects.
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, please
ask your doctor or your 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.
The name of your medicine is Pletal 100 mg
Tablets and will be referred to as Pletal
throughout this patient information leaflet.
In this leaflet:
1. What Pletal is and what it is used for
2. Before you take Pletal
3. How to take Pletal
4. Possible side effects
5. How to store Pletal
6. Contents of the pack and other information

1. What Pletal is and what it is used for
Pletal belongs to a group of medicines called
phosphodiesterase type 3 inhibitors.
It has several actions which include widening of
some blood vessels and reducing the clotting
activity (clumping) of some blood cells called
platelets inside your vessels.
You have been prescribed Pletal for
"intermittent
claudication".
Intermittent
claudication is the cramp-like pain in your legs
when you walk and is caused by insufficient
blood supply in your legs. Pletal can increase
the distance you can walk without pain since it
improves the blood circulation in your legs.
Cilostazol is only recommended for patients
whose symptoms have not improved sufficiently
after making life-style modifications (such as
stopping smoking and increasing exercise) and
after other appropriate interventions. It is
important that you continue the modifications
you have made to your life-style whilst taking
cilostazol.

2. Before you take Pletal
Do not take Pletal
• if you are allergic (hypersensitive) to
cilostazol or any of the other ingredients of
Pletal.
• if you have the condition "heart failure".
• if you have persistent chest pain at rest, or
have had a “heart attack” or any heart
surgery in the last six months
• if you have now or previously suffered from
blackouts due to heart disease, or any
severe disturbances of the heart beat.
• if you know that you have a condition which
increases your risk of bleeding or bruising,
such as:
- active stomach ulcer(s).
- stroke in the past six months.
- problems with your eyes if you have
diabetes.
- if your blood pressure is not well
controlled.
• if you are taking both acetylsalicylic acid
and clopidogrel, or any combination of two
or more medicines which can increase your
risk of bleeding [ask your doctor or
pharmacist if you are not sure] if you have
severe kidney disease or moderate or
severe liver disease.
• if you are pregnant.
Take special care with Pletal
Before taking Pletal make sure your doctor
knows:
• if you have a severe heart problem or any
problems with your heart beat.
• if you have problems with your blood
pressure.
During treatment with Pletal make sure that
• If you need to have surgery including
having teeth removed, tell your doctor or
dentist that you are taking Pletal.
• If you experience easy bruising or bleeding, stop taking Pletal and tell your doctor.

Taking other medicines
Before you start taking Pletal, please tell your
doctor or pharmacist if you are taking or have
recently taken any other medicines, including
medicines obtained without a prescription.
You should specifically inform your doctor if you
take some medicines usually used to treat
painful and/or inflammatory conditions of
muscle or joints, or if you take medicines to
reduce blood clotting. These medicines include:
• acetylsalicylic acid
• clopidogrel
• anticoagulant medicines (e.g. warfarin,
dabigatran, rivaroxaban, apixaban or low
molecular weight heparins).
If you are taking such medicines with Pletal your
doctor may perform some routine blood tests.
Certain medicines may interfere with the effect
of Pletal when taken together. They may either
increase the side effects of Pletal or make Pletal
less effective. Pletal may do the same to other
medicines. Before you start taking Pletal,
please tell your doctor if you are taking:
• erythromycin, clarithromycin or rifampicin
(antibiotics)
• ketoconazole (to treat fungal infections)
• omeprazole (to treat excess acid in the
stomach)
• diltiazem (to treat high blood pressure or
chest pain)
• cisapride (to treat stomach disorders)
• lovastatin, simvastatin or atorvastatin (to
treat high cholesterol in the blood)
• halofantrine (to treat malaria)
• pimozide (to treat mental illnesses)
• ergot derivatives (to treat migraine, e.g.
ergotamine, dihydroergotamine)
• carbamazepine or phenytoin (to treat
convulsions)
• St. John’s wort (a herbal remedy)
If you are not sure if this applies to your
medicines ask your doctor or pharmacist.
Before you start taking Pletal, please inform
your doctor if you are taking medicines for high
blood pressure because Pletal may have an
additional lowering effect on your blood
pressure. If your blood pressure falls too low,
this could cause a fast heartbeat. These
medicines include:
• Diuretics
(e.g.,
hydrochlorothiazide,
furosemide)
• calcium channel blockers (e.g., verapamil,
amlodipine)
• ACE inhibitors (e.g. captopril, lisinopril)
• angiotensin II receptor blockers (e.g.,
valsartan, candesartan)
• beta blockers (e.g., labetalol, carvedilol)
It may still be all right for you to take the above
mentioned medicines and Pletal together and
your doctor will be able to decide what is
suitable for you.
Taking Pletal with food and drink
Pletal tablets should be taken 30 minutes
before breakfast and the evening meal.
Always take your tablets with a drink of water.
Pregnancy and breast-feeding
Pletal MUST NOT be used during pregnancy.
For breast-feeding mothers use of Pletal is NOT
RECOMMENDED.
If you are pregnant, think you may be pregnant
or if you are breast-feeding ask your doctor or
pharmacist for advice before taking any
medicine.
Driving and using machines
Pletal may cause dizziness. If you feel dizzy
after taking Pletal tablets, DO NOT drive and do
not use any tools or machines and inform your
doctor or pharmacist.

3. How to take Pletal
• Always take Pletal exactly as your doctor
has told you. You should check with your
doctor or pharmacist if you are not sure.
• The usual dose is one 100 mg tablet twice
a day (morning and evening). This dose
does not need to be changed for elderly
people. However, your doctor may
prescribe a lower dose if you are taking
other medicines which may have an effect
on Pletal.
• Pletal tablets should be taken 30 minutes
before breakfast and the evening meal.
Always take your tablets with a drink of
water.

BACK PAGE
Some benefits of taking Pletal may be felt within
4-12 weeks of treatment. Your doctor will
assess your progress after 3 months of
treatment and may recommend that you
discontinue cilostazol if the effect of treatment is
insufficient.
Pletal is not suitable for children.
If you take more Pletal than you should
If for any reason you have taken more Pletal
tablets than you should, you may have signs
and symptoms such as severe headache,
diarrhoea, a fall in blood pressure and
irregularities of your heartbeat.
If you have taken more tablets than your
prescribed dose, contact your doctor or
your local hospital immediately. Remember
to take the pack with you so that it is clear
what medicine you have taken.
If you forget to take Pletal
If you miss a dose, do not worry; wait until the
next dose to take your next tablet and then carry
on as normal. DO NOT take a double dose to
make up for a forgotten tablet.
If you stop taking Pletal
If you stop taking Pletal the pain in your legs
may come back or get worse. Therefore, you
should only stop taking Pletal if you notice side
effects requiring urgent medical attention (see
section 4) or if your doctor tells you to.

4. Possible side effects
Like all medicines, Pletal can cause side
effects, although not everybody gets them.
If any of the following side effects happen,
you may need urgent medical attention.
Stop taking Pletal and contact a doctor or go
to the nearest hospital immediately.
• stroke
• heart attack
• heart problems which can cause shortness
of breath or ankle swelling
• irregular heart beat (new or worsening)
• noticeable bleeding
• easy bruising
• serious illness with blistering of the skin,
mouth, eyes and genitals
• yellowing of the skin or whites of the eyes
caused by liver or blood problems
(jaundice)
You should also tell your doctor immediately if
you have a fever or sore throat. You may need
to have some blood tests and your doctor will
decide on your further treatment.
The following side effects have been
reported for Pletal. You should tell your
doctor as soon as possible:
Very common side effects (affecting more
than 1 in 10 people)
• headache
• abnormal stools
• diarrhoea
Common side effects (affecting less than 1 in
10, but more than 1 in 100 people)
• fast heart beat
• heart pounding (palpitation)
• chest pain
• dizziness
• sore throat
• runny nose (rhinitis)
• abdominal pain
• abdominal discomfort (indigestion)
• feeling or being sick (nausea or vomiting)
• loss of appetite (anorexia)
• excessive burping or wind (flatulence)
• swelling of ankles, feet or face
• rash or changes in appearance of the skin
• itchy skin
• patchy bleeding in the skin
• general weakness
Uncommon side effects (affecting less than 1
in 100, but more than 1 in 1,000 people)
• heart attack
• irregular heart beat (new or worsening)
• heart problems that can cause shortness of
breath or ankle swelling
• pneumonia
• cough
• chills
• unexpected bleeding
• tendency to bleed (e.g., of the stomach,
eye or muscle, nose bleed and blood in spit
or urine)
• decrease in red cells in the blood
• dizziness on standing up
• fainting
• anxiety
• difficulty sleeping








unusual dreams
allergic reaction
aches and pains
diabetes and increased blood sugar
stomach ache (gastritis)
malaise

There may be a higher risk of bleeding into the
eye in people with diabetes.
Rare side effects (affecting less than 1 in
1,000, but more than 1 in 10,000 people):
• tendency to bleed for longer than usual
• increase in the platelets in the blood
• problems with the kidneys
The following side effects have been
reported during the use of Pletal but it is not
known how frequently they may occur:
• changes in the blood pressure
• decrease in red cells, white cells and
platelets in your blood
• difficulty breathing
• difficulty moving
• fever
• hot flushes
• eczema and other skin rashes
• reduced sensation of the skin
• runny or sticky eyes (conjunctivitis)
• ringing in the ears (tinnitus)
• liver problems including hepatitis
• changes in the urine
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.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. 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 Pletal
Keep Pletal out of the sight and reach of
children.
Do not use Pletal after the expiry date which is
stated on the carton and blister after "EXP". The
expiry date refers to the last date of the month.
If the tablets become discoloured or show signs
of any deterioration, you should seek the advice
of your pharmacist.
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. Contents of
information

the

pack

and

other

What Pletal contains
• The active substance is cilostazol. Each
tablet contains 100 mg cilostazol.
• The other ingredients are maize starch,
microcrystalline
cellulose,
carmellose
calcium, hypromellose and magnesium
stearate.
What Pletal looks like and contents of the
pack
Pletal is a white, round, flat-faced tablet,
debossed with “OG30” on one side and plain on
the reverse.
Pletal tablets are available in blister packs of 56
tablets.
Manufacturer and Product Licence Holder
This medicine is manufactured by Brecon
Pharmaceuticals Ltd., Wye Valley Business
Park, Brecon Road, Hay-on-Wye, Hereford
HR3 5PG. It is procured from within the EU by
the Product Licence Holder: Swinghope
Limited, Brandon House, Marlowe Way,
Croydon CR0 4XS and repackaged by Interport
Limited, Brandon House, Marlowe Way,
Croydon CR0 4XS.
POM

PL No: 10380/1410

Leaflet revision date: 27/12/2013
Pletal® is a registered trademark of Otsuka
Pharmaceutical Co., Ltd.

T04596

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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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