PLETAL 100 MG TABLETS

Active substance: CILOSTAZOL

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Pletal® 100 mg tablets
(cilostazol)
PATIENT INFORMATION LEAFLET
This medicine is called Pletal 100 mg tablets but will be referred
to as Pletal throughout this leaflet.

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 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 get serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.

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 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 or simvastatin (to treat high cholesterol in the
blood)

halofantrine (to treat malaria)

pimozide (to treat mental illnesses)

ergot derivatives (to treat migraine)

carbamazepin 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.

1)
2)
3)
4)
5)
6)

What Pletal is and what it is used for
Before you take Pletal
How to take Pletal
Possible side effects
How to store Pletal
Further information

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.
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.

1)

WHAT PLETAL IS AND WHAT IT IS USED FOR

Taking Pletal with food and drink

In this leaflet:

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.

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 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 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.
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 (e.g. aspirin [acetylsalicylic acid], clopidogrel,
warfarin). If you are taking such medicines with Pletal your
doctor may perform some routine blood tests.

Pletal tablets should be taken 30 minutes before or 2 hours after
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.
Pletal tablets should be taken 30 minutes before or 2
hours after breakfast and the evening meal.
Always take your tablets with a drink of water.

Sometimes you may feel the benefits of taking Pletal within 4-12
weeks of treatment whilst for others it maybe by between 16-24
weeks.
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.

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)

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)

not wanting to eat (anorexia)

liver problems including hepatitis

changes in the urine

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.

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 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

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.
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.
If the tablets show any signs of deterioration seek the
advice of your pharmacist.

4)

POSSIBLE SIDE EFFECTS

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)

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)

problems with the blood supply to the heart

shortness of breath

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)
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





6) FURTHER INFORMATION
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 100 mg tablets are white, round, flat-faced and debossed
with “OG30” on one side and plain on reverse.
Your medicine is supplied in packs of 56 tablets.

Manufacturer
Brecon Pharmaceuticals Ltd.,
Wye Valley Business Park,
Brecon Road,
Hay-on-Wye,
Hereford, HR3 5PG,
United Kingdom.
This product is procured from within the EU and repackaged by
Mediwin Limited, Product Licence Holder: Mediport Limited,
13 Martello Enterprise Centre,
Courtwick Lane,
Littlehampton,
West Sussex,
BN17 7PA,
United Kingdom.

POM

PL No: 18980/0849

PLETAL® IS A REGISTERED TRADEMARK OF OTSUKA
PHARMACEUTICAL CO., LTD
Date of leaflet preparation: 22/04/2013

REF: ####
MCP-0849v1

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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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