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CILOSTAZOL 100MG TABLETS

Active substance(s): CILOSTAZOL

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CUSTOMER:

Waymade

PRODUCT:

Pletal 100mg tabs

CODE:

06464/2789E

PRE-PRESS NO.:

06 1257

ARTWORKER:

DT

DATE OF PROOF:

30/01/14

Q.A.
APPROVED:

CUSTOMER
APPROVED:

DATE:

DATE:

PROOF HISTORY:
v.3 - waymade - 30/01/14

«PAdBì
Leaflet Flat Size = 296 x 317
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED OCTOBER 2013
REPORTING OF SIDE EFFECTS

Pg 1

Pg 4

5. How to store Pletal
Keep out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
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 any other signs of deterioration, you should seek the
advice of your pharmacist who will tell you what to do.
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 the pack and other information
What Pletal contains
Pletal 100mg Tabets/Cilostazol 100mg Tablets contain 100 mg of the active ingredient cilostazol.
Pletal 100mg Tabets/Cilostazol 100mg Tablets also contain the following inactive ingredients: maize starch,
microcrystalline cellulose, carmellose calcium, hypromellose and magnesium stearate.
What Pletal looks like and the contents of the pack
Pletal 100mg Tabets/Cilostazol 100mg Tablets are a white, round, flat-faced tablet, debossed with “OG30” on
one side.
Pletal 100mg Tabets/Cilostazol 100mg Tablets are available in blister packs of 56 tablets.
Product Licence Holder and Manufacturer
POM

PL No: 06464/2789

This product is manufactured by Brecon Pharmaceuticals Ltd., Wye Valley Business Park Brecon Road,
Hay-on-Wye, Hereford HR3 5PG, United Kingdom and procured within the EU and repackaged by the Product
Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 27.1.2014
Pletal is a registered trademark of Otsuka Pharmaceutical Co. Ltd

PLETAL® 100mg TABLETS/CILOSTAZOL 100mg TABLETS
(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.
This medicine is known as one of the above names but will be referred to throughout this leaflet as Pletal.
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 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 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 increased 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.

Pg 2 !

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

-7Æ7»³
û¬ET).

XÆE)f

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

CUSTOMER:

Waymade

PRODUCT:

Pletal 100mg tabs

CODE:

06464/2789E

PRE-PRESS NO.:

06 1257

ARTWORKER:

DT

DATE OF PROOF:

30/01/14

Q.A.
APPROVED:

CUSTOMER
APPROVED:

DATE:

DATE:

PROOF HISTORY:
v.3 - waymade - 30/01/14

«PAdBì
Leaflet Flat Size = 296 x 317
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED OCTOBER 2013
REPORTING OF SIDE EFFECTS

Pg 2

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.

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 cilosazol 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)

Pg 3

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 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, Website:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.

Pg 4 !

Pg 3 !

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

-7Æ7»³
û¬ET).

XÆE)f

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

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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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