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CILOSTAZOL 50 MG TABLETS

Active substance(s): CILOSTAZOL

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Package leaflet: Information for the user

Pletal 50 mg tablets
(cilostazol)
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.
Your medicine is called Pletal 50 mg tablets but throughout this leaflet
will be referred to 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 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.
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 breastfeeding 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 two 50 mg tablets 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 interfere with the effect of
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 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 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 Pletal
Keep 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.
6. Contents of the pack and other information
What Pletal contains
The active substance is cilostazol. Each tablet contains 50 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
The Pletal 50 mg tablet is a white, round, flat-faced tablet,
debossed with “OG31” on one side and plain on the reverse.
Your medicine is supplied in packs of 56 tablets
Pletal is available in other strengths.
Manufactured by: AndersonBrecon (UK) Ltd
Wye Valley Business Park, Brecon Road, Hay-on-Wye,
Hereford HR3 5PG, UK.
Procured within the EU.
Product Licence holder: Ecosse Pharmaceuticals Limited
3 Young Place, East Kilbride G75 0TD.
Re-packaged by: Munro Wholesale Medical Supplies Limited
3 Young Place, East Kilbride G75 0TD.
PL: 19065/0498
This leaflet was revised: 16/11/2015

POM

E0498/1
®Pletal is a registered trade mark of Otsuka Pharmaceutical Co. Ltd

Package leaflet: Information for the user

Cilostazol 50 mg tablets
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.
Your medicine is called cilostazol 50 mg tablets but throughout this
leaflet will be referred to as cilostazol.
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.
In this leaflet:
1. What Cilostazol is and what it is used for
2. Before you take Cilostazol
3. How to take Cilostazol
4. Possible side effects
5. How to store Cilostazol
6. Contents of the pack and other information
1. What Cilostazol is and what it is used for
Cilostazol 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 Cilostazol 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. Cilostazol
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 Cilostazol
Do not take Cilostazol
• if you are allergic (hypersensitive) to cilostazol or any of the other
ingredients of Cilostazol.
• 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 Cilostazol
Before taking Cilostazol 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 Cilostazol make sure that
• If you need to have surgery including having teeth removed, tell
your doctor or dentist that you are taking Cilostazol.
• If you experience easy bruising or bleeding, stop taking Cilostazol
and tell your doctor.

Taking other medicines
Before you start taking Cilostazol 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 Cilostazol your doctor may
perform some routine blood tests.
Certain medicines may interfere with the effect of Cilostazol when
taken together. They may either increase the side effects of Cilostazol
or make Cilostazol less effective. Cilostazol may do the same to other
medicines. Before you start taking Cilostazol, 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 Cilostazol, please inform your doctor if you are
taking medicines for high blood pressure because Cilostazol 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 Cilostazol together and your doctor will be able to decide what is
suitable for you.
Taking Cilostazol with food and drink
Cilostazol 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
Cilostazol MUST NOT be used during pregnancy.
For breast-feeding mothers use of Cilostazol 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
Cilostazol may cause dizziness. If you feel dizzy after taking Cilostazol
tablets, DO NOT drive and do not use any tools or machines and
inform your doctor or pharmacist.
3. How to take Cilostazol
• Always take Cilostazol exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
• The usual dose is two 50 mg tablets 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 interfere with the effect of
Cilostazol.
• Cilostazol 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 Cilostazol 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.

Cilostazol is not suitable for children.
If you take more Cilostazol than you should
If for any reason you have taken more Cilostazol 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 Cilostazol
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 Cilostazol
If you stop taking Cilostazol the pain in your legs may come back or
get worse. Therefore, you should only stop taking Cilostazol 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, Cilostazol 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 Cilostazol 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 Cilostazol. 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
Cilostazol 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 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 Cilostazol
Keep out of the sight and reach of children.
Do not use Cilostazol 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.
6. Contents of the pack and other information
What Cilostazol contains
The active substance is cilostazol. Each tablet contains 50 mg
cilostazol.
The other ingredients are maize starch, microcrystalline cellulose,
carmellose calcium, hypromellose and magnesium stearate.
What Cilostazol looks like and contents of the pack
The Cilostazol 50 mg tablet is a white, round, flat-faced tablet,
debossed with “OG31” on one side and plain on the reverse.
Your medicine is supplied in packs of 56 tablets
Cilostazol is available in other strengths.
Manufactured by: AndersonBrecon (UK) Ltd
Wye Valley Business Park, Brecon Road, Hay-on-Wye,
Hereford HR3 5PG, UK.
Procured within the EU.
Product Licence holder: Ecosse Pharmaceuticals Limited
3 Young Place, East Kilbride G75 0TD.
Re-packaged by: Munro Wholesale Medical Supplies Limited
3 Young Place, East Kilbride G75 0TD.
POM
PL: 19065/0498
This leaflet was revised: 16/11/2015
E0498(C)/1

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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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