Document: leaflet MAH GENERIC_PL 00289-1850 change

• leaflet MAH BRAND_PLPI 30900-2387
• leaflet MAH BRAND_PLPI 39352-0073
• leaflet MAH GENERIC_PL 00289-1850
• leaflet MAH GENERIC_PL 04569-1427
• leaflet MAH GENERIC_PL 14894-0722
• leaflet MAH GENERIC_PL 24837-0048
• leaflet MAH GENERIC_PL 32854-0039

---

TEVA UK Ref: 231-30-40404-C LEA CILOSTAZOL 100mg TAB TUK <ULM Version: 2 23 March 2016

Cilostazol 100 mg tablets cilostazol

Package leaflet: Information for the user

▼ 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 because it contains important information for you.

•    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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

What is in this leaflet

1.    What Cilostazol is and what it is used for

2.    What do you need to know 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

OWhat 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 What you need to know before you take Cilostazol

Do not take Cilostazol

• if you are allergic (hypersensitive) to Cilostazol or any of the other ingredients of this medicine (listed in section 6)

• 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 have severe kidney disease or moderate or severe liver disease • 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 are pregnant.

Warnings and precautions

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.

Other medicines and Cilostazol

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

Before you start taking Cilostazol, 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)

•    protease inhibitors (antivirals)

•    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)

•    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. 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 these medicines and Cilostazol together and your doctor will be able to decide what is suitable for you.

Cilostazol with food, drink and alcohol 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.

Breast-feeding mothers use of Cilostazol is not recommended.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, 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.

^ How to take Cilostazol

•    Always take Cilostazol exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.