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Pletal 100mg Tablets

Document: leaflet MAH BRAND_PLPI 16369-1358 change

1. What Pletal is and what it is used for


2. Before you take Pletal


3. How to take Pletal


PACKAGE LEAFLET: INFORMATION FOR THE USER

PLETAL® 100mg 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 available as the above name 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 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.    Further information

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.

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.

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.

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.

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.

Taking Pletal with food and drink

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 breastfeeding ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machine

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.

•    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

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