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PLETAL 50MG TABLETS

Active substance(s): CILOSTAZOL

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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 reduced sensation of the skin decrease in red cells, white cells and platelets runny or sticky eyes (conjunctivitis) in your blood ringing in the ears (tinnitus) difficulty breathing not wanting to eat (anorexia) difficulty moving liver problems including hepatitis fever changes in the urine hot flushes eczema and other skin rashes 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.

PACKAGE LEAFLET: INFORMATION FOR THE USER

P L E TA L 5 0 m g TA B L E T S ( C I L O S TA Z O L )

5. HOW TO STORE PLETAL
Keep Pletal out of the reach and sight 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.

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 1. 3. 5. this leaflet: What Pletal is and what it is used for How to take Pletal How to store Pletal

6. FURTHER INFORMATION
What Pletal contains The active substance is cilostazol. One 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. Your medicine is supplied in packs of 14, 20, 28, 30, 50, 56, 98, 100, 112 or 168 tablets or hospital packs with 70 (5x14) tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing authorisation holder Distributed by: Otsuka Pharmaceutical Europe Ltd. Otsuka Pharmaceuticals (UK) Ltd. Hunton House 3 Furzeground Way Highbridge Business Park Stockley Park Oxford Road Uxbridge Uxbridge Middlesex UB11 1EZ Middlesex UB8 1HU United Kingdom United Kingdom Manufacturer Brecon Pharmaceuticals Ltd. Wye Valley Business Park Brecon Road Hay-on-Wye Hereford HR3 5PG United Kingdom This medicinal product is the following names: France Pletal 50 Germany Pletal 50 Ireland Pletal 50 Italy Pletal 50 authorised in the Member States of the EEA under mg, comprim mg Tabletten mg tablets mg compresse Spain Sweden United Kingdom Pletal 50 mg comprimidos Pletal 50 mg tabletter Pletal 50 mg tablets

2. Before you take Pletal 4. Possible side effects 6. Further 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 cramplike 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.

This leaflet was last approved in 10/2009.

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. 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. Johns 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 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.

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 easy bruising heart attack serious illness with blistering of the skin, heart problems which can cause shortness of breath mouth, eyes and genitals or ankle swelling yellowing of the skin or whites of the irregular heart beat (new or worsening) eyes caused by liver or blood problems noticeable bleeding (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 diarrhoea abnormal stools Common side effects (affecting less than 1 in 10, but more than 1 in 100 people) fast heart beat excessive burping or wind (flatulence) heart pounding (palpitation) swelling of ankles, feet or face chest pain rash or changes in appearance dizziness of the skin sore throat itchy skin runny nose (rhinitis) patchy bleeding in the skin abdominal pain general weakness abdominal discomfort (indigestion) feeling or being sick (nausea or vomiting) 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 dizziness on standing up shortness of breath fainting pneumonia anxiety cough difficulty sleeping chills unusual dreams unexpected bleeding allergic reaction tendency to bleed (e.g., of the stomach, eye or muscle, aches and pains nose bleed and blood in spit or urine) diabetes and increased blood sugar decrease in red cells in the blood 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 problems with the kidneys increase in the platelets in the blood

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. 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.

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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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