POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.
The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet are: PL 11515/0002, PL 11515/0001.
Pletal 50 mg and 100 mg tablets
Package leaflet: Information for the user
Pletal 50 mg tablets
Pletal 100 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.
Read all of this leaflet carefully before you start taking this medicine.
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
Take special care with Pletal
Before taking Pletal make sure your doctor knows:
During treatment with Pletal make sure that
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:
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:
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:
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
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.
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)
Common side effects (affecting less than 1 in 10, but more than 1 in 100 people)
Uncommon side effects (affecting less than 1 in 100, but more than 1 in 1,000 people)
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):
The following side effects have been reported during the use of Pletal but it is not known how frequently they may occur:
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 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.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Pletal contains
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.
The Pletal 100 mg tablet is a white, round, flat-faced tablet, debossed with “OG30” 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
This medicinal product is authorised in the Member States of the EEA under the following names:
France PLETAL 50 mg, comprimé, PLETAL 100 mg, comprimé,
Germany Pletal 50 mg Tabletten, Pletal 100 mg Tabletten
Italy Pletal 50 mg compresse, Pletal 100 mg compresse
Spain Pletal 50 mg comprimidos, Pletal 100 mg comprimidos
Sweden Pletal 50 mg tabletter, Pletal 100 mg comprimidos
United Kingdom Pletal 50 mg tablets, Pletal 100 mg tablets,
This leaflet was last revised in 10/2013.