Document: leaflet MAH BRAND_PL 11515-0002 change

• leaflet MAH BRAND_PL 11515-0002
• leaflet MAH BRAND_PLPI 15184-1516

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The following side effects hove been reported during the use of Pletal but it is riot known how frequently they may occur:

changes in the blood pressure

decrease in red cells, while cells and platelets in your blood difficulty breathing difficulty moving fever

hot Rushes

eczema and other skin rashes reduced sensation of the skin

runny or sticky eyes (conjunctivitis)    i

ringing in the ears (tinnitus) liver problems including hepatitis changes in the urine

If any of the side effects gets serious, or H you notice any side effects not listed m this leaflet, please tel 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. I You can also report side effects directly via Yellow Card Scheme, Website: www.mhra.gov.uk/yelbwcard. 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 of the month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to ho longer required. These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

Mat Pletal contains

5* 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, flahfacea 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 pocks with 70 (5x14| tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Pocltog» ledfleh Information for the user

Pletal 50 mg tablets (Cilostazol)

Pletal

i ▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You c i help by reporting any side effects you may get. See the end of section 4 For how to report side effects.

I Read all of this leaflet carefully before you start taking this medicine.

s Keep this leaflet. You may need to read it again,

* If you have any further questions, please ask your doctor or your pharmacist.

j This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms ore the same as yours.

t?" 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 I pharmacist.

What Pletal is and what it is used for Before you take Pletal How to take Pletal Possible side effects How to store Pletal

Contents of the pack and other information

1. WHAT PLETAL IS AND WHAT IT IS USED FOR

t

Pletal belongs to a group of medicines called phosphodiesterase type 3 inhibitors.

It has several actions which indude 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 daudication 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. Glostozol 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 taka Pletal

if you ore allergic (hypersensitive) to cilostazol or any of the other ingredients of Pletal. p 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 hove 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).

I - 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.

You should specifically inform your doctor ifyou take some medicines usually used lo treat painful and/or inflammatory conditions of muscle or joints, or if you take medicines to reduce blood clotting. These medicines include:

¹ acetyfsalicylic 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 ihe 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 poin) je cisapride (to treat stomach disorders!

lovastotin, simvastatin or otorvaslatin (to treat high cholesterol in the blood] halofantrine [to treat malaria) l^{1 2} 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);

ft 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

If you slop taking Plata!

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.

tf any of the following sklo effects happen/ you may need urgent medical attention. Stop taking PI and contact a doctor or go to the nearest hospital immediately.

« stroke <8 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 jy«ir doctor will decide on your further treatment.

Thu following cide effects have been reported for Pletal. You should tefl your doctor as soon as

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 n fast heart boot 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 I in 1,000 people) heart attack

irregular heart beat (new or worsening)

heart problems that can cause shortness of breath or ankle swelling pneumonia

cMlf

unexpected bleeding

tendency to bleed (e.g., of the stomach, eye or muscle, r 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

ifhere may be o higher risk of bleeding into the eye in people with diabetes.

Rare fid* effects (affecting less than 1 in 1,000, but n tendency to bleed for longer than usual increase in the platelets in the blood Li problems with the kidneys _ _ _

1

Always take Pletal exactly as your doctor has told you. You should check with your doctor or pharmacist if you c i'« The usual dose is two 50 mg tablets twice a day [morning and evening). This dose does not need to be changed for

2

elderly people. However, your doctor may prescribe a fewer dose if you are faking other medicines which may have an effector Pletal.

j» 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 cifeslazol if the effect of treatment is insufficient,

Pletal is not suitable for children, ff you take more Pletal than you should

|f for any reason you have taken more Pletal tablets than you should, you may have signs and symptoms such as severe headache, diarrhoea, a foil in blood pressure and irregularities of your heartbeat.

If you have taken more tablets than your prescribed dose, contact your doctor or your local hospitd I immediately. Remember to lake the pack with you so that it is clear what medicine you have taken.

If you forget to fake 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. _ _ _ _ _ _ _ _ _ _ _!