EKISTOL 50 mg TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ekistol 50 mg tablets

Cilostazol

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.

Contents of the pack

1. What Ekistol is and what it is used for
2. What you need to know before you take Ekistol
3. How to take Ekistol
4. Possible side effects
5. Storing Ekistol
6. Contents of the pack and other information

1. What Ekistol is and what it is used for

Ekistol belongs to a group of medicines called phosphodiesterase type 3 inhibitors. It has several actions including the dilation of certain blood vessels and the reduction of the clotting activity (aggregation) of certain blood cells called platelets in the blood vessels.

You have been prescribed Ekistol for "intermittent claudication". Intermittent claudication is the pain in your legs that you get when you walk and which is caused by an insufficient supply of blood to your legs. Ekistol may help you to increase the distance you can walk. It improves blood flow to your legs. Cilostazol is only recommended for patients whose symptoms have not improved sufficiently after making lifestyle changes (such as stopping smoking and increasing exercise) and after other appropriate interventions. It is important that you continue with the lifestyle changes you have made while taking cilostazol.

2. What you need to know before you take Ekistol

Do not takeEkistol

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

? if you have a known condition called "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 fainted due to a heart condition or serious heart rhythm disorders.

? if you know you have a condition that increases the risk of bleeding or bruising, such as:

• active stomach ulcers.
• stroke in the last six months.
• eye problems if you have diabetes.
• uncontrolled high blood pressure.
• if you are taking aspirin and clopidogrel, or any combination of two or more medicines that may increase your risk of bleeding (consult your doctor or pharmacist if you are not sure).

? severe kidney disease or moderate to severe liver disease.

? if you are pregnant.

Warnings and precautions

Before taking Ekistol, make sure your doctor knows:

? if you have any serious heart problems or any heart rhythm disorders.

? if you have any blood pressure disorders.

During treatment with Ekistol, make sure that:

? if you have to undergo surgery, including dental extraction, inform your doctor or dentist that you are taking Ekistol.

? if you bruise or bleed easily, stop taking Ekistol and inform your doctor.

Taking Ekistol with other medicines

Before starting to take Ekistol, tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription.

You must specifically inform your doctor if you are taking medicines that are usually taken to treat painful and/or inflammatory conditions in the muscles or joints, as well as medicines to reduce blood clotting. These medicines include:

? aspirin

? clopidogrel

? anticoagulant medicines (e.g. warfarin, dabigatran, rivaroxaban, apixaban or low molecular weight heparins).

If you are taking these medicines with Ekistol, your doctor may need to perform routine blood tests.

Certain medicines may interfere with the effect of Ekistol when taken together. They may increase the side effects of Ekistol or reduce its efficacy. Ekistol may have these same effects on other medicines. Before starting to take Ekistol, tell your doctor or pharmacist if you are taking:

? erythromycin, clarithromycin or rifampicin (antibiotics);

? ketoconazole (to treat fungal infections);

? omeprazole (to treat excess stomach acid);

? diltiazem (to treat high blood pressure or chest pain);

? cisapride (to treat certain stomach disorders);

? lovastatin, simvastatin or atorvastatin (to treat high cholesterol in the blood);

? halofantrine (to treat malaria);

? pimozide (to treat mental disorders);

? ergot derivatives (to treat migraines, e.g. ergotamine, dihydroergotamine);

? carbamazepine or phenytoin (to treat seizures);

? St. John's Wort (a herbal product).

If you are unsure whether this applies to the medicines you are taking, consult your doctor or pharmacist.

Before starting to take Ekistol, tell your doctor or pharmacist if you are taking medicines to treat high blood pressure, as Ekistol may have an additional blood pressure lowering effect. If your blood pressure drops too low, you may experience an increased heart rate. These medicines include:

? diuretics (e.g. hydrochlorothiazide, furosemide)

? calcium antagonists (e.g. verapamil, amlodipine)

? ACE inhibitors (e.g. captopril, lisinopril)

? angiotensin II receptor antagonists (e.g. valsartan, candesartan)

? beta blockers (e.g. labetalol, carvedilol).

It may be possible for you to take these medicines with Ekistol. Your doctor will decide whether this is suitable for you.

Taking Ekistol with food and drink

You should take Ekistol tablets 30 minutes before breakfast and dinner.

Always take the tablets with a glass of water.

Pregnancy, breast-feeding and fertility

DO NOT TAKEEkistol during pregnancy.

DO NOT RECOMMENDtaking Ekistol during breast-feeding.

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 this medicine.

Driving and using machines

Ekistol may cause dizziness. If you feel dizzy after taking Ekistol, DO NOTdrive or use any tools or machines and inform your doctor or pharmacist.

3. How to take Ekistol

? Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

? The recommended dose is two 50 mg tablets twice a day (in the morning and at night). The dose does not need to be modified for elderly patients. However, your doctor may prescribe a lower dose if you are taking other medicines that may interfere with the effect of Ekistol.

? You should take Ekistol tablets 30 minutes before breakfast and dinner. Always take the tablets with a glass of water.

You may notice the benefits of taking Ekistol 4 to 12 weeks after starting treatment. At 3 months of treatment, your doctor will assess your progress and may recommend that you stop taking cilostazol if the treatment effect is not sufficient.

Ekistol is not suitable for children.

If you take moreEkistolthan you should

If you take more Ekistol than you should, you may experience symptoms such as severe headache, diarrhea, low blood pressure, and irregular heartbeats.

If you take more tablets than prescribed, contact your doctor or the nearest hospital immediately. Remember to take the pack with you so that the medicine can be identified.

You can also call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to takeEkistol

Do not worry if you forget to take a dose. Wait until the next dose and continue treatment as usual. DO NOTtake a double dose to make up for forgotten doses.

If you stop takingEkistol

If you stop taking Ekistol, the pain in your legs may worsen again. Therefore, you should only stop taking Ekistol if you experience side effects that require urgent medical attention (see section 4) or if your doctor tells you to do so.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ekistol can cause side effects, although not everybody gets them.

If you experience any of the following side effects, you may need urgent medical attention. Stop takingEkistoland contact a doctor or go to the nearest hospital immediately.

? stroke

? heart attack

? heart problems that can cause difficulty breathing or swelling of the ankles

? irregular heartbeats (new or worsening)

? significant bleeding

? tendency to bruise

? severe skin condition with blistering of the skin, mouth, eyes, or genitals

? yellowing of the skin or the whites of the eyes due to liver or blood problems (jaundice).

You should also inform your doctor immediately if you experience fever or sore throat. You may need to have blood tests; your doctor will decide on the treatment to be given to you.

The following side effects have been observed in patients treated withEkistol. If you experience them, you must inform your doctor immediately:

Very common side effects(may affect more than 1 in 10 people)

? headache

? abnormal stools

? diarrhea

Common side effects(may affect up to 1 in 10 people)

? rapid heartbeats

? heart palpitations

? chest pain

? dizziness

? sore throat

? runny nose or nasal discharge (rhinitis)

? abdominal pain

? indigestion

? nausea or vomiting

? loss of appetite (anorexia)

? excess gas or flatulence

? swelling of the ankles, feet, or face

? skin rash or changes in skin appearance

? itching of the skin

? hemorrhagic patches on the skin

? general weakness

Uncommon side effects(may affect up to 1 in 100 people)

? heart attack (myocardial infarction)

? irregular heartbeats (new or worsening)

? heart problems that can cause difficulty breathing or swelling of the ankles

? pneumonia

? cough

? chills

? unexpected bleeding

? tendency to bleed (e.g. in the stomach, eyes, or muscles, nosebleeds, or blood in the sputum or urine)

? decrease in the number of red blood cells in the blood

? dizziness when standing up

? fainting

? anxiety

? difficulty sleeping

? abnormal dreams

? allergic reaction

? pain and discomfort

? diabetes and increased blood sugar levels

? stomach pain (gastritis)

? general malaise

Diabetic patients may be at higher risk of eye bleeding.

Rare side effects(may affect up to 1 in 1,000 people)

? tendency to bleed for longer than usual

? increase in platelet count in the blood

? kidney problems

The following side effects have been observed during the use of Ekistol, but the frequency with which they occur is unknown:

? changes in blood pressure

? decrease in red blood cell, white blood cell, and platelet count in the blood

? difficulty breathing

? difficulty moving

? fever

? hot flashes

? eczema and other skin rashes

? decreased sensation in the skin

? watery or sticky eyes (conjunctivitis)

? ringing in the ears (tinnitus)

? liver problems including hepatitis

? changes in urine

Reporting of side effects

If you experience 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 Spanish Medicines and Health Products Agency (AEMPS) website: https://www.notificaram.es

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Ekistol

Keep Ekistol out of the sight and reach of children.

Do not use Ekistol after the expiry date which is stated on the carton and blister after "EXP". The expiry date refers to the last day of that 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 protect the environment.

6. Contents of the pack and other information

Composition ofEkistol

The active substance is cilostazol. One tablet contains 50 mg of cilostazol.

The other ingredients are corn starch, microcrystalline cellulose, calcium carmellose, hypromellose, and magnesium stearate.

Appearance and packaging

The 50 mg Ekistol tablet is a white to off-white, round, flat-faced tablet with the text "I" engraved on one side.

This product is available in packs of 14, 20, 28, 30, 50, 56, 98, 100, 112, or 168 tablets, as well as hospital packs with 70 tablets (5 x 14).

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

LACER, S.A. - Boters, 5

08290 Cerdanyola del Vallès

Barcelona - Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Spain Ekistol 50 mg tablets

This leaflet was approved in February 2015

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/