PATIENT INFORMATION LEAFLET

Ekistol 50 mg tablets

Cilostazol

Read this leaflet carefully before you start taking this medicine because it contains important information for you

-Keep this leaflet as you may need to read it again

-If you have any questions, ask your doctor or pharmacist

-This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms, as it may harm them

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

1.What Ekistol is and what it is used for

2.What you need to know before you start taking Ekistol

3.How to take Ekistol

4.Possible side effects

5.Storage of Ekistol

6.Contents of the pack and additional information

Ekistol belongs to a group of medications known as type 3 phosphodiesterase inhibitors. It has various actions, including the dilation of certain blood vessels and the reduction of the coagulant activity (agglutination) of certain blood cells, called platelets, in blood vessels.

Ekistol has been prescribed for "intermittent claudication". Intermittent claudication is the cramping pain that you experience in your legs when walking and is caused by an insufficient blood supply to the legs. Ekistol may help you increase the walking distance, as it improves blood circulation in the legs. Cilostazol is only recommended for patients whose symptoms have not improved enough after making lifestyle changes (such as quitting smoking and exercising more) and after other appropriate interventions. It is essential that you continue with the lifestyle changes you have made while taking cilostazol.

Do not takeEkistol

?if you are allergic (hypersensitive) to cilostazol or any of the other components of this medication (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 or have had previous fainting spells due to heart disease or severe heart rhythm disorders.

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

- active stomach ulcers.

- stroke (cerebral hemorrhage) within 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 medications that may increase your risk of bleeding (consult your doctor or pharmacist if you are unsure).

?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 severe 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 experience bruising or bleeding easily, stop taking Ekistol and inform your doctor.

Taking Ekistol with other medications

Before starting to takeEkistol, inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including over-the-counter medications.

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

?aspirin

?clopidogrel

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

In the case of taking these medications with Ekistol, your doctor may need to perform routine blood tests.

Determined medications may interfere with the effect of Ekistol when taken together. They may increase the side effects of Ekistol or reduce its effectiveness. Ekistol may have the same effects on other medications. Before starting to take Ekistol, inform 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 some 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 or hypericum (herbal remedy).

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

Before starting to take Ekistol, inform your doctor or pharmacist if you are taking medications to treat high blood pressure, as Ekistol may have an additional effect of lowering blood pressure. In the case of excessive blood pressure lowering, you may experience an acceleration of heart rhythm. Among these medications are:

?diuretics (e.g., hydrochlorothiazide, furosemide)

?calcium channel blockers (e.g., verapamil, amlodipine)

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

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

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

You may be able to take the aforementioned medications together with Ekistol. Your doctor will decide if this is suitable in your case.

Taking Ekistol with food and drinks

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

Take the tablets always with a glass of water.

Pregnancy, breastfeeding, and fertility

DO NOT TAKEEkistol during pregnancy.

DO NOT RECOMMENDtaking Ekistol during breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medication.

Driving and operating machinery

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

?Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

?The recommended dose is two 50 mg tablets twice a day (in the morning and in the evening). It is not necessary to modify this dose for elderly patients. However, your doctor may prescribe a lower dose if you are taking other medications that could interfere with the effect of Ekistol.

?You must take the 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 at 4 to 12 weeks of treatment. At 3 months of treatment, your doctor will evaluate 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 any reason more tablets of 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 the prescribed dose, contact your doctor or the nearest hospital immediately. Remember to bring the packaging with you so it is clear what medication you have taken.

You can also call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to takeEkistol

Do not worry if you forget to take a dose. Wait until the next dose and continue taking the treatment normally.DO NOTtake a double dose to compensate for the missed doses.

If you interrupt the treatment withEkistol

If you stop taking Ekistol, the pain in your legs may worsen again. Therefore, you should only stop taking Ekistol if you detect emergency medical attention required side effects (see section 4) or if your doctor tells you to.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, Ekistol can cause side effects, although not everyone will experience them.

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

stroke (apoplejía)

heart attack (infarto de miocardio)

heart problems, which can cause difficulty breathing or swelling of the ankles

irregular heartbeats (new or worsening)

notable bleeding

easily bruising

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

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

You should also inform your doctor immediately if you experience fever or sore throat. Blood tests may be required; your doctor will decide on the treatment to be administered.

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

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

headache

abnormal stools

diarrhea

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

rapid heartbeats

palpitations

chest pain

dizziness

sore throat

runny nose or nasal discharge (rinitis)

abdominal pain

abdominal discomfort (indigestion)

nausea or vomiting

loss of appetite (anorexia)

excessive gas or flatulence

swelling of the ankles, feet, or face

skin rash or changes in skin appearance

itching of the skin

bruises on the skin

general weakness

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

heart attack (infarto de miocardio)

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, nasal bleeding or presence of blood in sputum or urine)

decrease in the number of red blood cells in the blood

dizziness when standing up

syncope

anxiety

difficulty falling asleep

abnormal dreams

allergic reaction

pain and discomfort

diabetes and increased blood sugar concentration

stomach pain (gastritis)

general malaise

People with diabetes may be at a higher risk of eye bleeding.

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

prolonged bleeding

increase in platelet concentration 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 the concentration of red blood cells, white blood cells, and platelets in the blood

difficulty breathing

difficulty moving

fever

seizures

eczema and other skin rashes

decreased sensation in the skin

tearful or sticky eyes (conjunctivitis)

tinnitus (ringing in the ears)

liver problems, including hepatitis

changes in urine

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es

By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep Ekistol out of sight and reach of children.

Do not use Ekistol after the expiration date that appears on the box and blister after "CAD". The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drain or in the trash.Dispose of the packaging and medicines you no longer need at theSIGREcollection pointofthe pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Ekistol

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

The other components are cornstarch, microcrystalline cellulose, calcium carmelose, hypromellose, and magnesium stearate.

Appearance of the product and contents of the packaging

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

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

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

LACER, S.A. - Boters, 5

08290 Cerdanyola del Vallès

Barcelona – Spain

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Spain Ekistol 50 mg tablets

This prospectus was approved in February 2015

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/