Ekistol 50 mg tablets

Package leaflet: Information for the user

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 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 and must not be given to other people, even if they have the same symptoms as you, because it may harm them
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet.

Contents of the leaflet

1. What Ekistol is and what it is used for
2. What you need to know before taking Ekistol
3. How to take Ekistol
4. Possible adverse effects
5. How to store 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 known as phosphodiesterase type 3 inhibitors. It has various 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 cramp-like pain in the legs that occurs 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 recommended only for patients whose symptoms have not improved sufficiently after making lifestyle changes (such as quitting smoking and increasing physical activity) and after other appropriate interventions. It is important that you continue with any lifestyle changes you have made while taking cilostazol.

2. What you need to know before taking Ekistol

Do not take Ekistol

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

? if you have a condition known as "heart failure".

? if you have persistent chest pain at rest, or have had a "heart attack" or any heart surgery within the last six months.

? if you currently have or have previously had fainting spells due to heart disease or serious heart rhythm disorders.

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

• active stomach ulcers.
• stroke (cerebrovascular accident) within the last six months.
• eye problems if you have diabetes.
• uncontrolled high blood pressure.
• if you are taking acetylsalicylic acid and clopidogrel, or any combination of two or more medicines that could 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 serious heart problems or any heart rhythm disorders.

? if you have any blood pressure disorders.

While being treated with Ekistol, ensure that:

? If you need to undergo any surgical procedure, including dental extractions, inform your doctor or dentist that you are taking Ekistol.

? If you develop easy bruising or bleeding, stop taking Ekistol and inform your doctor immediately.

Taking Ekistol with other medicines

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

You must specifically inform your doctor if you are taking medicines commonly used to treat painful and/or inflammatory conditions of the muscles or joints, or if you are taking medicines to reduce blood clotting. These include:

? acetylsalicylic acid

? clopidogrel

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

If you are taking any of 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 effectiveness. Ekistol may also affect the action of other medicines. Before starting Ekistol, inform your doctor or pharmacist if you are taking:

? erythromycin, clarithromycin, or rifampicin (antibiotics);

? ketoconazole (used to treat fungal infections);

? omeprazole (used to treat excess stomach acid);

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

? cisapride (used to treat certain stomach disorders);

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

? halofantrine (used to treat malaria);

? pimozide (used to treat mental disorders);

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

? carbamazepine or phenytoin (used to treat seizures);

? St. John’s wort (Hypericum perforatum) (a herbal remedy).

If you are unsure whether any of these apply to the medicines you are taking, consult your doctor or pharmacist.

Before starting Ekistol, inform 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 much, you may experience an increased heart rate. These medicines include:

? 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 above-mentioned medicines together with Ekistol. Your doctor will decide whether this is appropriate for you.

Taking Ekistol with food and drink

Take Ekistol tablets 30 minutes before breakfast and dinner.

Always take the tablets with a glass of water.

Pregnancy, breastfeeding, and fertility

DO NOT TAKE Ekistol during pregnancy.

IT IS NOT RECOMMENDED to take 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 medicine.

Driving and using machines

Ekistol may cause dizziness. If you feel dizzy after taking Ekistol, DO NOT drive or operate any tools or machinery, and inform your doctor or pharmacist.

3. How to take Ekistol

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

? The recommended dose is two 50 mg tablets twice daily (in the morning and at night). It is not necessary to adjust this dose for elderly patients. However, your doctor may prescribe a lower dose if you are taking other medicines that could 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 begin to notice the benefits of taking Ekistol between 4 and 12 weeks after starting treatment. After 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 more Ekistol than you should

If you take more Ekistol tablets than prescribed for any reason, you may experience symptoms such as severe headache, diarrhea, low blood pressure, and irregular heartbeat.

If you take more tablets than prescribed, contact your doctor or nearest hospital immediately. Remember to bring the packaging with you so it is clear which medicine you have taken.

You may also call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Ekistol

Do not worry if you forget to take a dose. Wait until your next scheduled dose and continue taking the medicine as usual. DO NOT take a double dose to make up for missed doses.

If you stop taking Ekistol

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

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

4. Possible adverse effects

Like all medicines, Ekistol may cause adverse effects, although not everyone experiences them.

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

? stroke (cerebrovascular accident)

? myocardial infarction (heart attack)

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

? irregular heartbeat (new or worsening)

? significant bleeding

? increased tendency to bruise

? serious illness with blistering of the skin, mouth, eyes, or genitals

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

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

The following adverse effects have been observed in patients treated with Ekistol. If you experience any of them, you must inform your doctor immediately:

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

? headache

? abnormal stools

? diarrhea

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

? rapid heartbeat

? palpitations

? chest pain

? dizziness

? sore throat

? runny or stuffy nose (rhinitis)

? abdominal pain

? abdominal discomfort (indigestion)

? stomach discomfort (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

? skin itching

? bleeding patches on the skin

? general weakness

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

? heart attack (myocardial infarction)

? irregular heartbeat (new or worsening)

? heart problems that may 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 sputum or urine)

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

? dizziness upon standing

? fainting

? anxiety

? difficulty falling asleep

? abnormal dreams

? allergic reaction

? pain and discomfort

? diabetes and increased blood sugar levels

? stomach pain (gastritis)

? general malaise

Diabetic patients may have a higher risk of ocular bleeding.

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

? tendency to bleed longer than normal

? increased platelet count in the blood

? kidney problems

The following adverse effects have been observed during treatment with Ekistol, but their frequency 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

? hot flushes

? eczema and other skin rashes

? decreased skin sensation

? watery or sticky eyes (conjunctivitis)

? ringing in the ears (tinnitus)

? liver problems, including hepatitis

? changes in urine

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es

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

5. Storage of 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 the month indicated.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ekistol

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

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

Appearance of the product and contents of the pack

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

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

LACER, S.A. - Boters, 5

08290 Cerdanyola del Vallès

Barcelona – Spain

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

Spain: Ekistol 50 mg tablets

This summary of product characteristics was approved in February 2015

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