Leaflet: information for the user

Cilostazol Aristo 50 mg tablets EFG

Cilostazol Aristo 100 mg tablets EFG

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, consult your doctor or pharmacist.

- This medicine has been prescribed for you only and should not be given to others even if they have the same symptoms as you, 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. See section 4.

1. What Cilostazol Aristo is and what it is used for

2. What you need to know before you start taking Cilostazol Aristo

3. How to take Cilostazol Aristo

4. Possible side effects

5. Storage of Cilostazol Aristo

6. Contents of the pack and additional information

Cilostazol Aristo 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.

Cilostazol 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. Cilostazol 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 take Cilostazol Aristo

• if you are allergic (hypersensitive) to cilostazol or to 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 ulcers in the stomach.

-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 cilostazol, 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 Cilostazol Aristo ensure that

• If you need to undergo surgery, including dental extraction, inform your doctor or dentist that you are taking cilostazol.

• If you are prone to bruising or bleeding, stop taking cilostazol and inform your doctor.

Children and adolescents

Cilostazol is not suitable for children.

Use of Cilostazol Aristo with other medications

Before starting to take cilostazol, 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 the muscles or joints, as well as if you are taking medications to reduce blood clotting. These medications include:

• aspirin

• clopidogrel

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

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

Determined medications may interfere with the effect of cilostazol when taken together. They may increase the side effects of cilostazol or reduce its efficacy. Cilostazol may have the same effects on other medications. Before starting to take cilostazol, inform your doctor or pharmacist 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 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 (herbal product)

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

Before starting to take cilostazol, inform your doctor or pharmacist if you are taking medications to treat high blood pressure, as cilostazol may have an additional blood pressure-lowering effect.

In the case of excessive blood pressure lowering, you may experience an acceleration of heart rate. 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 cilostazol.

Your doctor will decide whether this is suitable in your case.

Use of Cilostazol Aristo with food and drinks

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

Always take the tablets with a glass of water.

Pregnancy and breastfeeding

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

DO NOT TAKEcilostazol during pregnancy.

DO NOT RECOMMENDtaking cilostazol during breastfeeding.

Driving and operating machinery

Cilostazol may cause dizziness. If you feel dizzy after takingcilostazol c,DO NOTdrive or operate any tools or machinery and inform your doctor or pharmacist.

• Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

• The recommended dose is two 50 mg tablets (or one 100 mg tablet) 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 cilostazol.

• You must take the cilostazol tablets 30 minutes before breakfast and dinner. Always take the tablets with a glass of water.

You may notice the benefits of taking cilostazol at 4-12 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.

Use in children and adolescents

Cilostazol is not suitable for children.

If you take more Cilostazol Aristo than you should

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

Immediately contact your doctor or the nearest hospital if you take more tablets than prescribed. Remember to bring the packaging with you so it is clear what medication you have taken.

If you forget to take Cilostazol Aristo

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 make up for the missed doses.

If you interrupt treatment with Cilostazol Aristo

If you stop taking cilostazol, the pain in your legs may return or worsen. Therefore, you should only stop taking cilostazol 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 medications, cilostazol may 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 cilostazol and contact a doctor or go immediately to the nearest hospital.

• Stroke (cerebral hemorrhage)

• Myocardial infarction (heart attack)

• Heart problems, which may cause difficulty breathing or swelling of the ankles

• Irregular heartbeat (new or worsening)

• Notable bleeding

• Easy bruising

• Severe skin disease with blister formation on 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 cilostazol. If you experience them, you should 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 heartbeat

• Palpitations

• Chest pain

• Dizziness

• Sore throat

• Runny nose (rhinitis)

• Abdominal pain

• Abdominal discomfort (indigestion)

• Nausea or vomiting

• Loss of appetite (anorexia)

• Excessive gas or flatulence

• Inflammation of the ankles, feet, or face

• Rash or changes in skin appearance

• Itching skin

• Hemorrhagic patches on the skin

• General weakness

Uncommon side 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, nosebleed, or presence of blood in sputum or urine)

• Decreased red blood cell count in the blood

• Dizziness when standing up

• Fainting

• Anxiety

• Difficulty falling asleep

• Abnormal dreams

• Allergic reaction

• Pain and discomfort

• Diabetes and increased blood sugar concentration

• Stomach pain (gastritis)

• General discomfort

Diabetics may be at a higher risk of eye bleeding.

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

• Prolonged bleeding tendency

• Increased platelet count in the blood

• Kidney problems

The following side effects have been observed during cilostazol use, but the frequency at which they occur is unknown:

• Changes in blood pressure

• Decreased red blood cell, white blood cell, and platelet count in the blood

• Difficulty breathing

• Difficulty moving

• Fever

• Hot flashes

• Eczema and other skin eruptions

• Decreased skin sensation

• Runny or sticky eyes (conjunctivitis)

• Tinnitus (ringing in the ears)

• Liver problems, including hepatitis

• Changes in urine

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

Reporting side effects

If you experience any type of side effect, consult your doctor, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es

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

This medication does not require special conditions for conservation.

Keep Cilostazol Aristo out of sight and reach of children.

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

Do not use this medication if you notice visible signs of deterioration (for example, discoloration).

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Cilostazol Aristo

The active ingredient is cilostazol. Each tablet contains 50 mg or 100 mg of cilostazol.

Other ingredients are cornstarch, microcrystalline cellulose, calcium carmelose, hypromellose, and magnesium stearate.

Aspect of the product and content of the packaging

Appearance:

50 mg: White or almost white, round, smooth, bisected, engraved with “E” on one face and “601” on the other.

100 mg: White or almost white, round, smooth, bisected, engraved with “E” on one face and “602” on the other.

This product is supplied in boxes of 28 (2x14) or 56 (4x14) tablets packaged in PCV/PVdC and aluminum blisters in a cardboard box with the leaflet.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Aristo Pharma Iberia, S.L

c/ Solana, 26

28850, Torrejón de Ardoz

Madrid. Spain

Responsible for manufacturing

EGIS Pharmaceuticals PLC

Bökényföldi ùt 118-120

Budapest

H-1165 Hungary

This medicine is approved in the EEA member states with the following names:

Spain: Cilostazol Aristo 50 mg tablets EFG

United Kingdom: Cilostazol 50 mg tablets

Spain: Cilostazol Aristo 100 mg tablets EFG

United Kingdom: Cilostazol 100 mg tablets

Last review date of this leaflet: May 2017.

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/