CILOSTAZOL ARISTO 100 mg TABLETS

Introduction

Package Leaflet: Information for the User

Cilostazol Aristo 50 mg tablets EFG

Cilostazol Aristo 100 mg tablets EFG

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. See section 4.

Contents of the pack

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

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

Cilostazol Aristo belongs to a group of medicines known as phosphodiesterase type 3 inhibitors.

It has several actions, including the dilation of certain blood vessels and the reduction of the coagulant activity (aggregation) of certain blood cells, called platelets, in the blood vessels.

You have been prescribed cilostazol for "intermittent claudication". Intermittent claudication is the pain in the legs when walking, which is caused by insufficient blood supply to the legs. Cilostazol may help you increase the distance you can walk, as it improves blood circulation in the legs. Cilostazol is only recommended for patients whose symptoms have not improved sufficiently after making lifestyle changes (such as stopping smoking and exercising more) 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 Cilostazol Aristo

Do not take Cilostazol Aristo

• 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 disorder 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 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 serious heart problems or any heart rhythm disorders;
• if you have any blood pressure disorders.

During treatment with Cilostazol Aristo, make sure that

• In case you need to undergo surgery, including dental extraction, inform your doctor or dentist that you are taking cilostazol.
• If you bruise or bleed easily, stop taking cilostazol and inform your doctor.

Children and adolescents

Cilostazol is not suitable for children.

Taking Cilostazol Aristo with other medicines

Before starting to take cilostazol, inform 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 if you are taking 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 cilostazol, your doctor may need to perform routine blood tests.

Certain medicines may interfere with the effect of cilostazol when taken together. They may increase the side effects of cilostazol or reduce its effectiveness. Cilostazol may have these same effects on other medicines. 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 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 cilostazol, inform your doctor or pharmacist if you are taking medicines to treat high blood pressure, as cilostazol 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 to take these medicines with cilostazol.

Your doctor will decide if this is suitable for you.

Using Cilostazol Aristo with food and drink

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

Always take the tablets with a glass of water.

Pregnancy and 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.

DO NOT TAKEcilostazol during pregnancy.

IT IS NOT RECOMMENDEDto take cilostazol during breast-feeding.

Driving and using machines

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

3. How to take Cilostazol Aristo

• Follow the instructions for administration of this medicine exactly as prescribed by your doctor. If you are unsure, 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 at night). The dose does not need to be adjusted for elderly patients. However, your doctor may prescribe a lower dose if you are taking other medicines that may interfere with the effect of cilostazol.
• You should 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 within 4-12 weeks of 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.

Use in children and adolescents

Cilostazol is not suitable for children.

If you take more Cilostazol Aristo than you should

If you take more tablets 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 it is clear what medicine 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 with your treatment as usual. DO NOTtake a double dose to make up for forgotten doses.

If you stop taking 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 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, cilostazol 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 taking cilostazol and 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
• easy bruising
• 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 you should receive.

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)

• fast heart rate
• heart palpitations
• chest pain
• dizziness
• sore throat
• runny nose (rhinitis)
• abdominal pain
• indigestion
• nausea or vomiting
• loss of appetite (anorexia)
• excess gas or flatulence
• swelling of the ankles, feet, or face
• rash or changes in skin appearance
• itching
• bleeding spots 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)
• reduced red blood cell count
• 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 a higher risk of eye bleeding.

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

• prolonged bleeding time
• increased platelet count in the blood
• kidney problems

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

• changes in blood pressure
• reduced red blood cell, white blood cell, and platelet count in the blood
• difficulty breathing
• difficulty moving
• fever
• hot flashes
• eczema and other skin rashes
• reduced sensation in the skin
• tearful or sticky eyes (conjunctivitis)
• ringing in the ears (tinnitus)
• liver problems, including hepatitis
• changes in urine

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

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 Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es

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

5. Storage of Cilostazol Aristo

This medicine does not require any special storage conditions.

Keep Cilostazol Aristo out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date is the last day of the month stated.

Do not use this medicine if you notice visible signs of deterioration (e.g. discoloration).

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 of Cilostazol Aristo

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

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

Appearance and packaging

Appearance:

50 mg: White or almost white, round, smooth, beveled tablets, engraved with "E" on one side and "601" on the other.

100 mg: White or almost white, round, smooth, beveled tablets, engraved with "E" on one side and "602" on the other.

This product is available in packs of 28 (2x14) or 56 (4x14) tablets, packaged in PVC/PVdC and aluminum blisters in a cardboard box with the leaflet.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Aristo Pharma Iberia, S.L.

c/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

Manufacturer

EGIS Pharmaceuticals PLC

Bökényföldi út 118-120

Budapest

H-1165 Hungary

This medicine is authorized 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

Date of last revision of this leaflet: May 2017.

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