CILOSTAZOL VIR 100 mg TABLETS

Introduction

Package Leaflet: Information for the User

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

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

Cilostazol VIR 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 clotting activity (aggregation) of certain blood cells, called platelets, in the blood vessels.

You have been prescribed Cilostazol VIR for "intermittent claudication". Intermittent claudication is the pain in the legs that you experience when walking and is caused by an insufficient supply of blood to the legs. Cilostazol VIR 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 VIR

Do not take CilostazolVIR

• if you are allergic to cilostazol or any of the other ingredients of this medicine,
• 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 severe heart rhythm disorders,
• if you know you have a disorder that increases the risk of bleeding or bruising, for example:

• 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 VIR, make sure your doctor knows:

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

During treatment with Cilostazol VIR, make sure that

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

Taking CilostazolVIRwith other medicines

Before starting to take Cilostazol VIR, tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines 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 VIR, your doctor may need to perform some routine blood tests.

Certain medicines may interfere with the effect of Cilostazol VIR when taken together. They may increase the adverse effects of Cilostazol VIR or reduce its efficacy. Cilostazol VIR may have these same effects on other medicines. Before starting to take Cilostazol VIR, tell 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 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 (herbal medicine)

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

Before starting to take Cilostazol VIR, tell your doctor or pharmacist if you are taking medicines for high blood pressure, as Cilostazol VIR 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 Cilostazol VIR. Your doctor will decide if this is suitable for you.

Using CilostazolVIRwith food, drinks and alcohol

You should take Cilostazol VIR tablets 30 minutes before breakfast and dinner.

Always take the tablets with a glass of water.

Pregnancy, breast-feeding and fertility

DO NOT TAKECilostazol VIR during pregnancy.

IT IS NOT RECOMMENDEDto take Cilostazol VIR 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

Cilostazol VIR may cause dizziness. If you feel dizzy after taking Cilostazol VIR, do not drive or use any tools or machines and inform your doctor or pharmacist.

3. How to take Cilostazol VIR

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

The usual dose is one 100 mg tablet twice a day (in the morning and at night). It is not necessary to modify this dose for elderly patients. However, your doctor may need to prescribe a lower dose if you are taking other medicines that may interfere with the effect of cilostazol.

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

You may notice the benefits of taking Cilostazol VIR 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

CilostazolVIRis not suitable for children.

If you take more CilostazolVIRthan you should

In case you take more Cilostazol VIR tablets than you should, you may experience symptoms such as severe headache, diarrhea, low blood pressure and irregular heartbeats.

In case of overdose or accidental ingestion, consult your doctor immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take CilostazolVIR

Do not worry if you forget to take a dose. Wait until the next dose and continue with the treatment as normal.

Do nottake a double dose to make up for forgotten doses.

If you stop taking CilostazolVIR

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

4. Possible side effects

Like all medicines, Cilostazol VIR 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 CilostazolVIRand 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 heartbeat (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 have a 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 CilostazolVIR. 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 heartbeats
• 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 skin changes
• 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. from 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 a higher risk of eye bleeding.

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

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

The following side effects have been observed during treatment with CilostazolVIRbut 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
• tearful 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 Monitoring System for human use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cilostazol VIR

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

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

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 CilostazolVIR

• The active ingredient is cilostazol. Each tablet contains 100 mg of cilostazol.
• The other ingredients are corn starch, microcrystalline cellulose, calcium carmellose, hypromellose and magnesium stearate.

Appearance of the product and pack contents

Cilostazol VIR 100 mg is a white, round and scored tablet on one side. Your medicine is supplied in packs of 56 tablets or in hospital packs with 70 (5x14) tablets.

Marketing authorisation holder and manufacturer

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

Date of last revision of this leaflet:November 2013

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