Leaflet: Information for the User

CilostazolVIR 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you and you should not give it 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 is Cilostazol VIR and for what it is used

2.What you need to know before starting to take Cilostazol VIR

3.How to take Cilostazol VIR

4.Possible side effects

5.Storage of Cilostazol VIR

6.Contents of the pack and additional information

CilostazolVIRbelongs 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.

CilostazolVIRhas been prescribed for «intermittent claudication». Intermittent claudication is the cramping pain that occurs in the legs when walking and is caused by an insufficient blood supply to the legs. CilostazolVIRmay help increase the walking distance, 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 quitting smoking and increasing exercise) and after other appropriate interventions. It is essential to continue with the lifestyle changes made while taking cilostazol.

Do not take CilostazolVIR

• if you are allergic to cilostazol or any of the other components of this medication,
• 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 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 you have a condition that increases the risk of bleeding or bruising, for example:

• active stomach ulcers
• stroke (cerebral hemorrhage) 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 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 CilostazolVIR, make sure your doctor knows:

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

During treatment with CilostazolVIR make sure that

•if you need to undergo surgery, including dental extractions, inform your doctor or dentist that you are taking CilostazolVIR.

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

Taking CilostazolVIR with other medications

Before starting to take CilostazolVIR, 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 should 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. Among these medications are:

•aspirin

•clopidogrel

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

In the case that you are taking the aforementioned medications with CilostazolVIR, your doctor may need to perform routine blood tests.

Determined medications may interfere with the effect of CilostazolVIRwhen taken together. They may increase the adverse effects of CilostazolVIRor reduce its efficacy. CilostazolVIRmay have the same effects on other medications. Before starting to take CilostazolVIR, 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 or hypericum (herbal medicine)

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

Before starting to take CilostazolVIR, inform your doctor or pharmacist about any medications you are taking to treat high blood pressure, as CilostazolVIRmay have an additional effect of lowering blood pressure. If your blood pressure drops too low, 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 CilostazolVIR. Your doctor will decide if this is suitable for you.

Use of CilostazolVIR with food, drinks, and alcohol

You should take the CilostazolVIRtablets 30 minutes before breakfast and dinner.

Always take the tablets with a glass of water.

Pregnancy, breastfeeding, and fertility

DO NOT TAKECilostazolVIRduring pregnancy.

DO NOT RECOMMENDtaking CilostazolVIRduring 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.

Driving and operating machinery

CilostazolVIRmay cause dizziness. If you feel dizzy after taking CilostazolVIR, DO NOT drive 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 usual dose is one 100 mg tablet taken twice a day (in the morning and in the evening). It is not necessary to adjust this dose for elderly patients. However, your doctor may need to prescribe a lower dose if you are taking other medications that could interfere with the effect of cilostazol.

You must take the 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 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 VIR is not suitable for children.

If you take more Cilostazol VIR than you should

If you take more Cilostazol VIR tablets than you should for any reason, 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 medication and the amount ingested.

If you forget to take Cilostazol VIR

Do not worry if you forget to take a dose. Wait until the next dose and continue taking the treatment normally.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Cilostazol VIR

If you interrupt treatment with Cilostazol VIR, the pain in your legs may return or worsen. Therefore, you should only stop taking Cilostazol VIR if you detect emergency medical attention required side effects (see section 4) or if your doctor advises you to do so.

Like all medications, Cilostazol VIR may have side effects, although not everyone will experience them.

If any of the following side effects occur, you may need urgent medical attention. Stop taking Cilostazol VIR and contact your doctor or go to the nearest hospital immediately.

• stroke (ictus)

• heart attack (myocardial infarction)
• heart problems, which may cause difficulty breathing or swelling of the ankles
• irregular heartbeat (new or worsening)
• notable bleeding
• easily bruising
• severe skin condition with blistering, mouth, eye, or genital involvement
• 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 have a 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 VIR. 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
• indigestion
• nausea or vomiting
• loss of appetite (anorexia)
• excessive gas or flatulence
• inflammation of the ankles, feet, or face
• skin rash or changes in skin appearance
• itching skin
• skin hemorrhages
• general weakness

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 VIR treatment, but the frequency with 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 walking
• fever
• seizures
• eczema and other skin eruptions
• numbness 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 not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after "CAD". The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at your pharmacy.If in doubt, ask your pharmacist how to dispose of unused packaging and medications.By doing so, you will help protect the environment.

Composition of CilostazolVIR

• The active ingredient is cilostazol. Each tablet contains 100 mg of cilostazol.
• The other components are cornstarch, microcrystalline cellulose, calcium carmelose, hypromellose, and magnesium stearate.

Appearance of the product and content of the packaging

CilostazolVIR100 mg is a white, round, and scored tablet on one side. Your medication is supplied in packaging of 56 tablets or in hospital packaging with 70 (5x14) tablets.

Holder of the marketing authorizationandResponsible for manufacturing

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

Date of the last review of this leaflet:November 2013

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