Package Leaflet: Information for the User

Cilostazol Sandoz 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 only. Do not pass it on to others even if they have similar symptoms, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

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

3.How to take Cilostazol Sandoz

4.Possible side effects

5.Storage of Cilostazol Sandoz

6. Contents of the pack and additional information

Cilostazol Sandoz contains the active ingredient cilostazol, which belongs to a group of medicines called phosphodiesterase type 3 inhibitors.

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

You have been prescribed Cilostazol Sandoz to treat your "intermittent claudication". Intermittent claudication is the cramping pain you experience in your legs when walking, caused by insufficient blood flow to your legs. Cilostazol Sandoz may help you increase the distance you can walk without pain, as it stimulates blood circulation in your legs. Cilostazol is only recommended for patients whose symptoms have not improved sufficiently after making lifestyle changes (for example, quitting smoking and increasing physical exercise) and after other appropriate interventions. It is essential that you continue the lifestyle changes you have made while taking cilostazol.

Do not take Cilostazol Sandoz:

• if you are allergic to cilostazol or any of the other ingredients of this medication (listed in section 6),
• if you have a 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 6 months,
• if you have now or have had in the past fainted due to heart disease, or any severe alteration of heartbeats,
• if you know you have a condition that increases the risk of bleeding or bruising, such as:
• • active stomach ulcers,
  • stroke in the last 6 months,
  • eye problems if you have diabetes,
  • if your blood pressure is not well controlled,
• if you have a severe kidney disease or moderate to severe liver insufficiency,
• if you are taking aspirin and clopidogrel, or any combination of two or more medications that may increase the risk of bleeding (consult your doctor or pharmacist if you are unsure),
• if you are pregnant.

Warnings and precautions

Consult your doctor before taking Cilostazol Sandoz. Make sure your doctor knows:

• if you have a severe heart problem or any heart rhythm problem,
• if you have blood pressure problems.

During treatment with Cilostazol Sandoz you should know that:

• if you need to undergo surgery including tooth extraction, inform your doctor or dentist that you are taking cilostazol,
• if you experience bruising or easy bleeding, stop taking cilostazol and inform your doctor.

Children and adolescents

Cilostazol Sandoz is not suitable for use in children.

Use of Cilostazol Sandoz with other medications

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication.

You should inform your doctor especially if you take medications used regularly to treat painful and/or inflammatory muscle or joint conditions or if you take medications to reduce blood clotting. These medications include:

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

If you are taking these medications with cilostazol, your doctor may perform some routine blood tests.

Certain medications may interfere with the effect of cilostazol when taken together. They may increase the adverse effects of cilostazol or make cilostazol less effective. Cilostazol may do the same to other medications. Before starting to take Cilostazol Sandoz, inform your doctor if you are taking:

• erythromycin, clarithromycin or rifampicin (antibiotics),
• ketoconazole (to treat fungal infections),
• protease inhibitors (antivirals),
• omeprazole (to treat excess acid in the stomach),
• diltiazem (to treat high blood pressure or chest pain),
• cisapride (to treat stomach problems),
• lovastatin, simvastatin or atorvastatin (to treat high cholesterol in the blood),
• halofantrine (to treat malaria),
• pimozide (to treat mental health conditions),
• ergot derivatives (to treat migraine, e.g.: ergotamine, dihydroergotamine),
• carbamazepine or phenytoin (to treat seizures),
• St. John's Wort (herbal medicine).

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

Before starting treatment with Cilostazol Sandoz, inform your doctor if you are taking medications for high blood pressure, because cilostazol may have an additional reducing effect on your blood pressure. If your blood pressure decreases rapidly, this may cause an increase in your heart rate. These medications include:

• diuretics (e.g.: hydrochlorothiazide, furosemide),
• calcium channel blockers (e.g.: verapamil, amlodipine),
• ACE inhibitors (e.g.: captopril, lisinopril),
• angiotensin II receptor blockers (e.g.: valsartan, candesartan),
• beta blockers (e.g.: labetalol, carvedilol).

However, it may be advisable to take the above-mentioned medications together with Cilostazol Sandoz. Your doctor will decide what is best for you.

Pregnancy and breastfeeding

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

Cilostazol SandozSHOULD NOT BE USEDduring pregnancy.

IT IS NOT RECOMMENDEDto use Cilostazol Sandoz in breastfeeding mothers.

Driving and operating machines

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

• Follow exactly the administration instructions for Cilostazol Sandoz as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.
• The recommended dose is one 100 mg tablet twice a day (in the morning and in the evening). This dose does not need to be adjusted in elderly people. However, your doctor may prescribe a lower dose if you are taking other medications that may affect cilostazol.
• The tablet can be divided into equal doses.
• Cilostazol Sandoz tablets should be taken 30 minutes before breakfast and dinner. Always take your tablets with a glass of water.

You may feel some beneficial effects of taking Cilostazol Sandoz within 4 to 12 weeks of treatment. Your doctor will evaluate your progress after 3 months of treatment and may recommend that you discontinue treatment with cilostazol if the effects are insufficient.

If you take more Cilostazol Sandoz than you should

If for any reason you take more cilostazol tablets than you should, you may experience symptoms such as intense headache, diarrhea, a rapid decrease in blood pressure, and irregular heartbeats.

If you have taken more Cilostazol Sandoz than you should, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. Remember to bring the packaging to clearly indicate which medication you have taken.

If you forget to take Cilostazol Sandoz

If you forget to take a dose, do not worry; wait until the next dose to take your next tablet and continue with your usual treatment.DO NOTtake a double dose to compensate for the missed doses.

If you interrupt treatment with Cilostazol Sandoz

If you interrupt treatment with cilostazol, the pain in your legs may reappear or worsen. Therefore, you should only stop taking cilostazol if you experience urgent 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 medicines, this medicine may cause side effects, although not everyone will experience them.

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

• Allergic reactions,
• Cerebral infarction,
• Heart attack,
• Cardiac problems that may cause difficulty breathing or swelling of the ankles,
• Irregular heartbeats (new or existing),
• Visible bleeding,
• Easily forming bruises,
• Severe disease with blisters on the skin, mouth, eyes, and genitals,
• Yellow discoloration of the skin or the white of the eyes caused by liver or blood problems (jaundice).

You must inform your doctor immediately if you have a fever or sore throat. You may need to undergo some blood tests before restarting treatment.

The following side effects have been reported for cilostazol. Inform your doctor as soon as possible:

Very common(may affect more than 1 in 10 patients)

• Headache,
• Abnormal stools,
• Diarrhea.

Common(may affect up to 1 in 10 patients)

• Fast heartbeats,
• Palpitations,
• Chest pain,
• Dizziness,
• Sore throat,
• Runny nose (rhinitis),
• Abdominal pain,
• Indigestion,
• Unpleasant feeling (nausea or vomiting),
• Loss of appetite (anorexia),
• Excessive gas or belching (flatulence),
• Swelling of the ankles, feet, or face,
• Skin eruptions or changes in skin appearance,
• Itching skin,
• Focal bleeding in the skin,
• General weakness.

Rare(may affect up to 1 in 1,000 patients)

• Tendency to bleed for longer periods than usual,
• Increased platelets in the blood,
• Problems with the kidneys.

Frequency not known(cannot be estimated from available data)

• Changes in blood pressure,
• Decreased red and white blood cells and platelets in the blood,
• Difficulty breathing,
• Difficulty moving,
• Fever,
• Heat strokes,
• Eczema and other skin eruptions,
• Reduced skin sensitivity,
• Watery or crusty eyes (conjunctivitis),
• Tinnitus (ringing in the ears),
• Liver problems including hepatitis,
• Changes in urine.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the 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.

This medication does not require any special storage conditions.

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

Cilostazol Sandoz Composition

Appearance of Cilostazol Sandoz and packaging contents

Cilostazol Sandoz 100 mg tablets are white, round, scored on one side, with an approximate diameter of 8 mm.

Your medicine is supplied in PVC/Aluminum blisters of 14, 20, 28, 30, 50, 56, 60, 84, and 100 tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1,

39179 Barleben,

Germany

or

Noucor Health, S.A..

Avda. Camí Reial, 51-57

08184 Palau-solita i Plegamans (Barcelona),

Spain

or

Lek Pharmaceuticals d.d

Verovskova ulica 57,

Ljubljana, 1526

Slovenia

or

Galenicum Health S.L.U.

Sant Gabriel, 50,

Esplugues de Llobregat,

08950 Barcelona

Spain

This medicine is authorized in the European Economic Area member states with the following names:

Germany:Cilostazol HEXAL 100 mg Tabletten

Bulgaria:?????????? ?????? 100 MG ????????

Estonia:Dilsatan, 100 mg tabletid

Italy:CILOSTAZOLO SANDOZ

Lithuania:Dilsatan 100 mg tabletes

Latvia:Dilsatan 100 mg tabletes

Malta:Cilostazol Sandoz 100mg Tablets

Poland:DECILOSAL, 100 MG, TABLETKI

Romania:CILOSTAZOL SANDOZ 100 mg comprimate

Dateofthelastreviewofthisleaflet:July 2018

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