Package Insert: Information for the Patient

Cilostazol Stada 100 mg Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4

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

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

3.How to take Cilostazol Stada

4.Possible adverse effects

5.Storage of Cilostazol Stada

6.Contents of the package and additional information

CilostazolStadabelongs 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 coagulant activity (agglutination) of certain blood cells, called platelets, in blood vessels.

Cilostazolhas 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. Cilostazolmay help increase the walking distance, as it improves blood circulation in the legs. Cilostazolis 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 Cilostazol Stada

• if you are allergic to cilostazol or any of the other ingredients of this medication (listed in section 6),
• 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) 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

Consult your doctor or pharmacist before starting to take Cilostazol Stada.

Before taking cilostazol, 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 cilostazol, make sure 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.

Taking Cilostazol Stada with other medications

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

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. Among these medications are:

• 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 adverse 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 medicine)

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 about any medications you are taking to treat high blood pressure, as cilostazol may have an additional effect of lowering blood pressure. If your blood pressure drops excessively, 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 mentioned medications together with cilostazol. Your doctor will decide if this is suitable in your case.

Taking Cilostazol Stada with food, drinks, and alcohol

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

Always take the tablets with a glass of water.

Pregnancy, breastfeeding, and fertility

DO NOT TAKEcilostazol during pregnancy.

DO NOT RECOMMENDtaking cilostazol during breastfeeding.

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

Driving and operating machinery

Cilostazol may cause dizziness. If you feel dizzy after taking cilostazol, 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. If in doubt, consult your doctor or pharmacist again.

The usual dose is a 100 mg tablet taken twice a day (in the morning and at night). 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 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.

Taking more Cilostazol Stada than you should

If you take any reason more tablets of cilostazol 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

Missing a dose of Cilostazol Stada

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.

Stopping treatment with Cilostazol Stada

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 advises you to do so.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication mayproduceside effects, although not all people will experience them.

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

• stroke (apoplejía)
• heart attack (infarto de miocardio)
• heart problems, which may cause difficulty breathing or swelling of the ankles
• irregular heartbeat (new or worsening)
• notable bleeding
• easily bruising
• serious skin condition with blistering, in 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 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. 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)
• excess gas or flatulence
• swelling 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
• increased platelet count in the blood
• kidney problems

The following side effects have been observed during cilostazol use, 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 a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effectsyoucan contribute to providing more information on the safety of this medication.

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

No special conditions of conservation 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.

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

C omposition of Cilostazol Stada

• 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.

Aspect of the product and content of the container

Cilostazol Stada 100 mg is a white, round, and scored tablet on one side.

Your medicine is supplied in containers of 56 tablets or in hospital containers with 70 (5x14) tablets.

Only some container sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

Noucor Health, S.A.

Av. Camí Reial 51-57

08184 Pala u-solità i Plegamans

(Barcelona)

Spain

or

Galenicum Health, S.L.U.

Sant Gabriel, 50

08950 - Esplugues de Llobregat (Barcelona)

Spain

Last review date of this leaflet: June 2016

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

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