Prospect: Information for the User

Cilostazol Kern Pharma 100 mg Tablets EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you, and you should not give it to other people 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 prospect. See section 4

1.What is Cilostazol Kern Pharma and for what it is used

2.What you need to know before starting to take Cilostazol Kern Pharma

3.How to take Cilostazol Kern Pharma

4.Possible adverse effects

5.Storage of Cilostazol Kern Pharma

6.Contents of the package and additional information

Cilostazol Kern Pharma belongs 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.

Cilostazol Kern Pharma has been prescribed for «intermittent claudication». Intermittent claudication is the cramping pain that you experience in your legs when walking and is caused by an insufficient blood supply to the legs. Cilostazol Kern Pharma may help you increase your walking distance, as it improves blood circulation in the legs. Cilostazol is only recommended for patients whose symptoms have not improved enough after making lifestyle changes (such as quitting smoking and exercising more) and after other appropriate interventions. It is essential that you continue with the lifestyle changes you have made while taking cilostazol.

Do not take Cilostazol Kern Pharma

• 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 suffer from persistent chest pain at rest, or have had a "heart attack" or any heart surgery in the last six months,
• if you suffer or have previously suffered from fainting 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 ulcers in the stomach
• 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

Consult your doctor or pharmacist before starting to take Cilostazol Kern Pharma.

Before taking Cilostazol Kern Pharma, 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 Kern Pharma make sure that
• if you need to undergo surgery, including dental extractions, 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 Kern Pharma with other medications

Before starting to take Cilostazol Kern Pharma, 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 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 that you are taking these medications with Cilostazol Kern Pharma, your doctor may need to perform routine blood tests.

Certain medications may interfere with the effect of Cilostazol Kern Pharma 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 Kern Pharma, 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 whether this applies to the medications you are taking, consult your doctor or pharmacist.

Before starting to take Cilostazol Kern Pharma, inform your doctor 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 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 blockers (e.g., valsartan, candesartan)
• beta-blockers (e.g., labetalol, carvedilol)

You may be able to take the aforementioned medications together with Cilostazol Kern Pharma. Your doctor will decide if this is suitable in your case.

Use of Cilostazol Kern Pharma with food, drinks, and alcohol

You should take the Cilostazol Kern Pharma tablets 30 minutes before breakfast and dinner.

Always take the tablets with a glass of water.

Pregnancy, breastfeeding, and fertility

DO NOT TAKECilostazol Kern Pharma during pregnancy.

DO NOT RECOMMENDtaking Cilostazol Kern Pharma during breastfeeding.

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

Driving and operating machinery

Cilostazol Kern Pharma may cause dizziness. If you feel dizzy after taking Cilostazol Kern Pharma tablets, 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 a 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 Kern Pharma tablets 30 minutes before breakfast and dinner. Always take the tablets with a glass of water.

You may notice the benefits of taking Cilostazol Kern Pharma 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 Kern Pharma is not suitable for children.

Taking too much Cilostazol Kern Pharma

If you take more Cilostazol Kern Pharma 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

Missing a dose

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 dose.

Stopping treatment with Cilostazol Kern Pharma

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

Like all medicines, Cilostazol Kern Pharma 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 taking Cilostazol Kern Pharma and contact your doctor or go immediately to the nearest hospital.

•apoplexy (stroke)

•myocardial infarction (heart attack)

•heart problems, which can cause difficulty breathing or inflammation

of the

ankles

•irregular heartbeat (new or worsening)

•notable hemorrhage

•easy bruising

•severe skin disease with blister formation on 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. You may need to have blood tests; 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

•abdominal discomfort

•nausea or vomiting

•excess gas or flatulence

•inflammation of the ankles, feet, or face

•exanthema or changes in skin appearance

•itching skin

•petechiae or skin hemorrhages

•general weakness

Uncommon side effects(may affect up to 1 in 100 people)

•myocardial infarction (heart attack)

•irregular heartbeat (new or worsening)

•heart problems that can cause difficulty breathing or inflammation of the

ankles

•pneumonia

•toes

•chills

•unexpected hemorrhage

•tendency to bleed (e.g. from the stomach, eyes, or muscles, nasal bleeding, or presence of blood in sputum or urine)

•decrease in red blood cell count

•dizziness when standing up

•syncope

•anxiety

•difficulty falling asleep

•abnormal dreams

•allergic reaction

•discomfort and pain

•diabetes and increased blood sugar concentration

•gastritis (stomach pain)

•general malaise

People with diabetes may be at a higher risk of eye hemorrhage.

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

•prolonged bleeding

•increased platelet count

•kidney problems

The following side effects have been observed during the use of Cilostazol but 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 walking

•fever

•seizures

•eczema and other skin eruptions

•decreased sensation in the skin

•conjunctivitis (watery or sticky eyes)

•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 not listed in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use: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.

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.

Do not dispose of medications through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of packaging and unused medications if you are unsure. By doing so, you will help protect the environment.

Cilostazol Kern Pharma Composition

• 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 contents of the packaging

Cilostazol Kern Pharma 100 mg is a white, round, and scored tablet on one side.The tablet can be divided into two equal halves.

Your medicine is supplied in packs of 56 tablets or in hospital packs with 70 (5x14) tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder

Kern Pharma, S.L.

Colón II Industrial Estate

Venus 72

08228 Terrassa (Spain)

Responsible for Manufacturing

NOUCOR HEALTH, S.A.

Av. Camí Reial 51-57

08184 Palau-solità i Plegamans

Barcelona - Spain

Last review date of this leaflet: October 2013

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/.