Package Leaflet: Information for the User

Cilostazol Cinfa 100 mg Tablets EFG

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.Because
it containsinformationimportantforyou.

• 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 their symptoms are the same as yours. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

1. What is cilostazol cinfa and what it is used for

2. What you need to know beforestartingtotake cilostazol cinfa

3. How to take cilostazol cinfa

4. Possible side effects

5. Storage of cilostazol cinfa

6.Contents of the pack and additional information

Cilostazol cinfa belongs to a group of medicines 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 cinfa has been prescribed for «intermittent claudication». Intermittent claudication is the cramp-like pain that you suffer in your legs when walking and is caused by an insufficient blood supply to the legs. Cilostazol cinfa may help you increase the 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 cinfa

• If you are allergic to cilostazol or any of the other ingredients of this medication (listed in section 6).
• 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 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, such as: 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

Consult your doctor or pharmacist before starting to take cilostazol cinfa.

• If you have a severe heart problem or any heart rhythm disorder.
• If you have any blood pressure disorder.

• During treatment with cilostazol, ensure 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 cinfa 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 commonly used to treat painful and/or inflammatory conditions in muscles or joints, as well as 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 need to perform routine blood tests.

Determined medications may interfere with the effect of cilostazol when taken together. They may increase the side effects of cilostazol or reduce its effectiveness. Cilostazol may have the same effects on other medications. Before starting to take cilostazol cinfa, 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 certain stomach disorders).
• Lovastatin, simvastatin, or atorvastatin (to treat high cholesterol in the blood).
• Halofantrine (to treat malaria).
• Pimozide (to treat mental disorders).
• Derivatives of ergot (to treat migraines, e.g., ergotamine, dihydroergotamine).
• Carbamazepine or phenytoin (to treat seizures).
• St. John's Wort (phytotherapeutic product).
• 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 if you are taking medications to treat high blood pressure, as cilostazol may have an additional effect of lowering blood pressure.

If your blood pressure decreases 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 aforementioned medications with cilostazol. Your doctor will decide if this is suitable in your case.

Taking cilostazol cinfa with food and drinks

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

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

DO NOT TAKE cilostazol during pregnancy.

DO NOT RECOMMEND taking cilostazol during breastfeeding.

Driving and use of machines

Cilostazol may cause dizziness. If you feel dizzy after taking cilostazol cinfa, DO NOT drive or use any tools or machines and inform your doctor or pharmacist.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

• The recommended dose is one 100 mg tablet twice a day (morning and evening). It is not necessary to modify this dose for elderly patients. However, your doctor may 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. The tablet can be divided into equal doses.

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

Cilostazol is not suitable for children.

If you take more cilostazol cinfa than you should

If you take for any reason more tablets of cilostazol than you should, you may experience symptoms such as acute headache, diarrhea, low blood pressure and irregular heartbeats.

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

If you forget to take cilostazol cinfa

Do not worry if you forget to take a dose. Wait until the next dose and follow the treatment normally. Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with cilostazol

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 tells you to.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

• Stroke (cerebral hemorrhage).
• Myocardial infarction (heart attack).
• Heart problems, which can cause difficulty breathing or swelling of the ankles.
• Irregular heartbeat (new or worsening).
• Notable hemorrhage.
• Tendency to bruise.
• Severe disease with blister formation on the skin, mouth, eyes, or genitals.
• Yellow discoloration of the skin or white of the eyes due to liver or blood problems (jaundice).

You should also inform your doctor immediately if you experience 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 cilostazol cinfa. If you experience them, you should inform your doctor immediately:

Very common side effects (can affect more than 1 in 10 people)

• Headache.
• Abnormal stools.
• Diarrhea.

Common side effects (can affect up to 1 in 10 people)

• Fast heartbeats.
• Palpitations.
• Chest pain.
• Dizziness.
• Sore throat.
• Runny nose (rhinitis).
• Abdominal pain.
• Indigestion.
• Nausea or vomiting.
• Loss of appetite (anorexia).
• Excess gas or flatulence.
• Inflammation of the ankles, feet, or face.
• Rash or changes in skin appearance.
• Itching skin.
• Bleeding patches on the skin.
• General weakness.

Rare side effects (can affect up to 1 in 100 people)

• Heart attack (myocardial infarction).
• Irregular heartbeat (new or worsening).
• Heart problems that can cause difficulty breathing or swelling of the ankles.
• Pneumonia.
• Cough.
• Chills.
• Unexpected hemorrhage.
• Tendency to bleed (e.g., in the stomach, eyes, or muscles, nasal bleeding or presence of blood in sputum or urine).
• Decreased red blood cell count in the blood.
• Dizziness when standing up.
• Fainting.
• Anxiety.
• Difficulty falling asleep.
• Abnormal dreams.
• Allergic reaction.
• Pain and discomfort.
• Diabetes and increased blood sugar concentration.
• Stomach pain (gastritis).
• General malaise.

Diabetic patients may be at a higher risk of eye hemorrhage.

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

• Tendency to bleed for a longer time than normal.
• Increased platelet count in the blood.
• Kidney problems.

The following side effects have been observed during the use of cilostazol cinfa, 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.
• Hot flashes.
• Eczema and other skin eruptions.
• Decreased sensation in the skin.
• Runny or sticky eyes (conjunctivitis).
• Tinnitus in the ears (acoustic neuroma).
• 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 that does not appear in this leaflet. 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.

Keepthis medication out of the sight and reach of children.

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

This medication does not require special conditions for conservation.

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

Cilostazol Cinfa Composition

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

Appearance of the product and contents of the package

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

It is presented in PVC/ALU blisters. Each package contains 56 or 70 (clinical package) tablets.

Only some package sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Cinfa, S.A

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Responsible for manufacturing

Noucor Health, S.A.Av. Camí Reial 51-57

08184 Palau-solità i Plegamans

(Barcelona – Spain)

Or

Galenicum Health, S.L.U

Sant Gabriel, 50, Esplugues de Llobregat,

08950, Barcelona (Spain)

Or

Laboratorios Cinfa, S.A

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Last review date of this leaflet:July 2020

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/

You can access detailed and updated information on this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/78222/P_78222.html

QR code to:https://cima.aemps.es/cima/dochtml/p/78222/P_78222.html