CILOSTAZOL CINFA 100 mg TABLETS

Introduction

Package Leaflet: Information for the User

Cilostazol cinfa 100 mg Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is cilostazol cinfa and what is it used for
2. What you need to know before you take cilostazol cinfa
3. How to take cilostazol cinfa
4. Possible side effects
5. Storage of cilostazol cinfa
6. Contents of the pack and other information

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

Cilostazol cinfa belongs to a group of medicines called phosphodiesterase type 3 inhibitors.

It has various actions, including the dilation of certain blood vessels and the reduction of the clotting activity (aggregation) of certain blood cells, called platelets, in the blood vessels.

You have been prescribed cilostazol cinfa for 'intermittent claudication'. Intermittent claudication is the pain in the legs that you get when you walk and is caused by insufficient blood supply to the legs. Cilostazol cinfa may help you to increase the distance you can walk, 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 stopping smoking and taking more exercise) and after other appropriate interventions. It is important that you continue with the lifestyle changes you have made while taking cilostazol.

2. What you need to know before you take cilostazol cinfa

Do not take cilostazol cinfa

• If you are allergic to cilostazol or any of the other ingredients of this medicine (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 fainted due to a heart condition or have had 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 (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 medicines 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 treatment with cilostazol cinfa.

• If you have any severe heart problems or any heart rhythm disorders.
• If you have any blood pressure disorders.

• During treatment with cilostazol, make sure that:
• In case you need to undergo surgery, including dental extraction, inform your doctor or dentist that you are taking cilostazol.
• If you bruise or bleed easily, stop taking cilostazol and inform your doctor.

Taking cilostazol cinfa with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

You must specifically inform your doctor if you are taking medicines that are usually taken to treat painful and/or inflammatory conditions in the muscles or joints, as well as if you are taking medicines to decrease blood clotting. These medicines include:

• Aspirin.
• Clopidogrel.
• Anticoagulant medicines (e.g. warfarin, dabigatran, rivaroxaban, apixaban or low molecular weight heparins).

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

Certain medicines 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 these same effects on other medicines. Before starting treatment with 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 stomach acid).
• 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).
• Ernestine derivatives (to treat migraines, e.g. ergotamine, dihydroergotamine).
• Carbamazepine or phenytoin (to treat seizures).
• St. John's Wort (herbal product).
• If you are unsure whether this applies to the medicines you are taking, consult your doctor or pharmacist.

Before starting treatment with cilostazol, inform your doctor or pharmacist if you are taking medicines to treat high blood pressure, as cilostazol may have an additional blood pressure lowering effect. If your blood pressure drops too low, you may experience an increased heart rate. These medicines include:

• Diuretics (e.g. hydrochlorothiazide, furosemide).
• Calcium antagonists (e.g. verapamil, amlodipine).
• ACE inhibitors (e.g. captopril, lisinopril).
• Angiotensin II receptor antagonists (e.g. valsartan, candesartan).
• Beta-blockers (e.g. labetalol, carvedilol).

It may be possible for you to take these medicines with cilostazol. Your doctor will decide whether this is suitable for you.

Taking cilostazol cinfa with food and drink

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

Always take the tablets with a glass of water.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

DO NOT TAKEcilostazol during pregnancy.

IT IS NOT RECOMMENDEDto take cilostazol during breast-feeding.

Driving and using machines

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

3. How to take cilostazol cinfa

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

• The recommended dose is one 100 mg tablet twice a day (in the morning and at night). The dose does not need to be modified for elderly patients. However, your doctor may prescribe a lower dose if you are taking other medicines that may interfere with the effect of cilostazol.
• You should take cilostazol tablets 30 minutes before breakfast and dinner. Always take the tablets with a glass of water. The tablet can be divided into two equal doses.

You may notice the benefits of taking cilostazol at 4-12 weeks of treatment. At 3 months of treatment, your doctor will assess 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 more cilostazol 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 or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take cilostazol cinfa

Do not worry if you forget to take a dose. Wait until the next dose and continue treatment as normal. DO NOTtake a double dose to make up for forgotten doses.

If you stop taking cilostazol cinfa

If you stop taking cilostazol, the pain in your legs may return or worsen. Therefore, you should only stop taking cilostazol if you experience side effects that require urgent medical attention (see section 4) or if your doctor tells you to.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 to the nearest hospital immediately.

• Stroke.
• Heart attack.
• Heart problems that can cause difficulty breathing or swelling of the ankles.
• Irregular heartbeats (new or worsening).
• Severe bleeding.
• Easy bruising.
• Severe skin condition with blistering of the skin, mouth, eyes, or genitals.
• Yellowing of the skin or the whites 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 to be administered.

The following side effects have been observed in patients treated with cilostazol cinfa. If you experience them, you must 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)

• Fast heartbeats.
• Heart palpitations.
• Chest pain.
• Dizziness.
• Sore throat.
• Runny nose (rhinitis).
• Abdominal pain.
• Indigestion.
• Feeling sick (nausea or vomiting).
• Lack of appetite (anorexia).
• Excess gas or flatulence.
• Swelling of the ankles, feet, or face.
• Rash or changes in skin appearance.
• Itching of the skin.
• Bleeding spots on the skin.
• General weakness.

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

• Heart attack (myocardial infarction).
• Irregular heartbeats (new or worsening).
• Heart problems that can cause difficulty breathing or swelling of the ankles.
• Pneumonia.
• Cough.
• Chills.
• Unexpected bleeding.
• Tendency to bleed (e.g. in the stomach, eyes, or muscles, nosebleeds, or blood in the sputum or urine).
• Decrease in the number of red blood cells in the blood.
• Dizziness when standing up.
• Fainting.
• Anxiety.
• Difficulty sleeping.
• Abnormal dreams.
• Allergic reaction.
• Pain and discomfort.
• Diabetes and increased blood sugar levels.
• Stomach pain (gastritis).
• General malaise.

Diabetic patients may be at higher risk of eye bleeding.

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

• Bleeding for longer than normal.
• Increased platelet count in the blood.
• Kidney problems.

The following side effects have been observed during treatment with cilostazol cinfa, but the frequency with which they occur is unknown:

• Changes in blood pressure.
• Decrease in the number of red blood cells, white blood cells, and platelets in the blood.
• Difficulty breathing.
• Difficulty walking.
• Fever.
• Hot flushes.
• Eczema and other skin rashes.
• Decreased sensation in the skin.
• Watery or sticky eyes (conjunctivitis).
• Ringing in the ears (tinnitus).
• Liver problems, including hepatitis.
• Changes in urine.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Agency's online platform: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of cilostazol cinfa

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of cilostazol cinfa

• The active substance is cilostazol. Each tablet contains 100 mg of cilostazol.
• The other ingredients are cornstarch, microcrystalline cellulose, calcium carmellose, hypromellose, and magnesium stearate.

Appearance of the product and pack contents

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

It is available in PVC/ALU blister packs. Each pack contains 56 or 70 (clinical pack) tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

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

Date of last revision of this leaflet: July 2020

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (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