Cilostazol Cinfa 100 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Cilostazolcinfa 100 mg tablets EFG

Read the entire 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, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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 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 cramp-like pain in the legs that occurs when walking and is caused by 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 recommended only for patients whose symptoms have not improved sufficiently after making lifestyle changes (such as quitting smoking and increasing physical activity) and following other appropriate interventions. It is important that you continue with any lifestyle changes you have made while taking cilostazol.

2. What you need to know before taking cilostazol cinfa

Do not take cilostazol cinfa

• If you are allergic to cilostazol or to any of the other ingredients of this medicine (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 within the last six months.
• If you currently have or have previously had fainting episodes due to heart disease or serious heart rhythm disorders.
• If you know you have any condition that increases the risk of bleeding or bruising, such as: active stomach ulcers.
• Stroke (cerebrovascular accident) within the last six months.
• Eye problems if you have diabetes.
• Uncontrolled high blood pressure.
• If you are taking acetylsalicylic acid and clopidogrel, or any combination of two or more medicines that could 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

Talk to your doctor or pharmacist before starting cilostazol cinfa.

• If you have any serious heart condition or any heart rhythm disorder.

• If you have any blood pressure disorder.

• While being treated with cilostazol, make sure that:

• If you need to undergo any surgical procedure, including dental extractions, inform your doctor or dentist that you are taking cilostazol.

• If you bruise or bleed easily, stop taking cilostazol and contact your doctor.

Taking cilostazol cinfa with other medicines

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

You must specifically inform your doctor if you are taking medicines commonly used to treat painful and/or inflammatory conditions of muscles or joints, as well as medicines to reduce blood clotting. These include:

• Acetylsalicylic acid.
• Clopidogrel.
• Anticoagulant medicines (for example, warfarin, dabigatran, rivaroxaban, apixaban, or low molecular weight heparins).

If you are taking any of these medicines together with cilostazol, your doctor may need to perform 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 also have similar effects on other medicines. Before starting cilostazol cinfa, inform your doctor or pharmacist if you are taking:

• Erythromycin, clarithromycin, or rifampicin (antibiotics).
• Ketoconazole (used to treat fungal infections).
• Omeprazole (used to treat excess stomach acid).
• Diltiazem (used to treat high blood pressure or chest pain).
• Cisapride (used to treat certain stomach disorders).
• Lovastatin, simvastatin, or atorvastatin (used to treat high cholesterol in the blood).
• Halofantrine (used to treat malaria).
• Pimozide (used to treat mental disorders).
• Ergot derivatives (used to treat migraines, e.g., ergotamine, dihydroergotamine).
• Carbamazepine or phenytoin (used to treat seizures).
• St. John’s wort (a herbal remedy).

If you are unsure whether this applies to any medicine you are taking, consult your doctor or pharmacist.

Before starting 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 much, you may experience a rapid heartbeat. These medicines include:

• 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 above-mentioned medicines together with cilostazol. Your doctor will decide whether this is appropriate for you.

Taking cilostazol cinfa with food and drinks

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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

DO NOT take cilostazol during pregnancy.

IT IS NOT RECOMMENDED to take cilostazol during breastfeeding.

Driving and using machines

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

3. How to take cilostazol cinfa

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

• The recommended dose is one 100 mg tablet twice daily (in the morning and at night). There is no need to adjust this dose for elderly patients. However, your doctor may prescribe a lower dose if you are taking other medicines that could interfere with the effect of cilostazol.
• You should take the cilostazol tablets 30 minutes before breakfast and dinner. Always take the tablets with a glass of water. The tablet may be divided into equal doses.

You may begin to notice the benefits of taking cilostazol within 4 to 12 weeks of treatment. After 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 tablets of cilostazol than you should, for any reason, you may experience symptoms such as severe headache, diarrhea, low blood pressure, and irregular heartbeat.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 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 your next scheduled dose and continue taking the medicine as normal. Do not take a double dose to make up for missed 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 adverse effects requiring urgent medical attention (see section 4) or if your doctor specifically instructs you to do so.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

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

• Stroke (cerebrovascular accident).
• Myocardial infarction (heart attack).
• Heart problems, which may cause difficulty breathing or swelling of the ankles.
• Irregular heartbeat (new onset or worsening).
• Noticeable bleeding.
• Easy bruising.
• Serious illness with blistering of the skin, mouth, eyes, or genitals.
• Yellowing of the skin or whites of the eyes due to liver or blood problems (jaundice).

You should also inform your doctor immediately if you develop fever or sore throat. You may need to have blood tests; your doctor will decide on the appropriate treatment.

The following adverse effects have been observed in patients treated with cilostazol cinfa. If you experience any of them, you must inform your doctor immediately:

Very common adverse effects (may affect more than 1 in 10 people)

• Headache.
• Abnormal stools.
• Diarrhea.

Common adverse effects (may affect up to 1 in 10 people)

• Rapid heartbeat.
• Palpitations.
• Chest pain.
• Dizziness.
• Sore throat.
• Runny nose (rhinitis).
• Abdominal pain.
• Abdominal discomfort (indigestion).
• Stomach discomfort (nausea or vomiting).
• Loss 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 patches on the skin.
• General weakness.

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

• Heart attack (myocardial infarction).
• Irregular heartbeat (new onset or worsening).
• Heart problems that may 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 sputum or urine).
• Decrease in the number of red blood cells in the blood.
• Dizziness upon standing.
• Fainting.
• Anxiety.
• Difficulty falling asleep.
• Abnormal dreams.
• Allergic reaction.
• Pain and discomfort.
• Diabetes and increased blood sugar levels.
• Stomach pain (gastritis).
• General malaise.

Diabetic patients may have a higher risk of eye bleeding.

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

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

The following adverse effects have been observed during treatment with cilostazol cinfa, but their frequency is unknown:

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

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the packaging and the blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at a SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This 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 components are corn starch, microcrystalline cellulose, calcium carmellose, hypromellose and magnesium stearate.

Appearance of the product and contents of the container

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

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 the most recent revision of this leaflet: July 2020

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and carton. 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