CILOSTAZOL PENSA 100 mg TABLETS

Introduction

Package Leaflet: Information for theuser

Cilostazol Pensa 100 mg tablets EFG

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

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

Contents of the package leaflet:

1. What Cilostazol Pensa is and what it is used for
2. What you need to know before taking Cilostazol Pensa
3. How to take Cilostazol Pensa
4. Possible side effects
5. Storage of Cilostazol Pensa
6. Package contents and additional information

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

Cilostazol Pensa belongs to a group of medications known as phosphodiesterase type 3 inhibitors.

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

You have been prescribed Cilostazol Pensa for "intermittent claudication". Intermittent claudication is the cramp-like pain you experience in your legs when walking, which is caused by an insufficient blood supply to the legs. Cilostazol Pensa may help you 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 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.

2. What you need to know before taking Cilostazol Pensa

Do not take Cilostazol Pensa:

• if you are allergic to cilostazol or any of the other components of this medication,
• 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 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 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 Pensa.

Before taking Cilostazol Pensa, 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 Pensa, ensure that:

• In case you need to undergo surgery, including dental extraction, inform your doctor or dentist that you are taking cilostazol.
• If you experience bruising or bleeding easily, stop taking cilostazol and inform your doctor.

Taking Cilostazol Pensa with other medications

Before starting to take Cilostazol Pensa, inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication, including over-the-counter medications.

You must specifically inform your doctor 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. These medications include:

• aspirin
• clopidogrel
• anticoagulant medications (e.g., warfarin, dabigatran, rivaroxaban, apixaban, or low molecular weight heparins).

In case you are taking these medications with Cilostazol Pensa, your doctor may need to perform routine blood tests.

Certain medications may interfere with the effect of Cilostazol Pensa when taken together. They may increase the side effects of cilostazol or reduce its effectiveness. Cilostazol Pensa may have these same effects on other medications. Before starting to take Cilostazol Pensa, 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 certain stomach disorders)
• lovastatin, simvastatin, or atorvastatin (to treat high cholesterol)
• 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 remedy)

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

Before starting to take Cilostazol Pensa, inform your doctor if you are taking medications for high blood pressure, as cilostazol may have an additional blood pressure-lowering effect. In case your blood pressure drops excessively, you may experience an increased heart rate. These medications 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)

It may be possible for you to take these medications with Cilostazol Pensa. Your doctor will decide if this is suitable for you.

Using Cilostazol Pensa with food, drinks, and alcohol

You should take Cilostazol Pensa tablets 30 minutes before breakfast and dinner.

Always take the tablets with a glass of water.

Pregnancy, breastfeeding, and fertility

DO NOT TAKECilostazol Pensa during pregnancy.

IT IS NOT RECOMMENDEDto take Cilostazol Pensa during breastfeeding.

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

Driving and using machines

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

3. How to take Cilostazol Pensa

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

The usual dose is one 100 mg tablet twice a day (in the morning and at night). The dose does not need to be adjusted for elderly patients. However, your doctor may need to prescribe a lower dose if you are taking other medications that may interfere with the effect of cilostazol.

You should take Cilostazol Pensa tablets 30 minutes before breakfast and dinner. Always take the tablets with a glass of water.

You may notice the benefits of taking Cilostazol Pensa within 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 and adolescents

Cilostazol Pensa is not suitable for children.

If you take more Cilostazol Pensa than you should

In case you take more Cilostazol Pensa 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 call the Toxicology Information Service immediately, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Cilostazol Pensa

Do not worry if you forget to take a dose. Wait until the next dose and continue taking the treatment as usual.

Do not take a double dose to make up for the missed doses.

If you stop taking Cilostazol Pensa

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

4. Possible side effects

Like all medications, Cilostazol Pensa may have 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 Pensa and contact a doctor or go to the nearest hospital immediately.

• stroke (apoplexy)
• heart attack (myocardial infarction)
• heart problems that can cause difficulty breathing or swelling of the ankles
• irregular heartbeats (new or worsening)
• significant 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 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 heartbeats
• heart palpitations
• chest pain
• dizziness
• sore throat
• runny nose (rhinitis)
• abdominal pain
• abdominal discomfort
• nausea or vomiting
• excess gas or flatulence
• swelling of the ankles, feet, or face
• rash or skin changes
• itching
• 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., from 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 a higher risk of eye bleeding.

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

• prolonged bleeding time
• increased platelet count in the blood
• kidney problems

The following side effects have been observed during the use of Cilostazol Pensa, 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 moving
• fever
• hot flashes
• eczema and other skin rashes
• decreased sensation in the skin
• tearful or sticky eyes (conjunctivitis)
• ringing in the ears (tinnitus)
• liver problems, including hepatitis
• changes in urine

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's online system: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Cilostazol Pensa

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 stated on the packaging after "EXP". The expiration date is the last day of the month indicated.

Medications should not be disposed of via wastewater or household waste. Return the packaging and any unused medication to the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the packaging and medication you no longer need. This will help protect the environment.

6. Package contents and additional information

Cilostazol Pensa composition

• The active ingredient 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 package contents

Cilostazol Pensa 100 mg is a white, round, and scored tablet on one side. Your medication is supplied in packages of 56 tablets.

Marketing authorization holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

NOUCOR HEALTH, S.A.

Avda. Camí Reial 51-57

08184 Palau-solità i Plegamans

Barcelona, Spain

Date of the last revision of this package leaflet:November 2013

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS)http://www.aemps.gob.es/