Cilostazol Pensa 100 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Cilostazol Pensa 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 may 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.

Leaflet contents:

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. How to store Cilostazol Pensa
6. Contents of the pack and other information

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

Cilostazol Pensa 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 Pensa for "intermittent claudication". Intermittent claudication is cramp-like pain in the legs that occurs when walking and is caused by an insufficient blood supply to the legs. Cilostazol Pensa can 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 sufficiently after making lifestyle changes (such as, for example, quitting smoking and increasing physical activity) and after 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 Pensa

Do not take Cilostazol Pensa:

• if you are allergic to cilostazol or any of the other ingredients of this medicine,
• 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 within the past 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 a condition that increases your risk of bleeding or bruising, for example:
  • 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 Pensa.

Before taking Cilostazol Pensa, make sure your doctor knows:

• if you have any serious heart problems or other heart rhythm disorders;
• if you have any blood pressure disorders.

While being treated with Cilostazol Pensa, ensure 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 immediately.

Taking Cilostazol Pensa with other medicines

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

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

• acetylsalicylic acid
• clopidogrel
• anticoagulant medicines (e.g., warfarin, dabigatran, rivaroxaban, apixaban, or low molecular weight heparins).

If you are taking any of these medicines together with Cilostazol Pensa, your doctor may need to perform routine blood tests.

Certain medicines 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 also have similar effects on other medicines. Before starting Cilostazol Pensa, 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 blood cholesterol)
• 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 (Hypericum perforatum) (herbal remedy)

If you have any doubts about whether this applies to the medicines you are taking, consult your doctor or pharmacist.

Before starting Cilostazol Pensa, inform your doctor if you are taking medicines for 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 Pensa. Your doctor will decide whether this is appropriate for your case.

Use of Cilostazol Pensa with food, drinks, and alcohol

Take the Cilostazol Pensa tablets 30 minutes before breakfast and dinner.

Always take the tablets with a glass of water.

Pregnancy, breastfeeding, and fertility

DO NOT TAKE Cilostazol Pensa during pregnancy.

IT IS NOT RECOMMENDED to take Cilostazol Pensa during breastfeeding.

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

Driving and using machines

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

3. How to take Cilostazol Pensa

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

The usual dose is one 100 mg tablet twice daily (in the morning and at night). There is no need to adjust this dose in elderly patients. However, your doctor may need to prescribe you a lower dose if you are taking other medicines that could 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 begin to notice the benefits of taking Cilostazol Pensa 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 and adolescents

Cilostazol Pensa is not suitable for children.

If you take more Cilostazol Pensa than you should

If you take more Cilostazol Pensa tablets 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 immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Cilostazol Pensa

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 forgotten doses.

If you stop taking Cilostazol Pensa

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

4. Possible adverse effects

Like all medicines, Cilostazol Pensa may have adverse effects, although not everyone experiences them.

If you experience any of the following adverse effects, you may require urgent medical attention. Stop taking Cilostazol Pensa 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 or worsening)
• significant bleeding
• increased tendency to bruise easily
• severe illness with blister formation on 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 blood tests; your doctor will decide the appropriate treatment.

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

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

• headache
• abnormal bowel movements
• 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
• stomach discomfort (nausea or vomiting)
• excess gas or flatulence
• swelling of the ankles, feet, or face
• skin rash or changes in skin appearance
• itching of the skin
• bleeding spots on the skin

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

• heart attack (myocardial infarction)
• irregular heartbeat (new or worsening)
• heart problems that may 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 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 concentration
• stomach pain (gastritis)
• general malaise

Diabetic patients may have a higher risk of ocular bleeding.

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

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

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

• changes in blood pressure
• decrease in the 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 sensation in the skin
• 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 an effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Cilostazol Pensa

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

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 Pensa

• 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.

Description of the product and contents of the pack

Cilostazol Pensa 100 mg is a white, round tablet, scored on one side. Your medicine is supplied in packs 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 most recent review of this leaflet: November 2013

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