CILOSTAZOL NORMON 100 mg TABLETS

Introduction

Package Leaflet: Information for the User

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

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

Cilostazol NORMON belongs to a group of medicines known as phosphodiesterase type 3 inhibitors.

It has several 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 NORMON for "intermittent claudication". Intermittent claudication is the pain in the legs when walking, which is caused by insufficient blood supply to the legs. Cilostazol NORMON 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 stopping smoking and exercising more) 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 NORMON

Do not take Cilostazol NORMON:

• 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 serious heart rhythm disorders.
• if you know you have a disorder 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

Before taking Cilostazol NORMON, make sure your doctor knows:

• if you have any serious heart problems or any heart rhythm disorders;
• if you have any blood pressure disorders.
• During treatment with Cilostazol NORMON, make sure that
• In case you need to undergo surgery, including dental extraction, inform your doctor or dentist that you are taking Cilostazol NORMON.
• If you bruise or bleed easily, stop taking Cilostazol NORMON and inform your doctor.

Taking Cilostazol NORMON with other medicines

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

You must specifically tell 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 reduce 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 NORMON, your doctor may need to perform routine blood tests.

Certain medicines may interfere with the effect of Cilostazol NORMON when taken together. They may increase the side effects of Cilostazol NORMON or reduce its effectiveness. Cilostazol NORMON may have these same effects on other medicines. Before starting to take Cilostazol NORMON, tell 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)
• ergot derivatives (to treat migraines, e.g. ergotamine, dihydroergotamine)
• carbamazepine or phenytoin (to treat seizures)
• hypericum or 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 to take Cilostazol NORMON, tell your doctor or pharmacist if you are taking medicines to treat high blood pressure, as Cilostazol NORMON 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 to take these medicines with Cilostazol NORMON. Your doctor will decide if this is suitable for you.

Using Cilostazol NORMON with food and drink

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

Pregnancy, breastfeeding and fertility

DO NOT TAKECilostazol NORMON during pregnancy.

IT IS NOT RECOMMENDEDto take Cilostazol NORMON during breastfeeding.

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

Driving and using machines

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

Cilostazol NORMON contains sorbitol

This medicine contains 40 mg of sorbitol in each tablet.

3. How to take Cilostazol NORMON

• Follow exactly the instructions for administration 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 adjusted 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 NORMON.
• You should take Cilostazol NORMON tablets 30 minutes before breakfast and dinner. Always take the tablets with a glass of water.

You may notice the benefits of taking Cilostazol NORMON 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 NORMON is not suitable for children.

If you take more Cilostazol NORMON than you should

If you accidentally take more Cilostazol NORMON 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, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Cilostazol NORMON

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 NORMON

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

If you have any further questions on the use of this product, ask your doctor or pharmacist.

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 NORMON 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 heartbeat (new or worsening)
• significant bleeding
• easy bruising
• severe skin disease 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 immediately inform your doctor 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 NORMON. 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)

• rapid heartbeat
• heart palpitations
• chest pain
• dizziness
• sore throat
• runny nose (rhinitis)
• abdominal pain
• indigestion
• nausea or vomiting
• loss of appetite (anorexia)
• 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. 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):

• prolonged bleeding
• increase in platelet count in the blood
• kidney problems

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

• changes in blood pressure
• decrease in red blood cell, white blood cell, and platelet count in the blood
• difficulty breathing
• difficulty walking
• fever
• hot flashes
• eczema and other skin rashes
• decreased skin sensation
• tearful or sticky eyes (conjunctivitis)
• ringing in the ears (tinnitus)
• liver problems, including hepatitis
• changes in urine

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet.

You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: www.notificaram.es By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cilostazol NORMON

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

Store below 25°C. Store in the original packaging to protect from moisture.

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

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 further information

Composition of Cilostazol NORMON

The active substance is cilostazol. Each tablet contains 100 mg of cilostazol.

The other ingredients are sorbitol (E-420), talc, microcrystalline cellulose, crospovidone, calcium carmellose, colloidal anhydrous silica, magnesium stearate, and stearic acid.

Appearance and packaging of the product

The 100 mg Cilostazol NORMON tablet is a white or almost white, round, flat tablet with a score line.

This product is available in boxes of 56 tablets.

Marketing authorisation holder and manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of last revision of this leaflet:October 2013.

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/