Prospect: information for the user

Cilostazol NORMON 100 mg tablets EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. (See section 4).

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

2.What you need to know before starting to take Cilostazol NORMON

3.How to take Cilostazol NORMON

4.Possible adverse effects

5.Storage of Cilostazol NORMON
6.Contents of the package and additional information

Cilostazol NORMON 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 coagulant activity (agglutination) of certain blood cells, called platelets, in blood vessels.

Cilostazol NORMON has been prescribed for «intermittent claudication». Intermittent claudication is the cramping pain that you experience in your legs when walking and is caused by an insufficient blood supply to the legs. Cilostazol NORMON may 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 enough 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.

Do not take Cilostazol NORMON:

• if you are allergic to cilostazol or any of the other ingredients of this medication (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 or have had previous fainting spells due to heart disease 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 (cerebral hemorrhage) within 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

Before taking Cilostazol NORMON, make sure your doctor knows:

• if you have any severe heart problems or any heart rhythm disorders;
• if you have any blood pressure disorders.
• During treatment with Cilostazol NORMON ensure that
• If you need to undergo surgery, including dental extraction, inform your doctor or dentist that you are taking Cilostazol NORMON.
• If you are prone to bruising or bleeding, stop taking Cilostazol NORMON and inform your doctor.

Taking Cilostazol NORMON with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

You must inform your doctor specifically if you are taking medications that are usually taken to treat painful and/or inflammatory conditions in 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 the case of taking these medications with Cilostazol NORMON, your doctor may need to perform routine blood tests.

Determined medications may interfere with the effect of Cilostazol NORMON when taken together. They may increase the side effects of Cilostazol NORMON or reduce its efficacy. Cilostazol NORMON may have the same effects on other medications. Before starting to take Cilostazol NORMON, inform 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 some 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)
• St. John's Wort or hypericum (herbal medication)

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

Before starting to take Cilostazol NORMON, inform your doctor or pharmacist if you are taking medications to treat high blood pressure, as Cilostazol NORMON may have an additional effect of lowering blood pressure. If your blood pressure decreases excessively, you may experience an acceleration of heart rate. Among these medications are:

• diuretics (e.g., hydrochlorothiazide, furosemide)
• calcium channel blockers (e.g., verapamil, amlodipine)
• ACE inhibitors (e.g., captopril, lisinopril)
• angiotensin II receptor blockers (e.g., valsartan, candesartan)
• beta-blockers (e.g., labetalol, carvedilol)

You may be able to take the previously mentioned medications together with Cilostazol NORMON. Your doctor will decide if this is suitable in your case.

Use of Cilostazol NORMON with food and drinks

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.

DO NOT RECOMMENDtaking Cilostazol NORMON during breastfeeding.

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

Driving and operating machinery

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

Cilostazol NORMON contains sorbitol

This medication contains 40 mg of sorbitol in each tablet.

• Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.
• The recommended dose is one 100 mg tablet taken twice a day (in the morning and in the evening). It is not necessary to adjust this dose for elderly patients. However, your doctor may prescribe a lower dose if you are taking other medications that could interfere with the effect of Cilostazol NORMON.
• You must take the 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 at 4-12 weeks of treatment. At 3 months of treatment, your doctor will evaluate 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 take any reason more tablets of Cilostazol NORMON 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication 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 taking the treatment normally. DO NOT take a double dose to compensate for the missed doses.

If you interrupt the treatment with 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 detect emergency medical attention required side effects (see section 4) or if your doctor advises you to do so.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause 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 NORMON and contact a doctor or go immediately to the nearest hospital.

• stroke (apoplejía)
• heart attack (infarto de miocardio)
• heart problems, which can cause difficulty breathing or inflammation of the ankles
• irregular heartbeat (new or worsening)
• notable bleeding
• easily bruising
• serious disease with blister formation on the skin, mouth, eyes, or genitals
• yellowing of the skin or white of the eyes due to liver or blood problems (jaundice)

You should also inform your doctor immediately if you experience fever or sore throat. Blood tests may be required; 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 should inform your doctor immediately:

Very common side effects(can affect more than 1 in 10 people)

• headache
• abnormal stools
• diarrhea

Common side effects(can affect up to 1 in 10 people)

• rapid heartbeat
• palpitations
• chest pain
• dizziness
• sore throat
• runny nose (rhinitis)
• abdominal pain
• indigestion
• nausea or vomiting
• loss of appetite (anorexia)
• excess gas or flatulence
• inflammation of the ankles, feet, or face
• exanthema or changes in skin appearance
• itching skin
• hemorrhagic patches on the skin
• general weakness

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

• heart attack (infarto de miocardio)
• irregular heartbeat (new or worsening)
• heart problems that can cause difficulty breathing or inflammation of the ankles
• pneumonia
• cough
• chills
• unexpected bleeding
• tendency to bleed (e.g., in the stomach, eyes, or muscles, nasal bleeding or presence of blood in sputum or urine)
• decrease in red blood cell count
• dizziness when standing up
• syncope
• 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 be at a higher risk of eye bleeding.

Rare side effects(can affect up to 1 in 1000 people):

• tendency to bleed for a longer time than normal
• increase in platelet count in the blood
• kidney problems

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

If you experience side effects, consult your doctor or pharmacist, even if they do not appear in this prospectus.

Reporting side effects

If you experience any type of side effects, consult your doctor or pharmacist, even if they do not appear in this prospectus.

You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaram.esBy reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

Do not use this medication after the expiration date that appears on the box and the blister pack after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE point of the pharmacy.Ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Cilostazol CompositionNORMON

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

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

Product appearance and packaging contents

The 100 mg Cilostazol NORMON tablet is a white or almost white, round, flat, and marked tablet.

This product is supplied in boxes of 56 tablets.

Marketing authorization holder and manufacturer responsible

Laboratorios Normon, S.A.

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

Last review date of this prospectus:October 2013.

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