Cilostazol Normon 100 mg tablets EFG

Package leaflet: Information for the user

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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. (See section 4.)

Leaflet contents:

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

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

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 clotting activity (aggregation) of certain blood cells called platelets in the blood vessels.

Your doctor has prescribed Cilostazol NORMON 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 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 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 NORMON

Do not take Cilostazol NORMON:

• 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

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.

While on treatment with Cilostazol NORMON, ensure that:

• If you need to undergo any surgical procedure, including dental extractions, inform your doctor or dentist that you are taking Cilostazol NORMON.
• If you experience easy bruising or bleeding, stop taking Cilostazol NORMON and inform your doctor.

Taking Cilostazol NORMON with other medicines

Inform 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 the muscles or joints, or medicines to 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 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 also have similar effects on other medicines. Before starting Cilostazol NORMON, 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) (a 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 NORMON, inform your doctor or pharmacist if you are taking medicines for high blood pressure, as Cilostazol NORMON 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)

It may be possible to take the above-mentioned medicines together with Cilostazol NORMON. Your doctor will decide whether this is appropriate for your case.

Use of Cilostazol NORMON with food and drink

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

Pregnancy, breastfeeding, and fertility

DO NOT TAKE Cilostazol NORMON during pregnancy.

IT IS NOT RECOMMENDED to take Cilostazol NORMON 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 using this medicine.

Driving and using machines

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

Cilostazol NORMON contains sorbitol

This medicine contains 40 mg of sorbitol per tablet.

3. How to take Cilostazol NORMON

• Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, 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 NORMON.
• You should take Cilostazol NORMON 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 NORMON within 4 to 12 weeks of starting 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 insufficient.

Use in children and adolescents

Cilostazol NORMON is not suitable for children.

If you take more Cilostazol NORMON than you should

If for any reason you take more Cilostazol NORMON tablets than you should, you may experience symptoms such as severe headache, diarrhoea, 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 medicine and the amount ingested.

If you forget to take Cilostazol NORMON

Do not worry if you forget to take a dose. Wait until your next scheduled dose and continue taking the medicine as usual. DO NOT take a double dose to make up for a missed dose.

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 adverse effects requiring urgent medical attention (see section 4) or if your doctor advises you to do so.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody gets them.

If you experience any of the following adverse effects, you may need urgent medical attention. Stop taking Cilostazol NORMON and contact a doctor or go immediately 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)
• 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 treatment you should receive.

The following adverse effects have been observed in patients treated with Cilostazol NORMON. 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
• diarrhoea

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 skin changes
• itching of the skin
• haemorrhagic patches on the skin
• general weakness

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., 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 concentration
• 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 NORMON, 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 skin sensation
• watery or sticky eyes (conjunctivitis)
• ringing in the ears (tinnitus)
• liver problems, including hepatitis
• changes in urine

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are adverse effects 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 NORMON

Keep this medicine out of sight and reach of children.

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

Do not use this medicine after the expiry date stated on the carton and blister pack after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point located at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Cilostazol NORMON

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

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

Appearance of the product and contents of the pack

Cilostazol NORMON 100 mg tablet is a white or almost white, round, flat tablet with markings.

This product is supplied in packs of 56 tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

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

Date of the most recent review of this leaflet: October 2013.

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