CILOSTAZOL STADA 100 MG TABLETS EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Cilostazol Stada 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. 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. Do not pass it on to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Cilostazol Stada belongs to a group of medicines known as type 3 phosphodiesterase 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 blood vessels.

You have been prescribed cilostazol 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 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 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 Stada

Do not take Cilostazol Stada

• if you are allergic to cilostazol or 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 spells due to heart disease or serious heart rhythm disorders,
• if you know you have any 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 to take Cilostazol Stada.

Before taking cilostazol, 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, 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 inform your doctor.

Taking Cilostazol Stada with other medicines

Tell 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 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, your doctor may need to carry out routine blood tests.

Certain medicines may interfere with the effect of cilostazol when taken at the same time. They may increase the adverse effects of cilostazol or reduce its effectiveness.

Cilostazol may also have similar effects on other medicines. Before starting to take cilostazol, 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 cholesterol in the blood)
• 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 are unsure whether this applies to any medicines you are taking, consult your doctor or pharmacist.

Before starting to take cilostazol, inform your doctor or pharmacist 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 an increased heart rate. 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 for you to take the above-mentioned medicines together with cilostazol. Your doctor will decide whether this is appropriate for you.

Taking Cilostazol Stada with food, drinks, and alcohol

Take cilostazol tablets 30 minutes before breakfast and dinner.

Always take the tablets with a glass of water.

Pregnancy, breast-feeding, and fertility

DO NOT TAKE cilostazol during pregnancy.

IT IS NOT RECOMMENDED to take cilostazol during breast-feeding.

If you are pregnant or breast-feeding, 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 may cause dizziness. If you feel dizzy after taking cilostazol, DO NOT drive or operate any tools or machinery, and inform your doctor or pharmacist.

3. How to take Cilostazol Stada

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

The usual dose is one 100 mg tablet twice daily (in the morning and at night). This dose does not usually need to be adjusted 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.

Take the cilostazol 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 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 not sufficient.

Use in children and adolescents

Cilostazol is not suitable for children.

If you take more Cilostazol Stada than you should

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

If you forget to take Cilostazol Stada

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 missed doses.

If you stop taking Cilostazol Stada

If you stop treatment with cilostazol, the pain in your legs may return or worsen. Therefore, you should only stop taking cilostazol 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 everyone will experience them.

If you experience any of the following adverse effects, you may require urgent medical attention. Stop taking cilostazol and contact a doctor immediately or go to the nearest hospital.

• stroke (cerebral infarction)
• myocardial infarction (heart attack)
• heart problems, which may cause difficulty breathing or swelling of the ankles
• irregular heartbeat (new onset or worsening)
• significant 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 what treatment you should receive.

The following adverse effects have been observed in patients treated with cilostazol. 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 (dyspepsia)
• stomach discomfort (nausea or vomiting)
• loss of appetite (anorexia)
• excess gas or flatulence
• swelling of the ankles, feet or face
• rash or skin changes
• skin itching
• bleeding spots on the skin

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

• heart attack (myocardial infarction)
• irregular heartbeat (new onset 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 an increased 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, 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

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Cilostazol Stada

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 unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Cilostazol Stada

• 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.

Appearance of the product and contents of the pack

Cilostazol Stada 100 mg is a white, round tablet, scored on one side.

Your medicine is supplied in packs of 56 tablets or hospital packs containing 70 (5x14) tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Noucor Health, S.A.

Av. Camí Reial 51-57

08184 Palau-solità i Plegamans

(Barcelona)

Spain

or

Galenicum Health, S.L.U.

Sant Gabriel, 50

08950 - Esplugues de Llobregat (Barcelona)

Spain

Date of the most recent review of this leaflet: June 2016

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