Cilostazol Aristo 100 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Cilostazol Aristo 50 mg tablets EFG

Cilostazol Aristo 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 must not be given to other people, even if they have the same symptoms as you, because it could 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.

Contents of the leaflet

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

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

Cilostazol Aristo 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 for "intermittent claudication". Intermittent claudication is cramp-like pain in the legs that occurs when walking and is caused by an inadequate blood supply to the legs. Cilostazol may help you increase the walking distance, as it improves blood circulation in the legs. Cilostazol is recommended only for patients whose symptoms have not improved sufficiently after making lifestyle changes (such as 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 Aristo

Do not take Cilostazol Aristo

• if you are allergic (hypersensitive) 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 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 any condition that increases the risk of bleeding or bruising, such as:

• active stomach ulcers.

• stroke (cerebral infarction) within the past 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, 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 being treated with Cilostazol Aristo, ensure that

• If you need to undergo any surgical procedure, including tooth extraction, inform your doctor or dentist that you are taking cilostazol.
• If you bruise or bleed easily, stop taking cilostazol and inform your doctor.

Children and adolescents

Cilostazol is not suitable for children.

Taking Cilostazol Aristo with other medicines

Before starting to take cilostazol, 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 of 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 perform routine blood tests.

Certain medicines may interfere with the effect of cilostazol when taken together. They may increase the side effects of cilostazol or reduce its effectiveness. Cilostazol may also have similar effects on other medicines. Before starting 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 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 are unsure whether this applies to any medicine you are taking, consult your doctor or pharmacist.

Before starting to take cilostazol, inform your doctor or pharmacist if you are taking medicines to treat 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)

It may be possible for you to take the above-mentioned medicines together with cilostazol.

Your doctor will decide whether this is appropriate for your case.

Use of Cilostazol Aristo with food and drink

Take the cilostazol tablets 30 minutes before breakfast and dinner.

Always take the tablets with a glass of water.

Pregnancy and 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.

DO NOT TAKE cilostazol during pregnancy.

IT IS NOT RECOMMENDED to take cilostazol during breastfeeding.

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 Aristo

• 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 two 50 mg tablets (or one 100 mg tablet) twice daily (in the morning and at night). This 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 could interfere with the effect of cilostazol.
• You should take cilostazol tablets 30 minutes before breakfast and dinner. Always take the tablets with a glass of water.

You may start to notice the benefits of taking cilostazol 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 is not suitable for children.

If you take more Cilostazol Aristo 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.

If you take more tablets than prescribed, contact your doctor or nearest hospital immediately. Remember to take the packaging with you so that it is clear which medicine you have taken.

If you forget to take Cilostazol Aristo

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 a missed dose.

If you stop taking Cilostazol Aristo

If you stop taking 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 specifically 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, cilostazol can cause adverse effects, although not everyone will experience them.

If you experience any of the following adverse effects, you may need urgent medical attention. Stop taking cilostazol 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 onset or worsening)
• significant bleeding
• easy bruising
• severe 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 appropriate treatment.

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

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

• headache
• abnormal stools
• 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 (indigestion)
• stomach discomfort (nausea or vomiting)
• loss of appetite (anorexia)
• excess gas or flatulence
• swelling of the ankles, feet, or face
• rash or changes in skin appearance
• skin itching
• bleeding spots on the skin
• general weakness

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., 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 levels
• stomach pain (gastritis)
• general malaise

Diabetic patients may have an increased risk of eye bleeding.

Rare adverse effects (may affect up to 1 in 1000 people)

• tendency to bleed for longer than normal
• increased platelet count in the blood
• kidney problems

The following adverse effects have been reported during treatment with cilostazol, but their frequency is unknown:

• changes in blood pressure
• decreased 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, talk to your doctor, 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 Medicinal Products: https://www.notificaram.es

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Cilostazol Aristo

This medicine does not require special storage conditions.

Keep Cilostazol Aristo out of the sight and reach of children.

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

Do not use this medicine if there are visible signs of deterioration (for example, discoloration).

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point located at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Cilostazol Aristo

?? The active substance is cilostazol. Each tablet contains 50 mg or 100 mg of cilostazol.

?? Other ingredients are corn starch, microcrystalline cellulose, calcium carmellose, hypromellose and magnesium stearate.

Appearance of the product and contents of the pack

Appearance:

50 mg: White or almost white, round, smooth, bevelled tablets, engraved with “E” on one side and “601” on the other.

100 mg: White or almost white, round, smooth, bevelled tablets, engraved with “E” on one side and “602” on the other.

This medicinal product is supplied in boxes containing 28 (2x14) or 56 (4x14) tablets, packaged in PVC/PVdC and aluminium blisters in a cardboard box with the package leaflet.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Aristo Pharma Iberia, S.L
c/ Solana, 26
28850, Torrejón de Ardoz
Madrid, Spain

Manufacturer

EGIS Pharmaceuticals PLC
Bökényföldi út 118-120
Budapest
H-1165 Hungary

This medicinal product is approved in the EEA Member States under the following names:

Spain: Cilostazol Aristo 50 mg tablets EFG
United Kingdom: Cilostazol 50 mg tablets

Spain: Cilostazol Aristo 100 mg tablets EFG
United Kingdom: Cilostazol 100 mg tablets

Date of the most recent review of this leaflet: May 2017.

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