Cilostazol Sandoz 100 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Cilostazol Sandoz 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, and you must not give it to others, 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.

Leaflet contents:

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

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

Cilostazol Sandoz contains the active substance cilostazol, which belongs to a group of medicines called 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 within your blood vessels.

You have been prescribed Cilostazol Sandoz to treat your "intermittent claudication". Intermittent claudication is cramp-like pain in the legs that occurs when walking and is caused by insufficient blood flow to the legs. Cilostazol Sandoz may help you increase the walking distance without pain, as it improves blood circulation in the legs. Cilostazol is only recommended for patients whose symptoms have not improved sufficiently after making lifestyle changes (for example, quitting smoking and increasing physical activity) and after other appropriate interventions. It is important that you continue the lifestyle changes you have made while taking cilostazol.

2. What you need to know before taking Cilostazol Sandoz

Do not take Cilostazol Sandoz:

• if you are allergic to cilostazol or to any of the other ingredients of this medicine (listed in section 6),
• if you have "heart failure",
• if you have persistent chest pain at rest, or have had a "heart attack" or heart surgery within the last 6 months,
• if you now or previously have experienced fainting due to heart conditions, or any serious heart rhythm disturbances,
• if you know you have a condition that increases the risk of bleeding or bruising, such as:
  • active stomach ulcer(s),
  • stroke within the last 6 months,
  • eye problems related to diabetes,
  • if your blood pressure is not well controlled,
• if you have severe kidney disease or moderate to severe liver impairment,
• if you are taking acetylsalicylic acid and clopidogrel, or any combination of two or more medicines that may increase the risk of bleeding (consult your doctor or pharmacist if you are unsure),
• if you are pregnant.

Warnings and precautions

Talk to your doctor before taking Cilostazol Sandoz. Make sure your doctor knows:

• if you have a serious heart condition or any problem with your heart rhythm,
• if you have blood pressure problems.

While being treated with Cilostazol Sandoz, you should know that:

• if you need to undergo any surgical procedure, including dental extraction, inform your doctor or dentist that you are taking cilostazol,
• if you experience bruising or easy bleeding, stop taking cilostazol and contact your doctor immediately.

Children and adolescents

Cilostazol Sandoz is not intended for use in children.

Taking Cilostazol Sandoz with other medicines

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

You should especially inform your doctor if you are taking medicines commonly used to treat painful and/or inflammatory conditions of muscles or joints, or if you are taking medicines to reduce blood clotting. These medicines include:

• acetylsalicylic acid,
• clopidogrel,
• anticoagulant medicines (e.g.: warfarin, dabigatran, rivaroxaban, apixaban or low molecular weight heparins).

If you are taking these medicines with cilostazol, your doctor may perform routine blood tests.

Certain medicines may interfere with the effect of cilostazol when taken together. They may increase the adverse effects of cilostazol or make cilostazol less effective. Cilostazol may also affect other medicines in the same way. Before starting Cilostazol Sandoz, tell your doctor if you are taking:

• erythromycin, clarithromycin or rifampicin (antibiotics),
• ketoconazole (for treating fungal infections),
• protease inhibitors (antivirals),
• omeprazole (for treating excess stomach acid),
• diltiazem (for treating high blood pressure or chest pain),
• cisapride (for treating stomach disorders),
• lovastatin, simvastatin or atorvastatin (for treating high blood cholesterol),
• halofantrine (for treating malaria),
• pimozide (for treating mental illnesses),
• ergot derivatives (for treating migraine, e.g.: ergotamine, dihydroergotamine),
• carbamazepine or phenytoin (for treating seizures),
• St. John's wort (herbal remedy).

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

Before starting treatment with Cilostazol Sandoz, inform your doctor if you are taking medicines for high blood pressure, because cilostazol may have an additional blood pressure-lowering effect. If your blood pressure drops too quickly, this may cause an increase in your 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 blockers (e.g.: valsartan, candesartan),
• beta-blockers (e.g.: labetalol, carvedilol).

However, it may still be appropriate to take the above-mentioned medicines together with Cilostazol Sandoz. Your doctor will decide what is most suitable for you.

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 using this medicine.

Cilostazol Sandoz MUST NOT be used during pregnancy.

USE OF Cilostazol Sandoz IS NOT RECOMMENDED in breastfeeding mothers.

Driving and use of machines

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

3. How to take Cilostazol Sandoz

• Follow exactly the instructions for administering Cilostazol Sandoz provided by your doctor. If in doubt, consult your doctor or pharmacist again.
• The recommended dose is one 100 mg tablet twice daily (in the morning and in the evening). This dose does not need to be adjusted in elderly patients. However, your doctor may prescribe a lower dose if you are taking other medicines that may interact with cilostazol.
• The tablet may be divided into equal doses.
• Cilostazol Sandoz tablets should be taken 30 minutes before breakfast and dinner. Always take your tablets with a glass of water.

You may experience some beneficial effects from taking Cilostazol Sandoz within 4 to 12 weeks of treatment. Your doctor will assess your progress after 3 months of treatment and may recommend that you discontinue cilostazol therapy if the effects are insufficient.

If you take more Cilostazol Sandoz than you should

If for any reason you take more cilostazol tablets than you should, you may experience signs and symptoms such as severe headache, diarrhea, a rapid drop in blood pressure, and irregular heartbeat.

If you have taken more Cilostazol Sandoz than you should, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medication and the amount ingested. Remember to bring the packaging to clearly indicate which medication you have taken.

If you forget to take Cilostazol Sandoz

If you forget to take a dose, do not worry; wait until your next scheduled dose and take your tablet as usual. DO NOT take a double dose to make up for the missed dose.

If you stop taking Cilostazol Sandoz

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 experiences 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.

• Allergic reactions,
• stroke,
• heart attack,
• heart problems that may cause difficulty breathing or swelling of the ankles,
• irregular heartbeat (new or pre-existing),
• visible bleeding,
• increased tendency to bruising,
• severe illness with blistering of the skin, mouth, eyes, and genitals,
• yellowing of the skin or whites of the eyes due to liver or blood problems (jaundice).

You should inform your doctor immediately if you develop fever or sore throat. You may need to undergo certain blood tests before restarting treatment.

The following adverse effects have been reported for cilostazol. In such cases, you must inform your doctor as soon as possible:

Very common (may affect more than 1 in 10 patients)

• headache,
• abnormal stools,
• diarrhea.

Common (may affect up to 1 in 10 patients)

• rapid heartbeat,
• palpitations,
• chest pain,
• dizziness,
• sore throat,
• runny nose (rhinitis),
• abdominal pain,
• stomach discomfort (indigestion),
• feeling of malaise (nausea or vomiting),
• loss of appetite (anorexia),
• excessive gas or burping (flatulence),
• swelling of the ankles, feet, or face,
• skin rashes or changes in skin appearance,
• skin itching,
• localized bleeding under the skin,
• generalized weakness.

Uncommon (may affect up to 1 in 100 patients)

• heart attack,
• irregular heartbeat (new or pre-existing),
• 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, eye, muscle, nose, or blood in saliva or urine),
• decrease in red blood cells in the blood,
• dizziness upon standing,
• fainting,
• anxiety,
• difficulty sleeping,
• unusual dreams,
• allergic reactions,
• aches and discomfort,
• diabetes and high blood sugar levels,
• stomach pain (gastritis),
• malaise.

There may be an increased risk of eye bleeding in people with diabetes.

Rare (may affect up to 1 in 1,000 patients)

• tendency to bleed for longer than usual,
• increase in platelets in the blood,
• kidney problems.

Frequency not known (cannot be estimated from available data)

• changes in blood pressure,
• decrease in red blood cells, white blood cells, and platelets in your blood,
• difficulty breathing,
• difficulty moving,
• fever,
• hot flushes,
• eczema and other skin rashes,
• reduced skin sensitivity,
• 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 type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect 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 Sandoz

Keep this medicine 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.

This medicine does not require any special storage conditions.

Medicines should 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 are unsure, ask your pharmacist how to 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 Sandoz

• 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.

What Cilostazol Sandoz looks like and contents of the pack

Cilostazol Sandoz 100 mg tablets are white, round, biconvex tablets, scored on one side, with an approximate diameter of 8 mm.

Your medicine is supplied in packs of 14, 20, 28, 30, 50, 56, 60, 84, and 100 tablets in PVC/Aluminum blisters.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1,

39179 Barleben,

Germany

or

Noucor Health, S.A.

Avda. Camí Reial, 51-57

08184 Palau-solita i Plegamans (Barcelona),

Spain

or

Lek Pharmaceuticals d.d

Verovskova ulica 57,

Ljubljana, 1526

Slovenia

or

Galenicum Health S.L.U.

Sant Gabriel, 50,

Esplugues de Llobregat,

08950 Barcelona

Spain

This medicinal product is authorised in the European Economic Area member states under the following names:

Germany: Cilostazol HEXAL 100 mg Tabletten

Bulgaria: ?????????? ?????? 100 MG ????????

Estonia: Dilsatan, 100 mg tabletid

Italy: CILOSTAZOLO SANDOZ

Lithuania: Dilsatan 100 mg tabletes

Latvia: Dilsatan 100 mg tabletes

Malta: Cilostazol Sandoz 100mg Tablets

Poland: DECILOSAL, 100 MG, TABLETKI

Romania: CILOSTAZOL SANDOZ 100 mg comprimate

Date of the most recent revision of this leaflet: July 2018

Detailed 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/