Cilostazol Lek-am

Package Leaflet: Information for the Patient

Cilostazol LEK-AM, 50 mg, tablets

Cilostazol LEK-AM, 100 mg, tablets

Cilostazol

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package 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, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Cilostazol LEK-AM and what is it used for
• 2. Important information before taking Cilostazol LEK-AM
• 3. How to take Cilostazol LEK-AM
• 4. Possible side effects
• 5. How to store Cilostazol LEK-AM
• 6. Contents of the pack and other information

1. What is Cilostazol LEK-AM and what is it used for

Cilostazol LEK-AM belongs to a group of medicines called phosphodiesterase type III inhibitors.
The action of the medicine involves the dilation of certain blood vessels and the reduction of the blood clotting process (aggregation) of certain blood cells, called platelets, within the blood vessels.
Cilostazol LEK-AM has been prescribed for the treatment of a disease called "intermittent claudication".
Intermittent claudication is characterized by the occurrence of cramp-like pain in the lower limbs during walking and is caused by insufficient blood flow to the legs. Cilostazol LEK-AM allows the patient to increase the distance they can walk without experiencing pain, by improving blood circulation in the legs. Cilostazol LEK-AM is recommended only for patients in whom a change in lifestyle (such as quitting smoking and increasing physical activity) and other treatment methods have not sufficiently alleviated the symptoms. It is important for the patient to continue making lifestyle changes while taking Cilostazol LEK-AM.

2. Important information before taking Cilostazol LEK-AM

When not to take Cilostazol LEK-AM:

• if you are allergic to cilostazol or any of the other ingredients of this medicine (listed in section 6).
• if you have heart failure.
• if you experience persistent chest pain at rest or have had a heart attack or heart surgery in the last 6 months.
• if you have had a transient loss of consciousness due to a heart condition or any severe heart rhythm disorders.
• if you have conditions that may increase the risk of bleeding or bruising, such as:
• active gastric ulcer,
• stroke in the last 6 months,
• eye problems in patients with diabetes,
• uncontrolled high blood pressure.
• if you are taking aspirin and clopidogrel or any other combination of two or more medicines that may increase the risk of bleeding (if in doubt, consult your doctor or pharmacist).
• if you have severe kidney disease.
• if you have moderate or severe liver disease.
• if you are pregnant.

Warnings and precautions

Before starting to take Cilostazol LEK-AM, discuss it with your doctor or pharmacist.
Tell your doctor if you have:

• severe heart disease or heart rhythm disorders.
• blood pressure problems.

While taking Cilostazol LEK-AM:

• if you are going to have surgery, including dental procedures, inform your doctor or dentist that you are taking Cilostazol LEK-AM.
• if you notice an increased tendency to bruise or bleed, as well as any other symptoms that may indicate early signs of blood disorders, such as fever and sore throat, stop taking the medicine and inform your doctor.
• be cautious when taking any other medicine that may lower blood pressure or inhibit platelet aggregation.

Children and adolescents

Cilostazol LEK-AM is not indicated for use in children and adolescents.

Cilostazol LEK-AM and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take.
In particular, inform your doctor about taking certain medicines used to treat pain and inflammatory conditions of muscles and joints, and about taking medicines that reduce blood clotting. These include:

• aspirin,
• clopidogrel,
• anticoagulants (e.g. warfarin, dabigatran, rivaroxaban, apixaban, heparin). If you need to take any of these medicines with Cilostazol LEK-AM, your doctor may recommend regular blood tests.

Some medicines taken at the same time may affect the action of Cilostazol LEK-AM.
They may increase the risk of side effects of Cilostazol LEK-AM or reduce its effectiveness. Similarly, Cilostazol LEK-AM may affect the action of other medicines. Before starting to take Cilostazol LEK-AM, inform your doctor if you are taking:

• erythromycin, clarithromycin, or rifampicin (antibiotics),
• ketoconazole (an antifungal medicine),
• protease inhibitors (antiviral medicines used to treat HIV and hepatitis C infections, e.g. saquinavir, ritonavir, boceprevir),
• omeprazole (a medicine used to treat excessive stomach acid),
• diltiazem (a medicine used to treat high blood pressure and chest pain),
• cisapride (a medicine used to treat disorders of stomach emptying),
• lovastatin, simvastatin, or atorvastatin (medicines used to treat high cholesterol),
• halofantrine (a medicine used to treat malaria),
• pimozide (a medicine used to treat mental disorders),
• ergot alkaloids (medicines used to treat migraines, e.g. ergotamine, dihydroergotamine),
• carbamazepine or phenytoin (antiepileptic medicines),
• St. John's Wort (a herbal medicine used to treat depression). If in doubt, consult your doctor or pharmacist.

It has been shown that smoking reduces the blood levels of cilostazol, which may reduce its effect. You should avoid smoking while taking Cilostazol LEK-AM.
Before starting to take Cilostazol LEK-AM, inform your doctor if you are taking blood pressure-lowering medicines, as cilostazol may have an additional blood pressure-lowering effect. If your blood pressure drops too low, it may lead to a rapid heart rate. Blood pressure-lowering 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).

It may still be possible to take these medicines with Cilostazol LEK-AM. Your doctor will decide what treatment is suitable for you.

Cilostazol LEK-AM with food and drink

The medicine should be taken 30 minutes before breakfast and 30 minutes before the evening meal.
Tablets should always be swallowed with water.
Consuming grapefruit juice while taking Cilostazol LEK-AM may increase its effect and increase the risk of side effects. You should avoid consuming large amounts of grapefruit juice (more than 240 ml) while taking Cilostazol LEK-AM.

Pregnancy and breastfeeding

Cilostazol LEK-AM MUST NOTbe used during pregnancy.
IT IS NOT RECOMMENDEDto use Cilostazol LEK-AM during breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Cilostazol LEK-AM may cause dizziness. If you experience dizziness after taking the medicine, DO NOTdrive or operate tools or machines.
Inform your doctor or pharmacist about this.

3. How to take Cilostazol LEK-AM

Take this medicine always as directed by your doctor. If you are unsure, ask your doctor or pharmacist.
Recommended dose
The recommended dose is 100 mg twice a day (in the morning and in the evening).
Take the medicine 30 minutes before breakfast and 30 minutes before the evening meal.
Swallow the tablets with water.
No dose adjustment is necessary for elderly patients. However, your doctor may prescribe a lower dose of the medicine if you are taking other medicines that may affect the action of Cilostazol LEK-AM.
Some benefits of taking Cilostazol LEK-AM may be noticeable after 4-12 weeks of treatment. After 3 months, your doctor will assess the progress of the treatment and may recommend stopping the treatment with cilostazol if the therapy is not effective enough.

Use in children and adolescents

Cilostazol LEK-AM is not indicated for use in children and adolescents.

Taking a higher dose of Cilostazol LEK-AM than recommended

If for any reason you take more tablets of Cilostazol LEK-AM than you should, you may experience the following symptoms: severe headache, diarrhea, decreased blood pressure, and irregular heartbeat.

If you take more tablets than prescribed, contact your doctor or go to the nearest hospital immediately. Remember to take the package with you, so that it is known what medicine has been taken.

Missing a dose of Cilostazol LEK-AM

If you miss a dose of Cilostazol LEK-AM, do not worry. Wait and take the next dose at the right time, and then continue taking the medicine as directed. DO NOTtake a double dose to make up for the missed dose.

Stopping the treatment with Cilostazol LEK-AM

If you stop taking Cilostazol LEK-AM, the pain in your lower limbs may return or worsen. Therefore, you should only stop taking Cilostazol LEK-AM if you experience side effects that require immediate medical attention (see section 4) or if your doctor recommends it.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following side effects, you may need urgent medical attention. Stop taking Cilostazol LEK-AM, contact your doctor or go to the nearest hospital immediately, if you experience:

Cilostazol LEK-AM:

• stroke,
• heart attack,
• heart problems that may cause shortness of breath or swelling in the ankles,
• irregular heartbeat (new or worsening symptom),
• bleeding,
• tendency to bruise,
• severe skin disease with blisters on the skin, in the mouth, on the eyes, and on the genitals,
• yellowing of the skin and the whites of the eyes due to liver or blood disorders (jaundice).

You should also contact your doctor immediately if you experience fever or sore throat.
Your doctor may need to perform some blood tests, and will decide on further treatment.
The following side effects have been reported in patients taking cilostazol.
Tell your doctor as soon as possible if you experience:
Very common(occurring in more than 1 in 10 patients)

• headache,
• abnormal stools,
• diarrhea.

Common(occurring in less than 1 in 10 but more than 1 in 100 patients)

• rapid heartbeat,
• palpitations,
• chest pain,
• dizziness,
• sore throat,
• runny nose (rhinitis),
• abdominal pain,
• discomfort in the abdomen (indigestion),
• nausea or vomiting,
• loss of appetite (anorexia),
• excessive belching or passing wind (flatulence),
• swelling of the ankles, feet, and face,
• rash or skin changes,
• itching,
• petechiae (small red or purple spots on the skin),
• general weakness.

Uncommon(occurring in less than 1 in 100 but more than 1 in 1000 patients)

• heart attack,
• irregular heartbeat (new or worsening symptom),
• heart problems that may cause shortness of breath or swelling in the ankles,
• shortness of breath,
• pneumonia,
• cough,
• chills,
• unexpected bleeding,
• tendency to bruise (e.g. in the stomach, eye, nosebleed),
• decrease in the number of red blood cells in the blood,
• dizziness when standing up,
• fainting,
• anxiety,
• sleep disorders,
• nightmares,
• allergic reaction,
• diabetes and elevated blood sugar levels,
• stomach pain (gastritis),
• muscle pain,
• malaise.

Rare(occurring in less than 1 in 1000 but more than 1 in 10,000 patients)

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

Side effects of cilostazol with unknown frequency:

• stroke,
• changes in blood pressure,
• decrease in the number of red and white blood cells and platelets in the blood,
• blood in sputum or urine,
• bleeding into muscles, subcutaneous,
• difficulty breathing (interstitial pneumonia),
• difficulty moving (paresis),
• fever,
• pain,
• hot flashes,
• rash and other skin changes, including severe skin reactions,
• hives,
• decreased skin sensitivity to stimuli,
• runny or sticky discharge from the eyes (conjunctivitis),
• ringing in the ears (tinnitus),
• liver problems, including hepatitis and jaundice,
• frequent urination,
• changes in some laboratory tests (elevated uric acid, elevated urea, elevated creatinine in the blood).

In patients with diabetes, there may be an increased risk of bleeding into the eye.
In patients over 70 years of age, an increased frequency of diarrhea and palpitations has been observed.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,
e-mail: ndl@urpl.gov.pl.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cilostazol LEK-AM

Keep the 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 the expiry date.
The expiry date refers to the last day of the month.
No special precautions for storage are necessary.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Cilostazol LEK-AM contains

• The active substance of the medicine is cilostazol. One tablet of Cilostazol LEK-AM, 50 mg, contains 50 mg of cilostazol. One tablet of Cilostazol LEK-AM, 100 mg, contains 100 mg of cilostazol.
• The other ingredients are: microcrystalline cellulose 101 and 102; maize starch; hypromellose; sodium croscarmellose; magnesium stearate.

What Cilostazol LEK-AM looks like and contents of the pack

Cilostazol LEK-AM, 50 mg, is a white or almost white, flat, round tablet, with the letter "C" embossed on one side of the tablet.
Cilostazol LEK-AM, 100 mg, is a white or almost white, flat, round tablet.
Cilostazol LEK-AM, 50 mg, is packed in blisters of PAP/Aluminum/PVC foil, containing 10 or 14 tablets, placed in a cardboard box.
The pack contains 28, 30, 56, 60, 84, 90 or 120 tablets.
Cilostazol LEK-AM, 100 mg, is packed in blisters of PAP/Aluminum/PVC or Aluminum/PVC foil, containing 10 or 14 tablets, placed in a cardboard box.
The pack contains 28, 56, 60, 84, 90 or 120 tablets.

Marketing authorization holder and manufacturer

LEK-AM Pharmaceutical Company Limited
Ostrzykowizna 14A
05-170 Zakroczym, Poland
tel: +48 22 785 20 69
fax: +48 22 785 20 69 ext. 106

Date of last revision of the package leaflet: