Cilostazol Lek-am

Leaflet attached to the packaging: patient information

Cilostazol LEK-AM, 50 mg, tablets

Cilostazol LEK-AM, 100 mg, tablets

Cilostazol

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

• 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 a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the 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 packaging 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 for an increase in the distance that the patient can walk without experiencing pain, by improving blood circulation in the legs. Cilostazol LEK-AM is only recommended for patients who have not experienced sufficient relief from symptoms after changing their lifestyle (such as quitting smoking and increasing physical activity) and other treatment methods. It is essential that the patient continues to make lifestyle changes while taking Cilostazol LEK-AM.

2. Important information before taking Cilostazol LEK-AM

When not to take Cilostazol LEK-AM:

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

Warnings and precautions

Before starting to take Cilostazol LEK-AM, the patient should discuss it with their doctor or pharmacist.
The patient should inform their doctor if they have:

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

While taking Cilostazol LEK-AM:

• if the patient is going to have surgery, including dental procedures, they should inform their doctor or dentist that they are taking Cilostazol LEK-AM.
• if the patient notices an increased tendency to bruise or bleed, as well as any other symptoms that may indicate the development of blood abnormalities, such as fever and sore throat, they should stop taking the medicine and inform their doctor.
• the patient should 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

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
In particular, the patient should inform their doctor about taking certain medicines used to treat pain and inflammatory conditions of muscles and joints, as well as medicines that reduce blood clotting. These medicines include:

• aspirin,
• clopidogrel,
• anticoagulants (e.g. warfarin, dabigatran, rivaroxaban, apixaban, heparin). If the patient needs to take any of these medicines at the same time as Cilostazol LEK-AM, the doctor may recommend regular blood tests.

Some medicines taken at the same time as Cilostazol LEK-AM may affect its action. 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, the patient should inform their doctor if they 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 migraine, e.g. ergotamine, dihydroergotamine),
• carbamazepine or phenytoin (antiepileptic medicines),
• St. John's Wort (a herbal medicine used to treat depression). In case of any doubts, the patient should consult their doctor or pharmacist.

It has been shown that smoking reduces the concentration of cilostazol in the blood, which may weaken its action. The patient should avoid smoking while taking Cilostazol LEK-AM.
Before starting to take Cilostazol LEK-AM, the patient should inform their doctor if they are taking medicines that lower blood pressure, as cilostazol may cause additional blood pressure lowering effects. If excessive blood pressure lowering occurs, it may lead to 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-adrenergic blockers (e.g. labetalol, carvedilol).

It may be possible to continue taking these medicines with Cilostazol LEK-AM. The doctor will decide what treatment is suitable for the patient.

Cilostazol LEK-AM with food and drink

The medicine should be taken 30 minutes before breakfast and 30 minutes before the evening meal.
The tablets should always be taken with water.
Consuming grapefruit juice while taking Cilostazol LEK-AM may enhance its action and increase the risk of side effects. The patient 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 the patient is pregnant or breastfeeding, thinks they may be pregnant or are planning to have a baby, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

Cilostazol LEK-AM may cause dizziness. If the patient experiences dizziness after taking the medicine, they MUST NOTdrive or operate tools or machines.
The patient should inform their doctor or pharmacist about this.

3. How to take Cilostazol LEK-AM

This medicine should always be taken exactly as prescribed by the doctor. In case of any doubts, the patient should consult their doctor or pharmacist.
Recommended dose
The recommended dose is 100 mg twice a day (in the morning and in the evening).
The medicine should be taken 30 minutes before breakfast and 30 minutes before the evening meal.
The tablets should always be taken with water.
There is no need to modify the dosage in elderly patients. However, the doctor may prescribe a lower dose of the medicine if the patient is 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, the 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 the patient has taken more tablets of Cilostazol LEK-AM than they should have, they may experience the following symptoms: severe headache, diarrhea, decreased blood pressure, and irregular heart rhythm.

If the patient has taken more tablets than the prescribed dose, they should immediately consult their doctor or go to the nearest hospital. They should take the packaging with them so that it is known what medicine was taken.

Missing a dose of Cilostazol LEK-AM

If the patient misses a dose of Cilostazol LEK-AM, they should not worry. They should wait and take the next dose at the right time, and then continue taking the medicine as prescribed. The patient MUST NOTtake a double dose to make up for the missed dose.

Stopping the treatment with Cilostazol LEK-AM

If the patient stops taking Cilostazol LEK-AM, the pain in the lower limbs may return or worsen. For this reason, the patient should only stop taking Cilostazol LEK-AM if they experience side effects that require immediate medical attention (see section 4) or if their doctor recommends it.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Cilostazol LEK-AM can cause side effects, although not everybody gets them.

In case of the following side effects, the patient may need immediate medical attention. They should stop taking Cilostazol LEK-AM, contact their doctor or go to the nearest hospital, if they experience:

Cilostazol LEK-AM, and consult their doctor or go to the nearest hospital, if they experience:

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

The patient should also contact their doctor immediately if they experience fever or sore throat.
It may be necessary to perform certain blood tests, and the doctor will decide on further treatment.
The following side effects have been reported during treatment with cilostazol.
The patient should inform their doctor as soon as possible if they experience:

Very common(occurring in more than 1 in 10 people)

• headache,
• abnormal stools,
• diarrhea.

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

• rapid heart rate,
• heart palpitations,
• chest pain,
• dizziness,
• sore throat,
• runny nose (rhinitis),
• abdominal pain,
• discomfort in the abdominal area (indigestion),
• nausea or vomiting,
• loss of appetite (anorexia),
• excessive belching or passing gas (flatulence),
• swelling of the ankles, feet, and face,
• rash or skin changes,
• itching of the skin,
• 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 people)

• heart attack,
• irregular heart rhythm (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 bleed (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 people)

• tendency to bleed for a longer time than normal,
• increase in the number of platelets in the blood,
• kidney function disorders.

Side effects of cilostazol with unknown frequency:

• stroke,
• blood pressure changes,
• decrease in the number of red and white blood cells and platelets in the blood,
• presence of 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,
• discharge or sticky secretion from the eyes (conjunctivitis),
• tinnitus (ringing in the ears),
• liver function disorders, including hepatitis and jaundice,
• frequent urination,
• changes in some laboratory tests (elevated uric acid, elevated urea in the blood, elevated creatinine in the blood).

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

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Cilostazol LEK-AM

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after the expiry date symbol. The expiry date refers to the last day of the month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging 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 packaged in blisters of PAP/Aluminium/PVC foil, containing 10 or 14 tablets, placed in a cardboard box.
The packaging contains 28, 30, 56, 60, 84, 90 or 120 tablets.
Cilostazol LEK-AM, 100 mg, is packaged in blisters of PAP/Aluminium/PVC or Aluminium/PVC foil, containing 10 or 14 tablets, placed in a cardboard box.
The packaging contains 28, 56, 60, 84, 90 or 120 tablets.

Marketing authorization holder and manufacturer

LEK-AM Pharmaceutical Company Ltd.
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 leaflet: