Cilostazol lek-am

Package leaflet: Information for the patient

Cilostazol LEK-AM, 50 mg, tablets
Cilostazol LEK-AM, 100 mg, tablets
Cilostazolum
< logo of the marketing authorization holder>
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are identical.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist immediately. See section 4.

Table of contents

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

Cilostazol LEK-AM belongs to a group of medicines called phosphodiesterase type III inhibitors.
The medicine acts by dilating certain blood vessels and by reducing the process of blood clotting (aggregation) of certain blood cells known as platelets within blood vessels.
Cilostazol LEK-AM has been prescribed for the treatment of a condition called "intermittent claudication".
Intermittent claudication is characterized by cramp-like pain in the lower limbs during walking, caused by inadequate blood flow to the legs. Cilostazol LEK-AM helps increase the distance a patient can walk without pain, by improving blood circulation in the legs. Cilostazol LEK-AM is recommended only for patients in whom changes in lifestyle (such as quitting smoking and increasing physical activity) and other treatment methods have not sufficiently alleviated symptoms. It is important that, during treatment with Cilostazol LEK-AM, the patient continues to maintain the recommended lifestyle modifications.

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 within the last 6 months.
• if the patient has currently or previously experienced transient loss of consciousness due to heart disease or any severe heart disorders.
• if the patient has conditions that may increase the risk of bleeding or bruising, such as:
• active gastric ulcer,
• stroke within the last 6 months,
• eye problems in patients with diabetes,
• poorly controlled blood pressure.
• if the patient is concurrently taking acetylsalicylic acid 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 treatment with Cilostazol LEK-AM, discuss this with your doctor or pharmacist.
Inform your doctor if the patient has:

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

While taking Cilostazol LEK-AM:

• if the patient needs to undergo surgery, including dental procedures, he or she should inform the doctor or dentist about taking Cilostazol LEK-AM.
• if the patient notices increased tendency to bruise or bleed, or any other symptoms suggesting early development of blood abnormalities, such as fever and sore throat, the medicine should be discontinued and the doctor should be informed immediately.
• caution should be exercised when used concomitantly with 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 medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
In particular, inform the doctor about taking certain medicines used to treat pain and inflammatory conditions of muscles and joints, and medicines that reduce blood clotting. These include:

• acetylsalicylic acid,
• clopidogrel,
• anticoagulants (e.g. warfarin, dabigatran, rivaroxaban, apixaban, heparin). If the patient needs to take any of the above medicines together with Cilostazol LEK-AM, the doctor may recommend routine blood tests.

Some concomitantly administered medicines may affect the action of Cilostazol LEK-AM.
They may increase the risk of adverse effects of Cilostazol LEK-AM or reduce its effectiveness. In the same way, Cilostazol LEK-AM may affect the action of other medicines. Before starting treatment with Cilostazol LEK-AM, inform the doctor if the patient is taking:

• erythromycin, clarithromycin or rifampicin (antibiotics),
• ketoconazole (antifungal medicine),
• protease inhibitors (antiviral medicines used in the treatment of HIV and hepatitis C virus infections, e.g. saquinavir, ritonavir, boceprevir),
• omeprazole (medicine used for excessive gastric acid secretion),
• diltiazem (medicine used to treat hypertension and chest pain),
• cisapride (medicine used to treat delayed gastric emptying),
• lovastatin, simvastatin or atorvastatin (medicines used to treat high blood cholesterol),
• halofantrine (medicine used to treat malaria),
• pimozide (medicine used to treat psychiatric disorders),
• ergot alkaloids (medicines used to treat migraine, e.g. ergotamine, dihydroergotamine),
• carbamazepine or phenytoin (anticonvulsant medicines),
• St. John's wort (herbal medicine used, among others, for low mood).
  If in doubt whether any of the above situations apply, consult a doctor or pharmacist.

It has been shown that smoking reduces plasma concentrations of cilostazol, which may weaken its effect. Smoking should be avoided during treatment with Cilostazol LEK-AM.
Before starting treatment with Cilostazol LEK-AM, inform the doctor if the patient is taking medicines that lower blood pressure, as cilostazol may cause additional blood pressure-lowering effects. If blood pressure drops excessively, it may lead to rapid heart rate. Medicines that lower blood pressure 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).

Concomitant use of the above-mentioned medicines with Cilostazol LEK-AM may still be acceptable. The doctor will decide which treatment is appropriate 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.
Tablets should always be taken with water.
Drinking grapefruit juice during treatment with Cilostazol LEK-AM may enhance its effect and increase the risk of adverse effects. Avoid drinking large amounts of grapefruit juice (more than 240 ml) during treatment with Cilostazol LEK-AM.
Pregnancy and breastfeeding
Cilostazol LEK-AM MUST NOT be used during pregnancy.
Cilostazol LEK-AM IS NOT RECOMMENDED during breastfeeding.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Driving and using machines
Cilostazol LEK-AM may cause dizziness. If dizziness occurs after taking the medicine, DO NOT drive or operate tools or machinery.
Inform your doctor or pharmacist about this.

3. How to take Cilostazol LEK-AM

This medicine should always be taken as directed by the doctor. If in doubt, consult
your doctor or pharmacist.
Recommended dose
The recommended dose is 100 mg twice daily (in the morning and evening).
The medicine should be taken 30 minutes before breakfast and 30 minutes before the evening meal.
Tablets should always be swallowed with water.
There is no need to adjust the dosage in elderly patients. However, the doctor
may prescribe a lower dose if the patient is taking other medicines simultaneously that may
affect the action of Cilostazol LEK-AM.
Some benefits of treatment with Cilostazol LEK-AM may become noticeable after 4–12 weeks
of treatment. After 3 months, the doctor will assess treatment progress and may recommend discontinuation
of cilostazol therapy if treatment efficacy is insufficient.
Use in children and adolescents
Cilostazol LEK-AM is not indicated for use in children and adolescents.
Taking more than the recommended dose of Cilostazol LEK-AM
If for any reason the patient has taken more tablets of Cilostazol LEK-AM than prescribed,
the following symptoms may occur: severe headache, diarrhoea, decreased blood pressure,
and arrhythmia.
If the patient has taken more tablets than prescribed, seek medical advice immediately
from a doctor or go to the nearest hospital. Remember to bring the packaging
so that it is clear which medicine has been taken.
Missed dose of Cilostazol LEK-AM
If a dose of Cilostazol LEK-AM is missed, do not be concerned. Wait and take the next dose at the
scheduled time, then continue taking the medicine as directed. DO NOT take a double dose to
make up for a missed dose.
Stopping treatment with Cilostazol LEK-AM
If the patient stops taking Cilostazol LEK-AM, pain in the lower limbs may return or worsen.
Therefore, Cilostazol LEK-AM should only be discontinued if the patient experiences
adverse reactions requiring immediate medical attention (see section 4) or if otherwise advised by the doctor.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur, the patient may require immediate medical attention. The medicine Cilostazol LEK-AM must be discontinued immediately, and the patient should contact a doctor or go to the nearest hospital if the following occur:

• stroke,
• heart attack,
• heart problems that may cause shortness of breath or swelling in the ankle area,
• irregular heartbeat (new or worsening symptom),
• bleeding,
• tendency to develop bruises,
• severe illness with blistering rash on the skin, in the mouth, eyes, or genital organs,
• yellowing of the skin and whites of the eyes due to liver or blood disorders (jaundice).

One should also contact a doctor immediately if fever or sore throat occurs.
Blood tests may be necessary, and the doctor will decide on further treatment.
The following adverse reactions have been reported during treatment with cilostazol.
One should inform the doctor as soon as possible if any of these occur:

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

• headache,
• abnormal bowel movements,
• diarrhea.

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

• rapid heartbeat,
• palpitations,
• chest pain,
• dizziness,
• sore throat,
• cold symptoms (nasal congestion),
• abdominal pain,
• abdominal discomfort (indigestion),
• nausea or vomiting,
• loss of appetite (anorexia),
• excessive belching or flatulence,
• swelling of ankles, feet, or face,
• skin rash or skin changes,
• itching,
• skin bruising or petechiae,
• general weakness.

Uncommon (occur in less than 1 in 100 but more than 1 in 1000 people)

• heart attack,
• irregular heart rhythm (new or worsening symptom),
• heart disorders causing shortness of breath or ankle swelling,
• dyspnea,
• pneumonia,
• cough,
• chills,
• unexpected bleeding,
• tendency to bleed (e.g. in stomach, eye, nosebleeds),
• decreased number of red blood cells,
• dizziness upon standing,
• fainting,
• anxiety,
• sleep disturbances,
• nightmares,
• allergic reaction,
• diabetes and elevated blood glucose levels,
• stomach pain (gastritis),
• muscle pain,
• malaise.

Rare (occur in less than 1 in 1000 but more than 1 in 10,000 people)

• prolonged bleeding tendency,
• increased number of platelets in blood,
• kidney function disorders.

Adverse reactions observed during cilostazol treatment with unknown frequency:

• stroke,
• changes in blood pressure,
• decreased number of red blood cells, white blood cells, and platelets,
• presence of blood in sputum or urine,
• bleeding into muscles, subcutaneous bleeding,
• breathing difficulties (interstitial pneumonia),
• movement difficulties (paresis),
• fever,
• pain,
• hot flushes,
• rash and other skin eruptions, including severe skin reactions,
• urticaria,
• reduced skin sensitivity to stimuli,
• watery or sticky eye discharge (conjunctivitis),
• tinnitus (ringing in the ears),
• liver function disorders, including hepatitis and jaundice,
• frequent urination,
• changes in certain laboratory tests (increased serum uric acid, increased blood urea, increased serum creatinine).

In diabetic patients, there may be an increased risk of bleeding into the eye.
In patients over 70 years of age, diarrhea and palpitations have been observed more frequently.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,
e-mail: [email protected].
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Cilostazol LEK-AM

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and blister after the expiry symbol. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Cilostazol LEK-AM contains

• The active substance 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.
• Other ingredients are: microcrystalline cellulose 101 and 102; pregelatinized corn 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.
Cilostazol LEK-AM 100 mg is a white or almost white, flat, round tablet.

Cilostazol 50 mg is packed in blisters made of PAP/Aluminium/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 100 mg is packed in blisters made of PAP/Aluminium/PVC or Aluminium/PVC foil, containing 10 or 14 tablets, placed in a cardboard box.
The pack contains 28, 56, 60, 84, 90 or 120 tablets.

Marketing Authorisation Holder and Manufacturer
Przedsiębiorstwo Farmaceutyczne LEK-AM Sp. z o.o.
ul. Ostrzykowizna 14A
05-170 Zakroczym, Poland
tel: +48 22 785 20 69
fax: +48 22 785 20 69 ext. 106