Cilozek

Leaflet included in the packaging: patient information

CILOZEK, 50 mg, tablets

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor 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 undesirable effects, including any undesirable effects not mentioned in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Cilozek and what is it used for
• 2. Important information before taking Cilozek
• 3. How to take Cilozek
• 4. Possible undesirable effects
• 5. How to store Cilozek
• 6. Contents of the packaging and other information

1. What is Cilozek and what is it used for

Cilozek belongs to a group of medicines called phosphodiesterase type 3 inhibitors. The action of the medicine includes the dilation of certain blood vessels and the reduction of the blood clotting process (aggregation) of certain blood cells called platelets.
Cilozek has been prescribed for the treatment of a disease called "intermittent claudication". Intermittent claudication is characterized by painful cramps in the legs during walking and is caused by insufficient blood supply to the legs. Cilozek allows patients to increase the distance they can walk without pain, thanks to improved blood circulation in the legs. Cilostazol is recommended only for patients who have not responded sufficiently to changes in their lifestyle (such as quitting smoking and increasing physical activity) and other treatment methods.
It is essential to continue making lifestyle changes while taking Cilostazol.

2. Important information before taking Cilozek

When not to take Cilozek

• if the patient is allergic (hypersensitive) 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 had episodes of loss of consciousness due to heart disease, or other 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 blood pressure.
• if the patient is taking aspirin and clopidogrel, or other combinations 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 severe or moderate liver disease.
• if the patient is pregnant.

Warnings and precautions

Before starting to take Cilozek, the patient should discuss it with their doctor or pharmacist.
The patient should inform their doctor if:

• they have severe heart problems or heart rhythm disorders.
• they have blood pressure problems.

While taking Cilozek:

• if the patient is going to have surgery, including dental procedures, they should inform their doctor or dentist about taking Cilozek.
• if the patient notices an increased tendency to bruise or bleed, they should stop taking the medicine and inform their doctor.

Cilozek and other medicines

The patient should tell their doctor or pharmacist about all the 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 medicines used to treat pain and inflammatory conditions of muscles and joints, and about taking medicines that reduce blood clotting.
These medicines include:

• aspirin,
• clopidogrel,
• anticoagulants (e.g., warfarin, dabigatran, rivaroxaban, apixaban, and low molecular weight heparins).

If the patient needs to take any of the above medicines at the same time as Cilozek, the doctor may recommend regular blood tests.
Some medicines may affect the action of Cilozek if taken at the same time. They may either increase the risk of undesirable effects of Cilozek or reduce its effectiveness.
Before starting to take Cilozek, the patient should inform their doctor if they are taking:

• erythromycin, clarithromycin, or rifampicin (antibiotics),
• ketoconazole (an antifungal medicine),
• 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 stomach disorders),
• lovastatin, simvastatin, or atorvastatin (medicines used to treat high cholesterol),
• halofantrine (a medicine used to treat malaria),
• pimozide (a medicine used to treat psychiatric disorders),
• ergot alkaloids (medicines used to treat migraines, e.g., ergotamine, dihydroergotamine),
• carbamazepine or phenytoin (antiepileptic medicines),
• St. John's Wort (a herbal medicine).

In case of any doubts about whether any of the above situations apply to the patient, they should consult their doctor or pharmacist.
Before starting to take Cilozek, the patient should inform their doctor if they are taking medicines that lower blood pressure, as Cilozek may have an additional blood pressure-lowering effect. If blood pressure drops too low, it may cause rapid heartbeat. 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-adrenergic blockers (e.g., labetalol, carvedilol).

In many cases, it is possible to take these medicines and Cilozek at the same time. The doctor will decide which medicines the patient can take.

Cilozek with food and drink

The medicine should be taken 30 minutes before breakfast and 30 minutes before the evening meal.
The tablets should not always be taken with water.

Pregnancy, breastfeeding, and fertility

Cilozek should NOT be taken during pregnancy.
It is NOT recommended to take Cilozek during breastfeeding.
If the patient is pregnant, breastfeeding, or thinks they may be pregnant, or plans to become pregnant, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

Cilozek may cause dizziness. If the patient experiences dizziness after taking the medicine, they should NOTdrive vehicles or operate machinery. They should inform their doctor or pharmacist.

3. How to take Cilozek

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.
The recommended dose of Cilozek is two 50 mg tablets twice a day (taken as two tablets in the morning and two tablets in the evening). There is no need to modify the dosage in elderly patients.
However, the doctor may reduce the dose of Cilozek if the patient is taking other medicines that may affect the action of Cilozek. The medicine should be taken 30 minutes before breakfast and 30 minutes before the evening meal. The tablets should not always be taken with water.
Sometimes, the benefits of taking Cilozek may be noticeable within 4-12 weeks of treatment. After 3 months, the doctor will assess the progress of the treatment and may recommend stopping cilostazol if the treatment results are insufficient.

Use in children and adolescents

Cilozek is not indicated for use in children.

Taking a higher dose of Cilozek than recommended

If the patient has taken more tablets than they should, they may experience the following symptoms: severe headache, diarrhea, decreased blood pressure, and heart rhythm disorders.
If the patient has taken more tablets than prescribed, they should immediately consult their doctor or go to the nearest hospital. They should bring the packaging with them so that it is known which medicine was taken.

Missing a dose of Cilozek

If the patient misses a dose of Cilozek, they should not worry. They should wait until the next dose is due and take the recommended dose according to the prescribed dosage regimen. They should NOT take a double dose to make up for the missed dose.

Stopping treatment with Cilozek

If the patient stops taking Cilozek, the pain in their legs may return or worsen.
Therefore, Cilozek should only be stopped if the patient experiences undesirable effects that require immediate medical attention (see section 4) or if the doctor recommends it.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible undesirable effects

Like all medicines, Cilozek can cause undesirable effects, although not everybody gets them.
The frequency of undesirable effects is defined as follows:
Very common: occurs in more than 1 in 10 patients
Common: occurs in less than 1 in 10 patients but more than 1 in 100 patients
Uncommon: occurs in less than 1 in 100 patients but more than 1 in 1000 patients
Rare: occurs in less than 1 in 1000 patients but more than 1 in 10,000 patients
Very rare: occurs in less than 1 in 10,000 patients
Frequency not known: cannot be estimated from the available data.

In case of the following undesirable effects, the patient may need immediate medical attention. They should stop taking the medicine, contact their doctor, or go to the nearest hospital:

• stroke,
• heart attack,
• heart disorders causing shortness of breath or swelling in the legs,
• irregular heartbeat (occurring for the first time or worsening of existing),
• bleeding,
• tendency to bruise,
• skin disease with blistering of the skin, mouth, eyes, and genitals,
• jaundice caused by liver and blood disorders.

The patient should also contact their doctor immediately if they experience fever or sore throat.
It may be necessary to perform blood tests, and the doctor will decide on further treatment.
There have been reports of the following undesirable effects during treatment with Cilozek.

The patient should contact their doctor immediately:

Very common undesirable effects(may occur in more than 1 in 10 people)

• headache,
• abnormal stools,
• diarrhea.

Common undesirable effects(may occur in less than 1 in 10 people)

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

Uncommon undesirable effects(may occur in less than 1 in 100 people)

• heart attack,
• irregular heartbeat (occurring for the first time or worsening of existing),
• heart disorders causing shortness of breath or swelling in the legs,
• pneumonia,
• cough,
• chills,
• unexpected bleeding,
• tendency to bleed (e.g., gastrointestinal, eye, muscle, or nose bleeding, presence of blood in sputum or urine),
• decreased red blood cell count,
• dizziness when changing position from lying down to standing,
• fainting,
• anxiety,
• difficulty sleeping,
• nightmares,
• allergic reactions,
• pain or discomfort,
• diabetes and increased blood sugar levels,
• abdominal pain (gastritis),
• malaise.

In patients with diabetes, there may be an increased risk of bleeding into the eyeball.
Rare undesirable effects(may occur in less than 1 in 1000 people)

• tendency to bleed for a longer time than usual,
• increased red blood cell count,
• kidney function disorders.

Undesirable effects of unknown frequency:

• changes in blood pressure,
• decreased red, white blood cell, and platelet count,
• breathing difficulties,
• movement difficulties,
• fever,
• heat stroke,
• rash and skin eruptions,
• decreased skin sensitivity to stimuli,
• stuffy nose, conjunctivitis,
• tinnitus (ringing in the ears),
• liver disorders, including hepatitis,
• changes in urine.

Reporting undesirable effects

If the patient experiences any undesirable effects, including any undesirable effects not mentioned in the leaflet, they should inform their doctor or pharmacist. Undesirable 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
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Undesirable effects can also be reported to the marketing authorization holder or its representative.
Reporting undesirable effects helps to gather more information on the safety of the medicine.

5. How to store Cilozek

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 "EXP".
The expiry date refers to the last day of the month stated.
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 Cilozek contains

• The active substance of Cilozek is cilostazol. Each tablet contains 50 mg of cilostazol.
• The other ingredients are: cornstarch, microcrystalline cellulose, calcium carmellose, hypromellose, magnesium stearate.

What Cilozek looks like and contents of the pack

Cilozek, 50 mg tablets are white or almost white, round, flat tablets with the inscription "50" on one side.
Cilozek is available in packs of 30, 60, 98 tablets, packaged in PVC/PVDC/Aluminum blisters.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Manufacturer

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet:02.2023