Cilozek

Package Leaflet: Information for the Patient

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Cilozek, 100 mg, Tablets

Cilostazol

The patient should carefully read the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be read again if necessary.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for one person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. 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 side effects
• 5. How to store Cilozek
• 6. Contents of the pack 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 for an increase in the distance that the patient can walk without pain, thanks to improved blood circulation in the legs. Cilostazol is only recommended 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 that the patient continues to make lifestyle changes while taking Cilozek.

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 or has had 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, the patient should 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 disease 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 medicines they are taking, have recently taken, or plan to take. In particular, the patient should inform their doctor about taking medicines for pain and inflammation 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 these medicines at the same time as Cilozek, their 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 side effects of Cilozek or reduce its effectiveness. Similarly, Cilozek may affect the action of other medicines. 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 mental illnesses),
• 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 these 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 blood pressure-lowering medicines, as Cilozek may have an additional blood pressure-lowering effect. If blood pressure drops too low, it may cause rapid heartbeat. 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).

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 always be swallowed with water.

Pregnancy, breastfeeding, and fertility

Cilozek MUST NOTbe used during pregnancy. IT IS NOT RECOMMENDEDto use Cilozek during breastfeeding. If the patient is pregnant, breastfeeding, or thinks they may be pregnant, or are planning to have a baby, they should ask their doctor or pharmacist for advice before taking this medicine.

Driving and using machines

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

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 one 100 mg tablet, twice a day (taken as one tablet in the morning and one in the evening). There is no need to modify the dose in elderly patients. However, the doctor may reduce the dose of the medicine if the patient is taking other medicines that affect the action of Cilozek. The medicine should be taken 30 minutes before breakfast and 30 minutes before the evening meal. The tablets should always be swallowed 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 effects 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 prescribed, 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 take 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 dosing schedule. THE PATIENT MUST NOTtake 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 side 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 side effects

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

If the patient experiences any of the following side effects, they 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 ankles,
• irregular heartbeat (occurring for the first time or worsening of existing),
• bleeding,
• tendency to bruise,
• severe disease characterized by blisters on the skin, mouth, eyes, and genitals,
• yellowing of the skin and whites of the eyes due to liver and blood disorders (jaundice).

The patient should also contact their doctor immediately if they experience fever or sore throat. Blood tests may be necessary, and the doctor will decide on further treatment.

The following side effects have been reported during treatment with Cilozek.

The patient should contact their doctor immediately:

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

• headache,
• abnormal stools,
• diarrhea.

Common side 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 (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,
• petechiae (small red or purple spots on the skin),
• general weakness.

Uncommon side 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 ankles,
• pneumonia,
• cough,
• chills,
• unexpected bleeding,
• tendency to bleed (e.g., gastrointestinal, eye, muscle, or nosebleeds),
• decrease in 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 side effects(may occur in less than 1 in 1000 people)

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

Side effects of Cilozek with unknown frequency:

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

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the National Institute of Pharmacy and Nutrition (OGYÉI)
Address: Alkotmány u. 3-5, 1054 Budapest, Hungary
Phone: +36 1 888 4334
Fax: +36 1 888 4367
E-mail: [ogyei@ogyei.gov.hu](mailto:ogyei@ogyei.gov.hu)
Website: www.ogyei.gov.hu
By reporting side effects, more information can be gathered 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. 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 pack and other information

What Cilozek contains

• The active substance of Cilozek is cilostazol. Each tablet contains 100 mg of cilostazol.
• The other ingredients are: cornstarch, microcrystalline cellulose, calcium carmellose, hypromellose, and magnesium stearate.

What Cilozek looks like and contents of the pack

Cilozek 100 mg tablets are white or almost white, round, flat tablets with the inscription "100" on one side. The medicine is available in packs of 60 tablets, packaged in PVC/PVDC/Aluminum blisters. For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Hungary, the country of export:

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

Manufacturer:

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

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Hungarian license number: OGYI-T-22653/08

Parallel import license number: 174/20

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

Date of approval of the leaflet: 18.06.2025

[Information about the trademark]