Cilozek

Package Leaflet: Information for the Patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Cilozek, 100 mg, Tablets

Cilostazol
▼This medicinal product is subject to additional monitoring. This will allow for the quick
identification of new safety information. The user of the medicinal product can also help by
reporting any adverse reactions that occur after taking the medicinal product. To find out how to
report adverse reactions, see section 4.

You should carefully read the contents of the leaflet before taking the medicinal product, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicinal product has been prescribed specifically for you. Do not pass it on to others. The medicinal product may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should tell 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 adverse reactions
• 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 medicinal products called phosphodiesterase type 3 inhibitors. The action of the medicinal product
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 the occurrence of painful leg cramps 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 medicinal product (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 in the past 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 medicinal products 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 disease or heart rhythm disorders,
• they have blood pressure disorders.

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 bruising or bleeding, they should stop taking the medicinal product and inform their doctor.

Cilozek and other medicinal products

The patient should tell their doctor or pharmacist about all the medicinal products they are taking, or have recently taken, as well as any medicinal products they plan to take.
In particular, the patient should inform their doctor about taking medicinal products used to treat pain and inflammatory conditions of the muscles and joints, as well as medicinal products that reduce blood clotting.
These medicinal products 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-mentioned medicinal products at the same time as Cilozek, the doctor may recommend regular blood tests.
Some medicinal products may affect the action of Cilozek if taken at the same time.
They may either increase the risk of adverse reactions to Cilozek or reduce the effectiveness of its action. Similarly, Cilozek may affect the action of other medicinal products.
Before starting to take Cilozek, the patient should inform their doctor if they are taking:

• erythromycin, clarithromycin, or rifampicin (antibiotics),
• ketoconazole (an antifungal medicinal product),
• omeprazole (a medicinal product used to treat excessive stomach acid),
• diltiazem (a medicinal product used to treat high blood pressure and chest pain),
• cisapride (a medicinal product used to treat stomach disorders),
• lovastatin, simvastatin, or atorvastatin (medicinal products used to treat high cholesterol),
• halofantrine (a medicinal product used to treat malaria),
• pimozide (a medicinal product used to treat psychiatric disorders),
• ergot alkaloids (medicinal products used to treat migraines, e.g., ergotamine, dihydroergotamine),
• carbamazepine or phenytoin (antiepileptic medicinal products),
• St. John's Wort (a herbal medicinal product).

In case of 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 medicinal products 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. Medicinal products 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).

In many cases, it is possible to take the above-mentioned medicinal products and Cilozek at the same time.
The doctor will decide which medicinal products the patient can take.

Cilozek with food and drink

The medicinal product should be taken 30 minutes before breakfast and 30 minutes before the evening meal.
The tablets should always be taken 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 or breastfeeding, thinks they may be pregnant, or plans to become pregnant, they should consult their doctor or pharmacist before taking this medicinal product.

Driving and using machines

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

3. How to take Cilozek

This medicinal product should always be taken according to the doctor's instructions. In case of doubts, the patient should consult their doctor or pharmacist.
The recommended dose of the medicinal product 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 dosage in elderly patients.
However, the doctor may reduce the dose of the medicinal product if the patient is taking other medicinal products that affect the action of Cilozek. The medicinal product should be taken 30 minutes before breakfast and 30 minutes before the evening meal. The tablets should always be taken with water.
Sometimes, the benefits of taking Cilozek are 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 of Cilozek 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 the prescribed dose, they should immediately consult their doctor or go to the nearest hospital. They should remember to take the packaging with them, so that it is known which medicinal product was taken.

Missing a dose of Cilozek

If the patient misses a dose of Cilozek, they should not worry. They should wait until the time when the next dose is due and take the recommended dose, according to the prescribed dosage regimen. They 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.
For this reason, Cilozek may only be stopped if the patient experiences adverse reactions that require immediate medical attention (see section 4) or if the doctor recommends it.

• In case of any further doubts about taking this medicinal product, the patient should consult their doctor or pharmacist.

In case of any doubts about taking this medicinal product, the patient should consult their doctor or pharmacist.

4. Possible adverse reactions

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

If the patient experiences any of the following adverse reactions, they may need immediate medical attention. They should stop taking the medicinal product, 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 bruising,
• severe disease characterized by the occurrence of 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.
It may be necessary to perform blood tests, and the doctor will decide on further treatment.

The following adverse reactions have been reported during treatment with Cilozek.

The patient should contact their doctor immediately:

Very common adverse reactions(may occur more frequently than in 1 in 10 patients)

• headache,
• abnormal stools,
• diarrhea.

Common adverse reactions(may occur less frequently than in 1 in 10 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 gas (flatulence),
• swelling of the ankles, feet, and face,
• rash or changes in skin appearance,
• itching,
• petechiae (small red or purple spots on the skin),
• general weakness.

Uncommon adverse reactions(may occur less frequently than in 1 in 100 patients)

• 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 bleeding (e.g., gastrointestinal, eye, or muscle bleeding, nosebleeds, presence of blood in sputum or urine),
• decrease in red blood cell count,
• dizziness when changing body position 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 adverse reactions(may occur less frequently than in 1 in 1000 patients)

• tendency to bleeding that lasts longer than usual,
• increase in red blood cell count,
• kidney disorders.

Adverse reactions observed during treatment with Cilozek, with unknown frequency:

• changes in blood pressure,
• decrease in red and white blood cell count and platelet count,
• difficulty breathing,
• difficulty moving,
• fever,
• hot flashes,
• 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 adverse reactions

If the patient experiences any adverse reactions, including any adverse reactions not listed in the leaflet, they should tell their doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309;
website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions can help gather more information on the safety of the medicinal product.

5. How to store Cilozek

The medicinal product should be stored out of sight and reach of children.
The medicinal product should not be used after the expiry date stated on the packaging.
The expiry date refers to the last day of the month stated.
There are no special precautions for storage.
Medicinal products should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicinal products they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Cilozek contains

• The active substance of the medicinal product is cilostazol. Each tablet contains 100 mg of cilostazol.
• The other ingredients are: corn starch, microcrystalline cellulose, calcium carmellose, hypromellose, and magnesium stearate.

What Cilozek looks like and what the packaging contains

Cilozek, 100 mg tablets, are white or almost white, round, flat tablets with the inscription "100" on one side.
The medicinal product is available in packs of 28, 56 tablets, packaged in PVC/PVDC/Al blisters.
For more detailed information, the patient should consult the marketing authorization holder or parallel importer.

Marketing authorization holder in the Czech Republic, the country of export:

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

Manufacturer:

Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice
Poland

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in the Czech Republic, the country of export:83/176/14-C
Parallel import authorization number:100/18

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

Approval date of the leaflet: 13.02.2023

[Information about the trademark]