Cilozek

Package leaflet: Information for the patient

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Cilozek, 100 mg, tablets
Cilostazolum
▼This medicinal product will be subject to additional monitoring. This will allow rapid
identification of new safety information. You, as a user of the medicine, can also help by
reporting any side effects that occur after using the medicine. For information on how to
report side effects – see section 4.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse symptoms, including any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Cilozek is and what it is 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 Cilozek is and what it is used for

Cilozek belongs to a group of medicines called phosphodiesterase type 3 inhibitors. The action of this medicine includes widening certain blood vessels and reducing the process of blood clotting (aggregation) of certain blood cells called platelets within blood vessels. Cilozek has been prescribed for the treatment of a condition 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 helps increase the distance a patient can walk without pain by improving blood circulation in the legs. Cilostazol 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 reduced the symptoms. It is important that the patient continues to maintain the lifestyle changes introduced 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 within the last 6 months;
• if the patient has or has previously experienced episodes of loss of consciousness caused by heart disease, or other severe heart rhythm disorders;
• if conditions that may increase the risk of bleeding or bruising have been diagnosed in the patient, such as:
  • active gastric ulcer,
  • stroke suffered within the last 6 months,
  • eye problems in diabetic patients,
  • blood pressure disorders not adequately controlled;
• 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 severe or moderate liver disease;
• if the patient is pregnant.

Warnings and precautions
Before starting treatment with Cilozek, discuss this with your doctor or pharmacist.
Inform your doctor if:

• the patient has severe heart disorders or heart rhythm disorders,
• the patient has blood pressure disorders.

While taking Cilozek:

• if the patient needs to undergo surgery, including dental procedures, the patient should inform the doctor or dentist about taking Cilozek,
• if the patient notices an increased tendency to bruise or bleed, the medicine should be discontinued and the doctor informed.

Cilozek 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 medicines used to treat pain and inflammatory conditions of muscles and joints, and about using medicines that reduce blood clotting.
These include:

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

If the patient needs to take any of the above-mentioned medicines concurrently with Cilozek, the doctor may recommend routine blood tests.
Some medicines may affect the action of Cilozek when used simultaneously.
They may either increase the risk of adverse effects of Cilozek or reduce its effectiveness.
Likewise, Cilozek may affect the action of other medicines.
Before starting treatment with Cilozek, inform the doctor if the patient is taking:

• erythromycin, clarithromycin, or rifampicin (antibiotics),
• ketoconazole (antifungal medicine),
• omeprazole (medicine used for excessive gastric acid secretion),
• diltiazem (medicine used to treat hypertension and chest pain),
• cisapride (medicine used to treat stomach disorders),
• lovastatin, simvastatin, or atorvastatin (medicines used to treat high cholesterol levels),
• 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 remedy).

If in doubt whether any of the above situations apply to the patient, consult a doctor or pharmacist.
Before starting treatment with Cilozek, inform the doctor if the patient is taking medicines that lower blood pressure, because 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-blockers (e.g. labetalol, carvedilol).

In many cases, it is possible to take the above-mentioned medicines together with Cilozek.
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.
Tablets should always be taken with water.

Pregnancy, breastfeeding and fertility
Cilozek MUST NOT be used during pregnancy.
IT IS NOT RECOMMENDED to use Cilozek during breastfeeding.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning a pregnancy, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
Cilozek 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 Cilozek

This medicine should always be taken as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
The recommended dose is one 100 mg tablet taken twice daily (one tablet in the morning and one in
the evening). There is no need to adjust the dosage in elderly patients.
However, your doctor may reduce the dose if you are 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. Tablets should always be taken with water.
Sometimes the benefits of treatment with Cilozek become noticeable within 4–12 weeks of
treatment. After 3 months, your doctor will assess treatment progress and may recommend
discontinuation of cilostazol if treatment effects are insufficient.
Use in children and adolescents
Cilozek is not indicated for use in children.
Taking more Cilozek than recommended
If for any reason a patient takes more tablets of Cilozek than prescribed, the following symptoms may
occur: severe headache, diarrhea, decreased blood pressure, and heart rhythm disturbances.
If a patient takes more tablets than the prescribed dose, seek medical advice immediately or go to
the nearest hospital. Remember to bring the packaging along so that it is clear which medicine has
been taken.
Missed dose of Cilozek
If a dose of Cilozek is missed, do not be alarmed. Wait until the next scheduled dose and take the
recommended dose according to the prescribed dosing schedule. DO NOT take a double dose to
make up for the missed dose.
Stopping Cilozek
If a patient stops taking Cilozek, leg pain may return or worsen. For this reason, Cilozek should be
discontinued only 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 questions about 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.
The frequency of adverse reactions 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 1,000 patients
Very rare: occurs in less than 1 in 10,000 patients
Frequency not known: frequency cannot be estimated from the available data.

If any of the adverse reactions listed below occur, the patient may require immediate medical attention. The medicine should be discontinued immediately, and the patient should contact a doctor or go to the nearest hospital:

• stroke,
• heart attack,
• heart disorders causing shortness of breath or swelling in the ankle area,
• irregular heartbeat (occurring for the first time or worsening of existing condition),
• bleeding,
• tendency to develop bruises,
• severe illness with blistering rash on the skin, mouth, eyes, and genital organs,
• yellowing of the skin and whites of the eyes due to liver or blood disorders (jaundice).

Immediate medical advice should also be sought if fever or sore throat occurs.
Blood tests may be required, and further treatment will be decided by the doctor.
The following adverse reactions have been reported during treatment with Cilozek.
Contact a doctor immediately:

Very common adverse reactions (may affect more than 1 in 10 people)

• headache,
• abnormal bowel movements,
• diarrhoea.

Common adverse reactions (may affect less than 1 in 10 people)

• rapid heartbeat,
• palpitations,
• chest pain,
• dizziness,
• sore throat,
• cold (nasal congestion),
• abdominal pain,
• discomfort in the abdomen (dyspepsia),
• nausea or vomiting,
• loss of appetite (anorexia),
• excessive belching or gas (bloating with flatulence),
• swelling of the ankles, feet, and face,
• rash or skin changes,
• itching,
• petechial skin rash,
• general weakness.

Uncommon adverse reactions (may affect less than 1 in 100 people)

• heart attack,
• irregular heartbeat (occurring for the first time or worsening of existing condition),
• heart disorders causing shortness of breath or swelling in the ankle area,
• pneumonia,
• cough,
• chills,
• unexpected bleeding,
• tendency to bleed (e.g. gastrointestinal, ocular or muscular bleeding, nosebleeds, blood in sputum or urine),
• decreased number of red blood cells,
• dizziness upon changing body position to standing,
• fainting,
• anxiety,
• difficulty sleeping,
• nightmares,
• allergic reactions,
• pain or aches,
• diabetes and increased blood glucose levels,
• abdominal pain (gastritis),
• malaise.

Patients with diabetes may have an increased risk of bleeding inside the eyeball.

Rare adverse reactions (may affect less than 1 in 1,000 people)

• tendency for bleeding to last longer than usual,
• increased number of red blood cells,
• kidney function disorders.

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

• changes in blood pressure,
• decreased number of red and white blood cells and platelets,
• difficulty breathing,
• difficulty moving,
• fever,
• hot flushes,
• rash and skin eruptions,
• reduced skin sensitivity to stimuli,
• stuffy nose, conjunctivitis,
• tinnitus (ringing in the ears),
• liver disorders, including hepatitis,
• changes in urine.

Reporting of adverse reactions
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. 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: +48 22 49 21 301, Fax: +48 22 49 21 309; website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Cilozek

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
No special storage conditions apply.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Cilozek contains

• The active substance is cilostazol. Each tablet contains 100 mg of cilostazol.
• The other ingredients are: maize starch, 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 imprint "100" on one side.
Cilozek is available in packs of 28 and 56 tablets, packed in PVC/PVDC/Al blisters.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation 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 in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in the Czech Republic, the country of export: 83/176/14-C
Parallel Import Authorisation Number: 100/18
This medicinal product is authorised for sale in the European Economic Area countries under the following names: