STEPCIL 100 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Stepcil, 100 mg, Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
3. What is Stepcil and what is it used for
4. Important information before taking Stepcil
   1. When not to take Stepcil:
   2. Warnings and precautions
   3. Children and adolescents
   4. Stepcil and other medicines
   5. Stepcil with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
5. How to take Stepcil
   1. Taking more Stepcil than prescribed
   2. If you take more tablets than prescribed, seek medical attention immediately or go to the nearest hospital emergency department. Remember to take the packaging with you so that it is known which medicine was taken.
   3. Missing a dose of Stepcil
   4. Stopping treatment with Stepcil
6. Possible side effects
   1. If you experience any of the following side effects, you may need urgent medical attention. Stop taking the medicine, contact your doctor, or go to the nearest hospital emergency department:
   2. The following side effects have been reported during treatment with Stepcil.
   3. Contact your doctor immediately:
   4. Side effects of Stepcil with unknown frequency:
   5. Reporting side effects
7. How to store Stepcil
8. Contents of the pack and other information
   1. What Stepcil looks like and contents of the pack
   2. Marketing authorization holder
   3. Manufacturer

Package Leaflet: Information for the Patient

Stepcil, 100 mg, Tablets

Cilostazol

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Stepcil and what is it used for

Stepcil belongs to a group of medicines called phosphodiesterase type 3 inhibitors.
It has various effects, including the dilation of certain blood vessels and the reduction of the activity of blood clotting (aggregation) of certain blood cells, called platelets, within blood vessels.
Stepcil has been prescribed to treat "intermittent claudication". Intermittent claudication is a cramp-like pain in the legs that occurs during walking and is caused by insufficient blood flow to the legs. Stepcil increases the distance that a patient can walk without pain by improving blood circulation in the legs. Stepcil is only recommended for patients in whom lifestyle modifications (including smoking cessation and increased exercise intensity) and other appropriate interventions have not sufficiently alleviated symptoms. It is important that during treatment with cilostazol, the patient continues to apply the introduced lifestyle modifications.

2. Important information before taking Stepcil

When not to take Stepcil:

• if you are allergic to cilostazol or any of the other ingredients of this medicine (listed in section 6);
• if you have heart failure;
• if you have persistent chest pain at rest, or have had a heart attack or heart surgery in the last 6 months;
• if you have had or have had in the past loss of consciousness due to heart disease, or other severe heart rhythm disorders;
• if you have conditions that may increase the risk of bleeding or bruising, such as:
• active stomach ulcer,
• stroke in the last 6 months,
• eye problems in diabetic patients,
• uncontrolled blood pressure;
• if you have severe kidney disease;
• if you have severe or moderate liver disease;
• if you are taking aspirin and clopidogrel, or other combinations of two or more medicines that may increase the risk of bleeding (if in doubt, consult your doctor or pharmacist);
• if you are pregnant.

Warnings and precautions

Before starting treatment with Stepcil, discuss it with your doctor or pharmacist.
Tell your doctor if:

• you have severe heart disease or heart rhythm disorders;
• you have blood pressure problems.

While taking Stepcil:

• if you need to have surgery, including dental procedures, tell your doctor or dentist that you are taking Stepcil;
• if you notice an increased tendency to bruise or bleed, stop taking the medicine and tell your doctor.

Children and adolescents

Stepcil is not indicated for use in children and adolescents.

Stepcil and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take.
In particular, tell your doctor if you are taking medicines for pain and inflammation of muscles and joints, and if you are taking medicines that reduce blood clotting.
These medicines include:

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

If you need to take any of the above medicines at the same time as Stepcil, your doctor may recommend regular blood tests.
Some medicines may affect the action of Stepcil if taken at the same time.
They may either increase the risk of side effects of Stepcil or reduce its effectiveness. Similarly, Stepcil may affect the action of other medicines.
Before starting treatment with Stepcil, tell your doctor if you are taking:

• erythromycin, clarithromycin, or rifampicin (antibiotics);
• ketoconazole (an antifungal medicine);
• protease inhibitors (antiviral medicines);
• omeprazole (a medicine used to reduce 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);

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).

If you are unsure whether any of the above situations apply to you, consult your doctor or pharmacist.
Before starting treatment with Stepcil, tell your doctor if you are taking blood pressure-lowering medicines, as Stepcil may have an additional blood pressure-lowering effect. If excessive blood pressure lowering occurs, 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 Stepcil at the same time.
Your doctor will decide which medicines you can take.

Stepcil with food and drink

The medicine should be taken 30 minutes before breakfast and 30 minutes before the evening meal.
Tablets should always be swallowed with water.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
DO NOT TAKEStepcil during pregnancy.
DO NOT RECOMMENDtaking Stepcil during breastfeeding.

Driving and using machines

Stepcil may cause dizziness. If you experience dizziness after taking the medicine, DO NOTdrive or operate tools or machines. Tell your doctor or pharmacist.

3. How to take Stepcil

Always take this medicine exactly as your doctor has told you.
If you are unsure, ask your doctor or pharmacist.
The recommended dose is 2 tablets a day (100 mg) (1 tablet in the morning and 1 tablet in the evening).
No dose adjustment is necessary in elderly patients.
However, your doctor may reduce the dose of the medicine if you are taking other medicines that affect the action of Stepcil.
The tablet can be divided into equal doses.
Take the medicine 30 minutes before breakfast and 30 minutes before the evening meal.
Tablets should always be swallowed with water.
Sometimes the benefits of taking Stepcil are noticeable within 4-12 weeks of treatment. After 3 months, your doctor will assess the progress of the treatment and may recommend stopping cilostazol if the therapy is not effective enough.

Taking more Stepcil than prescribed

If for any reason you take more Stepcil tablets than you should, you may experience the following symptoms: severe headache, diarrhea, decreased blood pressure, and heart rhythm disturbances.

If you take more tablets than prescribed, seek medical attention immediately or go to the nearest hospital emergency department. Remember to take the packaging with you so that it is known which medicine was taken.

Missing a dose of Stepcil

If you miss a dose of Stepcil, do not worry. Wait until it is time for your next dose and take the recommended dose as scheduled. DO NOT TAKEa double dose to make up for a missed dose.

Stopping treatment with Stepcil

If you stop taking Stepcil, the pain in your legs may return or worsen.
Therefore, Stepcil should only be stopped if you experience side effects that require immediate medical attention (see section 4) or if your doctor recommends it.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Stepcil can cause side effects, although not everybody gets them.

If you experience any of the following side effects, you may need urgent medical attention. Stop taking the medicine, contact your doctor, or go to the nearest hospital emergency department:

• allergic reactions;
• stroke;
• heart attack;
• heart problems causing shortness of breath or swelling in the ankles;
• irregular heartbeat (new or worsening);
• bleeding;
• tendency to bruise;
• severe skin disease with blisters on the skin, mouth, eyes, and genitals;
• yellowing of the skin and whites of the eyes due to liver and blood disorders (jaundice).

You should also contact your doctor immediately if you experience fever or sore throat.
It may be necessary to perform blood tests, and your doctor will decide on further treatment.

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

Contact your doctor immediately:

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

• headache;
• abnormal stools;
• diarrhea.

Common side effects(may affect up to 1 in 10 people)

• rapid heartbeat;
• palpitations;
• chest pain;
• dizziness;
• sore throat;
• runny nose (rhinitis);
• stomach pain;
• discomfort in the stomach (indigestion);
• nausea or vomiting;
• loss of appetite (anorexia);
• excessive belching or passing gas (bloating with gas);
• 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 affect up to 1 in 100 people)

• heart attack;
• irregular heartbeat (new or worsening);
• heart problems causing shortness of breath or swelling in the ankles;
• pneumonia;
• cough;
• chills;
• unexpected bleeding;
• tendency to bleed (e.g. gastrointestinal, eye, or muscle bleeding, nosebleeds, blood in sputum or urine);
• decrease in red blood cell count;
• dizziness when changing position;
• fainting;
• anxiety;
• difficulty sleeping;
• nightmares;
• allergic reactions;
• pain or discomfort;
• diabetes and high blood sugar;
• stomach pain (gastritis);
• malaise.

In diabetic patients, there may be an increased risk of bleeding into the eyeball.
Rare side effects(may affect up to 1 in 1,000 people)

• tendency to bleed for longer than usual;
• increase in platelet count;
• kidney problems.

Side effects of Stepcil with unknown frequency:

• blood pressure changes;
• decrease in red and white blood cell and platelet count;
• breathing difficulties;
• mobility difficulties;
• fever;
• hot flashes;
• rash and skin changes;
• decreased skin sensitivity;
• discharge or sticky discharge from the eyes (conjunctivitis);
• ringing in the ears (tinnitus);
• liver problems, including hepatitis;
• changes in urine test results.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C,
02-222 Warsaw,
Phone: +48 22 49 21 301, Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Stepcil

Keep the medicine out of the 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.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Stepcil contains

• The active substance is cilostazol. One tablet contains 100 mg of cilostazol.
• The other ingredients are cornstarch, microcrystalline cellulose, calcium carmellose, hypromellose 5/6 cP, and magnesium stearate.

What Stepcil looks like and contents of the pack

Stepcil is a white, round tablet with a dividing line on one side. The tablet can be divided into equal doses.
The pack contains 56, 100, 112, or 120 tablets in a cardboard box.

Marketing authorization holder

Aflofarm Farmacja Polska Sp. z o.o.
Partyzancka 133/151
95-200 Pabianice
phone: (42) 22-53-100

Manufacturer

Noucor Health, S.A.
Camí Reial 51-57
Palau-Solità i Plegamans
08184 Barcelona, Spain
Galenicum Health, S.L.U.
Sant Gabriel, 50 Esplugues de Llobregat, 08950 Barcelona, Spain
Date of last revision of the leaflet:09.04.2024