Stepcil

Package leaflet: Information for the patient

Stepcil, 100 mg, tablets
Cilostazol
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform 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 known as phosphodiesterase type 3 inhibitors.
It produces various effects, including the dilation of certain blood vessels and
reduction of clotting (aggregation) activity of certain blood cells called platelets within blood vessels.
Stepcil has been prescribed for the treatment of "intermittent claudication". Intermittent claudication is
cramp-like pain in the lower limbs occurring during walking, caused by insufficient blood flow to the legs. Stepcil increases the distance a patient can walk without experiencing pain, by improving blood circulation in the lower limbs. Stepcil is recommended only for patients in whom lifestyle modifications (including smoking cessation and increased physical activity) and other appropriate interventions have not sufficiently alleviated symptoms. It is important that the patient continues to maintain the recommended lifestyle changes during treatment with cilostazol.

2. Information before taking Stepcil

When not to take Stepcil:

• if the patient is allergic 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 had or currently has episodes of loss of consciousness caused by heart disease, or other serious heart rhythm disorders;
• if the patient has conditions that may increase the risk of bleeding or bruising, such as:
  • active peptic ulcer,
  • stroke occurred within the last 6 months,
  • eye problems in diabetic patients,
  • uncontrolled blood pressure;
• if the patient has severe kidney disease;
• if the patient has severe or moderate liver disease;
• if the patient is currently taking acetylsalicylic acid and clopidogrel, or any other combination of two or more medicines that may increase the risk of bleeding (if in doubt, consult a doctor or pharmacist);
• if the patient is pregnant.

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

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

While taking Stepcil:

• if the patient needs to undergo surgery, including dental procedures, the doctor or dentist should be informed about taking Stepcil;
• if the patient notices an increased tendency to bruising or bleeding, the medicine should be discontinued and the doctor informed immediately.

Children and adolescents
Stepcil is not indicated for use in children and adolescents.

Stepcil with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
In particular, inform the doctor about taking medicines used for pain relief and inflammatory conditions of muscles and joints, as well as 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 medicines together with Stepcil, the doctor may recommend routine blood tests.
Some medicines may affect the action of Stepcil when taken simultaneously.
They may either increase the risk of adverse effects of Stepcil or reduce its effectiveness.
Likewise, Stepcil may affect the action of other medicines.
Before starting Stepcil, inform the doctor if the patient is taking:

• erythromycin, clarithromycin, or rifampicin (antibiotics);

• ketoconazole (antifungal medicine);

• protease inhibitors (antiviral medicines);

• 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, consult a doctor or pharmacist.
Before starting Stepcil, inform the doctor if the patient is taking medicines that lower blood pressure, because Stepcil may have an additional blood pressure-lowering effect. If blood pressure drops excessively, 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 may be possible to take these medicines together with Stepcil.
The doctor will decide which medicines the patient 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 taken with water.

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

Driving and operating machinery
Stepcil 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 Stepcil

This medicine should always be taken as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
The recommended dose of the medicine is 1 tablet (100 mg) twice daily (one tablet in the morning and one tablet
in the evening).
There is no need to adjust the dosage in elderly patients.
However, the doctor may reduce the dose if the patient is taking other medicines
that affect the action of Stepcil.
The tablet may be divided into equal doses.
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 using Stepcil become noticeable within 4–12 weeks of treatment. After 3
months, the doctor will assess treatment progress and may recommend discontinuation of cilostazol if the therapeutic effect
is insufficient.
Taking more Stepcil than recommended
If for any reason a patient has taken more tablets of Stepcil than prescribed, the following symptoms
may occur: severe headache, diarrhoea, decreased blood pressure, and heart rhythm disturbances.
If a patient has taken more tablets than prescribed, seek medical advice immediately or go to the nearest hospital emergency department. Remember to bring the packaging along so that it is clear which medicine has been taken.
Missing a dose of Stepcil
If a dose of Stepcil is missed, do not be alarmed. Wait until the next dose is due and take the recommended dose as per the prescribed schedule. DO NOT take a double dose to make up for the missed dose.
Stopping Stepcil treatment
If a patient stops taking Stepcil, leg pain may return or worsen.
For this reason, Stepcil should only be discontinued if the patient experiences adverse reactions requiring immediate medical attention (see section 4) or if 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 any medicine, this medicine may cause adverse reactions, although not everyone will experience them.
If any of the adverse reactions listed below occur, the patient may require
immediate medical attention. The medicine should be discontinued immediately,
contact a doctor or go to the nearest hospital emergency department:

• allergic reactions;
• stroke;
• heart attack;
• heart disorders causing shortness of breath or swelling in the ankles;
• irregular heartbeat (either newly occurring 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).

Also, contact a doctor immediately if fever or sore throat occurs.
Blood tests may be necessary, and further treatment will be decided by the doctor.
The following adverse reactions have been reported during treatment with
Stepcil.
Contact a doctor immediately:
Very common adverse reactions (may affect more than 1 in 10 people)

• headache;
• abnormal stools;
• diarrhoea.

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

• rapid heartbeat;
• palpitations;
• chest pain;
• dizziness;
• sore throat;
• cold symptoms (nasal inflammation);
• abdominal pain;
• discomfort in the abdomen (dyspepsia);
• 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;
• skin petechiae (small red or purple spots caused by bleeding under the skin);
• general weakness.

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

• heart attack;
• irregular heartbeat (either newly occurring or worsening of existing condition);
• heart disorders causing shortness of breath or swelling in the ankles;
• pneumonia;
• cough;
• chills;
• unexpected bleeding;
• tendency to bleed (e.g. from gastrointestinal tract, eye or muscle, nosebleeds, blood in sputum or urine);
• decrease in number of red blood cells;
• dizziness upon changing to upright position;
• fainting;
• anxiety;
• difficulty sleeping;
• nightmares;
• allergic reactions;
• pain or aches;
• diabetes and increased blood sugar levels;
• abdominal pain (gastritis);
• malaise.

In patients with diabetes, there may be an increased risk of bleeding inside the eyeball.
Rare adverse reactions (may affect less than 1 in 1000 people)

• tendency for bleeding lasting longer than usual;
• increased number of platelets in blood;
• kidney function disorders.

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

• 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;
• watery or sticky eye discharge (conjunctivitis);
• tinnitus (ringing in the ears);
• liver disorders, including hepatitis;
• changes in laboratory urine test results.

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 Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Stepcil

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following:
"EXP".
The expiry date refers to the last day of the stated month.
No special storage conditions required.
Medicines must 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 the medicine Stepcil contains

• The active substance is cilostazol. One tablet contains 100 mg of cilostazol.
• The other ingredients are: maize starch, 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 score line on one side. The tablet can be divided into equal doses.
Pack sizes: 56, 100, 112 or 120 tablets in a cardboard box.

Marketing Authorisation Holder
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
tel. (42) 22-53-100

Manufacturer
Noucor Health, S.A.
Avda. 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