Decilosal

Package Leaflet: Information for the Patient

Decilosal, 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.
In case of further questions, consult a doctor or pharmacist.
This medicine has been prescribed to you by a doctor and should not be given 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 Decilosal and what is it used for
• 2. Important information before taking Decilosal
• 3. How to take Decilosal
• 4. Possible side effects
• 5. How to store Decilosal
• 6. Contents of the pack and other information

1. What is Decilosal and what is it used for

Decilosal contains the active substance cilostazol, which belongs to a group of medicines called phosphodiesterase type 3 inhibitors.
Its various actions include the dilation of certain blood vessels and the weakening of the blood clotting process (aggregation) of certain blood cells called platelets within blood vessels.
Decilosal is prescribed for the treatment of intermittent claudication. Intermittent claudication is characterized by cramp-like pain in the lower limbs that occurs during walking and is caused by insufficient blood flow to the legs. By improving blood circulation in the legs, Decilosal can increase the distance a patient can walk without pain. Decilosal should only be used in patients who have not had their symptoms alleviated sufficiently by lifestyle modifications (e.g., quitting smoking and increasing exercise intensity) and other appropriate treatment methods. It is essential to continue implementing lifestyle modifications while taking Decilosal.

2. Important information before taking Decilosal

When not to take Decilosal

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 experience persistent chest pain at rest or have had a heart attack or heart surgery in the last 6 months;
if you have had episodes of loss of consciousness due to heart disease or any severe heart rhythm disorders;
if you have conditions that increase the risk of bleeding or bruising, such as:

• active stomach ulcer
• stroke in the last 6 months
• eye disease due to diabetes
• poorly controlled high blood pressure if you have severely impaired kidney function or moderate to severe liver disease; if you are taking aspirin with clopidogrel or any combination of two or more medicines that may increase the risk of bleeding (in case of doubt, consult your doctor or pharmacist); if you are pregnant.

Warnings and precautions

Before starting Decilosal, discuss it with your doctor.
You should be sure that your doctor knows about any of the following conditions you have:
severe heart disease or any heart rhythm disorders;
blood pressure disorders.
While taking Decilosal, you should:
tell your doctor or dentist that you are taking Decilosal if you need to undergo surgery, including tooth extraction;
stop taking Decilosal and inform your doctor if you easily bruise or experience bleeding.

Children and adolescents

Decilosal is not suitable for use in children.

Decilosal and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Especially, tell your doctor if you are taking certain medicines used to treat pain and/or inflammation of muscles and joints or medicines that reduce blood clotting. These include:
aspirin
clopidogrel
anticoagulants (e.g., warfarin, dabigatran, rivaroxaban, apixaban, or heparins).
If you are taking any of these medicines with cilostazol, your doctor may recommend routine blood tests.
Certain medicines taken with Decilosal may interfere with each other's effects. They may increase side effects or reduce efficacy. Before starting Decilosal, inform your doctor about taking the following medicines:
erythromycin, clarithromycin, or rifampicin (antibiotics)
ketoconazole (a medicine used to treat fungal infections);
protease inhibitors (antiviral medicines);
omeprazole (a medicine that reduces excessive stomach acid);
diltiazem (a medicine used to treat high blood pressure or 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 disorders);
ergot alkaloids (i.e., ergotamine, dihydroergotamine, used to treat migraines);
carbamazepine or phenytoin (antiepileptic medicines);
St. John's Wort (a herbal medicine).
In case of doubts about taking these medicines, consult your doctor or pharmacist.
Before starting Decilosal, inform your doctor if you are taking medicines to treat high blood pressure, as Decilosal may cause additional blood pressure lowering. Excessive blood pressure lowering may cause rapid heart rate.
These medicines include:
diuretics (e.g., hydrochlorothiazide, furosemide);
calcium channel blockers (e.g., verapamil, amlodipine);
angiotensin-converting enzyme inhibitors (e.g., captopril, lisinopril);
angiotensin II receptor antagonists (e.g., valsartan, candesartan);
beta-blockers (e.g., labetalol, carvedilol).
It is possible to take these medicines with Decilosal, but the decision to do so should be made by your doctor.

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 TAKEDecilosal during pregnancy.
DO NOT RECOMMENDtaking Decilosal during breastfeeding.

Driving and using machines

Decilosal may cause dizziness. If you experience dizziness after taking the medicine, inform your doctor or pharmacist. DO NOTdrive or operate machinery in such cases.

3. How to take Decilosal

Always take this medicine exactly as your doctor has told you.
In case of doubts, consult your doctor or pharmacist.
The recommended dose is 100 mg twice a day (morning and evening). This dose does not need to be adjusted for elderly patients. However, your doctor may recommend a lower dose if you are taking other medicines that may affect Decilosal's action.
The tablet can be divided into equal doses.
Take Decilosal tablets 30 minutes before breakfast and dinner. Always swallow the tablets with water.
The beneficial effect of Decilosal may be noticeable within 4-12 weeks of treatment. After 3 months of treatment, your doctor will assess the progress of therapy and may recommend stopping Decilosal if the results are insufficient.

Taking more Decilosal than prescribed

If you have taken more Decilosal tablets than you should, you may experience the following symptoms: severe headache, diarrhea, decreased blood pressure, and heart rhythm disturbances.

If you have taken more tablets than prescribed, seek medical attention immediately or go to the nearest hospital. Remember to take the package with you so that the doctor knows what medicine you have taken.

Missing a dose of Decilosal

If you miss a dose, take the next dose at the usual time. DO NOTtake a double dose to make up for the missed tablet.

Stopping Decilosal treatment

Stopping Decilosal treatment may cause the return or worsening of leg pain. Therefore, Decilosal should only be discontinued in case of side effects that require urgent medical attention (see section 4) or on the advice of a doctor.
In case of further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Decilosal 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 Decilosal and consult your doctor or go to the nearest hospital immediately.

allergic reactions
stroke
heart attack
heart rhythm disturbances that cause shortness of breath or swelling of the ankles
irregular heart rhythm (new or worsening)
notable bleeding
easy bruising
severe skin disease with blistering, including in the mouth, eyes, and genitals
yellowing of the skin and whites of the eyes due to liver or blood disorders (jaundice).
You should also tell your doctor immediately if you experience fever or sore throat. You may need to have some blood tests before resuming treatment.

The following side effects have been reported during Decilosal treatment. Inform your doctor as soon as possible:

Very common(may affect more than 1 in 10 people)
headache
abnormal stools
diarrhea
Common(may affect up to 1 in 10 people)
rapid heart rate
palpitations
chest pain
dizziness
sore throat
runny nose (rhinitis)
abdominal pain
discomfort in the abdomen (nausea)
nausea or vomiting
loss of appetite (anorexia)
excessive gas or bloating (flatulence)
swelling of the ankles, feet, or face
rash or skin changes
itching
petechiae (small red or purple spots on the skin)
general weakness
Uncommon(may affect up to 1 in 100 people)
heart attack
new or worsening irregular heart rhythm
heart rhythm disturbances that cause shortness of breath or swelling of the ankles
pneumonia
cough
chills
unexpected bleeding
tendency to bleed (e.g., in the stomach, eye, or muscle, bleeding from the nose, and blood in sputum or urine)
reduced red blood cell count
dizziness upon standing
fainting
anxiety
sleep disturbances
nightmares
allergic reaction
pain, including persistent pain
diabetes and increased blood sugar levels
stomach pain (gastritis)
malaise
In patients with diabetes, there may be a higher risk of bleeding into the eyeball.
Rare(may affect up to 1 in 1000 people)

• prolonged bleeding
• increased platelet count
• kidney function disorders

Frequency not known(frequency cannot be estimated from the available data)

• changes in blood pressure
• reduced red blood cell, white blood cell, and platelet count
• breathing difficulties
• movement difficulties
• fever
• hot flashes
• rash or other skin eruptions
• reduced skin sensitivity to touch
• rare or thick eye discharge (conjunctivitis)
• ringing in the ears (tinnitus)
• liver function disorders, including hepatitis
• changes in urine

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Post-Marketing Surveillance 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.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Decilosal

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 that month.
There are no special storage precautions.
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 Decilosal contains

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

What Decilosal looks like and contents of the pack

Decilosal tablets are white, round, with a dividing line on one side, approximately 8 mm in diameter.
The medicine is available in PVC/Aluminum blisters in a carton, containing 28, 30, 56, 60, and 84 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Manufacturer/Importer
Noucor Health, S.A. Av. Camí Reial 51-57
08184 Palau-solità i Plegamans
Barcelona, Spain
Galenicum Health S.L.U.
Sant Gabriel, 50,
Esplugues de Llobregat,
08950, Barcelona, Spain
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia

For more information about this medicine and its names in the European Economic Area member states, please contact:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
Date of last revision of the leaflet:09/2023
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