Patient Information Leaflet

Warning! Keep this leaflet – the packaging label is in a foreign language!
Decilosal (Dilsatan)
100 mg, tablets
Cilostazol
Decilosal and Dilsatan are different brand names for the same medicine.
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

Keep this leaflet so that you can read it again if necessary.
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. It may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

What Decilosal is and what it is used for
Important information before taking Decilosal
How to take Decilosal
Possible side effects
How to store Decilosal
Contents of the pack and other information

1. What Decilosal is and what it is used for

Decilosal contains the active substance cilostazol, which belongs to a group of medicines called phosphodiesterase type 3 inhibitors.
Its various actions include widening certain blood vessels and reducing the blood clotting (aggregation) process 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, occurring during walking and caused by insufficient blood flow to the legs. By improving blood circulation in the legs, Decilosal may increase the distance a patient can walk without pain. Decilosal should be used only in patients in whom lifestyle modifications (e.g. quitting smoking and increasing exercise intensity) and other appropriate treatments have not sufficiently alleviated disease symptoms. It is important that the patient continues to maintain the lifestyle changes introduced while taking Decilosal.

2. Important information before using Decilosal

When not to use Decilosal
if the patient is allergic to cilostazol or to 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 myocardial infarction or heart surgery within the previous 6 months;
if the patient has experienced or has a history of episodes of loss of consciousness due to heart disease or any severe heart function disorders;
if the patient has or has had disorders that increase the risk of bleeding or bruising, such as:

active gastric ulcer
stroke within the last 6 months
diabetic eye disease
uncontrolled high blood pressure if the patient has severe kidney disease or moderate to severe liver disease;
if the patient is taking acetylsalicylic acid with clopidogrel or any combination of two or more medicines that may increase the risk of bleeding (in case of doubt, consult a doctor or pharmacist);
if the patient is pregnant.

Warnings and precautions
Before starting treatment with Decilosal, discuss this with your doctor. The patient should ensure that the doctor is aware of any:
severe heart diseases or any heart rhythm disorders;
blood pressure disorders.

While taking Decilosal:
inform your doctor or dentist that you are taking Decilosal if you need to undergo any surgical procedure, including tooth extraction;
discontinue Decilosal and inform your doctor if the patient bruises easily or experiences bleeding.

Children and adolescents
Decilosal is not appropriate for use in children.

Decilosal 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.
Especially inform your doctor if the patient is taking certain medicines commonly used to treat pain and/or muscle and joint inflammation, or medicines that reduce blood clotting.
This includes the following medicines:
acetylsalicylic acid
clopidogrel
anticoagulants (e.g. warfarin, dabigatran, rivaroxaban, apixaban or low molecular weight heparins).

If the patient takes any of these medicines together with cilostazol, the doctor may recommend certain routine blood tests.

Some medicines taken concomitantly with Decilosal may interfere with each other’s effects. For example, they may increase the risk of adverse reactions or reduce effectiveness. Before starting Decilosal, inform your doctor if the patient is taking any of the following medicines:
erythromycin, clarithromycin or rifampicin (antibiotics)
ketoconazole (a medicine used to treat fungal infections);
protease inhibitors (antiviral medicines);
omeprazole (a medicine used to reduce excess stomach acid);
diltiazem (a medicine used to treat high blood pressure or chest pain);
cimetidine (a medicine used for stomach disorders);
lovastatin, simvastatin or atorvastatin (medicines used to treat high blood cholesterol);
halofantrine (a medicine used to treat malaria);
pimozide (a medicine used to treat psychiatric disorders);
ergot alkaloids (e.g. ergotamine, dihydroergotamine, used to treat migraine);
carbamazepine or phenytoin (antiepileptic medicines);
St. John's wort (a herbal medicine).

If in doubt about using any of the above medicines, consult your doctor or pharmacist.

Before starting Decilosal, inform your doctor if the patient is taking medicines to treat high blood pressure, as Decilosal may cause additional lowering of blood pressure. Excessive reduction in blood pressure may lead to increased heart rate.

These include:
diuretics (e.g. hydrochlorothiazide, furosemide);
calcium channel blockers (e.g. verapamil, amlodipine);
angiotensin-converting enzyme (ACE) inhibitors (e.g. captopril, lisinopril);
angiotensin II receptor antagonists (e.g. valsartan, candesartan);
beta-blockers (e.g. labetalol, carvedilol).

It may be possible to take these medicines together with Decilosal, but the decision on whether such treatment is appropriate for the patient must be made by the doctor.

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

Driving and operating machinery
Decilosal may cause dizziness. If the patient experiences dizziness after taking the medicine, he or she should inform the doctor or pharmacist. DO NOT drive or operate tools or machinery in such cases.

3. How to use Decilosal

This medicine should always be used as directed by the physician. In case of doubt,
consult a doctor or pharmacist.
The recommended dose is 100 mg twice daily (in the morning and evening). This dose does not need
to be adjusted for elderly patients. However, the physician may recommend a lower dose if the patient
is taking other medicines that may interact with Decilosal.
The tablet may be divided into equal doses.
Decilosal tablets should be taken 30 minutes before breakfast and dinner. Tablets
should always be swallowed with water.
The beneficial effect of Decilosal may become noticeable within 4–12 weeks of treatment. After
3 months of treatment, the physician will assess the therapy progress and may recommend discontinuing
Decilosal if results are insufficient.
Taking more Decilosal than recommended
If for any reason a patient takes more Decilosal tablets than prescribed, the following symptoms
may occur: severe headache, diarrhea, 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. Remember to bring the packaging so that it is clear which medicine has been taken.
Missing a dose of Decilosal
If a patient misses a dose, take the next dose at the usual time. DO NOT take a double dose to make up for a missed tablet.
Stopping Decilosal
Stopping treatment with Decilosal may cause recurrence or worsening of leg pain. Therefore, Decilosal should only be discontinued if adverse reactions occur that require urgent medical attention (see section 4) or on the advice of a physician.
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.
If the patient experiences any of the listed adverse reactions, urgent medical help may be required. The use of Decilosal must be stopped immediately and the patient should consult a doctor or go to the nearest hospital.
Allergic reactions
Stroke
Heart attack
Heart function disorders causing shortness of breath or ankle swelling
Irregular heartbeat (occurring for the first time or worsening of existing disorders)
Noticeable bleeding
Easy bruising
Severe illness with blistering of the skin, mouth, eyes, and genital organs
Yellowing of the skin and whites of the eyes due to liver or blood disorders (jaundice).
Fever or sore throat must also be reported to the doctor immediately. Certain blood tests may be required before resuming treatment.
The following adverse reactions have been reported during treatment with Decilosal. Their occurrence must be reported to a doctor as soon as possible:
Very common (may affect more than 1 in 10 people)
Headache
Abnormal bowel movements
Diarrhea
Common (may affect up to 1 in 10 people)
Fast heartbeat
Palpitations
Chest pain
Dizziness
Sore throat
Cold (nasal congestion)
Abdominal pain
Feeling of discomfort in the abdominal cavity (dyspepsia)
Nausea or vomiting
Loss of appetite (anorexia)
Excessive belching or gas (bloating)
Swelling of ankles, feet, or face
Rash or skin changes
Itchy skin
Spotty bleeding under the skin
General weakness
Uncommon (may affect up to 1 in 100 people)
Heart attack
Irregular heartbeat (occurring for the first time or worsening of existing disorders)
Heart function disorders causing shortness of breath or ankle swelling
Lung inflammation
Cough
Chills
Unexpected bleeding
Tendency to bleed (e.g. in the stomach, eye, or muscles, nosebleeds, and presence of blood in sputum or urine)
Decreased number of red blood cells
Dizziness upon standing
Fainting
Anxiety
Sleep disturbances
Nightmares
Allergic reaction
Pain, including persistent pain
Diabetes and increased blood sugar levels
Stomach pain (inflammation of the gastric mucosa)
Malaise
In diabetic patients, there may be an increased risk of bleeding into the eyeball.
Rare (may affect up to 1 in 1000 people)
Tendency to prolonged bleeding
Increased number of platelets
Kidney function disorders
Frequency not known (frequency cannot be determined from available data)
Changes in blood pressure
Decreased number of red blood cells, white blood cells, and platelets
Breathing difficulties
Difficulty moving
Fever
Hot flushes
Skin rash and other skin eruptions
Reduced skin sensitivity to touch
Rare or sticky eye discharge (conjunctivitis)
Ringing in the ears (tinnitus)
Liver function disorders, including hepatitis
Changes in urine
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for 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 collect more information on the safety of this medicine.

5. How to store Decilosal

Keep this medicine out of 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 no longer in use. Such measures help protect the environment.

6. Contents of the packaging and other information

What Decilosal contains
The active substance is cilostazol. Each tablet contains 100 mg of cilostazol.
The other ingredients are: maize starch, 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 division line on one side, approximately 8 mm in diameter.
The medicine is available in PVC/aluminum foil blisters packed in a cardboard box containing 28, 56
or 84 tablets.

For more detailed information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Lithuania, country of export:
Sandoz d.d.
Verovškova 57
SI-1000 Ljubljana
Slovenia

Manufacturers:
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben
Germany

Galenicum Health, S.L.U.
Sant Gabriel, 50
Esplugues de Llobregat
08950 Barcelona
Spain

Noucor Health, S.A.
Av. Camí Reial 51-57
08184 Palau-solità i Plegamans (Barcelona)
Spain

Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana
Slovenia

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Relabeled in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing Authorisation numbers in Lithuania, country of export: LT/1/13/3380/003
LT/1/13/3380/006
LT/1/13/3380/008

Parallel Import Authorisation number: 252/25