Cilostazol Sandoz

Package leaflet: Information for the patient

Cilostazol Sandoz 100 mg tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Cilostazol Sandoz is and what it is used for
2. What you need to know before taking Cilostazol Sandoz
3. How to take Cilostazol Sandoz
4. Possible side effects
5. How to store Cilostazol Sandoz
6. Contents of the pack and other information

1. What Cilostazolo Sandoz is and what it is used for

Cilostazolo Sandoz contains the active substance cilostazol, which belongs to a group of
medicines called type 3 phosphodiesterase inhibitors.
Cilostazolo Sandoz produces a series of effects, including the dilation of certain blood
vessels and the reduction of the clotting activity (aggregation) of certain blood cells
called platelets within the blood vessels.
You have been prescribed Cilostazolo Sandoz to treat "intermittent claudication".
"Intermittent claudication" is cramp-like pain affecting the legs when walking, caused by an
inadequate blood supply to the legs. Cilostazolo Sandoz can increase the distance you are
able to walk without pain, as it improves blood circulation in the legs. Cilostazolo Sandoz is
recommended only for patients whose symptoms have not improved sufficiently after
lifestyle modifications (such as quitting smoking and increasing physical activity) and other
appropriate interventions. It is important to continue maintaining lifestyle changes while taking Cilostazolo Sandoz.

2. What you should know before taking Cilostazolo Sandoz

Do not take Cilostazolo Sandoz:

• if you are allergic to cilostazol or to any of the other ingredients of this medicine (listed in section 6).
• if you have "heart failure".
• if you suffer from persistent chest pain at rest, or if you have had a "heart attack" or undergone any heart surgery within the last six months.
• if you currently have or have previously had fainting spells due to heart disease or serious irregularities in your heartbeat.
• if you know you have a condition that increases the risk of bleeding or bruising, such as:
  • one or more active gastric ulcers
  • stroke within the last six months
  • eye disorders in the presence of diabetes
  • uncontrolled high blood pressure.
• if you have severe kidney disease or moderate to severe liver disease.
• if you are taking acetylsalicylic acid together with clopidogrel, or any combination 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
Talk to your doctor before taking Cilostazolo Sandoz. Make sure your doctor is informed:

• if you have a serious heart condition or any problems related to your heartbeat.
• if you have blood pressure problems.

While being treated with Cilostazolo Sandoz, remember to:

• inform your doctor or dentist that you are taking Cilostazolo Sandoz if you are scheduled for any surgical procedure, including dental extraction.
• stop taking Cilostazolo Sandoz and inform your doctor if you experience frequent bruising or bleeding.

Children and adolescents
Cilostazolo Sandoz is not intended for use in children.
Other medicines and Cilostazolo Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You must specifically inform your doctor if you are taking medicines commonly used to treat muscle and/or joint pain and inflammation, or if you are taking medicines that reduce blood clotting. These include:

• acetylsalicylic acid
• clopidogrel
• anticoagulant medicines (e.g. warfarin, dabigatran, rivaroxaban, apixaban, or low molecular weight heparins).

If you are taking these medicines together with Cilostazolo Sandoz, your doctor may prescribe routine blood tests.
Some medicines may interfere with the effect of Cilostazolo Sandoz when taken at the same time. They may increase the side effects of Cilostazolo Sandoz or reduce its effectiveness. Conversely, Cilostazolo Sandoz may have a similar effect on other medicines. Before starting Cilostazolo Sandoz, inform your doctor if you are taking:

• erythromycin, clarithromycin, or rifampicin (antibiotics)
• ketoconazole (used to treat fungal infections)
• protease inhibitors (antivirals)
• omeprazole (used to treat excess stomach acid)
• diltiazem (used to treat high blood pressure or chest pain)
• cisapride (for the treatment of stomach disorders)
• lovastatin, simvastatin, or atorvastatin (used to treat high cholesterol)
• halofantrine (used to treat malaria)
• pimozide (for the treatment of mental illnesses)
• ergot derivatives (used to treat migraine, such as ergotamine, dihydroergotamine)
• carbamazepine or phenytoin (for the treatment of seizures)
• St. John’s wort (a herbal remedy).

If you are unsure whether this applies to the medicines you are taking, consult your doctor or pharmacist.
Before starting to take Cilostazolo Sandoz, inform your doctor if you are taking medicines for high blood pressure, as Cilostazolo Sandoz may have an additive effect in lowering blood pressure. If blood pressure drops too much, this could cause an increased heart rate. These medicines include:

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

Nevertheless, taking these medicines together with Cilostazolo Sandoz may still be appropriate: your doctor will determine the most suitable treatment for your condition.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Cilostazolo Sandoz MUST NOT be used during pregnancy.
The use of Cilostazolo Sandoz by breastfeeding mothers IS NOT RECOMMENDED.
Driving and using machines
Cilostazolo Sandoz may cause dizziness. If you feel dizzy after taking Cilostazolo Sandoz, DO NOT drive or operate any tools or machinery, and inform your doctor or pharmacist.

3. How to take Cilostazolo Sandoz

• Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
• The recommended dose is one 100 mg tablet twice daily (in the morning and evening). Dose adjustment is not generally required for elderly patients; however, your doctor may prescribe a lower dose if you are taking other medicines that may interact with Cilostazolo Sandoz.
• The tablet may be divided into equal parts.
• Cilostazolo Sandoz should be taken 30 minutes before breakfast and dinner. Always take the tablets with a glass of water.

Benefits may already become apparent within 4–12 weeks of treatment with Cilostazolo Sandoz. After 3 months of treatment, your doctor will assess your progress and, if the treatment effect is not sufficient, may instruct you to stop taking Cilostazolo Sandoz.

If you take more Cilostazolo Sandoz than you should
If you have taken more Cilostazolo Sandoz than prescribed for any reason, you may experience signs and symptoms such as severe headache, diarrhoea, low blood pressure, and irregular heartbeat.
If you have taken more tablets than prescribed, contact your doctor or the nearest hospital immediately. Remember to bring the pack with you so that medical personnel know which medicine you have taken.

If you forget to take Cilostazolo Sandoz
If you forget to take a dose, do not worry; wait until the next scheduled dose and take the next tablet as usual, then continue with your regular dosing schedule. DO NOT take a double dose to make up for the missed tablet.

If you stop taking Cilostazolo Sandoz
If you stop treatment with Cilostazolo Sandoz, leg pain may return or worsen. Therefore, stop taking Cilostazolo Sandoz only if you experience adverse effects requiring urgent medical attention (see section 4), or as directed by your doctor.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience any of the following side effects, you may need urgent medical
attention. Stop taking Cilostazolo Sandoz and contact a doctor immediately or go to the
nearest hospital straight away.

• allergic reactions
• stroke
• heart attack
• heart problems that may cause shortness of breath or swelling of the ankles
• irregular heartbeat (new onset or worsening of a pre-existing condition)
• obvious bleeding
• easy bruising
• severe condition with blistering of the skin, mouth, eyes, and genitals
• yellowing of the skin or whites of the eyes due to liver or blood problems (jaundice).

You must inform your doctor immediately if you develop fever or sore throat. Some blood tests may be required before restarting treatment.
The following side effects have been reported with cilostazol. You must inform your
doctor as soon as possible:
Very common (may affect more than 1 in 10 people)

• headache
• abnormal stools
• diarrhoea.

Common (may affect up to 1 in 10 people)

• fast heartbeat
• palpitations
• chest pain
• dizziness
• sore throat
• runny nose (rhinitis)
• abdominal pain
• abdominal discomfort (indigestion)
• feeling unwell or being unwell (nausea or vomiting)
• loss of appetite (anorexia)
• excessive belching or flatulence
• swelling of ankles, feet or face
• skin rash or changes in skin appearance
• itchy skin
• irregular bleeding under the skin
• general weakness.

Uncommon (may affect up to 1 in 100 people)

• heart attack
• irregular heartbeat (new onset or worsening of a pre-existing condition)
• heart problems that may cause shortness of breath or swelling of the ankles
• pneumonia
• cough
• chills
• unexpected bleeding
• tendency to bleed (e.g. stomach, eyes or muscles, nosebleeds, blood in saliva or urine)
• decrease in red blood cell count
• dizziness when standing up
• fainting
• anxiety
• difficulty sleeping
• unusual dreams
• allergic reaction
• pains and twinges
• diabetes and increased blood sugar levels
• stomach pain (gastritis)
• malaise.

People with diabetes may have an increased risk of bleeding in the eye.
Rare (may affect up to 1 in 1,000 people)

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

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

• changes in blood pressure
• decrease in red blood cells, white blood cells and platelets in the blood
• difficulty breathing
• difficulty moving
• fever
• hot flushes
• eczema and other skin rashes
• reduced skin sensitivity
• watery or sticky eyes (conjunctivitis)
• ringing in the ears (tinnitus)
• liver problems, including hepatitis
• changes in urine.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects via the website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cilostazolo Sandoz

Keep this 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.
This medicine requires no special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Cilostazolo Sandoz contains

• The active substance is cilostazol. Each tablet contains 100 mg of cilostazol.
• The other components are maize starch, microcrystalline cellulose, calcium carmellose, hypromellose and magnesium stearate.

Description of the appearance of Cilostazolo Sandoz and the contents of the pack
Cilostazolo Sandoz 100 mg tablets are white, round tablets with a score line on one side and a diameter of approximately 8 mm.
The medicine is available in packs of 14, 20, 28, 30, 50, 56, 60, 84, 98 and 100 tablets in PVC/Aluminum blisters.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A.
Largo Umberto Boccioni 1
21040 Origgio (VA)
Italy

Manufacturers
J. Uriach y Compañía, S.A.
Av. Camí Reial 51-57 - 08184 Palau-solità i Plegamans (Barcelona)
Spain
Galenicum Health, S.L.,
Avda. Cornellá 144, 7º-1ª Edificio LEKLA Esplugues de Llobregat
08950 Barcelona, Spain
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Lek Pharmaceuticals d.d.
Verovskova ulica 57
1526 Ljubljana
Slovenia

This medicinal product is authorized in the European Economic Area Member States under the following names: