CILOSTAZOLO 100 mg Coated Tablet

Зміст інструкції

1. Cilostazolo Sandoz 100 mg tablets
   1. What is Cilostazolo Sandoz and what it is used for
   2. What you need to know before taking Cilostazolo Sandoz
2. Cilostazolo Sandoz, do NOT drive or use any tools or machinery and inform your doctor or
   1. How to take Cilostazolo Sandoz
   2. Possible side effects
   3. How to store Cilostazolo Sandoz
   4. Contents of the pack and other information

Cilostazolo Sandoz 100 mg tablets

Generic medicine
Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Cilostazolo Sandoz contains the active ingredient cilostazol, which belongs to a group of
medicines called phosphodiesterase type 3 inhibitors.
Cilostazolo Sandoz exerts a series of effects, which include the dilation of some blood
vessels and the reduction of the coagulating (aggregation) activity of some blood cells,
called platelets, inside the blood vessels.
You have been prescribed Cilostazolo Sandoz to treat “intermittent claudication”. Intermittent
“claudication” is the cramp-like pain that affects the legs when walking and is caused by an
insufficient blood supply to the legs. Cilostazolo Sandoz is able to increase the distance you
can walk without experiencing pain, as it improves blood circulation in the legs. Cilostazolo
Sandoz is recommended only for patients whose symptoms have not improved sufficiently after
making changes to their lifestyle (such as quitting smoking and increasing exercise) and after
other appropriate interventions. It is important to continue maintaining the changes made to
your lifestyle while taking Cilostazolo Sandoz.

2. What you need to know before taking Cilostazolo Sandoz

Do not take Cilostazolo Sandoz:

• if you are allergic to cilostazol or any of the other ingredients of this medicine (listed in section 6).
• if you suffer from “heart failure”.
• if you suffer from persistent chest pain at rest, or if you have suffered a “heart attack” or undergone any heart surgery in the last six months.
• if you suffer from or have previously suffered from fainting due to heart disease or severe irregular heartbeat.
• if you know you suffer from a condition that increases the risk of bleeding or bruising, such as for example:
• one or more active stomach ulcers
• stroke occurring in the last six months
• eye disorders in the presence of diabetes
• poorly controlled blood pressure.
• if you suffer from severe kidney disease or moderate or severe liver disease.
• if you are taking acetylsalicylic acid together with clopidogrel, or any combination of two or more drugs 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 suffer from a severe heart condition or any problem related to your heartbeat.
• if you suffer from blood pressure problems.

While taking Cilostazolo Sandoz, remember to:

• inform your doctor or dentist that you are taking Cilostazolo Sandoz if you need to undergo surgery, including tooth extraction.
• stop taking Cilostazolo Sandoz and inform your doctor if you experience frequent bruising or bleeding.

Children and adolescents
Cilostazolo Sandoz is not suitable for use in children.

Other medicines and Cilostazolo Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
You must expressly inform your doctor if you are taking some medicines
commonly used for the treatment of painful and/or inflammatory conditions of the
muscles or joints, or if you are taking medicines to reduce
coagulation. These medicines include:

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

If you are taking these medicines together with Cilostazolo Sandoz, your doctor may
prescribe some routine blood tests.
Some medicines can interfere with the effect of Cilostazolo Sandoz when they are
taken at the same time. They may increase the side effects of Cilostazolo Sandoz
or reduce its effectiveness. In turn, Cilostazolo Sandoz may have a
similar effect on other medicines. Before starting to take Cilostazolo Sandoz, tell 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 acid in the stomach)
• 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 illness)
• 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 not sure if this applies to the medicines you are taking, consult your doctor or
pharmacist.
Before starting to take Cilostazolo Sandoz, tell your doctor if you are taking medicines
for high blood pressure, as Cilostazolo Sandoz may have an additive effect of
reducing blood pressure. If blood pressure drops excessively,
this could cause an acceleration of the heartbeat. These medicines
include:

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

Nevertheless, taking these medicines in combination with Cilostazolo Sandoz
may still be indicated: your doctor will determine the most appropriate therapy for your case.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are
breastfeeding, ask your doctor or pharmacist for advice before taking this
medicine.
Cilostazolo Sandoz MUST NOTbe used during pregnancy.
The use of Cilostazolo Sandoz by breastfeeding mothers IS NOT
RECOMMENDED.

Driving and using machines
Cilostazolo Sandoz can cause dizziness. If you experience dizziness after taking

Cilostazolo Sandoz, do NOT drive or use any tools or machinery and inform your doctor or

pharmacist.

3. How to take Cilostazolo Sandoz

• Take this medicine following exactly the instructions of your doctor. If you have doubts, consult your doctor or pharmacist.
• The recommended dose is one 100 mg tablet twice a day (in the morning and in the evening). It is not necessary to modify this dose for elderly people; however, your doctor may prescribe a lower dose if you are taking other medicines that may have an effect on Cilostazolo Sandoz.
• The tablet can 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 be observed within 4-12 weeks of treatment with Cilostazolo Sandoz.
After 3 months of treatment, your doctor will assess your progress and, if the effect
of the treatment is not sufficient, may tell you to stop taking
Cilostazolo Sandoz.

If you take more Cilostazolo Sandoz than you should
If for any reason you have taken a quantity of Cilostazolo Sandoz greater than that
indicated, you may experience signs and symptoms such as severe headache, diarrhea, decreased
blood pressure and irregular heartbeat.

If you have taken a higher number of tablets than prescribed, contact
your doctor or local hospital immediately. Remember to bring the package with you,
so that healthcare 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 time of the next dose
and take the next tablet, then continue with the normal dosage. DO NOT
take a double dose to make up for a missed tablet.

If you stop taking Cilostazolo Sandoz
If you stop treatment with Cilostazolo Sandoz, leg pain may
reappear or worsen. Therefore, stop taking Cilostazolo Sandoz only if
you notice undesirable effects that require urgent medical attention (see paragraph 4),
or as directed by your doctor.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

If any of the following side effects occur, you may need urgent medical attention. Stop taking Cilostazolo Sandoz and contact your doctor immediately or go to the nearest hospital.

• allergic reactions
• stroke
• heart attack
• heart problems that can cause shortness of breath or swelling of the ankles
• irregular heartbeat (newly occurring or worsening of a pre-existing condition)
• significant bleeding
• easy bruising
• severe disorder with blistering on skin, mouth, eyes and genitals
• yellowing of the skin or whites of the eyes, caused by liver or blood problems (jaundice).

You should also inform your doctor immediately if you develop a fever or sore throat. Before restarting treatment, some blood tests may be necessary.

The following side effects have been reported with cilostazol. You should 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 or being sick (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 in the skin
• general weakness.

Uncommon(may affect up to 1 in 100 people)

• heart attack
• irregular heartbeat (newly occurring or worsening of a pre-existing condition)
• heart problems that can cause shortness of breath or swelling of the ankles
• pneumonia
• cough
• chills
• unexpected bleeding
• tendency to bleed (for example of stomach, eyes or muscles, blood from the nose and blood in saliva or urine)
• decreased red blood cell count in the blood
• dizziness when standing up
• fainting
• anxiety
• difficulty sleeping
• unusual dreams
• allergic reaction
• pains and aches
• diabetes and increased blood sugar levels
• stomach pain (gastritis)
• feeling unwell.

People with diabetes may have a higher risk of bleeding in the eye.

Rare(may affect up to 1 in 1000 people)

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

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

• changes in blood pressure
• decreased 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
• eyes watering or becoming sticky (conjunctivitis)
• ringing in the ears (tinnitus)
• liver problems, including hepatitis
• changes in urine.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through 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 sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the package and on the
blister, after “Exp”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in 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 pack and other information

What Cilostazolo Sandoz contains

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

Description of the appearance of Cilostazolo Sandoz and contents of the pack
Cilostazolo Sandoz 100 mg tablets are white, round tablets with a fracture line
on one side and a diameter of approximately 8 mm.
The medicinal product 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 Authorisation Holder
Sandoz S.p.A.
Largo Umberto Boccioni 1
21040 Origgio (VA)

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 Barcellona 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 authorised in the Member States of the European Economic Area
under the following denominations: