CILOSTAZOLO 100 mg Tablets

Зміст інструкції

1. Cilostazolo Mylan Pharma 100 mg tablets
   1. What is Cilostazolo Mylan Pharma and what is it used for
   2. What you need to know before taking Cilostazolo Mylan Pharma
   3. How to take Cilostazolo Mylan Pharma
   4. Possible side effects
   5. How to store Cilostazolo Mylan Pharma
   6. Contents of the pack and other information

Cilostazolo Mylan Pharma 100 mg tablets

Generic medicine

This medicine is subject to additional monitoring. This will allow the rapid identification of new
information on safety. You can contribute by reporting any adverse effects you experience
while taking this medicine. See the end of section 4 for information on how to
report adverse effects.

Read this leaflet carefully before you start 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 you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Cilostazolo Mylan Pharma and what is it used for

Cilostazolo Mylan Pharma belongs to a group of medicines called phosphodiesterase type 3 inhibitors.
It works in various ways, including dilating some blood vessels and reducing the coagulation activity of
certain blood cells called platelets within the blood vessels.
Cilostazolo Mylan Pharma has been prescribed for you for “intermittent claudication”. Intermittent
claudication is the pain, similar to a cramp, that you feel in your legs when walking, and is caused by
an insufficient blood supply to the legs. Cilostazolo, by improving blood circulation in the
legs, allows you to walk without feeling pain for a greater distance. Cilostazolo Mylan
Pharma is recommended only for patients whose symptoms have not improved sufficiently after
modifying their lifestyle (e.g., quitting smoking and doing more physical activity) and after
taking other measures. It is important that you continue to follow the changes you have made to your lifestyle while taking cilostazolo.

2. What you need to know before taking Cilostazolo Mylan Pharma

Do not take Cilostazolo Mylan Pharma:

• if you are allergic (hypersensitive) to cilostazol or any of the other ingredients of this medicine (listed in section 6)
• if you suffer from a condition called “heart failure”
• if you experience persistent chest pain at rest, or if you have had a “heart attack” or any heart surgery in the last six months
• if you suffer from or have previously suffered from fainting caused by a heart condition, or from severe heart rhythm disturbances
• if you know you have a condition that increases the risk of bleeding or bruising, for example:
• one or more active stomach ulcers.
• a stroke that occurred in the last six months.
• eye problems if you suffer from diabetes.
• if your blood pressure is not well controlled
• if you have a severe kidney disease or a severe or moderate liver disease
• if you are taking both acetylsalicylic acid and clopidogrel, or any combination of two or more medicines that may increase the risk of bleeding [if you have doubts, consult your doctor or pharmacist]
• if you are pregnant.

Warnings and precautions
Before taking Cilostazolo Mylan Pharma, make sure to inform your doctor:

• if you have a serious heart problem, or any problem with your heart rhythm.
• if you have blood pressure problems.

During treatment with Cilostazolo Mylan Pharma, make sure:

• if you need to undergo surgery, including a tooth extraction, to inform your doctor or dentist that you are taking Cilostazolo Mylan Pharma.
• if you bruise or bleed easily, to stop taking Cilostazolo Mylan Pharma and inform your doctor.

Other medicines and Cilostazolo Mylan Pharma
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Before taking Cilostazolo Mylan Pharma, inform your doctor specifically if you are taking
some medicines commonly used for painful and/or inflammatory conditions of the muscles or
joints, or if you are taking medicines that reduce blood clotting. These medicines
include:

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

If you are taking these medicines together with Cilostazolo Mylan Pharma, your doctor may subject you to
some routine blood tests.
Some medicines can interfere with the effect of Cilostazolo Mylan Pharma if they are taken
at the same time. They may increase the undesirable effects of Cilostazolo Mylan Pharma, or
reduce the effectiveness of Cilostazolo Mylan Pharma. Cilostazolo Mylan Pharma may do the same in
relation to other medicines. Before starting to take Cilostazolo Mylan Pharma, tell your doctor if
you are taking:

• erythromycin, clarithromycin or rifampicin (antibiotics)
• ketoconazole (for the treatment of fungal infections)
• omeprazole (for the treatment of excessive stomach acidity)
• diltiazem (for high blood pressure or chest pain)
• cisapride (for the treatment of stomach disorders)
• lovastatin, simvastatin or atorvastatin (for high cholesterol levels in the blood)
• alofantrine (for the treatment of malaria)
• pimozide (for the treatment of mental illnesses)
• ergot derivatives (for migraine, e.g. ergotamine, dihydroergotamine)
• carbamazepine or phenytoin (for the treatment of seizures)
• St. John's Wort (herbal medicine).

If you have any doubts about the validity of the above for the medicines you are taking, ask your doctor or
pharmacist.
Before taking Cilostazolo Mylan Pharma, inform your doctor if you are taking medicines for
high blood pressure (hypertension), as Cilostazolo Mylan Pharma may enhance the blood pressure-lowering effect
If your blood pressure drops too low, your heart rate may increase. These medicines include:

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

It may still be possible to take the above medicines together with Cilostazolo Mylan
Pharma and your doctor will be able to decide what is suitable in your case.

Cilostazolo Mylan Pharma with food, beverages and alcohol
The Cilostazolo Mylan Pharma tablets must be taken 30 minutes before breakfast
and dinner.
Always take the tablets with water.

Pregnancy and breastfeeding
Cilostazolo Mylan Pharma MUST NOTbe used during pregnancy.
For women who are breastfeeding, the use of Cilostazolo Mylan Pharma is NOT
RECOMMENDED.
If you are pregnant, suspect you are pregnant, or are planning to become pregnant, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.

Driving and operating machinery
Cilostazolo Mylan Pharma may cause dizziness. If you experience dizziness after taking the tablets of
Cilostazolo Mylan Pharma, DO NOTdrive vehicles and do not use tools or machinery, and inform your doctor or
pharmacist.

3. How to take Cilostazolo Mylan Pharma

• 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 (morning and evening). This dose does not require adjustments for elderly people. However, your doctor may prescribe a lower dose if you are taking other medicines that may interfere with the effect of Cilostazolo Mylan Pharma.
• The tablets of Cilostazolo Mylan Pharma must be taken 30 minutes before breakfast and dinner. Always take the tablets with water.

You may feel the benefits of taking Cilostazolo Mylan Pharma within 4-12 weeks of
treatment. The doctor will assess your progress after 3 months of treatment and may recommend that you
stop taking Cilostazolo Mylan Pharma if the effect of the treatment is insufficient.

Cilostazolo Mylan Pharma is not suitable for children.

If you take more Cilostazolo Mylan Pharma than you should
If for any reason you have taken more tablets of Cilostazolo Mylan Pharma than you
should, you may have signs and symptoms such as severe headache, diarrhea, decreased blood pressure and
irregular heartbeat.

If you have taken more tablets than your prescribed dose, contact your doctor or
the nearest hospital immediately. Remember to bring the medicine package with you, so that
it is clear what you have taken.
If you forget to take Cilostazolo Mylan Pharma
If you miss a dose, do not worry; wait until the time of the next dose and take the
next tablet, then continue normally. DO NOTtake a double dose to compensate for the
forgotten tablet.

If you stop taking Cilostazolo Mylan Pharma
If you stop taking Cilostazolo Mylan Pharma, leg pain may return or worsen.
Therefore, stop taking Cilostazolo Mylan Pharma only if you notice undesirable effects that require
urgent medical attention (see paragraph 4), or if your doctor tells you to.
If you have any doubts about the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, Cilostazolo Mylan Pharma 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 Cilostazolo Mylan Pharma and contact a 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 (new or worsening)
• significant bleeding
• easy bruising
• severe illness with blistering of the skin, mouth, eyes and genitals
• yellowing of the skin or the whites of the eyes, due to problems with the liver or blood (jaundice)

Also, tell your doctor immediately if you have a fever or sore throat. Some blood tests may be necessary before you start treatment again.

The following side effects have been reported for Cilostazolo Mylan Pharma. Tell your doctor as soon as possible:

Very common side effects(may affect more than 1 in 10 people)

• headache
• abnormal stools
• diarrhea

Common side effects(may affect up to 1 in 10 people)

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

Uncommon side effects(may affect up to 1 in 100 people)

• heart attack
• myocardial infarction
• irregular heartbeat (new or worsening)
• heart problems that can cause shortness of breath or swelling of the ankles
• pneumonia
• cough
• chills
• unexplained bleeding
• tendency to bleed (for example from the stomach, eyes or muscles, nosebleeds and blood in saliva or urine)
• reduced number of red blood cells in the blood
• dizziness when standing up
• fainting
• feeling anxious
• insomnia
• unusual dreams
• allergic reaction
• generalized pain
• diabetes and increased blood sugar
• stomach pain (gastritis)
• feeling unwell.

In people with diabetes, the risk of bleeding inside the eye may increase.

Rare side effects(may affect up to 1 in 1,000 people)

• tendency to bleed for longer than usual
• increased number of platelets in the blood
• kidney problems

Side effects with unknown frequency(frequency cannot be estimated from available data):

• changes in blood pressure
• reduced number of red blood cells, white blood cells and platelets in the blood
• difficulty breathing
• movement difficulties
• 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/it/responsabili
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Cilostazolo Mylan Pharma

Keep this medicine out of the 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 waste water 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 containsCilostazolo Mylan Pharma

• 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 Mylan Pharma and contents of the pack
Cilostazolo Mylan Pharma 100 mg tablets are white, round tablets, with a score line
on one side, with an approximate diameter of 8 mm.
The medicine is supplied in packs of 28 tablets, in PVC/aluminium blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani, 20, 20124 Milano
Manufacturer

• J. Uriach y Compañía S.A. Polígon Industrial Riera de Caldes Avinguda 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

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Malta: Cilostazol Mylan 100 mg tablets
Italy: Cilostazolo Mylan Pharma