Cilostazol Mylan Pharma

Package leaflet: Information for the user

Cilostazolo Mylan Pharma 100 mg tablets

Generic medicine
This medicine is under additional monitoring. This will allow any new safety information to be rapidly identified. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read all of 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to 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 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

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

Cilostazolo Mylan Pharma belongs to a group of medicines called type 3 phosphodiesterase inhibitors.
It works in several ways, including by dilating certain blood vessels and reducing the clotting activity of
some blood cells called platelets within the blood vessels.
Cilostazolo Mylan Pharma has been prescribed to you for "intermittent claudication". Intermittent
claudication is the cramp-like pain you feel in your legs when walking, caused by insufficient blood flow
to the legs. By improving blood circulation in the legs, cilostazol allows you to walk longer distances without
experiencing pain. Cilostazolo Mylan Pharma is recommended only for patients whose symptoms have not
improved sufficiently after making lifestyle changes (e.g. quitting smoking and increasing physical activity)
and after other measures have been taken. It is important that you continue to maintain the lifestyle
changes you have made while taking cilostazol.

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 to any of the other ingredients of this medicine (listed in section 6)
• if you have a condition called "heart failure"
• if you experience persistent chest pain while at rest, or if you have had a "heart attack" or any heart surgery within the last six months
• if you currently have or have previously had fainting episodes caused by heart disease, or serious heart rhythm disorders
• 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 within the last six months
  • eye problems if you have diabetes
• if your blood pressure is not well controlled
• if you have severe kidney disease or 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 in doubt, 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 condition or any problems with your heart rhythm.
• if you have blood pressure issues.

While taking Cilostazolo Mylan Pharma, make sure:

• if you need to undergo any surgical procedure, including tooth extraction, to inform your doctor or dentist that you are taking Cilostazolo Mylan Pharma.
• if you bruise easily or experience bleeding, to stop taking Cilostazolo Mylan Pharma and inform your doctor immediately.

Other medicines and Cilostazolo Mylan Pharma
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Before taking Cilostazolo Mylan Pharma, specifically inform your doctor if you are taking certain medicines commonly used for pain and/or inflammatory conditions affecting muscles or joints, or if you are taking medicines that reduce blood clotting. These 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 perform routine blood tests.
Some medicines may interfere with the effect of Cilostazolo Mylan Pharma when taken at the same time. They may increase the undesirable effects of Cilostazolo Mylan Pharma, or reduce its effectiveness. Cilostazolo Mylan Pharma may also have similar effects on other medicines. Before starting Cilostazolo Mylan Pharma, inform your doctor if you are taking:

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

If you have any doubts about whether the above applies to the medicines you are taking, consult 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 blood pressure drops too low, your heart rate may increase. 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).

It may still be possible to take the medicines listed above together with Cilostazolo Mylan Pharma, and your doctor will decide what is appropriate in your case.
Cilostazolo Mylan Pharma with food, drinks and alcohol
Cilostazolo Mylan Pharma tablets should be taken 30 minutes before breakfast and dinner.
Always take the tablets with water.
Pregnancy and breastfeeding
Cilostazolo Mylan Pharma MUST NOT be used during pregnancy.
For women who are breastfeeding, the use of Cilostazolo Mylan Pharma IS NOT RECOMMENDED.
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Cilostazolo Mylan Pharma may cause dizziness. If you feel dizzy after taking Cilostazolo Mylan Pharma tablets, DO NOT drive or operate tools or machinery, and inform your doctor or pharmacist.

3. How to take Cilostazolo Mylan Pharma

• Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
• The recommended dose is one 100 mg tablet twice daily (morning and evening). This dose does not require adjustment in elderly patients. However, your doctor may prescribe a lower dose if you are taking other medicines that could interact with Cilostazolo Mylan Pharma.
• Cilostazolo Mylan Pharma tablets should be taken 30 minutes before breakfast and dinner. Always take the tablets with water.

You may begin to experience the benefits of Cilostazolo Mylan Pharma within 4–12 weeks of starting treatment. Your doctor will assess your progress after 3 months of treatment and may advise you to stop taking Cilostazolo Mylan Pharma if the treatment effect is insufficient.
Cilostazolo Mylan Pharma is not suitable for children.

If you take more Cilostazolo Mylan Pharma than you should
If you have taken more tablets 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 your prescribed dose, contact your doctor or the nearest hospital immediately. Remember to bring the medicine pack 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 next scheduled dose and take your next tablet as usual, then continue your regular dosing schedule. DO NOT take a double dose to make up for the missed tablet.

If you stop taking Cilostazolo Mylan Pharma
If you stop taking Cilostazolo Mylan Pharma, leg pain may return or worsen. Therefore, only stop taking Cilostazolo Mylan Pharma if you experience adverse effects requiring urgent medical attention (see section 4), or if your doctor advises you to do so.

If you have any questions about the use of this medicine, consult 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, urgent medical attention may be required.
Stop taking Cilostazolo Mylan Pharma and contact a doctor immediately or go to the nearest hospital.

• allergic reactions
• stroke
• heart attack
• heart problems that may cause shortness of breath or swelling of the ankles
• irregular heartbeat (new or worsening)
• obvious bleeding
• easy bruising
• severe illness with blisters appearing on the skin, in the mouth, eyes, and genitals
• yellowing of the skin or whites of the eyes, due to liver or blood problems (jaundice)

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 Cilostazolo Mylan Pharma. Inform your doctor as
soon as possible:

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

• headache
• abnormal stools
• diarrhoea

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

• rapid 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 skin changes
• itching of the skin
• blotchy bleeding under the skin
• generalised weakness

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

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

In diabetic patients, the risk of bleeding inside the eye may increase.
Rare side effects (may affect up to 1 in 1,000 people)

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

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

• changes in blood pressure
• reduced number of red blood cells, white blood cells, and platelets in the blood
• breathing difficulties
• motor 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 experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 carton and blister after
EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Cilostazolo Mylan Pharma contains

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

Description of the appearance of Cilostazolo Mylan Pharma and the contents of the pack
Cilostazolo Mylan Pharma 100 mg tablets are white, round tablets with a score line on one side and a diameter of approximately 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, Italy

Manufacturers
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 European Economic Area (EEA) Member States under the following names:
Malta: Cilostazol Mylan 100 mg tablets
Italy: Cilostazolo Mylan Pharma