CILOSTAZOL VIATRIS 100 mg TABLETS

Introduction

Package Leaflet: Information for the User

Cilostazol Viatris 100 mg Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet:

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

1. What is Cilostazol Viatris and what is it used for

Cilostazol Viatris belongs to a group of medicines called phosphodiesterase type 3 inhibitors.

It has several actions, including the dilation of certain blood vessels and the reduction of the clotting activity (aggregation) of certain blood cells, called platelets, in the blood vessels.

You have been prescribed cilostazol for "intermittent claudication". Intermittent claudication is the pain in the legs when you walk and is caused by insufficient blood supply to the legs. Cilostazol may increase the distance you can walk without pain, as it improves blood circulation in the legs. Cilostazol is only recommended for patients whose symptoms have not improved sufficiently after making lifestyle changes (such as stopping smoking and exercising more) and after other relevant interventions. It is important that you continue with the lifestyle changes you have made while taking cilostazol.

2. What you need to know before you take Cilostazol Viatris

Do not take Cilostazol Viatris

• If you are allergic (hypersensitive) to cilostazol or any of the other ingredients of this medicine (listed in section 6).
• If you have a known condition called "heart failure".
• If you have persistent chest pain at rest, or have had a "heart attack" or any heart surgery in the last six months.
• If you have fainted due to a heart condition or any heart rhythm disorder.
• If you know you have a condition that increases the risk of bleeding or bruising, such as:

• Active stomach ulcers.
• Stroke in the last six months.
• Eye problems if you have diabetes.
• Uncontrolled high blood pressure.

• If you are taking aspirin and clopidogrel, or any combination of two or more medicines that may increase the risk of bleeding [consult your doctor or pharmacist if you are unsure].
• Severe kidney disease or moderate to severe liver disease.
• If you are pregnant.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Cilostazol Viatris.

Make sure your doctor knows:

• If you have any serious heart problems or any heart rhythm problems.
• If you have any blood pressure problems.

During treatment with Cilostazol Viatris, make sure that:

• In case you need to undergo surgery, including dental extraction, inform your doctor or dentist that you are taking cilostazol.
• If you bruise or bleed easily, stop taking cilostazol and inform your doctor.

Taking Cilostazol Viatris with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained without a prescription.

You must specifically inform your doctor if you are taking medicines that are usually taken to treat painful and/or inflammatory conditions in the muscles or joints, as well as if you are taking medicines to reduce blood clotting. These medicines include:

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

If you are taking these medicines with Cilostazol Viatris, your doctor may need to perform some routine blood tests.

Certain medicines may interfere with the effect of cilostazol when taken together. They may increase the side effects of cilostazol or reduce its effectiveness. Cilostazol Viatris may have these same effects on other medicines. Before starting to take Cilostazol Viatris, inform your doctor if you are taking:

• erythromycin, clarithromycin, or rifampicin (antibiotics).
• ketoconazole (to treat fungal infections).
• omeprazole (to treat excess stomach acid).
• diltiazem (to treat high blood pressure or chest pain).
• cisapride (to treat certain stomach disorders).
• lovastatin, simvastatin, or atorvastatin (to treat high cholesterol in the blood).
• halofantrine (to treat malaria).
• pimozide (to treat mental disorders).
• ergot derivatives (to treat migraines, e.g., ergotamine, dihydroergotamine).
• carbamazepine or phenytoin (to treat seizures).
• St. John's Wort (herbal product).

If you are unsure whether this applies to the medicines you are taking, consult your doctor or pharmacist.

Before starting to take Cilostazol Viatris, inform your doctor if you are taking medicines to treat high blood pressure, as cilostazol may have an additional blood pressure-lowering effect. If your blood pressure drops too low, you may experience 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).

It may be possible for you to take the above-mentioned medicines with Cilostazol Viatris. Your doctor will decide if this is suitable for you.

Taking Cilostazol Viatris with food and drink

You should take the cilostazol tablets 30 minutes before breakfast and dinner.

Always take the tablets with a glass of water.

Pregnancy, breastfeeding, and fertility

DO NOTtake cilostazol during pregnancy.

IT IS NOT RECOMMENDEDto take cilostazol during breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Cilostazol may cause dizziness. If you feel dizzy after taking cilostazol, DO NOTdrive or use any tools or machines and inform your doctor or pharmacist.

3. How to take Cilostazol Viatris

• Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.
• The recommended dose is one 100 mg tablet twice a day (in the morning and at night). The dose does not need to be adjusted for elderly patients. However, your doctor may prescribe a lower dose if you are taking other medicines that may have an effect on cilostazol. You should take the Cilostazol Viatris tablets 30 minutes before breakfast and dinner. Always take the tablets with a glass of water.

You may notice the benefits of taking Cilostazol Viatris 4-12 weeks after starting treatment. At 3 months of treatment, your doctor will assess your progress and may recommend that you stop taking cilostazol if the treatment effect is not sufficient.

Use in children and adolescents

Cilostazol Viatris is not suitable for children.

If you take more Cilostazol Viatris than you should

If you take more tablets than you should, you may experience symptoms such as severe headache, diarrhea, low blood pressure, and irregular heartbeats.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Cilostazol Viatris

Do not worry if you forget to take a dose. Wait until your next dose, take your next tablet, and continue with your treatment as usual. DO NOTtake a double dose to make up for forgotten doses.

If you stop taking Cilostazol Viatris

If you stop taking cilostazol, the pain in your legs may return or worsen. Therefore, you should only stop taking cilostazol if you experience side effects that require urgent medical attention (see section 4) or if your doctor tells you to do so.

If you have any further questions 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 you experience any of the following side effects, you may need urgent medical attention. Stop taking Cilostazol Viatris and contact a doctor or go to the nearest hospital immediately.

• Stroke
• Heart attack
• Heart problems that can cause difficulty breathing or swelling of the ankles
• Irregular heartbeats (new or worsening)
• Significant bleeding
• Easy bruising
• Severe skin condition with blistering of the skin, mouth, eyes, and genitals
• Yellowing of the skin or the whites of the eyes due to liver or blood problems (jaundice)

You should also inform your doctor immediately if you experience fever or sore throat. You may need to have blood tests; your doctor will decide on the treatment to be administered.

The following side effects have been observed with cilostazol. If you experience them, you should inform 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 heartbeats
• Strong heartbeats (palpitations)
• Chest pain
• Dizziness
• Sore throat
• Runny nose (rhinitis)
• Abdominal pain
• Indigestion
• Feeling sick (nausea or vomiting)
• Lack of appetite (anorexia)
• Excess wind or gas (flatulence)
• Swelling of the ankles, feet, or face
• Rash or changes in skin appearance
• Itching of the skin
• Irregular bleeding of the skin
• General weakness

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

• Heart attack
• Irregular heartbeats (new or worsening)
• Heart problems that can cause difficulty breathing or swelling of the ankles
• Pneumonia
• Cough
• Chills
• Unexpected bleeding
• Tendency to bleed (e.g., in the stomach, eyes, or muscles, nosebleeds, or blood in the sputum or urine)
• Decrease in the number of red blood cells in the blood
• Dizziness when standing up
• Fainting
• Anxiety
• Difficulty sleeping
• Abnormal dreams
• Allergic reaction
• Pain and discomfort
• Diabetes and increased blood sugar levels
• Stomach pain (gastritis)
• General malaise

People with diabetes may be at higher risk of eye bleeding.

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

• Bleeding for longer than usual
• Increased platelet count in the blood
• Kidney problems

The following side effects have been observed during the use of cilostazol, but the frequency with which they occur is unknown.

• Changes in blood pressure
• Decrease in the number of red blood cells, white blood cells, and platelets in the blood
• Difficulty breathing
• Difficulty moving
• Fever
• Hot flashes
• Eczema and other skin rashes
• Decreased sensation in the skin
• 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 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 via the Spanish Medicines and Healthcare Products Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cilostazol Viatris

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 is the last day of the month stated.

Do not use this medicine if you notice any visible signs of deterioration.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Cilostazol Viatris

The active substance is cilostazol. One tablet contains 100 mg of cilostazol.

The other ingredients are cornstarch, microcrystalline cellulose, calcium carmellose, hypromellose, and magnesium stearate.

Appearance of Cilostazol Viatris and pack contents

The 100 mg Cilostazol Viatris tablet is white, white-yellowish, round, flat, and marked with "100" on one side.

This medicine is supplied in packs containing 7, 14, 20, 28, 30, 50, 56, 60, 98, and 100 tablets in PVC/PVDC/aluminum blisters.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer:

Adamed Pharma S.A.

ul. Marszalka Józefa Pilsudskiego 5,

95-200 Pabianice

Poland

or

Terapia SA

Strada Fabricii nr. 124, Cluj-Napoca

Romania

You can request more information about this medicine from the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet:April 2019

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/