Prospect: information for the user

Cilostazol Viatris 100 mg tablets EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed to you alone, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Cilostazol Viatris belongs to a group of medications known as type 3 phosphodiesterase inhibitors.

It has various actions, including the dilation of certain blood vessels and the reduction of the coagulant activity (agglutination) of certain blood cells, called platelets, in blood vessels.

Cilostazol has been prescribed for «intermittent claudication». Intermittent claudication is the cramping pain that occurs in the legs when walking and is caused by an insufficient blood supply to the legs. Cilostazolmay increase the distance that can be walked 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 quitting smoking and exercising more) and after other relevant interventions. It is essential to continue with the lifestyle changes made while taking cilostazol.

Do not take Cilostazol Viatris

• If you are allergic (hypersensitive) to cilostazol or any of the other components of this medication (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 "myocardial infarction" or any heart surgery in the last six months.
• If you have or have had previous fainting spells due to heart disease or any heart rhythm disorder.
• If you know you have a condition that increases the risk of bleeding or bruising, such as:

• Active ulcers in the stomach.
• Stroke (cerebral hemorrhage) 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 medications 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 severe heart problems or any heart rhythm disorders.
• If you have any blood pressure disorders.

During treatment with Cilostazol Viatris, make sure that:

• If you need to undergo surgery, including dental extraction, inform your doctor or dentist that you are taking cilostazol.
• If you have easy bruising or bleeding, stop taking cilostazol and inform your doctor.

Taking Cilostazol Viatris with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription.

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

• Aspirin.
• Clopidogrel.
• Anticoagulant medications (e.g., warfarin, dabigatran, rivaroxaban, apixaban, or low molecular weight heparins).

In the case of taking these medications with Cilostazol Viatris, your doctor may need to perform routine blood tests.

Determined medications may interfere with the effect of cilostazol when taken together. They may increase the adverse effects of cilostazol or reduce its efficacy. Cilostazol Viatris may have the same effects on other medications. 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 excessive stomach acid).
• Diltiazem (to treat high blood pressure or chest pain).
• Cisapride (to treat some stomach disorders).
• Atorvastatin, simvastatin, or lovastatin (to treat high cholesterol in the blood).
• Halofantrine (to treat malaria).
• Pimozide (to treat mental disorders).
• Derivatives of ergot (to treat migraines, e.g., ergotamine, dihydroergotamine).
• Carbamazepine or phenytoin (to treat seizures).
• St. John's Wort or Hypericum (phytotherapeutic product).

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

Before starting to take Cilostazol Viatris, inform your doctor if you are taking medications to treat high blood pressure, as cilostazol may have an additional effect of lowering blood pressure. In the case of excessive blood pressure lowering, you may experience an acceleration of heart rate. Among these medications are:

• Diuretics (e.g., hydrochlorothiazide, furosemide).
• Calcium channel blockers (e.g., verapamil, amlodipine).
• ACE inhibitors (e.g., captopril, lisinopril).
• Angiotensin II receptor blockers (e.g., valsartan, candesartan).
• Beta-blockers (e.g., labetalol, carvedilol).

You may be able to take the mentioned medications together with Cilostazol Viatris. Your doctor will decide if this is suitable in your case.

Taking Cilostazol Viatris with food and drinks

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 NOT TAKEcilostazol during pregnancy.

DO NOT RECOMMENDtaking cilostazol during breastfeeding.

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

Driving and operating machinery

Cilostazol may cause dizziness. If you feel dizzy after taking cilostazol, DO NOT drive or operate any tools or machinery and inform your doctor or pharmacist.

• Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.
• The recommended dose is one 100 mg tablet twice a day (in the morning and in the evening). It is not necessary to adjust this dose for elderly patients. However, your doctor may prescribe a lower dose if you are taking other medications that could affect cilostazol. Take 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 at 4-12 weeks of treatment. At 3 months of treatment, your doctor will evaluate 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 any tablets of cilostazol for any reason more 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Cilostazol Viatris

Do not worry if you forget to take a dose. Wait until the next dose, take your next tablet, and continue treatment as usual. DO NOT take a double dose to compensate for the missed doses.

If you interrupt treatment with 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 detect emergency medical attention required side effects (see section 4) or if your doctor advises you to do so.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications,thismedication may cause side effects, although not everyone will experience them.

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

• Stroke
• Heart attack
• Heart problems, which may cause difficulty breathing or swelling of the ankles
• Irregular heartbeats (new or worsening)
• Notable bleeding
• Tendency to bruise easily
• Severe skin condition with blistering of the skin, mouth, eyes, and genitals
• Yellowing of the skin or white of the eyes due to liver or blood problems (jaundice)

You should also inform your doctor immediately if you experience fever or sore throat. Blood tests may be required; your doctor will decide on the treatment you should receive.

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
• Unpleasant feeling (nausea or vomiting)
• Loss of appetite (anorexia)
• Excessive belching or gas (flatulence)
• Inflammation of the ankles, feet, or face
• Rash or changes in skin appearance
• Itching 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 may cause difficulty breathing or swelling of the ankles
• Pneumonia
• Cough
• Chills
• Unexpected bleeding
• Tendency to bleed (e.g., in the stomach, eyes, or muscles, nosebleed, or presence of blood in sputum or urine)
• Decreased red blood cell count in the blood
• Dizziness when standing up
• Fainting
• Anxiety
• Difficulty falling asleep
• Abnormal dreams
• Allergic reaction
• Pain and discomfort
• Diabetes and increased blood sugar concentration
• Stomach pain (gastritis)
• General discomfort

Diabetics may be at a higher risk of eye bleeding.

Rare side effects(may affect up to 1 in 1000 people).

• Tendency to bleed for a longer time 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
• Decreased red blood cell, white blood cell, and platelet count in the blood
• Difficulty breathing
• Difficulty moving
• Fever
• Hot flashes
• Eczema and other skin eruptions
• Decreased sensation in the skin
• Runny or sticky eyes (conjunctivitis)
• Tinnitus in the ears (tinnitus)
• Liver problems, including hepatitis
• Changes in urine

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es.By reporting these side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the carton box and the blister pack, after "CAD". The expiration date is the last day of the month indicated.

Do not use this medication if you detect visible signs of deterioration.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Cilostazol Viatris Composition

The active ingredient is cilostazol. A tablet contains 100 mg of cilostazol.

The other ingredients are cornstarch, cellulose microcrystalline, calcium carmelose, hypromelose, and magnesium stearate.

Appearance of Cilostazol Viatris and packaging contents

The 100 mg Cilostazol Viatris tablet is white, off-white, round, flat-faced, and marked with "100" on one face.

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

Only some packaging sizes may be commercially available.

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

Further information about this medication can be obtained by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medication is authorized in the European Economic Area member states with the following trade names:

Fechadelaúltimarevisióndeesteprospecto:April 2019

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/