Cilostazol Kern Pharma 100 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Cilostazol Kern Pharma 100 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet as 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 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 adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Cilostazol Kern Pharma is and what it is used for

Cilostazol Kern Pharma belongs to a group of medicines known as type 3 phosphodiesterase inhibitors.

It has various 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 Kern Pharma for "intermittent claudication". Intermittent claudication is cramp-like pain in the legs that occurs when walking and is caused by an insufficient blood supply to the legs. Cilostazol Kern Pharma may help you increase the walking distance, as it improves blood circulation in the legs. Cilostazol is recommended only for patients whose symptoms have not improved sufficiently after making lifestyle changes (such as quitting smoking and increasing physical activity) and after other appropriate interventions. It is important that you continue with any lifestyle changes you have made while taking cilostazol.

2. What you need to know before taking Cilostazol Kern Pharma

Do not take Cilostazol Kern Pharma

• if you are allergic to cilostazol or any of the other ingredients of this medicine,

• 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 within the last six months,

• if you currently have or have previously had episodes of fainting due to heart disease or serious heart rhythm disorders,

• if you know you have any condition that increases the risk of bleeding or bruising, for example:

  • active stomach ulcers
  • stroke (cerebrovascular accident) within the past six months
  • eye problems if you have diabetes
  • uncontrolled high blood pressure

• if you are taking acetylsalicylic acid and clopidogrel, or any combination of two or more medicines that could increase your 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

Talk to your doctor or pharmacist before starting to take Cilostazol Kern Pharma.

Before taking Cilostazol Kern Pharma, make sure your doctor knows:

• if you have any serious heart problems or any other heart rhythm disorders;

• if you have any blood pressure disorders.

• While being treated with Cilostazol Kern Pharma, ensure that:

• If you need to undergo surgery, including dental extractions, inform your doctor or dentist that you are taking cilostazol.

• If you bruise or bleed easily, stop taking cilostazol and contact your doctor.

Taking Cilostazol Kern Pharma with other medicines

Before starting Cilostazol Kern Pharma, tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including over-the-counter medicines.

You must specifically inform your doctor if you are taking medicines commonly used to treat pain and/or inflammation in muscles or joints, or if you are taking medicines that reduce blood clotting. These include:

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

If you are taking any of these medicines together with Cilostazol Kern Pharma, your doctor may need to perform routine blood tests.

Certain medicines may interfere with the effect of Cilostazol Kern Pharma when taken together. They may increase the side effects of cilostazol or reduce its effectiveness. Cilostazol may also have similar effects on other medicines. Before starting Cilostazol Kern Pharma, inform your doctor or pharmacist if you are taking:

• erythromycin, clarithromycin, or rifampicin (antibiotics)
• ketoconazole (for treating fungal infections)
• omeprazole (for treating excess stomach acid)
• diltiazem (for treating high blood pressure or chest pain)
• cisapride (for treating certain stomach disorders)
• lovastatin, simvastatin, or atorvastatin (for treating high cholesterol)
• halofantrine (for treating malaria)
• pimozide (for treating mental disorders)
• ergot derivatives (for treating migraines, e.g., ergotamine, dihydroergotamine)
• carbamazepine or phenytoin (for treating seizures)
• St. John’s wort (Hypericum perforatum) (herbal remedy)

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

Before starting Cilostazol Kern Pharma, inform your doctor if you are taking medicines for high blood pressure, as cilostazol may have an additional blood pressure-lowering effect. If your blood pressure drops too much, you may experience a rapid heartbeat. 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)

You may be able to take the above-mentioned medicines together with Cilostazol Kern Pharma. Your doctor will decide whether this is appropriate for you.

Use of Cilostazol Kern Pharma with food, drinks, and alcohol

Take the Cilostazol Kern Pharma tablets 30 minutes before breakfast and dinner.

Always take the tablets with a glass of water.

Pregnancy, breastfeeding, and fertility

DO NOT TAKE Cilostazol Kern Pharma during pregnancy.

IT IS NOT RECOMMENDED to take Cilostazol Kern Pharma during breastfeeding.

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

Driving and using machines

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

3. How to take Cilostazol Kern Pharma

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

The usual dose is one 100 mg tablet twice daily (in the morning and at night). It is not necessary to adjust this dose in elderly patients. However, your doctor may need to prescribe you a lower dose if you are taking other medicines that could interfere with the effect of cilostazol.

You should take Cilostazol Kern Pharma tablets 30 minutes before breakfast and dinner. Always take the tablets with a glass of water.

You may begin to notice the beneficial effects of taking Cilostazol Kern Pharma within 4 to 12 weeks of treatment. After 3 months of treatment, your doctor will evaluate your progress and may recommend that you stop taking cilostazol if the treatment effect is insufficient.

Use in children and adolescents

Cilostazol Kern Pharma is not suitable for children.

If you take more Cilostazol Kern Pharma than you should

If you take more Cilostazol Kern Pharma tablets than you should, for any reason, you may experience symptoms such as severe headache, diarrhea, low blood pressure, and irregular heartbeat.

In case of overdose or accidental ingestion, contact your doctor immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Cilostazol Kern Pharma

Do not worry if you forget to take a dose. Wait until your next scheduled dose and continue taking the medicine as normal.

Do not take a double dose to make up for forgotten doses.

If you stop taking Cilostazol Kern Pharma

If you stop treatment with Cilostazol Kern Pharma, the pain in your legs may return or worsen. Therefore, you should only stop taking Cilostazol Kern Pharma if you experience adverse effects requiring urgent medical attention (see section 4) or if your doctor instructs you to do so.

4. Possible adverse effects

Like all medicines, Cilostazol Kern Pharma can have adverse effects, although not everyone experiences them.

If any of the following adverse effects occur, you may need urgent medical attention. Stop taking Cilostazol Kern Pharma and contact a doctor immediately or go to the nearest hospital.

• stroke (cerebrovascular accident)
• myocardial infarction (heart attack)
• heart problems, which may cause difficulty breathing or swelling of the
  ankles
• irregular heartbeat (new onset or worsening)
• significant bleeding
• easy bruising
• serious illness with blister formation on the skin, mouth, eyes, or genitals
• yellowing of the skin or whites of the eyes due to liver or blood problems (jaundice)

You should also inform your doctor immediately if you develop fever or sore throat. You may need blood tests; your doctor will decide on the appropriate treatment.

The following adverse effects have been observed in patients treated with cilostazol. If you experience any of these, inform your doctor immediately:

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

• headache
• abnormal bowel movements
• diarrhoea

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

• rapid heartbeat
• palpitations
• chest pain
• dizziness
• sore throat
• runny nose (rhinitis)
• abdominal pain
• abdominal discomfort
• stomach discomfort (nausea or vomiting)
• excess gas or flatulence
• swelling of the ankles, feet, or face
• rash or skin changes
• itching of the skin
• bleeding spots on the skin
• general weakness

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

• heart attack (myocardial infarction)
• irregular heartbeat (new onset or worsening)
• heart problems that may cause difficulty breathing or swelling of the
  ankles
• pneumonia
• cough
• chills
• unexpected bleeding
• tendency to bleed (e.g. from the stomach, eyes, or muscles, nosebleeds, or blood in sputum or urine)
• decrease in the number of red blood cells in the blood
• dizziness upon standing
• fainting
• anxiety
• difficulty falling asleep
• abnormal dreams
• allergic reaction
• pain and discomfort
• diabetes and increased blood sugar concentration
• stomach pain (gastritis)
• general malaise

Diabetic patients may have an increased risk of ocular bleeding.

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

• tendency to bleed for longer than normal
• increased platelet concentration in the blood
• kidney problems

The following adverse effects have been observed during treatment with Cilostazol, but their frequency is unknown:

• changes in blood pressure
• decrease in the concentration of red blood cells, white blood cells, and platelets in the
  blood
• difficulty breathing
• difficulty moving
• fever
• hot flushes
• eczema and other skin rashes
• decreased skin sensation
• watery or sticky eyes (conjunctivitis)
• ringing in the ears (tinnitus)
• liver problems, including hepatitis
• changes in urine

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is an effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Cilostazol Kern Pharma

Keep this medicine out of sight and reach of children.

No special storage conditions required.

Do not use this medicine after the expiry date indicated on the packaging after "EXP". The expiry date refers to the last day of the month shown.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Cilostazol Kern Pharma

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

Appearance of the product and contents of the pack

Cilostazol Kern Pharma 100 mg is a white, round tablet, scored on one side. The tablet can be divided into equal halves.

Your medicine is supplied in packs of 56 tablets or in hospital packs containing 70 (5x14) tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder

Kern Pharma, S.L.

Polígono Ind. Colón II

Venus 72

08228 Terrassa (Spain)

Manufacturer

NOUCOR HEALTH, S.A.

Av. Camí Reial 51-57

08184 Palau-solità i Plegamans

Barcelona - Spain

Date of the most recent revision of this leaflet: October 2013

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