Cilostazol Vir 100 mg tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
Cilostazol VIR 100 mg tablets EFG
Read the entire leaflet carefully before you start taking this medicine, as 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 and should not be given to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Cilostazol VIR is and what it is used for
- What you need to know before taking Cilostazol VIR
- How to take Cilostazol VIR
- Possible side effects
- How to store Cilostazol VIR
- Contents of the pack and other information
1. What Cilostazol VIR is and what it is used for
Cilostazol VIR belongs to a group of medicines known as 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.
Your doctor has prescribed Cilostazol VIR 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 VIR 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 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 starting to take Cilostazol VIR
Do not take Cilostazol VIR
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if you are allergic to cilostazol or any of the other ingredients of this medicine,
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if you have a condition known as "heart failure",
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if you have persistent chest pain at rest, or have had a "heart attack" or any heart surgery in the last six months,
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if you currently have or have previously had fainting episodes due to heart disease or serious heart rhythm disorders,
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if you know you have any condition that increases your 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
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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]
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severe kidney disease or moderate to severe liver disease,
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if you are pregnant.
Warnings and precautions
Before taking Cilostazol VIR, make sure your doctor knows:
- if you have any serious heart problems or other heart rhythm disorders;
- if you have any blood pressure disorders.
While being treated with Cilostazol VIR, ensure that:
- If you need to undergo any surgical procedure, including tooth extraction, inform your doctor or dentist that you are taking Cilostazol VIR.
- If you bruise or bleed easily, stop taking Cilostazol VIR and inform your doctor.
Taking Cilostazol VIR with other medicines
Before starting Cilostazol VIR, 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 should specifically inform your doctor if you are taking medicines commonly used to treat painful and/or inflammatory conditions of the muscles or joints, as well as medicines to 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 VIR, your doctor may need to carry out routine blood tests.
Certain medicines may interfere with the effect of Cilostazol VIR when taken together. They may increase the side effects of Cilostazol VIR or reduce its effectiveness. Cilostazol VIR may also have similar effects on other medicines. Before starting Cilostazol VIR, 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 in the blood)
- 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 medicine)
If you have any doubts about whether this applies to the medicines you are taking, consult your doctor or pharmacist.
Before starting Cilostazol VIR, inform your doctor or pharmacist if you are taking medicines for high blood pressure, as Cilostazol VIR may have an additional blood pressure-lowering effect. If your blood pressure drops too much, 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 to take the above-mentioned medicines together with Cilostazol VIR. Your doctor will decide whether this is appropriate for you.
Use of Cilostazol VIR with food, drinks, and alcohol
Take Cilostazol VIR tablets 30 minutes before breakfast and dinner.
Always take the tablets with a glass of water.
Pregnancy, breast-feeding, and fertility
DO NOT TAKE Cilostazol VIR during pregnancy.
IT IS NOT RECOMMENDED to take Cilostazol VIR during breast-feeding.
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Cilostazol VIR may cause dizziness. If you feel dizzy after taking Cilostazol VIR, DO NOT drive or operate any tools or machinery, and inform your doctor or pharmacist.
3. How to take Cilostazol VIR
Follow exactly the instructions for use of this medicine as given by your doctor. 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 a lower dose if you are taking other medicines that could interfere with the effect of cilostazol.
You should take Cilostazol VIR tablets 30 minutes before breakfast and dinner. Always take the tablets with a glass of water.
You may start to notice beneficial effects of Cilostazol VIR within 4 to 12 weeks of treatment. After 3 months of treatment, your doctor will assess your progress and may recommend that you stop taking cilostazol if the treatment effect is insufficient.
Use in children and adolescents
Cilostazol VIR is not suitable for children.
If you take more Cilostazol VIR than you should
If you take more Cilostazol VIR 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 VIR
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 a missed dose.
If you stop taking Cilostazol VIR
If you stop treatment with Cilostazol VIR, the pain in your legs may return or worsen. Therefore, you should only stop taking Cilostazol VIR if you experience adverse effects requiring urgent medical attention (see section 4) or if your doctor advises you to do so.
4. Possible adverse effects
Like all medicines, Cilostazol VIR 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 VIR 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
- Increased tendency to bruise
- Severe illness with blistering of 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 VIR. If you experience any of them, you must inform your doctor immediately:
Very common adverse effects (may affect more than 1 in 10 people)
- Headache
- Abnormal bowel movements
- Diarrhea
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 (indigestion)
- Stomach discomfort (nausea or vomiting)
- Loss of appetite (anorexia)
- 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 presence of 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 concentration of platelets in the blood
- Kidney problems
The following adverse effects have been observed during treatment with Cilostazol VIR, 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 sensation in the skin
- 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 type of adverse effect, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Cilostazol VIR Storage
Keep this medicine out of the sight and reach of children.
No special storage conditions required.
Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Cilostazol VIR
- 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 medicine and contents of the pack
Cilostazol VIR 100 mg is a white, round tablet, scored on one side. Your medicine is supplied in packs of 56 or 60 tablets, or in hospital packs containing 70 tablets (5x14).
Marketing Authorization Holder and Manufacturer
Industria Química y Farmacéutica VIR, S.A.
C/ Laguna 66-70, Polígono Industrial URTINSA II
28923 Alcorcón (Madrid)
Spain
Date of the most recent review of this leaflet: November 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/