50 mg and 100 mg tablets of 
cilostazol

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, 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 give it to others. It may harm them, even if they show symptoms similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

This leaflet contains information about: 
1. What Cilostazol Evolan is and what it is used for 
2. What you need to know before you use Cilostazol Evolan 
3. How to use Cilostazol Evolan 
4. Possible side effects 
5. How to store Cilostazol Evolan 6. Contents of the pack 
and other information 

What Cilostazol Evolan is and what it is used for

Cilostazol Evolan belongs to a group of medicines called phosphodiesterase type 3 inhibitors. It works in several different ways, including dilation of certain blood vessels and reduction of the coagulation (clumping) of the so-called platelets in the blood vessels.

You have been prescribed Cilostazol Evolan for “ intermittent claudication ”. Peephole disease is a cramp-like pain in the legs when walking due to insufficient blood supply to the legs. Cilostazol Evolan can increase the distance you can walk without pain because it improves blood circulation in the legs. Cilostazol is only recommended for patients whose symptoms have not improved enough after lifestyle-related changes (eg smoking cessation and increased exercise) and after other appropriate measures. It is important that you continue with the changes you have made to your lifestyle while taking cilostazol.

Cilostazol contained in Cilostazol Evolan may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before using Cilostazol Evolan

Do not use Cilostazol Evolan

If you are allergic (hypersensitive) to cilostazol or any of the other ingredients of this medicine (listed in section 6).

• if you have 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 or have been suffering from temporary unconsciousness due to heart disease or severe heart rhythm disorders.

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

– active stomach ulcer

– has suffered a stroke in the last six months

– have eye problems and have diabetes

– if your blood pressure is not well controlled

• if you are taking both acetylsalicylic acid and clopidogrel or any other combination of 2 or more medicines that may increase the risk of bleeding (ask your doctor or pharmacist if you are not sure).

• if you have severe kidney disease or moderate to severe liver disease.

• if you are pregnant.

Warnings and cautions

Talk to your doctor or pharmacist before taking Cilostazol Evolan.

Before taking Cilostazol Evolan, you must tell your doctor:

• if you have a serious heart condition or heart rhythm problem

• if you have problems with blood pressure.

During treatment with Cilostazol Evolan

• tell your doctor or dentist that you are taking Cilostazol Evolan, if you are going to have surgery, including having a tooth extracted.

• stop taking Cilostazol Evolan and talk to a doctor if you experience bruising or bleeding easily.

Other medicines and Cilostazol Evolan

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, you should tell your doctor if you are taking any medicines commonly used to treat painful and/or inflammatory conditions in muscles or joints, or if you are taking medicines that reduce the blood’s ability to form blood clots.

These medicines include:

– acetylsalicylic acid

– clopidogrel

– blood thinners (eg warfarin, dabigatran, rivaroxaban, apixaban, or low molecular weight heparins ).

If you are taking such medicines with Cilostazol Evolan, your doctor may take some routine blood tests.

Some medicines may affect the effect of Cilostazol Evolan when taken together. They can either increase the side effects of Cilostazol Evolan or make Cilostazol Evolan less effective. Cilostazol Evolan may have the same effect on other medicines. Before you start taking Cilostazol Evolan, talk to your doctor if you are using:

• erythromycin, clarithromycin, or rifampicin ( antibiotics )

• ketoconazole (for the treatment of fungal infections)

• omeprazole (for the treatment of too much stomach acid)

• diltiazem (for the treatment of high blood pressure or chest pain)

• cisapride (for the treatment of stomach upset)

• lovastatin, simvastatin, or atorvastatin (for the treatment of high cholesterol in the blood)

• halofantrine (for the treatment of malaria )

• pimozide (for the treatment of mental illness)

• powdery mildew derivatives (for the treatment of migraines eg ergotamine, dihydroergotamine)

• carbamazepine or phenytoin (for the treatment of seizures)

• wort (a herbal product)

If you are not sure if this applies to your medicines, talk to your doctor or pharmacist.

Before you start taking Cilostazol Evolan Tell your doctor if you are taking medicines for high blood pressure as Cilostazol Evolan may have a further lowering effect on your blood pressure. If your blood pressure drops too low, it can cause a rapid heartbeat. These medicines include:

• diuretics (eg hydrochlorothiazide, furosemide )

Calcium channel blockers (eg verapamil, amlodipine)

• ACE inhibitors (eg captopril, lisinopril)

• angiotensin II receptor blockers (e.g., valsartan, candesartan)

Beta-blockers (eg labetalol, carvedilol).

It may be a good idea to take the above medicines together with Cilostazol Evolan and your doctor will be able to decide what is right for you.

Cilostazol Evolan with food, drink, and alcohol

Cilostazol Evolan tablets should be taken 30 minutes before breakfast or supper.

Always take your tablets with some water.

Pregnancy, breastfeeding, and fertility

Cilostazol Evolan SHOULD NOT be used during pregnancy.

Cilostazol Evolan is NOT RECOMMENDED in breast-feeding women.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Cilostazol Evolan may cause dizziness. If you feel dizzy after taking Cilostazol Evolan tablets, DO NOT drive or use any tools or machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects

is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

3. How to use Cilostazol Evolan

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose is 100 mg (two 50 mg tablets or one 100 mg tablet) twice daily (morning and evening) This dose does not need to be changed in the elderly.

However, your doctor may give you a lower dose if you are taking other medicines that may affect the way Cilostazol Evolan works.

Cilostazol Evolan should be taken 30 minutes before breakfast and supper. Always take the tablets with some water.

In some cases, the effect of Cilostazol Evolan is noticeable within 4 – 12 weeks of treatment. Your doctor will evaluate the treatment results after 3 months of treatment and may recommend that you stop taking cilostazol if the effect of the treatment is insufficient.

Use for children and adolescents

Cilostazol Evolan is not suitable for children

If you use more Cilostazol Evolan than you should  

If for any reason you happen to take more Cilostazol Evolan tablets than you should, you may experience signs and symptoms such as severe headache, diarrhea, drop in blood pressure, and irregular heartbeat.

If you forget to use Cilostazol Evolan

If you happen to miss a dose, you do not have to worry; wait for the next dose and take that tablet as usual. DO NOT take a double dose to make up for a forgotten tablet.

If you stop using Cilostazol Evolan

If you stop taking Cilostazol Evolan, your leg pain may return or worsen. Therefore, you should only stop taking Cilostazol Evolan if you notice side effects that require urgent medical attention (see section 4) or if your doctor tells you to.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If any of the following side effects occur, you may need urgent medical attention. Stop taking Cilostazol Evolan and contact a doctor or see your nearest hospital immediately.

• stroke

• heart attack

• heart problems that cause shortness of breath or swelling of the ankles

• irregular heartbeat (new or worsening condition)

• visible bleeding

• easy to get bruises

• severe disease with blistering of the skin, mouth, eyes, or genitals

Yellowing of the skin and/or eyes caused by liver or blood problems (jaundice).

You should also immediately inform your doctor if you get a fever or sore throat. You may need blood tests and your doctor will decide on your further treatment.

The following side effects have been reported with Cilostazol Evolan. Inform your doctor as soon as possible.

Very common (may affect more than 1 user in 10)

• headache

• abnormal stools

• diarrhea.

Common (may affect up to 1 in 10 people)

• fast heartbeat

• palpitations

• chest pain

• dizziness

• sore throat

• runny nose ( rhinitis )

• abdominal pain

• stomach upset (indigestion)

• nausea or vomiting

• loss of appetite

• gases or weather stress (copious belching, bloating)

• swollen ankles, feet, or face

• eczema or skin changes

• itching of the skin

• spotty bleeding in the skin

• general feeling of weakness.

Uncommon (may affect up to 1 in 100 people)

• heart attack

• irregular heartbeat (new or worsening condition)

• heart problems that cause shortness of breath or swelling of the ankles

• pneumonia

• cough

• chills

• unexpected bleeding

• bleeding tendency (eg from stomach, eyes or muscle, nosebleeds, and blood in saliva or urine)

• reduction of red blood cells in the blood

• dizziness when getting up from sitting or lying down

• fainting

• or

• sleeping problems

• unusual dreams

• allergic reaction

• aches and pains

• diabetes and high blood sugar

• abdominal pain ( gastritis )

• general malaise.

There may be an increased risk of bleeding in the eyes of diabetics.

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

• tendency to bleed longer than usual

• increased amount of platelets

• kidney problems.

The following side effects have been reported with the use of Cilostazol Evolan but it is not known how often they can occur:

• changed blood pressure

• decreased amount of red blood cells, white blood cells, and platelets

• difficulty breathing

• difficulty moving

• fever

• hot flashes

• eczema and other skin rashes

• decreased skin sensitivity

• watery or itchy eyes ( conjunctivitis )

• tinnitus ( tinnitus )

• liver problems incl. hepatitis

• changes in the urine.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Cilostazol Evolan

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. date: The expiration date is the last day of the specified month.

No special storage instructions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

– The active substance is cilostazol.

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

What the medicine looks like and the contents of the pack

Cilostazol Evolan 50 mg tablets are white, off-white, round, flat tablets imprinted with “50” on one side.

Cilostazol Evolan 100 mg tablets are white, off-white, round, flat tablets imprinted with “100” on one side.

The drug is sold in packs of 7, 14, 20, 28, 30, 50, 56, 60, 98, 100 tablets packed in PVC / PVDC aluminum blisters.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Evolan Pharma AB

Box 120

182 12 Danderyd


Manufacturer

Adamed Pharma SA

ul. Marszałka Józefa Piłsudskiego Str. 5,

95-200 Pabianice

Poland

Muhammad Nadeem

Leave a Reply