CILOSTOP 100 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. CILOSTOP
3. 100 mg, tablets
   1. Please read the contents of the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is Cilostop and what is it used for
5. Important information before taking Cilostop
   1. When not to take Cilostop
   2. Warnings and precautions
   3. Children
   4. Cilostop and other medicines
   5. Cilostop with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
6. How to take Cilostop
   1. Cilostop is not intended for children.
   2. Taking more Cilostop than prescribed
   3. In case of taking more tablets than prescribed, the patient should immediately contact their doctor or local hospital. They should also bring the packaging of the medicine, so it is clear what medicine was taken.
   4. Missing a dose of Cilostop
   5. Stopping Cilostop treatment
7. Possible side effects
   1. If the patient experiences any of the following side effects, they may need urgent medical attention. They should immediately stop taking Cilostop and contact their doctor or go to the nearest hospital:
   2. The following side effects have been reported with Cilostop. The patient should inform their doctor as soon as possible if they occur:
   3. The following side effects have been reported with Cilostop, but it is not known how often they may occur:
   4. Reporting side effects
8. How to store Cilostop
9. Package contents and other information
   1. What Cilostop contains
   2. What Cilostop looks like and what the package contains
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the leaflet: 12.06.2023

Leaflet attached to the packaging: patient information

CILOSTOP

100 mg, tablets

Cilostazol

Please read the contents of the leaflet carefully before using the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Cilostop and what is it used for
• 2. Important information before taking Cilostop
• 3. How to take Cilostop
• 4. Possible side effects
• 5. How to store Cilostop
• 6. Package contents and other information

1. What is Cilostop and what is it used for

Cilostop belongs to a group of medicines called phosphodiesterase type 3 inhibitors.
It causes various effects, including the dilation of certain blood vessels and the reduction of the activity of blood clotting (aggregation) of certain blood cells, called platelets, within blood vessels.
Cilostop has been prescribed to treat "intermittent claudication".
Intermittent claudication is a type of cramp-like pain in the lower limbs that occurs during walking and is caused by insufficient blood flow to the legs.
Cilostop increases the distance that a patient can walk without experiencing pain, by improving blood circulation in the lower limbs.
Cilostazol is recommended only for patients in whom lifestyle modifications (including smoking cessation and increased exercise intensity) and other appropriate interventions have not sufficiently alleviated symptoms.
It is essential that the patient continues to apply the introduced lifestyle modifications during treatment with cilostazol.

2. Important information before taking Cilostop

When not to take Cilostop

• if the patient is allergic to cilostazol or any of the other ingredients of this medicine (listed in section 6);
• if the patient has heart failure;
• if the patient has resting chest pain or has had a "heart attack" or any heart surgery in the last six months;
• if the patient has currently or in the past experienced transient loss of consciousness due to heart disease or any severe heart rhythm disorders;
• if the patient has been diagnosed with a condition that increases the risk of bleeding or bruising, such as:
• active gastric ulcer,
• stroke in the last six months,
• eye problems in diabetes,
• uncontrolled high blood pressure,
• treatment with both acetylsalicylic acid and clopidogrel or any combination of two or more medicines that may increase the risk of bleeding [in case of doubt, consult a doctor or pharmacist];
• if the patient has severe kidney disease or moderate to severe liver disease;
• if the patient is pregnant.

Warnings and precautions

Before starting treatment with Cilostop, the patient should discuss it with their doctor or pharmacist.
Additionally, before starting treatment with Cilostop, the patient should ensure that their doctor is aware of:

• any severe heart disease or heart rhythm problems;
• any blood pressure problems.

During treatment with Cilostop:

• if surgery is required, including tooth extraction, the doctor or dentist should be informed about the use of Cilostop;
• in case of suspected bruising or bleeding, the patient should stop taking Cilostop and inform their doctor.

Children

Cilostop is not intended for children.

Cilostop and other medicines

Before starting treatment with Cilostop, the patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription.
In particular, the patient should inform their doctor about taking certain medicines that are usually used to treat pain and/or inflammation of muscles or joints, as well as medicines that reduce blood clotting. These medicines include:

• acetylsalicylic acid,
• clopidogrel,
• anticoagulants (e.g., warfarin, dabigatran, rivaroxaban, apixaban, or low molecular weight heparins). If such medicines are used together with Cilostop, the doctor may perform certain routine blood tests. Some concomitantly used medicines may interfere with the action of Cilostop. They may enhance the side effects of Cilostop or reduce its effectiveness. Cilostop may similarly affect other medicines. Before starting treatment with Cilostop, the patient should inform their doctor about taking:
• erythromycin, clarithromycin, or rifampicin (antibiotics);
• ketoconazole (used to treat fungal infections);
• omeprazole (used to treat increased stomach acid);
• diltiazem (used to treat high blood pressure or chest pain);
• cisapride (used to treat stomach disorders);
• lovastatin, simvastatin, or atorvastatin (used to treat high cholesterol);
• halofantrine (used to treat malaria);
• pimozide (used to treat mental disorders);
• ergot derivatives (used to treat migraines, e.g., ergotamine, dihydroergotamine);
• carbamazepine or phenytoin (used to treat seizures);
• St. John's Wort (herbal preparation).

In case of doubt whether the above requirement applies to the medicines taken by the patient, they should consult their doctor or pharmacist.
Before starting treatment with Cilostop, the patient should inform their doctor if they are taking medicines for high blood pressure, as Cilostop may cause additional blood pressure-lowering effects. If excessive blood pressure lowering occurs, it may lead to rapid 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 blockers (e.g., valsartan, candesartan),
• beta-blockers (e.g., labetalol, carvedilol).

It is possible that concomitant use of the above medicines and Cilostop will still be acceptable, and the doctor will be able to decide what treatment is appropriate for the patient.
It is recommended that the patient brings the packaging of Cilostop and other medicines they are taking to their doctor, who will decide on their further use.

Cilostop with food and drink

Cilostop tablets should be taken 30 minutes before breakfast and dinner.
The tablets should always be swallowed with water.

Pregnancy and breastfeeding

Cilostop MUST NOTbe used during pregnancy.
IT IS NOT RECOMMENDEDto use Cilostop in breastfeeding mothers.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.

Driving and using machines

Cilostop may cause dizziness. If dizziness occurs after taking Cilostop tablets, the patient MUST NOTdrive or use any tools or machines; they should inform their doctor or pharmacist.

3. How to take Cilostop

• This medicine should always be taken as directed by the doctor. In case of doubt, the patient should consult their doctor or pharmacist.
• The recommended dose is one 100 mg tablet twice a day (in the morning and evening). No dose adjustment is required for elderly patients. However, the doctor may prescribe a lower dose if the patient is taking medicines that may affect the action of Cilostop.
• Cilostop tablets should be taken 30 minutes before breakfast and dinner.
• The tablets should always be taken with water.
• The tablet can be divided into two equal doses.

Some benefits of using Cilostop may be noticeable after 4-12 weeks of treatment.
The doctor will assess the effectiveness after 3 months of treatment and may recommend stopping cilostazol treatment if the therapy is not effective enough.

Cilostop is not intended for children.

Taking more Cilostop than prescribed

If the patient has taken more Cilostop tablets than they should, they may experience objective and subjective symptoms, such as severe headaches, diarrhea, low blood pressure, and irregular heart rhythm.

In case of taking more tablets than prescribed, the patient should immediately contact their doctor or local hospital. They should also bring the packaging of the medicine, so it is clear what medicine was taken.

Missing a dose of Cilostop

There is no reason to worry if a dose is missed. The patient should wait and take the next dose at the right time, and then continue taking the medicine as directed. THE PATIENT MUST NOTtake a double dose to make up for the missed tablet.

Stopping Cilostop treatment

If the patient stops taking Cilostop, the pain in the lower limbs may return or worsen. Therefore, the patient should only stop taking Cilostop if they experience side effects that require urgent medical attention (see section 4) or on the advice of their doctor.

4. Possible side effects

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

If the patient experiences any of the following side effects, they may need urgent medical attention. They should immediately stop taking Cilostop and contact their doctor or go to the nearest hospital:

• stroke
• heart attack
• heart problems that can cause shortness of breath or swelling of the ankles (ankle joints)
• irregular heart rhythm (new or worsening symptom)
• visible bleeding
• easy bruising
• severe skin disease with blisters, in the mouth, eyes, and genitals
• yellowing of the skin or whites of the eyes due to liver or blood disorders (jaundice) The patient should also immediately inform their doctor if they experience fever or sore throat. The doctor may need to perform certain blood tests and decide on further treatment.

The following side effects have been reported with Cilostop. The patient should inform their doctor as soon as possible if they occur:

Very common side effects(occurring in more than 1 in 10 people):

• headache
• abnormal stools
• diarrhea Common side effects(occurring in 1 to 10 people in 100):
• rapid heart rate
• palpitations (irregular heart rhythm)
• chest pain
• dizziness
• sore throat
• runny nose (rhinitis)
• abdominal pain
• discomfort in the abdominal area (indigestion)
• nausea or vomiting
• loss of appetite (anorexia)
• excessive gas or belching (bloating with gas)
• swelling of the ankles, feet, or face
• rash or skin changes
• itching
• petechiae (small red or purple spots on the skin)
• general weakness

Uncommon side effects(occurring in 1 to 10 people in 1,000):

• heart attack
• irregular heart rhythm (new or worsening symptom)
• heart problems that can cause shortness of breath or swelling of the ankles (ankle joints)
• pneumonia
• cough
• chills
• unexpected bleeding
• tendency to bleed (e.g., in the stomach, eye, or muscles, nosebleeds, and blood in sputum or urine)
• reduced red blood cell count
• dizziness when standing up
• fainting
• anxiety
• sleep disorders
• nightmares
• allergic reaction
• pain and aches
• diabetes and high blood sugar
• stomach pain (gastritis)
• malaise

In people with diabetes, there may be a higher risk of bleeding into the eye.
Rare side effects(occurring in 1 to 10 people in 10,000):

• tendency to bleed longer than normal
• increased platelet count
• kidney problems

The following side effects have been reported with Cilostop, but it is not known how often they may occur:

• blood pressure changes
• reduced red blood cell, white blood cell, and platelet count
• breathing difficulties
• mobility problems
• fever
• hot flashes
• rash and other skin eruptions
• numbness of the skin
• conjunctivitis (discharge or sticky eyes)
• tinnitus (ringing in the ears)
• liver problems, including hepatitis
• changes in urine

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Cilostop

The medicine should be stored out of sight and reach of children.
There are no special storage instructions for the medicine.
Do not use this medicine after the expiry date stated on the carton and blister.
The expiry date refers to the last day of the month stated.
The expiry date is stated on the carton as "Expiry date (EXP)" and on the blister as "EXP:". The batch number is stated on the carton as "Batch number (Lot)" and on the blister as "Lot:". Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer required. This will help protect the environment.

6. Package contents and other information

What Cilostop contains

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

What Cilostop looks like and what the package contains

Cilostop, 100 mg tablet, is a white, round tablet with a dividing line on one side.
The tablets are packaged in PVC/Aluminum blisters, which are placed together with the patient leaflet in a cardboard box.
The package contains 14, 25, 28, 30, 50, 56, 60, 70, 84, 90, 98, 100, 112, 120, or 168 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

BIOFARM Sp. z o.o.
Wałbrzyska Street 13
60-198 Poznań
phone: +48 61 66 51 500
fax: +48 61 66 51 505
[email protected]

Manufacturer

BIOFARM Sp. z o.o.
Wałbrzyska Street 13
60-198 Poznań
Camí Reial Avenue 51-57,
Palau-solità i Plegamans
08184 Barcelona
Spain
Galenicum Health, S.L.U.
Sant Gabriel, 50
Esplugues de Llobregat
08950 Barcelona
Spain

Date of last revision of the leaflet: 12.06.2023