Fripass

Patient Information Leaflet: Information for the User

Fripass 50 mg tablets

Cilostazol
Generic medicine
Read this entire leaflet carefully before you start taking this medicine, as it contains
important information for you.

• Keep this leaflet. 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 other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Fripass is and what it is used for

Fripass belongs to a group of medicines called antithrombotic and antiplatelet agents that
prevent the formation of blood clots and platelet aggregation, which contribute to thrombus
formation.
Fripass is indicated for the treatment of intermittent claudication (pain caused by inadequate
blood supply to the legs that occurs during walking).
Fripass is indicated in patients in whom lifestyle changes (including smoking cessation,
exercise programs, and other appropriate measures) have not sufficiently reduced the
symptoms of intermittent claudication.

2. What you need to know before taking Fripass

Do not take Fripass

• if you are allergic to cilostazol or to any of the other ingredients of this medicine (listed in section 6).
• if you have a condition called "heart failure".
• if you experience persistent chest pain at rest, or if you have had a "heart attack" or any heart surgery within the last six months.
• if you have ever had or currently have fainting episodes caused by heart disease, or serious heart rhythm disorders.
• if you know you have a condition that increases the risk of bleeding or bruising, for example:
• one or more active stomach ulcers.
• a stroke that occurred within the last six months.
• eye problems if you have diabetes.
• if your blood pressure is not well controlled.
• if you are taking both acetylsalicylic acid and clopidogrel, or any combination of two or more medicines that may increase the risk of bleeding (see Other medicines and Fripass).
• if you have severe kidney disease or severe or moderate liver disease.
• if you are pregnant (see Pregnancy, breastfeeding, and fertility).

Warnings and precautions
Before taking Fripass, inform your doctor if you have heart problems or suffer from diabetes.
During treatment with Fripass, it is important to inform your doctor if you bruise easily, or if you experience bleeding, fever, or sore throat.
Treatment must be promptly discontinued in case of retinal haemorrhage (bleeding in the retina, a membrane lining the inside of the eye).
If you need to undergo surgery or dental extraction, inform healthcare professionals that you are taking Fripass.
Health education notes
It is important to maintain lifestyle changes (quitting smoking, proper diet, and adequate physical activity) and to continue lipid-lowering therapies (to reduce blood fat levels) and antiplatelet treatments (to reduce the risk of blood clot formation), in order to minimize the risk of cardiovascular events, such as cardiac and cerebral ischemia (heart and brain damage due to reduced oxygen supply), renal failure (severe impairment of kidney function), and diffuse vascular disease (narrowing of the arteries).

Other medicines and Fripass
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor if you are taking:

• acetylsalicylic acid and clopidogrel (medicines that prevent blood clot formation and platelet aggregation contributing to thrombus formation)
• warfarin and other anticoagulants (medicines that delay blood clotting)
• erythromycin, clarithromycin, rifampicin, and other antibiotics (used to treat bacterial infections)
• ketoconazole and itraconazole (used to treat fungal infections)
• diltiazem (used to treat high blood pressure or heart conditions)
• omeprazole and cisapride (used to treat stomach disorders)
• lovastatin, simvastatin, or atorvastatin (used to reduce cholesterol levels in the blood)
• halofantrine (used to treat malaria, a tropical infectious disease)
• pimozide (used to treat mental disorders)
• ergot derivatives (used to treat migraine, a neurological disorder characterized by headache)
• carbamazepine or phenytoin (used to treat epilepsy, a disease causing loss of consciousness and violent involuntary muscle contractions)
• medicines used to treat HIV and hepatitis C (viral diseases)
• St. John’s wort (a herbal remedy used as an antidepressant).

Fripass and beverages
It is recommended to avoid consuming large amounts of grapefruit juice during treatment.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Fripass MUST NOT be used during pregnancy.
For women who are breastfeeding, the use of Fripass IS NOT RECOMMENDED.

Driving and using machines
Fripass may cause dizziness. If you experience dizziness after taking Fripass tablets, DO NOT drive or operate tools or machinery, and inform your doctor or pharmacist.

3. How to take Fripass

• Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
• The recommended dose is 100 mg twice daily. This dose does not require adjustment in elderly patients. However, your doctor may prescribe a lower dose if you are taking other medicines that may interfere with the effect of Fripass.
• Fripass should be taken 30 minutes before meals, in the morning and in the evening. Your doctor will assess your progress after 3 months of treatment and may advise you to discontinue cilostazol if the treatment effect is insufficient.

Children and adolescents
The safety and efficacy in children and adolescents have not been established.
If you take more Fripass than you should
If you have taken more Fripass tablets than prescribed for any reason, you may experience signs and symptoms such as severe headache, diarrhoea, low blood pressure, and irregular heartbeat.
If you have taken more tablets than your prescribed dose, contact your doctor or the nearest hospital immediately. Remember to bring the medicine package with you so that it is clear what you have taken.
If you forget to take Fripass
If you miss a dose, do not worry; wait until the time for your next dose and take the next tablet, then continue as normal. DO NOT take a double dose to make up for the missed tablet.
If you stop taking Fripass
If you stop taking Fripass, the pain in your legs may return or worsen. Therefore, stop taking Fripass only if you experience adverse effects requiring urgent medical treatment (see section 4), or if your doctor tells you to do so.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience any of the following side effects, urgent medical treatment may be required.
Stop taking Fripass and contact a doctor immediately or go to the nearest hospital.

• heart attack (death of heart cells due to prolonged lack of oxygen supply)
• congestive heart failure (inability of the heart to deliver adequate blood flow to the body, causing shortness of breath and swelling of the ankles)
• arrhythmia (irregular heartbeat)
• unspecified haemorrhage (bleeding)
• ecchymosis (bruising)
• Stevens-Johnson syndrome and toxic epidermal necrolysis (severe skin and mucous membrane reactions)
• jaundice (yellowing of the skin or whites of the eyes)
• pyrexia (fever)
• pharyngitis (sore throat)

The following side effects have been reported with Fripass. Inform your doctor as soon as possible if any of the following occur:

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

• headache
• abnormal stools
• diarrhoea

Common side effects (affect up to 1 in 10 people)

• tachycardia (increased heart rate)
• palpitations (awareness of heartbeat)
• chest pain
• dizziness
• rhinitis (inflammation of the nose)
• abdominal pain
• ventricular extrasystoles (irregular heartbeat)
• dyspepsia (indigestion)
• nausea
• vomiting
• anorexia (reduced or loss of appetite)
• flatulence (passing intestinal gas through the anus)
• peripheral and facial oedema (swelling of the ankles, feet and face)
• rash (skin irritation)
• pruritus (itching)
• subcutaneous haemorrhage (bleeding under the skin)
• asthenia (weakness)

Uncommon side effects (affect up to 1 in 100 people)

• syncope (sudden, temporary loss of consciousness)
• atrial fibrillation, supraventricular tachycardia, ventricular tachycardia (irregular heartbeats)
• pneumonia (lung infection)
• cough
• chills
• ocular haemorrhage (bleeding in the eye)
• epistaxis (nosebleed)
• gastrointestinal haemorrhage (bleeding from the stomach or intestine)
• anaemia (decrease in haemoglobin, a protein in red blood cells that carries oxygen in the blood)
• orthostatic hypotension (dizziness upon standing due to a drop in blood pressure)
• anxiety
• insomnia
• abnormal dreams
• allergic reaction
• myalgia (muscle pain)
• diabetes (a disease characterized by high blood glucose levels due to reduced insulin production by the pancreas)
• hyperglycaemia (increased blood glucose)
• gastritis (inflammation of the stomach)
• malaise
• dyspnoea (difficulty breathing)

Rare side effects (affect less than 1 in 1,000 people)

• prolonged bleeding time (time required for a wound to stop bleeding)
• thrombocythaemia (increased number of platelets)
• renal failure and kidney damage (kidney problems)

Frequency not known (frequency cannot be estimated from the available data):

• hypertension (high blood pressure)
• hypotension (low blood pressure)
• haemorrhagic tendency (tendency to bleed)
• thrombocytopenia (reduced number of platelets)
• granulocytopenia (reduced number of granulocytes, a type of white blood cell)
• agranulocytosis (severe reduction in granulocytes)
• leucopenia (decreased number of white blood cells)
• aplastic pancytopenia (reduction in all blood cell types)
• paresis (reduced mobility)
• hot flushes (sensation of heat)
• eczema (skin inflammation)
• skin rashes
• urticaria (hives, skin irritation)
• hypoesthesia (reduced sensation)
• conjunctivitis (red, watery eyes)
• tinnitus (persistent ringing or noise in the ears)
• hepatitis (liver inflammation)
• abnormal liver function (liver disorders)
• haematuria (blood in urine)
• pollakiuria (increased frequency of urination)
• interstitial pneumonia (lung inflammation)
• cerebral haemorrhage (bleeding in the brain)
• pulmonary haemorrhage
• muscular haemorrhage
• respiratory tract haemorrhage
• increased levels of certain substances in the blood (uric acid, azotemia, creatininemia)
• pain

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fripass

Keep this medicine out of the sight and reach of children.
Do not use Fripass after the expiry date stated on the packaging and blister after 'Exp.'.
The expiry date refers to the last day of that month.
Do not use this medicine if you notice any visible signs of deterioration.
This medicine requires no special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Fripass contains
The active substance is cilostazol. One tablet contains 50 mg of cilostazol.
The other components are maize starch, microcrystalline cellulose, calcium carmellose,
hypromellose and magnesium stearate.
Description of the appearance of Fripass and the contents of the pack
White or almost white, round, flat tablet, embossed with the number “50” on one side.
Pack sizes of 14, 20, 28, 30, 50, 56, 98, 100, 112, 168, and 70 tablets in
PVC/PVDC/Al blisters are available.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Italfarmaco S.p.A
Viale F. Testi, 330
20126 Milan
Italy
Responsible manufacturers for batch release:
Adamed Pharma S.A
ul. Marszałka Józefa Piłsudskiego, 5
95-200 Pabianice
Poland
This medicinal product is authorized in the European Economic Area countries
under the following names:
Italy Fripass 50 mg tablets
Malta Fripass 50 mg tablets

Package leaflet: Information for the user

Fripass 100 mg tablets

Cilostazol
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Fripass is and what it is used for

Fripass belongs to a group of medicines called antithrombotics and antiplatelet agents that
prevent the formation of blood clots and platelet aggregation, which contribute to thrombus
formation.
Fripass is indicated for the treatment of intermittent claudication (pain caused by insufficient
blood supply to the legs that occurs during walking).
Fripass is indicated in patients in whom lifestyle changes (including smoking cessation,
exercise programs, and other appropriate measures) have not sufficiently reduced the
symptoms of intermittent claudication.

2. What you need to know before taking Fripass

Do not take Fripass

• if you are allergic to cilostazol or to any of the other ingredients of this medicine (listed in section 6).
• if you have a condition called "heart failure".
• if you experience persistent chest pain at rest, or if you have had a "heart attack" or any heart surgery in the last six months.
• if you currently have or have previously had fainting spells due to heart disease, or serious heart rhythm disorders.
• if you know you have a disorder that increases the risk of bleeding or bruising, for example:
• one or more active stomach ulcers.
• a stroke that occurred within the last six months.
• eye problems if you have diabetes.
• if your blood pressure is not well controlled.
• if you are taking both acetylsalicylic acid and clopidogrel, or any combination of two or more medicines that may increase the risk of bleeding (see Other medicines and Fripass).
• if you have severe kidney disease or severe or moderate liver disease.
• if you are pregnant (see Pregnancy, breastfeeding and fertility).

Warnings and precautions
Before taking Fripass, tell your doctor if you have heart problems or suffer from diabetes.
During treatment with Fripass, it is important to inform your doctor if you bruise easily, or experience bleeding, fever, or sore throat.
Treatment must be promptly discontinued in case of retinal haemorrhage (bleeding in the retina, a membrane lining the inner part of the eye).
If you are scheduled for surgery or dental extraction, inform your healthcare providers that you are taking Fripass.
Health education notes
It is important to maintain lifestyle changes (quitting smoking, proper diet, and appropriate physical activity) and to continue lipid-lowering therapies (to reduce blood fat levels) and antiplatelet treatments (to reduce the risk of blood clot formation), in order to minimize the risk of cardiovascular events, such as cardiac and cerebral ischemia (heart and brain damage due to reduced oxygen supply), renal failure (severe impairment of kidney function), and widespread vascular disease (narrowing of the arteries).

Other medicines and Fripass
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor if you are taking:

• acetylsalicylic acid and clopidogrel (medicines that prevent blood clot formation and platelet aggregation, contributing to thrombus formation)
• warfarin and other anticoagulants (medicines that delay blood clotting)
• erythromycin, clarithromycin, rifampicin, and other antibiotics (used to treat bacterial infections)
• ketoconazole and itraconazole (used to treat fungal infections)
• diltiazem (used to treat high blood pressure or heart disorders)
• omeprazole and cisapride (used to treat stomach disorders)
• lovastatin, simvastatin, or atorvastatin (used to reduce cholesterol levels in the blood)
• halofantrine (used to treat malaria, a tropical infectious disease)
• pimozide (used to treat mental disorders)
• ergot derivatives (used to treat migraine, a neurological disorder characterized by headache)
• carbamazepine or phenytoin (used to treat epilepsy, a disease causing loss of consciousness and violent involuntary muscle contractions)
• medicines used to treat HIV and hepatitis C (viral diseases)
• St. John's Wort (a herbal remedy used as an antidepressant).

Fripass and beverages
It is recommended to avoid consuming large amounts of grapefruit juice during treatment.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Fripass MUST NOT be used during pregnancy.
For women who are breastfeeding, the use of Fripass IS NOT RECOMMENDED.
Driving and using machines
Fripass may cause dizziness. If you experience dizziness after taking Fripass tablets, DO NOT drive or operate tools or machinery, and inform your doctor or pharmacist.

3. How to take Fripass

• Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
• The recommended dose is 100 mg twice daily. This dose does not require adjustment in elderly patients. However, your doctor may prescribe a lower dose if you are taking other medicines that may interfere with the effect of Fripass.
• Fripass should be taken 30 minutes before meals, in the morning and in the evening. Your doctor will assess your progress after 3 months of treatment and may advise you to stop taking cilostazol if the treatment effect is insufficient.

Children and adolescents
The safety and efficacy in children and adolescents have not been established.

If you take more Fripass than you should
If for any reason you have taken more Fripass tablets than prescribed, you may experience signs and symptoms such as severe headache, diarrhoea, low blood pressure, and irregular heartbeat.
If you have taken more tablets than your prescribed dose, contact your doctor or the nearest hospital immediately. Remember to bring the medicine pack with you so that it is clear what you have taken.

If you forget to take Fripass
If you miss a dose, do not worry; wait until the time for your next dose and take the next tablet, then continue as normal. DO NOT take a double dose to make up for the missed tablet.

If you stop taking Fripass
If you stop taking Fripass, the pain in your legs may return or worsen. Therefore, stop taking Fripass only if you experience side effects requiring urgent medical treatment (see section 4), or if your doctor tells you to do so.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience any of the following side effects, urgent medical attention may be required.
Stop taking Fripass and contact a doctor immediately or go to the nearest hospital.

• heart attack (death of heart cells due to prolonged lack of oxygen supply)
• congestive heart failure (inability of the heart to deliver adequate blood flow to the body, causing shortness of breath and swelling of the ankles)
• arrhythmia (irregular heartbeat)
• unspecified hemorrhage (bleeding)
• ecchymosis (bruising)
• Stevens-Johnson syndrome and toxic epidermal necrolysis (severe skin and mucous membrane reactions)
• jaundice (yellowing of the skin or whites of the eyes)
• pyrexia (fever)
• pharyngitis (sore throat)
  The following side effects have been reported with Fripass. Inform your doctor as soon as possible if you experience any of the following:

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

• headache
• abnormal stools
• diarrhea

Common side effects (affect up to 1 in 10 people)

• tachycardia (increased heart rate)
• palpitations (awareness of heartbeat)
• chest pain
• dizziness
• rhinitis (nasal inflammation)
• abdominal pain
• ventricular extrasystoles (irregular heartbeat)
• dyspepsia (indigestion)
• nausea
• vomiting
• anorexia (reduced or loss of appetite)
• flatulence (passing intestinal gas through the anus)
• peripheral and facial edema (swelling of ankles, feet, and face)
• rash (skin irritation)
• pruritus (itching)
• subcutaneous hemorrhage (bleeding under the skin)
• asthenia (weakness)

Uncommon side effects (affect up to 1 in 100 people)

• syncope (sudden, temporary loss of consciousness)
• atrial fibrillation, supraventricular tachycardia, ventricular tachycardia (irregular heart rhythms)
• pneumonia (lung infection)
• cough
• chills
• ocular hemorrhage (bleeding in the eye)
• epistaxis (nosebleed)
• gastrointestinal hemorrhage (bleeding from stomach or intestine)
• anemia (reduction in hemoglobin, a protein in red blood cells that carries oxygen)
• orthostatic hypotension (dizziness upon standing due to drop in blood pressure)
• anxiety
• insomnia
• abnormal dreams
• allergic reaction
• myalgia (muscle pain)
• diabetes (a condition characterized by high blood glucose levels due to reduced insulin production by the pancreas)
• hyperglycemia (increased blood glucose)
• gastritis (inflammation of the stomach)
• malaise
• dyspnea (difficulty breathing)

Rare side effects (affect less than 1 in 1,000 people)

• prolonged bleeding time (time required for a wound to stop bleeding)
• thrombocytosis (increased number of platelets)
• renal failure and kidney damage (kidney problems)

Frequency not known (frequency cannot be estimated from available data):

• hypertension (high blood pressure)
• hypotension (low blood pressure)
• bleeding tendency
• thrombocytopenia (reduced number of platelets)
• granulocytopenia (reduced number of granulocytes, a type of white blood cell)
• agranulocytosis (severe reduction in granulocytes)
• leukopenia (decreased number of white blood cells)
• aplastic pancytopenia (reduction in all blood cell types)
• paresis (reduced mobility)
• hot flushes (sensation of warmth)
• eczema (skin inflammation)
• skin eruptions
• urticaria (skin rash with itching)
• hypoesthesia (reduced sensation)
• conjunctivitis (red, watery eyes)
• tinnitus (persistent ringing or noise in the ear)
• hepatitis (liver inflammation)
• abnormal liver function (liver disorders)
• hematuria (blood in urine)
• pollakiuria (increased frequency of urination)
• interstitial pneumonia (lung inflammation)
• cerebral hemorrhage (bleeding in the brain)
• pulmonary hemorrhage
• muscular hemorrhage
• respiratory tract hemorrhage
• increased levels of certain substances in blood (uric acid, blood urea nitrogen, creatinine)
• pain

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fripass

Keep this medicine out of the sight and reach of children.
Do not use Fripass after the expiry date stated on the packaging and blister after 'Exp.'.
The expiry date refers to the last day of that month.
Do not use this medicine if you notice any visible signs of deterioration.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

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

Description of the appearance of Fripass and contents of the pack
White or almost white, round, flat tablet, imprinted with "100" on one side.
Pack sizes of 14, 20, 28, 30, 50, 56, 98, 100, 112, 168, and 70 tablets in
PVC/PVDC aluminium blisters are available.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Italfarmaco S.p.A
Viale F. Testi, 330
20126 Milan
Italy

Responsible manufacturers for batch release:
Adamed Pharma S.A
ul. Marszałka Józefa Piłsudskiego, 5
95-200 Pabianice
Poland

This medicinal product is authorised in the European Economic Area Member States
under the following names:
Italy Fripass 100 mg tablets
Malta Fripass 100 mg tablets