Piofelek

Package Leaflet: Information for the Patient

PIOFELEK 50 mg film-coated tablets

Sildenafil
Equivalent medicine
Please read all of 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

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

1. What PIOFELEK is and what it is used for

PIOFELEK contains the active substance sildenafil, which belongs to a class of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It helps relax the blood vessels in the penis, allowing blood to flow into the penis when sexually stimulated. PIOFELEK will help you achieve an erection only if you are sexually stimulated.

PIOFELEK is a treatment for adult men who have erectile dysfunction, sometimes called impotence. This condition occurs when a man is unable to achieve or maintain an erection sufficient for sexual intercourse.

2. What you need to know before taking PIOFELEK

Do not take PIOFELEK

• if you are allergic to sildenafil or to any of the other ingredients of this medicine (listed in section 6)
• if you are taking medicines called nitrates, because this combination may cause a dangerous drop in blood pressure. Inform your doctor if you are taking any of these medicines, which are often used to relieve angina pectoris attacks (or “chest pain”). If you have any doubts, consult your doctor or pharmacist
• if you are taking medicines known as nitric oxide donors, such as amyl nitrite

(“poppers”), because this combination may also cause a dangerous drop in blood pressure

• if you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high blood pressure in the lungs due to blood clots). PDE5 inhibitors, such as PIOFELEK, have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or have any doubts, inform your doctor.
• if you have a serious heart or liver problem
• if you have recently had a stroke or heart attack, or if you have low blood pressure
• if you have a rare inherited eye disease (such as retinitis pigmentosa)
• if you have previously experienced sudden vision loss caused by non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking PIOFELEK.

• if you have sickle cell anemia (an abnormality of red blood cells), leukemia (a blood cell tumor), or multiple myeloma (a tumor of the bone marrow)
• if you have a penile deformity or Peyronie's disease
• if you have heart problems. Your doctor must carefully assess whether your heart condition allows you to tolerate the physical strain of sexual intercourse
• if you currently have a stomach ulcer or bleeding disorders (such as hemophilia)
• if you experience sudden decrease or loss of vision, stop taking PIOFELEK and contact your doctor immediately.

You must not use PIOFELEK together with other oral or topical treatments for erectile dysfunction.
You must not use PIOFELEK together with treatments for pulmonary arterial hypertension (PAH) containing
sildenafil or any other phosphodiesterase type 5 (PDE5) inhibitor.
You must not take PIOFELEK if you do not have erectile dysfunction.
You must not take PIOFELEK if you are a woman.
Special precautions for patients with kidney or liver problems
If you have kidney or liver problems, inform your doctor. Your doctor may decide to prescribe a lower dose.
Children and adolescents
PIOFELEK must not be administered to individuals under 18 years of age.
Other medicines and PIOFELEK
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
PIOFELEK tablets may interact with certain medicines, particularly those used to treat chest pain. In case of a medical emergency, you must inform the doctor, pharmacist, or nurse that you have taken PIOFELEK and when you took it. Do not take PIOFELEK together with other medicines unless authorized by your doctor.
Do not take PIOFELEK if you are taking medicines called nitrates, because the combination of these medicines may cause a dangerous drop in blood pressure. Inform your doctor, pharmacist, or nurse if you are taking any of these medicines, which are often used to relieve angina pectoris attacks (or “chest pain”).
Do not take PIOFELEK if you are using medicines known as nitric oxide donors, such as amyl nitrite (“poppers”), because this combination may also cause a dangerous drop in blood pressure.
Inform your doctor or pharmacist if you are already taking riociguat.
If you are taking protease inhibitors, for example medicines used to treat HIV, your doctor may initially prescribe the lowest dose of PIOFELEK (25 mg).
Some patients taking alpha-blockers for high blood pressure or enlarged prostate may experience dizziness or mental confusion, which may be caused by low blood pressure when sitting or standing up quickly. Some patients have reported these symptoms when taking PIOFELEK together with alpha-blockers. This is most likely to occur within 4 hours after taking PIOFELEK. To reduce the likelihood of these symptoms, you should already be on a stable dose of an alpha-blocker before starting PIOFELEK treatment. Your doctor may start you on a lower dose of PIOFELEK (25 mg).
If you are taking medicines containing sacubitril with valsartan (used to treat heart failure), inform your doctor or pharmacist.
PIOFELEK with food, drinks and alcohol
PIOFELEK can be taken with or without food. However, you may notice that the onset of action of PIOFELEK may be slower if taken after a heavy meal.
Drinking alcohol may temporarily impair your ability to get an erection. To obtain the maximum benefit from this medicine, it is advisable to avoid consuming large amounts of alcohol before taking PIOFELEK.
Pregnancy, breastfeeding and fertility
PIOFELEK is not indicated for use in women.
Driving and using machines
PIOFELEK may cause dizziness and may affect vision. Before driving or operating machinery, make sure you know how you react to PIOFELEK.
PIOFELEK contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
PIOFELEK contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially “sodium-free”.

3. How to take PIOFELEK

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. The recommended starting dose is 50 mg.
PIOFELEK must not be taken more than once a day.
Do not take PIOFELEK film-coated tablets in combination with Viagra or other medicines containing sildenafil.
You should take PIOFELEK approximately one hour before anticipated sexual activity. Swallow the tablet whole with a glass of water.
If you feel that the effect of PIOFELEK is too strong or too weak, consult your doctor or pharmacist.
PIOFELEK will help you achieve an erection only if you are sexually stimulated. The time required for PIOFELEK to take effect varies from person to person, but generally ranges from half an hour to one hour. The effect of PIOFELEK may take longer if you have just consumed a heavy meal.
If PIOFELEK does not help you achieve an erection, or if the erection does not last long enough to complete sexual intercourse, inform your doctor.
If you take more PIOFELEK than you should:
You may notice an increase in the frequency and severity of side effects.
Doses higher than 100 mg do not increase effectiveness.
Do not take more tablets than prescribed by your doctor.
If you take more tablets than prescribed, contact your doctor.
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. The side effects reported in association with the use of PIOFELEK are usually mild to moderate in severity and short-lived.
If you experience any of the following serious side effects, stop taking
PIOFELEK and contact your doctor immediately:

• Allergic reaction – occurs uncommonly (may affect up to 1 in 100 people).
  Symptoms include sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat.

• Chest pain – occurs uncommonly: If it occurs during or after sexual intercourse:

  • Sit in a semi-upright position and try to relax.
  • Do not use nitrates to treat chest pain.

• Prolonged and sometimes painful erections occur rarely (may affect up to 1 in 1,000 people). If this type of erection persists continuously for more than 4 hours, contact your doctor immediately.

• Sudden decrease or loss of vision – occurs rarely.

• Severe skin reactions – occur rarely. Symptoms may include severe peeling and swelling of the skin, mouth sores, sores in the genital area and around the eyes, fever.

• Seizures or convulsions – occur rarely.

Other side effects:
Very common (may affect more than 1 in 10 people): headache.
Common (may affect up to 1 in 10 people): nausea, facial flushing, hot flushes (symptoms include a sudden feeling of warmth in the upper body), indigestion, enhanced colour vision, blurred vision, visual disturbances, nasal congestion and dizziness.
Uncommon (may affect up to 1 in 100 people): vomiting, rash, eye irritation, eye redness, eye pain, flashes of light, increased light sensitivity, sensitivity to light, tearing, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced sensitivity to touch, vertigo, tinnitus, dry mouth, blocked or congested sinuses, inflammation of the nasal mucosa (symptoms include runny nose, sneezing and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (including heartburn), blood in urine, pain in arms or legs, nosebleeds, sensation of warmth and fatigue.
Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, temporary reduction in blood flow to certain areas of the brain, sensation of throat tightness, numbness of the mouth, bleeding from the back of the eye, double vision, reduced visual acuity, abnormal eye sensitivity, swelling of the eyes or eyelids, appearance of spots or floaters in the visual field, seeing halos around lights, pupil dilation, changes in the white colour of the sclera (part of the eye), penile bleeding, presence of blood in semen, dry nose, swelling of the nasal mucosa, irritability and sudden decrease or loss of hearing.

From post-marketing experience, rare cases of unstable angina (a heart condition) and sudden death have been reported. It should be noted that most of the men who experienced these side effects, but not all, already had pre-existing heart problems before taking this medicine. It is not possible to determine whether these events are directly related to the use of PIOFELEK.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. 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 PIOFELEK

Keep this medicine out of the sight and reach of children.
Do not use this medicine 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 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 PIOFELEK contains

• The active substance is sildenafil. Each tablet contains 50 mg of sildenafil (as citrate salt).
• The other components (excipients) are:
• Tablet core: microcrystalline cellulose, calcium hydrogen phosphate (anhydrous), sodium croscarmellose (see section 2 “PIOFELEK contains sodium”), magnesium stearate.
• Coating: hypromellose, titanium dioxide (E171), monohydrate lactose (see section 2 “PIOFELEK contains lactose”), triacetin, aluminium lake containing indigo carmine (E132).

Description of the appearance of PIOFELEK and contents of the pack
PIOFELEK tablets are film-coated, blue in colour, rounded, biconvex, with the number “50” engraved on one side.
The tablets are available in blisters in packs of 2, 4 or 8 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland

Manufacturer
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice, Poland

Patient Information Leaflet

PIOFELEK

100 mg film-coated tablets
Sildenafil
Equivalent 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, pharmacist, or nurse.
• 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 could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet
1 What PIOFELEK is and what it is used for
2 What you need to know before taking PIOFELEK
3 How to take PIOFELEK
4 Possible side effects
5 How to store PIOFELEK
6 Package contents and other information.

1. What PIOFELEK is and what it is used for

PIOFELEK contains the active substance sildenafil, which belongs to a class of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It helps relax the blood vessels in the penis, allowing blood to flow into the penis when sexually stimulated. PIOFELEK will help you achieve an erection only if you are sexually stimulated.
PIOFELEK is a treatment for adult men who have erectile dysfunction, sometimes called impotence. This condition occurs when a man is unable to achieve or maintain an erection sufficient for sexual intercourse.

2. What you need to know before taking PIOFELEK

Do not take PIOFELEK

• if you are allergic to sildenafil or to any of the other ingredients of this medicine (listed in section 6)
• if you are taking medicines called nitrates, because this combination may cause a dangerous drop in blood pressure. Inform your doctor if you are taking any of these medicines, which are often used to relieve angina pectoris attacks (or "chest pain"). If you have any doubts, consult your doctor or pharmacist
• if you are taking medicines known as nitric oxide donors, such as amyl nitrite ("poppers"), because this combination may also cause a dangerous drop in blood pressure
• if you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high blood pressure in the lungs due to blood clots). PDE5 inhibitors such as PIOFELEK have been shown to increase the blood pressure-lowering effect of riociguat. If you are taking riociguat or have any doubts, inform your doctor
• if you have a serious heart or liver problem
• if you have recently had a stroke or heart attack, or if you have low blood pressure
• if you have a rare inherited eye disease (such as retinitis pigmentosa)
• if you have previously experienced vision loss caused by non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking PIOFELEK.

• if you have sickle cell anaemia (an abnormality of red blood cells), leukaemia (blood cell cancer), or multiple myeloma (a cancer of the bone marrow)
• if you have a penile deformity or Peyronie's disease
• if you have heart problems. Your doctor must carefully assess whether your heart condition allows you to tolerate the physical strain of sexual intercourse
• if you currently have a stomach ulcer or bleeding disorders (such as haemophilia)
• if you experience a sudden decrease or loss of vision, stop taking PIOFELEK and contact your doctor immediately.

You must not use PIOFELEK together with other oral or topical treatments for erectile dysfunction.
You must not use PIOFELEK together with treatments for pulmonary arterial hypertension (PAH) containing
sildenafil or with any other phosphodiesterase type 5 (PDE5) inhibitor.
You must not take PIOFELEK if you do not have erectile dysfunction.
You must not take PIOFELEK if you are a woman.
Special precautions for patients with kidney or liver problems
If you have kidney or liver problems, inform your doctor. Your doctor may decide to prescribe a lower dose.
Children and adolescents
PIOFELEK must not be given to individuals under 18 years of age.
Other medicines and PIOFELEK
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
PIOFELEK tablets may interact with certain medicines, particularly those used to treat chest pain. In case of a medical emergency, you must inform the doctor, pharmacist, or nurse that you have taken PIOFELEK and when. Do not take PIOFELEK with other medicines unless your doctor has specifically authorized it.
Do not take PIOFELEK if you are taking medicines called nitrates, because combining these medicines may cause a dangerous drop in blood pressure. Inform your doctor, pharmacist, or nurse if you are taking any of these medicines, which are often used to relieve angina pectoris attacks (or "chest pain").
Do not take PIOFELEK if you are using medicines known as nitric oxide donors, such as amyl nitrite ("poppers"), because this combination may also cause a dangerous drop in blood pressure.
Inform your doctor or pharmacist if you are already taking riociguat.
If you are taking protease inhibitors, for example medicines used to treat HIV, your doctor may initially prescribe the lowest dose of PIOFELEK (25 mg).
Some patients taking alpha-blockers for high blood pressure or enlarged prostate may experience dizziness or confusion, which may be caused by low blood pressure when sitting or standing up quickly. Some patients have reported these symptoms when taking PIOFELEK together with alpha-blockers. This is more likely to occur within 4 hours after taking PIOFELEK. To reduce the risk of these symptoms, you should already be on a stable dose of an alpha-blocker before starting PIOFELEK treatment. Your doctor may start you on a lower dose of PIOFELEK (25 mg).
If you are taking medicines containing sacubitril with valsartan (used to treat heart failure), inform your doctor or pharmacist.
PIOFELEK with food, drinks and alcohol
PIOFELEK can be taken with or without food. However, you may notice that the onset of PIOFELEK's effect is slower if taken after a heavy meal.
Drinking alcohol may temporarily impair your ability to get an erection. To get the maximum benefit from this medicine, it is advisable to avoid consuming large amounts of alcohol before taking PIOFELEK.
Pregnancy, breastfeeding and fertility
PIOFELEK is not indicated for use in women.
Driving and using machines
PIOFELEK may cause dizziness and may affect vision. Before driving or operating machinery, make sure you know how you react to PIOFELEK.
PIOFELEK contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
PIOFELEK contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially "sodium-free".

3. How to take PIOFELEK

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist. The recommended starting dose is 50 mg.
PIOFELEK must not be taken more than once a day.
Do not take PIOFELEK film-coated tablets in combination with Viagra or other medicines containing sildenafil.
You should take PIOFELEK approximately one hour before anticipated sexual activity. Swallow the tablet whole with a glass of water.
If you feel that the effect of PIOFELEK is too strong or too weak, consult your doctor or pharmacist.
PIOFELEK will help you achieve an erection only if you are sexually stimulated. The time needed for PIOFELEK to take effect varies from person to person, but generally ranges from half an hour to one hour. The effect of PIOFELEK may take longer if you have just eaten a heavy meal.
If PIOFELEK does not help you achieve an erection, or if the erection does not last long enough to complete sexual intercourse, inform your doctor.
If you take more PIOFELEK than you should
You may experience an increase in the frequency and severity of side effects.
Doses higher than 100 mg do not increase effectiveness.
Do not take more tablets than prescribed by your doctor.
If you take more tablets than prescribed, contact your doctor.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. The side effects reported in association with the use of PIOFELEK are usually mild to moderate in severity and short-lived.
If you experience any of the following serious side effects, stop taking
PIOFELEK and contact your doctor immediately:

• Allergic reaction – occurs uncommonly (may affect up to 1
  person in 100).
  Symptoms include sudden wheezing, difficulty breathing or dizziness, swelling
  of the eyelids, face, lips or throat.

• Chest pain – occurs uncommonly . If it occurs during or after sexual intercourse:

  • Sit in a semi-upright position and try to relax.
  • Do not use nitrates to treat chest pain.

• Prolonged and sometimes painful erections occur rarely (may affect up to 1 person in 1,000). If this type of erection persists continuously for more than 4 hours, contact your doctor immediately.

• Sudden decrease or loss of vision – occurs rarely .

• Severe skin reactions – occur rarely . Symptoms may include severe peeling and swelling of the skin, blisters in the mouth, genital area, or around the eyes, fever.

• Seizures or convulsions – occur rarely .

Other side effects:
Very common (may affect more than 1 in 10 people): headache.
Common (may affect up to 1 in 10 people): nausea, facial flushing, hot flushes (symptoms
include a sudden feeling of warmth in the upper part of the body), indigestion, increased intensity of colours in vision, blurred vision, visual disturbances, nasal congestion and dizziness.
Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation,
eye redness, eye pain, flashes of light, increased light perception, light sensitivity,
tearing, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced sensitivity to touch, vertigo, ringing in the ears, dry mouth, blocked or congested sinuses, inflammation of the nasal mucosa (symptoms include runny nose, sneezing and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (including heartburn), blood in urine, pain in arms or legs, nosebleeds, feeling of warmth and fatigue.
Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, temporary reduction in blood flow to certain areas of the brain, sensation of tightness in the throat, numbness of the mouth, bleeding at the back of the eye, double vision, reduced visual acuity, abnormal eye sensitivity, swelling of the eyes or eyelids, appearance of spots or floaters in the visual field, seeing halos around lights, pupil dilation, changes in the white colour of the sclera (part of the eye), penile bleeding, blood in semen, dry nose, swelling of the nasal mucosa, irritability and sudden decrease or loss of hearing.
Rare cases of unstable angina (a heart condition) and sudden death have been reported after marketing experience. It should be noted that most, but not all, of the men who experienced these side effects already had pre-existing heart problems before using this medicine. It is not possible to determine whether these events are directly related to the use of PIOFELEK.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. 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 . Reporting side effects can help provide more information on the safety of this medicine.

5. How to store PIOFELEK

Keep this medicine out of the sight and reach of children.
Do not use this medicine 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 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 PIOFELEK contains

• The active substance is sildenafil. Each tablet contains 100 mg of sildenafil (as citrate salt).
• The other ingredients are:
• Tablet core: microcrystalline cellulose, calcium hydrogen phosphate (anhydrous), sodium croscarmellose (see section 2 “PIOFELEK contains sodium”), magnesium stearate.
• Coating: hypromellose, titanium dioxide (E171), lactose monohydrate (see section 2 “PIOFELEK contains lactose”), triacetin, aluminium lake containing indigo carmine (E132).

Description of the appearance of PIOFELEK and contents of the pack
PIOFELEK tablets are film-coated, blue, oval-shaped, biconvex tablets with the number “100” engraved on one side.
The tablets are available in blisters in packs containing 2, 4 or 8 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland

Manufacturer
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice, Poland