Sildenafil Pensa Pharma

PACKAGE LEAFLET: INFORMATION FOR THE USER

Sildenafil Pensa Pharma 25 mg chewable tablets

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

1. What SILDENAFIL PENSA PHARMA is and what it is used for

Sildenafil Pensa Pharma contains the active substance sildenafil, which belongs to a class of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by helping to relax blood vessels in the penis, allowing blood to flow into the penis when sexually stimulated. Sildenafil Pensa Pharma will help you achieve an erection only if you are sexually stimulated.
Sildenafil Pensa Pharma 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 suitable for sexual intercourse.

2. What you need to know before taking SILDENAFIL PENSA PHARMA

Do not take Sildenafil Pensa Pharma

• 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 can cause a dangerous drop in your blood pressure. If you are taking any of these medicines, which are often used to relieve angina attacks (or "chest pain"), inform your doctor. If you are unsure, ask your doctor or pharmacist.
• If you are using any medicines known as nitric oxide donors such as amyl nitrite ("poppers"), because this combination can also cause a dangerous drop in your blood pressure.
• 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 certain rare inherited eye diseases (such as retinitis pigmentosa).
• If you have previously experienced sudden vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Sildenafil Pensa Pharma:

• If you have sickle cell anemia (an abnormality of red blood cells), leukemia (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 activity.
• If you currently have a stomach ulcer or bleeding disorders (such as hemophilia).
• If you experience a sudden decrease or loss of vision, stop taking Sildenafil Pensa Pharma and contact your doctor immediately.

You must not use Sildenafil Pensa Pharma together with any other oral or local treatment for erectile dysfunction.
You must not use Sildenafil Pensa Pharma together with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or with any other phosphodiesterase type 5 (PDE5) inhibitors.
You must not take Sildenafil Pensa Pharma if you do not have erectile dysfunction.
You must not take Sildenafil Pensa Pharma 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
Sildenafil Pensa Pharma must not be administered to individuals under 18 years of age.

Other medicines and Sildenafil Pensa Pharma
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Sildenafil Pensa Pharma can interact with certain medicines, especially those used to treat chest pain. In a medical emergency, you must inform your doctor, pharmacist, or nurse that you have taken Sildenafil Pensa Pharma and when you took it. Do not take Sildenafil Pensa Pharma together with other medicines unless authorized by your doctor.
If you are taking medicines called nitrates, you must not take Sildenafil Pensa Pharma, because this combination can cause a dangerous drop in your blood pressure. Always inform your doctor, pharmacist, or nurse if you are taking medicines commonly used to relieve angina attacks (or "chest pain").
If you are using medicines known as nitric oxide donors such as amyl nitrite ("poppers"), you must not take Sildenafil Pensa Pharma, because this combination can also cause a dangerous drop in your blood pressure.
If you are taking protease inhibitors, such as medicines used for the treatment of HIV, your doctor may initially prescribe the lowest dose of Sildenafil Pensa Pharma (25 mg).
Some patients taking alpha-blockers for high blood pressure or enlarged prostate may experience dizziness or confusion, which may be due to low blood pressure when rising quickly from bed or from a sitting position (orthostatic hypotension). Some patients have experienced these symptoms when taking Sildenafil Pensa Pharma together with alpha-blockers. This is more likely to occur within 4 hours after taking Sildenafil Pensa Pharma. To reduce the risk of these symptoms, you should already be on a stable daily regimen of alpha-blockers before starting Sildenafil Pensa Pharma. Your doctor may start you on a lower dose of Sildenafil Pensa Pharma (25 mg).

Use of Sildenafil Pensa Pharma with food, drinks, and alcohol
Sildenafil Pensa Pharma can be taken with or without food. However, you may notice that the onset of effect of Sildenafil Pensa Pharma is slower if taken after a heavy meal.
Drinking alcohol may temporarily impair your ability to achieve an erection. To get the maximum benefit from this medicine, do not consume excessive amounts of alcohol before taking Sildenafil Pensa Pharma.

Pregnancy, breastfeeding, and fertility
Sildenafil Pensa Pharma is not intended for use in women.

Driving and using machines
Sildenafil Pensa Pharma may cause dizziness and may affect vision. Before driving or operating machinery, make sure you know how you react to Sildenafil Pensa Pharma.

Sildenafil Pensa Pharma contains monohydrate lactose
If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

Sildenafil Pensa Pharma contains aspartame
Aspartame is a source of phenylalanine. It may be harmful for people with phenylketonuria.

3. How to take SILDENAFIL PENSA PHARMA

Always take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, you should consult your doctor or pharmacist. The recommended starting dose is 50 mg.
Do not take Sildenafil Pensa Pharma more than once a day.
Take Sildenafil Pensa Pharma approximately one hour before planned sexual activity. The tablet
must be chewed and swallowed.
If you feel that the effect of Sildenafil Pensa Pharma is too strong or too weak, discuss this with your
doctor or pharmacist.
Sildenafil Pensa Pharma will help you achieve an erection only if you are sexually stimulated. The
time it takes for Sildenafil Pensa Pharma to work varies from person to person, but generally ranges from
half an hour to one hour. You may notice that the effect of Sildenafil Pensa Pharma may be slower if taken
after a heavy meal.
If Sildenafil Pensa Pharma 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 Sildenafil Pensa Pharma 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 have taken 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 will experience them.
Side effects reported with Sildenafil Pensa Pharma are usually mild to moderate and short-lived.
If you experience any of the following serious side effects, stop taking
Sildenafil Pensa Pharma 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, 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, 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 perception, light sensitivity, tearing, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced sensitivity to touch, vertigo, tinnitus, dry mouth, blocked or congested nasal passages, inflammation of the nasal mucosa (symptoms include runny nose, sneezing and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (includes heartburn), blood in urine, pain in arms or legs, epistaxis, 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 tightness in the throat, 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 particles 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, sudden decrease or loss of hearing.
Rare cases of unstable angina (a heart condition) and sudden death have been reported during post-marketing experience. It should be noted that most, but not all, of the men who experienced these side effects had pre-existing heart problems before taking this medicine. It is not possible to determine whether these events were directly related to sildenafil.

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: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store SILDENAFIL PENSA PHARMA

• Keep this medicine out of sight and reach of children.
• Store in the original packaging to protect it from light.
• This medicine does not require any special storage conditions.
• Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
• 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 Sildenafil Pensa Pharma contains

• The active substance is sildenafil. Each chewable tablet contains 25 mg of sildenafil produced in situ from 35.12 mg of sildenafil citrate.
• The other components are: potassium polacrylin, magnesium stearate, anhydrous colloidal silicon dioxide, aspartame, sodium croscarmellose, peppermint flavour, lactose monohydrate and povidone K-30.

Description of the appearance of Sildenafil Pensa Pharma and contents of the pack
Sildenafil Pensa Pharma 25 mg chewable tablets are white, triangular and biconvex. They are marked with "25" on one side.
The chewable tablets are available in blisters containing 4, 8 or 12 chewable tablets. Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder
Pensa Pharma S.p.A.
Via Ippolito Rosellini, 12
20124 Milano, Italy

Manufacturer
Genepharm, S.A
18 km Marathon Avenue
153 51 Pallini Attikis (Greece)
Cemelog BRS Ltd
2040 Budaörs
Vasút u. 13
Hungary
Pharmadox Healthcare Ltd
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta

This medicinal product is authorised in the Member States of the European Union under the following names:
Italy: Sildenafil Pensa Pharma 25 mg chewable tablets
Portugal: Sildenafil toLife, 25 mg, Chewable tablets
Spain: Sildenafilo Pensa, 25 mg, Comprimidos masticables EFG

This leaflet was last approved on

PACKAGE LEAFLET: INFORMATION FOR THE USER

Sildenafil Pensa Pharma 100 mg chewable tablets

Generic medicine
Please read this leaflet carefully before 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

2. What SILDENAFIL PENSA PHARMA is and what it is used for

Sildenafil Pensa Pharma contains the active substance sildenafil, which belongs to a class of medicines
called phosphodiesterase type 5 (PDE5) inhibitors. It works by helping to relax blood vessels in the
penis, allowing blood to flow into the penis during sexual stimulation. Sildenafil Pensa Pharma
will help you achieve an erection only if you are sexually stimulated.
Sildenafil Pensa Pharma 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.

4. What you need to know before taking SILDENAFIL PENSA PHARMA

Do not take Sildenafil Pensa Pharma

• 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 your blood pressure. If you are taking any of these medicines, which are often used to relieve angina attacks (or "chest pain"), inform your doctor. If you are in any doubt, ask your doctor or pharmacist.
• 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 your blood pressure.
• if you have severe heart or liver problems.
• if you have recently had a stroke or heart attack, or if you have low blood pressure.
• if you have certain rare inherited eye diseases (such as retinitis pigmentosa).
• if you have previously experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Sildenafil Pensa Pharma:

• if you have sickle cell anemia (an abnormality of red blood cells), leukemia (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 cope with the physical strain of sexual activity.
• if you currently have a stomach ulcer or bleeding disorders (such as hemophilia).
• if you experience a sudden decrease or loss of vision, stop taking Sildenafil Pensa Pharma and contact your doctor immediately.

You must not use Sildenafil Pensa Pharma with any other oral or topical treatment for erectile dysfunction.
You must not use Sildenafil Pensa Pharma together with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or with any other phosphodiesterase type 5 (PDE5) inhibitors.
You must not take Sildenafil Pensa Pharma if you do not have erectile dysfunction.
You must not take Sildenafil Pensa Pharma 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
Sildenafil Pensa Pharma must not be administered to individuals under 18 years of age.

Other medicines and Sildenafil Pensa Pharma
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Sildenafil Pensa Pharma may interact with certain medicines, particularly those used to treat chest pain. In a medical emergency, you must inform your doctor, pharmacist, or nurse that you have taken Sildenafil Pensa Pharma and when you took it. Do not take Sildenafil Pensa Pharma with other medicines unless authorized by your doctor.

If you are taking medicines called nitrates, you must not take Sildenafil Pensa Pharma, because this combination of medicines may cause a dangerous drop in your blood pressure. Always inform your doctor, pharmacist, or nurse if you are taking any of the medicines commonly used to relieve angina attacks (or "chest pain").

If you are using medicines known as nitric oxide donors such as amyl nitrite ("poppers"), you must not take Sildenafil Pensa Pharma, because this combination may also cause a dangerous drop in your blood pressure.

If you are taking protease inhibitors, such as medicines used for the treatment of HIV, your doctor may initially prescribe Sildenafil Pensa Pharma at the lowest dose (25 mg).

Some patients receiving alpha-blockers for the treatment of high blood pressure or enlarged prostate may experience dizziness or confusion, which may be caused by low blood pressure occurring when rising quickly from bed or a chair (orthostatic hypotension). Some patients have experienced these symptoms when taking Sildenafil Pensa Pharma together with alpha-blockers. This is more likely to occur within 4 hours after taking Sildenafil Pensa Pharma. To reduce the likelihood of these symptoms, you should already be on a stable daily regimen of alpha-blockers before starting Sildenafil Pensa Pharma. Your doctor may initiate treatment with a lower dose of Sildenafil Pensa Pharma (25 mg).

Use of Sildenafil Pensa Pharma with food, drinks, and alcohol
Sildenafil Pensa Pharma can be taken with or without food. However, you may notice that the onset of action of Sildenafil Pensa Pharma is slower if taken after a heavy meal.
Alcohol consumption may temporarily impair your ability to achieve an erection. To obtain the maximum benefit from the medicine, do not consume excessive amounts of alcohol before taking Sildenafil Pensa Pharma.

Pregnancy, breastfeeding, and fertility
Sildenafil Pensa Pharma is not indicated for use in women.

Driving and using machines
Sildenafil Pensa Pharma may cause dizziness and may affect vision. Before driving or operating machinery, make sure you know how you react to Sildenafil Pensa Pharma.

Sildenafil Pensa Pharma contains lactose monohydrate
If your doctor has informed you of an intolerance to certain sugars, consult your doctor before taking this medicine.

Sildenafil Pensa Pharma contains aspartame
Aspartame is a source of phenylalanine. It may be harmful for people with phenylketonuria.

5. How to take SILDENAFIL PENSA PHARMA

Always take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, you should consult your doctor or pharmacist. The recommended starting dose is 50 mg.
Do not take Sildenafil Pensa Pharma more than once a day.
Take Sildenafil Pensa Pharma approximately one hour before anticipated sexual activity. The tablet
should be chewed and swallowed.
If you feel that the effect of Sildenafil Pensa Pharma is too strong or too weak, discuss this with your
doctor or pharmacist.
Sildenafil Pensa Pharma will help you achieve an erection only if you are sexually stimulated. The time
required for Sildenafil Pensa Pharma to take effect varies from person to person, but generally ranges from
half an hour to one hour. You may notice that the effect of Sildenafil Pensa Pharma may be slower if taken
after a heavy meal.
If Sildenafil Pensa Pharma 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 Sildenafil Pensa Pharma 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 have taken more tablets than prescribed, contact your doctor.
If you have any questions about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. The adverse effects reported with Sildenafil Pensa Pharma are usually mild to moderate and of short duration.
If you experience any of the following serious adverse effects, stop taking Sildenafil Pensa Pharma 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 semi-upright 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 blisters, genital or eye-area blisters, fever.
• Seizures or convulsions – occur rarely.

.
.
Other adverse 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, increased intensity of colours, blurred vision, visual disturbances, nasal congestion, dizziness.
Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, eye redness, eye pain, flashing lights, increased light perception, light sensitivity, 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, epistaxis, 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 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, 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 adverse effects, but not all, already had pre-existing heart problems before taking this medicine. It is not possible to determine whether these events were directly related to sildenafil.

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You may also report adverse effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. How to store SILDENAFIL PENSA PHARMA

• Keep this medicine out of the sight and reach of children.
• Store in the original packaging to protect it from light.
• This medicine does not require any special storage conditions.
• Do not use this medicine after the expiry date stated on the packaging. 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 Sildenafil Pensa Pharma contains

• The active substance is sildenafil. Each chewable tablet contains 100 mg of sildenafil produced in situ from 140.48 mg of sildenafil citrate.
• The other components are: cross-linked polyacrylic acid potassium, magnesium stearate, anhydrous colloidal silica, aspartame, sodium croscarmellose, peppermint flavour, lactose monohydrate and povidone K-30.

Description of the appearance of Sildenafil Pensa Pharma and pack contents
Sildenafil Pensa Pharma 100 mg chewable tablets are white, triangular and biconvex.
They are marked with "100" on one side.
The chewable tablets are available in blisters containing 4, 8 and 12 chewable tablets.
Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder
Pensa Pharma S.p.A.
Via Ippolito Rosellini, 12
20124 Milano
Italy

Manufacturers
Genepharm, S.A
18 km Marathon Avenue.
153 51 Pallini Attikis (Greece)
Cemelog BRS Ltd
2040 Budaörs
Vasút u. 13
Hungary
Pharmadox Healthcare Ltd
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta

This medicinal product is authorised in European Union Member States under the following names:
Italy: Sildenafil Pensa Pharma 100 mg chewable tablets
Portugal: Sildenafil toLife, 100 mg, Comprimidos para mastigar
Spain: Sildenafilo Pensa, 100 mg, Comprimidos masticables EFG

This leaflet was last approved

PACKAGE LEAFLET: INFORMATION FOR THE USER

Sildenafil Pensa Pharma 50 mg chewable tablets

Equivalent medicine
Please read this leaflet carefully before 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, 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 effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

3. What SILDENAFIL PENSA PHARMA is and what it is used for

Sildenafil Pensa Pharma contains the active substance sildenafil, which belongs to a class of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by helping to relax blood vessels in the penis, allowing increased blood flow to the penis during sexual stimulation. Sildenafil Pensa Pharma will help you achieve an erection only if you are sexually stimulated.
Sildenafil Pensa Pharma 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.

6. What you need to know before taking SILDENAFIL PENSA PHARMA

Do not take Sildenafil Pensa Pharma

• 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 your blood pressure. If you are taking any of these medicines, which are often used to relieve angina attacks (or “chest pain”), inform your doctor. If in doubt, ask your doctor or pharmacist.
• 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 your blood pressure.
• 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 certain rare inherited eye diseases (such as retinitis pigmentosa).
• if you have previously experienced sudden vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Sildenafil Pensa Pharma:

• if you have sickle cell anemia (an abnormality of red blood cells), leukemia (a blood cell cancer), or multiple myeloma (a bone marrow cancer).
• if you have a penile deformity or Peyronie’s disease.
• if you have heart problems; your doctor should carefully assess whether your heart condition allows you to tolerate the physical exertion of sexual activity.
• if you currently have a stomach ulcer or bleeding disorders (such as hemophilia).
• if you experience sudden decrease or loss of vision, stop taking Sildenafil Pensa Pharma and contact your doctor immediately.

You must not use Sildenafil Pensa Pharma together with any other oral or local treatment for erectile dysfunction.
You must not use Sildenafil Pensa Pharma together with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or with any other phosphodiesterase type 5 (PDE5) inhibitors.
You must not take Sildenafil Pensa Pharma if you do not have erectile dysfunction.
You must not take Sildenafil Pensa Pharma 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
Sildenafil Pensa Pharma must not be administered to individuals under 18 years of age.

Other medicines and Sildenafil Pensa Pharma
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Sildenafil Pensa Pharma may interact with certain medicines, particularly those used to treat chest pain. In case of medical emergency, you must inform your doctor, pharmacist, or nurse that you have taken Sildenafil Pensa Pharma and when you took it. Do not take Sildenafil Pensa Pharma with other medicines unless authorized by your doctor.
If you are taking medicines called nitrates, you must not take Sildenafil Pensa Pharma, because this combination may cause a dangerous drop in your blood pressure. Always inform your doctor, pharmacist, or nurse if you are taking medicines commonly used to relieve angina attacks (or “chest pain”).
If you are using medicines known as nitric oxide donors such as amyl nitrite (“poppers”), you must not take Sildenafil Pensa Pharma, because this combination may also cause a dangerous drop in your blood pressure.
If you are taking protease inhibitors, such as medicines used to treat HIV, your doctor may initially prescribe the lowest dose of Sildenafil Pensa Pharma (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 rising quickly from bed or a chair (orthostatic hypotension). Some patients have experienced these symptoms when taking Sildenafil Pensa Pharma together with alpha-blockers. This is more likely to occur within 4 hours after taking Sildenafil Pensa Pharma. To reduce the likelihood of these symptoms, you should already be on stable daily therapy with alpha-blockers before starting Sildenafil Pensa Pharma. Your doctor may start treatment with a lower dose (25 mg).

Use of Sildenafil Pensa Pharma with food, drinks, and alcohol
Sildenafil Pensa Pharma can be taken with or without food. However, you may notice that the onset of effect of Sildenafil Pensa Pharma is slower if taken after a heavy meal.
Alcohol consumption may temporarily impair your ability to achieve an erection. To obtain the maximum benefit from the medicine, do not consume excessive amounts of alcohol before taking Sildenafil Pensa Pharma.

Pregnancy, breastfeeding, and fertility
Sildenafil Pensa Pharma is not indicated for use in women.

Driving and using machines
Sildenafil Pensa Pharma may cause dizziness and may affect vision. Before driving or operating machinery, make sure you know how you react to Sildenafil Pensa Pharma.

Sildenafil Pensa Pharma contains lactose monohydrate
If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

Sildenafil Pensa Pharma contains aspartame
Aspartame is a source of phenylalanine. It may be harmful to people with phenylketonuria.

7. How to take SILDENAFIL PENSA PHARMA

Always take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, you must consult your doctor or pharmacist. The recommended starting dose is 50 mg.
Do not take Sildenafil Pensa Pharma more than once a day.
Take Sildenafil Pensa Pharma approximately one hour before anticipated sexual activity. The tablet
should be chewed and swallowed.
If you feel that the effect of Sildenafil Pensa Pharma is too strong or too weak, discuss this with your
doctor or pharmacist.
Sildenafil Pensa Pharma will help you achieve an erection only if you are sexually stimulated. The time
required for Sildenafil Pensa Pharma to take effect varies from person to person, but generally ranges from
half an hour to one hour. You may notice that the effect of Sildenafil Pensa Pharma may be slower if taken
after a heavy meal.
If Sildenafil Pensa Pharma 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 Sildenafil Pensa Pharma 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 have taken more tablets than you should, 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 Sildenafil Pensa Pharma are usually mild to moderate and short-lived.
If you experience any of the following serious side effects, stop taking Sildenafil Pensa Pharma and contact your doctor immediately:

• Allergic reaction – occurs with uncommon frequency (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 with uncommon frequency: 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, blisters in the mouth, genital area and around the eyes, fever.
• Seizures or fits – 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, increased intensity of colours, 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 perception, light sensitivity, 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, nasal mucosal inflammation (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 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, dilated pupils, changes in the white colour of the sclera (part of the eye), penile bleeding, blood in semen, dry nose, nasal mucosal swelling, irritability, and sudden decrease or loss of hearing.

Since marketing authorisation, 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 were directly related to sildenafil.

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 http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store SILDENAFIL PENSA PHARMA

• Keep this medicine out of the sight and reach of children.
• Store in the original packaging to protect it from light.
• This medicine does not require any special storage conditions.
• Do not use this medicine after the expiry date stated on the packaging. 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. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Sildenafil Pensa Pharma contains

• The active substance is sildenafil. Each chewable tablet contains 50 mg of sildenafil produced in situ from 70.24 mg of sildenafil citrate.
• The other components are: cross-linked polyvinylpyrrolidone, magnesium stearate, anhydrous colloidal silica, aspartame, sodium croscarmellose, peppermint flavour, monohydrate lactose and povidone K-30.

Description of the appearance of Sildenafil Pensa Pharma and contents of the pack
Sildenafil Pensa Pharma 50 mg chewable tablets are white, triangular and biconvex. They are marked with "50" on one side.
Chewable tablets are available in blisters containing 4, 8 and 12 chewable tablets. Not all pack sizes may be marketed in your country.

Marketing Authorization Holder
Pensa Pharma S.p.A.
Via Ippolito Rosellini, 12
20124 Milano
Italy

Manufacturer
Genepharm, S.A
18 km Marathon Avenue.
153 51 Pallini Attikis (Greece)
Cemelog BRS Ltd
2040 Budaörs
Vasút u. 13
Hungary
Pharmadox Healthcare Ltd
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta

This medicinal product is authorized in European Union Member States under the following names:
Italy: Sildenafil Pensa Pharma 50 mg chewable tablets
Portugal: Sildenafil toLife, 50 mg, Chewable tablets
Spain: Sildenafil Pensa, 50 mg, Chewable tablets EFG

This leaflet was last approved on