SILDENAFIL 25 mg Tabletki Do Żucia

Treść ulotki

1. Sildenafil Pensa Pharma 25 mg chewable tablets
   1. What is SILDENAFIL PENSA PHARMA and what is it 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. Sildenafil Pensa Pharma 100 mg chewable tablets
   1. What is SILDENAFIL PENSA PHARMA and what is it 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. Sildenafil Pensa Pharma 50 mg chewable tablets
   1. What is SILDENAFIL PENSA PHARMA and what is it 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. PACKAGE CONTENTS AND OTHER INFORMATION

Sildenafil Pensa Pharma 25 mg chewable tablets

Generic medicine

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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even 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 you take 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 is SILDENAFIL PENSA PHARMA and what is it used for

Sildenafil Pensa Pharma contains the active substance sildenafil which belongs
to the class of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by helping to
relax the blood vessels in the penis, allowing blood flow to the penis when it is sexually stimulated.
Sildenafil Pensa Pharma will only help you to achieve an erection if you are sexually stimulated..
Sildenafil Pensa Pharma is a treatment for adult men who experience erectile dysfunction, sometimes
called impotence. This condition occurs when a man cannot 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 one of these medicines, which are often used to relieve angina attacks (or “chest pain”), tell your doctor. If you have any doubts, ask your doctor or pharmacist.
• If you are using one of the 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 severe heart or liver problem.
• If you have recently had a stroke or a 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 loss of vision caused by a 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 (cancer of the blood cells), multiple myeloma (cancer of the bone marrow).
• If you have a deformity of the penis or Peyronie's disease
• If you have heart problems. Your doctor will need to carefully check if your heart condition allows you to cope with the exertion of sexual intercourse.
• If you currently have a stomach ulcer or problems with blood clotting (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 type 5 phosphodiesterase (PDE5) inhibitor.
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, tell your doctor. The doctor may decide to give you a lower dose.

Children and adolescents
Sildenafil Pensa Pharma must not be given to people 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 interfere with some medicines, particularly those used to treat chest pain. In case of 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 your doctor has authorized it.
If you are taking medicines called nitrates, you must not take Sildenafil Pensa Pharma, because this combination of medicines can cause a dangerous drop in your blood pressure. Always tell your doctor, pharmacist or nurse if you are taking one of the medicines that are often used to relieve angina attacks (or “chest pain”).
If you are using one of the 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 medicines known as protease inhibitors, such as medicines for the treatment of HIV, your doctor may initially prescribe you Sildenafil Pensa Pharma at the lowest dose (25 mg).
Some patients taking alpha-blockers for high blood pressure or enlarged prostate may experience dizziness or lightheadedness, which can be caused by low blood pressure when getting up quickly from bed or a chair (orthostatic hypotension). Some patients have experienced these symptoms when taking Sildenafil Pensa Pharma with alpha-blockers. This is more likely to occur within 4 hours of taking Sildenafil Pensa Pharma. To reduce the possibility of these symptoms, you should already be on a regular daily therapy with alpha-blockers before starting to take 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 the effect of Sildenafil Pensa Pharma may be slower if you take it after consuming a heavy meal.
Drinking alcohol can temporarily impair your ability to achieve an erection. To get the most benefit from the medicine, do not consume excessive amounts of alcohol before taking Sildenafil Pensa Pharma.

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

Driving and using machines
Sildenafil Pensa Pharma can cause dizziness and can alter your vision. Before driving vehicles or using machines, you should be aware of how you react to Sildenafil Pensa Pharma.

Sildenafil Pensa Pharma contains lactose monohydrate
If you have been told by your doctor that you have an intolerance to some sugars, contact 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 your doctor or pharmacist has told you. If you have
any doubts, ask your doctor or pharmacist. The recommended starting dose is 50 mg.

You must not take Sildenafil Pensa Pharma more than once a day.
You should take Sildenafil Pensa Pharma approximately one hour before the 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, talk to your
doctor or pharmacist.
Sildenafil Pensa Pharma will only help you to achieve an erection if you are sexually stimulated. The time
it takes 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 you take it
after consuming a heavy meal.
If Sildenafil Pensa Pharma does not help you to 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 notice an increase in the undesirable effects and their severity. Doses greater than 100 mg do not increase
efficacy.

Do not take more tablets than your doctor has prescribed.
If you have taken more tablets than you should, contact your doctor.
If you have any doubts about the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The side effects reported in association with the use of Sildenafil Pensa Pharma are usually mild to moderate and of short duration.

If you experience any of the following serious side effects, stop taking
Sildenafil Pensa Pharma and contact your doctor immediately:

• Allergic reaction - occurs with an 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 an uncommon frequency: If it occurs during or after sexual intercourse:
• Assume a semi-sitting 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 uninterrupted for more than 4 hours, contact your doctor immediately.
• Sudden reduction or loss of vision - occurs rarely.
• Severe skin reactions - occur rarely. Symptoms may include severe exfoliation and swelling of the skin, blisters in the mouth, on the genitals and around the eyes, fever.
• Convulsions or seizures - 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 (the
symptoms include a sudden sensation of heat in the upper body), indigestion,
increased color intensity, blurred vision, visual disturbances, nasal congestion and dizziness.

Uncommon(may affect up to 1 in 100 people): vomiting, skin rash, eye irritation,
red eyes, eye pain, flashes of light, increased perception of light, sensitivity to light,
tearing, palpitations, fast heartbeat, high blood pressure, low blood pressure,
muscle pain, drowsiness, reduced sensitivity to touch, vertigo, ringing in the ears, dry mouth, obstructed or congested sinuses,
inflammation of the nasal mucosa (symptoms include runny nose, sneezing
and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (symptoms include
heartburn), blood in the urine, pain in the arms or legs, nosebleeds, feeling of heat and
fatigue.

Rare(may affect up to 1 in 1000): fainting, stroke, heart attack, irregular heartbeat,
temporary reduction of blood flow to certain areas of the brain, feeling of
constriction in the throat, numbness in 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
corpuscles in the visual field, seeing halos around lights, dilation of the pupils, alteration of the color
white of the sclera (part of the eye), bleeding of the penis,
presence of blood in the seminal fluid, dry nose, swelling of the nasal mucosa, irritability and sudden or loss of hearing.
From experience after marketing, rare cases of unstable angina
(a heart disease) and sudden death have been reported. It should be noted that most men
who experienced these side effects, but not all, had heart problems before using 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, tell your
doctor, pharmacist or nurse. You can also report side effects directly through 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 package to protect it from light
• This medicine does not require any particular storage conditions
• Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
• Do not dispose of any medicine in 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 pack and other information

What Sildenafil Pensa Pharma contains

• The active ingredient is sildenafil. Each chewable tablet contains 25 mg of sildenafil produced in situ from 35.12 mg of sildenafil citrate.
• The other ingredients are: potassium polyacrilin, 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 contents of the pack
Sildenafil Pensa Pharma 25 mg chewable tablets are white, triangular and biconvex. They are imprinted
with “25” on one side.
The chewable tablets are available in blisters containing 4, 8 and 12 chewable tablets. It is possible
that not all pack sizes are marketed in your country.

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

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 with the following denominations:
Italy: Sildenafil Pensa Pharma 25 mg chewable tablets
Portugal: Sildenafil toLife, 25 mg, Chewable Tablets
Spain: Sildenafilo Pensa, 25 mg, Comprimidos masticables EFG

Sildenafil Pensa Pharma 100 mg chewable tablets

Generic medicine

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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even 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 you take Sildenafil Pensa Pharma
• 3. How to take Sildenafil Pensa Pharma
• 4. Possible side effects
• 6. How to store Sildenafil Pensa Pharma
• 6. Contents of the pack and other information

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

Sildenafil Pensa Pharma contains the active substance sildenafil which belongs to the class of medicines
called phosphodiesterase type 5 (PDE5) inhibitors. It works by helping to relax the blood vessels in the
penis, allowing blood flow to the penis when it is sexually stimulated. Sildenafil Pensa Pharma
will only help you to achieve an erection if you are sexually stimulated.
Sildenafil Pensa Pharma is a treatment for adult men who experience erectile dysfunction, sometimes
called impotence. This condition occurs when a man cannot achieve, or
maintain, an erection suitable 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 can cause a dangerous drop in your blood pressure. If you are taking one of these medicines, which are often used to relieve angina pectoris (or “chest pain”), tell your doctor. If you have any doubts, ask your doctor or pharmacist.
• If you are using one of the 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 severe heart or liver problem.
• If you have recently had a stroke or a heart attack, or if you have low blood pressure.
• If you have certain rare hereditary eye diseases (such as retinitis pigmentosa).
• If you have previously experienced loss of vision caused by a 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 (cancer of the blood cells), multiple myeloma (cancer of the bone marrow).
• If you have a deformity of the penis or Peyronie's disease.
• If you have heart problems. Your doctor will need to carefully check if your heart condition allows you to cope with the exertion of sexual intercourse.
• If you currently have a stomach ulcer or problems with blood clotting (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 any other type 5 phosphodiesterase (PDE5) inhibitor.
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, tell your doctor. The doctor may decide to give you a lower dose.

Children and adolescents
Sildenafil Pensa Pharma must not be given to anyone under the age of 18 years.

Other medicines and Sildenafil Pensa Pharma
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
Sildenafil Pensa Pharma can interfere with some medicines, particularly those used to treat chest pain. In case of 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 your doctor has authorized it.
If you are taking medicines called nitrates, you must not take Sildenafil Pensa Pharma, because this combination of medicines can cause a dangerous drop in your blood pressure. Always inform your doctor, pharmacist or nurse if you are taking one of the medicines that are often used to relieve angina pectoris (or “chest pain”).
If you are using one of the 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 medicines known as protease inhibitors, such as medicines for the treatment of HIV, your doctor may initially prescribe you Sildenafil Pensa Pharma at the lowest dose (25 mg).
Some patients taking alpha-blockers for the treatment of high blood pressure or an enlarged prostate may experience dizziness or confusion, which may be caused by low blood pressure when getting up quickly from bed or a chair (orthostatic hypotension). Some patients have experienced these symptoms when taking Sildenafil Pensa Pharma with alpha-blockers. This is more likely to occur within 4 hours of taking Sildenafil Pensa Pharma. To reduce the possibility of these symptoms, you should already be on a regular daily therapy with alpha-blockers before starting to take 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 the effect of Sildenafil Pensa Pharma may be slower if you take it after consuming a large meal.
Drinking alcohol can temporarily impair your ability to achieve an erection. To get the maximum benefit from the medicine, do not consume excessive amounts of alcohol before taking Sildenafil Pensa Pharma.

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

Driving and operating machinery
Sildenafil Pensa Pharma can cause dizziness and can alter your vision. Before driving vehicles or operating machinery, you should be aware of how you react to Sildenafil Pensa Pharma.

Sildenafil Pensa Pharma contains lactose monohydrate
If you have been told by your doctor that you have an intolerance to some sugars, contact 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 your doctor or pharmacist has told you. If you have
any doubts, ask your doctor or pharmacist. The recommended starting dose is 50 mg.

You must not take Sildenafil Pensa Pharma more than once a day.
You should take Sildenafil Pensa Pharma approximately one hour before the 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, talk to your
doctor or pharmacist.
Sildenafil Pensa Pharma will only help you to achieve an erection if you are sexually stimulated. The time
it takes 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 you take it
after consuming a heavy meal.
If Sildenafil Pensa Pharma does not help you to 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 notice an increase in the undesirable effects and their severity. Doses greater than 100 mg do not increase
efficacy.

Do not take more tablets than your doctor has prescribed.
If you have taken more tablets than you should, contact your doctor.
If you have any doubts about the use of this medicine, ask your doctor, pharmacist or nurse.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The side effects reported in association with the use of Sildenafil Pensa Pharma are usually mild to moderate and of short duration.

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 activity:
• Assume a semi-sitting 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 uninterrupted for more than 4 hours, contact your doctor immediately.
• Sudden reduction 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, on the genitals and around the eyes, fever.
• Convulsions or seizures - 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 (the
symptoms include a sudden feeling of heat in the upper body), indigestion,
increased color intensity, blurred vision, visual disturbances, nasal congestion and dizziness.

Uncommon(may affect up to 1 in 100 people): vomiting, rash, eye irritation,
red eyes, eye pain, flashes of light, increased perception of light, sensitivity to light,
tearing, palpitations, fast heartbeat, high blood pressure, low blood pressure,
muscle pain, drowsiness, reduced sensitivity to touch, vertigo, ringing in the ears, dry mouth, obstructed or congested sinuses, inflammation of the nasal mucosa (symptoms include runny nose, sneezing
and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (symptoms include
heartburn), blood in the urine, pain in the arms or legs, nosebleeds, feeling of heat and
fatigue.

Rare(may affect up to 1 in 1000 people):, fainting, stroke, heart attack, irregular heartbeat,
temporary reduction of blood flow to certain areas of the brain, feeling of
constriction in the throat, numbness in the mouth, bleeding in the back of the eye, double vision,
reduced visual acuity, abnormal eye sensitivity, swelling of the eyes or eyelids, appearance of spots or
corpuscles in the visual field, seeing halos around lights, dilation of the pupils, alteration of the color
white of the sclera (part of the eye), bleeding of the penis,
presence of blood in the seminal fluid, dry nose, swelling of the nasal mucosa, irritability and sudden reduction or loss of hearing.
Cases of unstable angina (a heart condition) and sudden death have been reported rarely from post-marketing experience. It should be noted that most men who experienced these side effects, but not all, had pre-existing heart problems before using 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 effects, including those not listed in this leaflet, please inform your
doctor, pharmacist or nurse. You can also report side effects directly through the
national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-
una-sospetta-reazione-avversa. Reporting side effects 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 package to protect it from light
• This medicine does not require any special storage conditions
• Do not use this medicine after the expiry date which is reported on the pack. The expiry date refers to the last day of that month.
• Do not dispose of any medicine in 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 pack and other information

What Sildenafil Pensa Pharma contains

• The active ingredient is sildenafil. Each chewable tablet contains 100 mg of sildenafil produced in situ from 140.48 mg of sildenafil citrate.
• The other ingredients are: potassium polyacrilin, 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 contents of the pack
Sildenafil Pensa Pharma 100 mg chewable tablets are white, triangular and biconvex. They are
imprinted with “100” on one side.
The chewable tablets are available in blisters containing 4, 8 and 12 chewable tablets. It is possible
that not all pack sizes are marketed in your country.

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

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 with the following denominations:
Italy: Sildenafil Pensa Pharma 100 mg chewable tablets
Portugal: Sildenafil toLife, 100 mg, Chewable Tablets
Spain: Sildenafilo Pensa, 100 mg, Comprimidos masticables EFG

Sildenafil Pensa Pharma 50 mg chewable tablets

Generic medicine

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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

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

Sildenafil Pensa Pharma contains the active substance sildenafil which belongs to the class of medicines
called phosphodiesterase type 5 (PDE5) inhibitors. It works by helping to relax the blood vessels in the
penis, allowing blood flow to the penis when it is sexually stimulated. Sildenafil Pensa Pharma
will only help you to achieve an erection if you are sexually stimulated.
Sildenafil Pensa Pharma is a treatment for adult men who experience erectile dysfunction, sometimes
called impotence. This condition occurs when a man cannot achieve, or
maintain, an erection suitable 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 can cause a dangerous drop in your blood pressure. If you are taking one of these medicines, which are often used to relieve angina attacks (or “chest pain”), tell your doctor. If you have any doubts, ask your doctor or pharmacist.
• If you are using one of the 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 severe heart or liver problem.
• If you have recently had a stroke or a 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 loss of vision caused by a 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 (cancer of the blood cells), multiple myeloma (cancer of the bone marrow).
• If you have a deformity of the penis or Peyronie's disease.
• If you have heart problems your doctor will need to carefully check if your heart condition allows you to cope with the exertion of sexual activity.
• If you currently have a stomach ulcer or problems with blood clotting (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 any other type 5 phosphodiesterase (PDE5) inhibitor.
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, tell your doctor. Your doctor may decide to give you a lower dose.
Children and adolescents
Sildenafil Pensa Pharma should not be given to anyone 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 interfere with some medicines, particularly those used to treat chest pain. In case of 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 your doctor has authorized it.
If you are taking medicines called nitrates, you must not take Sildenafil Pensa Pharma, because this combination of medicines can cause a dangerous drop in your blood pressure. Always tell your doctor, pharmacist or nurse if you are taking one of the medicines that are often used to relieve angina attacks (or “chest pain”).
If you are using one of the 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 medicines known as protease inhibitors, such as medicines for the treatment of HIV, your doctor may initially prescribe Sildenafil Pensa Pharma at the lowest dose (25 mg).
Some patients taking alpha-blockers for high blood pressure or enlarged prostate may experience dizziness or lightheadedness, which may be caused by low blood pressure when getting up quickly from bed or a chair (orthostatic hypotension). Some patients have experienced these symptoms when taking Sildenafil Pensa Pharma with alpha-blockers. This is more likely to occur within 4 hours of taking Sildenafil Pensa Pharma. To reduce the possibility of these symptoms, you should already be on a regular daily dose of alpha-blockers before starting to take 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 effect of Sildenafil Pensa Pharma may be slower to start if you take it after a heavy meal.
Drinking alcohol may temporarily impair your ability to achieve an erection. To get the most benefit from the medicine, do not consume excessive amounts of alcohol before taking Sildenafil Pensa Pharma.

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

Driving and using machines
Sildenafil Pensa Pharma can cause dizziness and can alter your vision. Before driving vehicles or using machines, you should be aware of how you react to Sildenafil Pensa Pharma.

Sildenafil Pensa Pharma contains lactose monohydrate
If you have been told by your doctor that you have an intolerance to some sugars, contact 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.

7. How to take SILDENAFIL PENSA PHARMA

Always take this medicine exactly as your doctor or pharmacist has told you. If you have
any doubts, ask your doctor or pharmacist. The recommended starting dose is 50 mg.

You must not take Sildenafil Pensa Pharma more than once a day.
You should take Sildenafil Pensa Pharma approximately one hour before the expected 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, talk to your
doctor or pharmacist.
Sildenafil Pensa Pharma will only help you to achieve an erection if you are sexually stimulated. The time
it takes 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 you take
it after consuming a heavy meal.
If Sildenafil Pensa Pharma does not help you to 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 notice an increase in the undesirable effects and their severity. Doses higher than 100 mg do not increase
efficacy.

Do not take more tablets than your doctor has prescribed.
If you have taken more tablets than you should, contact your doctor.
If you have any doubts about the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

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

• Allergic reaction - occurs with a frequency that is uncommon (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 a frequency that is uncommon: If it occurs during or after sexual activity:
• Assume a semi-sitting 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 uninterrupted for more than 4 hours, contact your doctor immediately.
• Sudden reduction 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, on the genitals and around the eyes, fever.
• Convulsions or seizures - 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 (the
symptoms include a sudden feeling of heat in the upper part of the body), indigestion,
increased intensity of colors, blurred vision, visual disturbances, stuffy nose and dizziness.

Uncommon(may affect up to 1 in 100 people): vomiting, rash, eye irritation,
red eyes, eye pain, flashes of light, increased perception of light, sensitivity to light,
tearing, palpitations, fast 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 (symptoms include
heartburn), blood in the urine, pain in the arms or legs, nosebleeds, feeling of heat and
fatigue.

Rare(may affect up to 1 in 1000 people): fainting, stroke, heart attack, irregular heartbeat,
temporary reduction in blood flow to some areas of the brain, feeling of
constriction in the throat, numb mouth, bleeding in the back of the eye, double vision,
reduced visual acuity, abnormal eye sensitivity, swelling of the eyes or eyelids, appearance of spots or
corpuscles in the visual field, seeing halos around lights, dilation of the pupils, alteration of the color
white of the sclera (part of the eye), bleeding of the penis,
presence of blood in the seminal fluid, dry nose, swelling of the nasal mucosa, irritability and sudden or loss of hearing.
From experience after marketing, rare cases of unstable angina
(a heart disease) and sudden death have been reported. It should be noted that most men who have
experienced these side effects, but not all, had heart problems before using this
medicine. It is not possible to determine whether these events were directly related to sildenafil.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly through
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 package to protect it from light
• This medicine does not require any particular storage conditions
• Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
• Do not dispose of any medicine in 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 ingredient is sildenafil. Each chewable tablet contains 50 mg of sildenafil produced in situ from 70.24 mg of sildenafil citrate.
• The other ingredients are: potassium polyacrilin, 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 package contents
Sildenafil Pensa Pharma 50 mg chewable tablets are white, triangular and biconvex. They are imprinted
with “50” on one side.
The chewable tablets are available in blisters containing 4, 8 and 12 chewable tablets. It is possible
that not all pack sizes are marketed in your country.

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

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 with the following denominations:
Italy: Sildenafil Pensa Pharma 50 mg chewable tablets
Portugal: Sildenafil toLife, 50 mg, Chewable Tablets
Spain: Sildenafilo Pensa, 50 mg, Comprimidos masticables EFG