Tadalafil Pensapharma: detailed information

Package leaflet: Information for the user

Tadalafil Pensa Pharma

2.5 mg film-coated tablets
Tadalafil
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Tadalafil Pensa Pharma is and what it is used for
What you need to know before taking Tadalafil Pensa Pharma
How to take Tadalafil Pensa Pharma
Possible side effects
How to store Tadalafil Pensa Pharma
Contents of the pack and other information

1. What Tadalafil Pensa Pharma is and what it is used for

Tadalafil Pensa Pharma is a treatment for adult men with erectile dysfunction.
This condition occurs when a man is unable to achieve or maintain an erection sufficient for
sexual intercourse. Tadalafil Pensa Pharma has been shown to significantly improve the ability
to obtain an erection sufficient for sexual intercourse.
Tadalafil Pensa Pharma contains the active substance tadalafil, which belongs to a class of medicines
called phosphodiesterase type 5 inhibitors. Following sexual stimulation, Tadalafil Pensa Pharma
helps relax the blood vessels in the penis, allowing blood to flow into the penis. The result is improved
erectile function. Tadalafil Pensa Pharma will not help you if you do not have erectile dysfunction.
It is important to note that Tadalafil Pensa Pharma has no effect in the absence of sexual stimulation.
You and your partner will need to engage in foreplay, as you would if you were not taking a
medicine for erectile dysfunction.

2. What you need to know before taking Tadalafil Pensa Pharma

Do not take Tadalafil Pensa Pharma if:

you are allergic to tadalafil or to any of the other ingredients of this medicine (listed in section 6).
you are taking any form of organic nitrate or nitric oxide donors, such as amyl nitrite. These are a group of medicines ("nitrates") used to treat angina pectoris (or "chest pain"). Tadalafil Pensa Pharma has been shown to increase the effect of these medicines. If you are taking any form of nitrate or have any doubts, inform your doctor.
you have severe heart disease or have had a heart attack recently, within the last 90 days.
you have recently had a stroke, within the last 6 months.
you have low blood pressure or uncontrolled high blood pressure.
you have previously experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as "stroke of the eye".
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 secondary to blood clots). PDE5 inhibitors, such as Tadalafil Pensa Pharma, have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or have any doubts, inform your doctor.

sickle cell anemia (an abnormality of red blood cells).
multiple myeloma (a malignant tumor of the bone marrow).
leukemia (a malignant tumor of blood cells).
any deformity of the penis.
a serious liver problem.
a serious kidney problem.

It is not known whether Tadalafil Pensa Pharma is effective in patients who have undergone:

pelvic surgery
removal of all or part of the prostate gland where the nerves to the prostate have been severed (radical prostatectomy without nerve-sparing).

Children and adolescents
Tadalafil Pensa Pharma is not intended for use in children and adolescents under 18 years of age.

Other medicines and Tadalafil Pensa Pharma
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Do not take Tadalafil Pensa Pharma if you are already taking nitrates.
Some medicines may be affected by Tadalafil Pensa Pharma, or they may affect how Tadalafil Pensa Pharma works. Inform your doctor or pharmacist if you are already taking:

an alpha-blocker (used to treat high blood pressure or urinary problems associated with benign prostatic hyperplasia).
other medicines for high blood pressure.
riociguat.
a 5-alpha-reductase enzyme inhibitor (used to treat benign prostatic hyperplasia).
medicines such as ketoconazole tablets (for treating fungal infections) and protease inhibitors for the treatment of AIDS or HIV infection.
phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
rifampicin, erythromycin, clarithromycin, or itraconazole.
other treatments for erectile dysfunction.

Tadalafil Pensa Pharma with food, drinks and alcohol
Information on the effects of alcohol is provided in section 3. Grapefruit juice may affect how Tadalafil Pensa Pharma works and should be consumed with caution.
Talk to your doctor for further information.

Fertility
In treated dogs, reduced sperm development in the testes has been observed. In some men, a reduction in sperm count has been observed. These effects are unlikely to cause infertility.

Driving and using machines
Some men taking Tadalafil Pensa Pharma in clinical studies reported dizziness. Carefully monitor how you react to the tablets before driving or operating machinery.

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

Tadalafil Pensa Pharma contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take Tadalafil Pensa Pharma

Take this medicine exactly as your doctor has instructed. If you have any doubts, consult your doctor or pharmacist.
The Tadalafil Pensa Pharma tablets are for oral use and for men only. Swallow the tablet whole with water. The tablets can be taken regardless of food intake.
The recommended dose is one 5 mg tablet taken once daily at approximately the same time each day. Your doctor may adjust the dose to 2.5 mg depending on your response to Tadalafil Pensa Pharma. This dose will be given to you as a 2.5 mg tablet.
Do not take Tadalafil Pensa Pharma more than once a day.
Daily administration of Tadalafil Pensa Pharma may be suitable for men who anticipate having sexual activity two or more times per week.
When taken once daily, Tadalafil Pensa Pharma allows you to achieve an erection, if there is sexual stimulation, at any time during the 24-hour period following intake.
It is important to note that Tadalafil Pensa Pharma does not work without sexual stimulation. You and your partner will need to engage in foreplay as you normally would if you were not taking a medicine for erectile dysfunction.
Drinking alcohol may interfere with your ability to get an erection and may temporarily cause a drop in your blood pressure. If you have taken or plan to take Tadalafil Pensa Pharma, avoid excessive alcohol consumption (blood alcohol level of 0.08% or higher), as this may increase the risk of dizziness when standing up.
If you take more Tadalafil Pensa Pharma than you should
Contact your doctor. You may experience the side effects described in section 4.
If you forget to take Tadalafil Pensa Pharma
Take your dose as soon as you remember, but do not take a double dose to make up for the forgotten tablet. Do not take Tadalafil Pensa Pharma more than once a day.
If you have any doubts about how to use this medicine, speak to your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them. These side effects are usually mild to moderate in severity.
If you experience any of the following side effects, stop using the medicine and
seek immediate medical help:

allergic reactions, including skin rash (uncommon frequency).
Chest pain – do not use nitrates but seek immediate medical help (uncommon frequency).
Priapism, a prolonged and possibly painful erection after taking Tadalafil Pensa Pharma (rare frequency). If you have an erection of this type lasting for more than 4 consecutive hours, you must contact a doctor immediately.
Sudden loss of vision (rare frequency), distorted central vision, blurred or hazy vision, or sudden decrease in vision (frequency not known).

Other side effects reported include:
Common ( observed in 1 to 10 patients out of 100)

headache, back pain, muscle pain, arm and leg pain, facial flushing, nasal congestion, and digestive disturbances.

Uncommon (observed in 1 to 10 patients out of 1,000)

dizziness, stomach discomfort, feeling unwell, nausea (vomiting), acid reflux, blurred vision, eye discomfort, breathing difficulties, blood in urine, prolonged erection, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of the hands, feet or ankles, and feeling tired.

Rare (observed in 1 to 10 patients out of 10,000)

fainting, seizures, transient memory loss, eyelid swelling, red eyes, sudden decrease or loss of hearing, urticaria (itchy red patches on the skin), penile bleeding, blood in semen, and increased sweating.

Rarely, heart attacks and strokes have been reported in men taking Tadalafil Pensa Pharma. Most of these individuals already had pre-existing heart conditions before taking the medicine. Rarely, cases of partial, temporary or permanent reduction or loss of vision in one or both eyes have been reported.
Some additional rare side effects not observed during clinical studies have been reported in men taking Tadalafil Pensa Pharma. These include:

migraine, facial swelling, severe allergic reaction causing swelling of the face and throat, severe skin reactions, certain disorders affecting blood circulation to the eyes, irregular heartbeat, angina, and sudden cardiac death.
distorted central vision, blurred, hazy vision or sudden decrease in vision (frequency not known).

The side effect dizziness has been reported more frequently in men over 75 years of age taking Tadalafil Pensa Pharma. Diarrhoea has been reported more frequently in men over 65 years of age taking Tadalafil Pensa Pharma.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at 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 Tadalafil Pensa Pharma

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

6. Package contents and other information

What Tadalafil Pensa Pharma contains

The active substance is tadalafil. Each tablet contains 2.5 mg of tadalafil.
The other components are: Tablet core: monohydrate lactose (see end of section 2), microcrystalline cellulose, povidone, poloxamer, sodium lauryl sulfate, sodium croscarmellose, anhydrous colloidal silica and magnesium stearate. Film coating: polyvinyl alcohol, macrogol, talc and titanium dioxide (E171).

Description of the appearance of Tadalafil Pensa Pharma and package contents
Tadalafil Pensa Pharma 2.5 mg tablets are white or almost white, round, biconvex film-coated tablets of approximately 5 mm diameter.
Tadalafil Pensa Pharma 2.5 mg film-coated tablets are available in aluminum/PVD/PVDC blisters, in packs of 28 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Towa Pharmaceutical S.p.A.
Via Enrico Tazzoli, 6
20154 Milan
Italy

Manufacturer
Pharmaceutical Works POLPHARMA SA
19, Pelplińska Street
83-200 Starogard Gdański
Poland
Pharmaceutical Works POLPHARMA SA
2 Metalowca Street
39-460 Nowa Dęba
Poland
Pharmacare Premium Ltd.
HHF003 Hal Far Industrial Estate,
Hal Far Birzebbugia,
BBG 3000
Malta

Package leaflet: Information for the user

Tadalafil Pensa Pharma

5 mg film-coated tablets
Tadalafil
Generic Medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What Tadalafil Pensa Pharma is and what it is used for
What you need to know before taking Tadalafil Pensa Pharma
How to take Tadalafil Pensa Pharma
Possible side effects
How to store Tadalafil Pensa Pharma
Contents of the pack and other information

1. What Tadalafil Pensa Pharma is and what it is used for

Tadalafil Pensa Pharma contains the active substance tadalafil, which belongs to a class of medicines
called phosphodiesterase type 5 inhibitors.
Tadalafil Pensa Pharma 5 mg is a treatment for men with:

Erectile dysfunction. This condition occurs when a man is unable to achieve or maintain an erection sufficient for sexual intercourse. Tadalafil Pensa Pharma has been shown to significantly improve the ability to obtain an erection sufficient for sexual intercourse.

Following sexual stimulation, Tadalafil Pensa Pharma helps relax the blood vessels in the penis,
allowing increased blood flow into the penis. The result is improved erectile function. Tadalafil
Pensa Pharma will not help you if you do not have erectile dysfunction. It is important to note that
Tadalafil Pensa Pharma, when used for the treatment of erectile dysfunction, has no effect in the absence of
sexual stimulation. You and your partner will need to engage in foreplay, as you would if you were not
taking a medicine for erectile dysfunction.

Urinary symptoms associated with a common condition called benign prostatic hyperplasia. This condition occurs when the prostate gland enlarges with age. Symptoms include difficulty starting urination, feeling of incomplete bladder emptying, and increased need to urinate, including during the night. Tadalafil Pensa Pharma improves blood flow and relaxes the muscles of the prostate and bladder, which may reduce symptoms associated with benign prostatic hyperplasia. Tadalafil Pensa Pharma has been shown to improve these urinary symptoms as early as 1–2 weeks after starting treatment.

2. What you need to know before taking Tadalafil Pensa Pharma

Do not take Tadalafil Pensa Pharma if:

you are allergic to tadalafil or to any of the other ingredients of this medicine (listed in section 6).
you are taking any form of organic nitrate or nitric oxide donors, such as amyl nitrite. These are a group of medicines ("nitrates") used to treat angina pectoris (or "chest pain"). Tadalafil Pensa Pharma has been shown to increase the effect of these medicines. If you are taking any form of nitrate or have any doubts, inform your doctor.
you have a severe heart disease or have recently had a heart attack (within the last 90 days).
you have recently had a stroke (within the last 6 months).
you have low blood pressure or uncontrolled high blood pressure.
you have previously experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as "stroke of the eye".
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 Tadalafil Pensa Pharma, have been shown to increase the blood pressure-lowering effect of this medicine. If you are taking riociguat or have any doubts, inform your doctor.

Warnings and precautions
Talk to your doctor before taking Tadalafil Pensa Pharma.
Be aware that sexual activity involves a potential risk for patients with heart disease, as it places additional strain on the heart. If you have a heart condition, inform your doctor.
Since benign prostatic hyperplasia and prostate cancer can have similar symptoms, your doctor will perform tests for prostate cancer before starting treatment with Tadalafil Pensa Pharma for benign prostatic hyperplasia. Tadalafil Pensa Pharma does not treat prostate cancer.
Before taking the tablets, inform your doctor if you have:

sickle cell anemia (an abnormality of red blood cells).
multiple myeloma (a malignant bone marrow tumor).
leukemia (a malignant blood cell disorder).
any deformity of the penis.
a severe liver problem.
a severe kidney problem.

It is not known whether Tadalafil Pensa Pharma is effective in patients who have undergone:

pelvic surgery
removal of all or part of the prostate gland where the nerves to the prostate have been severed (radical prostatectomy without nerve-sparing).

If you experience a sudden decrease or loss of vision, or if your vision becomes distorted or blurred while taking Tadalafil Pensa Pharma, stop taking Tadalafil Pensa Pharma and contact your doctor immediately.
In some patients taking tadalafil, sudden decrease or loss of hearing has been observed. Although it is not known whether this event is directly related to tadalafil, if you experience sudden reduction or loss of hearing, stop taking Tadalafil Pensa Pharma and contact your doctor immediately.
Tadalafil Pensa Pharma is not intended for use by women.
Children and adolescents
Tadalafil Pensa Pharma is not intended for use in children and adolescents under 18 years of age.
Other medicines and Tadalafil Pensa Pharma
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Do not take Tadalafil Pensa Pharma if you are already taking nitrates.
Some medicines may be affected by Tadalafil Pensa Pharma or may themselves affect how Tadalafil Pensa Pharma works. Inform your doctor or pharmacist if you are taking:

an alpha-blocker (used to treat high blood pressure or urinary problems associated with benign prostatic hyperplasia).
other medicines for treating high blood pressure.
riociguat.
a 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia).
medicines such as ketoconazole tablets (for treating fungal infections) and protease inhibitors for the treatment of AIDS or HIV infection.
phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
rifampicin, erythromycin, clarithromycin, or itraconazole.
other treatments for erectile dysfunction.

Tadalafil Pensa Pharma with food and alcohol
Information on the effects of alcohol is provided in section 3. Grapefruit juice may affect how Tadalafil Pensa Pharma works and should be consumed with caution. Consult your doctor for further information.
Fertility
In treated dogs, reduced sperm development in the testes has been observed. In some men, reduced sperm count has been observed. These effects are unlikely to cause infertility.
Driving and using machines
Some men taking Tadalafil Pensa Pharma in clinical studies reported dizziness. Carefully assess how you react to the tablets before driving or operating machinery.
Tadalafil Pensa Pharma contains lactose
If your doctor has informed you of an intolerance to certain sugars, consult your doctor before taking this medicine.
Tadalafil Pensa Pharma contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".

3. How to take Tadalafil Pensa Pharma

Take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
Tadalafil Pensa Pharma tablets are for oral use and for men only. Swallow the tablet whole with water. The tablets can be taken regardless of food intake.
Consumption of alcoholic beverages may temporarily cause a reduction in your blood pressure. If you have taken or plan to take Tadalafil Pensa Pharma, avoid excessive alcohol consumption (blood alcohol level of 0.08% or higher), as this may increase the risk of dizziness when standing up.

For the treatment of erectile dysfunction
Recommended dose: One 5 mg tablet taken once daily at approximately the same time each day. Your doctor may adjust the dose to 2.5 mg depending on your response to Tadalafil Pensa Pharma. This lower dose will be provided as a 2.5 mg tablet.
Do not take Tadalafil Pensa Pharma more than once a day.
When taken once daily, Tadalafil Pensa Pharma allows you to achieve an erection, if there is sexual stimulation, at any time during the 24-hour period. Daily administration of Tadalafil Pensa Pharma may be beneficial for men who anticipate having sexual activity two or more times per week.
It is important to note that Tadalafil Pensa Pharma does not work without sexual stimulation. You and your partner will need to engage in foreplay as you normally would if you were not taking a medicine for erectile dysfunction.
Alcohol consumption may interfere with your ability to achieve an erection.

For the treatment of benign prostatic hyperplasia
Dose: One 5 mg tablet taken once daily at approximately the same time each day.
If you have both benign prostatic hyperplasia and erectile dysfunction, the dose remains one 5 mg tablet taken once daily.
DO NOT take Tadalafil Pensa Pharma more than once a day.

If you take more Tadalafil Pensa Pharma than you should
Contact your doctor. You may experience side effects described in section 4.

If you forget to take Tadalafil Pensa Pharma
Take your dose as soon as you remember, but do not take a double dose to make up for the forgotten tablet. You must not take Tadalafil Pensa Pharma more than once a day.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them. These side effects are usually mild to moderate in severity.
If you experience any of the following side effects, stop using the medicine and
seek immediate medical help:

allergic reactions, including skin rash (frequency not common).
Chest pain – do not use nitrates, but seek immediate medical help (frequency not common).
Priapism, a prolonged and possibly painful erection after taking Tadalafil Pensa Pharma (frequency rare). If you have an erection of this type lasting more than 4 hours, you must contact a doctor immediately.
Sudden loss of vision (frequency rare), distorted central vision, blurred, hazy, or sudden decrease in vision (frequency not known).

Other side effects have been reported:
Common ( observed in 1–10 patients out of 100)

headache, back pain, muscle pain, pain in arms and legs, facial flushing, nasal congestion, and digestive disturbances.

Not common (observed in 1–10 patients out of 1,000)

dizziness, stomach discomfort, feeling unwell, nausea (vomiting), acid reflux, blurred vision, eye discomfort, breathing difficulties, blood in urine, prolonged erection, palpitations, fast heartbeat, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of hands, feet or ankles, and feeling tired.

Rare (observed in 1–10 patients out of 10,000)

fainting, seizures, transient memory loss, eyelid swelling, red eyes, sudden decrease or loss of hearing, urticaria (red, itchy patches on the skin), penile bleeding, blood in semen, and increased sweating.

Rarely, heart attacks and strokes have been reported in men taking Tadalafil Pensa Pharma. Most of these individuals already had heart problems before taking the medicine. Rare cases of partial, temporary or permanent decrease or loss of vision in one or both eyes have also been reported.
Some additional rare side effects not observed during clinical studies have been reported in men taking Tadalafil Pensa Pharma. These include:

migraine, facial swelling, severe allergic reaction causing swelling of the face and throat,

severe skin reactions, certain disorders affecting blood circulation to the eyes, irregular heartbeat, angina, and sudden cardiac death.

distorted central vision, blurred, hazy, or sudden decrease in vision (frequency not known).

The side effect dizziness has been reported more frequently in men over 75 years of age taking Tadalafil Pensa Pharma. Diarrhoea has been reported more frequently in men over 65 years of age taking Tadalafil Pensa Pharma.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at 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 Tadalafil Pensa Pharma

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

6. Package contents and other information

What Tadalafil Pensa Pharma contains

The active substance is tadalafil. Each tablet contains 5 mg of tadalafil.
The other components are: Tablet core: monohydrate lactose (see end of section 2), microcrystalline cellulose, povidone, poloxamer, sodium lauryl sulfate, croscarmellose sodium, colloidal anhydrous silica and magnesium stearate. Film coating: polyvinyl alcohol, macrogol, talc, titanium dioxide (E171), yellow iron oxide (E172) and red iron oxide (E172).

Description of the appearance of Tadalafil Pensa Pharma and the contents of the pack
Tadalafil Pensa Pharma 5 mg tablets are light brown, film-coated, oblong, biconvex tablets of approximately 8 mm x 4 mm.
Tadalafil Pensa Pharma 5 mg film-coated tablets are available in aluminum/PVD/PVDC blisters in packs of 14 and 28 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Towa Pharmaceutical S.p.A.
Via Enrico Tazzoli, 6
20154 Milan
Italy

Manufacturers
Pharmaceutical Works POLPHARMA SA
19, Pelplińska Street
83-200 Starogard Gdański
Poland
Pharmaceutical Works POLPHARMA SA
2 Metalowca Street
39-460 Nowa Dęba
Poland
Pharmacare Premium Ltd.
HHF003 Hal Far Industrial Estate,
Hal Far, Birzebbugia,
BBG 3000
Malta

Patient Information Leaflet

Tadalafil Pensa Pharma

10 mg film-coated tablets
Tadalafil
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 or pharmacist.
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, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

What Tadalafil Pensa Pharma is and what it is used for
What you need to know before taking Tadalafil Pensa Pharma
How to take Tadalafil Pensa Pharma
Possible side effects
How to store Tadalafil Pensa Pharma
Contents of the pack and other information

1. What Tadalafil Pensa Pharma is and what it is used for

Tadalafil Pensa Pharma is a treatment for adult men with erectile dysfunction.
This condition occurs when a man is unable to achieve or maintain an erection sufficient for
sexual intercourse. Tadalafil Pensa Pharma has been shown to significantly improve the ability
to obtain an erection sufficient for sexual intercourse.
Tadalafil Pensa Pharma contains the active substance tadalafil, which belongs to a class of medicines
known as phosphodiesterase type 5 inhibitors. Following sexual stimulation, Tadalafil Pensa Pharma
helps relax the blood vessels in the penis, allowing blood to flow into the penis. The result is improved
erectile function. Tadalafil Pensa Pharma will not help you if you do not have erectile dysfunction.
It is important to note that Tadalafil Pensa Pharma has no effect in the absence of sexual stimulation.
You and your partner will need to engage in foreplay, as you would if you were not taking a
medication for erectile dysfunction.

2. What you need to know before taking Tadalafil Pensa Pharma

Do not take Tadalafil Pensa Pharma if:

you are allergic to tadalafil or to any of the other ingredients of this medicine (listed in section 6).
you are taking any form of organic nitrate or nitric oxide donors, such as amyl nitrite. These are a group of medicines ("nitrates") used to treat angina pectoris (or "chest pain"). Tadalafil Pensa Pharma has been shown to increase the effect of these medicines. If you are taking any form of nitrate or have any doubts, inform your doctor.
you have a severe heart disease or have recently had a heart attack, within the last 90 days.
you have recently had a stroke, within the last 6 months.
you have low blood pressure or uncontrolled high blood pressure.
you have previously experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as "stroke of the eye".
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 secondary to blood clots). PDE5 inhibitors, such as Tadalafil Pensa Pharma, have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or have any doubts, inform your doctor.

sickle cell anemia (an abnormality of red blood cells).
multiple myeloma (a malignant tumor of the bone marrow).
leukemia (a malignant tumor of blood cells).
any deformity of the penis.
a serious liver problem.
a serious kidney problem.

It is not known whether Tadalafil Pensa Pharma is effective in patients who have undergone:

pelvic surgery
removal of all or part of the prostate gland where the nerves to the prostate have been cut (non-nerve-sparing radical prostatectomy).

If you experience a sudden decrease or loss of vision, or if your vision becomes distorted or blurred while taking Tadalafil Pensa Pharma, stop taking Tadalafil Pensa Pharma and contact your doctor immediately.
In some patients taking tadalafil, sudden decrease or loss of hearing has been observed. Although it is not known whether this event is directly related to tadalafil, if you experience sudden reduction or loss of hearing, stop taking Tadalafil Pensa Pharma and contact your doctor immediately.
Tadalafil Pensa Pharma is not intended for use by women.
Children and adolescents
Tadalafil Pensa Pharma is not intended for use in children and adolescents under 18 years of age.
Other medicines and Tadalafil Pensa Pharma
Inform your doctor if you are taking, have recently taken, or might take any other medicine.
Do not take Tadalafil Pensa Pharma if you are already taking nitrates.
Some medicines may be affected by Tadalafil Pensa Pharma or may themselves affect how Tadalafil Pensa Pharma works. Inform your doctor or pharmacist if you are already taking:

an alpha-blocker (used to treat high blood pressure or urinary problems associated with benign prostatic hyperplasia).
other medicines for treating high blood pressure.
riociguat.
a 5-alpha reductase enzyme inhibitor (used to treat benign prostatic hyperplasia).
medicines such as ketoconazole tablets (for treating fungal infections) and protease inhibitors for the treatment of AIDS or HIV infection.
phenobarbital, phenytoin, or carbamazepine (anticonvulsant medicines).
rifampicin, erythromycin, clarithromycin, or itraconazole.
other treatments for erectile dysfunction.

Tadalafil Pensa Pharma with food and alcohol
Information on the effects of alcohol is provided in section 3. Grapefruit juice may affect how Tadalafil Pensa Pharma works and should be consumed with caution. Consult your doctor for further information.
Fertility
In treated dogs, reduced spermatozoa development in the testes has been observed. In some men, reduced sperm count has been observed. These effects are unlikely to cause infertility.
Driving and using machines
Some men taking Tadalafil Pensa Pharma in clinical studies reported dizziness. Carefully monitor how you react to the tablets before driving or operating machinery.
Tadalafil Pensa Pharma contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.
Tadalafil Pensa Pharma contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take Tadalafil Pensa Pharma

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your
doctor or pharmacist.
Tadalafil Pensa Pharma tablets are for oral use and for men only. Swallow the tablet whole with
water. The tablets can be taken regardless of food intake.
The recommended dose is one 10 mg tablet before sexual activity. If the effect of this dose is too weak,
your doctor may increase the dose to 20 mg.
Tadalafil Pensa Pharma tablets are for oral use.
You can take the Tadalafil Pensa Pharma tablet at least 30 minutes before sexual activity.
Tadalafil Pensa Pharma may still be effective up to 36 hours after taking the tablet.
Do not take Tadalafil Pensa Pharma more than once a day. Tadalafil Pensa Pharma 10 mg and 20 mg
is intended to be used before anticipated sexual activity and is not recommended for daily continuous
use.
It is important to note that Tadalafil Pensa Pharma will not work without sexual stimulation. You and
your partner will need to engage in foreplay as you would if you were not taking a medicine for erectile
dysfunction.
Drinking alcohol may interfere with your ability to get an erection and may temporarily cause a
reduction in blood pressure. If you have taken or plan to take Tadalafil Pensa Pharma, avoid excessive
alcohol consumption (blood alcohol levels of 0.08% or higher), as this may increase the risk of dizziness
upon standing.
If you take more Tadalafil Pensa Pharma than you should
Contact your doctor. You may experience the side effects described in section 4.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
These side effects are usually mild to moderate in severity.
If you experience any of the following side effects, stop using the medicine and
seek immediate medical help:

allergic reactions, including skin rashes (uncommon frequency).
Chest pain – do not use nitrates but seek immediate medical help (uncommon frequency).
Priapism, a prolonged and possibly painful erection after taking Tadalafil Pensa Pharma (rare frequency). If you have an erection of this type lasting more than 4 consecutive hours, you must contact a doctor immediately.
Sudden loss of vision (rare frequency), distorted central vision, blurred, hazy vision, or sudden decrease in vision (frequency not known).

Other side effects have been reported:
Common ( observed in 1–10 patients out of 100)

headache, back pain, muscle pain, pain in arms and legs, facial flushing, nasal congestion, and digestive disturbances.

Uncommon (observed in 1–10 patients out of 1,000)

dizziness, stomach discomfort, feeling unwell, nausea (vomiting), acid reflux, blurred vision, eye discomfort, breathing difficulties, blood in urine, prolonged erection, palpitations, fast heartbeat, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of the hands, feet or ankles, and feeling tired.

Rare (observed in 1–10 patients out of 10,000)

fainting, seizures, transient memory loss, eyelid swelling, red eyes, sudden decrease or loss of hearing, urticaria (red, itchy patches on the skin), bleeding from the penis, blood in semen, and increased sweating.

Rarely, heart attacks and strokes have been reported in men taking Tadalafil Pensa Pharma. Most of these individuals already had heart problems before taking the medicine.
Rarely, cases of partial, temporary or permanent decrease or loss of vision in one or both eyes have been reported.
Some additional rare side effects not observed during clinical studies
have been reported in men taking Tadalafil Pensa Pharma. These include:

migraine, facial swelling, severe allergic reaction causing swelling of the face and throat, severe skin reactions, certain disorders affecting blood circulation to the eyes, irregular heartbeat, angina, and sudden cardiac death.
distorted central vision, blurred, hazy vision, or sudden decrease in vision (frequency not known).

The side effect dizziness has been reported more frequently in men over 75 years of age taking Tadalafil Pensa Pharma. Diarrhea has been reported more frequently in men over 65 years of age taking Tadalafil Pensa Pharma.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at 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 Tadalafil Pensa Pharma

6. Package Contents and Other Information

What Tadalafil Pensa Pharma Contains

The active substance is tadalafil. Each tablet contains 10 mg of tadalafil.
The other components are: Tablet core: monohydrate lactose (see end of section 2), microcrystalline cellulose, povidone, poloxamer, sodium lauryl sulfate, croscarmellose sodium, anhydrous colloidal silica and magnesium stearate. Film coating: polyvinyl alcohol, macrogol, talc, titanium dioxide (E171), yellow iron oxide (E172) and red iron oxide (E172).

Description of the Appearance of Tadalafil Pensa Pharma and Pack Contents
Tadalafil Pensa Pharma 10 mg tablets are light orange, film-coated, oblong, biconvex tablets with a score line on one side and measuring approximately 11 mm x 6 mm.
Tadalafil Pensa Pharma 10 mg film-coated tablets are available in aluminum/PVD/PVDC blisters in packs of 4, 12 and 24 tablets.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Towa Pharmaceutical S.p.A.
Via Enrico Tazzoli, 6
20154 Milan
Italy

Package leaflet: information for the user

Tadalafil Pensa Pharma

20 mg film-coated tablets
Tadalafil
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, 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, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

What Tadalafil Pensa Pharma is and what it is used for
What you need to know before taking Tadalafil Pensa Pharma
How to take Tadalafil Pensa Pharma
Possible side effects
How to store Tadalafil Pensa Pharma
Contents of the pack and other information

1. What Tadalafil Pensa Pharma is and what it is used for

Tadalafil Pensa Pharma is a treatment for adult men with erectile dysfunction.
This condition occurs when a man is unable to achieve or maintain an erection sufficient for
sexual intercourse. Tadalafil has been shown to significantly improve the ability to obtain
an erection suitable for sexual intercourse.
Tadalafil Pensa Pharma contains the active substance tadalafil, which belongs to a class of medicines
known as phosphodiesterase type 5 inhibitors. Following sexual stimulation, Tadalafil Pensa Pharma
helps relax the blood vessels in the penis, allowing blood to flow into the penis. The result is improved
erectile function. Tadalafil Pensa Pharma will not help you if you do not have erectile dysfunction.
It is important to note that Tadalafil Pensa Pharma has no effect in the absence of sexual stimulation.
You and your partner will need to engage in foreplay, as you would if you were not taking a medicine for erectile dysfunction.

2. What you should know before taking Tadalafil Pensa Pharma

Do not take Tadalafil Pensa Pharma if:

you are allergic to tadalafil or to any of the other ingredients of this medicine (listed in section 6).
you are taking any form of organic nitrate or nitric oxide donors, such as amyl nitrite. These are a group of medicines ("nitrates") used to treat angina pectoris (or "chest pain"). It has been shown that tadalafil increases the effect of these medicines. If you are taking any form of nitrate or have any doubts, inform your doctor.
you have a severe heart condition or have had a heart attack recently, within the last 90 days.
you have recently had a stroke, within the last 6 months.
you have low blood pressure or uncontrolled high blood pressure.
you have previously experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as "stroke of the eye".
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 secondary to blood clots). PDE5 inhibitors, such as Tadalafil Pensa Pharma, have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or have any doubts, inform your doctor.

sickle cell anemia (an abnormality of red blood cells).
multiple myeloma (a malignant tumor of the bone marrow).
leukemia (a malignant tumor of blood cells).
any deformity of the penis.
a serious liver problem.
a serious kidney problem.

It is not known whether Tadalafil Pensa Pharma is effective in patients who have undergone:

pelvic surgery
removal of all or part of the prostate gland where the nerves to the prostate have been cut (radical prostatectomy without nerve-sparing).

If you experience sudden decrease or loss of vision, or if your vision becomes distorted or blurred while taking Tadalafil Pensa Pharma, stop taking Tadalafil Pensa Pharma and contact your doctor immediately.
Sudden decrease or loss of hearing has been observed in some patients taking tadalafil.
Although it is not known whether the event is directly related to tadalafil, if you experience sudden reduction or loss of hearing, stop taking Tadalafil Pensa Pharma and contact your doctor immediately.
Tadalafil Pensa Pharma is not intended for use by women.
Children and adolescents
Tadalafil Pensa Pharma is not intended for use in children and adolescents under 18 years of age.
Other medicines and Tadalafil Pensa Pharma
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Tadalafil Pensa Pharma if you are already taking nitrates.
Some medicines may be affected by Tadalafil Pensa Pharma or may themselves affect how Tadalafil Pensa Pharma works. Inform your doctor or pharmacist if you are already taking:

an alpha-blocker (used to treat high blood pressure or urinary problems associated with benign prostatic hyperplasia).
other medicines for treating high blood pressure.
riociguat.
a 5-alpha-reductase inhibitor (used to treat benign prostatic hyperplasia).
medicines such as ketoconazole tablets (for treating fungal infections) and protease inhibitors for the treatment of AIDS or HIV infection.
phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
rifampicin, erythromycin, clarithromycin, or itraconazole.
other treatments for erectile dysfunction.

Tadalafil Pensa Pharma with food and alcohol
Information on the effects of alcohol is provided in section 3. Grapefruit juice may affect how Tadalafil Pensa Pharma works and should be consumed with caution. Consult your doctor for further information.
Fertility
In treated dogs, reduced sperm development in the testes has been observed. A reduction in sperm count has been observed in some men. These effects are unlikely to cause infertility.
Driving and using machines
Some men taking Tadalafil Pensa Pharma in clinical studies reported dizziness. Carefully monitor how you react to the tablets before driving or operating machinery.
Tadalafil Pensa Pharma contains lactose
If your doctor has informed you of an intolerance to certain sugars, consult your doctor before taking this medicine.
Tadalafil Pensa Pharma contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take Tadalafil Pensa Pharma

Take this medicine exactly as your doctor or pharmacist has told you. If
you have any doubts, consult your doctor or pharmacist.
Tadalafil Pensa Pharma tablets are for oral use and for men only. Swallow the
tablet whole with water. The tablets can be taken regardless of food intake.
The recommended dose is one 10 mg tablet before sexual activity. However, you have been
prescribed a dose of one 20 mg tablet because your doctor has determined that the recommended
10 mg dose is too low for you.
You may take the Tadalafil Pensa Pharma tablet at least 30 minutes before sexual activity.
Tadalafil Pensa Pharma may still be effective up to 36 hours after taking the tablet.
Do not take Tadalafil Pensa Pharma more than once a day. Tadalafil Pensa Pharma 10 mg and 20 mg
is intended to be used before anticipated sexual activity and is not recommended for continuous
daily use.
It is important to note that Tadalafil Pensa Pharma will not work without sexual stimulation. You and
your partner will need to engage in foreplay, as you would if you were not taking a medicine for
erectile dysfunction.
Drinking alcohol may interfere with your ability to get an erection and may temporarily cause a
reduction in your blood pressure. If you have taken or plan to take Tadalafil Pensa Pharma, avoid
excessive alcohol consumption (blood alcohol level of 0.08% or higher), as this may increase the risk
of dizziness when standing up.
If you take more Tadalafil Pensa Pharma than you should:
Contact your doctor. You may experience the side effects described in section 4.
If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
These side effects are usually mild to moderate in intensity.
If you experience any of the following side effects, stop using the medicine and
seek immediate medical help:

allergic reactions, including skin rashes (uncommon frequency).
Chest pain – do not use nitrates, but seek immediate medical help (uncommon frequency).
Priapism, a prolonged and possibly painful erection after taking Tadalafil Pensa Pharma (rare frequency). If you have an erection of this type lasting more than 4 hours, you must contact a doctor immediately.
Sudden loss of vision (rare frequency), distorted central vision, blurred, hazy or sudden decrease in vision (frequency not known).

Other side effects reported include:
Common (observed in 1–10 patients out of 100)

headache, back pain, muscle pain, pain in arms and legs, facial flushing, nasal congestion, and digestive disturbances.

Uncommon (observed in 1–10 patients out of 1,000)

dizziness, stomach ache, feeling unwell, nausea (vomiting), reflux, blurred vision, eye discomfort, breathing difficulties, blood in urine, prolonged erection, palpitations, fast heartbeat, high blood pressure, low blood pressure,

nosebleeds, ringing in the ears, swelling of the hands, feet or ankles, and feeling tired.
Rare (observed in 1–10 patients out of 10,000)

fainting, seizures, and transient memory loss, eyelid swelling, red eyes, sudden decrease or loss of hearing, urticaria (red, itchy patches on the skin), bleeding from the penis, blood in semen, and increased sweating.

Rarely, heart attacks and strokes have been reported in men taking Tadalafil Pensa Pharma. Most of these individuals already had heart problems before taking the medicine.
Rarely, cases of partial, temporary or permanent decrease or loss of vision in one or both eyes have been reported.
Some additional rare side effects not observed during clinical studies have been reported in men taking Tadalafil Pensa Pharma. These include:

migraine, facial swelling, severe allergic reaction causing swelling of the face and throat, serious skin reactions, certain disorders affecting blood circulation to the eyes, irregular heartbeat, angina, and sudden cardiac death.
distorted, blurred, hazy central vision or sudden decrease in vision (frequency not known).

The side effect dizziness has been reported more frequently in men over 75 years of age taking Tadalafil Pensa Pharma. Diarrhoea has been reported more frequently in men over 65 years of age taking tadalafil.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at 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 Tadalafil Pensa Pharma

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

6. Package contents and other information

What Tadalafil Pensa Pharma contains

The active substance is tadalafil. Each tablet contains 20 mg of tadalafil.
The other components are:

Tablet core: monohydrate lactose (see end of section 2), microcrystalline cellulose, povidone, poloxamer, sodium lauryl sulfate, sodium croscarmellose, colloidal anhydrous silica, and magnesium stearate.
Film coating: polyvinyl alcohol, macrogol, talc, titanium dioxide (E171), yellow iron oxide (E172), and red iron oxide (E172).

Description of the appearance of Tadalafil Pensa Pharma and package contents
Tadalafil Pensa Pharma 20 mg tablets are light pink, film-coated, oblong, biconvex tablets with a score line on one side and measuring approximately 15 mm x 7 mm.
Tadalafil Pensa Pharma 20 mg film-coated tablets are available in aluminum/PVD/PVDC blisters in pack sizes of 2, 4, 8 and 12 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Towa Pharmaceutical S.p.A.
Via Enrico Tazzoli, 6
20154 Milan
Italy