Tadalafil Tecnigen

Package leaflet: Information for the user

Tadalafil TecniGen 5 mg film-coated tablets

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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What Tadalafil TecniGen is and what it is used for

Tadalafil TecniGen contains the active substance tadalafil, which belongs to a class of medicines called
phosphodiesterase type 5 inhibitors.
Tadalafil TecniGen 5 mg is used in adult men for the treatment of:

• 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. Following sexual stimulation, Tadalafil TecniGen helps relax the blood vessels in the penis, allowing blood to flow into the penis. The result is improved erectile function. Tadalafil TecniGen will not help you if you do not have erectile dysfunction. It is important to note that Tadalafil TecniGen has no effect in the treatment of erectile dysfunction 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 enlarges with age. Symptoms include difficulty starting urination, a sensation of incomplete bladder emptying, and a more frequent need to urinate, including during the night. Tadalafil TecniGen improves blood flow to the prostate and bladder and relaxes their muscular tissue, which may reduce the symptoms of benign prostatic hyperplasia. Tadalafil 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 TecniGen

Do not take Tadalafil TecniGen 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. This is a group of medicines ("nitrates") used to treat angina pectoris ("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 serious heart condition 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, have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or have any doubts, inform your doctor.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Tadalafil TecniGen.
Be aware that sexual activity involves a potential risk for patients with heart disease, as it puts extra 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 rule out prostate cancer before starting treatment with tadalafil for benign prostatic hyperplasia. Tadalafil TecniGen is not a treatment for prostate cancer.
Before taking the tablets, inform your doctor if you have:

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

It is not known whether tadalafil 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, stop taking Tadalafil TecniGen and contact your doctor immediately.

Reduced or lost vision has been reported in some patients treated with tadalafil. Although it is not known whether this event is directly related to tadalafil, if you experience reduced or loss of vision, stop taking Tadalafil TecniGen and contact your doctor immediately.

Tadalafil is not intended for use by women.

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

Other medicines and Tadalafil TecniGen
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
Do not take Tadalafil TecniGen if you are already taking nitrates.
Some medicines may be affected by tadalafil or may alter how tadalafil 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 inhibitor (used to treat benign prostatic hyperplasia)
• medicines such as ketoconazole tablets (used to treat 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 TecniGen with food and alcohol
Information on the effects of alcohol is provided in section 3. Grapefruit juice may affect the efficacy of tadalafil 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 treated with tadalafil in clinical studies reported dizziness. Carefully assess your response to the medicine before driving or operating machinery.

Tadalafil TecniGen contains lactose
If your doctor has informed you of an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Tadalafil TecniGen

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
Tadalafil TecniGen is for oral use and is intended only for men. Swallow the tablets whole with water. Tadalafil TecniGen can be taken with or without food.
Drinking alcohol may temporarily lower blood pressure. If you have taken or plan to take Tadalafil TecniGen, avoid excessive drinking (blood alcohol level equal to or greater than 0.08%) as this may increase the risk of dizziness when standing up.

For the treatment of erectile dysfunction
The recommended dose is one 5 mg tablet once daily, taken at approximately the same time each day.
Your doctor may reduce the dose to 2.5 mg based on your response to Tadalafil TecniGen, which will be prescribed as 5 mg tablets.
Do not take Tadalafil TecniGen more than once a day.
When taken once daily, Tadalafil TecniGen allows an erection to occur, provided there is sexual stimulation, at any time within 24 hours. Daily administration of Tadalafil TecniGen may be beneficial for men who anticipate having sexual activity two or more times per week.
It is important to note that Tadalafil TecniGen 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.
Drinking alcohol may interfere with your ability to achieve an erection.

For the treatment of benign prostatic hyperplasia
The dose is 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 once daily.
Do not take Tadalafil TecniGen more than once a day.

If you take more Tadalafil TecniGen than you should
Contact your doctor. You may experience one or more of the side effects described in section 4.

If you forget to take Tadalafil TecniGen
Take the missed dose as soon as you remember, but do not take a double dose to make up for the forgotten tablet. Do not take Tadalafil TecniGen more than once a day.

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 everybody gets them. These side effects are usually mild to moderate in intensity.
If you experience any of the following side effects, stop taking the medicine and seek immediate medical help:

• allergic reactions, including skin rash (uncommon frequency)
• chest pain – do not take nitrates but seek immediate medical help (uncommon frequency)
• priapism, a prolonged and sometimes painful erection after taking tadalafil (rare frequency). If you have an erection of this type lasting more than 4 hours in a row, you must contact a doctor immediately.
• sudden loss of vision (rare frequency).

Other side effects reported include:

Common (may affect from 1 to 10 people in 100)

• headache, back pain, muscle pain, pain in arms and legs, facial flushing, nasal congestion, and indigestion.

Uncommon (may affect from 1 to 10 people in 1000)

• dizziness, stomach discomfort, feeling unwell (vomiting), reflux, blurred vision, eye pain, breathing difficulties, blood in urine, prolonged erection, awareness of heartbeat, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, ringing in the ears (tinnitus), swelling of hands, feet and ankles, and fatigue.

Rare (may affect from 1 to 10 people in 10,000)

• fainting, seizures, temporary memory loss, eyelid swelling, red eyes, sudden decrease or loss of hearing, hives (itchy, red, swollen areas on the skin), penile bleeding, blood in semen, excessive sweating.

Heart attacks or strokes have been rarely reported in men being treated with tadalafil. Most of these men had pre-existing heart problems before taking this medicine.
Partial, temporary or permanent loss of vision in one or both eyes has been rarely reported.
Additional rare side effects not observed during clinical studies have been reported in men taking tadalafil. These include:

• migraine, facial swelling, severe allergic reactions causing swelling of the face and throat, severe skin rashes, certain disorders affecting blood circulation to the eyes, irregular heartbeat, angina, and sudden cardiac death.

The side effect dizziness has been reported more frequently in men over 75 years of age taking tadalafil. The side effect 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 the following website: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tadalafil TecniGen

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. 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. Pack contents and other information

What Tadalafil TecniGen contains
The active substance is tadalafil. Each film-coated tablet contains 5 mg of tadalafil.
The other components are:

• Tablet core: monohydrate lactose (see end of section 2), corn starch, pregelatinized corn starch, crospovidone, sodium lauryl sulfate and magnesium stearate.
• Tablet coating: monohydrate lactose, hypromellose, titanium dioxide (E171), triacetin, yellow iron oxide (E172) and red iron oxide (E172).

Description of the appearance of Tadalafil TecniGen and pack contents
Oblong, film-coated tablets, cream-yellowish in colour.
Tadalafil TecniGen 5 mg is available in blisters in packs containing 14 or 28 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Tecnigen S.r.l.
Via Galileo Galilei, 40
20092 Cinisello Balsamo (MI), Italy

Responsible person for batch release
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2, Abrunheira
2710-089 Sintra, Portugal

This medicinal product is authorized in the European Economic Area countries under the following names:
Portugal: Tadalafil Biofarmoz
Italy: Tadalafil TecniGen
Spain: Tadalafilo Tecnimede 5 mg comprimidos recubiertos con película EFG

Patient Information Leaflet: Information for the User

Tadalafil TecniGen 10 mg film-coated tablets

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

Contents of this leaflet

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

1. What Tadalafil TecniGen is and what it is used for

Tadalafil TecniGen 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 activity.
Tadalafil TecniGen contains the active substance tadalafil, which belongs to a class of medicines called phosphodiesterase type 5 inhibitors.
Following sexual stimulation, Tadalafil TecniGen helps relax the blood vessels in the penis, allowing blood to flow into the penis.
The result is improved erectile function. Tadalafil TecniGen will not benefit you if you do not have erectile dysfunction.
It is important to note that Tadalafil TecniGen 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.

7. What you need to know before taking Tadalafil TecniGen

Do not take Tadalafil TecniGen 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 (“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 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, have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or have any doubts, inform your doctor.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Tadalafil TecniGen.

Be aware that sexual activity involves a potential risk for patients with heart disease, as it puts extra strain on the heart. If you have a heart condition, inform your doctor.

Before taking the tablets, inform your doctor if you have:

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

It is not known whether tadalafil 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 a sudden decrease or loss of vision, stop taking Tadalafil TecniGen and contact your doctor immediately.
Vision decrease or loss has been reported in some patients treated with tadalafil. Although it is not known whether this event is directly related to tadalafil, if you experience a decrease or loss of vision, stop taking Tadalafil TecniGen and contact your doctor immediately.

Tadalafil is not indicated for use in women.

Children and adolescents

Tadalafil is not indicated for use in children or adolescents under 18 years of age.

Other medicines and Tadalafil TecniGen

Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.

Do not take Tadalafil TecniGen if you are already taking nitrates.

Some medicines may be affected by tadalafil or may alter how tadalafil 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 high blood pressure
• riociguat
• a 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia)
• medicines such as ketoconazole tablets (for treatment of 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 TecniGen with food and alcohol

Information on the effects of alcohol is provided in section 3. Grapefruit juice may affect the effectiveness of tadalafil 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, a reduction in sperm count has been observed. These effects are unlikely to cause infertility.

Driving and using machines

Some men treated with tadalafil in clinical studies reported dizziness. Carefully assess your response to the medicine before driving or operating machinery.

Tadalafil TecniGen contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.

8. How to take Tadalafil TecniGen

Take this medicine exactly as your doctor or pharmacist has told you. If you are
unsure, consult your doctor or pharmacist.
Tadalafil TecniGen is for oral use and is intended only for men. Swallow the tablets whole with water. Tadalafil
TecniGen can be taken with or without food.
The recommended starting dose is one 10 mg tablet taken before sexual activity. If the effect of this dose is
too weak, your doctor may increase the dose to 20 mg. Tadalafil TecniGen tablets are for oral use.
Take Tadalafil TecniGen at least 30 minutes before sexual activity.
Tadalafil TecniGen may remain effective for up to 36 hours after taking the tablet.
Do not take Tadalafil TecniGen more than once a day. Tadalafil TecniGen 10 mg and 20 mg is intended for
use prior to anticipated sexual activity and is not recommended for continuous daily use.
It is important to note that Tadalafil TecniGen 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 lower your blood
pressure. If you have taken or plan to take Tadalafil TecniGen, avoid drinking excessively (blood alcohol
level equal to or greater than 0.08%) as this may increase the risk of dizziness when standing up.
If you take more Tadalafil TecniGen than you should
Contact your doctor. You may experience one or more of the side effects described in section 4.
If you forget to take Tadalafil TecniGen
Take the missed dose as soon as you remember, but do not take a double dose to make up for the missed
tablet. Do not take Tadalafil TecniGen more than once a day.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

9. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. These side effects are usually mild to moderate in severity.
If you experience any of the following side effects, stop taking 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 sometimes painful erection after taking tadalafil (rare frequency). If you have an erection of this type lasting for more than 4 hours, you must contact a doctor immediately.
• sudden loss of vision (rare frequency).

Other side effects reported include:
Common (may affect from 1 to 10 people in 100)

• headache, back pain, muscle pain, arm and leg pain, facial flushing, nasal congestion, and indigestion.

Uncommon (may affect from 1 to 10 people in 1000)

• dizziness, stomach ache, feeling unwell (vomiting), reflux, blurred vision, eye pain, breathing difficulties, blood in urine, prolonged erection, awareness of heartbeat, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of hands, feet and ankles, and fatigue.

Rare (may affect from 1 to 10 people in 10,000)

• fainting, seizures and temporary memory loss, eyelid swelling, red eyes, sudden decrease or loss of hearing, urticaria (itchy, red, raised areas on the skin), bleeding from the penis, blood in semen, excessive sweating. Heart attacks or strokes have been rarely reported in men being treated with tadalafil. Most of these men already had pre-existing heart disease before taking this medicine.

Partial, temporary or permanent vision loss in one or both eyes has been rarely reported.
Other rare side effects not observed during clinical studies have been reported in men taking tadalafil. These include:

• migraine, facial swelling, severe allergic reactions causing swelling of the face and throat, severe skin rashes, certain disorders affecting blood circulation to the eyes, irregular heartbeat, angina, and sudden cardiac death.

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

10. How to store Tadalafil TecniGen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and on the blister after 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.

11. Package contents and other information

What Tadalafil TecniGen contains
The active substance is tadalafil. Each film-coated tablet contains 10 mg of tadalafil.
The other components are:

• Tablet core: monohydrate lactose (see end of section 2), maize starch, pregelatinized maize starch, crospovidone, sodium lauryl sulfate, and magnesium stearate.
• Film coating: monohydrate lactose, hypromellose, titanium dioxide (E171), triacetin, and yellow iron oxide (E172).

Description of the appearance of Tadalafil TecniGen and contents of the pack
Oblong, film-coated tablets, cream-yellow in colour.
Tadalafil TecniGen 10 mg is available in blisters containing 4 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Tecnigen S.r.l.
Via Galileo Galilei, 40
20092 Cinisello Balsamo (MI), Italy

Manufacturer responsible for batch release
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2, Abrunheira
2710-089 Sintra
Portugal

This medicinal product is authorized in the European Economic Area countries under the following names:
Portugal: Tadalafil Biofarmoz
Italy: Tadalafil TecniGen

Package leaflet: Information for the user

Tadalafil TecniGen 20 mg film-coated tablets

Equivalent medicine
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

1. What Tadalafil TecniGen is and what it is used for

Tadalafil TecniGen 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 activity.
Tadalafil TecniGen contains the active substance tadalafil, which belongs to a class of medicines called phosphodiesterase type 5 inhibitors. During sexual stimulation, Tadalafil TecniGen helps relax the blood vessels in the penis, allowing blood to flow into the penis. The result is improved erectile function. Tadalafil TecniGen will not help you if you do not have erectile dysfunction.
It is important to note that Tadalafil TecniGen 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.

12. What you need to know before taking Tadalafil TecniGen

Do not take Tadalafil TecniGen 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 ("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 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, have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or have any doubts, inform your doctor.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Tadalafil TecniGen.

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.

Before taking the tablets, inform your doctor if you have:

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

It is not known whether tadalafil is effective in patients who have undergone:

• pelvic surgery.
• removal of all or part of the prostate gland with cutting of the nerves to the prostate (non-nerve-sparing radical prostatectomy).

If you experience a sudden decrease or loss of vision, stop taking Tadalafil TecniGen and contact your doctor immediately.

Reduced or lost vision has been reported in some patients treated with tadalafil. Although it is not known whether this event is directly related to tadalafil, if you experience reduced or loss of vision, stop taking Tadalafil TecniGen and contact your doctor immediately.

Tadalafil is not intended for use in women.

Children and adolescents

Tadalafil is not indicated for use in children or adolescents under 18 years of age.

Other medicines and Tadalafil TecniGen

Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.

Do not take Tadalafil TecniGen if you are already taking nitrates.

Some medicines may be affected by tadalafil or may alter how tadalafil 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 high blood pressure
• riociguat
• a 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia)
• medicines such as ketoconazole tablets (for treatment of fungal infections) and protease inhibitors for treatment of AIDS or HIV infection
• phenobarbital, phenytoin, or carbamazepine (anticonvulsant medicines)
• rifampicin, erythromycin, clarithromycin, or itraconazole
• other treatments for erectile dysfunction

Tadalafil TecniGen with beverages and alcohol

Information on the effects of alcohol is provided in section 3. Grapefruit juice may affect the effectiveness of tadalafil 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 treated with tadalafil in clinical studies reported dizziness. Carefully assess your response to the medicine before driving or operating machinery.

Tadalafil TecniGen contains lactose

If your doctor has informed you of an intolerance to certain sugars, contact him or her before taking this medicine.

13. How to take Tadalafil TecniGen

Take this medicine exactly as your doctor or pharmacist has told you. If you have
any doubts, consult your doctor or pharmacist.
Tadalafil TecniGen is for oral use and for men only. Swallow the tablets whole with water. Tadalafil
TecniGen can be taken with or without food.
The recommended starting dose is one 10 mg tablet taken before sexual activity. However, your doctor may
prescribe a dose of one 20 mg tablet if the 10 mg dose is found to be insufficient.
Take Tadalafil TecniGen at least 30 minutes before sexual activity.
Tadalafil TecniGen may remain effective for up to 36 hours after taking the tablet.
Do not take Tadalafil TecniGen more than once a day. Tadalafil TecniGen 10 mg and 20 mg is intended
for use prior to anticipated sexual activity and is not recommended for continuous daily use.
It is important to note that Tadalafil TecniGen will have no effect 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 lower your blood pressure. If you have taken or plan to take Tadalafil TecniGen, avoid excessive drinking (blood alcohol level equal to or greater than 0.08%) as this may increase the risk of dizziness when standing up.
If you take more Tadalafil TecniGen than you should
Contact your doctor. You may experience one or more of the side effects described in section 4.
If you forget to take Tadalafil TecniGen
Take the missed dose as soon as you remember, but do not take a double dose to make up for the forgotten tablet. Do not take Tadalafil TecniGen more than once a day.
If you have any questions about using this medicine, consult your doctor or pharmacist.

14. 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 assistance:

• allergic reactions, including skin rash (uncommon frequency)
• chest pain – do not use nitrates but seek immediate medical assistance (uncommon frequency)
• priapism, a prolonged and sometimes painful erection after taking tadalafil (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).

Other side effects that have been reported:
Common (may affect from 1 to 10 people in 100)

• headache, back pain, muscle pain, pain in arms and legs, facial flushing, nasal congestion, and indigestion.

Uncommon (may affect from 1 to 10 people in 1000)

• dizziness, stomach ache, feeling unwell (nausea), acid reflux, blurred vision, eye pain, breathing difficulties, blood in urine, prolonged erection, awareness of heartbeat, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of hands, feet and ankles, and fatigue.
  Rare (may affect from 1 to 10 people in 10,000)
• fainting, seizures, and temporary memory loss, eyelid swelling, red eyes, sudden decrease or loss of hearing, hives (itchy, red, swollen skin), bleeding from the penis, blood in semen, excessive sweating.

Heart attacks or strokes have been rarely reported in men being treated with tadalafil. Most of these men had pre-existing heart problems before taking this medicine.
Partial, temporary or permanent loss of vision in one or both eyes has been rarely reported.
Some additional rare side effects not observed during clinical studies have been reported in men taking tadalafil. These include:

• migraine, facial swelling, severe allergic reactions causing swelling of the face and throat, severe skin rashes, certain disorders affecting blood circulation to the eyes, irregular heartbeat, angina, and sudden cardiac death.

The side effect dizziness has been reported more frequently in men over 75 years of age taking tadalafil. The side effect 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 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.

15. How to store Tadalafil TecniGen

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. The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

16. Package contents and other information

What Tadalafil TecniGen contains
The active substance is tadalafil. Each film-coated tablet contains 20 mg of tadalafil.
The other components are:

• Tablet core: monohydrate lactose (see end of section 2), corn starch, pregelatinized corn starch, crospovidone, sodium lauryl sulfate and magnesium stearate.
• Film coating: monohydrate lactose, hypromellose, titanium dioxide (E171), triacetin and yellow iron oxide (E172).

Description of the appearance of Tadalafil TecniGen and pack contents
Oblong, light cream-yellow film-coated tablets.
Tadalafil TecniGen 20 mg is available in blisters containing 2, 4, 8 or 12 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Tecnigen S.r.l.
Via Galileo Galilei, 40
20092 Cinisello Balsamo (MI), Italy

Responsible manufacturer for batch release
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2, Abrunheira
2710-089 Sintra, Portugal

This medicinal product is authorized in the European Economic Area countries under the following names:
Portugal: Tadalafil Biofarmoz
Italy: Tadalafil TecniGen
Spain: Tadalafilo Tecnimede 20 mg comprimidos recubiertos con película EFG