TADALAFIL 5 mg Tabletka Orodispersyjna

Treść ulotki

1. Tadalafil Laboratori Alter 5 mg orodispersible tablets
   1. What is Tadalafil Laboratori Alter and what is it used for
   2. What you need to know before taking Tadalafil Laboratori Alter
   3. How to take Tadalafil Laboratori Alter
   4. Possible side effects
   5. How to store Tadalafil Laboratori Alter
   6. Contents of the pack and other information
2. Tadalafil Laboratori Alter 10 mg orodispersible tablets
   1. What is Tadalafil Laboratori Alter and what is it used for
   2. What you need to know before taking Tadalafil Laboratori Alter
   3. How to take Tadalafil Laboratori Alter
   4. Possible side effects
   5. How to store Tadalafil Laboratori Alter
   6. Contents of the pack and other information
3. Tadalafil Laboratori Alter 20 mg orodispersible tablets
   1. What is Tadalafil Laboratori Alter and what is it used for
   2. What you need to know before taking Tadalafil Laboratori Alter
   3. How to take Tadalafil Laboratori Alter
   4. Possible side effects
   5. How to store Tadalafil Laboratori Alter
   6. Contents of the pack and other information

Tadalafil Laboratori Alter 5 mg orodispersible tablets

Tadalafil

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 or pharmacist.
• 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 or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Tadalafil Laboratori Alter and what is it used for

Tadalafil Laboratori Alter contains the active ingredient tadalafil, which belongs to a group of medicines
called phosphodiesterase type 5 inhibitors.
Tadalafil 5 mg is used for the treatment of adult men with:

• erectile dysfunction. This condition occurs when a man cannot achieve or maintain an erection adequate for sexual intercourse. Tadalafil has demonstrated a considerable improvement in the ability to achieve an erection adequate for sexual activity. Following sexual stimulation, tadalafil helps to relax the blood vessels in the penis, allowing blood flow to the penis. The result of this is improved erectile function. Tadalafil will not help you if you do not have erectile dysfunction. It is important to note that tadalafil for the treatment of erectile dysfunction does not work if there is no sexual stimulation. You and your partner will need to engage in foreplay, just 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 becomes larger with age. Symptoms include difficulty starting urination, a feeling of not emptying the bladder completely, and a more frequent need to urinate, even at night. Tadalafil improves blood flow, and relaxes the muscles of the prostate and bladder, which can reduce the symptoms associated with 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 Laboratori Alter

Do not take Tadalafil Laboratori Alter

• if you are allergic to tadalafil or to any of the other ingredients of this medicine (listed in section 6);
• if 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, tell your doctor;

• if you have a serious heart condition or have had a heart attack in the last 90 days;
• if you have recently had a stroke in the last 6 months;
• if you have low blood pressure or uncontrolled high blood pressure;
• if you have previously experienced loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “eye stroke”;
• if you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs secondary to blood clots). It has been shown that PDE5 inhibitors, such as tadalafil, increase the hypotensive effect of this medicine. If you are taking riociguat or have any doubts, tell your doctor.

Warnings and precautions
Talk to your doctor before taking Tadalafil Laboratori Alter.
Be aware that sexual activity involves a potential risk for patients with heart disease, because it puts extra strain on the heart. If you have a heart problem, tell your
doctor.
Since benign prostatic hyperplasia and prostate cancer can have the same symptoms, your
doctor will perform checks for prostate cancer before starting treatment with tadalafil
for benign prostatic hyperplasia. Tadalafil does not cure prostate cancer.
Before taking the tablets, tell your doctor if you have:

• sickle cell anemia (an abnormality of red blood cells);
• multiple myeloma (bone marrow cancer);
• leukemia (cancer of the blood cells);
• any deformation of the penis;
• a serious liver problem;
• a serious 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 have been cut (radical prostatectomy without nerve-sparing).

If you experience a sudden decrease or loss of vision or blurred vision while
taking tadalafil, stop taking tadalafil and contact your doctor immediately.
Decreased or sudden hearing impairment has been observed 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 sudden loss of hearing, stop taking tadalafil and contact
your doctor immediately.
Tadalafil is not indicated for use by women.

Children and adolescents
Tadalafil is not indicated for use by children and adolescents under the age of 18 years.

Other medicines and Tadalafil Laboratori Alter
Tell your doctor if you are taking, have recently taken or might take any other
medicines.
Do not take tadalafil if you are already taking nitrates.
Some medicines can be affected by tadalafil or they themselves can affect how
tadalafil works. Tell 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 to treat high blood pressure;
• riociguat;
• a 5-alpha reductase enzyme inhibitor (used to treat benign prostatic hyperplasia);
• medicines such as ketoconazole tablets (to treat 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 Laboratori Alter with drinks and alcohol
Information on the effects of alcohol is given in section 3. Grapefruit juice can affect
how tadalafil works and should be taken with caution. Ask your doctor for more
information.

Fertility
In dogs treated with tadalafil, a reduction in sperm development in the testicles was observed. A decrease in sperm count has been observed in some
men. These effects are unlikely to cause infertility.

Driving and operating machinery
Some men taking tadalafil during clinical studies have reported dizziness. Carefully
check how you react to the tablets before driving or operating machinery.

Tadalafil Laboratori Alter contains lactose
If you have been diagnosed with intolerance to certain sugars, contact your doctor before taking this
medicine.

Tadalafil Laboratori Alter contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is
essentially “sodium-free”.

Tadalafil Laboratori Alter contains aspartame
This medicine contains 2.04 mg of aspartame in each tablet. Aspartame is a source of
phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which
phenylalanine builds up because the body cannot remove it properly.

3. How to take Tadalafil Laboratori Alter

Take this medicine following exactly the instructions of your doctor. If you have doubts, consult your doctor or pharmacist.
The orodispersible tablets of tadalafil are for oral use and only for men. Place the entire orodispersible tablet in your mouth, on your tongue, where it will dissolve in a few seconds and be swallowed with saliva. The tablets can be taken with or without food.
Drinking alcohol may temporarily cause a decrease in your blood pressure. If you have taken or intend to take tadalafil, avoid excessive consumption of alcoholic beverages (blood alcohol level of 0.08% or higher) as this may increase the risk of dizziness when you stand up.

For the treatment of erectile dysfunction
The recommended doseis one 5 mg tablet to be taken once a day at approximately the same time of day. Your doctor may adjust the dose to 2.5 mg based on your response to tadalafil.
This dose will be given to you with a 2.5 mg tablet.
Do not take tadalafil more than once a day.
When taken once a day, tadalafil allows you to achieve an erection, if there is sexual stimulation, at any time of the day within 24 hours. Daily administration of tadalafil may be useful for men who anticipate having sexual activity two or more times a week.
It is important to note that tadalafil does not work if there is no sexual stimulation. You and your partner will need to engage in foreplay as you would if you were not taking medication for erectile dysfunction.
Drinking alcohol may interfere with your ability to achieve an erection.

For the treatment of benign prostatic hyperplasia
The doseis one 5 mg tablet to be taken once a day at approximately the same time of day. If you have benign prostatic hyperplasia and erectile dysfunction, the dose remains one 5 mg tablet to be taken once a day.
Do not take tadalafil more than once a day.

If you take more Tadalafil Laboratori Alter than you should
Contact your doctor. Adverse effects described in section 4 may occur.

If you forget to take Tadalafil Laboratori Alter
Take your dose as soon as you remember, but do not take a double dose to compensate for the forgotten tablet. You should not take tadalafil more than once a day.
If you have any doubts 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 gets them.
These effects are normally mild to moderate in severity.

If any of the following side effects occur, stop using the medicine and seek
immediate medical attention:

• allergic reactions, including skin rashes (uncommon frequency);
• chest pain - do not use nitrates but seek immediate medical attention (uncommon frequency);
• priapism, a prolonged and possibly painful erection after taking tadalafil (rare frequency). If you have an erection of this type that lasts for more than 4 hours, you should contact a doctor immediately;
• sudden loss of vision (rare frequency), distorted central vision, blurred, fuzzy or sudden decrease in vision (frequency not known).

Other side effects have been reported:

Common(observed in 1 - 10 patients per 100)

• headache, back pain, muscle aches, pain in the arms and legs, hot flushes in the face, nasal congestion and indigestion.

Uncommon(observed in 1 - 10 patients per 1,000)

• dizziness, stomach discomfort, nausea, feeling unwell (vomiting), reflux, blurred vision, eye pain, difficulty breathing, blood in the urine, prolonged erection, pounding sensation of heartbeat, a fast heart rate, 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 per 10,000)

• fainting, convulsions and transient memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing, hives (itchy red patches on the skin surface), bleeding of the penis, blood in the semen and increased sweating.

Rarely, in men taking tadalafil, heart attacks and strokes have been reported. Most of these subjects had heart problems already before using the medicine. Rarely cases of partial, temporary or permanent decrease or loss of vision in one or
both eyes have been reported.

Some further rare side effectsthat had not been observed during clinical trials have
been reported in men taking tadalafil. These include:

• migraine, facial swelling, severe allergic reaction causing swelling of the face or throat, severe skin reactions, some disorders that change blood flow to the eyes, irregular heartbeat, angina and sudden cardiac death.
• distorted central vision, blurred, fuzzy or sudden decrease in vision (frequency not known).

The side effect dizziness has been reported more frequently in men over the age of 75 years
taking tadalafil. Diarrhea has been reported more frequently in men over the age of 65
years taking tadalafil.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system directly to the address: https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse . By reporting side effects you can help provide more information
about the safety of this medicine.

5. How to store Tadalafil Laboratori Alter

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 package and on the blister after EXP.
The expiry date refers to the last day of that month.
Store at a temperature below 30°C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help to protect the environment.

6. Contents of the pack and other information

What Tadalafil Laboratori Alter contains

• The active substanceis tadalafil. Each orodispersible tablet contains 5 mg of tadalafil.
• The other ingredientsare: lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose, sodium croscarmellose, sodium lauryl sulfate, aspartame (E-951), ethyl vanillin, magnesium stearate.

Description of the appearance of Tadalafil Laboratori Alter and contents of the pack
Tadalafil Laboratori Alter 5 mg are orodispersible tablets of white to off-white color, smooth
without a score line.
Tadalafil Laboratori Alter 5 mg is available in blisters in packs of 14 or 28 orodispersible tablets
It is possible that not all pack sizes are marketed.

Marketing authorisation holder and manufacturer
Laboratori Alter S.r.l.
Via Egadi, 7
20144 Milan

Manufacturer
Laboratorios Alter S.A.
C/ Mateo Inurria 30
28036 Madrid
Spain

This medicinal product is authorised in the member states of the European Economic Area with the
following denominations:
Italy Tadalafil Laboratori Alter
Spain Tadalafilo Farmalter 5 mg bucodispersable tablets EFG

Tadalafil Laboratori Alter 10 mg orodispersible tablets

Tadalafil

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 or pharmacist.
• 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 or pharmacist. See section 4.

Contents of this leaflet

• 7. What is Tadalafil Laboratori Alter and what it is used for
• 8. What you need to know before you take Tadalafil Laboratori Alter
• 9. How to take Tadalafil Laboratori Alter
• 10. Possible side effects
• 11. How to store Tadalafil Laboratori Alter
• 12. Contents of the pack and other information

1. What is Tadalafil Laboratori Alter and what is it used for

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

2. What you need to know before taking Tadalafil Laboratori Alter

Do not take Tadalafil Laboratori Alter

• if you are allergic to tadalafil or to any of the other ingredients of this medicine (listed in section 6);
• if you are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite. This is a group of medicines (“nitrates”) used for the treatment of 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, tell your doctor;
• if you have a serious heart condition or have had a heart attack in the last 90 days;
• if you have recently had a stroke in the last 6 months;
• if you have low blood pressure or uncontrolled high blood pressure;
• if you have previously experienced loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “eye stroke”;
• if you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension

(i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension
(i.e., high blood pressure in the lungs secondary to blood clots). It has been shown
that PDE5 inhibitors, such as tadalafil, increase the hypotensive effect of this medicine. If you are
taking riociguat or if you have any doubts, tell your doctor.

Warnings and precautions
Talk to your doctor before taking tadalafil.
Be aware that sexual activity involves a potential risk for patients with heart disease, because it puts extra strain on the heart. If you have a heart problem, tell your
doctor.
Before taking the tablets, tell your doctor if you have:

• sickle cell anemia (an abnormality of red blood cells);
• multiple myeloma (bone marrow cancer);
• leukemia (cancer of the blood cells);
• any deformation of the penis;
• a serious liver problem;
• a serious 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 have been cut (radical prostatectomy without neurovascular bundle sparing).

If you experience a sudden decrease or loss of vision or blurred vision while
taking tadalafil, stop taking tadalafil and contact your doctor immediately.
Decreased or sudden hearing impairment has been observed in some patients treated with tadalafil. Although it is not known whether the event is directly related to tadalafil, if you experience a
decrease or sudden loss of hearing, stop taking tadalafil and contact
your doctor immediately.
Tadalafil is not indicated for use by women.

Children and adolescents
Tadalafil is not indicated for use by children and adolescents under the age of 18 years.

Other medicines and Tadalafil Laboratori Alter
Tell your doctor if you are taking, have recently taken or might take any other
medicines.
Do not take tadalafil if you are already taking nitrates.
Some medicines can be affected by tadalafil or they themselves can affect the way tadalafil works. Tell 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 to treat high blood pressure;
• riociguat;
• a 5-alpha reductase enzyme inhibitor (used to treat benign prostatic hyperplasia);
• medicines such as ketoconazole tablets (to treat 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 Laboratori Alter with drinks and alcohol
Information on the effects of alcohol is given in section 3. Grapefruit juice can affect
the way tadalafil works and should be taken with caution. Ask your doctor for more
information.

Fertility
In dogs treated, a reduction in sperm development in the testicles was observed. A decrease in sperm has been observed in some
men. These effects are unlikely to cause infertility.

Driving and operating machinery
Some men taking tadalafil during clinical studies have reported dizziness. Carefully
check how you react to the tablets before driving or using machinery.

Tadalafil Laboratori Alter contains lactose
If your doctor has told you that you have an intolerance to some sugars, contact your
doctor before taking this medicine.

Tadalafil Laboratori Alter contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is
essentially “sodium-free”.

Tadalafil Laboratori Alter contains aspartame
This medicine contains 4.08 mg of aspartame in each tablet. Aspartame is a source of
phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which
phenylalanine builds up because the body cannot remove it properly.

3. How to take Tadalafil Laboratori Alter

Take this medicine following exactly the instructions of your doctor. If you have doubts, consult your
doctor or pharmacist.
The orodispersible tablets of tadalafil are for oral use and only for men. Place the orodispersible tablet
whole in your mouth, on the tongue, where it will dissolve in a few seconds and be swallowed with the
saliva. The tablets can be taken with or without food. The score line is not designed for
breaking the tablet.

The recommended initial doseis one 10 mg tablet before sexual activity. If the effect of
this dosage is too weak, your doctor may increase the dose to 20 mg. The tadalafil tablets
are for oral use.
You can take the tadalafil tablet at least 30 minutes before sexual activity.
Tadalafil may still be effective up to 36 hours after taking the tablet.
Do not take tadalafil more than once a day. Tadalafil 10 mg and 20 mg is indicated to be used
before planned sexual activity and is not recommended for continuous daily use.
It is important to note that tadalafil does not work if there is no 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 have an erection and may
momentarily cause a decrease in your blood pressure. If you have taken or intend to
take tadalafil, avoid excessive alcohol consumption (blood alcohol level equal to
0.08% or higher) because this may increase the risk of dizziness when you stand up.

If you take more Tadalafil Laboratori Alter than you should
Contact your doctor. Side effects described in section 4 may occur.
If you have any doubts 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 gets them.
These effects are normally mild to moderate in severity.

If any of the following side effects occur, stop using the medicine and seek
immediate medical attention:

• allergic reactions, including skin rashes (uncommon frequency);
• chest pain - do not use nitrates but seek immediate medical attention (uncommon frequency);
• priapism, a prolonged and possibly painful erection after taking tadalafil (rare frequency). If you have an erection of this type that lasts for more than 4 hours, you should contact a doctor immediately;
• sudden loss of vision (rare frequency), distorted central vision, blurred vision, or sudden decrease in vision (frequency not known).

Other side effects have been reported:

Common(observed in 1 - 10 patients per 100)

• headache, back pain, muscle pain, pain in the arms and legs, hot flushes in the face, nasal congestion and indigestion.

Uncommon(observed in 1 - 10 patients per 1,000)

• dizziness, stomach pain, nausea, feeling unwell (vomiting), reflux, blurred vision, eye pain, difficulty breathing, blood in urine, prolonged erection, pounding sensation of heartbeat, a fast heart rate, 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 per 10,000)

• fainting, convulsions and transient memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing, hives (itchy red patches on the skin surface), bleeding of the penis, blood in semen and increased sweating.

Rarely, in men taking tadalafil, heart attacks and strokes have been reported. Most of these subjects
had heart problems already before using the medicine. Rarely, cases of partial, temporary or permanent
decrease or loss of vision in one or both eyes have been reported.

Some further rare side effectsthat had not been observed during clinical trials have been
reported in men taking tadalafil. These include:

• migraine, facial swelling, severe allergic reaction causing swelling of the face or throat, severe skin reactions, some disorders that change blood flow to the eyes, irregular heartbeat, angina and sudden cardiac death.
• distorted central vision, blurred 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. 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, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system directly at the address: https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse . By reporting side effects you can help provide more information
on the safety of this medicine.

5. How to store Tadalafil Laboratori Alter

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 package and on the blister after SCAD.
The expiry date refers to the last day of that month.
Store at a temperature below 30 °C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Tadalafil Laboratori Alter contains

• The active substanceis tadalafil. Each tablet contains 10 mg of tadalafil.
• The other ingredientsare: lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose, sodium croscarmellose, sodium lauryl sulfate, aspartame (E-951), ethyl vanillin, magnesium stearate.

Description of the appearance of Tadalafil Laboratori Alter and contents of the pack
Tadalafil Laboratori Alter 10 mg are orally disintegrating tablets of white to off-white color,
round, biconvex, with a score line on one side with no functional purpose.
Tadalafil Laboratori Alter 10 mg is available in blisters in packs of 4 orally disintegrating tablets.

Marketing authorisation holder and manufacturer
Laboratori Alter S.r.l.
Via Egadi, 7
20144 Milano

Manufacturer
Laboratorios Alter S.A.
C/ Mateo Inurria 30
28036 Madrid
Spain

This medicinal product is authorised in the member states of the European Economic Area with the
following denominations:
Italy Tadalafil Laboratori Alter
Spain Tadalafilo Farmalter 10 mg bucodispersable tablets EFG

Tadalafil Laboratori Alter 20 mg orodispersible tablets

Tadalafil
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 or pharmacist.
• 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 or pharmacist. See section 4.

Contents of this leaflet

• 13. What is Tadalafil Laboratori Alter and what it is used for
• 14. What you need to know before you take Tadalafil Laboratori Alter
• 15. How to take Tadalafil Laboratori Alter
• 16. Possible side effects
• 17. How to store Tadalafil Laboratori Alter
• 18. Contents of the pack and other information

1. What is Tadalafil Laboratori Alter and what is it used for

Tadalafil 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 achieve an erection sufficient for a
sexual intercourse.
Tadalafil contains the active ingredient tadalafil, which belongs to a group of medicines called
phosphodiesterase type 5 inhibitors. After sexual stimulation tadalafil helps to relax the blood
vessels in the penis, allowing blood flow to the penis. The result is improved erectile function.
Tadalafil will not be helpful if you do not have erectile dysfunction.
It is important to note that tadalafil has no effect unless there is 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 Laboratori Alter

Do not take Tadalafil Laboratori Alter

• if you are allergic to tadalafil or to any of the other ingredients of this medicine (listed in section 6);
• if you are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite. This is a group of drugs (“nitrates”) used for the treatment of 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, tell your doctor;
• if you have a serious heart condition or have had a heart attack in the last 90 days;
• if you have recently had a stroke in the last 6 months;
• if you have low blood pressure or uncontrolled high blood pressure;
• if you have previously experienced loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “eye stroke”;
• if you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension

(i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension
(i.e., high blood pressure in the lungs secondary to blood clots). It has been shown
that PDE5 inhibitors, such as tadalafil, increase the hypotensive effect of this medicine. If you are
taking riociguat or if you have any doubts, tell your doctor.

Warnings and precautions
Talk to your doctor before taking tadalafil.
Be aware that sexual activity involves a potential risk for patients with heart disease, because it puts extra strain on the heart. If you have a heart problem, tell your
doctor.
Before taking the tablets, tell your doctor if you have:

• sickle cell anemia (an abnormality of red blood cells);
• multiple myeloma (bone marrow cancer);
• leukemia (cancer of the blood cells);
• any deformation of the penis;
• a serious liver problem;
• a serious 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 have been cut (radical prostatectomy without neurovascular bundle preservation).

If you experience a sudden decrease or loss of vision or blurred vision while
taking tadalafil, stop taking tadalafil and contact your doctor immediately.
Decreased or sudden impairment of hearing has been observed in some patients treated with tadalafil. Although it is not known whether the event is directly related to tadalafil, if you experience a
sudden decrease or loss of hearing, stop taking tadalafil and contact
your doctor immediately.
Tadalafil is not indicated for use by women.

Children and adolescents
Tadalafil is not indicated for use by children and adolescents under the age of 18 years.

Other medicines and Tadalafil Laboratori Alter
Tell your doctor if you are taking, have recently taken, or might take any other
medicines.
Do not take tadalafil if you are already taking nitrates.
Some medicines can be affected by tadalafil or they themselves can affect how tadalafil works. Tell 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 to treat high blood pressure;
• riociguat;
• a 5-alpha reductase enzyme inhibitor (used to treat benign prostatic hyperplasia);
• medicines such as ketoconazole tablets (to treat 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 Laboratori Alter with drinks and alcohol
Information on the effects of alcohol is given in section 3. Grapefruit juice can affect
how tadalafil works and should be taken with caution. Ask your doctor for further
information.

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

Driving and using machines
Some men taking tadalafil during clinical trials have reported dizziness. Carefully
check how you react to the tablets before driving or using machines.

Tadalafil Laboratori Alter contains lactose
If your doctor has told you that you have an intolerance to some sugars, contact him before taking this
medicine.

Tadalafil Laboratori Alter contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, therefore it is
essentially “sodium-free”.

Tadalafil Laboratori Alter contains aspartame
This medicine contains 8.16 mg of aspartame in each tablet. Aspartame is a source of
phenylalanine. It may be harmful if you suffer from phenylketonuria (PKU), a rare genetic disorder in which
phenylalanine builds up because the body cannot remove it properly.

3. How to take Tadalafil Laboratori Alter

Take this medicine following exactly the instructions of your doctor. If you have doubts, consult your
doctor or pharmacist.
Tadalafil tablets are for oral use and only for men. Place the orodispersible tablet
whole in your mouth, on your tongue, where it will dissolve in a few seconds and be swallowed with saliva. The
tablets can be taken with or without food.

The recommended initial doseis one 10 mg tablet before sexual activity. However, you have
been given a dose of a 20 mg tablet because your doctor has decided that the recommended dose of
10 mg is too low.
You can take the tadalafil tablet at least 30 minutes before sexual activity.
Tadalafil may still be effective up to 36 hours after taking the tablet.
Do not take tadalafil more than once a day. Tadalafil 10 mg and 20 mg is indicated to be used
before planned sexual activity and is not recommended for continuous daily use.
It is important to note that tadalafil does not work if there is no sexual stimulation. You and your partner will
need to engage in foreplay as you would if you were not taking medication for
erectile dysfunction.
Drinking alcohol may interfere with your ability to achieve an erection and may
temporarily cause a decrease in your blood pressure. If you have taken or intend to
take tadalafil, avoid excessive alcohol consumption (blood alcohol level of
0.08% or higher) as this may increase the risk of dizziness when you stand up.

If you take more Tadalafil Laboratori Alter than you should
Contact your doctor. Adverse effects described in paragraph 4 may occur.
If you have any doubts 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 gets them.
These effects are normally 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 rashes (uncommon frequency);
• chest pain - do not use nitrates but seek immediate medical assistance (uncommon frequency);
• priapism, a prolonged and possibly painful erection after taking tadalafil (rare frequency). If you have an erection of this type that lasts for more than 4 hours, you should contact a doctor immediately;
• sudden loss of vision (rare frequency), distorted, blurred, or sudden decrease in central vision (frequency not known).

Other side effects have been reported:

Common(observed in 1 - 10 patients per 100)

• headache, back pain, muscle aches, pain in the arms and legs, hot flushes on the face, nasal congestion and indigestion.

Uncommon(observed in 1 - 10 patients per 1,000)

• dizziness, stomach discomfort, nausea, feeling unwell (vomiting), reflux, blurred vision, eye discomfort, difficulty breathing, blood in the urine, prolonged erection, pounding sensation of the heartbeat, a fast heart rate, 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 per 10,000)

• fainting, convulsions and transient memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing, hives (itchy red patches on the skin surface), bleeding of the penis, blood in the semen and increased sweating.

Rarely, in men taking tadalafil, heart attacks and strokes have been reported. Most of these subjects
already had heart problems before using the medicine. Rarely, cases of partial, temporary or permanent
decrease or loss of vision in one or both eyes have been reported.

Some further rare side effectsthat had not been observed during clinical trials have
been reported in men taking tadalafil. These include:

• migraine, swelling of the face, severe allergic reaction causing swelling of the face or throat, severe skin reactions, some disorders that change blood flow to the eyes, irregular heartbeat, angina and sudden cardiac death.
• distorted, blurred, or sudden decrease in central vision (frequency not known).

The side effect dizziness has been reported more frequently in men over 75 years of age
who were taking tadalafil. Diarrhea has been reported more frequently in men over 65 years
of age who were taking tadalafil.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system directly at: https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse . By reporting side effects you can help provide more information
about the safety of this medicine

5. How to store Tadalafil Laboratori Alter

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 package and on the blister after SCAD.
The expiry date refers to the last day of that month.
Store at a temperature below 30 °C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Tadalafil Laboratori Alter contains

• The active substanceis tadalafil. Each tablet contains 20 mg of tadalafil.
• The other ingredientsare: lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose, sodium croscarmellose, sodium lauryl sulfate, aspartame (E-951), ethyl vanillin, magnesium stearate.

Description of the appearance of Tadalafil Laboratori Alter and contents of the pack
Tadalafil Laboratori Alter 20 mg are orodispersible tablets of white to off-white color,
round, biconvex, without a score line.
Tadalafil Laboratori Alter 20 mg is available in blisters in packs of 4, 8 or 12 orodispersible tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Laboratori Alter S.r.l.
Via Egadi, 7
20144 Milan

Manufacturer
Laboratorios Alter S.A.
C/ Mateo Inurria 30
28036 Madrid
Spain

This medicinal product is authorised in the member states of the European Economic Area under the
following denominations:
Italy Tadalafil Laboratori Alter
Spain Tadalafilo Farmalter 20 mg bucodispersable tablets EFG