Tadalafil Laboratori Alter: detailed information

Package leaflet: Information for the user

Tadalafil Laboratori Alter 5 mg orodispersible tablets

Tadalafil
Equivalent medicine
Please read all of this leaflet carefully before you take 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 effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Tadalafil Laboratori Alter contains the active substance tadalafil, which belongs to a group of medicines
called phosphodiesterase type 5 inhibitors.
Tadalafil 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 demonstrated a significant improvement in the ability to obtain an erection suitable for sexual activity. Following sexual stimulation, tadalafil works by helping to relax the blood vessels in the penis, allowing blood to flow into the penis. The result 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 without 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 gland 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 improves blood flow and relaxes the muscles of the prostate and bladder, which may reduce 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 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, inform your doctor;
if you have a severe heart disease or have had a heart attack within the last 90 days;
if you have recently had a stroke within the last 6 months;
if you have low blood pressure or uncontrolled high blood pressure;
if you have previously experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “stroke of the eye”;
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). 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 before taking Tadalafil Laboratori Alter.
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 for benign prostatic hyperplasia. Tadalafil 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 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 with nerve bundles severed (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, stop taking tadalafil and contact your doctor immediately.
In some patients treated with tadalafil, reduced or sudden impairment of hearing has been observed. Although it is not known whether this 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 intended for use by women.
Children and adolescents
Tadalafil is not intended for use in children and adolescents under 18 years of age.
Other medicines and Tadalafil Laboratori Alter
Inform 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 may be affected by tadalafil or may themselves affect 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 (used 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 food and alcohol
Information on the effects of alcohol is provided in section 3. Grapefruit juice may affect how tadalafil works and should be consumed with caution. Consult your doctor for further information.
Fertility
In dogs treated with tadalafil, 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 during clinical studies reported dizziness. Carefully monitor how you react to the tablets before driving or operating machinery.
Tadalafil Laboratori Alter contains lactose
If your doctor has diagnosed you with an intolerance to certain 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 and is therefore 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 suffer from phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly remove it.

3. How to take Tadalafil Laboratori Alter

Take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
Tadalafil orodispersible tablets are for oral use and for men only. Place the whole orodispersible tablet on the tongue, where it will dissolve within a few seconds and be swallowed with saliva. The tablets can be taken with or without food.
Drinking alcohol may temporarily cause a drop in your blood pressure. If you have taken or are planning to take tadalafil, 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
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. This dose will be provided as a 2.5 mg tablet.
Do not take tadalafil more than once a day.
When taken once daily, tadalafil allows you to achieve an erection, if there is sexual stimulation, at any time during the 24-hour period. Daily administration of tadalafil may be beneficial for men who anticipate having sexual activity two or more times per week.
It is important to note that tadalafil 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.

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 benign prostatic hyperplasia and erectile dysfunction, the dose remains one 5 mg tablet taken once daily.
Do not take tadalafil more than once a day.

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

If you forget to take Tadalafil Laboratori Alter
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 more than once a day.

If you have any 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 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 (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 that have been reported:
Common (seen in 1 to 10 patients out of 100)

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

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

dizziness, stomach discomfort, nausea, malaise (vomiting), reflux, blurred vision, eye discomfort, breathing difficulties, presence of blood in urine, prolonged erection, pounding sensation of heartbeat, rapid heart rate, high blood pressure,
low blood pressure, nosebleeds, ringing in the ears, swelling of the hands,
feet or ankles, and feeling of fatigue.
Rare (seen in 1 to 10 patients out of 10,000)
fainting, seizures, and transient memory loss, eyelid swelling, red eyes, sudden decrease or loss of hearing, urticaria (itchy red patches on the skin), bleeding from the penis, blood in semen, and increased sweating.

Rarely, in men taking tadalafil, heart attacks and strokes have been reported. 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. These include:

migraine, facial swelling, severe allergic reaction causing swelling of the face or 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. Diarrhea 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: 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 stated on the carton and blister after EXP.
The expiry date refers to the last day of that month.
Store below 30°C.
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 Laboratori Alter contains

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

Description of the appearance of Tadalafil Laboratori Alter and the contents of the pack
Tadalafil Laboratori Alter 5 mg are orodispersible tablets, white to off-white in colour, 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 Authorization Holder and Manufacturer
Laboratori Alter S.r.l.
Via Egadi, 7
20144 Milan, Italy

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

This medicinal product is authorized in the European Economic Area member states under the following names:
Italy: Tadalafil Laboratori Alter
Spain: Tadalafilo Farmalter 5 mg comprimidos bucodispersables EFG

Package leaflet: information for the user

Tadalafil Laboratori Alter 10 mg orodispersible 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, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Tadalafil Laboratori Alter is and what it is 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 obtain an erection suitable for sexual intercourse.
Tadalafil contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. After sexual stimulation, tadalafil helps relax the blood vessels in the penis, allowing blood to flow into the penis. The result is improved erectile function.
Tadalafil will not benefit you if you do not have erectile dysfunction.
It is important to note that tadalafil 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 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, inform your doctor;
if you have a severe heart disease or have had a heart attack within the last 90 days;
if you have recently had a stroke within the last 6 months;
if you have low blood pressure or uncontrolled high blood pressure;
if you have previously experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “stroke of the eye”;
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). 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 before taking tadalafil.
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 anaemia (an abnormality of red blood cells);
multiple myeloma (a tumour of the bone marrow);
leukaemia (a tumour of blood cells);
any deformity 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 with nerves cut (nerve-sparing radical prostatectomy).

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

Other medicines and Tadalafil Laboratori Alter
Inform 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 may be affected by tadalafil or may affect 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 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.

Fertility
In treated dogs, reduced sperm development in the testes has been observed. In some men, a reduction in sperm has been observed. It is unlikely that these effects would cause infertility.

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

Tadalafil Laboratori Alter contains lactose
If your doctor has diagnosed you with an intolerance to certain 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 4.08 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 accumulates because the body cannot properly eliminate it.

3. How to take Tadalafil Laboratori Alter

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The orodispersible tablets of tadalafil are for oral use and intended only for men. Place the whole orodispersible tablet on the tongue, where it will dissolve within a few seconds and be swallowed with saliva. The tablets can be taken with or without food. The score line is not intended for dividing the tablet.
The recommended starting dose is one 10 mg tablet taken prior to sexual activity. If the effect of this dose is too weak, your doctor may increase the dose to 20 mg. Tadalafil tablets are for oral use.
You may 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 intended to be used prior to anticipated sexual activity and is not recommended for continuous daily use.
It is important to note that tadalafil will not work without sexual stimulation. You and your partner will need to engage in foreplay as you would normally do if you were not taking a medicine for erectile dysfunction.
Consuming alcoholic beverages may interfere with your ability to get an erection and may temporarily cause a lowering of your blood pressure. If you have taken or plan to take tadalafil, 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 Laboratori Alter 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 gets them. These side effects are usually mild to moderate in intensity.
If you experience any of the following side effects, stop using this medicine and seek
immediate medical assistance:

allergic reactions, including skin rashes (frequency not common);
chest pain – do not take nitrates but seek immediate medical assistance (frequency not common);
priapism, a prolonged and possibly 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), distorted central vision, blurred, fuzzy vision, or sudden decrease in vision (frequency not known).

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

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

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

dizziness, stomach ache, nausea, malaise (vomiting), reflux, blurred vision, eye discomfort, breathing difficulties, presence of blood in urine, prolonged erection, pounding sensation of heartbeat, rapid heart rate, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of the hands, feet or ankles, and feeling of fatigue.

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 (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. Most of these individuals already had pre-existing heart conditions before using 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. These include:

migraine, facial swelling, severe allergic reaction causing swelling of the face or throat, serious skin reactions, certain disorders affecting blood circulation to the eyes, irregular heartbeat, angina, and sudden cardiac death.
distorted, blurred, fuzzy 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. 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: 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 stated on the carton and blister after EXP.
The expiry date refers to the last day of that month.
Store below 30 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Tadalafil Laboratori Alter contains

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

Description of the appearance of Tadalafil Laboratori Alter and package contents
Tadalafil Laboratori Alter 10 mg are orodispersible tablets, white to off-white in colour,
round, biconvex, with a score line on one side without functional purpose.
Tadalafil Laboratori Alter 10 mg is available in blisters containing 4 orodispersible tablets.
Marketing Authorization 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 authorized in the European Economic Area member states with the
following names:
Italy Tadalafil Laboratori Alter
Spain Tadalafilo Farmalter 10 mg comprimidos bucodispersables EFG

Package leaflet: Information for the user

Tadalafil Laboratori Alter 20 mg orodispersible tablets

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

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor 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 may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Tadalafil Laboratori Alter is and what it is 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 obtain an erection suitable for sexual intercourse.
Tadalafil contains the active substance tadalafil, which belongs to a group of medicines known as phosphodiesterase type 5 inhibitors. Following sexual stimulation, tadalafil helps relax the blood vessels in the penis, allowing blood to flow into the penis. The result is improved erectile function.
Tadalafil will not help you if you do not have erectile dysfunction.
It is important to note that tadalafil 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 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. 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;
if you have a severe heart disease or have had a heart attack within the last 90 days;
if you have recently had a stroke within the last 6 months;
if you have low blood pressure or uncontrolled high blood pressure;
if you have previously experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “stroke of the eye”;
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). 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 before taking tadalafil.

Be aware that sexual activity carries a potential risk for patients with heart disease, as it puts 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;
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 with nerve-sparing not preserved (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, stop taking tadalafil and contact your doctor immediately.

In some patients treated with tadalafil, reduced or sudden hearing impairment has been observed. Although it is not known whether this event is directly related to tadalafil, if you experience sudden decrease or loss of hearing, stop taking tadalafil and contact your doctor immediately.

Tadalafil is not intended for use by women.

Children and adolescents

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

Other medicines and Tadalafil Laboratori Alter

Inform 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 may be affected by tadalafil or may themselves affect 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 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 Laboratori Alter with food, beverages and alcohol

Information on the effects of alcohol is provided in section 3. Grapefruit juice may affect how tadalafil 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 in clinical studies reported dizziness. Carefully assess how you react to the tablets before driving or operating machinery.

Tadalafil Laboratori Alter contains lactose

If your doctor has diagnosed you with an intolerance to certain 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 per tablet. Aspartame is a source of phenylalanine. It may be harmful if you suffer from phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly remove it.

3. How to take Tadalafil Laboratori Alter

Take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
Tadalafil tablets are for oral use and for men only. Place the orodispersible tablet whole in the mouth, on the tongue, where it will dissolve within a few seconds and be swallowed with saliva. The tablets can be taken with or without food.
The recommended starting dose is one 10 mg tablet taken before sexual activity. However, you have been prescribed a dose of one 20 mg tablet, as your doctor has decided that the recommended 10 mg dose is too low for you.
You may 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 intended to be used prior to anticipated sexual activity and is not recommended for continuous daily use.
It is important to note that tadalafil will not work without 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.
Drinking alcohol may interfere with your ability to get an erection and may temporarily cause a drop in blood pressure. If you have taken or plan to take tadalafil, 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 Laboratori Alter than you should
Contact your doctor. You may experience the side effects described in section 4.
If you have any doubts 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 will experience them. These side effects are usually mild to moderate in intensity.
If you experience any of the following side effects, stop using this medicine and seek immediate medical assistance:

allergic reactions, including skin rash (uncommon frequency);
chest pain – do not take 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 lasting more than 4 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 reported:
Common (seen in 1 to 10 patients out of 100)

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

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

dizziness, stomach ache, nausea, malaise (vomiting), reflux, blurred vision, eye discomfort, breathing difficulties, presence of blood in urine, prolonged erection, pounding sensation of heartbeat, rapid heart rate, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of the hands, feet or ankles, and feeling tired.

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

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

Rarely, heart attacks and strokes have been reported in men taking tadalafil. Most of these individuals already had pre-existing heart conditions 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. These include:

migraine, facial swelling, severe allergic reaction causing swelling of the face or 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. 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: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . Reporting side effects 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 stated on the carton and blister after EXP.
The expiry date refers to the last day of that month.
Store below 30 °C.
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 Laboratori Alter contains

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

Description of the appearance of Tadalafil Laboratori Alter and pack contents
Tadalafil Laboratori Alter 20 mg are orodispersible tablets, white to almost white in colour, round, biconvex, without a break line.
Tadalafil Laboratori Alter 20 mg is available in blisters in packs containing 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 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 under the following names:
Italy: Tadalafil Laboratori Alter
Spain: Tadalafilo Farmalter 20 mg comprimidos bucodispersables EFG