Tadalafil Eg Stada: detailed information

Patient Information Leaflet: Information for the User

TADALAFIL EUROGENERICI 2.5 mg film-coated tablets

Tadalafil
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4. Contents of this leaflet
1. What TADALAFIL EUROGENERICI is and what it is used for
2. What you need to know before taking TADALAFIL EUROGENERICI
3. How to take TADALAFIL EUROGENERICI
4. Possible side effects
5. How to store TADALAFIL EUROGENERICI
6. Contents of the pack and other information

1. What TADALAFIL EUROGENERICI is and what it is used for

TADALAFIL EUROGENERICI contains the active substance tadalafil, which belongs to a class of
medicines called phosphodiesterase type 5 inhibitors.
TADALAFIL EUROGENERICI is used to treat 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.

Following sexual stimulation, TADALAFIL EUROGENERICI helps relax the blood vessels in the
penis, allowing increased blood flow into the penis. The result is improved erectile function.
TADALAFIL EUROGENERICI will not help you if you do not have erectile dysfunction. It is important
to note that TADALAFIL EUROGENERICI 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 EUROGENERICI

DO NOT take TADALAFIL EUROGENERICI 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 suffer from a severe heart disease or have had a heart attack within the last 90 days;
you have 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 also described as “eye stroke”;
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 EUROGENERICI.

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 anaemia (an abnormality of red blood cells);
multiple myeloma (a malignant tumour of the bone marrow);
leukaemia (a malignant tumour of blood cells);
any deformity of the penis;
a serious liver problem;
a serious kidney problem.

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

pelvic surgery;
removal of all or part of the prostate gland where nerves to the prostate have been severed (radical prostatectomy without preservation of neurovascular bundles).

If you experience a sudden decrease or loss of vision, stop taking TADALAFIL
EUROGENERICI and contact your doctor immediately.
In some patients taking tadalafil, sudden decrease or loss of hearing has been observed. Although it is not known whether the event is directly related to tadalafil, if you experience sudden hearing decrease or loss, stop taking TADALAFIL
EUROGENERICI and contact your doctor immediately.
TADALAFIL EUROGENERICI is not intended for use in women.

Children and adolescents
TADALAFIL EUROGENERICI is not indicated for use in children and adolescents under 18 years of age.

Other medicines and TADALAFIL EUROGENERICI
Inform your doctor if you are taking, have recently taken, or might take any other
medicines.
Do not take TADALAFIL EUROGENERICI if you are already taking nitrates.
Some medicines may be affected by TADALAFIL EUROGENERICI or may themselves
affect how TADALAFIL EUROGENERICI 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 enzyme inhibitor (used to treat benign prostatic hyperplasia);
medicines such as ketoconazole tablets (for treating fungal infections) and protease inhibitors for the treatment of AIDS or HIV infection;
phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines);
rifampicin, erythromycin, clarithromycin, or itraconazole;
other treatments for erectile dysfunction.

Use of TADALAFIL EUROGENERICI with food, drinks and alcohol
Information on the effects of alcohol is provided in section 3. Grapefruit juice may
affect how TADALAFIL EUROGENERICI works and should be consumed with
caution. Consult your doctor for further information.

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

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

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

TADALAFIL EUROGENERICI contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially “sodium-free”.

3. How to take TADALAFIL EUROGENERICI

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Dose
The recommended dose is one 5 mg tadalafil 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 EUROGENERICI. This lower dose will be provided as a 2.5 mg tablet.
Tadalafil is also available as tablets containing 5, 10, and 20 mg. Not all strengths may be marketed.
Method of administration
TADALAFIL EUROGENERICI tablets are for oral use and intended only for men. Swallow the tablet whole with water. The tablet may be taken with or without food.
Do not take TADALAFIL EUROGENERICI more than once a day.
Important information
Daily administration of TADALAFIL EUROGENERICI may be suitable for men who anticipate engaging in sexual activity two or more times per week.
When taken once daily, TADALAFIL EUROGENERICI enables you to achieve an erection, if there is sexual stimulation, at any time within 24 hours after dosing.
It is important to remember that TADALAFIL EUROGENERICI does 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.
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 EUROGENERICI, avoid excessive alcohol consumption (for example, more than 900 ml of beer or 350 ml of wine), as this may increase the risk of dizziness upon standing.
If you take more TADALAFIL EUROGENERICI than you should
Contact your doctor. You may experience side effects as described in section 4.
If you forget to take TADALAFIL EUROGENERICI
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 EUROGENERICI more than once a day.
If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Other side effects have been reported
Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

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

Rare (may affect up to 1 in 1,000 people)

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

Rarely, heart attacks and strokes have been reported in men taking tadalafil. Most of these individuals already had heart problems before taking the medicine.
A partial, temporary or permanent decrease or 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 reaction causing swelling of the face or throat
severe skin rashes
certain disorders affecting blood circulation to the eyes
irregular heartbeat
angina
sudden cardiac death

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 EUROGENERICI

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

6. Package contents and other information

What TADALAFIL EUROGENERICI contains

The active substance is tadalafil. Each film-coated tablet contains 2.5 mg of tadalafil.
The other components are: Tablet core Lactose monohydrate Croscarmellose sodium Sodium lauryl sulfate (E487) Hydroxypropylcellulose Polysorbate Microcrystalline cellulose Magnesium stearate

Coating
Hypromellose
Lactose monohydrate
Titanium dioxide (E171)
Triacetin
Yellow iron oxide (E172)
Red iron oxide (E172)

Description of the appearance of TADALAFIL EUROGENERICI and package contents
Light orange-yellow, round, biconvex, film-coated tablets with a diameter of 5.1 ± 0.2 mm.
Available in blister packs containing 14x1, 28x1 and 56x1 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
EG S.p.A., via Pavia 6, 20136 Milano, Italy

Manufacturer
Stada Arzneimittel AG,
Stadastrasse 2-18,
61118 Bad Vilbel – Germany
Centrafarm Services B.V.,
Nieuwe Donk 9, Etten-Leur
4879 AC – The Netherlands

This medicinal product is authorized in the European Economic Area countries under the following names:
CZ Faberka
DE Tadalafil AL
DK Faberka
FI Faberka
IS Tadalafil Stada
IT TADALAFIL EUROGENERICI
NL Tadalafil CF
PT Faberka
SE Faberka

Package leaflet: Information for the user

TADALAFIL EUROGENERICI 5 mg film-coated tablets

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

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

Contents of this leaflet

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

1. What TADALAFIL EUROGENERICI is and what it is used for

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.

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

Urinary symptoms associated with a common condition called benign prostatic hyperplasia. This condition occurs when the prostate gland enlarges with age. Symptoms include difficulty starting urination, a sensation of not completely emptying the bladder, and a more frequent need to urinate, including during the night. TADALAFIL EUROGENERICI improves blood flow and relaxes the muscles of the prostate and bladder, which may reduce the symptoms associated with benign prostatic hyperplasia. Tadalafil has been shown to improve these urinary symptoms within 1–2 weeks after starting treatment.

2. What you need to know before taking TADALAFIL EUROGENERICI

DO NOT take TADALAFIL EUROGENERICI 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 enhances the effect of these medicines. If you are taking any form of nitrate or have any doubts, inform your doctor;
you suffer from a severe heart disease or have had a heart attack within the last 90 days;
you have had a stroke within the last 6 months;
you have low blood pressure or uncontrolled high blood pressure;
you have previously experienced sudden vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition also 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 before taking TADALAFIL EUROGENERICI. Be aware that sexual activity involves 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.

Since benign enlargement of the prostate and prostate cancer can
present with the same symptoms, your doctor will check that you do not have prostate cancer before
starting treatment with TADALAFIL EUROGENERICI.
TADALAFIL EUROGENERICI 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 malignant tumor of the bone marrow);
leukemia (a malignant tumor of blood cells);
any deformity of the penis;
a serious liver problem;
a serious kidney problem.

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

pelvic surgery;
removal of all or part of the prostate gland where the nerves to the prostate have been severed (radical prostatectomy without preservation of neurovascular bundles).

If you experience a sudden decrease or loss of vision, stop taking TADALAFIL
EUROGENERICI and contact your doctor immediately.
In some patients taking tadalafil, sudden decrease or loss of hearing has been observed. Although
it is not known whether the event is directly related to tadalafil, if you experience sudden reduction or
loss of hearing, stop taking TADALAFIL EUROGENERICI and contact your doctor immediately.
TADALAFIL EUROGENERICI is not intended for use in women.

Children and adolescents
TADALAFIL EUROGENERICI is not indicated for use in children and adolescents under 18 years of age.

Other medicines and TADALAFIL EUROGENERICI
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Do not take TADALAFIL EUROGENERICI if you are already taking nitrates.
Some medicines may be affected by TADALAFIL EUROGENERICI or may themselves affect how TADALAFIL EUROGENERICI 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 to treat high blood pressure;
riociguat;
a 5-alpha reductase enzyme inhibitor (used to treat benign prostatic hyperplasia);
medicines such as ketoconazole tablets (for treating fungal infections) and protease inhibitors for the treatment of AIDS or HIV infection;
phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines);
rifampicin, erythromycin, clarithromycin, or itraconazole;
other treatments for erectile dysfunction.

Use of TADALAFIL EUROGENERICI with food and alcohol
Information on the effects of alcohol is provided in section 3. Grapefruit juice may affect how TADALAFIL EUROGENERICI 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 operating machinery
Some men taking tadalafil in clinical studies reported dizziness. Carefully assess how you react to the tablets before driving or operating machinery.

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

TADALAFIL EUROGENERICI contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially “sodium-free”.

3. How to take TADALAFIL EUROGENERICI

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

Method of administration
TADALAFIL EUROGENERICI tablets are for oral use and for men only. Swallow the tablet whole with water. The tablet may be taken with or without food.

Do not take TADALAFIL EUROGENERICI more than once a day.

Alcohol intake may cause a temporary drop in blood pressure. If you have taken or plan to take TADALAFIL EUROGENERICI, avoid excessive consumption of alcoholic beverages (for example, more than 900 ml of beer or 350 ml of wine), as this may increase the risk of dizziness when standing up.

For the treatment of erectile dysfunction
Dosage
The recommended dose is one 5 mg tadalafil tablet taken once daily at approximately the same time each day. Your doctor may adjust your dose to 2.5 mg depending on your response to TADALAFIL EUROGENERICI. This lower dose will be provided as a 2.5 mg tablet.

Not all dosage recommendations may be achievable with 5 mg tablets alone; tadalafil may also be available in 2.5 mg, 10 mg, and 20 mg tablets. Not all strengths may be commercially available.

Important information
When taken once daily, TADALAFIL EUROGENERICI allows you to achieve an erection, if there is sexual stimulation, at any time during the 24-hour period. Daily administration of TADALAFIL EUROGENERICI may benefit men who anticipate having sexual activity two or more times per week.

It is important to remember that TADALAFIL EUROGENERICI 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.

Alcohol consumption may affect your ability to achieve an erection.

For the treatment of benign prostatic hyperplasia
Dosage
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 recommended dose remains one 5 mg tablet taken once daily.

If you take more TADALAFIL EUROGENERICI than you should
Contact your doctor. You may experience the adverse effects described in section 4.

If you forget to take TADALAFIL EUROGENERICI
Take your dose as soon as you remember, but do not take a double dose to make up for the missed tablet. Do not take TADALAFIL EUROGENERICI 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 intensity.
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 EUROGENERICI (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 have been reported
Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

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

Rare (may affect up to 1 in 1,000 people)

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

Rarely, in men taking tadalafil, heart attacks and strokes have been reported. Most of these individuals already had pre-existing heart conditions before using the medicine. A partial, temporary or permanent decrease or loss of vision in one or both eyes has also 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 reaction causing swelling of the face or throat
severe skin rashes
certain disorders affecting blood circulation to the eyes
irregular heartbeat
angina
sudden cardiac death

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 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 EUROGENERICI

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

6. Package contents and other information

What TADALAFIL EUROGENERICI contains

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

Tablet core
Monohydrate lactose
Sodium croscarmellose
Sodium lauryl sulfate (E487)
Hydroxypropylcellulose
Polysorbate
Microcrystalline cellulose
Magnesium stearate
Coating
Hypromellose
Monohydrate lactose
Titanium dioxide (E171)
Triacetin
Yellow iron oxide (E172)
Talc

Description of the appearance of TADALAFIL EUROGENERICI and the contents of the pack
Light yellow, round, biconvex film-coated tablets with a diameter of 6.1 ± 0.2 mm.
Available in blister packs containing 14x1, 28x1, 30x1, 56x1 and 84x1 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
EG S.p.A., via Pavia 6, 20136 Milano, Italy

Manufacturers
Stada Arzneimittel AG,
Stadastrasse 2-18,
61118 Bad Vilbel – Germany
Centrafarm Services B.V.,
Nieuwe Donk 9, Etten-Leur
4879 AC – The Netherlands

Package leaflet: Information for the user

TADALAFIL EUROGENERICI 10 mg film-coated tablets

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

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, because 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 EUROGENERICI is and what it is used for
What you need to know before taking TADALAFIL EUROGENERICI
How to take TADALAFIL EUROGENERICI
Possible side effects
How to store TADALAFIL EUROGENERICI
Contents of the pack and other information

1. What TADALAFIL EUROGENERICI is and what it is used for

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.

2. What you need to know before taking TADALAFIL EUROGENERICI

DO NOT take TADALAFIL EUROGENERICI 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 suffer from a severe heart disease or have had a heart attack within the last 90 days;
you have 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 also 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 before taking TADALAFIL EUROGENERICI.

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

It is not known whether TADALAFIL EUROGENERICI 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 EUROGENERICI and contact your doctor immediately.
In some patients taking tadalafil, sudden decrease or loss of hearing has been observed. Although it is not known whether this event is directly related to tadalafil, if you experience sudden decrease or loss of hearing, stop taking TADALAFIL EUROGENERICI and contact your doctor immediately.
TADALAFIL EUROGENERICI is not intended for use in women.

Children and adolescents
TADALAFIL EUROGENERICI is not indicated for use in children and adolescents under 18 years of age.

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

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

Use of TADALAFIL EUROGENERICI with food, beverages and alcohol
Information on the effects of alcohol is provided in section 3. Grapefruit juice may affect how TADALAFIL EUROGENERICI works and should be consumed with caution. Consult your doctor for further information.

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

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

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

TADALAFIL EUROGENERICI contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially "sodium-free".

3. How to take TADALAFIL EUROGENERICI

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

Dosage
The recommended starting dose is one 10 mg tablet taken prior to sexual activity. If this dose is not effective enough, your doctor may increase the dose to 20 mg.
Not all dosage recommendations may be achievable with 10 mg tablets; tadalafil is also available in 2.5 mg, 5 mg, and 20 mg tablets. Not all strengths may be commercially available.

Method of administration
TADALAFIL EUROGENERICI tablets are for oral use and are intended only for men. Swallow the tablet with water. The tablet may be taken with or without food.
The tablet may be divided into two equal doses.
You may take the TADALAFIL EUROGENERICI tablet at least 30 minutes before sexual activity. TADALAFIL EUROGENERICI may remain effective for up to 36 hours after taking the tablet.
Do not take TADALAFIL EUROGENERICI more than once a day. The 10 mg and 20 mg doses are intended for use prior to anticipated sexual activity and are not recommended for continuous daily use.

Important to remember
It is important to remember that TADALAFIL EUROGENERICI will not work without sexual stimulation. You and your partner will need to engage in foreplay, as you normally would if you were not taking a medicine for erectile dysfunction.
Drinking alcohol may interfere with your ability to get an erection and may temporarily lower your blood pressure. If you have taken or plan to take TADALAFIL EUROGENERICI, avoid excessive alcohol consumption (for example, more than 900 ml of beer or 350 ml of wine), as this may increase the risk of dizziness upon standing.

If you take more TADALAFIL EUROGENERICI than you should
Contact your doctor. You may experience side effects as described in section 4.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

allergic reactions, including skin rash (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 EUROGENERICI (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).

Other side effects have been reported
Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

dizziness
stomach ache
feeling unwell
malaise (vomiting)
reflux
blurred vision
eye pain
difficulty breathing
presence of blood in urine
prolonged erection
palpitations
rapid heartbeat
high blood pressure
low blood pressure
nosebleeds
ringing in the ears
swelling of hands, feet or ankles
feeling of fatigue

Rare (may affect up to 1 in 1,000 people)

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

Rarely, in men taking tadalafil, heart attacks and strokes have been reported. Most of these individuals already had pre-existing heart conditions before taking the medicine.
A partial, temporary or permanent decrease or loss of vision in one or both eyes has rarely 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 rashes
certain disorders affecting blood circulation to the eyes
irregular heartbeat
angina
sudden cardiac death

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 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 EUROGENERICI

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging or on the blister after the word “EXP.” The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Divided tablets must be discarded after 4 weeks of storage.
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 EUROGENERICI contains

The active substance is tadalafil. Each film-coated tablet contains 10 mg of tadalafil.
The other components are:
Tablet core: Monohydrate lactose, sodium croscarmellose, sodium lauryl sulfate (E487), hydroxypropylcellulose, polysorbate, microcrystalline cellulose, magnesium stearate.
Coating: Hypromellose, monohydrate lactose, titanium dioxide (E171), triacetin, yellow iron oxide (E172), talc.

Description of the appearance of TADALAFIL EUROGENERICI and package contents
Film-coated tablet, yellow in colour, round, biconvex, with a score line on one side, white in cross-section, with a diameter of 8.1 ± 0.2 mm. The tablet can be divided into two equal doses.

Available in blister packs containing 4x1, 8x1, 12x1, 24x1, 36x1 and 48x1 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
EG S.p.A., via Pavia 6, 20136 Milan, Italy

Manufacturers
Stada Arzneimittel AG,
Stadastrasse 2-18,
61118 Bad Vilbel – Germany
Centrafarm Services B.V.,
Nieuwe Donk 9, Etten-Leur 4879 AC – Netherlands

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
CZ Faberka
DE Tadalafil AL
DK Faberka
FI Faberka
IS Tadalafil Stada
IT TADALAFIL EUROGENERICI
NL Tadalafil CF
PT Faberka
SE Faberka

Package leaflet: Information for the user

TADALAFIL EUROGENERICI 20 mg film-coated tablets

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

Keep this leaflet. You may need to read it again.
If you have any questions, consult 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, because 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 EUROGENERICI is and what it is used for
What you need to know before taking TADALAFIL EUROGENERICI
How to take TADALAFIL EUROGENERICI
Possible side effects
How to store TADALAFIL EUROGENERICI
Contents of the pack and other information

1. What TADALAFIL EUROGENERICI is and what it is used for

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 sufficient for sexual intercourse. Following sexual stimulation, TADALAFIL EUROGENERICI helps relax the blood vessels in the penis, allowing blood to flow into the penis. The result is improved erectile function.

TADALAFIL EUROGENERICI will not help you if you do not have erectile dysfunction. It is important
to remember that TADALAFIL EUROGENERICI 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 EUROGENERICI

DO NOT take TADALAFIL EUROGENERICI 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 suffer from a severe heart disease or have had a heart attack within the last 90 days;
you have 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 also 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 before taking TADALAFIL EUROGENERICI.

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 malignant tumor of the bone marrow);
leukemia (a malignant tumor of blood cells);
any deformity of the penis;
a serious liver problem;
a serious kidney problem.

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

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

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

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

TADALAFIL EUROGENERICI is not intended for use in women.

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

Other medicines and TADALAFIL EUROGENERICI
Inform your doctor if you are taking, have recently taken, or might take any other medicines.

Do not take TADALAFIL EUROGENERICI if you are already taking nitrates.

Some medicines may be affected by TADALAFIL EUROGENERICI or may themselves affect how TADALAFIL EUROGENERICI 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 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.

Use of TADALAFIL EUROGENERICI with food and alcohol
Information on the effects of alcohol is provided in section 3. Grapefruit juice may affect how TADALAFIL EUROGENERICI works and should be taken 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 use of machines
Some men taking tadalafil in clinical studies reported dizziness. Carefully monitor how you react to the tablets before driving or operating machinery.

TADALAFIL EUROGENERICI contains lactose
If your doctor has informed you of an intolerance to certain sugars, contact him before taking this medicine.

TADALAFIL EUROGENERICI contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially “sodium-free”.

3. How to take TADALAFIL EUROGENERICI

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

Dose
The recommended starting dose is one 10 mg tablet taken before sexual activity.
If your doctor has determined that the recommended dose of 10 mg is too weak for you, a dose of 20 mg will be prescribed.
Not all dosage recommendations can be achieved using only 20 mg tablets; tadalafil is also available in tablets of 2.5 mg, 5 mg, and 10 mg. Not all strengths may be commercially available.

You may take the TADALAFIL EUROGENERICI tablet at least 30 minutes before sexual activity. TADALAFIL EUROGENERICI may remain effective for up to 36 hours after taking the tablet.
Do not take TADALAFIL EUROGENERICI more than once a day. The 10 mg and 20 mg doses are intended for use prior to anticipated sexual activity and are not recommended for daily continuous use.

Important to remember
It is important to remember that TADALAFIL EUROGENERICI 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.
Drinking alcohol may interfere with your ability to get an erection and may temporarily cause a reduction in blood pressure. If you have taken or plan to take TADALAFIL EUROGENERICI, avoid excessive alcohol consumption (for example, more than 900 ml of beer or 350 ml of wine), as this may increase the risk of dizziness when standing up.

If you take more TADALAFIL EUROGENERICI 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, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. These side effects are usually mild to moderate in 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 take nitrates but seek immediate medical help (uncommon frequency);
priapism, a prolonged and possibly painful erection after taking TADALAFIL EUROGENERICI (rare frequency). If you have an erection of this type lasting for more than 4 consecutive hours, you must contact a doctor immediately;
sudden loss of vision (rare frequency).

Other side effects have been reported
Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

dizziness
stomach ache
feeling unwell
malaise (vomiting)
acid reflux
blurred vision
eye pain
difficulty breathing
blood in the urine
prolonged erection
palpitations
rapid heartbeat
high blood pressure
low blood pressure
nosebleeds
ringing in the ears
swelling of the hands, feet or ankles
feeling of tiredness

Rare (may affect up to 1 in 1,000 people)

fainting
seizures
transient memory loss
eyelid swelling
red eyes
sudden decrease or loss of hearing
urticaria (red, itchy patches on the skin)
penile bleeding
blood in semen
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.
A partial, temporary or permanent decrease or loss of vision in one or both eyes has rarely 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 rashes
certain disorders affecting blood circulation to the eyes
irregular heartbeat
angina
sudden cardiac death

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 EUROGENERICI

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging or on the blister after the word “EXP.” The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Divided tablets must be discarded after 4 weeks of storage.
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 EUROGENERICI contains

The active substance is tadalafil. Each film-coated tablet contains 20 mg of tadalafil.
The other components are:
Tablet core
Lactose monohydrate
Sodium croscarmellose
Sodium lauryl sulfate (E487)
Hydroxypropylcellulose
Polysorbate
Microcrystalline cellulose
Magnesium stearate

Coating
Hypromellose
Lactose monohydrate
Titanium dioxide (E171)
Triacetin
Iron oxide yellow (E172)
Talc

Description of the appearance of TADALAFIL EUROGENERICI and contents of the pack
Film-coated tablet, yellow in colour, round, biconvex, with a score line on both sides, white in cross-section, with a diameter of 10.1 ± 0.2 mm.
The tablet can be divided into two equal doses.
Available in blister packs containing 4x1, 8x1, 12x1, 24x1, 36x1 and 48x1 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
EG S.p.A., via Pavia 6, 20136 Milan, Italy

Manufacturers
Stada Arzneimittel AG,
Stadastrasse 2-18,
61118 Bad Vilbel, Germany
Centrafarm Services B.V.,
Nieuwe Donk 9, Etten-Leur 4879 AC, Netherlands