TADALAFIL 2.5 мг Коированная таблетка

Содержание инструкции

1. TADALAFIL ABC 2,5 mg film-coated tablets
   1. What is TADALAFIL ABC and what is it used for
   2. What you need to know before taking TADALAFIL ABC
   3. How to take TADALAFIL ABC
   4. Possible side effects
   5. How to store TADALAFIL ABC
   6. Contents of the pack and other information
2. TADALAFIL ABC 5 mg film-coated tablets
   1. What is TADALAFIL ABC and what is it used for
   2. What you need to know before taking TADALAFIL ABC
   3. How to take TADALAFIL ABC
   4. Possible side effects
   5. How to store TADALAFIL ABC
   6. Contents of the pack and other information
3. TADALAFIL ABC 10 mg film-coated tablets
   1. What is TADALAFIL ABC and what is it used for
   2. What you need to know before taking TADALAFIL ABC
   3. How to take TADALAFIL ABC
   4. Possible side effects
   5. How to store TADALAFIL ABC
   6. Contents of the pack and other information
4. TADALAFIL ABC 20 mg film-coated tablets
   1. What is TADALAFIL ABC and what is it used for
   2. What you need to know before taking TADALAFIL ABC
   3. How to take TADALAFIL ABC
   4. Possible side effects
   5. How to store TADALAFIL ABC
   6. Contents of the pack and other information

TADALAFIL ABC 2,5 mg film-coated tablets

Tadalafil

“Generic medicine”
Read this leaflet carefully before you start 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 their symptoms are the same as yours, as it could 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 ABC is and what it is used for
• 2. What you need to know before you take TADALAFIL ABC
• 3. How to take TADALAFIL ABC
• 4. Possible side effects
• 5. How to store TADALAFIL ABC
• 6. Contents of the pack and other information

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

TADALAFIL ABC contains the active ingredient tadalafil which belongs to the class of medicines called
phosphodiesterase type 5 inhibitors.
TADALAFIL ABC 2.5 mg is a treatment for adult men with erectile dysfunction. This
condition occurs when a man cannot achieve or maintain an erection sufficient for
sexual intercourse. TADALAFIL ABC has been shown to significantly improve the ability to obtain
an erection sufficient for sexual intercourse.
After sexual stimulation TADALAFIL ABC helps to relax the blood vessels in the penis, allowing
blood flow to the penis. The result of this is improved erectile function. TADALAFIL ABC will not
help you if you do not have erectile dysfunction.
It is important to note that TADALAFIL ABC for the treatment of erectile dysfunction 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 ABC

Do not take TADALAFIL ABC if:

• you are allergic to tadalafil or 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 (or “chest pain”). It has been shown that TADALAFIL ABC increases the effect of these medicines. If you are taking any form of nitrate or have any doubts, tell your doctor.
• you have a serious heart condition or have had a heart attack recently, within the last 90 days.
• you have had a stroke recently, within the last 6 months.
• you have low blood pressure or uncontrolled high blood pressure. Page 1of 21
• you have previously experienced loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition 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). It has been shown that PDE5 inhibitors, such as TADALAFIL ABC, 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 or pharmacist before taking TADALAFIL ABC.
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 (a malignant tumor of the bone marrow).
• leukemia (a malignant tumor of the blood cells).
• any deformity of the penis.
• a serious liver problem.
• a serious kidney problem.

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

• pelvic surgery
• removal of all or part of the prostate gland where the nerves of the prostate have been cut (radical prostatectomy without neurovascular bundle preservation).

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

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

Other medicines and TADALAFIL ABC
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Do not take TADALAFIL ABC if you are already taking nitrates.
Some medicines can be affected by TADALAFIL ABC or they themselves can affect the
way TADALAFIL ABC 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 (medicine used to treat pulmonary hypertension).
• 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).

Page 2of 21

• rifampicin, erythromycin, clarithromycin or itraconazole.
• other treatments for erectile dysfunction.

TADALAFIL ABC with drinks and alcohol
Information about the effects of alcohol is given in section 3. Grapefruit juice can affect the
way TADALAFIL ABC works and should be taken with caution. Ask your doctor for
further information.

Fertility
In dogs treated with the drug, a reduction in sperm development in the testicles was observed. A reduction 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 using machinery.

TADALAFIL ABC contains lactose.
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this
medicine
TADALAFIL ABC contains less than 1 mmol (23 mg) of sodium per dose, that is to say it is essentially ‘sodium-free’

3. How to take TADALAFIL ABC

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
TADALAFIL ABC tablets are for oral use and for men only.
Swallow the tablet whole with water.
The tablets can be taken independently of food intake.
Drinking alcohol may temporarily cause a reduction in your blood pressure.
If you have taken or intend to take TADALAFIL ABC, avoid excessive alcohol consumption (blood alcohol
level of 0.08% or higher) as this may increase the risk of dizziness when you stand up.
The recommended dose is 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
ABC. This dose will be given to you with a 2.5 mg tablet.
Do not take TADALAFIL ABC more than once a day.
Daily administration of TADALAFIL ABC may be useful for men who anticipate
having sexual activity two or more times a week.
When taken once daily, TADALAFIL ABC allows you to achieve an erection, if there is
sexual stimulation, at any time of day within 24 hours.
It is important to note that TADALAFIL ABC will not work without sexual stimulation.
You and your partner will need to engage in foreplay as you would if you were not taking
medicine for erectile dysfunction.
Drinking alcohol may interfere with your ability to achieve an erection.

If you take more TADALAFIL ABC than you should
Contact your doctor. Side effects as described in section 4 may occur.

If you forget to take TADALAFIL ABC
Page 3of 21
Take your dose as soon as you remember, but do not take a double dose to make up for a missed tablet.
You should not take TADALAFIL ABC 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 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 ABC (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).

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
• flushing of the face
• nasal congestion
• digestive disorders

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

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

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

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

Rarely, in men taking TADALAFIL ABC, heart attacks and strokes have been reported. The
majority 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 effects that had not been observed during clinical trialsare
reported in men taking TADALAFIL ABC. These include:

• migraine Page 4of 21
• swelling of the face, severe allergic reaction causing swelling of the face and throat, severe skin reactions
• some disorders that alter blood circulation to the eyes
• irregular heartbeat, angina and sudden cardiac death.

The side effect “dizziness” has been reported more frequently in men over 75 years of age
taking TADALAFIL ABC. “Diarrhea” has been reported more frequently in men over
65 years of age taking TADALAFIL ABC.

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 via the website:
http:// 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 ABC

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.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What TADALAFIL ABC contains

• The active ingredient is tadalafil. Each tablet contains 2.5 mg of tadalafil.
• The other ingredients are: Tablet:lactose monohydrate (see the end of paragraph 2), sodium croscarmellose, hydroxypropylcellulose, sodium lauryl sulfate, magnesium stearate, povidone (K-25), anhydrous colloidal silica Film coating: hypromellose, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172)

Description of the appearance of TADALAFIL ABC and contents of the pack
TADALAFIL ABC 2.5 mg is a film-coated tablet of yellow to light yellow color with a round shape and
beveled edge, with '336' imprinted on one side and smooth on the other side.
TADALAFIL ABC 2.5 mg is available in blisters in packs of 14 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
ABC Farmaceutici S.p.A. – Corso Vittorio Emanuele II, 72 – 10121 Turin

Manufacturer
ABC Farmaceutici S.p.A. Canton Moretti, 29 – 10015 Loca San Bernardo – Ivrea (TO)
Page 5of 21

TADALAFIL ABC 5 mg film-coated 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 ABC is and what it is used for
• 2. What you need to know before you take TADALAFIL ABC
• 3. How to take TADALAFIL ABC
• 4. Possible side effects
• 5. How to store TADALAFIL ABC
• 6. Contents of the pack and other information

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

TADALAFIL ABC contains the active ingredient tadalafil, which belongs to the class of medicines known as
phosphodiesterase type 5 inhibitors.
TADALAFIL ABC 5 mg is a treatment for men with:

• Erectile dysfunction: this condition occurs when a man cannot achieve or maintain an erection adequate for sexual intercourse. TADALAFIL ABC has been shown to significantly improve the ability to achieve an erection adequate for sexual intercourse. After sexual stimulation TADALAFIL ABC helps to relax the blood vessels in the penis, allowing blood flow to the penis. The result of this is improved erectile function. TADALAFIL ABC will not help you if you do not have erectile dysfunction. It is important to note that TADALAFIL ABC for the treatment of erectile dysfunction 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 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 to urinate, a feeling of not emptying the bladder completely, and a more frequent need to urinate, even at night. TADALAFIL ABC improves blood flow and relaxes the muscles of the prostate and bladder, which can reduce the symptoms associated with benign prostatic hyperplasia. TADALAFIL ABC has been shown to improve these urinary symptoms within 1-2 weeks of starting treatment.

2. What you need to know before taking TADALAFIL ABC

Do not take TADALAFIL ABC if:

• you are allergic to tadalafil or 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. Page 6of 21

This is a group of medicines (“nitrates”) used for the treatment of angina pectoris (or “chest pain”). It has been shown that TADALAFIL ABC increases the effect of these medicines. If you are taking any form of nitrate or have any doubts, tell your doctor.

• you have a serious heart condition or have recently had a heart attack, within the last 90 days.
• you have recently had a stroke, within the last 6 months.
• you have low blood pressure or uncontrolled high blood pressure.
• you have previously experienced loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition 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). It has been shown that PDE5 inhibitors, such as TADALAFIL ABC, 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 or pharmacist before taking TADALAFIL ABC.
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 ABC for benign prostatic hyperplasia. TADALAFIL ABC 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 (a cancerous tumor of the bone marrow).
• leukemia (a cancerous tumor of the blood cells).
• any deformity of the penis.
• a serious liver problem.
• a serious kidney problem. It is not known whether TADALAFIL ABC is effective in patients who have undergone:
• pelvic surgery
• removal of all or part of the prostate gland where the nerves of the prostate have been cut (radical prostatectomy without neurovascular bundle sparing).

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

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

Other medicines and TADALAFIL ABC
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Do not take TADALAFIL ABC if you are already taking nitrates.
Some medicines can be affected by TADALAFIL ABC or they themselves can affect
how TADALAFIL ABC works. Tell your doctor or pharmacist if you are already taking:
Page 7of 21

• 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 medicine used to treat pulmonary hypertension).
• a 5 alpha-reductase enzyme inhibitor (used to treat benign prostatic hyperplasia)
• medicines such as ketoconazole tablets (for treating fungal infections) and protease inhibitors for the treatment of AIDS or HIV infection.
• phenobarbital, phenytoin and carbamazepine (anticonvulsant medicines).
• rifampicin, erythromycin, clarithromycin or itraconazole.
• other treatments for erectile dysfunction.

TADALAFIL ABC with drinks and alcohol
Information on the effects of alcohol is given in section 3. Grapefruit juice can affect
how TADALAFIL ABC 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 has been observed. A decrease in sperm has been observed in some men. These effects are unlikely to cause infertility.

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

TADALAFIL ABC contains lactose.
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this
medicine
TADALAFIL ABC contains less than 1 mmol (23 mg) of sodium per dose, that is to say it’s essentially ‘sodium-free’

3. How to take TADALAFIL ABC

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
TADALAFIL ABC tablets are for oral use and only for men.
Swallow the tablet whole with water.
The tablets can be taken independently of food intake.
Drinking alcohol may temporarily cause a decrease in your blood pressure.
If you have taken or intend to take TADALAFIL ABC, avoid excessive alcohol consumption (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 dose is 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
ABC. This dose will be given to you with a 2.5 mg tablet.
Do not take TADALAFIL ABC more than once a day.
Daily administration of TADALAFIL ABC may be useful for men who anticipate
having sexual activity two or more times a week.
Page 8of 21
When taken once a day, TADALAFIL ABC allows you to achieve an erection, if there is
sexual stimulation, at any time of the day within 24 hours. It is important to note that
TADALAFIL ABC 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
medicine for erectile dysfunction.
Drinking alcohol may interfere with your ability to achieve an erection.

For the treatment of benign prostatic hyperplasia
The dose is one 5 mg tablet 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 ABC more than once a day.

If you take more TADALAFIL ABC than you should
Contact your doctor. Undesirable effects described in paragraph 4 may occur.

If you forget to take TADALAFIL ABC
Take your dose as soon as you remember, but do not take a double dose to compensate for
forgetting the tablet. You must not take TADALAFIL ABC 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 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 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 ABC (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). Other side effects that have been reported include:

Common (observed in 1-10 patients per 100)

• headache
• back pain, muscle pain, pain in the arms and legs
• flushing of the face
• nasal congestion
• digestive disorders

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

• dizziness
• stomach pain, feeling unwell, malaise (vomiting), reflux
• blurred vision, eye pain
• difficulty breathing
• presence of blood in the urine
• prolonged erection, palpitations, fast heartbeat
• high blood pressure, low blood pressure
• nosebleeds
• ringing in the ears Page 9of 21
• 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
• urticaria (itchy red patches on the skin surface)
• penile bleeding, presence of blood in the semen and increased sweating.

Rarely, in men taking TADALAFIL ABC, heart attacks and strokes have been reported. The
majority 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 effects that had not been observed during clinical trialsare
reported in men taking TADALAFIL ABC. These include:

• migraine
• swelling of the face, severe allergic reaction causing swelling of the face and throat, severe skin reactions, some disorders that alter blood circulation to the eyes, irregular heartbeat, angina and sudden cardiac death.

The side effect “dizziness” has been reported more frequently in men over 75 years of age
who were taking TADALAFIL ABC. “Diarrhoea” has been reported more frequently in men over
65 years of age who were taking TADALAFIL ABC.

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 via the website:
http:// 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 ABC

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.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What TADALAFIL ABC contains

• The active ingredient is tadalafil. Each tablet contains 5 mg of tadalafil.
• The other ingredients are: Tablet:lactose monohydrate (see the end of paragraph 2), sodium croscarmellose, hydroxypropylcellulose, sodium lauryl sulfate, magnesium stearate, povidone (K-25), anhydrous colloidal silica Film coating: hypromellose, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172)

Page 10of 21
Description of the appearance of TADALAFIL ABC and contents of the pack
TADALAFIL ABC 5 mg is a film-coated tablet of yellow to light yellow color with a round shape and
beveled edge, with '337' imprinted on one side and smooth on the other side.
TADALAFIL ABC 5 mg is available in blisters in packs of 14, 28 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
ABC Farmaceutici S.p.A. – Corso Vittorio Emanuele II, 72 – 10121 Turin

Manufacturer
ABC Farmaceutici S.p.A. Canton Moretti, 29 – 10015 Loca San Bernardo – Ivrea (TO)
Page 11of 21

TADALAFIL ABC 10 mg film-coated tablets

Tadalafil

“Generic medicine”
Read 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 pass it on to others, even if their symptoms are the same as yours, as it could 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 ABC is and what it is used for
• 2. What you need to know before you take TADALAFIL ABC
• 3. How to take TADALAFIL ABC
• 4. Possible side effects
• 5. How to store TADALAFIL ABC
• 6. Contents of the pack and other information

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

TADALAFIL ABC contains the active ingredient tadalafil which belongs to the class of medicines called
phosphodiesterase type 5 inhibitors.
TADALAFIL ABC 10 mg is a treatment for adult men with erectile dysfunction. This
condition occurs when a man cannot achieve or maintain an erection sufficient for
sexual intercourse. TADALAFIL ABC has been shown to significantly improve the ability to obtain
an erection sufficient for sexual intercourse.
After sexual stimulation TADALAFIL ABC helps to relax the blood vessels in the penis, allowing
blood flow to the penis. The result of this is improved erectile function. TADALAFIL ABC will not
help you if you do not have erectile dysfunction.
It is important to note that TADALAFIL ABC for the treatment of erectile dysfunction 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 a medicine for erectile dysfunction.

2. What you need to know before taking TADALAFIL ABC

Do not take TADALAFIL ABC if:

• you are allergic to tadalafil or 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 (or “chest pain”). TADALAFIL ABC has been shown to increase the effect of these medicines. If you are taking any form of nitrate or have any doubts, tell your doctor.
• you have a serious heart condition or have had a heart attack recently, within the last 90 days.
• you have had a stroke recently, within the last 6 months.
• you have low blood pressure or uncontrolled high blood pressure. Page 12of 21
• you have previously experienced loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition 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 ABC, have been shown to 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 or pharmacist before taking TADALAFIL ABC.
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 (a cancer of bone marrow).
• leukemia (a cancer of blood cells).
• any deformity of the penis.
• a serious liver problem.
• a serious kidney problem.

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

• pelvic surgery
• removal of all or part of the prostate gland where the nerves of the prostate have been cut (radical prostatectomy without neurovascular bundle preservation).

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

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

Other medicines and TADALAFIL ABC
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Do not take TADALAFIL ABC if you are already taking nitrates.
Some medicines can be affected by TADALAFIL ABC or they themselves can affect the
way TADALAFIL ABC 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 medicine used to treat pulmonary hypertension).
• 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.

Page 13of 21

• phenobarbital, phenytoin and carbamazepine (anti-convulsant medicines).
• rifampicin, erythromycin, clarithromycin or itraconazole.
• other treatments for erectile dysfunction.

TADALAFIL ABC with food and alcohol
Information about the effects of alcohol is given in section 3. Grapefruit juice can affect the
way TADALAFIL ABC 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 reduction in sperm count has been observed in some men. It is unlikely that these effects will cause infertility.

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

TADALAFIL ABC contains lactose.
If you have been diagnosed with intolerance to certain sugars, contact your doctor before taking this
medicine
TADALAFIL ABC contains less than 1 mmol (23 mg) of sodium per dose, that is to say it is essentially ‘sodium-free’

3. How to take TADALAFIL ABC

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
TADALAFIL ABC tablets are for oral use and for men only.
Swallow the tablet whole with water.
The tablets can be taken independently of food intake.
The recommended dose is 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. TADALAFIL ABC
tablets are for oral use.
You can take the TADALAFIL ABC tablet at least 30 minutes before sexual activity.
TADALAFIL ABC may still be effective up to 36 hours after taking the tablet.
Do not take TADALAFIL ABC more than once a day. TADALAFIL ABC 10 mg and 20 mg is indicated for
use before planned sexual activity and is not recommended for continuous daily use.
It is important to note that TADALAFIL ABC 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 alcoholic beverages may interfere with your ability to have an erection and may
temporarily cause a decrease in your blood pressure. If you have taken or intend to
take TADALAFIL ABC, 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.

If you take more TADALAFIL ABC than you should
Contact your doctor. Undesirable effects as 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

Page 14of 21
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 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 ABC (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).

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 on the face
• nasal congestion
• digestive disorders

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

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

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

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

Rarely, in men taking TADALAFIL ABC, heart attacks and strokes have been reported. The
majority 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 effects that had not been observed during clinical trialsare
reported in men taking TADALAFIL ABC. These include:

• migraine
• swelling of the face, severe allergic reaction causing swelling of the face and throat, severe skin reactions, some disorders that alter blood circulation to the eyes, irregular heartbeat, angina and sudden cardiac death.

The side effect “dizziness” has been reported more frequently in men over 75 years of age
Page 15of 21
taking TADALAFIL ABC. “Diarrhoea” has been reported more frequently in men over
65 years of age taking TADALAFIL ABC.

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 website:
http:// 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 ABC

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.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What TADALAFIL ABC contains

• The active ingredient is tadalafil. Each tablet contains 10 mg of tadalafil.
• The other ingredients are: Tablet:lactose monohydrate (see the end of paragraph 2), sodium croscarmellose, hydroxypropylcellulose, sodium lauryl sulfate, magnesium stearate, povidone (K-25), anhydrous colloidal silica Film coating: hypromellose, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172)

Description of the appearance of TADALAFIL ABC and contents of the pack
TADALAFIL ABC 10 mg is a film-coated tablet of yellow to light yellow color with a round shape and
beveled edge, with '338' imprinted on one side and smooth on the other side.
TADALAFIL ABC 10 mg is available in blisters in packs of 4 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
ABC Farmaceutici S.p.A. – Corso Vittorio Emanuele II, 72 – 10121 Turin

Manufacturer
ABC Farmaceutici S.p.A. Canton Moretti, 29 – 10015 Loca San Bernardo – Ivrea (TO)
Page 16of 21

TADALAFIL ABC 20 mg film-coated tablets

Tadalafil

“Generic medicine”
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 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 ABC is and what it is used for
• 2. What you need to know before you take TADALAFIL ABC
• 3. How to take TADALAFIL ABC
• 4. Possible side effects
• 5. How to store TADALAFIL ABC
• 6. Contents of the pack and other information

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

TADALAFIL ABC contains the active ingredient tadalafil which belongs to the class of medicines called
phosphodiesterase type 5 inhibitors.
TADALAFIL ABC 20 mg is a treatment for adult men with erectile dysfunction. This
condition occurs when a man cannot achieve or maintain an erection sufficient for
sexual intercourse. TADALAFIL ABC has been shown to significantly improve the ability to obtain
an erection sufficient for sexual intercourse.
Following sexual stimulation TADALAFIL ABC helps to relax the blood vessels in the penis, allowing
blood flow to the penis. The result of this is improved erectile function. TADALAFIL ABC will not
be of help if you do not have erectile dysfunction.
It is important to note that TADALAFIL ABC for the treatment of erectile dysfunction 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 a medicine for erectile dysfunction.

2. What you need to know before taking TADALAFIL ABC

Do not take TADALAFIL ABC if:

• you are allergic to tadalafil or 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 for the treatment of angina pectoris (or “chest pain”). TADALAFIL ABC has been shown to increase the effect of these medicines. If you are taking any form of nitrate or have any doubts, tell your doctor.
• you have a serious heart condition or have had a heart attack recently, within the last 90 days.
• you have had a stroke recently, within the last 6 months.
• you have low blood pressure or uncontrolled high blood pressure. Page 17of 21
• you have previously experienced loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition 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 ABC, have been shown to 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 or pharmacist before taking TADALAFIL ABC.
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 (a cancerous tumor of the bone marrow).
• leukemia (a cancerous tumor of the blood cells).
• any deformity of the penis.
• a serious liver problem.
• a serious kidney problem.

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

• pelvic surgery
• removal of all or part of the prostate gland where the nerves of the prostate have been cut (radical prostatectomy without neurovascular bundle preservation).

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

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

Other medicines and TADALAFIL ABC
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Do not take TADALAFIL ABC if you are already taking nitrates.
Some medicines can be affected by TADALAFIL ABC or they themselves can affect
how TADALAFIL ABC 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 medicine used to treat pulmonary hypertension).
• 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). Page 18of 21
• rifampicin, erythromycin, clarithromycin or itraconazole.
• other treatments for erectile dysfunction.

TADALAFIL ABC with drinks and alcohol
Information about the effects of alcohol is given in section 3. Grapefruit juice can affect
how TADALAFIL ABC 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 studies have reported dizziness. Carefully check
how you react to the tablets before driving or using machines.

TADALAFIL ABC contains lactose.
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this
medicine
TADALAFIL ABC contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’

3. How to take TADALAFIL ABC

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
TADALAFIL ABC tablets are for oral use and only for men.
Swallow the tablet whole with water.
The tablets can be taken independently of food intake.
The recommended dose is one 10 mg tablet before sexual activity. However, you have been prescribed the
dose consisting 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 ABC tablet at least 30 minutes before sexual activity.
TADALAFIL ABC may still be effective up to 36 hours after taking the tablet.
Do not take TADALAFIL ABC more than once a day. TADALAFIL ABC 10 mg and 20 mg is indicated for
use before planned sexual activity and is not recommended for continuous daily use.
It is important to note that TADALAFIL ABC 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 alcoholic beverages 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 ABC, avoid excessive alcohol consumption (blood alcohol level
equal to 0.08% or higher) as this may increase the risk of dizziness when you stand up.

If you take more TADALAFIL ABC than you should
Contact your doctor. Undesirable 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 everyone will experience them.
These effects are normally mild to moderate in severity.
Page 19of 21
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 ABC (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).

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 on the face
• nasal congestion
• digestive disorders

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

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

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

• fainting
• convulsions and transient memory loss
• swelling of the eyelids, red eyes
• sudden decrease or loss of hearing
• urticaria (itchy red patches on the skin surface)
• bleeding of the penis, presence of blood in the semen and increased sweating. Rarely, in men taking TADALAFIL ABC, 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 ABC. These include:

• migraine
• swelling of the face, severe allergic reaction causing swelling of the face and throat, severe skin reactions, some disorders that alter blood circulation to the eyes, irregular heartbeat, angina and sudden cardiac death. The side effect “dizziness” has been reported more frequently in men over 75 years of age taking TADALAFIL ABC. “Diarrhea” has been reported more frequently in men over 65 years of age taking TADALAFIL ABC.

Page 20of 21
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly via the website:
http:// 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 ABC

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.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What TADALAFIL ABC contains

• The active ingredient is tadalafil. Each tablet contains 20 mg of tadalafil.
• The other ingredients are: Tablet:lactose monohydrate (see the end of paragraph 2), sodium croscarmellose, hydroxypropylcellulose, sodium lauryl sulfate, magnesium stearate, povidone (K-25), anhydrous colloidal silica Film coating: hypromellose, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172)

Description of the appearance of TADALAFIL ABC and contents of the pack
TADALAFIL ABC 20 mg is a film-coated tablet of yellow to light yellow color with a round shape and
beveled edge, with 'L339' imprinted on one side and smooth on the other side.
TADALAFIL ABC 20 mg is available in blisters in packs of 2, 4 and 8 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
ABC Farmaceutici S.p.A. – Corso Vittorio Emanuele II, 72 – 10121 Torino

Manufacturer
ABC Farmaceutici S.p.A. Canton Moretti, 29 – 10015 Loca San Bernardo – Ivrea (TO)
Page 21of 21