TADALAFIL 5 mg Tabletki Powlekane

Treść ulotki

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

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

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

Tadalafil Abdi contains the active ingredient tadalafil, which belongs to the class of medicines
called phosphodiesterase type 5 inhibitors.
Tadalafil Abdi is used for the treatment of adult men with:

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

2. What you need to know before taking Tadalafil Abdi

Do not take Tadalafil Abdi:

• if you are allergic to tadalafil or to any of the other ingredients of this medicine (listed in section 6).
• if you are taking any form of organic nitrate or nitric oxide donors, such as amyl nitrite. This is a group of medicines (“nitrates”) used to treat angina pectoris (“chest pain”). Tadalafil Abdi 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.
• if you have a serious heart condition or have had a heart attack recently, within the last 90 days.
• if you have had a stroke recently, within the last 6 months.
• if you have low blood pressure or uncontrolled high blood pressure.
• if you have previously experienced a loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “eye stroke”.
• if you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors, such as Tadalafil Abdi, 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 before taking Tadalafil Abdi.
Be aware that sexual activity involves a potential risk for patients with heart disease, as it puts extra strain on the heart. If you have a heart problem, report it to your doctor.
Since benign prostatic hyperplasia (enlarged prostate gland) and prostate cancer can have the same symptoms, your doctor will perform checks for prostate cancer before starting treatment with Tadalafil Abdi for benign prostatic hyperplasia.
This medicine 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 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 Abdi 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 nerve-sparing).

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

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

Other medicines and Tadalafil Abdi
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Do not take Tadalafil Abdi if you are already taking nitrates.
Some medicines can be affected by Tadalafil Abdi or they themselves can affect how Tadalafil Abdi 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 used to treat high blood pressure.
• riociguat (a medicine used to treat pulmonary hypertension). See also "Do not take Tadalafil Abdi".
• 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 to treat epilepsy).
• rifampicin, erythromycin, clarithromycin or itraconazole.
• other treatments for erectile dysfunction.

Tadalafil Abdi with drinks and alcohol
Information on the effects of alcohol is given in section 3. Grapefruit juice can affect how this medicine works and should be taken with caution. Ask your doctor for more information.

Fertility
In dogs treated with the drug, 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 Abdi during clinical studies reported dizziness.
Carefully check how you react to the tablets before driving vehicles or using machines.

Tadalafil Abdi contains lactose
If you have an intolerance to some sugars, contact your doctor before taking this medicine.

Tadalafil Abdi contains sodium
Tadalafil Abdi contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially ‘sodium-free’.

3. How to take Tadalafil Abdi

Take this medicine following exactly the instructions of your doctor. If you have doubts
consult your doctor or pharmacist.
Tadalafil Abdi tablets are for oral use and only for men. Swallow the
tablet whole with water. These tablets can be taken with or without food.
Drinking alcohol may temporarily cause a reduction in your
blood pressure. If you have taken or intend to take Tadalafil Abdi, 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 doseis 5 mg 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 Abdi.
This dose will be given to you with a 2.5 mg tablet.
Do not take Tadalafil Abdi more than once a day.
When taken once a day, Tadalafil Abdi allows you to achieve an erection, if there is
sexual stimulation, at any time of the day within 24 hours.
Daily administration of Tadalafil Abdi may be useful for men who
expect to have sexual activity two or more times a week.
It is important to note that Tadalafil Abdi does not have an effect in the absence of sexual stimulation. You and
your partner will need to engage in foreplay, as you would if you were not taking a
medicine for erectile dysfunction.
Drinking alcohol may interfere with your ability to achieve an erection.

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

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

If you forget to take Tadalafil Abdi
Take your dose as soon as you remember. Do not take a double dose to make up for the
missed tablet. Do not take this medicine more than once a day.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
These effects are generally mild or moderate in nature.

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

• allergic reactions, including skin rashes (uncommon frequency).
• chest pain - do not use nitrates but seek immediate medical attention (uncommon frequency).
• priapism, a prolonged and possibly painful erection after taking Tadalafil Abdi (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: may affect up to 1 in 10 people

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

Uncommon:may affect up to 1 in 100 people

• dizziness, stomach discomfort, feeling unwell, nausea (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, swelling of the

hands, feet or ankles and feeling tired.

Rare: may affect up to 1 in 1,000 people

• fainting, seizures and transient memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing, hives (itchy red patches on the skin surface), bleeding of the penis, presence of blood in the semen and increased sweating.
• Heart attack and stroke. Most of these subjects had pre-existing heart problems before using the medicine.
• Partial, temporary or permanent decrease or loss of vision in one or both eyes.

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

• migraine, facial swelling, 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 (heart attack).

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

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

5. How to store Tadalafil Abdi

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 the month.
This medicine does not require any particular storage precautions.
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 Abdi contains:

• The active ingredient is tadalafil. Each tablet contains 5 mg of tadalafil.
• The other ingredients are: Tablet core: sodium lauryl sulfate (E487), lactose monohydrate, hydroxypropyl cellulose (EF) (E463), sodium croscarmellose (E468), microcrystalline cellulose (type 102) (E460), magnesium stearate (E572), purified water Film coating: hydroxypropyl methylcellulose (HPMC) 5 cP (E464), titanium dioxide, talc, yellow iron oxide (E172), triacetin (E1518).

Description of the appearance of Tadalafil Abdi and contents of the pack
The 5 mg tablets are film-coated tablets, pale yellow in color, approximately 7.6
mm long, almond-shaped, biconvex, with "5" imprinted on one side.
Pack sizes;
Tadalafil Abdi 5 mg is available in blister packs containing 14, 28, 56, 84 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Abdi Farma GmbH
Donnersbergstraße 4
64646 Heppenheim
Germany
Manufacturer:
Interpharma Services Ltd.
43A Cherni Vrach Bvld. Sofia 1407
Bulgaria
Flavine Pharma France
3 Voie d’Allermagne, Vitrolles,
13127 France

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

Tadalafil Abdi contains the active ingredient tadalafil, which belongs to the class of medicines
called phosphodiesterase type 5 inhibitors.
Tadalafil Abdi 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 Abdi has been shown to significantly improve the ability to
achieve an erection sufficient for sexual intercourse.
After sexual stimulation TADALAFIL ABDI helps to relax the blood vessels in the penis,
allowing blood to flow into the penis. The result is improved erectile function.
Tadalafil Abdi will not help you if you do not have erectile dysfunction. It is important to note that
TADALAFIL ABDI, 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 medicine for erectile dysfunction.

• 2. What you need to know before you take Tadalafil Abdi

Do not take Tadalafil Abdi:

• if you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).
• if you are taking any form of organic nitrate or nitric oxide donors, such as amyl nitrite. This is a group of medicines (“nitrates”) used to treat angina pectoris (“chest pain”). Tadalafil Abdi has been shown to increase the effect of these medicines. If you are taking any form of nitrate or are unsure, tell your doctor.
• if you have a severe heart condition or have recently had a heart attack, in the last 90 days.
• if you have recently had a stroke, in the last 6 months.
• if you have low blood pressure or uncontrolled high blood pressure.
• if you have previously experienced loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “eye stroke”.
• if you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors, such as Tadalafil Abdi, have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or are unsure, tell your doctor.

Warnings and precautions
Talk to your doctor before taking Tadalafil Abdi.
Be aware that sexual activity carries 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 severe liver problem.
• a severe kidney problem.

It is not known whether Tadalafil Abdi is effective in patients who have had:

• pelvic surgery.
• removal of all or part of the prostate gland where the nerves of the prostate have been cut (radical prostatectomy without nerve-sparing).

If you experience a sudden decrease or loss of vision, stop taking this
medicine and contact your doctor immediately.
Decreased or sudden loss of hearing has been observed in some patients taking this medicine. Although it is not known whether this event is directly related to tadalafil, if you experience a sudden decrease or loss of hearing, stop taking Tadalafil Abdi and contact your doctor immediately.
The use of Tadalafil Abdi is not indicated in women.

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

Other medicines and Tadalafil Abdi
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Do not take Tadalafil Abdi if you are already taking nitrates.
Some medicines can be affected by Tadalafil Abdi or can affect how Tadalafil Abdi 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 used to treat high blood pressure.
• riociguat (a medicine used to treat pulmonary hypertension). See also "Do not take Tadalafil Abdi".
• 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.

Tadalafil Abdi with drinks and alcohol
Information about the effects of alcohol is given in section 3. Grapefruit juice can
affect the way this medicine works and should be taken with caution. Ask your
doctor for more information.

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

Driving and using machines
Some men taking Tadalafil Abdi in clinical studies have reported dizziness.
Check carefully how you react to the tablets before driving or using
machines.

Tadalafil Abdi contains lactose
If you have an intolerance to certain sugars, contact your doctor before taking this medicine.

Tadalafil Abdi contains sodium
Tadalafil Abdi contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially
‘sodium-free’.

• 3. How to take Tadalafil AbdiTake this medicine exactly as your doctor has told you. If you are unsure, ask your doctor or pharmacist.

The tablets of Tadalafil Abdi are for oral use and only for men. Swallow the
tablet whole with water. These tablets can be taken with or without food.
Drinking alcohol may temporarily cause a decrease in your blood pressure and impair your ability to get an erection. If you have taken or intend to take Tadalafil Abdi, 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 starting doseis one 10 mg tablet before sexual activity. If
the effect of this dose is too weak, your doctor may increase the dose to 20 mg.
You can take one tablet of Tadalafil Abdi at least 30 minutes before sexual activity.
This medicine may still be effective up to 36 hours after you have taken the tablet.
Do not take Tadalafil Abdi more than once a day. Tadalafil Abdi 10 mg and 20 mg should
be used before planned sexual activity and is not recommended for continuous daily
use.
It is important to note that Tadalafil Abdi 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.

If you take more Tadalafil Abdi than you should
Contact your doctor. Side effects described in section 4 may occur.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

• 4. Possible side effectsLike all medicines, this medicine can cause side effects, although not everybody gets them. These effects are generally mild or moderate.

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 Abdi (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 are:

Common: may affect up to 1 in 10 people

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

Uncommon:may affect up to 1 in 100 people

• dizziness, stomach upset, feeling unwell, nausea, acid reflux, blurred vision, eye pain, difficulty breathing, blood in 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: may affect up to 1 in 1,000
• fainting, seizures and temporary memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing, hives (itchy red patches on the skin), bleeding of the penis, blood in semen and increased sweating.
• Rarely, heart attacks and strokes have been reported in men taking TADALAFIL ABDI. Most of these subjects had heart problems already before using the medicine.
• Partial, temporary or permanent decrease or loss of vision in one or both eyes.

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

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

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

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, please
consult your doctor. You can also report adverse reactions directly through the national
reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting adverse reactions can help provide more information on the
safety of this medicine.

• 5. How to store Tadalafil AbdiKeep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the pack and blister
after "Exp". The expiry date refers to the last day of the month.
This medicine does not require any special 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. Package contents and other informationWhat Tadalafil Abdi contains:
• The active ingredient is tadalafil. Each tablet contains 10 mg of tadalafil.
• The other ingredients are: Tablet core: sodium lauryl sulfate (E487), lactose monohydrate, hydroxypropyl cellulose (EF) (E463), sodium croscarmellose (E468), microcrystalline cellulose (type 102) (E460), magnesium stearate (E572), purified water Film coating: hydroxypropyl methylcellulose (HPMC) 5 cP (E464), titanium dioxide, talc, yellow iron oxide (E172), triacetin (E1518).

Description of the appearance of Tadalafil Abdi and contents of the pack
The 10 mg tablets are film-coated tablets, yellow in colour, approximately 10.1
mm long, almond-shaped, biconvex, with "10" imprinted on one side.
Pack sizes;
Tadalafil Abdi 10 mg is available in blister packs containing 4 and 12 tablets.

Marketing authorisation holder and manufacturer
Marketing authorisation holder:
Abdi Farma GmbH
Donnersbergstraße 4
64646 Heppenheim
Germany
Manufacturer:
Interpharma Services Ltd.
43A Cherni Vrach Bvld. Sofia 1407
Bulgaria
Flavine Pharma France
3 Voie d’Allermagne, Vitrolles,
13127 France

Tadalafil Abdi 20 film-coated tablets.

Tadalafil

Generic medicine

Read all of 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 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 is Tadalafil Abdi and what it is used for
• 2. What you need to know before you take Tadalafil Abdi
• 3. How to take Tadalafil Abdi
• 4. Possible side effects 5 How to store Tadalafil Abdi
• 6. Contents of the pack and other information
• 1. What is Tadalafil Abdi and what it is used forTadalafil Abdi contains the active ingredient tadalafil, which belongs to the class of medicines called phosphodiesterase type 5 inhibitors.

Tadalafil Abdi is a treatment for adult men with erectile dysfunction. This condition
occurs when a man cannot achieve or maintain an erection sufficient for satisfactory
sexual intercourse. Tadalafil Abdi has been shown to significantly improve the ability to
achieve an erection sufficient for satisfactory sexual intercourse.
After sexual stimulation, this medicine helps to relax the blood vessels in the penis,
allowing blood to flow into the penis. The result is improved erectile function.
Tadalafil Abdi will not help you if you do not have erectile dysfunction. It is important to note that
TADALAFIL ABDI, for the treatment of erectile dysfunction, has no effect 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.

• 2. What you need to know before you take Tadalafil AbdiDo not take Tadalafil Abdi:
• if you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).
• if you are taking any form of organic nitrate or nitric oxide donors, such as amyl nitrite. This is a group of medicines (“nitrates”) used to treat angina pectoris (“chest pain”). Tadalafil Abdi 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.
• if you have severe heart disease or have had a heart attack recently, within the last 90 days.
• if you have had a stroke recently, within the last 6 months.
• if you have low blood pressure or uncontrolled high blood pressure.
• if you have previously experienced loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “eye stroke”.
• if you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors, such as Tadalafil Abdi, 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 before taking Tadalafil Abdi.
You should be aware that sexual activity carries a potential risk for patients with
heart disease, as 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 bone marrow disease).
• leukemia (a cancerous disease of the blood cells).
• any deformity of the penis.
• a severe liver problem.
• a severe kidney problem. It is not known whether Tadalafil Abdi is effective in patients who have been subjected to:
• pelvic surgery.
• removal of all or part of the prostate gland where the nerves of the prostate have been cut (radical prostatectomy without nerve-sparing).

If you experience a sudden decrease or loss of vision, stop taking this
medicine and contact your doctor immediately.
Decreased or sudden loss of hearing has been observed in some patients taking this
medicine. Although it is not known whether this event is directly related to tadalafil, in
the event of a sudden decrease or loss of hearing, stop taking
Tadalafil Abdi and contact your doctor immediately.
The use of Tadalafil Abdi in women is not indicated.

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

Other medicines and Tadalafil Abdi
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Do not take Tadalafil Abdi if you are already taking nitrates.
Some medicines can be affected by Tadalafil Abdi or can themselves
affect how Tadalafil Abdi 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 used to treat high blood pressure.
• riociguat (a medicine used to treat pulmonary hypertension). See also "Do not take Tadalafil Abdi".
• 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 to treat epilepsy).
• rifampicin, erythromycin, clarithromycin or itraconazole.
• other treatments for erectile dysfunction.

Tadalafil Abdi with drinks and alcohol
Information on the effects of alcohol is given in section 3. Grapefruit juice can
affect how this medicine works and should be taken with caution. Ask your
doctor for more information.

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

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

Tadalafil Abdi contains lactose
If you have an intolerance to certain sugars, contact your doctor before taking this medicine.

Tadalafil Abdi contains sodium
Tadalafil Abdi contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially
‘sodium-free’.

• 3. How to take Tadalafil AbdiTake this medicine exactly as your doctor has told you. If you have any doubts, ask your doctor or pharmacist.

Tadalafil Abdi tablets are for oral use and only for men. Swallow the
tablet whole with water. These tablets can be taken with or without food.
Drinking alcohol may temporarily cause a decrease in
your blood pressure and impair your ability to achieve an erection. If you have taken or
intend to take Tadalafil Abdi, 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 starting doseis one 10 mg tablet before sexual activity. However,
you have been given a 20 mg tablet dose because your doctor has decided that the recommended dose of 10 mg is too low.
You can take one Tadalafil Abdi tablet at least 30 minutes before sexual activity.
This medicine may still be effective up to 36 hours after taking the tablet.
Do not take Tadalafil Abdi more than once a day. Tadalafil Abdi 10 mg and 20 mg should
be used before planned sexual activity and is not recommended for continuous daily
use.
It is important to note that Tadalafil Abdi 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.

If you take more Tadalafil Abdi than you should
Contact your doctor. Side effects described in section 4 may occur.
If you have any questions about using this medicine, ask your doctor or pharmacist.

• 4. Possible side effectsLike all medicines, this medicine can cause side effects, although not everyone gets them. These effects are generally mild or moderate.

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 Abdi (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 are:

Common: may affect up to 1 in 10 people

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

Uncommon:may affect up to 1 in 100 people

• dizziness, stomach upset, feeling unwell, nausea, heartburn, blurred vision, eye pain, difficulty breathing, 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: may affect up to 1 in 1,000 people

• fainting, seizures and transient memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of vision in one or both eyes.

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

• migraine, facial swelling, 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 (heart attack).

Dizziness as a side effect has been reported more frequently in men over
75 years of age taking this medicine.
Diarrhea has been reported more frequently in men over 65 years of age
taking this medicine.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor. You can also report side effects directly through the national reporting system
at 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 AbdiKeep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister
pack after "Exp". The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not throw away any 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. Contents of the pack and other information

What Tadalafil Abdi contains:

• The active ingredient is tadalafil. Each tablet contains 20 mg of tadalafil.
• The other ingredients are: Tablet core: sodium lauryl sulfate (E487), lactose monohydrate, hydroxypropyl cellulose (EF) (E463), sodium croscarmellose (E468), microcrystalline cellulose (type 102) (E460), magnesium stearate (E572), purified water Film coating: hydroxypropyl methylcellulose (HPMC) 5 cP (E464), titanium dioxide, talc, yellow iron oxide (E172), triacetin (E1518).

Description of the appearance of Tadalafil Abdi and contents of the pack
The 20 mg tablets are film-coated tablets, dark yellow in colour, approximately
12.3 mm long, almond-shaped, biconvex, with "20" imprinted on one side.
Pack sizes;
Tadalafil Abdi 20 mg is available in blister packs containing 4, 8, 12, 24, 48, 56
tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Abdi Farma GmbH
Donnersbergstraße 4
64646 Heppenheim
Germany
Manufacturer:
Interpharma Services Ltd.
43A Cherni Vrach Bvld. Sofia 1407
Bulgaria
Flavine Pharma France
3 Voie d’Allermagne, Vitrolles,
13127 France