Tadalafil Abdi

Patient Information Leaflet: Information for the User

Tadalafil Abdi 5 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 their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact 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 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

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

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

• Erectile dysfunction. This condition occurs when a man is unable to achieve or maintain an erection sufficient for sexual intercourse. Tadalafil Abdi has been shown to significantly improve the ability to obtain an erection suitable for sexual activity. Following sexual stimulation, this medicine helps relax the blood vessels in the penis, allowing blood 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 this medicine, for the treatment of erectile dysfunction, 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 Abdi improves blood flow and relaxes the muscles of the prostate and bladder, which may reduce symptoms associated with benign prostatic hyperplasia. This medicine has been shown to improve these urinary symptoms as early as 1–2 weeks after starting treatment.

2. What you should 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. These are a group of medicines (“nitrates”) used to treat angina pectoris (“chest pain”). It has been shown that Tadalafil Abdi enhances the effect of these medicines. If you are taking any form of nitrate or have any doubts, inform your doctor.
• if you have severe heart disease or have had a heart attack recently, within the last 90 days.
• if you have recently had a stroke, within the last 6 months.
• if you have low blood pressure or uncontrolled high blood pressure.
• if you have previously experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “stroke of the eye”.
• if you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors, such as Tadalafil Abdi, 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 Abdi.
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 any heart problems, inform your doctor.
Since benign prostatic hyperplasia (enlargement of the prostate gland) and prostate cancer may have similar symptoms, your doctor will perform tests for prostate cancer before starting treatment with Tadalafil Abdi for benign prostatic hyperplasia.
This medicine does not treat prostate cancer.
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 Abdi 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 (nerve-sparing radical prostatectomy).

If you experience a sudden decrease or loss of vision, stop taking this medicine and contact your doctor immediately.
In some patients taking this medicine, 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 Abdi and contact your doctor immediately.
The use of Tadalafil Abdi in women is not indicated.
Children and adolescents
Tadalafil Abdi is not intended for use in children and adolescents under 18 years of age.
Other medicines and Tadalafil Abdi
Inform 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 may be affected by Tadalafil Abdi or may affect how Tadalafil Abdi works. Inform 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 inhibitor (used to treat benign prostatic hyperplia).
• medicines such as ketoconazole tablets (for fungal infections) and protease inhibitors for the treatment of AIDS or HIV infection.
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines used to treat epileptic seizures).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Tadalafil Abdi with drinks and alcohol
Information on the effects of alcohol is provided in section 3. Grapefruit juice may affect how this medicine works and should be consumed with caution. For further information, consult your doctor.
Fertility
In treated dogs, reduced sperm development in the testes has been observed. In some men, a reduction in sperm count has been observed. These effects are unlikely to cause infertility.
Driving and using machines
Some men taking Tadalafil Abdi in clinical studies reported dizziness. Carefully assess how you react to the tablets before driving or operating machinery.
Tadalafil Abdi contains lactose
If you have an intolerance to certain sugars, consult 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 exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Tadalafil Abdi tablets are for oral use and for men only. 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 are planning to take Tadalafil Abdi, avoid excessive consumption of alcoholic beverages (blood alcohol level of 0.08% or higher), as this may increase the risk of dizziness when standing up.

For the treatment of erectile dysfunction
The recommended dose is 5 mg taken once daily at approximately the same time each day. Your doctor may adjust the dose to 2.5 mg based on your response to Tadalafil Abdi. This dose will be provided as a 2.5 mg tablet.
Do not take Tadalafil Abdi more than once a day.
When taken once daily, Tadalafil Abdi allows you to achieve an erection, if sexual stimulation is present, at any time during the 24-hour period.
Daily administration of Tadalafil Abdi may benefit men who anticipate having sexual activity two or more times per week.
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.
Drinking alcohol may interfere with your ability to achieve an erection.

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

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

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 how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. These side effects are generally mild or moderate in nature.
If you experience any of the following side effects, stop using the medicine and
seek immediate medical assistance:

• 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 Abdi (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, and digestive disturbances.

Uncommon: may affect up to 1 in 100 people

• dizziness, stomach ache, feeling unwell, malaise (vomiting), reflux, blurred vision, eye discomfort, breathing difficulties, blood in urine, prolonged erection, palpitations, rapid 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, eyelid swelling, red eyes, sudden decrease or loss of hearing, urticaria (red, itchy patches on the skin), bleeding from the penis, blood in semen, and increased sweating.
• Heart attack and stroke. Most of these individuals already had heart problems before taking the medicine.
• Partial, temporary or permanent decrease or loss of vision in one or both eyes.

Some additional rare side effects not observed during clinical studies 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 affecting 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.
Diarrhoea has been reported more frequently in men over 65 years of age taking this medicine.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor. You can also report side effects directly via 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 stated on the carton 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 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 Abdi contains:

• The active substance is tadalafil. Each tablet contains 5 mg of tadalafil.
• The other components are:
  Tablet core: sodium lauryl sulfate (E487), monohydrate lactose, 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, iron oxide yellow (E172), triacetin (E1518).

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

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Abdi Farma GmbH
Donnersbergstraße 4
64646 Heppenheim
Germany

Manufacturers:
Interpharma Services Ltd.
43A Cherni Vrach Bvld. Sofia 1407
Bulgaria
Flavine Pharma France
3 Voie d’Allermagne, Vitrolles,
13127 France

Package leaflet: Information for the user

Tadalafil Abdi 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 their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact 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 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

---

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

Tadalafil Abdi contains the active substance tadalafil, which belongs to a class of medicines known as phosphodiesterase type 5 (PDE5) inhibitors.
Tadalafil Abdi is a treatment for adult men with erectile dysfunction. This condition occurs when a man is unable to achieve or maintain an erection sufficient for sexual intercourse. Tadalafil Abdi has been shown to significantly improve the ability to obtain an erection suitable for sexual activity.
Following sexual stimulation, TADALAFIL ABDI helps relax the blood vessels in the penis, allowing increased blood 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, when used to treat erectile dysfunction, 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 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. These are a group of medicines (“nitrates”) used to treat angina pectoris (“chest pain”). Tadalafil Abdi has been shown to enhance the effect of these medicines. If you are taking any form of nitrate or have any doubts, inform your doctor.
• if you have a severe heart disease or have had a heart attack in the last 90 days.
• if you have recently had a stroke, within the last 6 months.
• if you have low blood pressure or uncontrolled high blood pressure.
• if you have previously experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “stroke of the eye”.
• if you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors such as Tadalafil Abdi 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 Abdi.
Be aware that sexual activity carries 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.
• severe liver problems.
• severe kidney problems.

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 with damage to the nerves of the prostate (radical prostatectomy without nerve-sparing).

If you experience a sudden decrease or loss of vision, stop taking this medicine and contact your doctor immediately.
In some patients taking this medicine, 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 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 in children and adolescents under 18 years of age.

Other medicines and Tadalafil Abdi

Inform 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 may interact with Tadalafil Abdi, or Tadalafil Abdi may affect how other medicines work. 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 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 inhibitor (used to treat benign prostatic hyperplasia).
• medicines such as ketoconazole tablets (used to treat fungal infections) and protease inhibitors for the treatment of AIDS or HIV infection.
• phenobarbital, phenytoin, or carbamazepine (anticonvulsant medicines used to treat epileptic seizures).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Tadalafil Abdi with beverages and alcohol

Information on the effects of alcohol is provided in section 3. Grapefruit juice may affect how this medicine works and should be consumed with caution. For further information, consult your doctor.

Fertility

In treated dogs, 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 use of machines

Some men taking Tadalafil Abdi in clinical studies reported dizziness. Carefully assess how you react to the tablets before driving or operating machinery.

Tadalafil Abdi contains lactose

If you have an intolerance to certain sugars, consult 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 exactly as your doctor has instructed. If you are unsure, consult your doctor or pharmacist.

Tadalafil Abdi tablets are for oral use and for men only. Swallow the tablet whole with water. These tablets can be taken with or without food.
Consumption of alcoholic beverages may temporarily lower your blood pressure and impair your ability to achieve an erection. If you have taken or plan 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 standing up.

Recommended starting dose

The recommended starting dose is one 10 mg tablet taken before sexual activity. If the effect of this dose is too weak, your doctor may increase the dose to 20 mg.
You may take a Tadalafil Abdi tablet at least 30 minutes before sexual activity. This medicine may remain effective for 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 anticipated sexual activity and is not recommended for daily continuous 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. You may experience the side effects listed in section 4.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

---

4. Possible side effects

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

Stop using the medicine and seek immediate medical help if you experience any of the following:

• 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 Abdi (rare frequency). If you have an erection lasting more than 4 hours, contact a doctor immediately.
• sudden loss of vision (rare frequency).

Other side effects reported include:

Common: may affect up to 1 in 10 people

• headache, back pain, muscle pain, pain in arms and legs, facial flushing, nasal congestion, and digestive disturbances.

Uncommon: may affect up to 1 in 100 people

• dizziness, stomach discomfort, feeling unwell, nausea, acid reflux, blurred vision, eye discomfort, breathing difficulties, blood in urine, prolonged erection, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, tinnitus, swelling of hands, feet or ankles, and 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 (itchy red patches on the skin), penile bleeding, blood in semen, and increased sweating.
• Rarely, heart attacks and strokes have been reported in men taking TADALAFIL ABDI. Most of these individuals already had heart problems before using the medicine.
• Partial, temporary or permanent decrease or loss of vision in one or both eyes.

Additional rare side effects not 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, certain disorders affecting 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.
Diarrhoea has been reported more frequently in men over 65 years of age taking this medicine.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, contact your doctor. You may also report side effects directly via the national reporting system at: 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 Abdi

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after “Exp”. The expiry date refers to the last day of the 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 no longer used. This will help protect the environment.

---

6. Contents of the pack and other information

What Tadalafil Abdi contains:

• The active substance is tadalafil. Each tablet contains 10 mg of tadalafil.
• Other components are:
  Tablet core: sodium lauryl sulfate (E487), monohydrate lactose, hydroxypropyl cellulose (EF) (E463), sodium croscarmellose (E468), microcrystalline cellulose (type 102) (E460), magnesium stearate (E572), purified water.
  Film coating: hypromellose (HPMC) 5 cP (E464), titanium dioxide, talc, yellow iron oxide (E172), triacetin (E1518).

Description of the appearance of Tadalafil Abdi and pack sizes

The 10 mg tablets are yellow, film-coated, almond-shaped, biconvex tablets approximately 10.1 mm long, with “10” engraved on one side.
Pack sizes:
Tadalafil Abdi 10 mg is available in blister packs containing 4 or 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

Package leaflet: Information for the user

Tadalafil Abdi 20 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, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact 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 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

---

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

Tadalafil Abdi contains the active substance tadalafil, which belongs to a class of medicines called phosphodiesterase type 5 (PDE5) inhibitors.

Tadalafil Abdi is a treatment for adult men with erectile dysfunction. This condition occurs when a man is unable to achieve or maintain an erection sufficient for sexual intercourse. Tadalafil Abdi has been shown to significantly improve the ability to obtain an erection suitable for sexual activity.

Following sexual stimulation, this medicine helps relax blood vessels in the penis, allowing increased blood 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 a medicine for erectile dysfunction.

---

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. These are 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 nitrates or have any doubts, inform your doctor.
• if you have a severe heart condition or have recently had a heart attack (within the last 90 days).
• if you have recently had a stroke (within the last 6 months).
• if you have low blood pressure or uncontrolled high blood pressure.
• if you have previously experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition sometimes described as "stroke of the eye".
• if you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs due to blood clots). PDE5 inhibitors such as Tadalafil Abdi have been shown to enhance the hypotensive effect of riociguat. If you are taking riociguat or have any doubts, inform 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 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.
• severe liver problems.
• severe kidney problems.

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 with nerve-sparing techniques not preserved (radical prostatectomy without nerve bundle preservation).

If you experience sudden decrease or loss of vision, stop taking this medicine and contact your doctor immediately.

In some patients taking this medicine, 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 hearing loss or decrease, 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 intended for use in children and adolescents under 18 years of age.

Other medicines and Tadalafil Abdi

Inform 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 may interact with Tadalafil Abdi or affect how it 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 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 inhibitor (used to treat benign prostatic hyperplasia).
• medicines such as ketoconazole tablets (used to treat fungal infections) and protease inhibitors for the treatment of AIDS or HIV infection.
• phenobarbital, phenytoin, or carbamazepine (anticonvulsant medicines used to treat epileptic seizures).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Tadalafil Abdi with beverages and alcohol

Information on the effects of alcohol is provided in section 3. Grapefruit juice may affect how this medicine works and should be consumed with caution. For further information, consult your doctor.

Fertility

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

Driving and use of machines

Some men taking Tadalafil Abdi in clinical studies reported dizziness. Carefully assess how you react to the tablets before driving or operating machinery.

Tadalafil Abdi contains lactose

If you have an intolerance to certain sugars, consult 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 exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist.

Tadalafil Abdi tablets are for oral use and for men only. Swallow the tablet whole with water. These tablets can be taken with or without food.

Consumption of alcoholic beverages may temporarily lower your blood pressure and impair your ability to achieve an erection. If you have taken or plan to take Tadalafil Abdi, avoid excessive alcohol consumption (blood alcohol level equal to or above 0.08%) as this may increase the risk of dizziness when standing up.

Recommended starting dose: One 10 mg tablet taken before sexual activity. However, you have been prescribed a 20 mg dose because your doctor has determined that the recommended 10 mg dose is too low for you.

You may take a Tadalafil Abdi tablet at least 30 minutes before sexual activity. This medicine may remain effective for 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 prior to anticipated sexual activity and is not recommended for daily continuous 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. You may experience side effects described in section 4.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

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4. Possible side effects

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

Stop taking the medicine and seek immediate medical help if you experience any of the following:

• 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 Abdi (rare frequency). If you have an erection lasting more than 4 hours, contact a doctor immediately.
• sudden vision loss (rare frequency).

Other side effects reported:

Common: may affect up to 1 in 10 people

• headache, back pain, muscle pain, arm and leg pain, facial flushing, nasal congestion, and digestive disturbances.

Uncommon: may affect up to 1 in 100 people

• dizziness, stomach discomfort, feeling unwell, nausea, acid reflux, blurred vision, eye discomfort, breathing difficulties, blood in urine, prolonged erection, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, tinnitus, swelling of hands, feet or ankles, and 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 (itchy red patches on the skin), bleeding from the penis, blood in semen, and increased sweating.
• Heart attack and stroke. Most of these individuals already had pre-existing heart conditions before using the medicine.
• Partial, temporary or permanent decrease or loss of vision in one or both eyes.

Additional rare side effects not observed during clinical trials have been reported in men taking Tadalafil Abdi. These include:

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

The side effect of 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 side effects

If you experience any side effects, including those not listed in this leaflet, contact your doctor. You may also report side effects directly via the national reporting system at:
www.aifa.gov.it/content/segnalazioni-reazioni-avverse

Reporting side effects helps provide more information on the safety of this medicine.

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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 stated on the carton and blister pack after "Exp". The expiry date refers to the last day of that month.

This medicine requires no special storage conditions.

Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

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6. Contents of the pack and other information

What Tadalafil Abdi contains:

• The active substance is tadalafil. Each tablet contains 20 mg of tadalafil.
• Other components 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.
  Coating: hypromellose (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 yellowish-brown, film-coated, almond-shaped, biconvex tablets approximately 12.3 mm long, with "20" engraved on one side.

Pack sizes:
Tadalafil Abdi 20 mg is available in blister packs containing 4, 8, 12, 24, 48, or 56 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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