Tadap

Package leaflet: Information for the user

TADAP 5 mg film-coated tablets

Tadalafil
Generic medicine
Please 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Tadap is and what it is used for

Tadap contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.
Tadap 5 mg is a treatment for men with:

• Erectile dysfunction. This condition occurs when a man is unable to achieve or maintain an erection sufficient for sexual intercourse. Tadap has been shown to significantly improve the ability to obtain an erection sufficient for sexual intercourse. Following sexual stimulation, Tadap helps relax the blood vessels in the penis, allowing blood to flow into the penis. The result is improved erectile function. Tadap will not help you if you do not have erectile dysfunction. It is important to note that Tadap 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 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. Tadap improves blood flow and muscle function in the prostate and bladder, which may reduce symptoms associated with benign prostatic hyperplasia. Tadap has been shown to improve these urinary symptoms within 1-2 weeks after starting treatment.

2. What you need to know before taking Tadap

Do not take Tadap if:

• you are allergic to tadalafil or to any of the other ingredients of this medicine (listed in section 6).
• you are taking any form of organic nitrate or nitric oxide donors, such as amyl nitrite. This is a group of medicines ("nitrates") used to treat angina pectoris (or "chest pain"). Tadap has been shown to increase the effect of these medicines. If you are taking any form of nitrate or have any doubts, inform your doctor.
• you have a severe heart disease or have had a heart attack recently, 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 vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as "stroke of the eye".
• you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors, such as Tadap, have been shown to enhance 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 Tadap.
Be aware that sexual activity involves a potential risk for patients with heart disease, as it places additional strain on the heart. If you have a heart condition, inform your doctor.
Since benign prostatic hyperplasia and prostate cancer may have similar symptoms, your doctor will perform tests for prostate cancer before starting treatment with Tadap for benign prostatic hyperplasia. Tadap does not treat prostate cancer.
Before taking the tablets, inform your doctor if you have:

• sickle cell anemia (an abnormality of red blood cells);

• multiple myeloma (a 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 Tadap is effective in patients who have undergone:

• pelvic surgery;

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

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

Tadap is not intended for use by women.
Children and adolescents
Tadap is not intended for use in children and adolescents under 18 years of age.
Other medicines and Tadap
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Do not take Tadap if you are already taking nitrates.
Some medicines may be affected by Tadap, or may affect how Tadap works.
Inform your doctor or pharmacist if you are taking:

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

Tadap with food, beverages, and alcohol
Information on the effects of alcohol is provided in section 3.
Grapefruit juice may affect how Tadap works and should be consumed with caution. Consult your doctor for further information.
Fertility
In dogs treated with tadalafil, reduced sperm development in the testes has been observed. In some men, reduced sperm count has been observed. These effects are unlikely to cause infertility.
Driving and using machines
Some men taking Tadap in clinical studies reported dizziness. Carefully assess how you react to the tablets before driving or operating machinery.
Tadap contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Tadap

Take this medicine exactly as your doctor has told you. If you are in doubt, consult your doctor or pharmacist.
Tadap tablets are for oral use and for men only. Swallow the tablet whole with water. The tablets can be taken with or without food.
Drinking alcohol may temporarily lower your blood pressure. If you have taken or are planning to take Tadap, 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 one 5 mg tablet taken once daily at approximately the same time each day. Your doctor may adjust the dose to 2.5 mg depending on your response to Tadap. This lower dose will be given as a 2.5 mg tablet.
Do not take Tadap more than once a day.
When taken once daily, Tadap allows you to achieve an erection, provided there is sexual stimulation, at any time during the 24-hour period following administration. Daily administration of Tadap may be beneficial for men who anticipate having sexual activity two or more times per week.
It is important to note that Tadap will not work without sexual stimulation. You and your partner will need to engage in foreplay as you normally would if you were not taking a medicine for erectile dysfunction.
Drinking alcohol may interfere with your ability to get an erection.

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

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

If you forget to take Tadap
Take your missed dose as soon as you remember, but do not take a double dose to make up for the forgotten tablet. Do not take Tadap more than once a day.

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

4. Possible side effects

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

• allergic reactions, including skin rash (uncommon frequency).
• chest pain – do not use nitrates but seek immediate medical help (uncommon frequency).
• prolonged and possibly painful erection after taking Tadap (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), acid reflux, blurred vision, eye discomfort, breathing difficulties, blood in the urine, 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, 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 the semen, and increased sweating.

Rarely, in men taking Tadap, heart attacks and strokes have been reported. Most of these individuals already had heart problems before taking the medicine.
Rarely, cases of partial, temporary or permanent reduction or loss of vision in one or both eyes have also been reported.
Some additional rare side effects not observed during clinical studies have been reported in men taking Tadap.
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.

The side effect dizziness has been reported more frequently in men over 75 years of age taking Tadap.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at 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 Tadap

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./EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Tadap contains
The active substance is tadalafil. Each tablet contains 5 mg of tadalafil.
The other components are:
Tablet core: Monohydrate lactose, pregelatinized starch, colloidal anhydrous silica, sodium croscarmellose,
sodium lauryl sulfate, magnesium stearate.
Film coating: hypromellose, monohydrate lactose, titanium dioxide (E171), triacetin, talc (E553b), yellow iron oxide (E172), red iron oxide (E172).
Description of the appearance of Tadap and packaging contents
Tadap 5 mg is a yellowish film-coated oval tablet, marked with "5" on one side and smooth on the other.
The tablet has dimensions of 10 mm x 6.0 mm and a thickness of 3.3 - 3.9 mm.
Tadap 5 mg is available in blisters containing 14 or 28 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
00071 Pomezia (Rome) - Italy
Manufacturer
Balkanpharma Dupnitsa AD
3 Samokovsko Shosse Str.,
Dupnitsa 2600 – Bulgaria
Actavis Ltd.
BLB016, Bulebel Industrial Estate,
Zejtun ZTN 3000, Malta
This medicinal product is authorized in EEA Member States under the following names:
Sweden TADAP 5 mg film coated tablet
This leaflet was last revised on:

Patient Information Leaflet: Information for the User

TADAP 10 mg film-coated tablets

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

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

Contents of this leaflet:

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

1. What Tadap is and what it is used for

Tadap 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.
Tadap has been shown to significantly improve the ability to obtain an erection suitable for
sexual intercourse.
Tadap contains the active substance tadalafil, which belongs to a class of medicines called
phosphodiesterase type 5 inhibitors. Following sexual stimulation, Tadap helps relax the blood
vessels in the penis, allowing blood to flow into the penis. The result is improved erectile
function. Tadap will not help you if you do not have erectile dysfunction.
It is important to note that Tadap, used 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 Tadap

Do not take Tadap if:

• you are allergic to tadalafil or to any of the other ingredients of this medicine (listed in section 6).
• you are taking any form of organic nitrate or nitric oxide donors, such as amyl nitrite. This is a group of medicines ("nitrates") used to treat angina pectoris (or "chest pain"). Tadap has been shown to increase the effect of these medicines. If you are taking any form of nitrate or have any doubts, inform your doctor.
• you have a severe heart disease 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 vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as "stroke of the eye".
• you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors, such as Tadap, 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 Tadap.
Be aware that sexual activity involves a potential risk for patients with heart disease, as it puts additional strain on the heart. If you have a heart condition, inform your doctor.
Before taking the tablets, inform your doctor if you have:

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

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

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

If you experience a sudden decrease or loss of vision, stop taking Tadap and contact your doctor immediately.
Tadap is not intended for use by women.

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

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

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

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

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

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

Tadap contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Tadap

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Tadap tablets are for oral use and are intended only for men. Swallow the tablet whole with water. Tadap tablets may be taken with or without food.
The recommended dose is one 10 mg tablet taken before sexual activity. If this dose is not effective enough, your doctor may increase the dose to 20 mg.
Tadap tablets are for oral use.
You may take the Tadap tablet at least 30 minutes before sexual activity.
Tadap may remain effective for up to 36 hours after taking the tablet.
DO NOT take Tadap more than once a day.
Tadap 10 mg and 20 mg is intended to be used prior to anticipated sexual activity and is not recommended for daily continuous use.
It is important to note that Tadap will not work without sexual stimulation. You and your partner will need to engage in foreplay as you normally would if you were not taking a medicine for erectile dysfunction.
Drinking alcohol may interfere with your ability to get an erection and may temporarily cause a drop in blood pressure. If you have taken or plan to take Tadap, avoid excessive alcohol consumption (blood alcohol levels of 0.08% or higher), as this may increase the risk of dizziness upon standing.
If you take more Tadap than you should
Contact your doctor. You may experience the side effects described in section 4.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

• allergic reactions, including skin rash (uncommon frequency).
• chest pain – do not use nitrates but seek immediate medical assistance (uncommon frequency).
• prolonged and possibly painful erection after taking Tadap (rare frequency). If you have an erection of this type lasting more than 4 consecutive hours, you must contact a doctor immediately.
• sudden loss of vision (rare frequency).

Other side effects 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 discomfort, feeling unwell, nausea (vomiting), acid reflux, blurred vision, eye discomfort, breathing difficulties, blood in urine, palpitations, fast heartbeat, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of hands, feet or ankles, and feeling tired.

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

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

Rarely, heart attacks and strokes have been reported in men taking Tadap. Most of these individuals already had heart problems before taking the medicine.
Rarely, cases of partial, temporary or permanent decrease or loss of vision in one or both eyes have been reported.
Some additional rare side effects not observed during clinical studies have been reported in men taking Tadap.
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.

The side effect dizziness has been reported more frequently in men over 75 years of age taking Tadap.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at 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 Tadap

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./EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Tadap contains
The active substance is tadalafil. Each tablet contains 10 mg of tadalafil.
The other components are:
Tablet core: Monohydrate lactose, pregelatinized starch, colloidal anhydrous silica, croscarmellose
sodium, sodium lauryl sulfate, magnesium stearate.
Film coating: Hypromellose, monohydrate lactose, titanium dioxide (E171), triacetin, talc
(E553b), yellow iron oxide (E172), red iron oxide (E172).
Description of the appearance of Tadap and the contents of the pack
Tadap 10 mg is a light yellow, film-coated oval tablet, marked with “10” on one side and smooth on the other.
The tablet has dimensions of 11 mm x 6.6 mm and a thickness of 3.9 – 4.5 mm.
Tadap 10 mg is available in blisters containing 4 tablets.
It is possible that not all pack sizes are marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
00071 Pomezia (Rome) - Italy
Manufacturer
Balkanpharma Dupnitsa AD
3 Samokovsko Shosse Str.,
Dupnitsa 2600 – Bulgaria
Actavis Ltd.
BLB016, Bulebel Industrial Estate,
Zejtun ZTN 3000, Malta
This medicinal product is authorized in EEA Member States under the following names:
Sweden TADAP 10 mg film coated tablet
This leaflet was last revised on:

Patient Information Leaflet: Instructions for the User

TADAP 20 mg film-coated tablets

Tadalafil
Generic medicine
Please read this entire 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, 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 may 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 Tadap is and what it is used for

2. What you need to know before taking Tadap

3. How to take Tadap

4. Possible side effects

5. How to store Tadap

6. Contents of the pack and other information

7. What Tadap is and what it is used for

Tadap 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. Tadap has been shown to significantly improve the ability to obtain an erection adequate for sexual activity.

Tadap contains the active substance tadalafil, which belongs to a class of medicines called phosphodiesterase type 5 inhibitors. Following sexual stimulation, Tadap helps relax the blood vessels in the penis, allowing increased blood flow into the penis. The result is improved erectile function. Tadap will not benefit you if you do not have erectile dysfunction.

It is important to note that Tadap, when used 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.

2. What you need to know before taking Tadap

Do not take Tadap if:

• you are allergic to tadalafil or to any of the other ingredients of this medicine (listed in section 6).
• you are taking any form of organic nitrate or nitric oxide donors, such as amyl nitrite. This is a group of medicines (“nitrates”) used to treat angina pectoris (or “chest pain”). It has been shown that Tadap increases the effect of these medicines. If you are taking any form of nitrate or have any doubts, inform your doctor.
• you have a severe heart disease 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 vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “stroke of the eye”.
• you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors, such as Tadap, 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 Tadap.
Be aware that sexual activity involves a potential risk for patients with heart disease, as it places additional strain on the heart. If you have a heart condition, inform your doctor.
Before taking the tablets, inform your doctor if you have:

• sickle cell anemia (an abnormality of red blood cells);

• multiple myeloma (a malignant tumor of the bone marrow);

• leukemia (a malignant tumor of blood cells);

• any deformity of the penis;

• a severe liver problem;

• a severe kidney problem.

• It is not known whether Tadap is effective in patients who have undergone:

• pelvic surgery;

• removal of all or part of the prostate gland with nerve-sparing not preserved (radical prostatectomy without preservation of neurovascular bundles).

• If you experience a sudden decrease or loss of vision, stop taking Tadap and contact your doctor immediately. Tadap is not intended for use by women.

Children and adolescents
Tadap is not intended for use in children and adolescents under 18 years of age.
Other medicines and Tadap
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Do not take Tadap if you are already taking nitrates.
Some medicines may be affected by Tadap or may themselves affect how Tadap 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 for high blood pressure.
• riociguat.
• a 5-alpha-reductase enzyme inhibitor (used to treat benign prostatic hyperplasia).
• medicines such as ketoconazole tablets (for treating fungal infections) and protease inhibitors for the treatment of AIDS or HIV infection.
• phenobarbital, phenytoin, or carbamazepine (anticonvulsant medicines).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Tadap with food, beverages, and alcohol
Information on the effects of alcohol is provided in section 3.
Grapefruit juice may affect how Tadap works and should be taken with caution. Consult your doctor for further information.
Fertility
In treated dogs, reduced sperm development in the testes has been observed. A reduction in sperm count has also been observed in some men. These effects are unlikely to cause infertility.
Driving and operating machinery
Some men taking Tadap in clinical studies reported dizziness. Carefully monitor how you react to the tablets before driving or operating machinery.
Tadap contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Tadap

Take this medicine exactly as your doctor has instructed. If you have any doubts, consult your doctor or pharmacist.
Tadap tablets are for oral use and for men only. Swallow the tablet whole with water. The tablets can be taken with or without food.
The recommended dose is one 10 mg tablet taken before sexual activity.
However, you have been prescribed the 20 mg dose because your doctor has determined that the recommended 10 mg dose is too low for you.
You may take the Tadap tablet at least 30 minutes before sexual activity.
Tadap may still be effective up to 36 hours after taking the tablet.
DO NOT take Tadap more than once a day.
Tadap 10 mg and 20 mg is intended to be used as needed before anticipated sexual activity and is not recommended for daily continuous use.
It is important to note that Tadap will not work without sexual stimulation. You and your partner will need to engage in foreplay as you normally would if you were not taking a medicine for erectile dysfunction.
Drinking alcohol may interfere with your ability to get an erection and may temporarily cause a lowering of your blood pressure. If you have taken or plan to take Tadap, avoid excessive alcohol consumption (blood alcohol levels of 0.08% or higher), as this may increase the risk of dizziness when standing up.
If you take more Tadap than you should
Contact your doctor. You may experience the side effects described in section 4.
If you have any questions about the use of this medicine, talk to your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them. These side effects are usually mild to moderate in intensity.
If you experience any of the following side effects, stop using the medicine and seek
immediate medical help:

• allergic reactions, including skin rashes (uncommon frequency).
• chest pain – do not use nitrates, but seek immediate medical help (uncommon frequency).
• prolonged and possibly painful erection after taking Tadap (rare frequency). If you have an erection of this type lasting more than 4 consecutive hours, you must contact a doctor immediately.
• sudden loss of vision (rare frequency).

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

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

Uncommon (may affect up to 1 in 100 people)

• Dizziness, stomach ache, feeling unwell, malaise (vomiting), acid reflux, blurred vision, eye discomfort, breathing difficulties, blood in the urine, 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, transient memory loss, eyelid swelling, red eyes, sudden decrease or loss of hearing, hives (red, itchy patches on the skin), bleeding from the penis, blood in the semen, and increased sweating.

Rarely, heart attacks and strokes have been reported in men taking Tadap. Most of these individuals already had heart problems before taking the medicine.
Rarely, cases of partial, temporary or permanent decrease or loss of vision in one or both eyes have been reported.
Some additional rare side effects not observed during clinical studies have been reported in men taking Tadap.
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.

The side effect dizziness has been reported more frequently in men over 75 years of age taking Tadap.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at 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 Tadap

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./EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Tadap contains
The active substance is tadalafil. Each tablet contains 20 mg of tadalafil.
The other components are:
Tablet core: Monohydrate lactose, pregelatinized starch, colloidal anhydrous silica, croscarmellose
sodium, sodium lauryl sulfate, magnesium stearate.
Film coating: Hypromellose, monohydrate lactose, titanium dioxide (E171), triacetin, talc
(E553b), yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of Tadap and package contents
Tadap 20 mg is a light yellow, film-coated oval tablet, marked with "20" on one side and smooth on the other.
The tablet has a diameter of 12 mm x 7.4 mm and a thickness of 4.6 – 5.2 mm.
Tadap 20 mg is available in blisters containing 2, 4 or 8 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
00071 Pomezia (Rome) - Italy

Manufacturer
Balkanpharma Dupnitsa AD
3 Samokovsko Shosse Str.,
Dupnitsa 2600 – Bulgaria
Actavis Ltd.
BLB016, Bulebel Industrial Estate,
Zejtun ZTN 3000, Malta

This medicinal product is authorized in the EEA Member States under the following names:
Sweden TADAP 20 mg film coated tablet

This leaflet was last revised on: