Dalerpen

Patient Information Leaflet: Information for the User

Dalerpen 5 mg film-coated tablets

Tadalafil
Equivalent 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If any adverse reaction occurs, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Dalerpen is and what it is used for

Dalerpen contains the active substance tadalafil, which belongs to a class of medicines known as
phosphodiesterase type 5 inhibitors.
Dalerpen 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. Dalerpen has been shown to significantly improve the ability to obtain an erection suitable for sexual activity. Following sexual stimulation, Dalerpen helps relax the blood vessels in the penis, allowing increased blood flow into the penis. The result is improved erectile function. Dalerpen will not help you if you do not have erectile dysfunction. It is important to note that Dalerpen, 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.
• 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 incomplete bladder emptying, and increased need to urinate, including during the night. Dalerpen improves blood flow and relaxes the muscle tissue of the prostate and bladder, which may reduce symptoms associated with benign prostatic hyperplasia. Dalerpen has been shown to improve these urinary symptoms as early as 1-2 weeks after starting treatment.

2. What you should know before taking Dalerpen

Do not take Dalerpen if:

• you are allergic to tadalafil or to any of the other ingredients of this medicine (listed in section 6);
• you are taking any form of organic nitrate or nitric oxide donors, such as amyl nitrite. These are a group of medicines ("nitrates") used to treat angina pectoris (or "chest pain"). Dalerpen 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 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 "eye stroke";
• you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors such as Dalerpen 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 or pharmacist before taking Dalerpen.
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 any heart problems, 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 Dalerpen for benign prostatic hyperplasia. Dalerpen 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 Dalerpen 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 a sudden decrease or loss of vision, or if your vision becomes distorted or blurred while taking Dalerpen, stop taking Dalerpen and contact your doctor immediately.
In some patients taking tadalafil, sudden decrease or loss of hearing has been observed. Although it is not known whether this event is directly related to tadalafil, if you experience sudden reduction or loss of hearing, stop taking Dalerpen and contact your doctor immediately.
Dalerpen is not intended for use by women.
Children and adolescents
Dalerpen is not intended for use in children and adolescents under 18 years of age.
Other medicines and Dalerpen
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Dalerpen if you are already taking nitrates.
Some medicines may be affected by Dalerpen or may themselves affect how Dalerpen 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 used to treat AIDS or HIV infection;
• phenobarbital, phenytoin, or carbamazepine (anticonvulsant medicines);
• rifampicin, erythromycin, clarithromycin, or itraconazole;
• other treatments for erectile dysfunction.

Dalerpen with food and alcohol
Information on the effects of alcohol is provided in section 3. Grapefruit juice may affect how Dalerpen works and should be consumed with caution.
Consult your doctor for further information.
Fertility
In treated dogs, reduced sperm development in the testes has been observed. In some men, reduced sperm count has been observed. These effects are unlikely to cause infertility.
Driving and using machines
Some men taking Dalerpen in clinical studies reported dizziness. Carefully assess how you react to the tablets before driving or operating machinery.
Dalerpen contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
Dalerpen contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially "sodium-free".

3. How to take Dalerpen

If a dosage of 2.5 mg is prescribed, other tadalafil-containing products with this dosage should be used.
Take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
Dalerpen tablets are for oral use and for men only. Swallow the tablet whole with water. The tablets may be taken regardless of food intake.
Drinking alcohol may temporarily cause a reduction in your blood pressure. If you have taken or are planning to take Dalerpen, avoid excessive alcohol consumption (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 Dalerpen. This dose will be provided as a 2.5 mg tablet. Do not take Dalerpen more than once a day.
When taken once daily, Dalerpen allows you to achieve an erection if there is sexual stimulation, at any time during the 24-hour period. Daily administration of Dalerpen may be beneficial for men who anticipate having sexual activity two or more times per week.
It is important to note that Dalerpen does 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 achieve 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 Dalerpen more than once a day.

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
These side effects are usually mild to moderate in severity.
If you experience any of the following side effects, stop using this medicine and seek
immediate medical 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 Dalerpen (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), distorted central vision, blurred, fuzzy vision, or sudden decrease in vision (frequency not known).

Other side effects reported include:
Common (observed in 1–10 patients out of 100)

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

Uncommon (observed in 1–10 patients out of 1,000)

• dizziness, stomach discomfort, nausea, 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 hands, feet or ankles, and feeling of fatigue.

Rare (observed in 1–10 patients out of 10,000)

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

Rare cases of heart attacks and strokes have been reported in men taking Dalerpen. Most of these individuals already had pre-existing heart conditions before taking the medicine.
Rare cases of partial, temporary or permanent decrease 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 Dalerpen. These include:

• migraine, facial swelling, severe allergic reaction causing swelling of the face and throat, serious skin reactions, certain disorders affecting blood circulation to the eyes, irregular heartbeat, angina, and sudden cardiac death;
• distorted, blurred, fuzzy central vision or sudden decrease in vision (frequency not known).

The side effect dizziness has been reported more frequently in men over 75 years of age taking Dalerpen. Diarrhoea has been reported more frequently in men over 65 years of age taking Dalerpen.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa . Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Dalerpen

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 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 required. This will help protect the environment.

6. Package contents and other information

What Dalerpen contains

• The active substance is tadalafil. Each tablet contains 5 mg of tadalafil.
• The other components are: Tablet: monohydrate lactose (see end of section 2), croscarmellose sodium, hydroxypropylcellulose, povidone K25, colloidal silicon dioxide, sodium lauryl sulfate, magnesium stearate. Film coating: hypromellose, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172).

Description of the appearance of Dalerpen and the contents of the pack
Dalerpen 5 mg is a film-coated tablet, yellow to light yellow in colour, round, with bevelled edges, marked with '337' on one side and smooth on the other side.
Dalerpen 5 mg is available in blisters in packs of 14 or 28 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Ecupharma S.r.l.
Via Mazzini, 20
20123 Milano (MI)
Manufacturer
Pharmadox Healthcare Ltd.,
KW20A Kordin Industrial Park, Paola
PLA 3000
Malta

Package leaflet: Information for the user

Dalerpen 10 mg film-coated tablets, 20 mg film-coated tablets

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, 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 may be harmful.
• If any adverse reaction occurs, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Dalerpen is and what it is used for

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

Do not take Dalerpen if:

• you are allergic to tadalafil or to any of the other ingredients of this medicine (listed in section 6);
• you are taking any form of organic nitrate or nitric oxide donors, such as amyl nitrite. These are a group of medicines ("nitrates") used to treat angina pectoris (or "chest pain"). Dalerpen 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 condition or have had a heart attack recently, within the last 90 days;
• you have had a stroke recently, within the last 6 months;
• you have low blood pressure or uncontrolled high blood pressure;
• 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 Dalerpen 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 Dalerpen.
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 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 bone marrow tumour);
• leukaemia (a malignant blood cell tumour);
• any deformity of the penis;
• severe liver problems;
• severe kidney problems.

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

• pelvic surgery;
• removal of all or part of the prostate gland where the nerves to the prostate have been cut (non-nerve-sparing radical prostatectomy).

If you experience a sudden decrease or loss of vision, or if your vision becomes distorted or blurred while taking Dalerpen, stop taking Dalerpen and contact your doctor immediately.
In some patients taking tadalafil, sudden decrease or loss of hearing has been observed. Although it is not known whether this event is directly related to tadalafil, if you experience sudden reduction or loss of hearing, stop taking Dalerpen and contact your doctor immediately.
Dalerpen is not intended for use by women.
Children and adolescents
Dalerpen is not intended for use in children and adolescents under 18 years of age.
Other medicines and Dalerpen
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Do not take Dalerpen if you are already taking nitrates.
Some medicines may interact with Dalerpen or affect how Dalerpen works. Inform your doctor or pharmacist if you are taking:

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

Dalerpen with food and alcohol
Information about the effects of alcohol is provided in section 3. Grapefruit juice may affect how Dalerpen works and should be consumed with caution.
Consult your doctor for further information.
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 Dalerpen in clinical studies reported dizziness. Carefully assess how you react to the tablets before driving or operating machinery.
Dalerpen contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Dalerpen contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take Dalerpen

If a dosage of 2.5 mg is prescribed, other tadalafil-containing products with this dosage should be used.
Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Dalerpen tablets are for oral use and for men only. Swallow the tablet whole with water. The tablets may be taken regardless of food intake.
The recommended dose is one 10 mg tablet taken prior to sexual activity. If the effect of this dose is too weak, your doctor may increase the dose to 20 mg. Dalerpen tablets are for oral use.
You may take the Dalerpen tablet at least 30 minutes before sexual activity.
Dalerpen may still be effective up to 36 hours after taking the tablet.
Do not take Dalerpen more than once a day. Dalerpen 10 mg and 20 mg is intended to be used prior to anticipated sexual activity and is not recommended for continuous daily use.
It is important to note that Dalerpen 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 Dalerpen, 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 Dalerpen 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.

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 severity.
If you experience any of the following side effects, stop using the medicine and seek
immediate medical help:

• allergic reactions, including skin rashes (frequency not common);
• chest pain – do not use nitrates but seek immediate medical help (frequency not common);
• priapism, a prolonged and possibly painful erection after taking Dalerpen (frequency rare). If you have an erection of this type lasting more than 4 hours, you must contact a doctor immediately;
• sudden loss of vision (frequency rare), distorted central vision, blurred or fuzzy vision, or sudden decrease in vision (frequency not known).

Other side effects have been reported:
Common (seen in 1 to 10 patients out of 100)

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

Uncommon (seen in 1 to 10 patients out of 1,000)

• dizziness, stomach discomfort, nausea, vomiting, reflux, blurred vision, eye irritation, breathing difficulties, 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 of fatigue.

Rare (seen in 1 to 10 patients out of 10,000)

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

Rarely, heart attacks and strokes have been reported in men taking Dalerpen. Most of these individuals already had heart problems before using the medicine.
Rarely, cases of partial, temporary or permanent decrease or loss of vision in one or both eyes have been reported.
Some additional rare side effects not observed during clinical studies have been reported in men taking Dalerpen. 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;
• distorted, blurred, fuzzy central vision or sudden decrease in vision (frequency not known).

The side effect dizziness has been reported more frequently in men over 75 years of age taking Dalerpen. Diarrhoea has been reported more frequently in men over 65 years of age taking Dalerpen.
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 http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dalerpen

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

6. Package contents and other information

What Dalerpen contains
The active substance is tadalafil.
Dalerpen 10 mg film-coated tablets

• Each tablet contains 10 mg of tadalafil. Dalerpen 20 mg film-coated tablets
• Each tablet contains 20 mg of tadalafil.
• The other components are: Tablet core: monohydrate lactose (see end of section 2), sodium croscarmellose, hydroxypropylcellulose, povidone K25, colloidal silicon dioxide, sodium lauryl sulfate, magnesium stearate. Film coating: hypromellose, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172)

Description of the appearance of Dalerpen and package contents
Dalerpen 10 mg is a film-coated tablet, yellow to light yellow in colour, round, with bevelled edges, marked with '338' on one side and smooth on the other side.
Dalerpen 20 mg is a film-coated tablet, yellow to light yellow in colour, oval-shaped, with bevelled edges, marked with 'L 339' on one side and smooth on the other side.
Dalerpen 10 mg is available in blisters containing 4 tablets.
Dalerpen 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
Ecupharma S.r.l.
Via Mazzini, 20
20123 Milano (MI)
Italy

Manufacturer
Pharmadox Healthcare Ltd.,
KW20A Kordin Industrial Park, Paola
PLA 3000
Malta