DALERPEN 5 mg Tabletki Powlekane

Treść ulotki

1. Dalerpen 5mg film-coated tablets
   1. What is Dalerpen and what is it 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
2. Dalerpen 10mg film-coated tablets, 20mg film-coated tablets
   1. What is Dalerpen and what is it 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

Dalerpen 5mg film-coated tablets

Tadalafil
Generic medicine

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

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

Contents of this leaflet:

• 1. What Dalerpen is and what it is used for
• 2. What you need to know before you take 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 is Dalerpen and what is it used for

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

• erectile dysfunction. This condition occurs when a man cannot achieve or maintain an erection adequate for sexual intercourse. Dalerpen has been shown to significantly improve the ability to achieve an erection adequate for sexual intercourse. After sexual stimulation Dalerpen helps to relax the blood vessels in the penis, allowing blood flow to the penis. The result of this is improved erectile function. Dalerpen will not be helpful if you do not have erectile dysfunction. It is important to note that Dalerpen for the treatment of erectile dysfunction has no effect if there is no sexual stimulation. You and your partner will need to engage in foreplay, as you would if you were not taking medication for erectile dysfunction.
• 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 emptying the bladder completely, and a more frequent need to urinate, even at night. Dalerpen improves blood flow and relaxes the muscles of the prostate and bladder, which may reduce the symptoms associated with benign prostatic hyperplasia. Dalerpen has been shown to improve these urinary symptoms within 1-2 weeks of starting treatment.

2. What you need to know before taking Dalerpen

Do not take Dalerpen:

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Dalerpen.
Be aware that sexual activity involves a potential risk for patients with a heart condition, because it puts extra strain on the heart. If you have a heart problem, tell your doctor.
Since benign prostatic hyperplasia and prostate cancer can have the same symptoms, your doctor will perform checks for prostate cancer before starting treatment with Dalerpen for benign prostatic hyperplasia. Dalerpen does not cure prostate cancer.
Before taking the tablets, tell your doctor if you have:

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

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 of the prostate have been cut (radical prostatectomy without neurovascular bundle preservation). If you experience a sudden decrease or loss of vision, stop taking Dalerpen and contact your doctor immediately.

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

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

Other medicines and Dalerpen
Tell 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 can be affected by Dalerpen or they themselves can affect how Dalerpen works. Tell your doctor or pharmacist if you are already taking:

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

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

Fertility
In dogs treated, a reduction in sperm development in the testicles has been observed. In some men, a decrease in sperm has been observed. It is unlikely that these effects will cause infertility.

Driving and operating machinery
Some men taking Dalerpen during clinical trials have reported dizziness. Carefully check how you react to the tablets before driving or operating machinery.

Dalerpen contains lactose:
If you have been diagnosed with intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Dalerpen

If a dosage of 2.5 mg is prescribed, other products based on
tadalafil with that dosage should be used.
Take this medicine following exactly the instructions of your doctor. If you have any doubts consult
your doctor or pharmacist.
Dalerpen tablets are for oral use and only for men. Swallow the tablet whole with
water. The tablets can be taken independently of food intake.
Drinking alcohol may temporarily cause a reduction in your blood
pressure. If you have taken or intend to take Dalerpen, avoid excessive consumption of alcoholic
beverages (blood alcohol level of 0.08% or higher) as this may increase the risk of
dizziness when you stand up.

For the treatment of erectile dysfunction
The recommended dose is one 5 mg tablet to be taken once a day at approximately the
same time of day. Your doctor may adjust the dose to 2.5 mg based on your response to
Dalerpen. This dose will be given to you with a 2.5 mg tablet. Do not take Dalerpen more than once
a day.
When taken once a day, Dalerpen allows you to achieve an erection, if there is
sexual stimulation, at any time of the day within 24 hours. Daily administration
of Dalerpen may be useful for men who anticipate having sexual activity
two or more times a week.
It is important to note that Dalerpen does not work if there is no sexual stimulation. You and your partner
will need to engage in foreplay as you would if you were not taking a medicine for
erectile dysfunction.
Drinking alcohol may interfere with your ability to achieve an erection.

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

If you take more Dalerpen than you should
Contact your doctor. Undesirable effects as described in section 4 may occur.

If you forget to take Dalerpen
Take your dose as soon as you remember, but do not take a double dose to compensate for
forgetting the tablet. You should not take Dalerpen more than once a day.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
These effects are normally mild to moderate in severity.

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

• allergic reactions, including skin rashes (uncommon frequency);
• chest pain - do not use nitrates but seek immediate medical attention (uncommon frequency);
• prolonged and possibly painful erection after taking Dalerpen (rare frequency). If you have an erection of this type that lasts for more than 4 hours, you should contact a doctor immediately;
• sudden loss of vision (rare frequency). Other side effects that have been reported include: Common(observed in 1-10 patients per 100)
• headache, back pain, muscle pain, pain in the arms and legs, hot flushes on the face, nasal congestion and digestive disorders.

Uncommon(observed in 1-10 patients per 1,000)
dizziness, stomach pain,
feeling unwell, malaise (vomiting), reflux,

• blurred vision, eye discomfort, difficulty breathing, presence of blood in the urine,
• prolonged erection, palpitations, fast heartbeat, high blood pressure, low blood pressure, nosebleeds, ringing in the ears,
• ears, swelling of the hands, feet or ankles and feeling tired.

Rare(observed in 1-10 patients per 10,000)
fainting, convulsions and transient memory loss, swelling of the eyelids, red eyes,
sudden decrease or loss of hearing, hives (itchy red patches on the skin surface), bleeding of the penis, presence of blood in the semen and increased sweating.
Rarely, in men taking Dalerpen, heart attacks and strokes have been reported. The
majority of these subjects had heart problems already before using the medicine.
Rarely, cases of partial, temporary or permanent decrease or loss of
vision in one or both eyes have been reported.
Some further rare side effects that had not been observed during clinical trials 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, some disorders that alter blood circulation to the eyes, irregular heartbeat, angina and sudden cardiac death.

The side effects dizziness and diarrhoea have been reported more frequently in men over the age of
75 years who were taking Dalerpen.
Diarrhoea has been reported more frequently in men over the age of 65 years who were taking
CIALIS.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through
the 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 which is stated on the package and blister after
Exp.. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Dalerpen contains

• The active ingredient is tadalafil. Each tablet contains 5 mg of tadalafil.
• The other ingredients are: Tablet: lactose monohydrate (see the end of paragraph 2), sodium croscarmellose, hydroxypropylcellulose, 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 contents of the pack
Dalerpen 5 mg is a film-coated tablet, yellow to light yellow in colour, round, with
bevelled edges and with '337' embossed 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 Authorisation Holder
Ecupharma S.r.l.
Via Mazzini, 20
20123 Milano (MI)

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

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

Tadalafil
Generic medicine

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Dalerpen is and what it is used for
• 2. What you need to know before you take 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 is Dalerpen and what is it 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 adequate for sexual intercourse.
Dalerpen has been shown to significantly improve the ability to achieve an erection adequate for
sexual intercourse.
Dalerpen contains the active ingredient tadalafil which belongs to the class of medicines called
phosphodiesterase type 5 inhibitors. After sexual stimulation Dalerpen helps to relax the blood
vessels in the penis, allowing blood flow to the penis. The result is improved
erectile function. Dalerpen will not help if you do not have erectile dysfunction.
It is important to note that Dalerpen has no effect if there is no sexual stimulation. You and your partner
will need to engage in foreplay, as you would if you were not taking a medicine for
erectile dysfunction.

2. What you need to know before taking Dalerpen

Do not take Dalerpen:

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

Warnings and precautions
Talk to your doctor before taking Dalerpen.
Be aware that sexual activity involves a potential risk for patients with heart disease, because it puts extra strain on the heart. If you have a heart problem, tell your doctor.
Before taking the tablets, tell your doctor if you have:

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

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

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

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

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

Other medicines and Dalerpen
Tell 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 can be affected by Dalerpen or they themselves can affect the way Dalerpen works. Tell your doctor or pharmacist if you are already taking:

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

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

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

Driving and operating machinery
Some men taking Dalerpen during clinical studies have reported dizziness. Carefully check how you react to the tablets before driving or operating machinery.

Dalerpen contains lactose:
If you have been diagnosed with intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Dalerpen

If a dosage of 2.5 mg is prescribed, other products containing
tadalafil with that dosage should be used.
Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult
your doctor or pharmacist.
Dalerpen tablets are for oral use and only for men. Swallow the tablet whole with
water. The tablets can be taken independently of food intake.

The recommended doseis one 10 mg tablet before sexual activity. If the effect of this
dosage is too weak, your doctor may increase the dose to 20 mg. Dalerpen tablets are
for oral use.
You can 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 indicated to be used
before planned sexual activity and is not recommended for continuous daily use.
It is important to note that Dalerpen does not work if there is no sexual stimulation. You and your partner
will need to engage in foreplay as you would if you were not taking medication for
erectile dysfunction.
Drinking alcoholic beverages may interfere with your ability to achieve an erection and may
temporarily cause a decrease in your blood pressure. If you have taken or intend
to take Dalerpen, avoid excessive alcohol consumption (blood alcohol level
of 0.08% or higher) as this may increase the risk of dizziness when you stand up.

If you take more Dalerpen than you should
Contact your doctor. Adverse effects described in section 4 may occur.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
These effects are normally mild to moderate in severity.

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

• allergic reactions, including skin rashes (uncommon frequency);
• chest pain - do not use nitrates but seek immediate medical assistance (uncommon frequency);

priapism, a prolonged and possibly painful erection after taking Dalerpen (rare
frequency). If you have an erection of this type that lasts for more than 4 hours, you should
contact a doctor immediately;

• sudden loss of vision (rare frequency).

Other side effects have been reported:

Common(observed in 1-10 patients per 100)

• headache, back pain, muscle pain, pain in the arms and legs, hot flushes on the face, nasal congestion and digestive disorders.

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

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

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

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

Rarely, in men taking Dalerpen, heart attacks and strokes have been reported. The
majority of these subjects had heart problems already before using the medicine.
Rarely, cases of partial, temporary or permanent decrease or loss of
vision in one or both eyes have been reported.

Some further rare side effectsthat had not been observed during clinical trials
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, some disorders that alter blood flow to the eyes, irregular heartbeat, angina and sudden cardiac death.

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through
the 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 sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and blister after
Exp.. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Dalerpen contains
The active ingredient 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 ingredients are: Tablet: lactose monohydrate (see the end of paragraph 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 contents of the pack
Dalerpen 10 mg is a film-coated tablet of yellow to light yellow colour, round, with
beveled edge and with '338' imprinted on one side and smooth on the other side.
Dalerpen 20 mg is a film-coated tablet of yellow to light yellow colour, oval in shape,
with beveled edge and with 'L 339' imprinted on one side and smooth on the other side.
Dalerpen 10 mg is available in blisters in packs of 4 tablets.
Dalerpen 20 mg is available in blisters in packs of 2, 4 or 8 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Ecupharma S.r.l.
Via Mazzini, 20
20123 Milano (MI)

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