VICUM 5 mg Tabletki Powlekane

Treść ulotki

1. What is ZYRESTALI and what is it used for
2. What you need to know before you take ZYRESTALI
3. How to take ZYRESTALI
4. Possible side effects
5. How to store ZYRESTALI
6. Contents of the pack and other information
7. What is ZYRESTALI and what is it used for
8. What you need to know before taking ZYRESTALI Do not take ZYRESTALI if:
9. How to take ZYRESTALI
10. Possible side effects
11. How to store ZYRESTALI
12. Package Contents and Other Information
13. What is ZYRESTALI and what it is used for
14. What you need to know before taking
15. How to take ZYRESTALI
16. Possible side effects
17. How to store ZYRESTALI
18. Contents of the pack and other information What ZYRESTALI contains

ZYRESTALI 5 mg 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 their symptoms are the same as yours, 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 ZYRESTALIis and what it is used for
• 2. What you need to know before you take ZYRESTALI
• 3. How to take ZYRESTALI
• 4. Possible side effects
• 5. How to store ZYRESTALI
• 6. Contents of the pack and other information

1. What is ZYRESTALI and what is it used for

ZYRESTALIcontains the active substance tadalafil which belongs to the class of medicines called
phosphodiesterase type 5 inhibitors.

ZYRESTALI5 mg is a treatment for men with:

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

2. What you need to know before you take ZYRESTALI

Do not take ZYRESTALI if:

• you are allergic to tadalafil or 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 ZYRESTALIincreases the effect of these medicines.
  If you are taking any form of nitrate or have any doubts, tell your doctor.

amyle nitrite. This is a group of medicines (“nitrates”) used for the treatment of angina pectoris (or
“chest pain”). It has been demonstrated that ZYRESTALIincreases the effect of these medicines.
If you are taking any form of nitrate or have any doubts, please inform your doctor.

• you have a serious 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 loss of vision 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). It has been shown that PDE5 inhibitors, such as ZYRESTALI, 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 ZYRESTALI.
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.
Since benign prostatic hyperplasia and prostate cancer can have the same symptoms, your
doctor will perform checks for prostate cancer before starting treatment with

ZYRESTALIfor benign prostatic hyperplasia. ZYRESTALIdoes not cure prostate cancer.
Before taking the tablets, tell your doctor if you have:

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

It is not known whether ZYRESTALIis 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 ZYRESTALIand
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 this event is directly related to tadalafil, if you experience a
sudden decrease or loss of hearing, stop taking ZYRESTALIand contact your
doctor immediately.

ZYRESTALIis not indicated for use by women.

Children and adolescents
ZYRESTALIis not indicated for use in children and adolescents under the age of 18 years.

Other medicines and ZYRESTALI
Tell your doctor if you are taking, have recently taken or might take any other
medicines.
Do not take ZYRESTALIif you are already taking nitrates.
Some medicines can be affected by ZYRESTALIor they themselves can affect how ZYRESTALIworks. 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.

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

Fertility
A decrease in sperm development in the testicles has been observed in dogs treated with the substance. A decrease in sperm count has been observed in some
men. These effects are unlikely to cause infertility.

Driving and using machines
Some men taking ZYRESTALIduring clinical studies have reported dizziness. Carefully
check how you react to the tablets before driving or using machines.

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

3. How to take ZYRESTALI

Take this medicine following exactly the instructions of your doctor. If you have doubts, consult your
doctor or pharmacist.
The ZYRESTALItablets are for oral use and for men only. 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 ZYRESTALI, avoid excessive alcohol consumption (blood alcohol level of 0.08% or higher) as this may increase
the risk of dizziness when you stand up.

For the treatment of erectile dysfunction
The recommended doseis 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

ZYRESTALI. This dose will be given to you with a 2.5 mg tablet.

ZYRESTALIis not available in a 2.5mg dosage; if this dosage is needed you should
consider other medicinal specialties based on Tadalafil.
Do not take ZYRESTALImore than once a day.
When taken once a day, ZYRESTALIallows you to achieve an erection, if there is
sexual stimulation, at any time of the day within 24 hours. The administration of

ZYRESTALIonce a day may be useful for men who plan to have sexual activity
two or more times a week.
It is important to note that ZYRESTALIdoes 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 alcohol may interfere with your ability to achieve an erection.

For the treatment of benign prostatic hyperplasia
The doseis 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 ZYRESTALImore than once a day.

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

If you forget to take ZYRESTALI
Take your dose as soon as you remember, but do not take a double dose to make up for
forgetting the tablet. You must not take ZYRESTALImore than once a day.
If you have any questions about using 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 ZYRESTALI(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, flushing of 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, 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, urticaria (itchy red patches on the skin surface), bleeding of the penis, blood in the semen and increased sweating.
Rarely, in men taking ZYRESTALI, heart attacks and strokes have been reported. Most of these subjects had pre-existing 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 further rare side effectsthat had not been observed during clinical trials have been
reported in men taking ZYRESTALI. These include:

• migraine, facial swelling, severe allergic reaction causing swelling of the face or throat, severe skin reactions, some disorders that alter blood flow to the eyes, irregular heartbeat, angina and sudden cardiac death. The side effect of dizziness has been reported more frequently in men over 75 years of age taking ZYRESTALI. Diarrhea has been reported more frequently in men over 65 years of age taking ZYRESTALI.

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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help to provide more information on the safety of
this medicine.

5. How to store ZYRESTALI

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 box and blister after Exp.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ZYRESTALI contains

• The activeingredient is tadalafil. Each tablet contains 5 mg of tadalafil.
• The other ingredientsare: Tablet:lactose monohydrate (see the end of paragraph 2), corn starch, pregelatinized starch (corn), crospovidone, sodium lauryl sulfate, magnesium stearate. Film coating: lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin, yellow iron oxide (E172).

Description of the appearance of ZYRESTALI and contents of the pack
ZYRESTALI5 mg is an oblong, film-coated tablet ranging in colour from cream to light yellow.

ZYRESTALI5 mg is available in blisters in packs of 28.

Marketing authorisation holder and manufacturer
Marketing authorisation holder: Elleva Pharma S.r.l., Via S. Francesco 5, 80034
Marigliano (NA), Italy
Manufacturer: Atlantic Pharma – Produções Farmacêuticas, S.A., Rua da Tapada Grande, nº2, Abrunheira,
2710-089 Sintra, Portugal.

ZYRESTALI 10 mg film-coated tablets
Tadalafil
Generic medicine

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may harm them.
• 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 ZYRESTALIis and what it is used for
• 2. What you need to know before you take ZYRESTALI
• 3. How to take ZYRESTALI
• 4. Possible side effects
• 5. How to store ZYRESTALI
• 6. Contents of the pack and other information

1. What is ZYRESTALI and what is it used for

ZYRESTALIis a treatment for adult men with erectile dysfunction. This condition occurs when a man cannot achieve or maintain an erection adequate for sexual intercourse. ZYRESTALIhas been shown to significantly improve the ability to achieve an erection adequate for sexual intercourse.

ZYRESTALIcontains the active ingredient tadalafil, which belongs to the class of medicines called phosphodiesterase type 5 inhibitors. After sexual stimulation, ZYRESTALIhelps to relax the blood vessels in the penis, allowing blood flow to the penis. The result is improved erectile function. ZYRESTALIwill not help you if you do not have erectile dysfunction. It is important to note that ZYRESTALIhas no effect if there is no sexual stimulation. You and your partner will need to engage in foreplay, as you would if you were not taking medicine for erectile dysfunction.

2. What you need to know before taking ZYRESTALI Do not take ZYRESTALI if:

• you are allergic to tadalafil or 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 ZYRESTALIincreases the effect of these medicines. If you are taking any form of nitrate or have any doubts, tell your doctor.
• you have a serious 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 or uncontrolled high blood pressure.
• you have previously had a loss of vision 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). It has been shown that PDE5 inhibitors, such as ZYRESTALI, 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 ZYRESTALI.
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 cancer of bone marrow).
• leukemia (a cancer of blood cells).
• any deformity of the penis.
• a serious liver problem.
• a serious kidney problem.

It is not known whether ZYRESTALIis 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 ZYRESTALIand
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 this event is directly related to tadalafil, if you experience a decrease or sudden loss of hearing, stop taking ZYRESTALIand
contact your doctor immediately.

ZYRESTALIis not intended for use by women.

Children and adolescents
ZYRESTALIis not intended for use by children or adolescents under the age of 18 years.

Other medicines and ZYRESTALI
Tell your doctor if you are taking, have recently taken or might take any other
medicines.
Do not take ZYRESTALIif you are already taking nitrates.
Some medicines can be affected by ZYRESTALIor they themselves can affect how ZYRESTALIworks. 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.

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

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

Driving and using machines
Some men who were taking ZYRESTALIduring clinical trials reported dizziness. Carefully
check how you react to the tablets before driving or using machines.

ZYRESTALI contains lactose:
If you have intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take ZYRESTALI

Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.
The ZYRESTALItablets 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. The ZYRESTALI
tablets are for oral use.
You can take the ZYRESTALItablet at least 30 minutes before sexual activity.

ZYRESTALImay still be effective up to 36 hours after taking the tablet.
Do not take ZYRESTALImore than once a day. ZYRESTALI10 mg and 20 mg is indicated for
use before planned sexual activity and is not recommended for continuous daily use.
It is important to note that ZYRESTALIdoes 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 ZYRESTALI, avoid excessive alcohol consumption (blood alcohol level
equal to 0.08% or higher) as this may increase the risk of dizziness when you stand up.

If you take more ZYRESTALI than you should:
Contact your doctor. It is possible that the undesirable effects described in paragraph 4 may occur. If you have
any doubts about the use of 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 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 ZYRESTALI(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, 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, urticaria (itchy red patches on the skin surface), bleeding of the penis, blood in the semen and increased sweating.

Rarely, in men taking ZYRESTALI, 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 ZYRESTALI. These include:

• migraine, facial swelling, severe allergic reaction causing swelling of the face and throat, severe skin reactions, some disorders that change blood flow 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 ZYRESTALI. Diarrhea has been reported more frequently in men over
65 years of age taking ZYRESTALI.

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 https://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 ZYRESTALI

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
Expiry./EXP. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from moisture. Do not store at
a temperature above 30°C.
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. Package Contents and Other Information

What ZYRESTALI contains

• The activeingredient is tadalafil. Each tablet contains 10 mg of tadalafil.
• The other ingredientsare: Tablet:lactose monohydrate (see the end of paragraph 2), corn starch, pregelatinized starch (corn), crospovidone, sodium lauryl sulfate, magnesium stearate. Film coating: lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin, yellow iron oxide (E172).

Description of the appearance of ZYRESTALI and package contents
ZYRESTALI10 mg is an oblong, dark yellow film-coated tablet.

ZYRESTALI10 mg is available in blisters in packs of 4 and 8 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Elleva Pharma S.r.l., Via S. Francesco 5,
80034 Marigliano (NA), Italy
Manufacturer: Atlantic Pharma – Produções Farmacêuticas, S.A., Rua da Tapada Grande, nº2, Abrunheira,
2710-089 Sintra, Portugal.

ZYRESTALI 20 mg film-coated tablets
Tadalafil
Generic medicine

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may harm them.
• 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 ZYRESTALIis and what it is used for
• 2. What you need to know before you take ZYRESTALI
• 3. How to take ZYRESTALI
• 4. Possible side effects
• 5. How to store ZYRESTALI
• 6. Package Contents and Other Information

1. What is ZYRESTALI and what it is used for

ZYRESTALIis a treatment for adult men with erectile dysfunction. This condition occurs when a man cannot achieve or maintain an erection adequate for sexual intercourse. ZYRESTALIhas been shown to significantly improve the ability to achieve an erection adequate for sexual intercourse.

ZYRESTALIcontains the active ingredient tadalafil, which belongs to the class of medicines called phosphodiesterase type 5 inhibitors. After sexual stimulation, ZYRESTALIhelps to relax the blood vessels in the penis, allowing blood flow to the penis. The result is improved erectile function. ZYRESTALIwill not help you if you do not have erectile dysfunction. It is important to note that ZYRESTALIhas 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.

2. What you need to know before taking

ZYRESTALI Do not take ZYRESTALI if:

• you are allergic to tadalafil or 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 ZYRESTALIincreases the effect of these medicines. If you are taking any form of nitrate or have any doubts, tell your doctor.
• you have a serious 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 a loss of vision 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). It has been shown that PDE5 inhibitors, such as ZYRESTALI, 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 ZYRESTALI.
Be aware that sexual activity involves a potential risk for patients with heart disease, as it puts extra strain on the heart. If you have a heart problem, 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 ZYRESTALIis 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 ZYRESTALIand
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 ZYRESTALIand
contact your doctor immediately.

ZYRESTALIis not indicated for use by women.

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

Other medicines and ZYRESTALI
Tell your doctor if you are taking, have recently taken or might take any other
medicines.
Do not take ZYRESTALIif you are already taking nitrates.
Some medicines can be affected by ZYRESTALIor they themselves can affect the
way ZYRESTALIworks. 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.

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

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

Driving and using machines
Some men taking ZYRESTALIduring clinical studies have reported dizziness. Carefully
check how you react to the tablets before driving or using machines.

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

3. How to take ZYRESTALI

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.
The tablets of ZYRESTALIare 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. However, you have been
prescribed the dose consisting of a 20 mg tablet because your doctor has decided that the recommended
dose of 10 mg is too low.
You can take the ZYRESTALItablet at least 30 minutes before sexual activity.

ZYRESTALImay still be effective up to 36 hours after taking the tablet.
Do not take ZYRESTALImore than once a day. ZYRESTALI10 mg and 20 mg is indicated for
use before planned sexual activity and is not recommended for continuous daily use.
It is important to note that ZYRESTALIdoes 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
drug for erectile dysfunction.
Drinking alcoholic beverages may interfere with your ability to have an erection and may
temporarily cause a decrease in your blood pressure. If you have taken or intend to
take ZYRESTALI, 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 ZYRESTALI than you should:
Contact your doctor. It is possible that the undesirable effects described in paragraph 4 may occur.

If you forget to take ZYRESTALI
Take the dose as soon as you remember, do not take a double dose to compensate for forgetting
the tablet.
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 everyone will experience 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 ZYRESTALI(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, urticaria (itchy red patches on the skin surface), bleeding of the penis, presence of blood in the semen and increased sweating.

Rarely, in men taking ZYRESTALI, 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 ZYRESTALI. 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 effect dizziness has been reported more frequently in men over 75 years of age
taking ZYRESTALI. Diarrhoea has been reported more frequently in men over
65 years of age taking ZYRESTALI.

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 https://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 ZYRESTALI

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
Expiry Date/EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information What ZYRESTALI contains

• The active substanceis tadalafil. Each tablet contains 20 mg of tadalafil.
• The other ingredientsare: Tablet:lactose monohydrate (see the end of paragraph 2), corn starch, pregelatinized starch (corn), crospovidone, sodium lauryl sulfate, magnesium stearate. Film coating: lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin, yellow iron oxide (E172).

Description of the appearance of ZYRESTALI and contents of the pack
ZYRESTALI20 mg is a film-coated oblong tablet of dark yellow colour.

ZYRESTALI20 mg is available in blisters in packs of 4 tablets.

Marketing authorisation holder and manufacturer
Marketing authorisation holder: Elleva Pharma S.r.l., Via S. Francesco 5,
80034 Marigliano (NA), Italy
Manufacturer: Atlantic Pharma – Produções Farmacêuticas, S.A., Rua da Tapada Grande, nº2, Abrunheira,
2710-089 Sintra, Portugal.