Vicuma

Package leaflet: Information for the user

VICUM 5 mg film-coated tablets

Tadalafil
Generic medicine
Read this entire 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 pass it on 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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What VICUM is and what it is used for

VICUM contains the active substance tadalafil, which belongs to a class of medicines called phosphodiesterase type 5 inhibitors.
VICUM 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. VICUM has been shown to significantly improve the ability to obtain an erection suitable for sexual activity. Following sexual stimulation, VICUM helps relax the blood vessels in the penis, allowing increased blood flow into the penis. The result is improved erectile function. VICUM will not help you if you do not have erectile dysfunction. It is important to note that VICUM, 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 gland enlarges with age. Symptoms include difficulty starting urination, a sensation of incomplete bladder emptying, and a more frequent need to urinate, including during the night. VICUM improves blood flow and relaxes the muscles of the prostate and bladder, which may reduce symptoms related to benign prostatic hyperplasia. VICUM has been shown to improve these urinary symptoms within 1–2 weeks after starting treatment.

2. What you need to know before taking VICUM

Do not take VICUM 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"). VICUM 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 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 sometimes 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 VICUM, 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 VICUM.
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 condition, inform your doctor.
Since benign prostatic hyperplasia and prostate cancer can have similar symptoms, your doctor will perform tests for prostate cancer before starting treatment with VICUM for benign prostatic hyperplasia. VICUM 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.
• a serious liver problem.
• a serious kidney problem.

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

• pelvic surgery
• removal of all or part of the prostate gland with damage to the nerves of the prostate (radical prostatectomy without nerve-sparing).

If you experience a sudden decrease or loss of vision, stop taking VICUM 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 decrease or loss of hearing, stop taking VICUM and contact your doctor immediately.
VICUM is not intended for use by women.
Children and adolescents
VICUM is not intended for use in children and adolescents under 18 years of age.
Other medicines and VICUM
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Do not take VICUM if you are already taking nitrates.
Some medicines may interact with VICUM, or VICUM may affect how other medicines work. Inform your doctor or pharmacist if you are taking:

• an alpha-blocker (used to treat high blood pressure or urinary problems associated with benign prostatic hyperplasia).
• other medicines 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.

VICUM with food, beverages, and alcohol
Information on the effects of alcohol is provided in section 3. Grapefruit juice may affect how VICUM 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. A reduction in sperm count has also been observed in some men. It is unlikely that these effects would lead to infertility.
Driving and use of machines
Some men taking VICUM in clinical studies reported dizziness. Carefully assess how you react to the tablets before driving or operating machinery.
VICUM contains lactose:
If you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take VICUM

Take this medicine exactly as your doctor has told you. If you are unsure, consult your
doctor or pharmacist.
The VICUM 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 drop in your blood pressure. If you have taken or plan to take VICUM, 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 based on your response to VICUM. This dose will be provided as a 2.5 mg tablet.
VICUM is not available in the 2.5 mg dosage strength; if this dosage is required, you should consider other medicinal products containing Tadalafil.
Do not take VICUM more than once a day.
When taken once daily, VICUM allows you to achieve an erection, if there is sexual stimulation, at any time during the 24-hour period following administration. Daily administration of VICUM may be beneficial for men who anticipate having sexual activity two or more times per week.
It is important to note that VICUM does not work 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.
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 benign prostatic hyperplasia and erectile dysfunction, the dose remains one 5 mg tablet taken once daily.
DO NOT take VICUM more than once a day.

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

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

If you have any questions 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 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).
• priapism, a prolonged and possibly painful erection after taking VICUM (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 (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 ache, feeling unwell, nausea (vomiting), acid reflux, blurred vision, eye discomfort, breathing difficulties, presence of blood in urine, prolonged erection, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of the hands, feet or ankles, and feeling tired.

Rare (observed in 1-10 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 semen, and increased sweating.
  Rarely, heart attacks and strokes have been reported in men taking VICUM. Most of these individuals already had pre-existing heart conditions before using the medicine.
  Rarely, cases of partial, temporary or permanent reduction 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 VICUM. These include:

• migraine, facial swelling, severe allergic reaction causing swelling of the face or throat, serious 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 VICUM. Diarrhea has been reported more frequently in men over 65 years of age taking VICUM.
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 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 VICUM

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 carton and blister after Exp.
The expiry date refers to the last day of that month.
Do not dispose of medicines 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 VICUM contains

• The active substance is tadalafil. Each tablet contains 5 mg of tadalafil.
• The other components are: Tablet core: monohydrate lactose (see end of section 2), maize starch, pregelatinized starch (maize), crospovidone, sodium lauryl sulfate, magnesium stearate. Film coating: monohydrate lactose, hypromellose, titanium dioxide (E171), triacetin, yellow iron oxide (E172).

Description of the appearance of VICUM and package contents
VICUM 5 mg is an oblong, film-coated tablet of cream to light yellow colour.
VICUM 5 mg is available in blisters in packs of 28 tablets.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder: LANOVA FARMACEUTICI S.r.l - Via Conca d’Oro, 212 - 00141 Rome, Italy
Manufacturer: Atlantic Pharma – Produções Farmacêuticas, S.A., Rua da Tapada Grande, nº2, Abrunheira, 2710-089 Sintra, Portugal.

Package leaflet: Information for the user

VICUM 10 mg film-coated tablets

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

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

Contents of this leaflet:

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

1. What VICUM is and what it is used for

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

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

• pelvic surgery
• removal of all or part of the prostate gland with damage to the nerves of the prostate (radical prostatectomy without preservation of neurovascular bundles).

If you experience sudden decrease or loss of vision, stop taking VICUM 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 decrease or loss of hearing, stop taking VICUM and contact your doctor immediately.
VICUM is not intended for use by women.
Children and adolescents
VICUM is not intended for use in children or adolescents under 18 years of age.
Other medicines and VICUM
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Do not take VICUM if you are already taking nitrates.
Some medicines may interact with VICUM, or VICUM may affect how other medicines work. Inform your doctor or pharmacist if you are taking:

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

VICUM with food, beverages, and alcohol
Information on the effects of alcohol is provided in section 3. Grapefruit juice may affect how VICUM 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 VICUM in clinical studies reported dizziness. Carefully assess how you react to the tablets before driving or operating machinery.
VICUM contains lactose:
If you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take VICUM

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.
The VICUM tablets are for oral use and for men only. Swallow the tablet whole with water. The tablets can be taken regardless of food intake.
The recommended dose is one 10 mg tablet before sexual activity. If the effect of this dose is too weak, your doctor may increase the dose to 20 mg. VICUM tablets are for oral use.
You can take the VICUM tablet at least 30 minutes before sexual activity. VICUM may still be effective up to 36 hours after taking the tablet.
Do not take VICUM more than once a day. VICUM 10 mg and 20 mg is intended to be used before anticipated sexual activity and is not recommended for continuous daily use.
It is important to note that VICUM will not work 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.
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 VICUM, avoid excessive alcohol consumption (blood alcohol level of 0.08% or higher), as this may increase the risk of dizziness when standing up.
If you take more VICUM than you should:
Contact your doctor. You may experience side effects described in section 4. 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 everyone gets them. These side effects are usually mild to moderate in intensity.
If you experience any of the following side effects, stop taking the medicine and seek immediate medical help:

• allergic reactions, including skin rashes (uncommon frequency).
• chest pain – do not take nitrates but seek immediate medical help (uncommon frequency).
• priapism, a prolonged and possibly painful erection after taking VICUM (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 (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, feeling unwell, nausea (vomiting), acid reflux, blurred vision, eye discomfort, breathing difficulties, blood in the urine, prolonged erection, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of the hands, feet or ankles, and feeling tired.

Rare (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 the semen, and increased sweating.

Rarely, heart attacks and strokes have been reported in men taking VICUM. Most of these individuals already had heart problems before taking the medicine.
Rare 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 VICUM. 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.

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

Keep this medicine out of 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.
Store in the original packaging to protect the medicine from moisture. Do not store above 30°C.
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 VICUM contains

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

Description of the appearance of VICUM and package contents
VICUM 10 mg is an oblong, film-coated tablet, dark yellow in colour.
VICUM 10 mg is available in blisters containing 4 or 8 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder: LANOVA FARMACEUTICI S.r.l - Via Conca D’oro, 212 - 00141 Rome, Italy
Manufacturer: Atlantic Pharma – Produções Farmacêuticas, S.A., Rua da Tapada Grande, nº2, Abrunheira, 2710-089 Sintra, Portugal.

Package leaflet: information for the user

VICUM 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What VICUM is and what it is used for

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

Do not take VICUM 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"). It has been shown that VICUM enhances 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 VICUM, 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 VICUM.
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 serious liver problem.
• a serious kidney problem.

It is not known whether VICUM 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 nerve-sparing).

If you experience a sudden decrease or loss of vision, stop taking VICUM 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 VICUM and contact your doctor immediately.
VICUM is not intended for use by women.
Children and adolescents
VICUM is not intended for use in children and adolescents under 18 years of age.
Other medicines and VICUM
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Do not take VICUM if you are already taking nitrates.
Some medicines may be affected by VICUM, or they may affect how VICUM 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 enzyme inhibitor (used to treat benign prostatic hyperplasia).
• medicines such as ketoconazole tablets (for treating 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.

VICUM with food, beverages and alcohol
Information about the effects of alcohol is provided in section 3. Grapefruit juice may affect how VICUM 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 use of machines
Some men taking VICUM in clinical studies reported dizziness. Carefully monitor how you react to the tablets before driving or operating machinery.
VICUM contains lactose:
If you have an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take VICUM

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The VICUM 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 before sexual activity. However, your prescribed dose is one 20 mg tablet, as your doctor has determined that the recommended 10 mg dose is too low for you.
You may take the VICUM tablet at least 30 minutes before sexual activity.
VICUM may remain effective for up to 36 hours after taking the tablet.
Do not take VICUM more than once a day. VICUM 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 VICUM 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 VICUM, avoid excessive alcohol consumption (blood alcohol level of 0.08% or higher), as this may increase the risk of dizziness when standing up.
If you take more VICUM than you should:
Contact your doctor. You may experience the side effects described in section 4.
If you forget to take VICUM
Take the missed dose as soon as you remember. Do not take a double dose to make up for the forgotten tablet.
If you have any questions 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 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 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 VICUM (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 (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 ache, feeling unwell, nausea (vomiting), acid reflux, blurred vision, eye discomfort, breathing difficulties, blood in urine, prolonged erection, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, tinnitus, swelling of the hands, feet or ankles, and feeling tired.

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), bleeding from the penis, blood in semen, and increased sweating.

Rarely, heart attacks and strokes have been reported in men taking VICUM. Most of these individuals already had pre-existing heart conditions before using the medicine.
Rarely, 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 VICUM. 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 VICUM. Diarrhoea has been reported more frequently in men over 65 years of age taking VICUM.
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 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 VICUM

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.
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. Pack contents and other information What VICUM contains

• The active substance is tadalafil. Each tablet contains 20 mg of tadalafil.
• The other ingredients are: Tablet: monohydrate lactose (see end of section 2), maize starch, pregelatinized starch (maize), crospovidone, sodium lauryl sulfate, magnesium stearate. Film coating: monohydrate lactose, hypromellose, titanium dioxide (E171), triacetin, yellow iron oxide (E172).

Description of the appearance of VICUM and contents of the pack
VICUM 20 mg is a yellowish-brown, film-coated, oval tablet.
VICUM 20 mg is available in blisters, packs containing 4 tablets.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder: LANOVA FARMACEUTICI S.r.l - Via Conca D’oro, 212 - 00141 Rome, Italy
Manufacturer: Atlantic Pharma – Produções Farmacêuticas, S.A., Rua da Tapada Grande, nº2, Abrunheira, 2710-089 Sintra, Portugal.