Vintox

Package leaflet: Information for the user

VINTOX 10 mg film-coated tablets

tadalafil
Equivalent medicine
Please read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

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

Contents of this leaflet

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

1. What VINTOX is and what it is used for

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

Do not take VINTOX:

• if you are allergic to tadalafil or to 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. These are a group of medicines ("nitrates") used to treat angina pectoris (or "chest pain"). It has been shown that VINTOX enhances the effect of these medicines. If you are taking any form of nitrate or have any doubts, inform your doctor.
• if you have a severe heart disease or have had a heart attack recently, within the last 90 days.
• if you have recently had a stroke, within the last 6 months.
• if you have low blood pressure or uncontrolled high blood pressure.
• if you have previously experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as "stroke of the eye".
• 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). PDE5 inhibitors, such as tadalafil, 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 VINTOX.
Be aware that sexual activity involves a potential risk for patients with heart disease,
as it places additional strain on the heart. If you have a heart condition, inform your doctor.
Before taking the tablets, inform your doctor if you have:

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

It is not known whether VINTOX 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 (non-nerve-sparing radical prostatectomy). If you experience a sudden decrease or loss of vision, or if your vision becomes distorted or blurred while taking VINTOX, stop taking VINTOX 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 VINTOX and contact your doctor immediately.
VINTOX is not intended for use by women.
Children and adolescents
VINTOX is not intended for use in children or adolescents under 18 years of age.
Other medicines and VINTOX
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take VINTOX if you are already taking nitrates.
Some medicines may interact with VINTOX, or may affect how VINTOX works. Inform your doctor or pharmacist if you are taking:

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

• other medicines for high blood pressure.

• riociguat.

• a 5-alpha-reductase inhibitor (used to treat benign prostatic hyperplasia).

• medicines such as ketoconazole tablets (for fungal infections) and protease inhibitors for the treatment of AIDS or HIV infection.

• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).

• rifampicin, erythromycin, clarithromycin, or itraconazole.

• other treatments for erectile dysfunction.

VINTOX with food, drinks and alcohol
Information on the effects of alcohol is provided in section 3. Grapefruit juice may affect how VINTOX 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. It is unlikely that these effects would cause infertility.
Driving and using machines
Some men taking VINTOX in clinical studies reported dizziness. Carefully monitor how you react to the tablets before driving or operating machinery.
VINTOX contains lactose
If you have an intolerance to certain sugars, consult your doctor before taking this medicine.
VINTOX contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take VINTOX

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

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

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

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

Uncommon (may affect up to 1 in 100 people)

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

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

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

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

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

The side effect dizziness has been reported more frequently in men over 75 years of age taking VINTOX. Diarrhea has been reported more frequently in men over 65 years of age taking VINTOX.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store VINTOX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after Exp.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of 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. Pack contents and other information

What VINTOX contains

• The active substance is tadalafil. Each tablet contains 10 mg of tadalafil.
• The other components are: Tablet core: monohydrate lactose, pregelatinized starch, anhydrous colloidal silicon dioxide, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate. Film coating: hypromellose, monohydrate lactose, titanium dioxide (E171), triacetin, talc (E553b), yellow iron oxide (E172), red iron oxide (E172). Description of the appearance of VINTOX and pack contents 10 mg is a light yellow, film-coated, oval tablet, marked with "10" on one side and plain on the other, 11 mm x 6.6 mm in diameter and 3.9 - 4.5 mm thick.

VINTOX 10 mg is available in blisters containing 4 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
EBERLIFE FARMACEUTICI S.p.A.
Via G. Porzio snc
80143 Naples
Manufacturers:
Balkanpharma Dupnitsa AD
3 Samokovsko Shosse Str.,
Dupnitsa 2600
Bulgaria
Actavis Ltd.
BLB016, Bulebel Industrial Estate,
Zejtun ZTN 3000,
Malta
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR)
Italy
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Italy: VINTOX

Package leaflet: information for the user

VINTOX 5 mg film-coated tablets

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

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

Contents of this leaflet

1. What VINTOX is and what it is used for
2. What you need to know before taking VINTOX
3. How to take VINTOX
4. Possible side effects
5. How to store VINTOX
6. Package contents and other information

1. What VINTOX is and what it is used for

VINTOX contains the active substance tadalafil, which belongs to a class of medicines called phosphodiesterase type 5 inhibitors.
VINTOX 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. Tadalafil has been shown to significantly improve the ability to obtain an erection suitable for sexual activity. Following sexual stimulation, tadalafil helps relax the blood vessels in the penis, allowing increased blood flow into the penis. The result is improved erectile function. Tadalafil will not help you if you do not have erectile dysfunction. It is important to note that tadalafil for the treatment of erectile dysfunction has no effect in the absence of sexual stimulation. You and your partner will need to engage in foreplay, as you would if you were not taking a medicine for erectile dysfunction.
• Urinary symptoms associated with a common condition called benign prostatic hyperplasia. This condition occurs when the prostate enlarges with age. Symptoms include difficulty starting urination, a sensation of incomplete bladder emptying, and a more frequent need to urinate, including during the night. Tadalafil improves blood flow and relaxes the muscles of the prostate and bladder, which may reduce symptoms related to benign prostatic hyperplasia. Tadalafil has been shown to improve these urinary symptoms within 1-2 weeks after starting treatment.

2. What you need to know before taking VINTOX

Do not take VINTOX

• 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. These are a group of medicines ("nitrates") used to treat angina pectoris (or "chest pain"). It has been shown that VINTOX increases the effect of these medicines. If you are taking any form of nitrate or have any doubts, inform your doctor.
• if you have a severe heart disease or have recently had a heart attack (within the last 90 days).
• if you have recently had a stroke (within the last 6 months).
• if you have low blood pressure or uncontrolled high blood pressure.
• if you have previously experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as "stroke of the eye".
• 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). PDE5 inhibitors, such as tadalafil, 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 VINTOX.
Be aware that sexual activity involves a potential risk for patients with heart disease, as it puts additional strain on the heart. If you have a heart condition, inform your doctor.
Since benign prostatic hyperplasia and prostate cancer can have similar symptoms, your doctor will perform tests for prostate cancer before starting treatment with VINTOX for benign prostatic hyperplasia. VINTOX 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 blood cell disorder).
• any deformity of the penis.
• severe liver problems.
• severe kidney problems.

It is not known whether VINTOX 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 (nerve-sparing radical prostatectomy).

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

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

VINTOX with food, beverages, and alcohol
Information on the effects of alcohol is provided in section 3. Grapefruit juice may affect how VINTOX 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. These effects are unlikely to cause infertility.
Driving and operating machinery
Some men taking VINTOX in clinical studies reported dizziness. Carefully monitor how you react to the tablets before driving or operating machinery.
VINTOX contains lactose
If you have an intolerance to certain sugars, consult your doctor before taking this medicine.
VINTOX contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".

3. How to take VINTOX

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
VINTOX 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 lower your blood pressure. If you have taken or plan to take VINTOX, avoid excessive alcohol consumption (blood alcohol level of 0.08% or higher), as this may increase the risk of dizziness when standing up.

For the treatment of erectile dysfunction
The recommended dose is one 5 mg tablet taken once daily at approximately the same time each day. Your doctor may adjust the dose to 2.5 mg, depending on your response to VINTOX. This lower dose will be given as a 2.5 mg tablet. Do not take VINTOX more than once a day.
When taken once daily, VINTOX allows you to achieve an erection, if there is sexual stimulation, at any time during the 24-hour period following administration. Taking VINTOX once daily may be beneficial for men who anticipate having sexual activity two or more times per week.
It is important to note that VINTOX 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 both benign prostatic hyperplasia and erectile dysfunction, the dose remains one 5 mg tablet taken once daily.
DO NOT take VINTOX more than once a day.

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

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

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 everybody gets them. These effects are usually mild to moderate in intensity.
If you experience any of the following side effects, stop using the medicine and seek immediate medical assistance:

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

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

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

Uncommon (may affect up to 1 in 100 people)

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

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

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

Rarely, in men taking VINTOX, heart attacks and strokes have been reported. 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 VINTOX. These include:

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

The side effect dizziness has been reported more frequently in men over 75 years of age taking VINTOX. Diarrhea has been reported more frequently in men over 65 years of age taking VINTOX.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store VINTOX

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

6. Package contents and other information

What VINTOX contains

• The active substance is tadalafil. Each tablet contains 5 mg of tadalafil.
• The other components are: Tablet core: monohydrate lactose, pregelatinized starch, anhydrous colloidal silicon dioxide, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate. Film coating: hypromellose, monohydrate lactose, titanium dioxide (E171), triacetin, talc (E553b), yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of VINTOX and package contents
VINTOX 5 mg is a film-coated tablet, light yellow in colour, oval-shaped, with "5" engraved on one side and plain on the other side, 10 mm x 6.0 mm in diameter and 3.3 – 3.9 mm thick.
Pack sizes:
VINTOX 5 mg is available in blisters in packs of 14, 28 and 84 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
EBERLIFE FARMACEUTICI S.p.A.
Via G. Porzio snc
80143 Naples
Italy
Manufacturers:
Balkanpharma Dupnitsa AD
3 Samokovsko Shosse Str.,
Dupnitsa 2600
Bulgaria
Actavis Ltd.
BLB016, Bulebel Industrial Estate,
Zejtun ZTN 3000,
Malta
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR)
Italy

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Italy: VINTOX

Package leaflet: information for the user

VINTOX 20 mg film-coated tablets

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

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

1. What VINTOX is and what it is used for

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

Do not take VINTOX:

• if you are allergic to tadalafil or to 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. These are a group of medicines (“nitrates”) used to treat angina pectoris (or “chest pain”). VINTOX 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.
• if you have a severe heart disease or have recently had a heart attack (within the last 90 days).
• if you have recently had a stroke (within the last 6 months).
• if you have low blood pressure or uncontrolled high blood pressure.
• if you have previously experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “stroke of the eye”.
• 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). PDE5 inhibitors, such as tadalafil, have been shown to enhance the hypotensive effect of this medicine. If you are taking riociguat or have any doubts, inform your doctor.

Warnings and precautions
Talk to your doctor before taking VINTOX.
Be aware that sexual activity involves a potential risk for patients with heart disease,
as it puts additional strain on the heart. If you have any heart 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.
• severe liver problems.
• severe kidney problems.

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

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

If you experience a sudden decrease or loss of vision, or if your vision becomes distorted or blurred while taking
VINTOX, stop taking VINTOX 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
hearing decrease or loss, stop taking VINTOX and contact your doctor immediately.
VINTOX is not intended for use in women.
Children and adolescents
VINTOX is not intended for use in children and adolescents under 18 years of age.
Other medicines and VINTOX
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicines.
Do not take VINTOX if you are already taking nitrates.
Some medicines may be affected by VINTOX or may themselves affect how VINTOX 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 for the treatment of AIDS or HIV infection.
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

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

3. How to take VINTOX

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
VINTOX 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 doctor has prescribed you a dose of one 20 mg tablet because they have determined that the recommended 10 mg dose is too low for you.
You may take the VINTOX tablet at least 30 minutes before sexual activity. VINTOX may still be effective up to 36 hours after taking the tablet.
Do not take VINTOX more than once a day. VINTOX 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 VINTOX will not work without sexual stimulation. You and your partner will need to engage in foreplay as you normally would if you were not taking a medicine for erectile dysfunction.
Drinking alcohol may interfere with your ability to get an erection and may temporarily cause a lowering of your blood pressure. If you have taken or plan to take VINTOX, 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 VINTOX than you should
Contact your doctor. You may experience the side effects described in section 4. If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

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

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

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

Uncommon (may affect up to 1 in 100 people)

• dizziness, stomach discomfort, feeling unwell, malaise (vomiting), 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 (may affect up to 1 in 1,000 people)

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

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

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

The side effect dizziness has been reported more frequently in men over 75 years of age taking VINTOX. Diarrhoea has been reported more frequently in men over 65 years of age taking VINTOX.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store VINTOX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of 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 VINTOX contains

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

Description of the appearance of VINTOX and pack contents
20 mg is a yellowish film-coated tablet, oval-shaped, with "20" engraved on one side and plain on the other side, 12 mm x 7.4 mm in diameter and 4.6 – 5.2 mm thick.
Pack sizes:
VINTOX 20 mg is available in blisters containing 2, 4, 8 and 12 tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:
EBERLIFE FARMACEUTICI S.p.A.
Via G. Porzio snc
80143 Napoli
Italy

Manufacturers:
Balkanpharma Dupnitsa AD
3 Samokovsko Shosse Str.,
Dupnitsa 2600
Bulgaria

Actavis Ltd.
BLB016, Bulebel Industrial Estate,
Zejtun ZTN 3000,
Malta

Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR)
Italy

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Italy: VINTOX