VINTOX 5 mg Tabletki Powlekane

Treść ulotki

1. What is VINTOX and what is it 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
7. VINTOX 10 mg film-coated tablets
   1. What is VINTOX and what is it 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
8. VINTOX 20 mg film-coated tablets
   1. What is VINTOX and what is it 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

VINTOX 5 mg film-coated tablets
Generic medicine

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

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

Contents of this leaflet

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

VINTOX contains the active ingredient tadalafil which belongs to the 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 cannot achieve or maintain an erection adequate for sexual intercourse. Tadalafil has been shown to significantly improve the ability to achieve an erection adequate for sexual intercourse. After sexual stimulation tadalafil helps to relax the blood vessels in the penis, allowing blood flow to the penis. The result of this 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 if there is no sexual stimulation. You and your partner will need to engage in foreplay, as you would if you were not taking medication for erectile dysfunction.
• urinary symptoms associated with a common condition called benign prostatic hyperplasia.This condition occurs when the prostate gland enlarges with age. Symptoms include difficulty starting urination, a sensation of not emptying the bladder completely, and a more frequent need to urinate, even at night. Tadalafil improves blood flow and relaxes the muscles of the prostate and bladder, which can reduce the symptoms associated with benign prostatic hyperplasia. Tadalafil has been shown to improve these urinary symptoms within 1-2 weeks of 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. This is a group of medicines (“nitrates”) used for the treatment of 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, tell your doctor.

• if you have a serious heart condition or have recently had a heart attack, in the last 90 days.
• if you have recently had a stroke, in the last 6 months.
• if you have low blood pressure or uncontrolled high blood pressure.
• if you have previously experienced a loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “eye stroke”.
• 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 tadalafil, 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 VINTOX.
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.
Because benign prostatic hyperplasia and prostate cancer can have the same symptoms, your
doctor will perform checks for prostate cancer before starting treatment with
VINTOX for benign prostatic hyperplasia. VINTOX does not cure prostate cancer.
Before taking the tablets, tell your doctor if you have:

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

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 of the prostate have been cut (radical prostatectomy without neurovascular bundle preservation).

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

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

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

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

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

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

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

VINTOX contains lactose
If you have an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take VINTOX

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

For the treatment of benign prostatic hyperplasia
The doseis one 5 mg tablet to be taken once daily 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 daily.
DO NOT take VINTOX more than once a day.

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

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
forgotten tablet. You should not take VINTOX more than once a day.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

If any of the following side effects occur, stop using the medicine and seek
immediate medical 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 VINTOX (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(may affect up to 1 in 10 people)

• headache, back pain, muscle pain, pain in the arms and legs, hot flushes on the face, nasal congestion and digestive disorders. Uncommon(may affect up to 1 in 100 people)
• 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(may affect up to 1 in 1,000 people)
• fainting, convulsions and transient memory loss, eyelid swelling, 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 VINTOX, heart attacks and strokes have been reported. Most 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 VINTOX. 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 the age of 75 years
who were taking VINTOX. Diarrhea has been reported more frequently in men over the age of
65 years who were taking VINTOX.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at http ://www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store VINTOX

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and blister after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What VINTOX contains

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

Description of the appearance of VINTOX and contents of the pack
VINTOX 5 mg is a film-coated tablet of light yellow colour, oval in shape, 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 in thickness.
Pack sizes:
VINTOX 5 mg is available in blisters in packs of 14, 28 tablets. Not all pack sizes may be
marketed.

Marketing authorisation holder and manufacturer
Marketing authorisation holder:

Manufacturer:
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 denominations:
Italy: VINTOX

VINTOX 10 mg film-coated tablets

Generic medicine

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

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

Contents of this leaflet

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

VINTOXis a treatment for adult men with erectile dysfunction. This condition occurs
when a man is unable to achieve or maintain an erection adequate for sexual intercourse.

VINTOXhas been shown to significantly improve the ability to achieve an erection adequate for a
sexual intercourse.

VINTOXcontains the active substance tadalafil which belongs to the class of medicines called
phosphodiesterase type 5 inhibitors. After sexual stimulation VINTOXhelps to relax the blood
vessels in the penis, allowing blood flow to the penis. The result is improved erectile function.

VINTOXwill not be helpful if you do not have erectile dysfunction.
It is important to note that VINTOXhas 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 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. This is a group of medicines (“nitrates”) used to treat angina pectoris (or “chest pain”). It has been shown that VINTOXincreases the effect of these medicines. If you are taking any form of nitrate or have any doubts, tell your doctor.
• if you have a serious heart condition or have had a heart attack recently, within the last 90 days.
• if you have had a stroke recently, within the last 6 months.
• if you have low or uncontrolled high blood pressure.
• if you have previously experienced loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “eye stroke”.
• if you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high blood pressure in the lungs secondary to blood clots).

It has been shown that PDE5 inhibitors, such as tadalafil, 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 VINTOX.
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 the blood cells).
• any deformity of the penis.
• a serious liver problem.
• a serious kidney problem.

It is not known whether VINTOXis 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 VINTOXand contact your doctor immediately.

In some patients taking tadalafil, a 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 a sudden decrease or loss of hearing, stop taking VINTOXand contact your doctor immediately.

VINTOXis not indicated for use by women.

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

Other medicines and VINTOX
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take VINTOXif you are already taking nitrates.
Some medicines can be affected by VINTOXor they themselves can affect how VINTOXworks. 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.

VINTOX with food, drinks and alcohol
Information about the effects of alcohol is given in section 3. Grapefruit juice can affect how VINTOXworks and should be taken with caution. Ask your doctor for further information.

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

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

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

3. How to take VINTOX

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

VINTOXmay still be effective up to 36 hours after taking the tablet.
Do not take VINTOXmore than once a day. VINTOX10 mg and 20 mg is indicated to be used
before planned sexual activity and is not recommended for continuous daily use.
It is important to note that VINTOXdoes not work if there is no sexual stimulation. You and your partner will
need to engage in foreplay as you would if you were not taking a medicine for erectile
dysfunction.
Drinking 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 VINTOX, 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 VINTOX than you should
Contact your doctor. Undesirable effects as described in paragraph 4 may occur. If you have
any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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

• allergic reactions, including skin rashes (uncommon frequency).
• chest pain - do not use nitrates but seek immediate medical attention (uncommon frequency).
• Priapism, a prolonged and possibly painful erection after taking VINTOX(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(may affect up to 1 in 10 people)

• headache, back pain, muscle pain, pain in the arms and legs, flushing of the face, nasal congestion and digestive disorders.

Uncommon(may affect up to 1 in 100 people)

• dizziness, stomach pain, feeling unwell, nausea (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(may affect up to 1 in 1000 people)

• 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 VINTOX, heart attacks and strokes have been reported. Most 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 VINTOX. These include:

• migraine, swelling of the face, 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 who
were taking VINTOX. Diarrhoea has been reported more frequently in men over 65 years of age
who were taking VINTOX.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at http:// www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store VINTOX

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and on the blister after Exp.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What VINTOX contains

• The activesubstance is tadalafil. Each tablet contains 10 mg of tadalafil.
• The other componentsare: Tablet core: lactose monohydrate, pregelatinized starch, anhydrous colloidal silica, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate. Film coating: hypromellose, lactose monohydrate, titanium dioxide (E171), triacetin, talc (E553b), yellow iron oxide (E172), red iron oxide (E172). Description of the appearance of VINTOX and contents of the pack10 mg is a film-coated tablet of light yellow color, oval in shape, with “10” imprinted on one side and plain on the other side, 11 mm x 6.6 mm in diameter and 3.9 - 4.5 mm in thickness.

VINTOX10 mg is available in blisters in packs of 4 tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Marketing authorisation holder:
LANOVA FARMACEUTICI
Via Conca d’oro, 212
00141 ROMA

Manufacturer:
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

VINTOX 20 mg film-coated tablets

Tadalafil
Generic medicine

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

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

Contents of this leaflet

• 1. What VINTOX is and what it is used for
• 2. What you need to know before you take 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 is VINTOX and what is it 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 adequate for sexual intercourse.
VINTOX has been shown to significantly improve the ability to achieve an erection adequate for a
sexual intercourse.
VINTOX contains the active substance tadalafil which belongs to the class of medicines called
phosphodiesterase type 5 inhibitors. After sexual stimulation VINTOX helps to relax the blood
vessels in the penis, allowing blood flow to the penis. The result is improved
erectile function. VINTOX will not be helpful if you do not have erectile dysfunction.
It is important to note that VINTOX 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.

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. This is 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, tell your doctor.
• if you have a serious heart condition or have had a heart attack recently, within the last 90 days.
• if you have had a stroke recently, within the last 6 months.
• if you have low or uncontrolled high blood pressure.
• if you have previously experienced loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “eye stroke”.
• if you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high blood pressure in the lungs secondary to blood clots). It has been shown that PDE5 inhibitors, such as tadalafil, 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 VINTOX .
Be aware that sexual activity involves a potential risk for patients with a heart
condition, because it puts extra strain on the heart. If you have a heart problem, tell your doctor.
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 VINTOX is effective in patients who have undergone:

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

If you experience a sudden decrease or loss of vision, stop taking VINTOX and contact
your doctor immediately.
Decreased 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 sudden decrease or loss of hearing, stop taking VINTOX and contact
your doctor immediately.
VINTOX is not indicated for use by women.

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

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

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

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

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

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

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

3. How to take VINTOX

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
VINTOX tablets are for oral use and only for men. Swallow the tablet whole with
water. The tablets can be taken independently of food intake.

The recommended doseis one 10 mg tablet before sexual activity. However, you have been prescribed
a 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 VINTOX tablet at least 30 minutes before sexual activity. VINTOX may be
still 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 indicated to be used before
a planned sexual activity and is not recommended for continuous daily use.
It is important to note that VINTOX does not work if there is no sexual stimulation. You and your partner will
need to engage in foreplay as you would if you were not taking a medicine for erectile
dysfunction.
Drinking 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 VINTOX, 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 VINTOX than you should
Contact your doctor. Undesirable effects described in paragraph 4 may occur. If you have
any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

If any of the following side effects occur, stop using the medicine and seek
immediate medical 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 VINTOX (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(may affect up to 1 in 10 people)

• headache, back pain, muscle pain, pain in the arms and legs, flushing, nasal congestion and digestive disorders. Uncommon(may affect up to 1 in 100 people)
• 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(may affect up to 1 in 1000 people)

• 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 VINTOX, heart attacks and strokes have been reported. Most 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 VINTOX. 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 the age of 75 who
were taking VINTOX. Diarrhea has been reported more frequently in men over the age of 65
who were taking VINTOX

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at http :// www.agenziafarmaco.gov.it/content/come-
segnalare-una-sospetta-reazione-avversa .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store VINTOX

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and on the blister after Exp. The
expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What VINTOX contains

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

Description of the appearance of VINTOX and contents of the pack
20 mg is a film-coated tablet of light yellow color, oval in shape, with “20” imprinted on one side
and plain on the other side, 12 mm x 7.4 mm in diameter and 4.6 – 5.2 mm in thickness.
Packs:
VINTOX 20 mg is available in blisters in packs of 2, 4 and 8 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
LANOVA FARMACEUTICI SRL
Via Conca D’Oro, 212
00141 ROME

Manufacturer:
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
denominations:
Italy: VINTOX