Tadalafil Aristo: detailed information

Package leaflet: Information for the user

Tadalafil Aristo 5 mg film-coated tablets

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 other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What Tadalafil Aristo is and what it is used for
What you need to know before taking Tadalafil Aristo
How to take Tadalafil Aristo
Possible side effects
How to store Tadalafil Aristo
Contents of the pack and other information

1. What Tadalafil Aristo is and what it is used for

Tadalafil Aristo contains the active substance tadalafil, which belongs to a class of medicines called phosphodiesterase type 5 inhibitors.
Tadalafil Aristo 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 Aristo has been shown to significantly improve the ability to obtain an erection sufficient for sexual intercourse. Following sexual stimulation, Tadalafil Aristo helps relax the blood vessels in the penis, allowing blood to flow into the penis. The result is improved erectile function. Tadalafil Aristo will not help you if you do not have erectile dysfunction. It is important to note that Tadalafil Aristo 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 increased need to urinate, including during the night. Tadalafil Aristo improves blood flow and relaxes the smooth muscle of the prostate and bladder, which may reduce symptoms associated with benign prostatic hyperplasia. Tadalafil Aristo has been shown to improve these urinary symptoms as early as 1-2 weeks after starting treatment.

2. What you need to know before taking Tadalafil Aristo

Do not take Tadalafil Aristo 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"). It has been shown that Tadalafil Aristo increases 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 had a heart attack recently, 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 Tadalafil Aristo, 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 Tadalafil Aristo.
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.
Since benign prostatic hyperplasia and prostate cancer can have similar symptoms, your doctor will perform tests for prostate cancer before starting treatment with Tadalafil Aristo for benign prostatic hyperplasia. Tadalafil Aristo 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 bone marrow tumor);
leukemia (a malignant blood cell disorder);
any deformity of the penis;
a serious liver problem;
a serious kidney problem.

It is not known whether Tadalafil Aristo 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, stop taking Tadalafil Aristo and contact your doctor immediately.
The use of Tadalafil Aristo is not indicated in women.
Children and adolescents
Tadalafil Aristo is not indicated for use in children and adolescents under 18 years of age.
Other medicines and Tadalafil Aristo
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Do not take Tadalafil Aristo if you are already taking nitrates.
Some medicines may be affected by Tadalafil Aristo or may themselves affect how Tadalafil Aristo 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.

Tadalafil Aristo with food, drinks and alcohol
Information on the effects of alcohol is provided in section 3. Grapefruit juice may affect how Tadalafil Aristo works and should be consumed with caution. Consult your doctor for further information.
Fertility
In dogs treated with tadalafil, reduced sperm development in the testes was observed. A reduction in sperm count has been observed in some men. These effects are unlikely to cause infertility.
Driving and using machines
Some men taking Tadalafil Aristo in clinical studies reported dizziness. Carefully assess how you react to the tablets before driving or operating machinery.
Tadalafil Aristo contains lactose
If you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Tadalafil Aristo

Take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
Tadalafil Aristo tablets are for oral use and for men only. Swallow the tablet whole with water. The tablets can be taken with or without food.
Drinking alcohol may temporarily cause a reduction in your blood pressure. If you have taken or plan to take Tadalafil Aristo, 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 Tadalafil Aristo. This dose will be provided as a 2.5 mg tablet.
Do not take Tadalafil Aristo more than once a day.
When taken once daily, Tadalafil Aristo allows you to achieve an erection, if there is sexual stimulation, at any time during the 24-hour period. Daily administration of Tadalafil Aristo may be beneficial for men who anticipate having sexual activity two or more times per week.
It is important to note that Tadalafil Aristo 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 achieve 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 Tadalafil Aristo more than once a day.

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

If you forget to take Tadalafil Aristo
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 Tadalafil Aristo more than once a day.

If you have any questions 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 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 rash (uncommon frequency);
chest pain – do not take nitrates but seek immediate medical help (uncommon frequency);
prolonged and possibly painful erection after taking Tadalafil Aristo (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 (seen in 1 to 10 out of 100 patients)

headache, back pain, muscle aches, arm and leg pain, facial flushing, nasal congestion, and digestive disturbances.

Uncommon (seen in 1 to 10 out of 1,000 patients)

dizziness, stomach discomfort, feeling unwell, nausea (vomiting), acid reflux, blurred vision, eye discomfort, breathing difficulties, blood in urine, 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 (seen in 1 to 10 out of 10,000 patients)

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 semen, and increased sweating.

Rarely, heart attacks and strokes have been reported in men taking Tadalafil. 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 tadalafil. 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 tadalafil. Diarrhoea has been reported more frequently in men over 65 years of age taking tadalafil.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform 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 Tadalafil Aristo

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.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Tadalafil Aristo contains

The active substance is tadalafil. Each film-coated tablet contains 5 mg of tadalafil.
The other components are: Tablet core: monohydrate lactose (see end of paragraph 2), croscarmellose sodium, hydroxypropylcellulose, microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate. Film coating with Opadry II Yellow 32K220031: hydroxypropylmethylcellulose, monohydrate lactose, titanium dioxide (E171), triacetin, yellow iron oxide (E172), talc.

Description of the appearance of Tadalafil Aristo and the contents of the pack
Tadalafil Aristo 5 mg is a yellow, oval-shaped, film-coated tablet, measuring 8.70 x 4.50 mm, biconvex, with a score line on one side and "T 5" imprinted on the other. The tablet can be divided into two equal doses.
Tadalafil Aristo 5 mg is available in blister packs containing 14, 28 or 84 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Aristo Pharma GmbH
Wallenroder Straße 8 – 10
13435 Berlin
Germany

This medicinal product is authorised in the European Economic Area Member States under the following names:
Austria Tadalafil Aristo 5 mg Filmtabletten
Germany Tadalafil Aristo 5 mg Filmtabletten
Italy Tadalafil Aristo 5 mg film-coated tablet
Malta Tadalafil Aristo 5 mg film-coated tablets
Netherlands Tadalafil Aristo 5 mg filmomhulde tabletten
Portugal Tadalafil Aristo 5 mg Comprimido revestido por película
United Kingdom Tadalafil Aristo 5 mg film-coated tablets
Spain Tadalafil Aristo 5 mg comprimidos recubiertos con película EFG

Package leaflet: Information for the user

Tadalafil Aristo 10 mg film-coated tablets, 20 mg film-coated tablets

Equivalent 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 other people, 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, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What Tadalafil Aristo is and what it is used for
What you need to know before taking Tadalafil Aristo
How to take Tadalafil Aristo
Possible side effects
How to store Tadalafil Aristo
Contents of the pack and other information

1. What Tadalafil Aristo is and what it is used for

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

Do not take Tadalafil Aristo 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"). It has been shown that Tadalafil Aristo 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 Tadalafil Aristo, 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 Tadalafil Aristo.
Be aware that sexual activity poses 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;
a serious liver problem;
a serious kidney problem.

It is not known whether Tadalafil Aristo 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, stop taking Tadalafil Aristo and contact your doctor immediately.
The use of Tadalafil Aristo is not indicated in women.
Children and adolescents
Tadalafil Aristo is not indicated for use in children and adolescents under 18 years of age.
Other medicines and Tadalafil Aristo
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Do not take Tadalafil Aristo if you are already taking nitrates.
Some medicines may be affected by Tadalafil Aristo, or they may affect how Tadalafil Aristo 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 treating high blood pressure;
riociguat;
a 5-alpha-reductase 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, or carbamazepine (anticonvulsant medicines);
rifampicin, erythromycin, clarithromycin, or itraconazole;
other treatments for erectile dysfunction.

Tadalafil Aristo with food and alcohol
Information on the effects of alcohol is provided in section 3. Grapefruit juice may affect how Tadalafil Aristo works and should be consumed with caution. Consult your doctor for further information.
Fertility
In dogs treated with tadalafil, reduced sperm development in the testes was observed. In some men, a reduction in sperm count has been observed. These effects are unlikely to cause infertility.
Driving and using machines
Some men taking Tadalafil Aristo in clinical studies reported dizziness. Carefully assess how you react to the tablets before driving or operating machinery.
Tadalafil Aristo contains lactose
If you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Tadalafil Aristo

Take this medicine exactly as your doctor has instructed you. If you have any doubts, consult your doctor or pharmacist.
Tadalafil Aristo tablets are for oral use and are intended only for men. Swallow the tablet whole with water. The tablets may be taken regardless of food intake.
The recommended dose is one 10 mg tablet taken prior to sexual activity. However, your doctor has prescribed you a 20 mg tablet because he/she has determined that the recommended 10 mg dose is too weak for you.
You may take the Tadalafil Aristo tablet at least 30 minutes before sexual activity.
Tadalafil Aristo may remain effective for up to 36 hours after taking the tablet.
Do not take Tadalafil Aristo more than once a day. Tadalafil Aristo 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 Tadalafil Aristo 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 temporarily cause a drop in your blood pressure. If you have taken or plan to take Tadalafil Aristo, 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 Tadalafil Aristo than you should
Contact your doctor. You may experience the side effects described in section 4.
If you forget to take Tadalafil Aristo
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 Tadalafil Aristo more than once a day.
If you have any questions 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 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);
prolonged and possibly painful erection after taking Tadalafil Aristo (rare frequency). If you have an erection of this type lasting more than 4 hours in a row, you must contact a doctor immediately;
sudden loss of vision (rare frequency).

Other side effects have been reported:
Common (observed in 1 to 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 to 10 patients out of 1,000)

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

Rare (observed in 1 to 10 patients out of 10,000)

fainting, seizures, 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, heart attacks and strokes have been reported in men taking Tadalafil. Most of these individuals had pre-existing heart conditions before using 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 tadalafil. 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 tadalafil. Diarrhoea has been reported more frequently in men over 65 years of age taking tadalafil.
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 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 Tadalafil Aristo

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 pack after "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. Package Contents and Other Information

What Tadalafil Aristo Contains

The active substance is tadalafil. Each film-coated tablet contains 10 mg of tadalafil.
The active substance is tadalafil. Each film-coated tablet contains 20 mg of tadalafil.
The other ingredients are: Tablet core: monohydrate lactose (see end of section 2), croscarmellose sodium, hydroxypropylcellulose, microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate. Film coating with Opadry II Yellow 32K220019: hypromellose, monohydrate lactose, titanium dioxide (E171), triacetin, iron oxide yellow (E172), talc. Film coating with Opadry II Yellow 32K220019: hypromellose, monohydrate lactose, titanium dioxide (E171), triacetin, iron oxide yellow (E172), talc.

Description of the Appearance of Tadalafil Aristo and Contents of the Pack
Tadalafil Aristo 10 mg is a yellow, oval-shaped, film-coated tablet, 11.50 x 5.90 mm in size, biconvex, with a score on one side and engraved “T 10” on the other. The tablet can be divided into two equal doses.
Tadalafil Aristo 20 mg is a yellow, oval-shaped, film-coated tablet, 13.90 x 7.20 mm in size, biconvex, with a score on one side and engraved “T 20” on the other. The tablet can be divided into two equal doses.
Tadalafil Aristo 10 mg is available in blister packs containing 4, 8, 12, 20 or 30 film-coated tablets.
Tadalafil Aristo 20 mg is available in blister packs containing 2, 4, 8, 12, 20 or 30 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Aristo Pharma GmbH
Wallenroder Straße 8 – 10
13435 Berlin
Germany

This medicinal product is authorized in the European Economic Area countries under the following names:
Austria Tadalafil Aristo 10 mg Filmtabletten
Germany Tadalafil Aristo 10 mg Filmtabletten
Italy Tadalafil Aristo 10 mg film-coated tablet
Malta Tadalafil Aristo 10 mg film-coated tablets
Netherlands Tadalafil Aristo 10 mg filmomhulde tabletten
Portugal Tadalafil Aristo 10 mg Comprimido revestido por película
United Kingdom Tadalafil Aristo 10 mg film-coated tablets
Spain Tadalafil Aristo 10 mg comprimidos recubiertos con película EFG

Austria Tadalafil Aristo 20 mg Filmtabletten
Germany Tadalafil Aristo 20 mg Filmtabletten
Italy Tadalafil Aristo 20 mg film-coated tablet
Malta Tadalafil Aristo 20 mg film-coated tablets
Netherlands Tadalafil Aristo 20 mg filmomhulde tabletten
Portugal Tadalafil Aristo 20 mg Comprimido revestido por película
United Kingdom Tadalafil Aristo 20 mg film-coated tablets
Spain Tadalafil Aristo 20 mg comprimidos recubiertos con película EFG