Tadalafil Aurobindo

Package leaflet: Information for the user

Tadalafil Aurobindo 5 mg film-coated tablets

Generic 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 other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Tadalafil Aurobindo contains the active substance tadalafil, which belongs to a class of medicines called phosphodiesterase type 5 inhibitors.
Tadalafil Aurobindo 5 mg 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. Tadalafil Aurobindo has been shown to significantly improve the ability to obtain an erection sufficient for sexual intercourse. Following sexual stimulation, Tadalafil Aurobindo helps relax the blood vessels in the penis, allowing blood to 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 gland enlarges with age. Symptoms include difficulty starting urination, a feeling of incomplete bladder emptying, and a more frequent need to urinate, including during the night. Tadalafil improves blood flow and relaxes the smooth muscle of the prostate and bladder, which may reduce the symptoms associated with benign prostatic hyperplasia. Tadalafil 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 Aurobindo

Do not take Tadalafil Aurobindo:

• 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 ("chest pain"). Tadalafil Aurobindo 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 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 Aurobindo, 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 or pharmacist before taking Tadalafil Aurobindo.
You should 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 Tadalafil Aurobindo for benign prostatic hyperplasia. Tadalafil Aurobindo 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.
• severe liver problems.
• severe kidney problems.

It is not known whether Tadalafil Aurobindo 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 (non-nerve-sparing radical prostatectomy).

If you experience a sudden decrease or loss of vision, stop taking Tadalafil Aurobindo and contact your doctor immediately.
In some patients taking tadalafil, sudden decrease or loss of hearing has been observed.
Although it is not known whether this event is directly related to tadalafil, if you experience sudden decrease or loss of hearing, stop taking Tadalafil Aurobindo and contact your doctor immediately.
Tadalafil Aurobindo is not intended for use in women.
Children and adolescents
Tadalafil Aurobindo is not intended for use in children and adolescents under 18 years of age.
Other medicines and Tadalafil Aurobindo
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Do not take Tadalafil Aurobindo if you are already taking nitrates.
Some medicines may be affected by Tadalafil Aurobindo, or they may affect how Tadalafil Aurobindo 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 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 Aurobindo with food, beverages, and alcohol
Information on the effects of alcohol is provided in section 3. Grapefruit juice may affect how Tadalafil Aurobindo 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 using machines
Some men taking Tadalafil Aurobindo in clinical studies reported dizziness. Carefully assess how you react to the tablets before driving or operating machinery.
Tadalafil Aurobindo contains lactose monohydrate.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Tadalafil Aurobindo

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

The Tadalafil Aurobindo tablets are for oral use and only for men. Swallow the tablet whole with water. The tablets may be taken regardless of food intake.

Consumption of alcoholic beverages may temporarily cause a reduction in your blood pressure. If you have taken or plan to take Tadalafil Aurobindo, avoid excessive consumption of alcohol (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 your dose to 2.5 mg depending on your response to Tadalafil Aurobindo. This dose will be given to you as a 2.5 mg tablet.

Do not take Tadalafil Aurobindo more than once a day.

When taken once daily, Tadalafil Aurobindo enables you to achieve an erection, if there is sexual stimulation, at any time during the 24-hour period following administration. Daily administration of Tadalafil Aurobindo may be beneficial for men who anticipate having sexual activity two or more times per week.

It is important to note that Tadalafil Aurobindo does not work in the absence of 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.

Consumption of alcoholic beverages 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 both benign prostatic hyperplasia and erectile dysfunction, the dose remains one 5 mg tablet taken once daily.

Do not take Tadalafil Aurobindo more than once a day.

If you take more Tadalafil Aurobindo than you should

Contact your doctor. You may experience the adverse effects described in section 4.

If you forget to take Tadalafil Aurobindo

Take your missed 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 Aurobindo 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 will get them. These side effects are usually mild to moderate in severity.
If you experience any of the following side effects, stop taking 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).
• Priapism, a prolonged and possibly painful erection after taking Tadalafil Aurobindo (rare frequency). If you have an erection of this type lasting more than 4 hours, you must 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 arms and legs, facial flushing, nasal congestion, indigestion.

Uncommon (may affect up to 1 in 100 people)

• dizziness, stomach discomfort, feeling unwell, nausea, acid reflux, blurred vision, eye discomfort, breathing difficulties, blood in urine, prolonged erection, awareness of strong heartbeat, rapid 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, urticaria (red, itchy patches on the skin), bleeding from the penis, blood in semen, and increased sweating.

Rarely, heart attacks and strokes have been reported in men taking Tadalafil Aurobindo. Most of these individuals already had heart problems before taking 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 Tadalafil Aurobindo. 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 Aurobindo. Diarrhoea has been reported more frequently in men over 65 years of age taking Tadalafil Aurobindo.
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 Tadalafil Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the 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 Tadalafil Aurobindo contains

• The active substance is tadalafil. Each film-coated tablet contains 5 mg of tadalafil.
• The other components are:
  Tablet core: copovidone, glycerol hydroxyethyl stearate, monohydrate lactose, anhydrous colloidal silicon dioxide, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.
  Tablet coating: hypromellose, titanium dioxide (E171), talc (E553b), yellow iron oxide (E172), triacetin.

Description of the appearance of Tadalafil Aurobindo and pack contents
Film-coated tablets.
Light yellow, oval-shaped, film-coated tablets marked “5” on one side and “TL” on the other side.
Tadalafil Aurobindo is available in transparent PVC/PVdC – aluminum foil blister packs containing 14 and 28 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturers

Marketing Authorization Holder:
Aurobindo Pharma (Italia) S.r.l., via San Giuseppe 102 - 21047 Saronno (VA)

Manufacturers:
APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000

• Malta

Milpharm Limited Ares Block, Odyssey Business Park, West End Road, Ruislip HA4 6QD
Generis Farmacêutica, S.A., Rua João de Deus, 19, 2700-487, Amadora, Portugal

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Italy: Tadalafil Aurobindo
Portugal: Tadalafil Generis

Package leaflet: information for the user

Tadalafil Aurobindo 10 mg film-coated tablets

Generic medicine
Please 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 give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Tadalafil is a treatment for adult men with:

• erectile dysfunction. This condition occurs when a man is unable to achieve or maintain an erection suitable for sexual intercourse. Tadalafil Aurobindo has been shown to significantly improve the ability to obtain an erection suitable for sexual intercourse. Tadalafil Aurobindo contains the active substance tadalafil, which belongs to a class of medicines called phosphodiesterase type 5 inhibitors. Following sexual stimulation, Tadalafil Aurobindo helps relax the blood vessels in the penis, allowing blood to 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 has no effect without sexual stimulation. You and your
partner will need to engage in foreplay, as you would if you were not taking a
medication for erectile dysfunction.

2. What you should know before taking Tadalafil Aurobindo

Do not take Tadalafil Aurobindo:

• 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. This is a group of medicines ("nitrates") used to treat angina pectoris ("chest pain"). It has been shown that Tadalafil Aurobindo 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 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 Aurobindo, 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 or pharmacist before taking Tadalafil Aurobindo.
You should be aware that sexual activity involves a potential risk for patients with heart disease, as it places additional strain on the heart. If you have a heart condition, inform your doctor.
Before taking the tablets, inform your doctor if you have:

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

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

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

3. How to take Tadalafil Aurobindo

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Tadalafil Aurobindo tablets are for oral use and 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 before sexual activity. If the effect of this dose is too weak, your doctor may increase the dose to 20 mg. Tadalafil Aurobindo tablets are for oral use.
You may take the Tadalafil Aurobindo tablet at least 30 minutes before sexual activity.
Tadalafil Aurobindo may remain effective for up to 36 hours after taking the tablet.
Do not take Tadalafil Aurobindo more than once a day.
The use of Tadalafil Aurobindo 10 mg and 20 mg is indicated prior to anticipated sexual activity and is not recommended for continuous daily use.
It is important to note that Tadalafil Aurobindo 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 reduction in blood pressure. If you have taken or plan to take Tadalafil Aurobindo, avoid excessive alcohol consumption (blood alcohol levels of 0.08% or higher), as this may increase the risk of dizziness when standing up.
If you take more Tadalafil Aurobindo than you should
Contact your doctor. You may experience the side effects described in section 4.
If you have any questions 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 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).
• Priapism, a prolonged and possibly painful erection after taking Tadalafil Aurobindo (rare frequency). If you have an erection of this type lasting more than 4 hours, you must contact a doctor immediately.
• sudden loss of vision (rare frequency).

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, digestive disturbances and reflux.

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 urine, prolonged erection, awareness of heartbeat, 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 and transient memory loss, eyelid swelling, red eyes, sudden decrease or loss of hearing, and urticaria (red, itchy patches on the skin), bleeding from the penis, blood in semen, and increased sweating.
  Rarely, heart attacks and strokes have been reported in men taking Tadalafil Aurobindo. Most of these individuals already had heart problems before taking 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 Tadalafil Aurobindo. 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 Aurobindo. Diarrhoea has been reported more frequently in men over 65 years of age taking Tadalafil Aurobindo.
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 Tadalafil Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister after EXP. The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
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 Aurobindo contains

• The active substance is tadalafil. Each film-coated tablet contains 10 mg of tadalafil.
• The other components are:
  Tablet core: copovidone, macrogol glycerol hydroxystearate, lactose monohydrate, colloidal anhydrous silica, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.
  Tablet coating: hypromellose, titanium dioxide (E171), talc (E553b), yellow iron oxide (E172), triacetin.

Description of the appearance of Tadalafil Aurobindo and contents of the pack
Film-coated tablets.
Light yellow, oval-shaped, film-coated tablets, marked “10” on one side and “TL” on the other side.
Tadalafil Aurobindo film-coated tablets are available in transparent PVC/PVdC blister packs – aluminium foil leaflets containing 4 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturers
Marketing Authorisation Holder:
Aurobindo Pharma (Italia) s.r.l., via San Giuseppe 102, 21047 Saronno (VA)
Manufacturers:
APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000

• Malta
  Milpharm Limited Ares Block, Odyssey Business Park, West End Road, Ruislip HA4 6QD
  Generis Farmacêutica, S.A., Rua João de Deus, 19, 2700-487, Amadora, Portugal

This medicinal product is authorised in the European Economic Area countries under the following names:
Italy: Tadalafil Aurobindo
Portugal: Tadalafil Generis

Package leaflet: information for the user

Tadalafil Aurobindo 20 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 others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Tadalafil 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. Tadalafil Aurobindo has been shown to
  significantly improve the ability to obtain an erection suitable for sexual intercourse.
  Tadalafil Aurobindo contains the active substance tadalafil, which belongs to a class of medicines known as phosphodiesterase type 5 inhibitors. Following sexual stimulation, Tadalafil Aurobindo helps relax the blood vessels in the penis, allowing 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 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 Aurobindo

Do not take Tadalafil Aurobindo:

• 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. This is a group of medicines ("nitrates") used to treat angina pectoris ("chest pain"). It has been shown that Tadalafil Aurobindo increases the effect of these medicines. If you are taking any form of nitrate or have any doubts, inform your doctor.
• if you have 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 Aurobindo, 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 Aurobindo.
You should 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 any heart problems, 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 penile deformity.
• a serious liver problem.
• a serious kidney problem.

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

• pelvic surgery
• removal of all or part of the prostate gland with nerve-sparing radical prostatectomy (i.e. nerves to the prostate have been severed).

If you experience a sudden decrease or loss of vision, stop taking Tadalafil Aurobindo and contact your doctor immediately.
In some patients taking tadalafil, sudden decrease or loss of hearing has been observed.
Although it is not known whether this event is directly related to tadalafil, if you experience sudden decrease or loss of hearing, stop taking Tadalafil Aurobindo and contact your doctor immediately.
The use of Tadalafil Aurobindo is not indicated in women.
Children and adolescents
The use of Tadalafil Aurobindo is not indicated in children and adolescents under 18 years of age.
Other medicines and Tadalafil Aurobindo
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Do not take Tadalafil Aurobindo if you are already taking nitrates.
Some medicines may be affected by Tadalafil Aurobindo or may themselves affect how Tadalafil Aurobindo works. Inform 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 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.

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

3. How to take Tadalafil Aurobindo

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Tadalafil Aurobindo tablets are for oral use and for men only. Swallow the tablet whole with water. The tablets can be taken regardless of food intake.
The recommended dose is one 10 mg tablet before sexual activity. However, your doctor has prescribed you a dose of one 20 mg tablet because they have determined that the recommended dose of 10 mg is too low for you.
You may take the Tadalafil Aurobindo tablet at least 30 minutes before sexual activity.
Tadalafil Aurobindo may still be effective up to 36 hours after taking the tablet.
Do not take Tadalafil Aurobindo more than once a day.
The use of Tadalafil Aurobindo 10 mg and 20 mg is indicated prior to anticipated sexual activity and is not recommended for continuous daily use.
It is important to note that Tadalafil Aurobindo 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 reduction in blood pressure. If you have taken or plan to take Tadalafil Aurobindo, 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 Aurobindo than you should
Contact your doctor. You may experience the side effects described in section 4.
If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not 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).
• priapism, a prolonged and possibly painful erection after taking Tadalafil Aurobindo (rare frequency). If you have an erection of this type lasting more than 4 consecutive hours, you must contact a doctor immediately.
• sudden loss of vision (rare frequency).

Other side effects have been reported:
Common (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, nausea, acid reflux, blurred vision, eye discomfort, breathing difficulties, blood in the urine, prolonged erection, awareness of heartbeat, 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, 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 Tadalafil Aurobindo. Most of these individuals already had heart problems before taking the medicine.
Rare cases of partial, temporary or permanent reduction or loss of vision in one or both eyes have also been reported.
Some additional rare side effects not observed during clinical studies have been reported in men taking Tadalafil Aurobindo. 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 Aurobindo. Diarrhoea has been reported more frequently in men over 65 years of age taking Tadalafil Aurobindo.
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 Tadalafil Aurobindo

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 blister after EXP. The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not dispose of any 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 Tadalafil Aurobindo contains

• The active substance is tadalafil. Each film-coated tablet contains 20 mg of tadalafil.
• The other components are:
  Tablet core: copovidone, macrogol glyceryl hydroxystearate, lactose monohydrate, colloidal anhydrous silica, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.
  Film coating: hypromellose, titanium dioxide (E171), talc (E553b), yellow iron oxide (E172), triacetin.

Description of the appearance of Tadalafil Aurobindo and package contents
Film-coated tablets.
Yellow, oval-shaped, film-coated tablets marked “20” on one side and “TL” on the other side.
Tadalafil Aurobindo film-coated tablets are available in PVC/PVdC transparent – aluminium foil blister packs containing 2, 4 or 8 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aurobindo Pharma (Italia) s.r.l., via San Giuseppe 102 – 21047 Saronno (VA), Italy

Manufacturers:
APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000, Malta
Milpharm Limited Ares Block, Odyssey Business Park, West End Road, Ruislip HA4 6QD, United Kingdom
Generis Farmacêutica, S.A., Rua João de Deus, 19, 2700-487, Amadora, Portugal

This medicinal product is authorised in the European Economic Area (EEA) Member States under the following names:
Italy: Tadalafil Aurobindo
Portugal: Tadalafil Generis