Tadalafil Zentiva

Patient Information Leaflet: Information for the User

Tadalafil Zentiva 5 mg Film-coated Tablets

Tadalafil
“Generic medicine”
Please read all of 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 they have the same symptoms as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Tadalafil Zentiva contains the active substance tadalafil, which belongs to a class of medicines called phosphodiesterase type 5 inhibitors.
Tadalafil Zentiva 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 suitable for sexual intercourse. Tadalafil Zentiva has been shown to significantly improve the ability to obtain an erection suitable for sexual intercourse. Following sexual stimulation, Tadalafil Zentiva helps relax the blood vessels in the penis, allowing blood to flow into the penis. The result is improved erectile function. Tadalafil Zentiva will not help you if you do not have erectile dysfunction. It is important to note that Tadalafil Zentiva 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 not completely emptying the bladder, and a more frequent need to urinate, including during the night. Tadalafil Zentiva improves blood flow and relaxes the muscle tissue of the prostate and bladder, which may reduce 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 Zentiva

Do not take Tadalafil Zentiva:

• 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 Zentiva has been shown to increase the effect of these
  medicines. If you are taking any form of nitrate or have any doubts, inform your doctor.
• if you have a severe heart disease or have recently had a heart attack (within the last 90 days).
• if you have recently had a stroke (within the last 6 months).
• if you have low blood pressure or uncontrolled high blood pressure.
• if you have previously experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as "stroke of the eye".
• if you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors, such as Tadalafil Zentiva, 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 Zentiva.
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 may have similar symptoms, your doctor will perform tests for prostate cancer before starting treatment with
Tadalafil Zentiva for benign prostatic hyperplasia. Tadalafil Zentiva does not treat prostate cancer.
Before taking the tablets, inform your doctor if you have:

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

It is not known whether Tadalafil Zentiva 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 Zentiva and contact your doctor immediately.

The use of Tadalafil Zentiva is not indicated in women.
Children and adolescents
The use of Tadalafil Zentiva is not indicated in children and adolescents under 18 years of age.
Other medicines and Tadalafil Zentiva
Inform your doctor if you are taking, have recently taken, or might take any other
medicines.
Do not take Tadalafil Zentiva if you are already taking nitrates.
Some medicines may be affected by Tadalafil Zentiva or may themselves affect how Tadalafil Zentiva 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 Zentiva with beverages and alcohol
Information on the effects of alcohol is provided in section 3.
Grapefruit juice may affect how Tadalafil Zentiva works and should be consumed with caution. Consult your doctor for further information.
Fertility
In treated dogs, reduced sperm development in the testes has been observed. A reduction in sperm count has been observed in some men. These effects are unlikely to cause infertility.
Driving and use of machinery
Some men taking Tadalafil Zentiva in clinical studies reported dizziness.
Carefully monitor how you react to the tablets before driving or operating machinery.
Tadalafil Zentiva contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Tadalafil Zentiva

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Tadalafil Zentiva tablets are for oral use and are intended only for men. Swallow the tablet whole with water. The tablets can be taken regardless of food intake.
Drinking alcohol may temporarily cause a reduction in your blood pressure. If you have taken or are planning to take Tadalafil Zentiva, 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 Zentiva. This dose will be provided as a 2.5 mg tablet.
Do not take Tadalafil Zentiva more than once a day.
When taken once daily, Tadalafil Zentiva allows you to achieve an erection, if there is sexual stimulation, at any time during the 24-hour period. Once-daily administration of Tadalafil Zentiva may benefit men who anticipate having sexual activity two or more times per week.
It is important to note that Tadalafil Zentiva does 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 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 Zentiva more than once a day.

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

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

If you have any doubts 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 nature.
If you experience any of the following side effects, stop using the medicine and seek
immediate medical help:

• allergic reactions, including skin rashes (uncommon frequency).
• chest pain – do not use nitrates but seek immediate medical help (uncommon frequency).
• prolonged and possibly painful erection after taking Tadalafil Zentiva (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 include:

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, sensation of strong 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 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 Zentiva.
Most of these individuals already had heart problems before taking the medicine.
Rarely, cases of partial, temporary or permanent decrease 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 Zentiva. 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 effects dizziness and diarrhoea have been reported more frequently in men over 75 years of age taking Tadalafil Zentiva.
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 Zentiva

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

6. Package contents and other information

What Tadalafil Zentiva contains

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

Description of the appearance of Tadalafil Zentiva and package contents
Tadalafil Zentiva 5 mg is a film-coated tablet (tablet) of light yellow color, oval in shape, marked with "5" on one side and smooth on the other. The tablet measures 10 mm x 6.0 mm in diameter and 3.3 – 3.9 mm in thickness.
Pack sizes
Tadalafil Zentiva 5 mg is available in blister packs containing 14 and 28 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
ZENTIVA ITALIA S.r.l., Viale L. Bodio, 37/b, 20158 Milano, Italy (IT)
Manufacturers
Balkanpharma - Dupnitsa AD
3 Samokovsko Shosse Str.,
Dupnitsa 2600
Bulgaria
Actavis Ltd.
BLB016, Bulebel Industrial Estate,
Zejtun ZTN 3000
Malta

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
SE: Tadalafil Sigillata
IT: Tadalafil Zentiva

Package leaflet: Information for the user

Tadalafil Zentiva 10 mg film-coated tablets

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could 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:

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

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

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

Do not take Tadalafil Zentiva:

• 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 Zentiva 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 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 blood pressure or uncontrolled high blood pressure.
• if you have previously experienced sudden 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 Zentiva, 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 Zentiva.
You should be aware that sexual activity carries 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.
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 Zentiva is effective in patients who have undergone:

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

If you experience a sudden decrease or loss of vision, stop taking Tadalafil Zentiva and contact your doctor immediately.
The use of Tadalafil Zentiva is not indicated in women.
Children and adolescents
The use of Tadalafil Zentiva is not indicated in children and adolescents under 18 years of age.
Other medicines and Tadalafil Zentiva
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Do not take Tadalafil Zentiva if you are already taking nitrates.
Some medicines may be affected by Tadalafil Zentiva or may themselves affect how Tadalafil Zentiva 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 (used to treat fungal infections) and protease inhibitors used to treat AIDS or HIV infection.
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Tadalafil Zentiva with beverages and alcohol
Information on the effects of alcohol is provided in section 3. Grapefruit juice may affect how Tadalafil Zentiva 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 using machines
Some men taking Tadalafil Zentiva in clinical studies reported dizziness. Carefully assess how you react to the tablets before driving or operating machinery.
Tadalafil Zentiva contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Tadalafil Zentiva

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Tadalafil Zentiva tablets are for oral use and only for men. Swallow the tablet whole with water. The tablets may be taken with or without food.
The recommended starting dose is one 10 mg tablet before sexual activity.
If this dose is not effective enough, your doctor may increase the dose to 20 mg. Tadalafil Zentiva tablets are for oral use.
You can take the Tadalafil Zentiva tablet at least 30 minutes before sexual activity.
Tadalafil Zentiva may remain effective for up to 36 hours after taking the tablet.
Do not take Tadalafil Zentiva more than once a day. The use of Tadalafil Zentiva 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 Zentiva will not work without sexual stimulation. You and your partner will need to engage in foreplay as you would if you were not taking a medicine for erectile dysfunction.
Drinking alcohol may interfere with your ability to get an erection and may temporarily cause a lowering of your blood pressure. If you have taken or plan to take Tadalafil Zentiva, 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 Zentiva than you should
Contact your doctor. You may experience side effects described in section 4.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. These side effects are usually mild to moderate in nature.
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 Zentiva (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, digestive disturbances.

Uncommon (may affect up to 1 in 100 people)

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

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

• fainting, seizures and transient memory loss, eyelid swelling, red eyes, sudden decrease or loss of hearing, and 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 Zentiva.
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 Zentiva. These include:

• migraine, facial swelling, severe allergic reaction causing swelling of the face and throat, serious skin reactions, certain disorders affecting blood circulation to the eyes, irregular heartbeat, angina, and sudden cardiac death.

The side effect of dizziness has been reported more frequently in men over 75 years of age taking Tadalafil Zentiva.
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 Zentiva

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.
No special storage conditions are required for this medicine.
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 Zentiva contains

• The active substance is tadalafil. Each tablet contains 10 mg of tadalafil.
• The other components are: Tablet core: monohydrate lactose, pregelatinized starch, anhydrous colloidal silicon dioxide, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate. Tablet coating: hypromellose, monohydrate lactose, titanium dioxide (E171), triacetin, talc (E553b), yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of Tadalafil Zentiva and package contents
Tadalafil Zentiva 10 mg is a film-coated tablet (tablet) of light yellow colour,
oval in shape, marked with "10" on one side and smooth on the other side. The tablet is 11 mm x 6.6 mm in
diameter and 3.9–4.5 mm in thickness.
Packaging
Tadalafil Zentiva 10 mg is available in blister packs containing 4 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
ZENTIVA ITALIA S.r.l., Viale L. Bodio, 37/b, 20158 Milano, Italy (IT)
Manufacturers
Balkanpharma - Dupnitsa AD
3 Samokovsko Shosse Str.,
Dupnitsa 2600
Bulgaria
Actavis Ltd.
BLB016, Bulebel Industrial Estate,
Zejtun ZTN 3000
Malta

This medicinal product is authorised in the European Economic Area countries under the
following names:
SE: Tadalafil Sigillata
IT: Tadalafil Zentiva

Package leaflet: information for the user

Tadalafil Zentiva 20 mg film-coated tablets

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

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

Contents of this leaflet:

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

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

Do not take Tadalafil Zentiva:

• 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 Zentiva 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 condition 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 Zentiva, 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 Zentiva.
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.
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 Zentiva 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 cut (nerve-sparing radical prostatectomy).

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

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

Tadalafil Zentiva with beverages and alcohol
Information on the effects of alcohol is provided in section 3. Grapefruit juice may affect how Tadalafil Zentiva 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 using machines
Some men taking Tadalafil Zentiva in clinical studies reported dizziness. Carefully assess how you react to the tablets before driving or operating machinery.
Tadalafil Zentiva contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Tadalafil Zentiva

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Tadalafil Zentiva tablets are for oral use and only for men. Swallow the tablet whole with water. The tablets can be taken regardless of food intake.
The recommended starting dose is one 10 mg tablet before sexual activity.
However, your doctor has prescribed you a dose of one 20 mg tablet, because he has decided that the recommended dose of 10 mg is too low for you.
You may take the Tadalafil Zentiva tablet at least 30 minutes before sexual activity.
Tadalafil Zentiva may still be effective up to 36 hours after taking the tablet.
Do not take Tadalafil Zentiva more than once a day. The use of Tadalafil Zentiva 10 mg and 20 mg is intended prior to anticipated sexual activity and is not recommended for continuous daily use.
It is important to note that Tadalafil Zentiva will not work without sexual stimulation. You and your partner will need to engage in foreplay as you would if you were not taking a medicine for erectile dysfunction.
Drinking alcohol may interfere with your ability to get an erection and may temporarily cause a lowering of your blood pressure. If you have taken or plan to take Tadalafil Zentiva, 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 Zentiva 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, speak to your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. These side effects are usually mild to moderate in nature.
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 Zentiva (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.

Uncommon (may affect up to 1 in 100 people)

• dizziness, stomach ache, feeling unwell, nausea, acid reflux, blurred vision, eye discomfort, breathing difficulties, blood in urine, 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), penile bleeding, blood in semen, and increased sweating.

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

• migraine, facial swelling, severe allergic reaction causing swelling of the face and throat, serious skin reactions, certain disorders affecting blood circulation to the eyes, irregular heartbeat, angina, and sudden cardiac death.

The side effects dizziness and diarrhoea have been reported more frequently in men over 75 years of age taking Tadalafil Zentiva.
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 Zentiva

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

6. Package contents and other information

What Tadalafil Zentiva contains

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

Description of the appearance of Tadalafil Zentiva and package contents
Tadalafil Zentiva 20 mg is a yellow, film-coated oval tablet marked with "20" on one side and smooth on the other. The tablet measures 12 mm x 7.4 mm in diameter and 4.60–5.20 mm in thickness.
Pack sizes
Tadalafil Zentiva 20 mg is available in blister packs containing 2, 4, or 8 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
ZENTIVA ITALIA S.r.l., Viale L. Bodio, 37/b, 20158 Milan, Italy (IT)
Manufacturers
Balkanpharma - Dupnitsa AD
3 Samokovsko Shosse Str.,
Dupnitsa 2600
Bulgaria
Actavis Ltd.
BLB016, Bulebel Industrial Estate,
Zejtun ZTN 3000
Malta

This medicinal product is authorized in the European Economic Area countries under the following names:
SE: Tadalafil Sigillata
IT: Tadalafil Zentiva