Alfuzosin Zentiva

Package leaflet: Information for the patient

Alfuzosin Zentiva 2.5 mg film-coated tablets

Alfuzosin hydrochloride
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 side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Alfuzosina Zentiva contains alfuzosin hydrochloride, which belongs to a class of medicines called
"selective alpha 1-adrenergic receptor antagonists or alpha 1-blockers".
It acts on the bladder, urethra (the duct through which urine passes out of the body), and prostate.
Alfuzosina Zentiva is indicated for the treatment of symptoms caused by an enlarged prostate, a
condition known as "benign prostatic hyperplasia".

2. What you need to know before taking Alfuzosina Zentiva

Do not take Alfuzosina Zentiva

• If you are allergic to alfuzosin or to any of the other ingredients of this medicine (listed in section 6);
• If you have or have had sudden drops in blood pressure when standing up quickly after sitting or lying down (orthostatic hypotension);
• If you are taking other medicines belonging to the alpha-1 blockers group;
• If you have severe liver problems (severe hepatic insufficiency).

Warnings and precautions
Talk to your doctor or pharmacist before taking Alfuzosina Zentiva.
If you are taking medicines for high blood pressure (antihypertensives) or for chest pain (nitrates), your doctor will prescribe Alfuzosina Zentiva with caution.
Within a few hours after taking Alfuzosina Zentiva, sudden drops in blood pressure may occur when moving quickly from a sitting or lying position to standing (orthostatic hypotension), with or without symptoms (dizziness, fatigue, sweating). If this happens to you, lie down until symptoms completely disappear. These effects usually occur at the beginning of treatment, last for a short time, and generally do not require discontinuation of treatment.
If you have heart disease, are taking medicines to control your blood pressure, or are elderly, you have a higher risk of experiencing a significant drop in blood pressure (circulatory collapse) and adverse effects. Therefore, your doctor will prescribe Alfuzosina Zentiva with caution.
If you have previously experienced a significant drop in blood pressure after taking another alpha-1 blocker medicine, or if you are being treated with antihypertensives or nitrates, your doctor will prescribe Alfuzosina Zentiva with care.
Like all alpha-1 blockers, if you have acute heart failure (a condition in which the heart cannot pump enough blood), your doctor will prescribe Alfuzosina Zentiva with caution.
If you are being treated for coronary insufficiency (heart artery disorder) and chest pain recurs or worsens, your doctor will discontinue treatment with Alfuzosina Zentiva.
If you have a heart rhythm disorder or are taking medicines that may cause a heart rhythm disorder (QTc interval prolongation), your doctor will monitor you before and during treatment with Alfuzosina Zentiva.
Taking Alfuzosina Zentiva, as with other alpha-1 blockers, may cause a persistent, painful erection unrelated to sexual activity (priapism). If this occurs, inform your doctor, as failure to treat this condition appropriately may lead to permanent impotence (see "Possible side effects").
If you are scheduled for cataract surgery (clouding of the lens), inform your ophthalmologist that you are currently taking or have previously been treated with Alfuzosina Zentiva or another alpha-1 blocker. This is because Alfuzosina Zentiva or another alpha-1 blocker could cause complications during surgery, which can be managed if the specialist is informed beforehand.
The tablets must be swallowed whole. Do not crush, chew, grind, or reduce them to powder. Doing so may result in inappropriate release and absorption of the active ingredient and thus lead to possible adverse effects.
If you have previously experienced disorders of the blood vessels supplying the brain, with or without symptoms, Alfuzosina Zentiva increases the risk of insufficient blood supply to the brain (cerebral ischemia).

Other medicines and Alfuzosina Zentiva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You must not take Alfuzosina Zentiva if you are using other medicines belonging to the group of alpha-1 antagonists (see "Do not take Alfuzosina Zentiva"), as this may increase the blood pressure-lowering effect.
The effects of Alfuzosina Zentiva may be influenced by, or may influence, the following medicines:

• Medicines used to lower blood pressure (antihypertensives) (see "Warnings and precautions").
• Medicines used to treat chest pain (nitrates) (see "Warnings and precautions").
• Medicines used to treat fungal infections (such as ketoconazole, itraconazole) and medicines used to treat HIV infection (such as ritonavir), as they increase the concentration of alfuzosin in the blood.
  If you are scheduled for surgery requiring general anesthesia, inform your doctor that you are taking Alfuzosina Zentiva, as this medicine may affect your blood pressure.

Pregnancy, breastfeeding and fertility
Not applicable, as Alfuzosina Zentiva is intended for use in men only.

Driving and using machines
Undesirable effects such as dizziness, vertigo, and weakness may occur, especially at the beginning of treatment with Alfuzosina Zentiva. Take this into account if you need to drive or operate machinery.

Alfuzosina Zentiva contains lactose
This medicine 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 Alfuzosina Zentiva

Take this medicine exactly as prescribed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Adults
The recommended dose is: 1 tablet of Alfuzosina Zentiva 2.5 mg three times a day (for a total of
7.5 mg per day).
Take the first tablet before going to bed.
Use in elderly patients and patients treated with medicines to lower blood pressure
The recommended starting dose is: 1 tablet in the morning and 1 tablet in the evening.
Your doctor may increase this dose, without exceeding 4 tablets of 2.5 mg (10 mg) per
day.
Use in patients with kidney disease
If you suffer from kidney disease, the recommended starting dose is: 1 tablet of Alfuzosina Zentiva 2.5
mg twice daily. Your doctor may adjust the dose.
Use in patients with liver disease
If you suffer from mild to moderate liver disease, the recommended starting dose is: 1 tablet per
day of Alfuzosina Zentiva 2.5 mg, which may be increased by your doctor up to 2 tablets per
day.
Use in children and adolescents
Alfuzosina Zentiva must not be used in children and adolescents.
If you take more Alfuzosina Zentiva than you should
In case of accidental ingestion/overdose of Alfuzosina Zentiva, contact your
doctor immediately or go to the nearest hospital.
If you forget to take Alfuzosina Zentiva
Do not take a double dose to make up for the missed tablet.
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.
The following side effects may occur, according to the following frequency:

Common (may affect up to 1 in 10 people):

• Weakness or tiredness (asthenia).
• Feeling unwell (malaise).
• Nausea.
• Abdominal pain.
• Diarrhea.
• Dry mouth.
• Fainting.
• Dizziness (dizziness and vertigo).
• Headache.
• Drop in blood pressure when standing up quickly after sitting or lying down (orthostatic hypotension).

Uncommon (may affect up to 1 in 100 people):

• Increased heart rate (tachycardia).
• Irregular or pounding heartbeat (palpitations).
• Vision disorders.
• Swelling (edema).
• Chest pain.
• Drowsiness.
• Loss of consciousness (syncope).
• Cold (rhinitis).
• Skin redness (rash).
• Itching.
• Facial flushing (flushing).

Very rare (may affect up to 1 in 10,000 people):

• Chest pain that may spread to the arms, neck, or jaw (angina). This occurs if you already suffer from disorders of the blood vessels supplying blood to the heart (coronary artery disease).
• Urticaria.
• Swelling of the face, throat, or limbs, possibly causing breathing difficulties (angioedema).

Frequency not known (frequency cannot be estimated from the available data):

• Irregular heartbeat (atrial fibrillation).
• Iris (the colored part of the eye) becoming floppy during eye surgery (intraoperative floppy iris syndrome).
• Vomiting.
• Liver damage (hepatocellular injury).
• Blockage or suppression of bile flow (cholestatic liver disease).
• Reduction or interruption of blood flow to the brain (cerebral ischemia) in patients with disorders of the blood vessels supplying blood to the brain.
• Persistent and painful erection (priapism).
• Severe drop in blood pressure with various disturbances up to loss of consciousness (circulatory collapse).
• Decreased or absent white blood cells in the blood (neutropenia).
• Reduced number of blood platelets (thrombocytopenia).

Following the instructions contained in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the following address: http://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 Alfuzosina Zentiva

Store below 25°C.
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 medicines 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 Alfuzosina Zentiva contains

• The active substance is alfuzosin hydrochloride. Each tablet contains 2.5 mg of alfuzosin hydrochloride.
• The other components are: tablet core: lactose, microcrystalline cellulose, povidone, sodium carboxymethylcellulose, magnesium stearate. coating: hypromellose, macrogol 400, titanium dioxide (E171).

Description of the appearance of Alfuzosina Zentiva and contents of the pack
Alfuzosina Zentiva is available as film-coated tablets.
Blister packs containing 30 tablets are available.
Marketing Authorization Holder
Zentiva Italia S.r.l.
Viale L. Bodio, 37/B - Milan
Manufacturer
Sanofi Winthrop Industrie – 30-36 Avenue Gustave Eiffel - Tours (France)

Patient Information Leaflet

Alfuzosin Zentiva 5 mg prolonged-release coated tablets

Alfuzosin hydrochloride
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, consult 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 dangerous.
• 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:

7. What Alfuzosin Zentiva is and what it is used for
8. What you need to know before taking Alfuzosin Zentiva
9. How to take Alfuzosin Zentiva
10. Possible side effects
11. How to store Alfuzosin Zentiva
12. Contents of the pack and other information

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

Alfuzosina Zentiva contains alfuzosin hydrochloride, which belongs to a class of medicines called
"selective alpha-1 adrenergic receptor antagonists or alpha-1 blockers".
It acts on the bladder, urethra (the duct through which urine passes), and prostate.
Alfuzosina Zentiva is indicated for the treatment of symptoms caused by an enlarged prostate, a
condition known as "benign prostatic hyperplasia".

2. What you need to know before taking Alfuzosina Zentiva

Do not take Alfuzosina Zentiva

• If you are allergic to alfuzosin or to any of the other ingredients of this medicine (listed in section 6).
• If you suffer from or have suffered from sudden drops in blood pressure when standing up quickly after sitting or lying down (orthostatic hypotension).
• If you are taking other medicines belonging to the alpha-1 blockers group.
• If you have severe liver problems (severe hepatic insufficiency).

Warnings and precautions
Talk to your doctor or pharmacist before taking Alfuzosina Zentiva.
If you are taking medicines for high blood pressure (antihypertensives) or for chest pain (nitrates), your doctor will prescribe Alfuzosina Zentiva with caution.
Within a few hours of taking Alfuzosina Zentiva, sudden drops in blood pressure may occur when moving quickly from a sitting or lying position to standing (orthostatic hypotension), with or without symptoms (dizziness, fatigue, sweating). If this happens to you, lie down until symptoms completely disappear. These effects usually occur at the beginning of treatment, last for a short time, and normally do not require discontinuation of treatment.
If you have heart disease, are taking medicines to control blood pressure, or are elderly, you have a higher risk of experiencing a significant drop in blood pressure (circulatory collapse) and adverse effects. Therefore, your doctor will prescribe Alfuzosina Zentiva with caution.
If you have previously experienced a significant drop in blood pressure after taking another medicine in the alpha-1 blocker group, or if you are being treated with antihypertensives or nitrates, your doctor will prescribe Alfuzosina Zentiva with care.
Like all alpha-1 blockers, if you suffer from acute heart failure (a condition in which the heart cannot pump enough blood), your doctor will prescribe Alfuzosina Zentiva with caution.
If you are being treated for coronary insufficiency (heart artery disorder) and chest pain recurs or worsens, your doctor will discontinue treatment with Alfuzosina Zentiva.
If you have a heart rhythm disorder or are taking medicines that may cause heart rhythm disturbances (QTc interval prolongation), your doctor will perform monitoring tests before and during treatment with Alfuzosina Zentiva.
Taking Alfuzosina Zentiva, as with other alpha-1 blockers, may cause a persistent, painful erection of the penis unrelated to sexual activity (priapism). In such a case, inform your doctor, as if not properly treated, this condition may lead to permanent impotence (see "Possible side effects").
If you are scheduled for cataract surgery (clouding of the lens), inform your ophthalmologist that you are currently taking or have previously been treated with Alfuzosina Zentiva or another alpha-1 blocker. This is because Alfuzosina Zentiva or another alpha-1 blocker could cause complications during surgery, which can be managed if the specialist is informed beforehand.
The tablets must be swallowed whole. Do not crush, chew, grind, or pulverize them. Doing so may result in inappropriate release and absorption of the active substance and thus possible adverse effects.
If you have previously suffered from disorders affecting blood vessels supplying blood to the brain, with or without symptoms, Alfuzosina Zentiva increases the risk of inadequate blood supply to the brain (cerebral ischemia).
Occasionally, you may find tablets of Alfuzosina Zentiva in your stools that appear intact; in reality, the active ingredient has already been absorbed by the body.

Other medicines and Alfuzosina Zentiva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Alfuzosina Zentiva if you are using other medicines belonging to the group of alpha-1 antagonists (see "Do not take Alfuzosina Zentiva"), as this may increase the blood pressure-lowering effect.
The effects of Alfuzosina Zentiva may be influenced by, or may influence, the following medicines:

• Medicines used to lower blood pressure (antihypertensives) (see "Warnings and precautions").
• Medicines used to treat chest pain (nitrates) (see "Warnings and precautions").
• Medicines used to treat fungal infections (such as ketoconazole, itraconazole) and medicines used to treat HIV infection (such as ritonavir), as they increase the concentration of alfuzosin in the blood.

If you are scheduled for surgery requiring general anesthesia, inform your doctor that you are taking Alfuzosina Zentiva, as this medicine may affect blood pressure.

Pregnancy, breastfeeding and fertility
Not applicable, as Alfuzosina Zentiva is intended for use in men only.

Driving and using machines
Adverse effects such as dizziness, vertigo, and weakness may occur, especially at the beginning of treatment with Alfuzosina Zentiva. Take this into account if you need to drive or operate machinery.

Alfuzosina Zentiva contains hydrogenated castor oil
Hydrogenated castor oil may cause stomach discomfort and diarrhea.

3. How to take Alfuzosina Zentiva

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults
The recommended dose is: 1 tablet of Alfuzosina Zentiva 5 mg twice daily (morning and evening).
Take the first tablet in the evening.
Use in elderly patients and in patients treated with medicines to lower blood pressure
The recommended starting dose is: 1 tablet of Alfuzosina Zentiva 5 mg in the evening.
Your doctor may increase this dose up to 1 tablet of Alfuzosina Zentiva 5 mg twice daily (morning and evening).
Use in patients with kidney disease
If you suffer from kidney disease, the recommended starting dose is: 1 tablet of Alfuzosina Zentiva 5 mg in the evening, which may be increased to 2 tablets daily. The dose may be adjusted by your doctor.
Use in patients with liver disease (use Alfuzosina Zentiva 2.5 mg coated tablets, not
Alfuzosina Zentiva 5 mg prolonged-release coated tablets, unless otherwise directed by
the doctor)
If you have mild to moderate liver disease, the recommended starting dose is: a single 2.5 mg dose of Alfuzosina Zentiva, which may be increased by your doctor up to 1 tablet of Alfuzosina Zentiva 2.5 mg twice daily.
Alfuzosina Zentiva 5 mg tablets must be swallowed whole and must not be chewed.
Use in children and adolescents
Alfuzosina Zentiva must not be used in children and adolescents.
If you take more Alfuzosina Zentiva than you should
In case of accidental ingestion or overdose of Alfuzosina Zentiva, contact your doctor immediately or go to the nearest hospital.
If you forget to take Alfuzosina Zentiva
Do not take a double dose to make up for the missed tablet.
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 everybody gets them.
The following side effects may occur, with the frequencies listed below:

Common (may affect up to 1 in 10 people):

• Weakness or tiredness (asthenia).
• Feeling unwell (malaise).
• Nausea.
• Abdominal pain.
• Diarrhea.
• Dry mouth.
• Fainting.
• Dizziness (dizziness and vertigo).
• Headache.
• Drop in blood pressure when standing up quickly after sitting or lying down (orthostatic hypotension).

Uncommon (may affect up to 1 in 100 people):

• Increased heart rate (tachycardia).
• Irregular or forceful heartbeat (palpitations).
• Vision disorders.
• Swelling (edema).
• Chest pain.
• Drowsiness.
• Loss of consciousness (syncope).
• Cold (rhinitis).
• Skin redness (rash).
• Itching.
• Facial redness (flushing).

Very rare (may affect up to 1 in 10,000 people):

• Chest pain that may spread to the arms, neck, or jaw (angina). This occurs if you already suffer from disorders of the blood vessels supplying blood to the heart (coronary artery disease).
• Hives.
• Swelling of the face, throat, or limbs, possibly causing difficulty breathing (angioedema).

Frequency not known (frequency cannot be estimated from the available data):

• Heart rhythm disorder (atrial fibrillation).

• Iris (the coloured part of the eye) becoming floppy during eye surgery (intraoperative floppy iris syndrome).

• Vomiting.

• Liver damage (hepatocellular injury).

• Blockage or suppression of bile flow (cholestatic liver disease).

• Reduced or interrupted blood flow to the brain (cerebral ischemia) in patients with disorders of the blood vessels supplying blood to the brain.

• Persistent and painful erection (priapism).

• Severe drop in blood pressure with various disturbances up to loss of consciousness (circulatory collapse).

• Decrease or absence of white blood cells in the blood (neutropenia).

• Decrease in the number of blood platelets (thrombocytopenia).

Following the instructions contained in this leaflet reduces the risk of side effects.
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 the following address: http://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 Alfuzosina Zentiva

This medicine does not require any special storage conditions.
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 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 Alfuzosina Zentiva contains

• The active substance is alfuzosin hydrochloride. Each tablet contains 5 mg of alfuzosin hydrochloride.
• The other components are: tablet core: microcrystalline cellulose, povidone, dibasic calcium phosphate dihydrate, magnesium stearate, hydrogenated castor oil. coating: hypromellose, propylene glycol, titanium dioxide (E171), iron oxide (E172).

Description of the appearance of Alfuzosina Zentiva and the contents of the pack
Alfuzosina Zentiva is available as prolonged-release coated tablets.
Blister packs containing 20 tablets are available.
Marketing Authorization Holder
Zentiva Italia S.r.l.
Viale L. Bodio, 37/B - Milan
Manufacturer
Sanofi Winthrop Industrie – 30-36 Avenue Gustave Eiffel - Tours (France)

Patient information leaflet

Alfuzosina Zentiva 10 mg prolonged-release tablets

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

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

Contents of this leaflet:

7. What Alfuzosina Zentiva is and what it is used for
8. What you need to know before taking Alfuzosina Zentiva
9. How to take Alfuzosina Zentiva
10. Possible side effects
11. How to store Alfuzosina Zentiva
12. Contents of the pack and other information

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

Medicines used in benign prostatic hyperplasia: Alfuzosina Zentiva contains alfuzosin hydrochloride, which belongs to a class of medicines called "selective alpha-1 adrenergic receptor antagonists or alpha-1 blockers".
It acts on the bladder, urethra (the tube through which urine passes), and prostate.
Alfuzosina Zentiva is indicated for the treatment of symptoms caused by an enlarged prostate, a condition known as "benign prostatic hyperplasia".
Alfuzosina Zentiva is also indicated as an additional therapy to urethral catheterization (insertion of a small tube into the bladder through the urethra to allow urine to drain) in the treatment of acute urinary retention (a condition in which the patient is unable to empty the bladder) caused by enlargement of the prostate gland (benign prostatic hyperplasia).

2. What you need to know before taking Alfuzosina Zentiva

Do not use Alfuzosina Zentiva

• If you are allergic to alfuzosin or to any of the other ingredients of this medicine (listed in section 6).
• If you have or have had sudden drops in blood pressure when standing up quickly after sitting or lying down (orthostatic hypotension).
• If you are taking other medicines of the alpha-1 blocker group.
• If you have liver problems (hepatic insufficiency).

Warnings and precautions
Talk to your doctor or pharmacist before taking Alfuzosina Zentiva.
If you are taking medicines for high blood pressure (antihypertensives) or chest pain (nitrates), your doctor will prescribe Alfuzosina Zentiva with caution.
Within a few hours after taking Alfuzosina Zentiva, sudden drops in blood pressure may occur when moving quickly from a sitting or lying position to standing (orthostatic hypotension), with or without symptoms (dizziness, fatigue, sweating). If this happens to you, lie down until symptoms completely disappear. These effects usually occur at the beginning of treatment, last for a short time, and normally do not require discontinuation of treatment.
If you have heart disease, are taking medicines to control blood pressure, or are elderly, you have a higher risk of experiencing a significant drop in blood pressure (circulatory collapse) and adverse effects. Therefore, your doctor will prescribe Alfuzosina Zentiva with caution.
If you have experienced a significant drop in blood pressure after taking another medicine of the alpha-1 blocker group, or if you are being treated with antihypertensives or nitrates, your doctor will prescribe Alfuzosina Zentiva with care.
Like all alpha-1 blockers, if you have acute heart failure (a condition in which the heart cannot pump enough blood), your doctor will prescribe Alfuzosina Zentiva with caution.
If you are being treated for coronary insufficiency (heart artery disorder) and chest pain recurs or worsens, your doctor will discontinue treatment with Alfuzosina Zentiva.
If you have a heart rhythm disorder or are taking medicines that may cause a heart rhythm disorder (prolongation of the QTc interval), your doctor will perform checks before and during treatment with Alfuzosina Zentiva.
While taking Alfuzosina Zentiva, as with other alpha-1 blockers, you may experience a persistent, painful erection of the penis not related to sexual activity (priapism). In such a case, inform your doctor, as this condition, if not properly treated, may lead to permanent impotence (see "Possible side effects").
If you are scheduled for cataract surgery (clouding of the lens), inform your ophthalmologist that you are currently taking or have previously been treated with Alfuzosina Zentiva or another alpha-1 blocker. This is because Alfuzosina Zentiva or another alpha-1 blocker could cause complications during surgery, which can be managed if the specialist is informed beforehand.
If you have severe kidney disease (severe renal insufficiency, with creatinine clearance < 30 ml/min), you should not be given Alfuzosina Zentiva 10 mg, as prolonged-release tablets must not be administered to patients with severe kidney problems.
The tablets must be swallowed whole. Do not crush, chew, grind, or reduce them to powder. Doing so may lead to inappropriate release and absorption of the active substance and thus to possible adverse effects.

Other medicines and Alfuzosina Zentiva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
You must not take Alfuzosina Zentiva if you are using other medicines belonging to the group of alpha-1 antagonists (see "Do not take Alfuzosina Zentiva"), as this may increase the blood pressure-lowering effect.
The effects of Alfuzosina Zentiva may be influenced by, or may influence, the following medicines:

• Medicines used to lower blood pressure (antihypertensives) (see "Warnings and precautions");
• Medicines used to treat chest pain (nitrates) (see "Warnings and precautions");
• Medicines used to treat fungal infections (such as ketoconazole, itraconazole) and medicines used to treat HIV infection (such as ritonavir), as they increase the concentration of alfuzosin in the blood.

If you are scheduled for surgery requiring general anesthesia, inform your doctor that you are taking Alfuzosina Zentiva, as this medicine may affect blood pressure.

Pregnancy, breastfeeding and fertility
Not applicable, as Alfuzosina Zentiva is intended for use in men only.

Driving and using machines
Adverse effects such as dizziness, vertigo, and weakness may occur, especially at the beginning of treatment with Alfuzosina Zentiva. Take this into account if you need to drive or operate machinery.

Alfuzosina Zentiva contains hydrogenated castor oil
Hydrogenated castor oil may cause stomach discomfort and diarrhea.

3. How to take Alfuzosina Zentiva

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
For the treatment of enlarged prostate (benign prostatic hyperplasia)
The recommended dose is: 1 tablet of 10 mg once daily, to be taken after a meal.
For the treatment of inability to empty the bladder (acute urinary retention)
The recommended dose is: 1 tablet of 10 mg daily after a meal, starting from the first day
of catheter placement (a small tube inserted into the bladder through the urethra to allow urine to pass out).
The tablets must be swallowed whole.
Use in children and adolescents
Alfuzosina Zentiva must not be used in children and adolescents.
If you take more Alfuzosina Zentiva than you should
In case of accidental ingestion/overdose of Alfuzosina Zentiva, contact your doctor immediately or go to the nearest hospital.
If you forget to take Alfuzosina Zentiva
Do not take a double dose to make up for the missed tablet.
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 everybody gets them.
The following side effects may occur, with the following frequencies:

Common (may affect up to 1 in 10 people):

• Weakness or fatigue (asthenia).
• Nausea.
• Abdominal pain.
• Fainting.
• Dizziness (vertigo).
• Headache (cephalalgia).

Uncommon (may affect up to 1 in 100 people):

• Increased heart rate (tachycardia).
• Swelling (oedema).
• Chest pain.
• Diarrhoea.
• Sensation of loss of balance (vertigo).
• Loss of consciousness (syncope).
• Cold symptoms (rhinitis).
• Skin redness (rash).
• Itching.
• Drop in blood pressure when standing up quickly after sitting or lying down (orthostatic hypotension).
• Facial flushing (flushing).

Very rare (may affect up to 1 in 10,000 people):

• Chest pain that may spread to the arms, neck, or jaw (angina). This may occur if you already have blood vessel disorders affecting the heart (coronary artery disease).
• Urticaria (hives).
• Swelling of the face, throat, or limbs, possibly with breathing difficulties (angioedema).

Frequency not known (frequency cannot be estimated from the available data):

• Irregular heart rhythm (atrial fibrillation).
• Iris (coloured part of the eye) becoming floppy during eye surgery (intraoperative floppy iris syndrome).
• Vomiting.
• Liver damage (hepatocellular injury).
• Blockage or suppression of bile flow (cholestatic liver disease).
• Prolonged and painful erection (priapism).
• Severe drop in blood pressure with various disturbances up to loss of consciousness (circulatory collapse).
• Decrease in the number of white blood cells (neutropenia).
• Decrease in the number of blood platelets (thrombocytopenia).

Following the instructions contained in this leaflet reduces the risk of side effects.
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: http://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 Alfuzosina Zentiva

This medicine does not require any special storage conditions.
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 you no longer use. This will help protect the environment.

6. Package contents and other information

What Alfuzosina Zentiva contains

• The active substance is alfuzosin hydrochloride. Each tablet contains 10 mg of alfuzosin hydrochloride.
• The other components are: hypromellose, hydrogenated castor oil, ethylcellulose 20, yellow iron oxide (E172), hydrated colloidal silica, magnesium stearate, mannitol, povidone, microcrystalline cellulose.

Description of the appearance of Alfuzosina Zentiva and pack sizes
Alfuzosina Zentiva is available as prolonged-release tablets.
Pack sizes of 20 tablets and 30 tablets in blisters are available.

Marketing Authorization Holder
Zentiva Italia S.r.l.
Viale L. Bodio, 37/B - Milan

Manufacturer
Sanofi Winthrop Industrie – 30-36 Avenue Gustave Eiffel - Tours (France)
Sanofi-Synthelabo Limited - Edgefield Avenue - Fawdon - Newcastle-Upon-Tyne NE3 3TT (UK)