Xatral

Patient Information Leaflet

Xatral 2.5 mg coated tablets

Alfuzosin hydrochloride
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 they have the same symptoms as yours, because it may be harmful.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Xatral is and what it is used for

Xatral 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.
Xatral 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 Xatral

Do not take Xatral

• 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 severe liver problems (severe hepatic insufficiency);
• If you are taking ritonavir alone or in combination with ombitasvir/paritaprevir, lopinavir, or nirmatrelvir. See section “Other medicines and Xatral”.

Warnings and precautions
Talk to your doctor or pharmacist before taking Xatral.
If you are taking medicines for high blood pressure (antihypertensives) or for chest pain (nitrates), your doctor will prescribe Xatral with caution.
Within a few hours after taking Xatral, sudden drops in blood pressure may occur when quickly moving 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 therapy.
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 Xatral 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 Xatral carefully.
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 Xatral with caution.
If you are being treated for coronary insufficiency (heart artery disorder) and chest pain reappears or worsens, your doctor will discontinue treatment with Xatral.
If you have a heart rhythm disorder or are taking medicines that may cause heart rhythm disturbances (prolongation of the QTc interval), your doctor will perform checks before and during treatment with Xatral.
While taking Xatral, as with other alpha-1 blockers, you may experience a persistent, painful erection of the penis not related 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 Xatral or another alpha-1 blocker. This is because Xatral 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 may therefore lead to possible adverse effects.
If you have previously experienced disorders affecting blood vessels supplying the brain, with or without symptoms, Xatral increases the risk of insufficient blood supply to the brain (cerebral ischemia).

Other medicines and Xatral
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You must not take Xatral if you are using:

• Other medicines belonging to the group of alpha-1 antagonists (see "Do not take Xatral"), because there is a risk of increased blood pressure-lowering effect.
• Ritonavir alone or in combination with lopinavir (commonly used for the treatment of HIV) or ritonavir in combination with ombitasvir/paritaprevir (commonly used for the treatment of chronic hepatitis C infection) or ritonavir in combination with nirmatrelvir (commonly used for the treatment of mild to moderate COVID-19).

The effects of Xatral 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 itraconazole), as they increase the concentration of alfuzosin in the blood.
• Ketoconazole tablets (used to treat Cushing's syndrome, when the body produces excess cortisol).

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

Pregnancy, breastfeeding and fertility
Not applicable, as Xatral 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 Xatral. Take this into account if you need to drive or operate machinery.

Xatral contains lactose
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult your doctor before taking this medicine.

Xatral contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Xatral

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 Xatral 2.5 mg three times daily (for a total of 7.5 mg per day).
Take the first tablet before going to bed.

Use in elderly patients and in patients being 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 these doses, but 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 Xatral 2.5 mg twice daily. Your doctor may adjust the dose as needed.

Use in patients with liver disease
If you suffer from mild to moderate liver disease, the recommended starting dose is: 1 tablet of Xatral 2.5 mg once daily, which your doctor may increase up to 2 tablets per day.

Use in children and adolescents
Xatral must not be used in children and adolescents.

If you take more Xatral than you should
In case of accidental overdose or ingestion of an excessive dose of Xatral, contact your doctor immediately or go to the nearest hospital.

If you forget to take Xatral
Do not take a double dose to make up for the missed tablet.
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
everyone will experience 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 rapid heartbeat (palpitations).
• Vision disorders.
• Swelling (edema).
• Chest pain.
• Drowsiness.
• Loss of consciousness (syncope).
• Cold symptoms (rhinitis).
• Skin redness (rash).
• Itching (pruritus).
• Facial flushing (flushing).
• Vomiting.

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 disorders of the blood vessels supplying blood to the heart (coronary artery disease).
• Hives (urticaria).
• Swelling of the face, throat, or limbs, possibly with breathing difficulties (angioedema).

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

• Changes in heart rhythm (atrial fibrillation).

• The iris (the colored part of the eye) becoming floppy during eye surgery (intraoperative floppy iris syndrome).

• Liver damage (hepatocellular injury).

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

• Reduced or blocked 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 symptoms, up to loss of consciousness (circulatory collapse).

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

• Reduction 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 contact your doctor or pharmacist. You may also report side effects
directly via the national reporting system at the website
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 Xatral

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 Xatral 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 carboxymethyl starch, magnesium stearate. coating: hypromellose, macrogol 400, titanium dioxide (E171).

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

Patient information leaflet

Xatral 10 mg prolonged-release 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 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:

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

1. What Xatral is and what it is used for

Medicines used in benign prostatic hyperplasia: Xatral 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 exits), and prostate.
Xatral is indicated for the treatment of symptoms caused by an enlarged prostate, a condition known as "benign prostatic hyperplasia".
Xatral is also indicated as an add-on therapy to urethral catheterization (insertion of a small tube into the bladder through the urethra to allow urine drainage) in the treatment of acute urinary retention (a condition in which the patient is unable to empty the bladder of urine) caused by enlargement of the prostate gland (benign prostatic hyperplasia).

2. What you need to know before taking Xatral

Do not use Xatral

• If you are allergic to alfuzosin or to any of the other ingredients of this medicine (listed in section 6).
• If you suffer 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-antagonist group.
• If you have liver problems (hepatic insufficiency).
• If you are taking ritonavir alone or in combination with ombitasvir/paritaprevir, lopinavir, or nirmatrelvir. See section “Other medicines and Xatral”.

Warnings and precautions
Talk to your doctor or pharmacist before taking Xatral.
If you are taking medicines for high blood pressure (antihypertensives) or for chest pain (nitrates), your doctor will prescribe Xatral with caution.
Within a few hours after taking Xatral, 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 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 Xatral with caution.
If you have previously experienced a marked drop in blood pressure after taking another medicine from the alpha 1-blocker group, or if you are being treated with antihypertensives or nitrates, your doctor will prescribe Xatral carefully.
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 Xatral 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 Xatral.
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 Xatral.
When taking Xatral, 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 Xatral or another alpha 1-blocker. This is because Xatral or another alpha 1-blocker may 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 Xatral 10 mg, as the 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 result in inappropriate release and absorption of the active substance and possibly lead to adverse effects.

Other medicines and Xatral
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You must not take Xatral if you are using:

• Other medicines belonging to the alpha 1-antagonist group (see "Do not take Xatral"), because there is a risk of increasing the blood pressure-lowering effect.
• Ritonavir alone or in combination with lopinavir (commonly used for the treatment of HIV) or ritonavir in combination with ombitasvir/paritaprevir (commonly used for the treatment of chronic hepatitis C infection) or ritonavir in combination with nirmatrelvir (commonly used for the treatment of mild to moderate COVID-19).

The effects of Xatral 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 itraconazole), as they increase the concentration of alfuzosin in the blood.
• Ketoconazole tablets (used to treat Cushing's syndrome, when the body produces excess cortisol).

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

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

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

Xatral contains hydrogenated castor oil
Hydrogenated castor oil may cause stomach discomfort and diarrhoea.

3. How to take Xatral

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, 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 drain).
The tablets must be swallowed whole.
Use in children and adolescents
Xatral must not be used in children and adolescents.
If you take more Xatral than you should
In case of accidental ingestion of an excessive dose of Xatral, contact your doctor immediately or go to the nearest hospital.
If you forget to take Xatral
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 experiences them.
The following side effects may occur, with the following frequency:

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

• Weakness or tiredness (asthenia).
• Nausea.
• Abdominal pain.
• Fainting.
• Dizziness (vertigo).
• Headache (cephalaea).

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

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

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 disorders of the blood vessels supplying the heart (coronary artery disease).
• Hives (urticaria).
• Swelling of the face, throat, or limbs, possibly with breathing difficulties (angioedema).

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

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

Following the instructions provided 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 contact your doctor or pharmacist. You may also report side effects
directly via the national reporting system at the website
https://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 Xatral

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 pack 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 Xatral 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 Xatral and contents of the pack
Xatral is available as prolonged-release tablets.
Packages containing 20 tablets and 30 tablets in blisters are available.
Marketing Authorization Holder
Sanofi S.r.l.
Viale L. Bodio, 37/B - Milan
Manufacturer
Sanofi Winthrop Industrie – 30-36 Avenue Gustave Eiffel - Tours (France)