Mittoval

Package leaflet: Information for the patient

Mittoval 2.5 mg 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 others, even if their symptoms are the same as yours, as 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 Mittoval is and what it is used for
2. What you need to know before taking Mittoval
3. How to take Mittoval
4. Possible side effects
5. How to store Mittoval
6. Contents of the pack and other information

1. What Mittoval is and what it is used for

Mittoval 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.
Mittoval is indicated for the treatment of symptoms caused by an enlarged prostate, a condition known as "benign prostatic hyperplasia".

2. What you should know before taking Mittoval

Do not take Mittoval

• 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 blockers 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 Mittoval”.

Warnings and precautions
Talk to your doctor or pharmacist before taking Mittoval.

If you are taking medicines for high blood pressure (antihypertensives) or for chest pain (nitrates), your doctor will prescribe Mittoval with caution.

Within a few hours of taking Mittoval, you may experience sudden drops in blood pressure when moving quickly from a sitting or lying position to standing (orthostatic hypotension), with or without symptoms (dizziness, fatigue, sweating). If this happens, you should 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 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 Mittoval with caution.

If you 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 Mittoval 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 Mittoval 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 Mittoval.

If you have a heart rhythm disorder or are taking medicines that may cause heart rhythm disturbances (QTc interval prolongation), your doctor will perform checks before and during treatment with Mittoval.

Taking Mittoval, as with other alpha-1 blockers, may cause 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 Mittoval or another alpha-1 blocker. This is because Mittoval or another alpha-1 blocker may 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 substance and may therefore lead to possible adverse effects.

If you have previously suffered from disorders affecting the blood vessels supplying blood to the brain, with or without symptoms, Mittoval increases the risk of inadequate blood supply to the brain (cerebral ischemia).

Other medicines and Mittoval
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

You must not take Mittoval if you are using:

• Other medicines belonging to the group of alpha-1 antagonists (see "Do not take Mittoval"), 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 Mittoval 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 an excess of cortisol).

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

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

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

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

3. How to take Mittoval

Take this medicine exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Adults
The recommended dose is: 1 tablet of Mittoval 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 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 Mittoval 2.5 mg twice daily. The dose may be adjusted by your doctor.
Use in patients with liver disease
If you suffer from mild to moderate liver disease, the recommended starting dose is: 1 tablet of Mittoval 2.5 mg once daily, which may be increased by your doctor up to 2 tablets per day.
Use in children and adolescents
Mittoval must not be used in children and adolescents.
If you take more Mittoval than you should
In case of accidental ingestion or overdose of Mittoval, contact your doctor immediately or go to the nearest hospital.
If you forget to take Mittoval
Do not take a double dose to make up for the missed tablet.
If you have any doubts 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 experiences them.
The following side effects may occur, according to the following frequency:

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

• Weakness or fatigue (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 strong heartbeat (palpitations).
• Vision disturbances.
• Swelling (edema).
• Chest pain.
• Drowsiness.
• Loss of consciousness (syncope).
• Cold (rhinitis).
• Skin redness (rash).
• Itching.
• Flushing of the face (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 occurs if you already suffer from disorders of the blood vessels supplying blood to the heart (coronary artery disease).
• Hives (urticaria).
• Swelling of the face, throat, or limbs, possibly causing breathing difficulties (angioedema).

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

• Changes in heart rhythm (atrial fibrillation).
• Iris (the coloured part of the eye) becoming floppy during eye surgery (intraoperative floppy iris syndrome).
• Liver damage (hepatocellular injury).
• Blockage or interruption 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 symptoms up to loss of consciousness (circulatory collapse).
• Decrease or absence 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, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following 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 Mittoval

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 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 Mittoval 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 carboxymethylstarch, magnesium stearate. coating: hypromellose, macrogol 400, titanium dioxide (E171).

Description of the appearance of Mittoval and contents of the pack
Mittoval is available as coated tablets.
Packs 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

Mittoval 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 other people, even if their symptoms are the same as yours, as 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 Mittoval is and what it is used for
2. What you need to know before taking Mittoval
3. How to take Mittoval
4. Possible side effects
5. How to store Mittoval
6. Contents of the pack and other information

1. What Mittoval is and what it is used for

Medicines used in benign prostatic hyperplasia: Mittoval 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.
Mittoval is indicated for the treatment of symptoms caused by an enlarged prostate, a condition known as "benign prostatic hyperplasia".
Mittoval is also indicated as an add-on therapy to urethral catheterisation (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 of urine) caused by enlargement of the prostate gland (benign prostatic hyperplasia).

2. What you should know before taking Mittoval

Do not use Mittoval

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Mittoval.
If you are taking medicines for high blood pressure (antihypertensives) or chest pain (nitrates), your doctor will prescribe Mittoval with caution.
Within a few hours after taking Mittoval, sudden drops in blood pressure may occur when quickly changing 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 Mittoval with caution.
If you have experienced a significant drop in blood pressure after taking another medicine from the alpha-1 blockers group, or if you are being treated with antihypertensives or nitrates, your doctor will prescribe Mittoval 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 Mittoval 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 Mittoval.
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 Mittoval.
Taking Mittoval, as with other alpha-1 blockers, may cause a persistent, painful erection unrelated 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 Mittoval or another alpha-1 blocker. This is because Mittoval 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 Mittoval 10 mg, as prolonged-release tablets should not be administered to patients with severe kidney problems.
The tablets must be swallowed whole. Do not crush, chew, grind, or dissolve them in liquid. Doing so may result in inappropriate release and absorption of the active substance and could therefore lead to possible adverse effects.
Other medicines and Mittoval
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.
Do not take Mittoval if you are using:

• other medicines belonging to the group of alpha-1 antagonists (see "Do not take Mittoval"), as 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 Mittoval 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 undergoing surgery requiring general anesthesia, inform your doctor that you are taking Mittoval, as this medicine may affect your blood pressure.
Pregnancy, breastfeeding and fertility
Not applicable, as Mittoval 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 Mittoval. Take this into account if you need to drive or operate machinery.
Mittoval contains hydrogenated castor oil
Hydrogenated castor oil may cause stomach discomfort and diarrhea.

3. How to take Mittoval

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
For the treatment of enlarged prostate (benign prostatic hyperplasia)
Recommended dose: 1 tablet of 10 mg once daily, taken after a meal.
For the treatment of inability to empty the bladder (acute urinary retention)
Recommended dose: 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
Mittoval must not be used in children and adolescents.
If you take more Mittoval than you should
In case of accidental ingestion or overdose of Mittoval, contact your doctor immediately or go to the nearest hospital.
If you forget to take Mittoval
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, according to the following frequency:

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

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

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 (rhinitis).
• Skin redness (rash).
• Itching.
• 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 arms, neck or jaw (angina). This may occur if you already suffer from blood vessel disorders affecting the heart (coronary disease).
• Hives (urticaria).
• Swelling of the face, throat or limbs, possibly causing breathing difficulties (angioedema).

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

• Irregular heartbeat (atrial fibrillation).
• Iris (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).
• Persistent and painful erection (priapism).
• Severe drop in blood pressure with various disturbances up to loss of consciousness (circulatory collapse).
• Reduction in the number of white blood cells (neutropenia).
• Reduction in the 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, talk to your doctor or pharmacist.
You may also report side effects directly via the national reporting system at
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 Mittoval

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 on the 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 Mittoval 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 Mittoval and package contents
Mittoval 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)