LEVOBREN

Patient Information Leaflet

Levobren 25 mg tablets, 25 mg/ml oral drops solution, 25 mg/2 ml injectable solution

levosulpiride
Please read this leaflet carefully before using 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 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, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Levobren is and what it is used for

Levobren contains the active substance levosulpiride, which belongs to a class of medicines called “psycholeptics, antipsychotics (neuroleptics)”.
It works by stimulating gastric and intestinal motility (prokinetic effect).
Levobren is indicated for short-term treatment of:

• a condition caused by delayed gastric emptying (dyspeptic syndrome) due to factors such as tumors or somatization disorders related to anxiety, and characterized by loss of appetite (anorexia), excessive intestinal gas (meteorism), a feeling of fullness in the upper abdomen, headache after meals, heartburn, belching, diarrhea, constipation. Levobren has been prescribed to you because you did not respond previously to treatment with other medicines.
• symptoms of vomiting and nausea (caused by medications used in cancer treatment). Levobren has been prescribed to you because you did not respond previously to treatment with other medicines.
• symptoms of an inner ear disorder affecting balance and hearing (Ménière's syndrome), characterized by vertigo, ringing in the ears (tinnitus), hearing loss, and nausea.

2. What you need to know before taking Levobren

Do not take Levobren

• if you are allergic to levosulpiride or to any of the other ingredients of this medicine (listed in section 6)
• if you have a tumour of the adrenal gland (pheochromocytoma)
• if you suffer from seizures (epilepsy)
• if you have psychiatric disorders (manic states, manic phases of manic-depressive psychosis)
• if you have breast cancer (malignant mastopathy)
• if you have bleeding, mechanical obstructions, or perforations of the stomach or intestine
• if you are pregnant or suspect you may be pregnant, or if you are breastfeeding (see "Pregnancy and breastfeeding").

Warnings and precautions

Talk to your doctor or pharmacist before taking Levobren.

• Avoid using LEVOBREN concurrently with other psychotropic drugs (neuroleptics).

Your doctor will prescribe Levobren cautiously only after evaluating:

• whether you are elderly;
• whether you suffer from a condition that reduces your ability to remember, speak, and think (dementia);
• whether you have risk factors for stroke, if you suffer from diseases related to blood circulation (cardiovascular diseases), or if you have a family history of heart rhythm disturbances (QT prolongation).
• whether you or someone in your family has or has had blood clots (thrombi), as Levobren may cause blood clot formation.

Contact your doctor immediately if:
You develop fever (hyperpyrexia), muscle stiffness, movement difficulties (akinesia), irregular heartbeat (tachycardia, arrhythmias), irregular blood pressure, sweating, or disturbances in consciousness that may progress to stupor or coma, as you may be experiencing a condition known as "Neuroleptic Malignant Syndrome," which can be fatal. In this case, you must stop taking Levobren and contact your doctor immediately, who will prescribe appropriate treatment.
If you need to resume treatment with antipsychotics, your doctor will monitor you closely.
If you are taking anticholinergic medicines (drugs that block the action of acetylcholine, a substance involved in nerve impulse transmission), narcotics, or analgesics (painkillers), as they may reduce the effects of Levobren (see section "Other medicines and Levobren").

Other medicines and Levobren
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pay particular attention and inform your doctor if you are taking the following medicines:

• other psychotropic drugs, medicines used for psychiatric disorders, particularly neuroleptics;
• concomitantly with medicines that affect heart rhythm (prolong QT interval), increasing the risk of developing heart rhythm abnormalities (cardiac arrhythmias);
• medicines known as anticholinergics (used to counteract a substance involved in nerve impulse transmission in the body called "acetylcholine"), medicines used to induce sleep (narcotics), and medicines used for pain relief (analgesics), as they may influence the effects of Levobren on stomach and intestinal motility;
• medicines that cause changes in substances in the body called "electrolytes."

Levobren with food, drinks, and alcohol
Do not consume alcohol during treatment with Levobren.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy
Do not use Levobren if you are pregnant or think you might be pregnant.
If you take antipsychotics ("conventional or atypical"), including Levobren, during the last three months of pregnancy, your newborn may experience the following symptoms after birth: tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems.
Contact your doctor if your baby shows any of these symptoms.

Breastfeeding
Do not use Levobren during breastfeeding.

Driving and using machines
At high doses, drowsiness, lethargy, and involuntary movements (dyskinesias) may occur. Take this into account if you need to drive or operate machinery requiring a high level of alertness, due to potential danger.

Levobren tablets contain lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

Levobren oral drops contain parahydroxybenzoates
May cause allergic reactions (including delayed reactions).

3. How to use Levobren

Use this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Adults
The recommended dose is (according to medical prescription):

• Tablets: 1 tablet 3 times a day before meals.
• Ampoules: 1 vial of 25 mg injected into the muscle or vein (i.m. or i.v.) 2 or 3 times a day.
• Drops: 15 drops 3 times a day before meals (one drop contains 1.6 mg of levosulpiride). The dropper bottle has a child-resistant cap. To open, press down on the cap while unscrewing it normally. To close, screw the cap back on completely.

If you suffer from nausea and vomiting and oral administration is difficult, your doctor may
start treatment of your symptoms with Levobren injectable solution (i.m. or i.v.) 2 or 3
times a day for a few days, then switch, when symptoms become milder, to oral administration for 10–15 days.
The oral treatment course may subsequently be repeated for another 2 or 3 weeks, after a break of at least 8–10 days.
Treatment of vomiting caused by antineoplastic medicines
The recommended dose is:
one vial injected into the muscle or vein, possibly repeated 2–3 times a day, until symptoms disappear.
If the medicine is used to treat vomiting caused by antineoplastic agents (cisplatin, anthracyclines), you will be given a dose of 1–2 vials of Levobren injectable solution administered by slow intravenous injection or infusion 30 minutes before the antineoplastic agent is given, or during its administration, and the same dose will be repeated 30 minutes after completion of chemotherapy.
Use in the elderly
If you are elderly, your doctor will carefully determine the dosage and may consider reducing the doses indicated above.
Use in children and adolescents
This medicine must not be used in children and adolescents because relevant data are not available.
If you take more Levobren than you should
An overdose may cause movement disorders and sleep disturbances, which resolve upon discontinuation of therapy or dose reduction.
In case of accidental ingestion of an excessive dose of Levobren, contact your doctor immediately or go to the nearest hospital.
If you forget to use Levobren
Do not take a double dose to make up for the forgotten dose.
If you have any doubts about how to use Levobren, 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 have been observed also with the use of other medicines in the same class and/or with prolonged administration:
Rare (may affect up to 1 in 1,000 people):

• changes in heartbeat (QT interval prolongation, ventricular arrhythmias such as torsades de pointes, ventricular tachycardia, ventricular fibrillation), cardiac arrest.

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

• somnolence, "parkinsonism" (symptoms similar to those of Parkinson's disease such as, for example, tremor, difficulty and slowness of movement, rigidity and postural instability); involuntary muscle movements (dyskinesias); tremor; repetitive twisting movements or abnormal fixed postures (dystonia); Neuroleptic Malignant Syndrome (see section "Contact your doctor immediately if").
• cases of sudden death.

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

• absence of menstruation in women of childbearing age (amenorrhoea), breast development in men (gynaecomastia), breast tension, spontaneous milk discharge from the breasts unrelated to childbirth or breastfeeding (galactorrhoea), changes in sexual desire (libido).
• formation of blood clots (venous thrombosis), especially in the legs (symptoms include swelling, pain, redness of the leg), which may travel to the lungs and cause chest pain and breathing difficulties.
• neonatal withdrawal symptoms (see section 2, “Pregnancy and breastfeeding”), movement disorders (extrapyramidal symptoms).
• increased levels of a hormone called prolactin in the blood (hyperprolactinaemia).
• LEVOBREN is not indicated for the treatment of dementia. In elderly patients with dementia, a small increase in the number of deaths has been observed in patients taking antipsychotics compared to those not taking antipsychotics.

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 website:
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Levobren

This medicinal product 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 packaging 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 no longer in use. This will help protect the environment.

6. Package contents and other information

What LEVOBREN contains
Levobren 25 mg tablets
The active substance is levosulpiride. One tablet contains 25 mg of levosulpiride.
The other components are: carboxymethylcellulose, microcrystalline cellulose, lactose, magnesium stearate.
Levobren 25 mg/2 ml injectable solution
The active substance is levosulpiride. One vial contains 25 mg of levosulpiride.
The other components are: sulfuric acid 2 N, water for injections, sodium chloride.
Levobren 25 mg/ml oral drops, solution
The active substance is levosulpiride. 100 ml of solution contain 2.5 g of levosulpiride.
The other components are: anhydrous citric acid, purified water, lemon flavor, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, acesulfame K.

Description of the appearance of Levobren and contents of the pack
Levobren is available as:

• Tablets 25 mg: carton containing one blister (aluminum/PVC) with 20 tablets
• Injectable solution 25 mg/2 ml: carton containing 6 vials of 2 ml
• Oral drops, solution 25 mg/ml: carton containing one dropper bottle in glass, with child-resistant closure, containing 20 ml of solution

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
NEOPHARMED GENTILI S.p.A.
Via San Giuseppe Cottolengo, 15
20143 Milan, Italy

Manufacturer

• Injectable solution vials: Doppel Farmaceutici Srl - Via Volturno, 48 - Quinto de’ Stampi - Rozzano (Milan) Biologici Italia Laboratories S.r.l., Via Serpero, 2 - Masate (Milan)
• Tablets: AbbVie S.r.l. - Campoverde (Latina) Doppel Farmaceutici Srl - Via Volturno, 48 - Quinto de’ Stampi - Rozzano (Milan)
• Oral drops solution: Vamfarma S.r.l. - Via Kennedy, 5 - Comazzo (Lodi) Doppel Farmaceutici Srl - Via Martiri delle Foibe, 1 - Cortemaggiore (PC)

Patient Information Leaflet

Levobren 50 mg tablets

levosulpiride
Please read this leaflet carefully before using 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 Levobren is and what it is used for
2. What you need to know before taking Levobren
3. How to take Levobren
4. Possible side effects
5. How to store Levobren
6. Contents of the pack and other information

1. What Levobren is and what it is used for

Levobren contains the active substance levosulpiride, which belongs to a class of medicines called "psycholeptics, antipsychotics (neuroleptics)".
Levobren is indicated for the treatment of mental disorders such as:

• disorders characterized by physical symptoms suggesting an illness ("somatic symptom disorders")
• long-term or permanent illnesses causing severe and persistent disturbances in behaviour, affectivity, thinking, and perception ("chronic schizophrenia with negative symptoms").

3. What you need to know before taking Levobren

Do not take Levobren

• if you are allergic to levosulpiride or to any of the other ingredients of this medicine (listed in section 6)
• if you suffer from seizures (epilepsy)
• if you have mental disorders (manic states, manic phases of manic-depressive psychosis)
• if you have a tumor of the adrenal gland (pheochromocytoma)
• if you have bleeding, mechanical obstruction, or perforation of the stomach or intestines
• if you have breast cancer (malignant mastopathy).

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

• Avoid taking LEVOBREN concurrently with other psychotropic medicines (neuroleptics).

Your doctor will prescribe Levobren 50 mg tablets with caution:

• if you are elderly;
• if you suffer from a disease that impairs your ability to remember, speak, and reason (dementia); if you are pregnant or breastfeeding (see "Pregnancy and breastfeeding").
• if you have risk factors for stroke, if you suffer from diseases related to blood circulation (cardiovascular) or have a family history of heart rhythm disturbances (QT prolongation).
• if you or someone in your family has or has had blood clots (thrombi), as Levobren may cause blood clot formation. If you suffer from such conditions, contact your doctor before taking this medicine.

Contact your doctor immediately if you experience:

• fever (hyperpyrexia), muscle stiffness, difficulty in movement (akinesia), irregular heartbeat (tachycardia, arrhythmias), and irregular blood pressure, sweating, changes in consciousness that may progress to stupor and coma, as you may have a condition called "Neuroleptic Malignant Syndrome," which can be fatal. In this case, you must stop taking Levobren and contact your doctor immediately, who will prescribe appropriate treatment. If you need to resume treatment with antipsychotics, your doctor will monitor you closely.

Other medicines and Levobren
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Your doctor will prescribe Levobren with caution if you are being treated with medicines called "psychotropic drugs" used to treat mental disorders.
When taking a type of medicine called "neuroleptics," including Levobren, together with medicines that affect heart rhythm (prolong QT interval), the risk of developing heart rhythm abnormalities (cardiac arrhythmias) increases.
Do not take Levobren together with medicines that cause changes in substances in the body known as "electrolytes."

Levobren with food, drinks, and alcohol
Do not consume alcohol during treatment with Levobren.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy
This medicine will be administered during pregnancy only if clearly needed and under the direct supervision of your doctor.
If you take conventional or atypical antipsychotics, including Levobren, during the last three months of pregnancy, your newborn may experience the following symptoms after birth: tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems.
Contact your doctor if your baby shows any of these symptoms.

Breastfeeding
This medicine will be administered during breastfeeding only if clearly needed and under the direct supervision of your doctor.

Driving and use of machinery
Treatment with Levobren may cause drowsiness, dizziness, and involuntary movements (dyskinesias). Take this into account if you need to drive or operate machinery requiring a high level of alertness, due to potential danger.

3. How to use Levobren

Use this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Adults
The recommended dose in acute forms is:

• Tablets: 2-3 tablets of 100 mg per day.

Maintenance therapy
Tablets: 3 tablets of 50 mg per day, according to the doctor's judgment. This dose may
be gradually reduced.
Use in the elderly
If you are elderly, your doctor will carefully determine the dosage and may consider reducing the
doses indicated above.
If you take more Levobren than you should
An overdose may cause movement disorders and sleep disturbances, which resolve upon
discontinuation of therapy or reduction of the dose.
In case of accidental ingestion of an excessive dose of Levobren, contact your doctor immediately or go to the nearest hospital.
If you forget to use Levobren
Do not take a double dose to make up for the forgotten dose.
If you stop treatment with Levobren
If you have any questions about the use of Levobren, 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 have also been observed with the use of other medicines in the same class and/or with prolonged administration:

Very common (may affect more than 1 in 10 people):

• drowsiness, temporary loss of sensitivity and reflex responsiveness (stupor)

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

• dizziness, vertigo (a false sensation of movement)

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

• changes in heart rhythm (prolongation of QT interval, ventricular arrhythmias such as torsades de pointes, ventricular tachycardia, ventricular fibrillation), cardiac arrest.

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

• weight gain
• "parkinsonism" (symptoms similar to those of Parkinson's disease such as, e.g., tremor, difficulty and slowness of movement, rigidity and postural instability); involuntary muscle movements (dyskinesias); tremor; repetitive twisting movements or abnormal fixed postures (dystonia); psychomotor agitation (restlessness and purposeless involuntary movements);
• disorders affecting the autonomic nervous system (e.g. sweating, pallor, sensation of fainting, especially when standing up from a lying or sitting position, drop in blood pressure, slowing of heart rate).
• cases of sudden death.

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

• "Neuroleptic Malignant Syndrome" (see section "Take special care with LEVOBREN");
• absence of menstruation in women of childbearing age (amenorrhoea);
• breast development in men (gynaecomastia); breast tension,
• spontaneous milk discharge from the breasts not related to childbirth or breastfeeding (galactorrhoea);
• changes in sexual desire (libido);
• formation of blood clots (venous thrombosis), especially in the legs (symptoms include swelling, pain, redness of the leg), which may travel to the lungs and cause chest pain and breathing difficulties.
• neonatal withdrawal symptoms (see section 2 “Pregnancy and breastfeeding”), movement disorders (extrapyramidal symptoms)
• increased levels of a hormone called prolactin in the blood (hyperprolactinaemia).

LEVOBREN is not indicated for the treatment of dementia. In elderly patients with dementia, a small increase in the number of deaths has been observed among patients taking antipsychotics compared to those not taking antipsychotics.

Reporting of side effects
If you experience any side effects, 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.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Levobren

This medicinal product 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 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 no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Levobren contains
Levobren 50 mg tablets
The active substance is levosulpiride. One tablet contains 50 mg of levosulpiride.
The other ingredients are: carboxymethyl starch, microcrystalline cellulose, gelatin, magnesium stearate.

Description of the appearance of Levobren and pack contents
Levobren is available as:

• 50 mg tablets: carton pack containing one blister (aluminum/PVC) with 20 tablets

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
NEOPHARMED GENTILI S.p.A.
Via San Giuseppe Cottolengo, 15
20143 Milan, Italy

Manufacturer:
AbbVie S.r.l. – Campoverde (Latina)

Patient information leaflet

Levobren 100 mg tablets

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, 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 reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Levobren is and what it is used for

Levobren contains the active substance levosulpiride, which belongs to a class of medicines called "psycholeptics, antipsychotics (neuroleptics)".
Levobren is indicated for the treatment of mental disorders such as:

• disorders characterized by physical symptoms suggesting an illness (somatic symptom disorders)
• long-term or permanent illnesses causing severe and persistent disturbances in behaviour, affectivity, thought and perception (chronic schizophrenia with negative symptoms).

4. What you should know before taking Levobren

Do not take Levobren

• if you are allergic to levosulpiride or to any of the other ingredients of this medicine (listed in section 6)
• if you suffer from seizures (epilepsy)
• if you have mental disorders (manic states, manic phases of manic-depressive psychosis)
• if you have a tumor of the adrenal gland (pheochromocytoma)
• if you have gastrointestinal bleeding, mechanical obstructions, or perforations of the stomach or intestines
• if you have breast cancer (malignant mastopathy)

Warnings and precautions

Talk to your doctor or pharmacist before taking Levobren.

• Avoid using LEVOBREN concurrently with other psychotropic medicines (neuroleptics).

Your doctor will prescribe Levobren 100 mg tablets with caution

• if you are elderly;
• if you suffer from a disease that impairs your ability to remember, speak, and reason (dementia);
• if you are pregnant or breastfeeding (see "Pregnancy and breastfeeding");
• if you have risk factors for stroke, if you suffer from blood circulation disorders (cardiovascular diseases), or if you have a family history of heart rhythm disturbances (QT prolongation);
• if you or someone in your family has had or has blood clots (thrombi), as Levobren may cause blood clot formation.

If you have any of these conditions, contact your doctor before taking this medicine.
Contact your doctor immediately if you experience:

• fever (hyperpyrexia), muscle stiffness, movement difficulties (akinesia), irregular heartbeat (tachycardia, arrhythmias), irregular blood pressure, sweating, disturbances in consciousness that may progress to stupor and coma, as you may have a condition known as "Neuroleptic Malignant Syndrome," which can be fatal. In this case, you must stop taking Levobren and contact your doctor immediately, who will prescribe appropriate treatment. If you need to restart treatment with antipsychotics, your doctor will monitor you closely.

Other medicines and Levobren
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Your doctor will prescribe Levobren cautiously if you are being treated with medicines called "psychotropics" used to treat mental disorders.
When taking a type of medicine called "neuroleptics," including Levobren, together with medicines that affect heart rhythm (prolong QT interval), the risk of developing heart rhythm abnormalities (cardiac arrhythmias) increases.
Do not take Levobren concurrently with medicines that cause imbalances in substances in the body known as "electrolytes."

Levobren with food, drinks, and alcohol
Do not consume alcohol during treatment with Levobren.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
This medicine will be administered during pregnancy only if clearly needed and under direct medical supervision.
If you take conventional or atypical antipsychotics, including Levobren, during the last three months of pregnancy, your newborn may experience the following symptoms after birth: tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems.
Contact your doctor if your newborn shows any of these symptoms.

Breastfeeding
This medicine will be administered during breastfeeding only if clearly indicated and under direct medical supervision.

Driving and using machines
Levobren may cause drowsiness, dizziness, and involuntary movements (dyskinesias). Consider this when driving or operating machinery requiring a high level of alertness due to potential risks.

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

3. How to take Levobren

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 for acute conditions is:

• Tablets: 2-3 tablets of 100 mg daily.

Maintenance therapy
Tablets: 3 tablets of 50 mg daily, according to the physician's judgment. This dose may be gradually reduced.
Use in the elderly
If you are elderly, your doctor will carefully determine the dosage and may consider reducing the doses indicated above.
If you take more Levobren than you should
An overdose may cause movement disorders and sleep disturbances, which resolve upon discontinuation of treatment or reduction of the dose.
In case of accidental ingestion of an excessive dose of Levobren, inform your doctor immediately or go to the nearest hospital.
If you forget to take Levobren
Do not take a double dose to make up for the missed dose.
If you stop taking Levobren
If you have any questions about the use of Levobren, 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 have been observed also with the use of other medicines in the same
class and/or with prolonged administration:
Very common (may affect more than 1 in 10 people):

• drowsiness, temporary loss of sensitivity and reflex responsiveness (stupor)

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

• dizziness, vertigo (feeling of false sensation of movement)

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

• changes in heartbeat (QT interval prolongation, ventricular arrhythmias such as torsades de pointes, ventricular tachycardia, ventricular fibrillation), cardiac arrest.

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

• weight gain
• "parkinsonism" (symptoms similar to those of Parkinson's disease such as, e.g., tremor, difficulty and slowness of movement, rigidity and postural instability); involuntary muscle movements (dyskinesias); tremor; repetitive twisting movements or abnormal fixed postures (dystonia); psychomotor agitation (restlessness and purposeless involuntary movements);
• disorders affecting the autonomic nervous system (e.g. sweating, pallor, feeling of fainting, especially when standing up from a lying or sitting position, drop in blood pressure, slowing of heartbeat).
• cases of sudden death.

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

• "Neuroleptic Malignant Syndrome" (see section "Special warnings and precautions for use with LEVOBREN").
• absence of menstruation in women of childbearing age (amenorrhoea); breast tenderness,
• breast development in men (gynaecomastia);
• spontaneous milk discharge from the breasts not related to childbirth or breastfeeding (galactorrhoea);
• changes in sexual desire (libido);
• formation of blood clots (venous thrombosis), especially in the legs (symptoms include swelling, pain, redness of the leg), which may travel to the lungs and cause chest pain and breathing difficulties.
• neonatal withdrawal symptoms (see section 2 “Pregnancy and breastfeeding”), movement disorders (extrapyramidal symptoms).
• increased levels of a hormone called prolactin in the blood (hyperprolactinaemia).

LEVOBREN is not indicated for the treatment of dementia. In elderly patients with dementia,
a small increase in the number of deaths has been observed among patients taking
antipsychotics compared to those not taking antipsychotics.
Reporting of side effects
If you experience any side effects, 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.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Levobren

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 packaging 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 Levobren 100 mg tablets contain
The active substance is levosulpiride. One tablet contains 100 mg of levosulpiride.
The other components are: carboxymethyl starch, microcrystalline cellulose, gelatin, lactose,
magnesium stearate.
Description of the appearance of Levobren and package contents
Levobren 100 mg tablets are presented in a cardboard box containing a blister (aluminum/PVC) with 20
tablets of 100 mg.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
NEOPHARMED GENTILI S.p.A.
Via San Giuseppe Cottolengo, 15
20143 Milan
Manufacturer:
AbbVie S.r.l. – Campoverde (Latina)