LEVOBREN 25 mg Tabletka Powlekana

Treść ulotki

1. Levobren 25 mg tablets, 25 mg/ml oral drops solution, 25 mg/2 ml injectable solution
   1. What is Levobren and what is it used for
   2. What you need to know before using Levobren
   3. How to use Levobren
   4. Possible side effects
   5. How to store Levobren
   6. Package Contents and Other Information
2. Levobren 50 mg tablets
   1. What is Levobren and what is it used for
   2. What you need to know before using Levobren
   3. How to use Levobren
   4. Possible side effects
   5. How to store Levobren
   6. Contents of the pack and other information
3. Levobren 100 mg tablets
   1. What is Levobren and what is it used for
   2. What you need to know before taking Levobren
   3. How to take Levobren
   4. Possible side effects
4. LEVOBREN is not indicated for the treatment of dementia. In elderly patients with dementia,
   1. How to store Levobren
   2. Contents of the pack and other information

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

levosulpiride

Read this leaflet carefully before you start to use this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you use Levobren
• 3. How to use Levobren
• 4. Possible side effects
• 5. How to store Levobren
• 6. Contents of the pack and other information

1. What is Levobren and what is it used for

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

• of a disease due to delayed gastric emptying (dyspeptic syndrome) due to causes such as tumors or forms of somatization due to anxiety and characterized by loss of appetite (anorexia), excessive gas production in the intestine (meteorism), a feeling of tension in the upper abdomen, headache after meals, heartburn, belching, diarrhea, constipation. Levobren is prescribed by your doctor because you have not previously responded to therapy with other medicines.
• of symptoms of vomiting and nausea (caused by drugs used for the treatment of tumors). Levobren is prescribed by your doctor because you have not previously responded to therapy with other medicines.
• of symptoms of an inner ear disorder that affects balance and hearing (Mènière's syndrome), characterized by dizziness, ringing in the ears (tinnitus), hearing loss and nausea.

2. What you need to know before using Levobren

Do not take Levobren

• if you are allergic to levosulpiride or any of the other ingredients of this medicine (listed in section 6)
• if you have a tumor of the adrenal gland (pheochromocytoma)
• if you suffer from seizures (epilepsy)
• if you are affected by mental disorders (manic states, manic phases of manic-depressive psychoses)
• if you have breast cancer (malignant mastopathy)
• if you have bleeding, mechanical obstructions or perforations of the stomach and intestines
• if you are or suspect you are 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 simultaneously with other psychotropic drugs (neuroleptics).

The doctor will prescribe Levobren with caution only after evaluating:

• if you are elderly;
• if you suffer from a disease that reduces your ability to remember, speak and reason (dementia);
• 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 the formation of thrombi.

Immediately warn your doctor if:
You experience fever (hyperpyrexia), muscle rigidity, difficulty in movements (akinesia), irregular heartbeat (tachycardia, arrhythmias) and irregular blood pressure, sweating, alterations in consciousness that may progress to stupor and coma, because you may have a disease called "Neuroleptic Malignant Syndrome", which can be fatal. In this case you must stop taking Levobren and immediately contact your doctorwho will prescribe appropriate therapy.
If you need to resume treatment with antipsychotics, the doctor will subject you to checks.
If you are taking anticholinergic drugs (drugs that block the action of acetylcholine, a substance involved in nerve impulse transmission), narcotics and analgesics (pain relievers) as they may reduce the effects of Levobren (see section “Other medicines and Levobren").

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

• other psychotropic drugs, medicines used for psychiatric disorders, especially neuroleptics,
• in conjunction with medicines that alter the heartbeat (prolong the QT interval), the risk of developing heart rhythm abnormalities (cardiac arrhythmias) increases.
• medicines called anticholinergics (used to counteract a substance involved in nerve impulse transmission, present in our body called "acetylcholine"), medicines used for sleeping (narcotics) and medicines used for pain (analgesics) as they affect the effects of Levobren on gastric and intestinal motility.
• medicines that cause alterations of substances present in the body called “electrolytes”.

Levobren with food, drinks and alcohol
During treatment with Levobren do not drink alcohol.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast milk, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy

Do not useLevobren if you are pregnant or think you may be.
If you take antipsychotics (“conventional or atypical”), including Levobren, during the last 3 months of pregnancy, your baby may experience the following symptoms after birth: tremor, muscle rigidity and/or weakness, drowsiness, agitation, breathing problems and difficulty feeding.
Contact your doctor if your baby shows any of these symptoms.
Breastfeeding

Do not useLevobren during breastfeeding.

Driving and using machines
With the use of high doses, drowsiness, lethargy and involuntary movements (dyskinesias) may occur. Keep this in mind if you need to drive vehicles and operate machinery that requires a high level of vigilance due to its potential danger.

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

Levobren oral dropscontains para-hydroxybenzoates
May cause allergic reactions (even delayed).

3. How to use Levobren

Use this medicine following always exactly the instructions of the doctor or the pharmacist.
If you have doubts consult the doctor or the pharmacist.

Adults
The recommended dose is (according to medical prescription):

• Tablets: 1 tablet 3 times a day before meals.
• Vials: 1 vial of 25 mg injected into the muscle or in the 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 drops bottle has a “child-proof” closure. To open, press the capsule on the bottle and simultaneously unscrew normally. To close, screw the capsule back on tightly.

If you suffer from nausea and vomiting and oral administration is difficult, the doctor may
start the treatment of your symptoms with Levobren injectable solution (i.m. or i.v.) 2 or 3
times a day for a few days and then switch, when the symptoms become milder, to
administration by oral route for 10-15 days.
Eventually the oral therapy cycle can be repeated for another 2 or 3 weeks, after a
period of interruption of at least 8-10 days.
Treatment of vomiting caused by anticancer drugs
the recommended dose is:
one vial injected into the muscle or in the vein, possibly repeated 2-3 times a day, until
disappearance of symptoms.
If the medicine is used in the treatment of vomiting caused by anticancer drugs
(cisplatin, anthracyclines), you will be administered a dose of 1-2 vials of Levobren injectable solution
by slow intravenous route or by infusion 30 minutes before the administration
of the anticancer drug or during the administration of the anticancer drug and the same dose will be repeated
30 minutes after the end of chemotherapy.

Use in the elderly
If you are elderly, the doctor will carefully establish the dosage and evaluate a possible reduction
of the dosages indicated above.

Use in children and adolescents
This medicine should not be used in children and adolescents because there are no available
relevant data.

If you take more Levobren than you should
An overdose can cause movement disorders and sleep disorders, which resolve with
discontinuation of therapy or with dose reduction.
In case of accidental intake of an excessive dose of Levobren, immediately inform the
doctor or go to the nearest hospital.

If you forget to use Levobren
Do not use a double dose to make up for the missed dose.
If you have any doubts 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 of the same
class and/or with prolonged administrations:

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

• heartbeat alterations (prolongation of the 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):

• drowsiness, "parkinsonism" (symptoms similar to those present in Parkinson's disease such as, e.g., tremor, difficulty and slowing of movements, rigidity and postural instability); involuntary muscle movements (dyskinesias); tremor; repetitive twisting movements or abnormal fixed positions (dystonia); Neuroleptic Malignant Syndrome (see paragraph “Immediately inform your doctor if”).
• cases of sudden death.

Not known (frequency cannot be estimated based on available data):

• absence of menstruation in women of childbearing potential (amenorrhea), development of breast tissue in men (gynecomastia), feeling of tension in the breasts, spontaneous leakage of milk from the breasts not associated with childbirth or breastfeeding (galactorrhea), changes in sexual desire (libido).
• formation of blood clots (venous thrombosis), especially in the legs (symptoms include swelling, pain, redness of the leg), which can travel to the lungs and cause chest pain and difficulty breathing.
• neonatal withdrawal symptoms (see section 2 “Pregnancy and breastfeeding”), movement disorders (extrapyramidal symptoms).
• increased levels of a hormone called prolactin in the blood (hyperprolactinemia).
• 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 get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through 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 that is reported on the pack after “Exp.”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in 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 contains
Levobren 25 mg tablets
The active ingredient is levosulpiride. One tablet contains 25 mg of levosulpiride.
The other ingredients are: carboxymethylamide, microgranular cellulose, lactose, magnesium
stearate.

Levobren 25 mg/2 ml injectable solution
The active ingredient is levosulpiride. One vial contains 25 mg of levosulpiride.
The other ingredients are: 2 N sulfuric acid, water for injectable preparations, sodium chloride.

Levobren 25 mg/ml oral drops, solution
The active ingredient is levosulpiride. 100 ml of solution contain 2.5 g of levosulpiride.
The other ingredients are: anhydrous citric acid, purified water, lemon aroma, methyl p-
hydroxybenzoate, propyl p-hydroxybenzoate, acesulfame K.

Description of the appearance of Levobren and contents of the pack
Levobren is presented in the form of:

• Tablets 25 mg: pack containing a blister (aluminium/PVC) of 20 tablets
• Injectable solution 25 mg/2 ml: pack containing 6 vials of 2 ml.
• Oral drops, solution 25 mg/ml: pack containing a glass dropper bottle, with a “child-resistant” closure, containing 20 ml of solution.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
NEOPHARMED GENTILI S.p.A.
Via San Giuseppe Cottolengo, 15
20143 Milano
Manufacturer

• Vials of injectable solution: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)

Levobren 50 mg tablets

levosulpiride

Read this leaflet carefully before you start to use 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you use Levobren
• 3. How to use Levobren
• 4. Possible side effects
• 5. How to store Levobren
• 6. Contents of the pack and other information

1. What is Levobren and what is it 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-lasting or permanent diseases that cause a severe and persistent alteration of behavior, affect, thought, and perception ("chronic schizophrenias with negative symptoms").

3. What you need to know before using Levobren

Do not take Levobren

• if you are allergic to levosulpiride or any of the other ingredients of this medicine (listed in section 6)
• if you have convulsions (epilepsy)
• if you suffer from 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 obstructions or perforations of the stomach and intestines
• if you have a breast tumor (malignant mastopathy).

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

• Avoid using LEVOBREN at the same time as other psychotropic drugs (neuroleptics).

Your doctor will prescribe Levobren 50 mg tablets with caution:

• if you are elderly;
• if you suffer from a disease that reduces your ability to remember, speak and reason (dementia); if you are pregnant and if you are 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 the formation of thrombi. If you suffer from such conditions, contact your doctor before taking this medicine

Immediately warn your doctor if you experience:

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

Other medicines and Levobren
Tell your doctor or pharmacist if you are taking, have recently taken or may
take any other medicine.
Your doctor will prescribe Levobren with caution if you are being treated with medicines called
“psychotropic drugs” used to treat mental disorders.
When you take a type of medicines called “neuroleptics”, including Levobren, in
concomitance with medicines that alter the heartbeat (prolong the QT), the risk of
developing heart rhythm abnormalities (cardiac arrhythmias) increases.
Do not take Levobren in concomitance with medicines that cause alterations of substances
present in the body called “electrolytes”.

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

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are
breastfeeding with breast milk, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
If you are pregnant, the medicine will only be administered in cases of recognized and
actual indication, under the direct control of the doctor.
If you take conventional or atypical antipsychotics, including Levobren, during the last 3 months of
pregnancy, after birth your baby may experience the following symptoms: tremor,
muscle stiffness and/or weakness, drowsiness, agitation, breathing problems and difficulty
in feeding.
Contact your doctor if your baby shows any of these symptoms.
Breastfeeding
If you are breastfeeding with breast milk, the medicine will only be administered in cases of
recognized and actual indication, under the direct control of the doctor.

Driving and using machines
Drowsiness, dizziness and involuntary movements
(dyskinesias) may occur with the use of Levobren. Take this into account if you need to drive vehicles and operate machinery that requires
a high level of vigilance due to its potential hazard.

3. How to use Levobren

Use this medicine following exactly the instructions of 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 judgement. This dose may
be gradually reduced.

Use in the elderly
If you are elderly, your doctor will carefully establish the dosage and assess a possible reduction
of the dosages indicated above.

If you take more Levobren than you should
An overdose may cause movement disorders and sleep disturbances, which resolve with
discontinuation of therapy or with a reduction of the dose.
In case of accidental intake of an excessive dose of Levobren, immediately inform your
doctor or go to the nearest hospital.

If you forget to use Levobren
Do not use a double dose to make up for a missed dose.

If you stop the treatment withLevobren
If you have any doubts 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 of the same
class and/or with prolonged administrations:

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

• drowsiness, temporary loss of sensitivity and reflexes (torpor)

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

• dizziness, vertigo (feeling a false sense of movement)

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

• heartbeat alterations (prolongation of the 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):

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

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

• "Neuroleptic Malignant Syndrome" (see paragraph “ Special care should be taken withLEVOBREN”).
• absence of menstruation in women of childbearing potential (amenorrhea);
• development of breast tissue in men (gynecomastia); feeling of breast tension,
• spontaneous leakage of milk from the breasts not associated with childbirth or breastfeeding (galactorrhea);
• alterations of sexual desire (libido);
• formation of blood clots (venous thrombosis), especially in the legs (symptoms include swelling, pain, redness of the leg), which can reach the lungs and cause chest pain and difficulty breathing.
• neonatal withdrawal symptoms (see section 2 “Pregnancy and breastfeeding”), extrapyramidal movement disorders
• increased levels of a hormone called prolactin in the blood (hyperprolactinemia).

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 get any side effects, talk to your doctor or pharmacist. This includes any side effects not
listed in this leaflet. You can also report side effects directly through 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 that is reported on the pack after “Exp.”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Levobren 50 mg tablets contain

The active ingredient is levosulpiride. One tablet contains 50 mg of levosulpiride.
The other ingredients are: carboxymethylamide, microgranular cellulose, gelatin, magnesium
stearate.

Description of the appearance of Levobren and contents of the pack
Levobren is presented in the form of:

• 50 mg tablets: pack containing a blister (aluminium/PVC) of 20 tablets

Marketing authorisation holder and manufacturer
Marketing authorisation holder
NEOPHARMED GENTILI S.p.A.
Via San Giuseppe Cottolengo, 15
20143 Milan
Manufacturer:
AbbVie S.r.l. – Campoverde (Latina)

Levobren 100 mg tablets

levosulpiride

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Levobren and what is it used for

Levobren contains the active substance levosulpiride which belongs to a class of medicines
called “psycholeptic, antipsychotic (neuroleptic)” drugs.
Levobren is indicated for the treatment of mental disorders such as:

• disorders characterized by physical symptoms that suggest an illness (somatic symptom disorders)
• long-term or permanent diseases that cause a severe and persistent alteration of behaviour, affect, thought and perception (chronic schizophrenias with negative symptoms).

4. What you need to know before taking Levobren

Do not take Levobren

• if you are allergic to levosulpiride or any of the other ingredients of this medicine (listed in section 6)
• if you suffer from convulsions (epilepsy)
• if you are affected by 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 obstructions or perforations of the stomach and intestines.
• if you have a breast tumor (malignant mastopathy). Warnings and precautions

Contact your doctor or pharmacist before taking Levobren.

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

The doctor will prescribe Levobren 100 mg tablets with caution

• if you are elderly;
• if you suffer from a disease that reduces your ability to remember, speak and reason (dementia);
• if you are pregnant and if you are 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 the formation of thrombi.

If you suffer from these conditions, contact your doctor before taking this medicine.

Immediately warn your doctor if you experience:

• fever (hyperpyrexia), muscle rigidity, difficulty in movements (akinesia), irregular heartbeat (tachycardia, arrhythmias) and irregular blood pressure, sweating, alterations in consciousness that can progress to stupor and coma, because you may have a disease called "Neuroleptic Malignant Syndrome", which can be fatal. In this case you must stop taking Levobren and contactyour doctor immediatelywho will prescribe appropriate therapy. If you need to resume treatment with antipsychotics, your doctor will subject you to checks.

Other medicines and Levobren
Tell your doctor or pharmacist if you are taking, have recently taken or may
take any other medicine.
The doctor will prescribe Levobren with caution if you are being treated with medicines called
“psychotropic drugs” used to treat mental disorders.
When you take a type of medicines called “neuroleptics”, including Levobren, in
concomitance with medicines that alter the heartbeat (prolong the QT), the risk of
developing heart rhythm abnormalities (cardiac arrhythmias) increases.
Do not take Levobren in concomitance with medicines that determine alterations of substances
present in the body called “electrolytes”.

Levobren with food, drinks and alcohol
During treatment with Levobren, do not drink alcohol.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are
breastfeeding with breast milk, ask your doctor or pharmacist for advice before taking this
medicine.
Pregnancy
If you are pregnant, the medicine will only be administered in cases of recognized and
actual indication, under the direct control of the doctor.
If you take conventional or atypical antipsychotics, including Levobren, during the last 3 months of
pregnancy, after birth your baby may experience the following symptoms: tremor,
muscle rigidity and/or weakness, drowsiness, agitation, breathing problems and difficulty
in taking food.
Contact your doctor if your baby shows any of these symptoms.
Breastfeeding
If you are breastfeeding with breast milk, the medicine will only be administered in cases of
recognized and actual indication, under the direct control of the doctor.

Driving and operating machinery
Drowsiness, dizziness and involuntary movements
(dyskinesias) may occur with the use of Levobren. Keep this in mind if you need to drive vehicles and operate machinery that requires
a high level of vigilance due to its possible danger.
Levobren contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking
this medicine.

3. How to take Levobren

Take this medicine following exactly the instructions of 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 judgement. This dose may
be gradually reduced.

Use in the elderly
If you are elderly, your doctor will carefully establish the dosage and assess a possible reduction
of the dosages indicated above.

If you take more Levobren than you should
An overdose may cause movement disorders and sleep disturbances, which resolve with
discontinuation of therapy or with a reduction of the dose.
In case of accidental intake of an excessive dose of Levobren, immediately inform your
doctor or go to the nearest hospital.

If you forget to take Levobren
Do not take a double dose to make up for a missed dose.

If you stop taking Levobren
If you have any doubts 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 of the same
class and/or with prolonged administrations:

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

• drowsiness, temporary loss of sensitivity and reflexes (torpor)

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

• dizziness, vertigo (feeling a false sense of movement)

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

• alterations of the heartbeat (prolongation of the 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):

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

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

• "Neuroleptic Malignant Syndrome" (see paragraph “ Special care withLEVOBREN”).
• absence of menstruation in women of childbearing potential (amenorrhea); feeling of breast tension,
• development of breasts in men (gynecomastia);
• spontaneous leakage of milk from the breasts not associated with childbirth or breastfeeding (galactorrhea);
• alterations of sexual desire (libido);
• formation of blood clots (venous thrombosis), especially in the legs (symptoms include swelling, pain, redness of the leg), which can reach the lungs and cause chest pain and difficulty breathing.
• neonatal withdrawal symptoms (see section 2 “Pregnancy and breastfeeding”), extrapyramidal movement disorders.
• increased levels of a hormone called prolactin in the blood (hyperprolactinemia).

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 for patients taking
antipsychotics compared to those not taking antipsychotics.

Reporting of adverse reactions
If you experience any side effects, including those not listed in this leaflet, please
contact your doctor or pharmacist. You can also report side effects directly
through the national reporting system at:
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
Reporting adverse reactions can help provide more information on the
safety of this medicine.

5. How to store Levobren

This medicine does not require any particular storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “Exp.”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Levobren 100 mg tablets contain
The active ingredient is levosulpiride. One tablet contains 100 mg of levosulpiride.
The other ingredients are: carboxymethylamide, microgranular cellulose, gelatin, lactose,
magnesium stearate.

Description of the appearance of Levobren and contents of the pack
Levobren 100 mg tablets are presented in a pack containing a blister (aluminium/PVC) of 20
tablets of 100 mg.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
NEOPHARMED GENTILI S.p.A.
Via San Giuseppe Cottolengo, 15
20143 Milan
Manufacturer:
AbbVie S.r.l. – Campoverde (Latina)