LEVOBREN - PACKAGE LEAFLET - LEAFLETS

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Levobren - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Undesirable Effects Shelf Life and Storage

Active ingredients: Levosulpiride

Levobren 25 mg tablets
Levobren 25 mg / ml oral drops solution
Levobren 12.5 mg / ml solution for injection

Levobren package inserts are available for pack sizes:

Levobren 25 mg tablets, Levobren 25 mg / ml oral drops solution, Levobren 12.5 mg / ml solution for injection
Levobren 50 mg tablets, Levobren 25 mg / ml solution for injection
Levobren 100 mg tablets

Indications Why is Levobren used? What is it 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 of:

a disease due to delayed emptying of the stomach (dyspeptic syndrome), due to causes such as tumors or forms of somatization due to anxiety and characterized by loss of appetite (anorexia), excessive production of gas in the intestine (meteorism), sense of tension in the upper stomach, headache after meals, heartburn, belching, diarrhea, constipation
headache (essential headache) of different origin
vomiting and nausea (occurring after surgery or caused by drugs used to treat cancer)
dizziness of different origin.

Contraindications When Levobren should not be used

Do not use Levobren

if you are allergic to levosulpiride or any of the other ingredients of this medicine (listed in section 6)
if you have kidney cancer (pheochromocytoma)
if you suffer from fits (epilepsy)
if you suffer from mental disorders (manic states, manic phases of manic-depressive psychosis)
if you have breast cancer (malignant mastopathy)
if you are pregnant or breast-feeding (see "Pregnancy and breast-feeding").

Precautions for use What you need to know before taking Levobren

Talk to your doctor or pharmacist before using Levobren.

Do not use Levobren

if you have bleeding, mechanical obstruction or perforation of the stomach and intestines
simultaneously with other psychotropic drugs (neuroleptics).

Your doctor will prescribe Levobren with caution

if you have any risk factors for stroke, if you suffer from circulatory (cardiovascular) diseases or have a family history of altered heart beat (QT prolongation)
if you or someone in your family have or have ever had blood clots (thrombi), as Levobren can cause blood clots to form.

Interactions Which drugs or foods can modify the effect of Levobren

Tell 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 taking medicines called "psychiatric drugs" used to treat mental disorders.

When you take a type of medicine called 'neuroleptics', including Levobren, in conjunction with medicines that alter the heartbeat (prolong QT), the risk of developing an abnormal heartbeat (heart arrhythmias) increases.

Do not take Levobren at the same time as medicines that cause changes in substances in the body called 'electrolytes'.

Medicines used to counteract a substance present in our body called "acetylcholine", medicines used for sleep and against pain (anticholinergics, narcotics and analgesics) influence the effects of Levobren on the motility of the stomach and intestines.

Levobren with food, drink and alcohol

Do not drink alcohol while taking Levobren.

Warnings It is important to know that:

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

Do not use Levobren if you are pregnant or think you are pregnant.

If you take conventional or atypical antipsychotics, including Levobren, your baby may experience the following symptoms during the last 3 months of pregnancy: shaking, muscle stiffness and / or weakness, sleepiness, agitation, breathing problems and difficulty in eating.

Contact your doctor if your child shows any of these symptoms.

Feeding time

Do not use Levobren if you are breastfeeding.

Driving and using machines

Drowsiness, drowsiness and involuntary movements (dyskinesias) may occur with the use of high dosages. Take this into account if you have to drive and use machines that require a high level of alertness due to their possible danger.

Levobren tablets contain lactose

If you have been told by your doctor that you have "intolerance to some sugars, contact your doctor before taking this medicinal product.

Levobren oral drops contain para-hydroxybenzoates

It can cause allergic reactions (even delayed).

Dose, Method and Time of Administration How to use Levobren: Posology

Always use this medicine exactly as your doctor or pharmacist has told you. If in doubt, 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 ampoule 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 bottle of drops has a "child resistant" closure. To open, press the cap onto the bottle and at the same time unscrew normally.

To close, screw the capsule back in all the way.

If symptoms such as nausea and vomiting appear and oral administration is difficult, start treatment with Levobren solution for injection (IM or IV) 2 or 3 times a day for a few days and, when symptoms become milder, switch to oral administration. for 10-15 days.

If necessary, repeat the course of oral therapy for another 2 or 3 weeks, after an interruption period of at least 8-10 days.

Treatment of vomiting

the recommended dose is: one vial injected into the muscle or vein, possibly repeated 2-3 times a day, until the symptoms disappear.

If the medicine is used in the prevention or treatment of vomiting caused by anticancer medicines (cisplatin, anthracyclines), you will be given a dose of 1-2 ampoules of Levobren solution for injection slow intravenously or by infusion 30 minutes before the administration of the anticancer. or during the administration of the anticancer and the same dose will be repeated 30 minutes after the end of chemotherapy.

Use in the elderly

If you are an elderly person, your doctor will carefully determine the dosage and evaluate a possible reduction in the dosages indicated above.

If you forget to use Levobren

Do not use a double dose to make up for a forgotten dose.

If you stop taking Levobren

If you have any further questions on the use of Levobren, ask your doctor or pharmacist

Overdose What to do if you have taken too much Levobren

In case of accidental overdose of Levobren, notify your doctor immediately or go to the nearest hospital.

Side Effects What are the side effects of Levobren

Like all medicines, this medicine can cause side effects, although not everybody gets them.

For prolonged administration, some disorders have been reported in particular cases such as:

absence of menstruation (amenorrhea),
breast development in men (gynecomastia),
leaking of milk from the breasts (galactorrhea),
changes in sexual desire (libido)

The following side effects have been observed with other medicines of the same class:

rare cases of abnormal heart beat (QT prolongation, ventricular arrhythmias such as torsades de pointes, ventricular tachycardia, ventricular fibrillation),
cardiac arrest,
very rare cases of sudden death,
formation of blood clots (venous thrombi), especially in the legs (symptoms include swelling, pain, redness of the leg), which can travel to the lungs and cause chest pain and difficulty in breathing.

If you notice any of these symptoms, please contact your doctor immediately.

A small increase in the number of deaths was reported in elderly patients with dementia treated with antipsychotic medicines, such as Levobren, compared with those not treated with antipsychotics.

Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at: www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.

Expiry and Retention

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 which is stated on the carton after "EXP." The expiry date refers to the last day of that month.

Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

Other_information "> Other information

What it contains

Levobren 25 mg tablets

The active ingredient is levosulpiride. One tablet contains 25 mg of levosulpiride.

The other ingredients are: carboxymethyl starch, microgranular cellulose, lactose, magnesium stearate.

Levobren 12.5 mg / ml solution for injection

The active ingredient is levosulpiride. One ampoule contains 25 mg of levosulpiride.

The other ingredients are: 2 N sulfuric acid, water for injections, 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 flavor, methyl phydroxybenzoate, propyl p-hydroxybenzoate, acesulfame K.

What Levobren looks like and contents of the pack

Levobren comes in the form of:

25 mg tablets: carton containing a blister (aluminum / PVC) of 20 tablets.
Solution for injection 12.5 mg / ml: carton containing 6 ampoules of 2 ml.
Oral drops, solution 25 mg / ml: carton containing a glass dropper bottle, with a "child resistant" closure, containing 20 ml of solution.

Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.

Further information on Levobren can be found in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT - 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION - 03.0 PHARMACEUTICAL FORM - 04.0 CLINICAL PARTICULARS - 04.1 Therapeutic indications - 04.2 Posology and method of administration - 04.3 Contraindications - 04.4 Special warnings and appropriate precautions for use - 04.5 Interactions with other medicinal products and other forms of interaction - 04.6 Pregnancy and lactation - 04.7 Effects on the ability to drive and use machines - 04.8 Undesirable effects - 04.9 Overdose - 05.0 PHARMACOLOGICAL PROPERTIES - 05.1 "Pharmacodynamic properties - 05.2 Pharmacokinetic properties" - 05.3 Preclinical safety data - 06.0 PHARMACEUTICAL PARTICULARS - 06.1 Excipients - 06.2 Incompatibility "- 06.3 Shelf life" - 06.4 Special precautions for storage - 06.5 Nature of the primary packaging and contents of the package - 06.6 Instructions for use and handling - 07.0 AUTHORIZATION HOLDER ALL "PLACING ON THE MARKET - 08.0 MARKETING AUTHORIZATION NUMBER - 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION - 10.0 DATE OF REVISION OF THE TEXT - 11.0 FOR RADIO DRUGS, COMPLETE DATA ON INTERNAL RADIATION DOSIMETRY - 12.0 INSTRUCTIONS FOR RADIOPHONES ON EXTEMPORARY PREPARATION AND QUALITY CONTROL -

01.0 NAME OF THE MEDICINAL PRODUCT -

LEVOBREN

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -

LEVOBREN 25 mg Tablets

One tablet contains - Active principle: levosulpiride 25.0 mg.

LEVOBREN 12.5 mg / ml Solution for injection

One vial contains - Active principle: levosulpiride 25.0 mg.

LEVOBREN 25 mg / ml Oral drops solution

100 ml of solution contain - Active principle: levosulpiride 2.5 g.

For the full list of excipients, see section 6.1.

03.0 PHARMACEUTICAL FORM -

Tablets

Injectable solution

Oral drops solution

04.0 CLINICAL INFORMATION -

04.1 Therapeutic indications -

Dyspeptic syndrome (anorexia, meteorism, sense of epigastric tension, headache

postprandial, heartburn, belching, diarrhea, constipation) from delayed gastric emptying linked to organic (diabetic gastroparesis, neoplasms, etc.) and / or functional factors (visceral somatizations in anxious-depressive subjects).

Essential headache: vasomotor forms (classic, common, ophthalmic, hemiplegic, cluster migraine) and muscle-tensive forms.

Vomiting and nausea (postoperative or induced by antiblastic drugs).

Vertigo of central and / or peripheral origin.

04.2 Posology and method of administration -

Dosage in adults (according to medical prescription):

Tablets: 1 tablet 3 times a day before meals.

Solution for injection: 1 ampoule of 25 mg (i.m. or i.v.) 2 or 3 times a day.

Oral drops: 15 drops 3 times a day before meals (one drop contains 1.6 mg of levosulpiride).

If patients have severe symptoms with nausea and vomiting and oral administration is difficult, initiate treatment with Levobren 12.5 mg / ml Solution for injection (IM or IV) 2 or 3 times daily for a few days and, when symptoms become milder, switch to oral administration for 10-15 days. If necessary, repeat the course of oral therapy for another 2 or 3 weeks, after an interruption period of at least 8-10 days.

Treatment of vomiting: an i.m. vial or i.v., possibly repeated 2-3 times a day, until symptoms disappear. If the drug is used in the prevention or treatment of antiblastic vomiting (cisplatin, anthracyclines) administer 1-2 ampoules of LEVOBREN 12.5 mg / ml Solution for injection by slow intravenous route or by infusion 30 "before administration of the antiblastic or during the administration of the "antiblastic and repeat the same dose 30" after the end of chemotherapy.

In the treatment of elderly patients, the dosage must be carefully established by the doctor who will have to evaluate a possible reduction of the dosages indicated above.

04.3 Contraindications -

LEVOBREN is contraindicated in patients with pheochromocytoma because it can cause a hypertensive crisis probably due to the release of catecholamines from the tumor. Such hypertensive crises can be controlled with phentolamine.

Levobren is contraindicated in patients with known drug hypersensitivity or intolerance.

It should not be used in epilepsy, in manic states, in manic phases of psychosis

manic-depressive. In relation to the supposed correlations between the hyperprolactinemizing effect of most psychotropic drugs and breast dysplasia, it is advisable not to use

LEVOBREN in subjects already carriers of a malignant mastopathy.

04.4 Special warnings and appropriate precautions for use -

A potentially fatal symptom complex called Neuroleptic Malignant Syndrome has been reported with the use of neuroleptics (usually during antipsychotic treatment).

Clinical manifestations of this syndrome are: hyperpyrexia, muscle stiffness, akinesia, vegetative disorders (irregularities in the pulse and blood pressure, sweating, tachycardia, arrhythmias), alterations in the state of consciousness that can progress to stupor and coma. The treatment of the S.N.M. it consists in immediately suspending the administration of antipsychotic drugs and other non-essential drugs and in instituting intensive symptomatic therapy (particular care must be taken to reduce hyperthermia and correct dehydration). If the resumption of antipsychotic treatment is deemed essential, the patient should be carefully monitored. Avoid concomitant therapy with other neuroleptics.

The effects of levosulpiride on gastrointestinal motility can be antagonized by anticholinergic, narcotic and analgesic drugs.

Levosulpiride should not be used when the stimulation of gastrointestinal motility may be harmful, for example in the presence of gastrointestinal bleeding, mechanical obstructions or perforations.

An approximately three-fold increase in the risk of cerebrovascular events was observed in randomized clinical trials versus placebo in a population of patients with dementia treated with some atypical antipsychotics. The mechanism of this increased risk is unknown. An increased risk for other antipsychotics or other patient populations cannot be excluded. Levobren should be used with caution in patients with stroke risk factors.

Use with caution in patients with cardiovascular disease or a family history of QT prolongation.

Cases of venous thromboembolism have been reported during treatment with antipsychotic drugs.

As patients treated with antipsychotics frequently present with acquired risk factors for venous thromboembolism, all possible risk factors for venous thromboembolism should be identified and appropriate preventive measures taken before and during treatment with Levobren.

Avoid the simultaneous intake of alcohol.

Increased mortality in elderly patients with dementia.

Data from two large observational studies have shown that elderly patients with dementia treated with antipsychotics have a slightly increased risk of mortality compared to untreated patients. There is insufficient data to safely estimate the precise magnitude of the risk and the cause of the increased risk is unknown.

LEVOBREN is not indicated for the treatment of the behavioral disorders of dementia.

Levobren 25 mg tablets contain lactose therefore patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.

04.5 Interactions with other medicinal products and other forms of interaction -

The association with psychotropic drugs requires particular caution and vigilance on the part of the physician to avoid unexpected undesirable effects from interaction.

When neuroleptics are administered concomitantly with QT prolonging drugs, the risk of developing cardiac arrhythmias increases.

Do not administer concomitantly with drugs that cause electrolyte disturbances.

04.6 Pregnancy and breastfeeding -

Not to be used in confirmed or suspected pregnancy and during the lactation period.

Infants exposed to conventional or atypical antipsychotics including Levobren during the third trimester of pregnancy are at risk for side effects including extrapyramidal or withdrawal symptoms which may vary in severity and duration after birth. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, food intake disturbances. Infants should therefore be closely monitored.

04.7 Effects on ability to drive and use machines -

With high dosages, somnolence, drowsiness and dyskinesias may occur; Patients under treatment must be warned of this so that they avoid driving vehicles and waiting for operations requiring vigilance integrity due to their possible danger.

04.8 Undesirable effects -

For prolonged administration, some disorders such as amenorrhea, gynecomastia, galactorrhea and changes in libido, observed in particular cases, are attributable to a reversible effect of levosulpiride on the function of the hypothalamic-pituitary-gonadal axis, similar to that known for many neuroleptics.

The following side effects have been observed with other drugs of the same class: rare cases of QT prolongation, ventricular arrhythmias such as torsades de pointes, ventricular tachycardia, ventricular fibrillation and cardiac arrest.

Very rare cases of sudden death.

Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis, have been reported during treatment with antipsychotic drugs. The frequency is unknown.

Pregnancy, puerperium and perinatal conditions: neonatal withdrawal syndrome, frequency not known, extrapyramidal symptoms (See section 4.6).

04.9 Overdose -

In internal medicine, extrapyramidal disorders and sleep disturbances have never been observed which, from a theoretical point of view, could occur with very high dosages. In this case it is sufficient to interrupt the therapy or reduce the dosage according to the judgment of the doctor.

05.0 PHARMACOLOGICAL PROPERTIES -

05.1 "Pharmacodynamic properties -

Therapeutic drug category: psycholeptics, antipsychotics

ATC code: N05AL07

The biochemical, pharmacological and clinical data obtained with the two isomers of sulpiride indicate that the antidopaminergic activity, both at a central and peripheral level, is due to the left-handed enantiomer.

05.2 "Pharmacokinetic properties -

When levosulpiride is administered orally at a dose of 50 mg, the plasma peak is reached within 3 hours and averages 94.183 ng / ml. The t½ of elimination calculated after administration of 50 mg i.v. of levosulpiride is 4.305 hours.

The elimination of the drug occurs mainly via the urine.

05.3 Preclinical safety data -

The preclinical data have little clinical relevance in the light of the vast experience acquired with the use in humans of the active ingredient contained in the medicinal product.

06.0 PHARMACEUTICAL INFORMATION -

06.1 Excipients -

Levobren 25 mg Tablets - Carboxymethyl starch, microgranular cellulose, lactose, magnesium stearate

LEVOBREN 12.5 mg / ml Solution for injection - 2 N sulfuric acid, water for injections, sodium chloride

LEVOBREN 25 mg / ml Oral drops solution - Citric acid, purified water, lemon flavor, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, acesulfame K.