Leaflet: information for the user

Levosulpiride Aristo 25 mg tablets EFG

levosulpiride

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Levosulpirida belongs to a group of medications called gastrointestinal motility stimulants.

It is used for:

• Short-term treatment of the functional dyspepsia syndrome (anorexia, abdominal distension, epigastric hypersensitivity, postprandial headache, gastric acidity, belching, diarrhea, constipation) due to delayed gastric emptying related to organic factors (diabetic gastroparesis, cancer, etc.) and/or functional factors (visceral somatization in anxious-depressive subjects) in patients who did not respond to other therapy.
• Short-term symptomatic treatment of nausea and vomiting (induced by cancer medications) after failure of first-line therapy.

• Short-term symptomatic treatment of dizziness, tinnitus, hearing loss, and nausea associated with Meniere's syndrome (a disease affecting the inner ear).

Do not take levosulpirida:

• if you are allergic to levosulpirida or any of the other components of this medication (listed in section 6),
• if you have high blood pressure due to suspected phaeochromocytoma (adrenal gland tumor) or if you have heart failure. In such cases, caution is required.
• if you are epileptic or have a history of convulsive states or manic-depressive psychosis (manic states with hyperactivity, irritability, irritability, or decreased need for sleep).
• if you are pregnant or breastfeeding.
• if you have breast cancer (malignant mastopathy).
• if you have a risk or suffer from gastrointestinal hemorrhage, obstruction, or perforation.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Levosulpirida Aristo if:

• if you have dementia (loss of memory or other mental abilities). Levosulpirida is not authorized for the treatment of behavior disorders related to dementia. In elderly patients with dementia, a small increase in the number of deaths has been reported in patients taking antipsychotics compared to those not receiving antipsychotics.

• if you have ever had a stroke or "mini-stroke".

• if you have cardiovascular diseases (heart and circulation diseases) or if you have a family history of an abnormal ECG tracing showing a problem called QT interval prolongation.

• if you have blood clots or if someone in your family has a history of blood clots, as antipsychotics have been associated with the formation of blood clots.

• if you are being treated with other neuroleptics due to the risk of developing a potentially fatal complex symptom disorder called neuroleptic malignant syndrome, which has been reported with the use of these medications (usually during the course of treatment with antipsychotics).

Inform your doctor immediately if you experience any symptoms such as a combination of fever, muscle stiffness, agitated breathing, sweating, decreased consciousness, and sudden changes in blood pressure and heart rate, fainting (neuroleptic malignant syndrome).

Levosulpirida Aristo with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

It is especially important to inform your doctor if you take one of the following medications:

• Medications that prolong the QT interval (abnormal heart rhythm).
• Medications that cause electrolyte disorders (abnormal concentration of electrolytes in the body).

Levosulpirida with food, drinks, and alcohol

You should avoid taking levosulpirida simultaneously with alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Do not take levosulpirida during pregnancy, possible pregnancy, and during breastfeeding.

In newborn babies of mothers who used conventional or atypical antipsychotics, including levosulpirida, during the last trimester (last 3 months of pregnancy), the following symptoms have been observed: tremors, rigidity, and/or muscle weakness, drowsiness, agitation, respiratory problems, and difficulty feeding. If your child shows any of these symptoms, inform your doctor.

Driving and operating machinery

Levosulpirida may affect your ability to drive and operate machinery.

High doses of levosulpirida may cause drowsiness, numbness, or dyskinesias; therefore, do not drive, operate machinery, or engage in other activities that require special attention until your doctor assesses your response to this medication.

Levosulpirida Aristo contains lactose

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with him before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Adults

The recommended dose in adults (as prescribed by a doctor) is:

75 mg per day (1 tablet 3 times a day) before meals.

The treatment duration may be adjusted according to symptom relief and clinical remission. It is not recommended to use the treatment permanently. Treatment may be restarted when symptoms reappear.

Use in children and adolescents

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

Use in elderly patients

In the treatment of elderly patients, the dose should be prescribed by a doctor, who should carefully evaluate a possible reduction in the doses mentioned above.

If you take more Levosulpirida Aristo than you should

In this case, it is sufficient to interrupt treatment or reduce the dose, as decided by the doctor. No extrapyramidal effects and sleep disorders have been observed, which, from a theoretical point of view, may occur with very high doses.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Levosulpirida Aristo

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Levosulpirida Aristo

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may cause side effects, although not everyone will experience them.

The following side effects have been reported with this medication:

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

• Cardiac rhythm alteration: QT interval prolongation, ventricular arrhythmias such as torsades de pointes, ventricular tachycardia, ventricular fibrillation, cardiac arrest.

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

• Drowsiness, parkinsonism (tremor, bradykinesia, rigidity, and postural instability), dyskinesia (involuntary muscle movements), tremor, dystonia (involuntary, repetitive, or fixed abnormal postures or movements), psychomotor agitation (unintentional and purposeless movements), autonomic nervous system disorders (system that regulates involuntary, unconscious, and automatic bodily functions).

• Malignant Neuroleptic Syndrome (potentially fatal reaction, symptoms include hyperpyrexia, muscle rigidity, akinesia, irregular pulse and blood pressure, sweating, tachycardia, arrhythmias, altered level of consciousness that may progress to stupor and coma).

• Sudden death.

Unknown frequency(frequency cannot be estimated from available data)

• Amenorrhea (absence of menstrual period in a reproductive-aged woman), gynecomastia (enlargement of male breast tissue), galactorrhea (spontaneous milk flow from the breasts, not associated with childbirth or lactation), changes in libido (sexual impulse or desire for sexual activity).

• Thromboembolism (formation of a blood clot within a blood vessel, including cases of pulmonary embolism and deep vein thrombosis).

• Neonatal withdrawal syndrome (withdrawal syndrome in newborns after birth caused by intrauterine exposure to dependence-inducing medications), extrapyramidal symptoms (movement disorders induced by pharmacological treatment that include acute and tardive symptoms of posture and skeletal muscles).

• Hypoprolactinemia (presence of abnormally high levels of prolactin in the blood).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the blister after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be thrown down the drain or in the trash. Dispose of the containers and medications you no longer need atthe SIGRE Collection Pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

• Each tablet contains 25 mg of levosulpiride.
• The other components are microcrystalline cellulose (E40), lactose monohydrate, carboxymethylstarch sodium (Type A) (from potato) and magnesium stearate (E-572).

Appearance of the product and contents of the packaging

Levosulpiride Aristo 25 mg are white, convex tablets, 6 mm in diameter, and marked with "MC" on one of their faces.

PVC/PVDC/Aluminum blister in packaging of 20, 30, and 60 tablets.

Only some sizes of packaging may be commercially available.

Marketing Authorization Holder

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

Responsible for manufacturing

MEDOCHEMIE LTD

1-10 Constantinoupoleos street

3011 Limassol, Cyprus

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid. Spain

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Italy: Levosulpiride Aristo

Spain: Levosulpiride Aristo 25 mg tablets EFG

Last review date of this leaflet: June 2019

The detailed and updated information about this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/