Package Insert: Information for the User

Levosulpiride Stada 25 mg Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them..
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Levosulpirida belongs to a group of medications that enhance intestinal motility (gastrointestinal prokinetics). It is used for:

• Short-term treatment of functional dyspepsia (anorexia, abdominal distension, epigastric hypersensitivity, postprandial headache, gastric acidity, eructation, 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 Stada:

• If you are allergic to levosulpiride or any of the other components of this medication (listed in section 6).
• If you have high blood pressure that is suspected to be due to a phaeochromocytoma or if you have heart failure. In such cases, caution is required.
• If you are epileptic or have a mood disorder that may make you feel excited (manic states with hyperactivity, irritability, irritability, or decreased need for sleep).
• If you are pregnant or breastfeeding.
• If you have been diagnosed with breast cancer (malignant mastopathy).
• If you have a risk of or have experienced haemorrhage, obstruction, or perforation of the stomach or intestine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Levosulpirida Stada:

• If you suffer from dementia (loss of memory or other mental abilities). Levosulpiride is not licensed for the treatment of dementia-related behavioral disorders. In elderly patients with dementia, a small increase in the number of deaths of patients taking antipsychotics has been reported compared to those not receiving antipsychotics.
• If you have ever had a stroke or "mini" cerebral accident.
• If you have cardiovascular diseases (heart and circulation diseases) or if you have a family history of abnormal heart rhythm (ECG) showing a problem called QT interval prolongation.
• If you suffer from blood clots or 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 life-threatening complex symptom disorder called Neuroleptic Malignant Syndrome, which has been reported with the use of this medication (usually during treatment with antipsychotic medications).
• Inform your doctor immediately if you experience any symptoms,such as a combination of fever, muscle stiffness, rapid breathing, sweating, decreased consciousness, and sudden changes in blood pressure and heart rate, fainting (neuroleptic malignant syndrome).

Use of Levosulpirida Stada with other medications

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

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

Levosulpirida Stada and alcohol

You should avoid simultaneous consumption of alcohol.

Pregnancy, breastfeeding, and fertility

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

Do not use levosulpiride during pregnancy, possible pregnancy, and during breastfeeding.

The following symptoms have been observed in newborns of mothers who used conventional or atypical antipsychotics, including levosulpiride, during the last trimester (last 3 months of pregnancy): tremors, stiffness, and/or muscle weakness, drowsiness, agitation, respiratory problems, and difficulties with food intake. If your child shows any of these symptoms, consult your doctor.

Driving and operating machinery

Levosulpiride may affect your ability to drive and operate machinery.

High doses of levosulpiride may cause drowsiness, numbness, or dyskinesia; therefore, you should avoid driving or operating machinery and participating in activities that require special attention.

Levosulpirida Stadacontains lactose and sodium

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

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

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. Do not recommend long-term use. 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 decided by the doctor who should carefully evaluate a possible reduction in the doses mentioned above.

If you take more Levosulpirida Stada than you should

In this case, it is sufficient to suspend treatment or reduce the dose, as decided by the doctor. No extrapyramidal effects and sleep disorders, which may theoretically occur with very high doses, have been observed. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, call or the Toxicological Information Service Tel. 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Levosulpirida Stada

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

If you interrupt treatment with Levosulpirida Stada

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The following side effects have been reported:

Rare(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(may affect up to 1 in 10,000 people)

• Drowsiness, parkinsonism (tremor, bradycardia, rigidity, and postural instability), dyskinesia (involuntary muscle movements), tremor, dystonia (torsions and repetitive or abnormal postures), psychomotor agitation (involuntary and purposeless movements and restlessness), autonomic nervous system disorders (system that acts unconsciously and regulates bodily functions).
• Malignant neuroleptic syndrome (life-threatening reaction, symptoms include hyperpyrexia, muscle rigidity, akinesia, irregular pulse or blood pressure, sweating, tachycardia, arrhythmias, altered level of consciousness that can progress to stupor and coma).
• Sudden death.

Unknown frequency(cannot be estimated from available data)

• Amenorrhea (absence of a menstrual period in a woman of reproductive age), 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 exposure in the womb to dependence-inducing drugs), extrapyramidal symptoms (movement disorders induced by drugs that include acute and late symptoms of posture and skeletal muscles).
• Hypoprolactinemia (presence of abnormally high levels of prolactin in the blood).

Reporting of adverse effects

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

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofLevosulpirida Stada

• The active ingredient is levosulpirida.
• The other components are: microcrystalline cellulose (E460),monohydrate lactose, carboxymethylstarch sodium (type A) (from potato) and magnesium stearate (E572).

Appearance of the product and contents of the packaging

Levosulpirida Stada 25 mg tablets are white, round, convex tablets with a 6 mm diameter, with the marking “MC” on one of its faces.

Blister packs of 20, 30 and 60 tablets packaged in PVC/PVDC/Al.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

MEDOCHEMIE LTD,

1-10 Constantinoupoleos street,

3011 Limassol,

Cyprus

Last review date of this leaflet:June 2019

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