LEVOSULPIRIDE STADA 25 mg TABLETS

2. What you need to know before taking Levosulpirida Stada

Do not take Levosulpirida Stada:

• 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 that is suspected to be due to a pheochromocytoma 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, or decreased need for sleep).
• If you are pregnant or breastfeeding.
• If you have been diagnosed with breast cancer (malignant mastopathy).
• If you are at risk of or have bleeding, 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). Levosulpirida is not licensed for the treatment of behavioral 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 abnormal heart rhythm (ECG) showing a problem called QT interval prolongation.
• If you suffer from 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 complex syndrome of symptoms, potentially life-threatening, called Neuroleptic Malignant Syndrome, which has been reported with the use of this medication (generally during treatment with antipsychotic medications).
• Tell your doctor immediately if you have 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).

Using Levosulpirida Stada with Other Medications

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

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

Taking 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

Do not use levosulpirida during pregnancy, possible pregnancy, or during breastfeeding.

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

Driving and Using Machines

Levosulpirida may affect your ability to drive and use machines.

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

Levosulpirida Stada Contains Lactose and Sodium

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

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

3. How to Take Levosulpirida Stada

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult 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 duration of treatment can be adjusted according to the relief of symptoms and the remission of the clinical picture. Permanent use of the treatment is not recommended. Treatment can 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 of 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, according to the doctor's decision. Extrapyramidal effects and sleep disorders, which may theoretically occur with very high doses, have never been observed. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service at Tel. 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Take Levosulpirida Stada

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

4. Possible Side Effects

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

The following effects have been reported:

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

• Alteration of heart rhythm: 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 (tremors, bradykinesia, rigidity, and postural instability), dyskinesia (involuntary muscle movements), tremors, dystonia (twists and repetitive or fixed abnormal movements or postures), psychomotor agitation (involuntary and purposeless movements and restlessness), disorders of the autonomic nervous system (system that unconsciously controls bodily functions).
• Neuroleptic Malignant Syndrome (life-threatening reaction, symptoms include hyperpyrexia, muscle rigidity, akinesia, irregular pulse or blood pressure, sweating, tachycardia, arrhythmias, altered state of consciousness that can progress to stupor and coma).
• Sudden death.

Frequency Not Known(cannot be estimated from available data)

• Amenorrhea (absence of a menstrual period in a woman of reproductive age), gynecomastia (enlargement of male breasts), galactorrhea (spontaneous flow of milk from the breasts, not associated with childbirth or breastfeeding), 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 infants after birth caused by exposure to addictive drugs in the womb), extrapyramidal symptoms (drug-induced movement disorders that include acute and late symptoms of posture and skeletal muscles).
• Hyperprolactinemia (presence of abnormally high levels of prolactin in the blood).

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Levosulpirida Stada

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 stated on the package after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Levosulpirida Stada

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

Appearance of the Product and Package Contents

Levosulpirida Stada 25 mg tablets are white, round, convex tablets with a diameter of 6 mm, marked with "MC" on one side.

Packages of 20, 30, and 60 tablets are packaged in PVC/PVDC/Al blisters.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

MEDOCHEMIE LTD,

1-10 Constantinoupoleos street,

3011 Limassol,

Cyprus

Date of Last Revision of this Package Leaflet:June 2019

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).