Levosulpiride Stada 25 mg tablets EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the User

Levosulpiride Stada 25 mg Tablets EFG

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

• Keep this leaflet as 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 other people, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Levosulpiride Stada is and what it is used for
2. What you need to know before taking Levosulpiride Stada
3. How to take Levosulpiride Stada
4. Possible side effects
5. How to store Levosulpiride Stada
6. Contents of the pack and other information

1. What Levosulpiride Stada is and what it is used for

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

• Short-term treatment of dyspeptic syndrome (anorexia, abdominal distension, sensation of epigastric discomfort, postprandial headache, heartburn, eructation, diarrhoea, 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 anticancer drugs) after failure of first-line therapy.
• Short-term symptomatic treatment of dizziness, tinnitus, hearing loss and nausea associated with Ménière's syndrome (a disease affecting the inner ear).

2. What you need to know before taking Levosulpiride Stada

Do not take Levosulpiride Stada:

• If you are allergic to levosulpiride or to any of the other ingredients of this medicine (listed in section 6).
• If you have high blood pressure suspected to be due to a pheochromocytoma or if you have heart failure. In such cases, caution is required.
• If you have epilepsy or a mood disorder that may make you feel agitated (manic states with hyperactivity, irritability, irritability, or reduced 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 already have, bleeding, obstruction, or perforation of the stomach or intestine.

Warnings and precautions

Consult your doctor or pharmacist before taking Levosulpiride Stada:

• If you suffer from dementia (memory loss or other mental impairments). Levosulpiride is not licensed for the treatment of behavioral disorders associated with dementia. In elderly patients with dementia, a small increase in the number of deaths has been reported among those taking antipsychotics compared to those not receiving antipsychotics.
• If you have ever had a stroke or a "mini" stroke (transient ischemic attack).
• If you have cardiovascular diseases (heart and circulatory diseases) or if you or a family member have a history of abnormal heart rhythm (ECG) showing a condition 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 blood clot formation.
• If you are being treated with other neuroleptics due to the risk of developing a complex, potentially life-threatening disorder called Neuroleptic Malignant Syndrome, which has been reported with the use of this medicine (generally during treatment with antipsychotic drugs).
• Inform your doctor immediately if you experience any symptoms such as a combination of fever, muscle rigidity, rapid breathing, sweating, decreased consciousness, sudden changes in blood pressure and heart rate, or fainting (neuroleptic malignant syndrome).

Use of Levosulpiride Stada with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, such as:

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

Taking Levosulpiride Stada with alcohol

You should avoid consuming alcohol simultaneously.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

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

Driving and using machines

Levosulpiride may affect your ability to drive and use machines.

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

Levosulpiride Stada contains lactose and sodium

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with them before taking this medicine.

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

3. How to take Levosulpiride Stada

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist.

Adults

The recommended dose for adults (as prescribed by a physician) is: 75 mg per day (1 tablet three times daily) before meals.

The duration of treatment may be adjusted according to symptom relief and clinical remission. Long-term continuous treatment is not recommended. Treatment may be restarted if symptoms reappear.

Use in children and adolescents

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

Use in elderly patients

For elderly patients, the dose must be determined by the physician, who should carefully consider whether a reduction from the doses mentioned above may be necessary.

If you take more Levosulpiride Stada than you should

In such a case, it is sufficient to discontinue treatment or reduce the dose, as decided by the physician. Extrapyramidal effects and sleep disturbances have not been observed, although theoretically they could occur with very high doses. In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Levosulpiride Stada

Do not take a double dose to make up for missed doses.

If you stop taking Levosulpiride Stada

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

4. Possible adverse effects

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

The following effects have been reported:

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

• Changes in 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)

• Somnolence, parkinsonism (tremor, bradykinesia, rigidity, and postural instability), dyskinesia (involuntary muscle movements), tremor, dystonia (abnormal repetitive twisting movements or fixed abnormal postures), psychomotor agitation (purposeless involuntary movements and restlessness), disorders of the autonomic nervous system (the control system that acts unconsciously and regulates bodily functions).
• Neuroleptic malignant syndrome (a life-threatening reaction; symptoms include hyperpyrexia, muscle rigidity, akinesia, irregular pulse or blood pressure, sweating, tachycardia, arrhythmias, altered mental status which may progress to stupor and coma).
• Sudden death.

Frequency not known (cannot be estimated from the available data)

• Amenorrhoea (absence of menstrual period in a woman of reproductive age), gynaecomastia (enlargement of male breast tissue), galactorrhoea (spontaneous milk discharge from the breasts, not related to childbirth or lactation), changes in libido (sexual drive 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 in utero exposure to dependence-forming drugs), extrapyramidal symptoms (drug-induced movement disorders including acute and delayed symptoms affecting posture and skeletal muscles).
• Hyperprolactinaemia (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 not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Levosulpiride Stada

Keep this medicine out of sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levosulpiride Stada

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

Appearance of the medicinal product and contents of the pack

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

Packs of 20, 30 and 60 tablets in PVC/PVDC/Al blisters.

Only some pack 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 the most recent revision of this leaflet: June 2019

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