Package Insert: Information for the User

Levogastrol 25 mg Tablets

Levosulpiride

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 to you alone and should not be given 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.

1. What is Levogastrol and how is it used

2. What you need to know before starting to take Levogastrol

3. How to take Levogastrol

4. Possible adverse effects

5. Storage of Levogastrol

6. Contents of the package and additional information

Levosulpiride 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 medication) 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 Levogastrol

• If you are allergic (hypersensitive) to levosulpiride or to any of the other components of this medication (listed in section 6).
• 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 have a risk or suffer from gastrointestinal hemorrhage, obstruction, or perforation.
• If you have phaeochromocytoma (adrenal gland tumor).
• If you are diagnosed with malignant breast disease.
• If you are pregnant or breastfeeding.

Be especially careful with Levogastrol

If you think that bowel movements may cause discomfort, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Levogastrol:

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

Immediately inform your doctor if you have 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).

Other medications and Levogastrol

Inform your doctor or pharmacist if you are using, or have recently used, other medications, including those purchased without a prescription.

Certain medications may interact with Levogastrol. In these cases, it may be necessary to change the dose or discontinue treatment with one of the medications.

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

• Pain medications (narcotics, analgesics)
• Anticholinergics and antidopaminergics, ask your doctor if you have any doubts.

Levogastrol and food, drinks, and alcohol:

Do not take alcohol while taking Levogastrol.

Take Levogastrol at least 20 minutes before meals.

Pregnancy, breastfeeding, and fertility:

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

Do not take levosulpiride during pregnancy or lactation.

Driving and operating machinery:

Levosulpiride may cause symptoms such as drowsiness, numbness, or dyskinesia, dizziness, visual disturbances, and decreased reaction time. These effects, as well as the digestive alteration, may impair your ability to drive vehicles or operate machinery. Therefore, do not drive or operate machinery or engage in other activities that require special attention until your doctor assesses your response to this medication.

Important information about some of the components of Levogastrol

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

Follow exactly the administration instructions for Levogastrol as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The usual dose in adults is 1 tablet (25 mg of levosulpiride) every 8 hours, that is, 3 tablets (75 mg of levosulpiride) per day orally, divided into three doses, at least 20 minutes before meals.

Levogastrol tablets should be swallowed whole with a sufficient amount of water, and should not be broken or chewed.

Your doctor will indicate the duration of treatment with Levogastrol.

Use in children

No data is available. The efficacy and safety of levosulpiride in the pediatric population have not been established.

Use in elderly patients

In elderly patients, the daily dose of Levogastrol will be established by the doctor according to the patient's needs.

If you take more Levogastrol than you should

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. The symptoms of overdose are mainly drowsiness and tremors.

The symptoms of Levogastrol overdose are mainly drowsiness and tremors.

If you forget to take Levogastrol

Do not take a double dose to compensate for the missed doses. It is recommended to consult your doctor or pharmacist.

If you interrupt treatment with Levogastrol

Do not discontinue treatment as indicated by your doctor, as the desired effect will not be achieved.

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

Like all medications, Levogastrol may produce adverse effects, although not everyone will experience them.

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

• Drowsiness, sedation, parkinsonism (tremor, bradykinesia, rigidity, and postural instability), dyskinesia (involuntary muscle movements), tremor, dystonia (involuntary twisting and repetitive movements or abnormal fixed postures), extrapyramidal disorder (system that regulates voluntary bodily functions and muscle tone), vertigo, insomnia.

• Snoring (hoarse and low-pitched vocal sounds).

• Abdominal pain, excessive salivation, constipation, and fatigue.

• Gynecomastia (enlargement of male breast tissue), galactorrhea (spontaneous milk flow in the breasts, not associated with childbirth or lactation), menstrual disorder, breast discomfort.

• Hyperprolactinemia (presence of abnormally high levels of prolactin in the blood) and weight gain.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:http://www.notificaram.esby reporting adverse 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 packaging. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at your local SIGRE collection point. 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 of Levogastrol

The active principle is levosulpiride 25 mg per tablet.

The other components are: lactose monohydrate, carboxymethylcellulose sodium type A (gluten-free potato starch), microcrystalline cellulose, and magnesium stearate.

Appearance of the product and content of the packaging

Levogastrol 25 mg tablets are presented in the form of white tablets with the inscription “25” on one of their faces.

Packaging of 30 and 60 tablets.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization

Laboratorios Salvat, S.A.

C/ Gall 30-36 - 08950

Esplugues de Llobregat

Barcelona - Spain

Responsible for manufacturing

Laboratorios Salvat, S.A.

C/Gall 30-36 - 08950

Esplugues de Llobregat

Barcelona-Spain

Or

PHARMALOOP, S.L.

C/Bolivia, 15- Industrial Park Azque

28806 Alcalá de Henares, Madrid

Last review date of this leaflet: February 2022

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