LEVOGASTROL 25 mg TABLETS

Introduction

Package Leaflet: Information for the User

Levogastrol 25 mg Tablets

Levosulpiride

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

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

1. What is Levogastrol and what is it used for

Levosulpiride belongs to a group of medicines called gastrointestinal motility stimulants.

It is used for:

• Short-term treatment of dyspeptic syndrome (anorexia, abdominal distension, epigastric sensitivity, postprandial headache, heartburn, 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 have not responded 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 that affects the inner ear).

2. What you need to know before you take Levogastrol

Do not take Levogastrol

• If you are allergic (hypersensitive) to levosulpiride or any of the other ingredients of this medicine (listed in section 6).
• If you are epileptic or have a history of convulsive states or manic-depressive psychosis (manic states with hyperactivity, irritation, irritability, or decreased need for sleep).
• If you are at risk of or have gastrointestinal bleeding, obstruction, or perforation.
• If you have pheochromocytoma (a tumor of the adrenal gland).
• If you have been diagnosed with malignant mastopathy (breast disease).
• If you are pregnant or breastfeeding.

Be cautious with Levogastrol

If you think that intestinal movements may cause you 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 complex syndrome of symptoms, potentially fatal, called malignant neuroleptic syndrome, which has been reported with the use of these medications (in general, during the course of treatment with antipsychotics).

Inform your doctor immediately 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 (malignant neuroleptic syndrome).

Other medicines and Levogastrol

Tell your doctor or pharmacist if you are using, or have recently used, other medicines, including those obtained without a prescription.

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

It is especially important that you 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 doubts.

Taking Levogastrol with food, drinks, and alcohol:

Do not drink alcohol if you are being treated with Levogastrol.

Take Levogastrol at least 20 minutes before meals.

Pregnancy, breastfeeding, and fertility:

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

Do not take levosulpiride during pregnancy or breastfeeding.

Driving and using machines:

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

Important information about some of the ingredients of Levogastrol

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

3. How to take Levogastrol

Follow exactly the administration instructions of Levogastrol indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The normal dose in adults is 1 tablet (25 mg of levosulpiride) every 8 hours, i.e., 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

There are no available data. 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 based on 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested. The symptoms of overdose are mainly drowsiness and tremors.

The symptoms of overdose of Levogastrol are mainly drowsiness and tremors.

If you forget to take Levogastrol

Do not take a double dose to make up for forgotten doses. It is recommended to consult your doctor or pharmacist.

If you stop taking Levogastrol

Do not stop the treatment indicated by your doctor, as the expected effect will not be achieved.

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

4. Possible side effects

Like all medicines, Levogastrol can cause side effects, although not everybody gets them.

Very rare side 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.

• Hoarseness (vocal sounds that are rough and not sonorous).

• Abdominal pain, hypersalivation, constipation, and fatigue.

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

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

If you think any of the side effects you are suffering from is serious, or if you notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency: http://www.notificaram.es by reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Levogastrol

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

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

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Levogastrol

The active substance is levosulpiride 25 mg per tablet.

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

Appearance of the product and pack contents

Levogastrol 25 mg tablets are presented as white tablets with the inscription "25" on one of their faces.

Pack sizes of 30 and 60 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Laboratorios Salvat, S.A.

C/ Gall 30-36 - 08950

Esplugues de Llobregat

Barcelona - Spain

Manufacturer

Laboratorios Salvat, S.A.

C/Gall 30-36 - 08950

Esplugues de Llobregat

Barcelona-Spain

Or

PHARMALOOP, S.L.

C/Bolivia, 15- Polig.Industrial Azque

28806 Alcalá de Henares, Madrid

Date of last revision of this leaflet: February 2022

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