LEVOGASTROL 25 MG TABLETS

Package leaflet: Information for the user

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, 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 and must not be given to other people, 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 these are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Levogastrol is and what it is 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 fullness, 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 did not respond to other therapies.
• Short-term symptomatic treatment of nausea and vomiting (induced by anticancer medication) following failure of first-line therapy.
• Short-term symptomatic treatment of dizziness, tinnitus, hearing loss, and nausea associated with Ménière's syndrome (a disorder affecting the inner ear).

2. What you need to know before taking Levogastrol

Do not take Levogastrol

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

Take special care with Levogastrol

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Levogastrol:

If you are being treated with other neuroleptic medicines, due to the risk of developing a complex disorder with potentially life-threatening symptoms known as neuroleptic malignant syndrome, which has been reported with the use of these medicines (generally during treatment with antipsychotics).

Immediately inform your doctor if you experience any symptoms such as a combination of fever, muscle rigidity, rapid or labored breathing, sweating, reduced level of consciousness, sudden changes in blood pressure and heart rate, or fainting (neuroleptic malignant syndrome).

Other medicines and Levogastrol

Inform your doctor or pharmacist if you are currently taking, or have recently taken, any other medicines, including those obtained without a prescription.

Certain medicines may interact with Levogastrol. In such cases, it may be necessary to adjust the dose or discontinue treatment with one of the medicines.

It is especially important that you inform your doctor if you are taking any of the following drugs:

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

Taking Levogastrol with food, drinks, and alcohol

Do not consume alcohol while 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not take levosulpiride during pregnancy or while breastfeeding.

Driving and using machines

Levosulpiride may cause symptoms such as drowsiness, numbness, dyskinesias, dizziness, visual disturbances, and reduced reaction time. These effects, as well as the underlying gastrointestinal disorder itself, may impair your ability to drive or operate machinery. Therefore, do not drive or operate machinery, or engage in other activities requiring special attention, until your doctor has assessed your response to this medicine.

Important information about some of the ingredients of Levogastrol

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

3. How to take Levogastrol

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

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

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

Your doctor will determine the duration of treatment with Levogastrol.

Use in children

No data 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 determined by the physician according to the individual patient's needs.

If you take more Levogastrol than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested. Symptoms of overdose are mainly drowsiness and tremors.

Symptoms of Levogastrol overdose are mainly drowsiness and tremors.

If you forget to take Levogastrol

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

If you stop taking Levogastrol treatment

Do not discontinue the treatment prescribed by your doctor, as the intended effect will not be achieved.

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

4. Possible adverse effects

Like all medicines, Levogastrol may cause adverse effects, although not everyone experiences them.

Very rare adverse effects (may affect up to 1 in 10,000 people)

• Somnolence, sedation, parkinsonism (tremor, bradykinesia, rigidity, and postural instability), dyskinesia (involuntary muscle movements), tremor, dystonia (repetitive or sustained involuntary twisting movements or abnormal fixed postures), extrapyramidal disorder (system regulating voluntary body functions and muscle tone), dizziness, insomnia.

• Hoarseness (dysphonic and weak vocal sounds).

• Abdominal pain, hypersalivation, constipation, and fatigue.

• Gynaecomastia (enlargement of male breast tissue), galactorrhoea (spontaneous milk flow from the breasts, not related to childbirth or lactation), menstrual disorders, breast discomfort.

• Hyperprolactinaemia (presence of abnormally high levels of prolactin in the blood) and weight increased.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse 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 stated on the container. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or in household waste. Dispose of empty containers and any unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This 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 components are: monohydrate lactose, sodium carboxymethylstarch type A (gluten-free potato starch), microcrystalline cellulose and magnesium stearate.

Appearance of the product and contents of the pack

Levogastrol 25 mg tablets are presented as white tablets with the inscription "25" on one side.

Pack sizes of 30 and 60 tablets.

Only certain 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 the most recent revision of this leaflet: February 2022

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