TOSYSTOP 20 mg ORAL SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

TOSYSTOP 20 mg oral solution

Dextromethorphan hydrobromide

Read the package leaflet carefully before starting to take this medicine, as it contains important information for you.

Follow the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.
• You should consult a doctor if your symptoms worsen, or if you also have a high fever, skin rash, or persistent headache, or if you do not improve after 7 days of treatment.

Contents of the package leaflet

1. What is Tosysptop and what is it used for
2. What you need to know before taking Tosysptop
3. How to take Tosysptop
4. Possible side effects
5. Storage of Tosysptop
6. Package contents and additional information

1. What is Tosystop and what is it used for

Dextromethorphan, the active ingredient of this medicine, is a cough suppressant that inhibits the cough reflex.

It is indicated for the symptomatic treatment of cough that is not accompanied by expectoration (irritative cough, nervous cough) for adults and adolescents from 12 years of age.

You should consult a doctor if your symptoms worsen or if you do not improve after 7 days of treatment.

2. What you need to know before taking Tosystop

Do not takeTosyptopif:

• You are allergic (hypersensitive) to dextromethorphan or any of the other components of this medicine (listed in section 6).
• Children under 12 years of age cannot take this medicine.
• You have a severe lung disease.
• You have asthma.
• You have a cough accompanied by abundant secretions.
• You are being treated or have been treated in the last 2 weeks with any monoamine oxidase inhibitor (MAOI) medication used to treat depression, Parkinson's disease, or other diseases, as well as other serotonin reuptake inhibitor medications used to treat depression, such as fluoxetine and paroxetine; or bupropion, which is a medication used to quit smoking, or linezolid, which is an antibacterial medication (see section: Use of other medications).

Warnings and precautions

You should consult your doctor or pharmacist before starting to take Tosysptop if you are a patient:

• with persistent or chronic cough, such as that caused by smoking. Especially in children, chronic cough could be an early symptom of asthma.
• with liver disease

• with atopic dermatitis (inflammatory skin disease characterized by erythema, itching, exudation, crusts, and scaling, which begins in childhood in individuals with a hereditary allergic predisposition)

• who is sedated, weakened, or bedridden
• if you are taking other medications such as antidepressants or antipsychotics, Tosysptop may interact with these medications and you may experience changes in your mental state (e.g., agitation, hallucinations, coma) and other effects such as body temperature above 38°C, increased heart rate, arterial hypertension, and exaggerated reflexes, muscle stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).

This medicine may cause dependence. Therefore, treatment should be short-term. There have been cases of abuse with medications containing dextromethorphan in adolescents, so this possibility should be taken into account, as serious side effects may occur (see section: If you take more Tosysptop than you should).

Children and adolescents

This medicine can only be taken by adolescents from 12 years of age.

Taking Tosystop with other medications

Tell your doctor or pharmacist if you are taking or have recently taken, or may need to take, any other medication.

Do not take this medicine during treatment or in the 2 weeks following treatment with the following medications, as excitement, high blood pressure, and fever above 40°C (hyperpyrexia) may occur:

• Monoamine oxidase inhibitor (MAOI) antidepressants (moclobemide, tranilcipromine)
• Serotonin reuptake inhibitor antidepressants (paroxetine, fluoxetine)
• Bupropion (used to quit smoking)
• Linezolid (used as an antibacterial)
• Procarbazine (used to treat cancer)
• Selegiline (used to treat Parkinson's disease)

Before starting to take this medicine, you should consult your doctor if you are using any of the following medications, as it may be necessary to modify the dose of one of them or interrupt treatment:

• Amiodarone and quinidine (to treat heart arrhythmias)
• Anti-inflammatory medications (celecoxib, parecoxib, or valdecoxib)
• Central nervous system depressants (some of which are used to treat mental illnesses, allergies, Parkinson's disease, etc.)
• Expectorants and mucolytics (used to eliminate phlegm and mucus).

Taking Tosysptop with food, drinks, and alcohol

Alcoholic beverages should not be consumed during treatment, as they may cause side effects.

Do not take with grapefruit or bitter orange juice, as they may increase the side effects of this medicine.

The rest of the food and drinks do not affect the efficacy of the medicine.

Pregnancy and breastfeeding

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 medicine.

Pregnant or breastfeeding women should not take this medicine without consulting their doctor.

Driving and using machines

Rarely, during treatment, mild drowsiness and dizziness may occur, so if you experience these symptoms, you should not drive vehicles or operate hazardous machinery.

Tosyptop contains maltitol (E-965), sodium benzoate (E-211), and amaranth (E-123)

This medicine contains maltitol (E-965). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

This medicine contains 10 mg of sodium benzoate (E-211) per sachet.

This medicine may cause allergic reactions because it contains amaranth (E-123).

3. How to take Tosystop

Follow the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents from 12 years of age:

-Take 1 sachet every 4-6 hours as needed. Do not exceed 6 sachets in 24 hours.

Always use the lowest effective dose.

Use in children

This medicine can only be taken by adolescents from 12 years of age.

How to take

Tosysptop is taken orally.

Pour the contents of the sachet directly into the mouth or take it dissolved in a liquid, preferably water.

It can be taken with or without food.

Do not take with grapefruit or bitter orange juice or with alcoholic beverages (see section: Taking Tosysptop with food or drinks).

If your symptoms worsen, if the cough persists for more than 7 days of treatment, or if it is accompanied by high fever, skin rash, or persistent headache, consult your doctor.

If you take more Tosysptop than you should

If you take more Tosysptop than indicated, you may experience the following symptoms: nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, consciousness disorders, rapid involuntary eye movements, cardiac disorders (accelerated heart rate), coordination disorders, psychosis with visual hallucinations, and hyperexcitability.

Other symptoms in case of massive overdose may be: coma, severe respiratory problems, and convulsions.

Contact your doctor or hospital immediately if you experience any of the mentioned symptoms.

Taking very high amounts of this medicine can cause children to enter a state of stupor, hallucinations, nervousness, nausea, vomiting, or changes in gait.

There have been cases of abuse with medications containing dextromethorphan, which can cause serious side effects such as: anxiety, panic, memory loss, tachycardia (accelerated heart rate), lethargy, hypertension or hypotension (high or low blood pressure), mydriasis (pupil dilation), agitation, vertigo, gastrointestinal disorders, slurred speech, nystagmus (involuntary and uncontrolled eye movement), fever, tachypnea (rapid and shallow breathing), brain damage, ataxia (uncoordinated movements), convulsions, respiratory depression, loss of consciousness, arrhythmias (irregular heartbeats), and death.

In case of overdose or accidental ingestion, consult your doctor or call the Toxicology Information Service (telephone: 91.5620420), indicating the medicine and the amount ingested.

4. Possible side effects

Like all medicines, Tosysptop can cause side effects, although not everyone experiences them.

During the use of dextromethorphan, the following side effects have been observed, whose frequency cannot be established with precision:

• In some cases: drowsiness, dizziness, vertigo, constipation, gastrointestinal disorders, nausea, vomiting
• In rarer cases: mental confusion and headache.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Tosystop

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

Store in the original packaging.

Do not use this medicine after the expiration date that appears on the packaging or on the sachet after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Tosystop

• Each sachet of oral solution contains 10 mg of dextromethorphan hydrobromide as the active ingredient.
• The other components (excipients) are: sodium benzoate (E-211), anhydrous citric acid, maltitol liquid (E-965), sodium saccharin, propylene glycol, strawberry flavor, contramaro flavor, amaranth (E-123), and purified water.

Appearance of the product and package contents

This medicine is a pink solution with a strawberry flavor.

It is presented in polyester-aluminum-polyethylene sachets with 5 ml of solution, contained in boxes of 12 or 24 sachets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Apotheke Laboratorios S.L.

Paseo de la Castellana nº40, 8ª planta

28046 Madrid

Spain

Manufacturers

FARMASIERRA MANUFACTURING S.L.

Ctra. Irún, km 26,200.

San Sebastián de los Reyes

28709 Madrid

Spain

or

LABORATORIOS ALCALÁ FARMA, S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares-Madrid

Spain

or

ZINEREO PHARMA, S.L.U.

A Relva, s/n.

36400 O Porriño – Pontevedra

Spain

or

EDEFARM, S.L.

Polígono Industrial Enchilagar del Rullo,

117, Villamarchante, 46191 Valencia

Date of the last revision of this package leaflet:May 2024

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