PATIENT INFORMATION LEAFLET

TOSYSTOP 20 mg oral solution

Dextromethorphan Hydrobromide

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

Follow exactly the administration instructions of the medicine contained in this leaflet or those indicated by your doctor, pharmacist.

- Keep this leaflet, as you may need to read it again.

- If you need advice or more information, consult your pharmacist.

- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

- You should consult a doctor if you get worse, or if you also have high fever, skin eruptions or persistent headache, or if you do not improve after 7 days of treatment.

1. What is Tosysptop and what it is used for

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

3. How to take Tosysptop

4. Possible side effects

5. Storage of Tosysptop

6. Contents of the pack and additional information

Dextromethorphan, the active ingredient of this medication, is an antitussive 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 12 years of age and older.

Consult a doctor if it worsens or does not improve after 7 days of treatment.

Do not takeTosyptop:

• If you are allergic (hypersensitive) to dextromethorphan or any of the other components of this medication (listed in section 6).
• Children under 12 years old cannot take this medication.
• If you have a serious lung disease.
• If you have asthma.
• If you have a cough accompanied by abundant secretions.
• If you are being treated or have been treated in the past 2 weeks with any monoamine oxidase inhibitor (MAOI) used for the treatment of depression, Parkinson's disease, or other diseases, as well as other medications that inhibit serotonin reuptake used for the treatment of depression such as fluoxetine and paroxetine; or also with 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 takeTosysptopif you are a patient:

• with persistent or chronic cough, such as that caused by tobacco. 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 desquamation, which begins in childhood in individuals with hereditary allergic predisposition)

• - who is sedated, weakened, or bedridden
• if you are taking other medications such as antidepressants or antipsychotics,Tosysptopmay 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, hypertension, and exaggeration of reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).

This medication may cause dependence. Therefore, treatment should be of short duration. Cases of abuse with medications containing dextromethorphan in adolescents have been reported, so this possibility should be taken into account, as it may cause severe adverse effects (see section: If you take moreTosysptopthan you should).

Children and adolescents

This medication can only be taken by adolescents 12 years old and above.

TakingTosysptopwith other medications

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

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

• MAOIs (moclobemide, tranilcipromine)
• SSRIs (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 medication, 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 (used 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 mucus and phlegm)

TakingTosysptopwith food, drinks, and alcohol

Do not consume alcoholic beverages during treatment, as it may cause adverse effects.

Do not take this medication with orange or bitter lemon juice, as it may increase the adverse effects of this medication.

The rest of foods and drinks do not affect the efficacy of the medication.

Pregnancy and breastfeeding

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

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

Driving and operating machinery

In rare cases, during treatment, you may experience mild drowsiness and dizziness, so if you notice these symptoms, you should not drive cars or operate hazardous machinery.

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

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

This medication contains 10 mg of sodium benzoate (E-211) in each sachet.

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

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents 12 years and older:

-Take 1 tablet every 4 – 6 hours as needed. Do not exceed 6 tablets in 24 hours.

Use the lowest effective dose.

Use in children

This medication can only be taken by adolescents 12 years and older.

How to take

Tosysptopis taken orally.

Empty the contents of the packet directly into the mouth or can be taken dissolved in a liquid, preferably water.

Can be taken with or without food.

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

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

If you take moreTosysptopthan you should

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

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

Immediately contact your doctor or hospital if you experience any of the mentioned symptoms.

High doses of this medication in children may produce a state of drowsiness, hallucinations, nervousness, nausea, vomiting, or gait disturbances.

Cases of abuse with medications containing dextromethorphan have been reported, which may lead to severe adverse effects such as: anxiety, panic, memory loss, tachycardia (rapid heart rate), lethargy, hypertension or hypotension (high or low blood pressure), mydriasis (pupil dilation), agitation, vertigo, gastrointestinal discomfort, mumbling speech, nystagmus (uncontrolled and involuntary eye movement), fever, tachypnea (rapid and shallow breathing), brain damage, ataxia (uncoordinated movements), seizures, respiratory depression, loss of consciousness, arrhythmias (irregular heartbeats), and death.

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

Like all medications,Tosysptopmay cause adverse effects, although not everyone will experience them.

During the period of dextromethorphan use, the following adverse effects have been observed, although their frequency cannot be established with precision:

- In some cases: drowsiness, dizziness, vertigo, constipation, gastrointestinal discomfort, nausea, vomiting

- In rare instances: mental confusion and headache.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it involves possible adverse effects not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Store in the original packaging.

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofTosystop

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

Appearance of the product and contents of the packaging

This medicine is a pink solution with a strawberry flavor.

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

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

Apotheke Laboratorios S.L.

Paseo de la Castellana nº40, 8th floor

28046 Madrid

Spain

Responsible manufacturers

FARMASIERRA MANUFACTURING S.L.

Irún Highway, 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.

Enchilagar del Rullo Industrial Estate,

117, Villamarchante, 46191 Valencia

Last review date of this leaflet:May 2024

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