Product Information for the User

Normotus Expectorant 2 mg/ml + 20 mg/ml Oral Solution

Dextromethorphan Hydrobromide / Guaifenesin

Read this entire product information carefully before starting to take this medication, as it contains important information for you.

Follow exactly the administration instructions contained in this product information or those indicated by your doctor or pharmacist.

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

It is a medication that contains dextromethorphan hydrobromide, which is an antitussive, and guaifenesin, which is an expectorant.

It is indicated for the relief of cough and to facilitate the expulsion of excess mucus and phlegm in colds and flu for adults and children aged 6 years and above.

Consult a doctor if symptoms worsen or do not improve after 7 days of treatment.

This medication may cause dependence. Therefore, treatment should be of short duration.

Do not take Normotus Expectorante:

• If you are allergic to guaifenesin or dextromethorphan hydrobromide or to any of the other components of this medication (listed in section 6).
• If you have asthma.
• If you have a persistent or chronic cough, such as that caused by smoking or that is associated with debilitation or bed rest.
• If you have a serious lung disease.
• If you are being treated or have been treated in the past two weeks with any monoamine oxidase inhibitor (MAOI) used to treat depression or Parkinson's disease or other conditions (see "Other medications and Normotus Expectorante").

Warnings and precautions

Consult your doctor or pharmacist before starting to take Normotus Expectorante if you are a patient:

• With liver disease.
• With atopic dermatitis (inflammatory skin disease characterized by erythema, pruritus, exudation, crusts, and desquamation, which begins in childhood in individuals with hereditary allergic predisposition).
• If you are taking other medications such as antidepressants or antipsychotics, Normotus Expectorante may interact with these medications and you may experience changes in your mental state (e.g., agitation, hallucinations, coma) and other effects such as high body temperature, increased heart rate, high blood pressure, and exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).

Patients with persistent or chronic cough, such as that caused by smoking or who are debilitated or bedridden, should not take this medication.

Cases of abuse with dextromethorphan-containing medications have been reported in adolescents. This may cause severe adverse effects (see "If you take more Normotus Expectorante than you should").

Interference with diagnostic tests

If you are to undergo any diagnostic test (including blood, urine, skin tests using allergens, etc.), inform your doctor that you are taking this medication, as it may alter the results.

Children and adolescents

This medication is contraindicated in children under 2 years of age. Children aged 2-6 years should not take this medication.

Other medications andNormotus Expectorante

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

Be aware that these instructions may also apply to medications that have been used before or may be used afterwards.

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

• Depression medications such as monoamine oxidase inhibitors (MAOIs) (moclobemide, tranylcypromine) and selective serotonin reuptake inhibitors (paroxetine, fluoxetine).
• Bupropion (used to quit smoking).
• Linezolid (used as an antibacterial).
• Procarbazine (used to treat cancer).
• Selegiline (used to treat Parkinson's disease).

If you are using any of the following medications, it may be necessary to modify the dose of one or both medications or discontinue 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).
• Haloperidol (antipsychotic).

TakingNormotus Expectorantewith food, drinks, and alcohol

Do not consume alcoholic beverages during treatment with this medication, as it may cause adverse reactions.

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

Pregnancy, breastfeeding, and fertility

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

Driving and operating machinery

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

Normotus Expectorante contains sodium, sodium benzoate, sorbitol, aspartame, and ethanol

This medication contains less than 1 mmol of sodium (23 mg) per milliliter; it is essentially "sodium-free".

This medication contains 3.50 mg of sodium benzoate per milliliter.

Sodium benzoate may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

This medication contains 400 mg of sorbitol per ml. Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

This medication contains 4 mg of aspartame per ml. Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

This medication contains 0.99 mg of alcohol (ethanol) per milliliter, which is equivalent to 0.1% v/v. The amount in ml of this medication is equivalent to less than 0.025 ml of beer or 0.010 ml of wine.

The small amount of alcohol in this medication has no perceptible effect.

Follow exactly the administration instructions of this medication contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults and adolescents 12 years and older: 5 ml or 10 ml, every 4-6 hours as needed. Maximum 60 ml / 24 hours.

Use in children

Children 6 to 12 years: 2.5 ml or 5 ml every 4-6 hours as needed. Maximum 30 ml / 24 hours.

Severe adverse effects may occur in children in case of overdose, including neurological alterations. Caregivers must not exceed the recommended dose.

Children 2 to 6 years: There are other presentations more suitable for this population. Administer only under medical supervision, due to the risk of paradoxical stimulation of the CNS.

Children under 2 years: Contraindicated.

Patients with liver disease: The dose must be reduced to half of the recommended dose for each population, not exceeding 4 daily doses.

This medication is taken orally.

How to take:

Measure the amount of medication to take with the dosing cup that comes with the bottle. After use, wash the dosing cup.

It is recommended to drink a glass of water after each dose and abundant liquid throughout the day. It can be taken with or without food.

Do not take with grapefruit or bitter orange juice or with alcoholic beverages (see section “Taking Normotus Expectorante with food, drinks, and alcohol”).

You should consult a doctor if it worsens, or if you also have high fever, skin eruptions, persistent headache, or if it does not improve after 7 days of treatment

If you take more Normotus Expectorante than you should

If you have taken moreNormotus Expectorantethan you should, you may notice: confusion, excitement, restlessness, nervousness, irritability, nausea, and vomiting.

Taking very high doses of this medication can cause in children a state of drowsiness, nervousness, nausea, vomiting, or alterations in gait.

Cases of abuse with medications containing dextromethorphan in adolescents have been reported, which can lead to severe adverse effects, such as anxiety, panic, memory loss, tachycardia (rapid heartbeat), 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 (discoordinated movements), seizures, respiratory depression, loss of consciousness, arrhythmias (irregular heartbeat), and death.

If you take more Normotus Expectorante than 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 disorders, 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.

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, this medication may produce adverse effects, although not everyone will experience them.

During the period of use of dextromethorphan and guaifenesin, the following adverse effects have been observed, whose frequency has not been established with precision:

• In some cases, the following have occurred: drowsiness, dizziness, vertigo, constipation, gastrointestinal discomfort, nausea, vomiting, headache, and skin itching (urticaria).
• In rare cases: mental confusion.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear 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.

No special storage conditions are required.

Once the container is opened, it should not be used after 12 months.

Do not use this medication after the expiration date that appears on the container 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 containers and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition ofNormotus Expectorante

Each milliliter contains 2 mg of dextromethorphan hydrobromide and 20 mg of guaifenesin, as active principles.

The other components (excipients) are: sodium benzoate (E-211), citric acid monohydrate, sorbitol (E-420), sodium saccharin, aspartame (E-951), povidone, orange flavor (contains ethanol) and purified water.

Appearance of the product and contents of the packaging

Normotus Expectorante is a transparent, slightly colored, and orange-flavored aqueous solution.

The medication is presented in amber-colored polyethylene terephthalate bottles with an aluminum capwith a 200 ml oral solution content.

Each package is provided with a 15 ml dosing cup, marked with the following measurements: 1 ml, 2.5 ml, 5 ml, 7.5 ml, 10 ml, and 15 ml.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 - 28760 Tres Cantos - Madrid (SPAIN)

Last review date of this leaflet: July 2023

The 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/).