NORMOTUS EXPECTORANT 2 mg/mL + 20 mg/mL ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

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

Dextromethorphan hydrobromide / Guaifenesin

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

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist exactly.

• 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 side effects not listed in this package leaflet. See section 4.
• You should consult your doctor if your condition worsens, or if you also have a high fever, skin rash, or persistent headache, or if it does not improve after 7 days of treatment.

Contents of the Package Leaflet

1. What Normotus Expectorant is and what it is used for
2. What you need to know before taking Normotus Expectorant
3. How to take Normotus Expectorant
4. Possible side effects
5. Storage of Normotus Expectorant
6. Package Contents and Additional Information

1. What Normotus Expectorant is and what it is used for

It is a medication that contains dextromethorphan hydrobromide, which is a cough suppressant, 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 from 6 years old.

You should consult a doctor if your condition worsens or does not improve after 7 days of treatment.

2. What you need to know before taking Normotus Expectorant

This medication can cause dependence. Therefore, treatment should be short-term.

Do not take Normotus Expectorant:

• If you are allergic to guaifenesin or dextromethorphan hydrobromide or any of the other components of this medication (listed in section 6).
• If you have asthma.
• If you have a cough with a large amount of mucus and phlegm.
• If you have a severe lung disease.
• If you are being treated or have been treated in the past 2 weeks with any monoamine oxidase inhibitor (MAOI) medication used to treat depression or Parkinson's disease or other diseases (see "Other medications and Normotus Expectorant").

Warnings and Precautions

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

• Liver disease.
• Atopic dermatitis (inflammatory skin disease characterized by erythema, itching, exudation, crusts, and scaling, which begins in childhood in individuals with a hereditary allergic predisposition).
• If you are taking other medications such as antidepressants or antipsychotics, Normotus Expectorant 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, hypertension, and exaggeration of reflexes, muscle stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).

Patient with persistent or chronic cough, such as that due to smoking or who are sedated, debilitated, or bedridden should not take this medication.

There have been cases of abuse with medications containing dextromethorphan by adolescents, which can cause serious side effects (see "If you take more Normotus Expectorant than you should").

Interference with laboratory tests

If you are going to undergo any diagnostic test (including blood tests, urine tests, 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 from 2 to 6 years old should not take this medication.

Other Medications and Normotus Expectorant

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

Note that these instructions may also apply to medications that have been used before or may be used after.

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):

• Medications used to treat depression such as monoamine oxidase inhibitors (MAOIs) (moclobemide, tranylcypromine) and 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 of them or interrupt treatment:

• Amiodarone and quinidine (to treat heart arrhythmias).
• Anti-inflammatory drugs (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).

Taking Normotus Expectorant with Food, Drinks, and Alcohol

Alcoholic beverages should not be consumed during treatment with this medication, as it may cause adverse reactions.

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

Pregnancy, Breastfeeding, and Fertility

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

Driving and Using Machines

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

Normotus Expectorant contains Sodium, Sodium Benzoate, Sorbitol, Aspartame, and Ethanol

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

This medication contains 3.50 mg of sodium benzoate in each milliliter.

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

This medication contains 400 mg of sorbitol in each milliliter. Sorbitol may cause gastrointestinal upset and a mild laxative effect.

This medication contains 4 mg of aspartame in each milliliter. Aspartame contains a source of phenylalanine, which may be harmful in cases of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it properly.

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

The small amount of alcohol in this medication does not produce any noticeable effect.

3. How to Take Normotus Expectorant

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

The recommended dose is:

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

Use in Children

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

Severe side effects may occur in children in case of overdose, including neurological disorders. Caregivers should not exceed the recommended dose.

Children from 2 to 6 years old: 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 old: contraindicated.

Patient with liver disease: the dose should be reduced to half of the recommended dose for each population, not exceeding 4 daily doses in any case.

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 plenty of 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 "Taking Normotus Expectorant with Food, Drinks, and Alcohol").

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

If you take more Normotus Expectorant than you should

If you have taken more Normotus Expectorant than you should, you may notice: confusion, excitability, restlessness, nervousness, irritability, nausea, and vomiting.

Taking very high doses of this medication can cause children to become drowsy, nervous, nauseous, vomit, or have changes in their gait.

There have been cases of abuse with medications containing dextromethorphan in adolescents, which can cause serious side 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 upset, 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.

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

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

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

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

During the use of dextromethorphan and guaifenesin, the following side effects have been observed, whose frequency could not be established with precision:

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

Reporting Side Effects

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

5. Storage of Normotus Expectorant

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

No special storage conditions are required.

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

Do not use this medication after the expiration date shown on the package after EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE collection point in the pharmacy. Ask your pharmacist how to dispose of the packages and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Normotus Expectorant

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

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 Package Contents

Normotus Expectorant is a clear, slightly colored aqueous solution with an orange flavor.

The medication is presented in topaz polyethylene terephthalate bottles with an aluminum cap, containing 200 ml of oral solution.

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

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

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

Date of the Last Revision of this Package Leaflet: July 2023

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