NORMOTUS COUGH SUPPRESSANT 2 mg/ml ORAL SOLUTION

Introduction

Leaflet: information for the user

Normotus antitussive 2 mg/ml oral solution

dextromethorphan hydrobromide

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

Follow the administration instructions for the medicine contained in this leaflet or as indicated by your doctor or 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.
• You should consult a doctor if your symptoms worsen, if they are accompanied by high fever, skin rash, or persistent headache, or if they do not improve after 7 days.

Contents of the leaflet

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

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

Dextromethorphan, the active ingredient in this medicine, 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 children from 2 years of age.

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

2. What you need to know before taking Normotus antitussive

Do not take Normotus antitussive:

• If you are allergic to dextromethorphan or any of the other components of this medicine (listed in section 6).
• Children under 2 years of age cannot take this medicine.
• If you have a severe lung disease.
• If you have asthmatic cough.
• If you have cough accompanied by abundant secretions.
• If you are being treated or have been treated in the last 2 weeks with a monoamine oxidase inhibitor (MAOI) used to treat depression, Parkinson's disease, or other diseases, as well as other serotonin reuptake inhibitors used to treat depression, such as fluoxetine and paroxetine; or also with bupropion, which is a medicine used to quit smoking, or with linezolid, which is an antibacterial medicine. (See section Interactions of Normotus antitussive with other medicines).

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Normotus antitussive in the following cases:

• Patient with persistent or chronic cough, such as that caused by smoking. Especially in children, chronic cough could be an early symptom of asthma.
• Patient with liver disease.
• Patient 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).
• Patient who is sedated, debilitated, or bedridden.

There have been cases of abuse with medicines containing dextromethorphan in adolescents, so this possibility should be taken into account, as serious side effects can occur (see section If you take more Normotus antitussive than you should).

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

Interactions of Normotus antitussive with other medicines:

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

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

• Antidepressant monoamine oxidase inhibitors (MAOIs) (moclobemide, tranylcypromine).
• Antidepressant 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).

Before taking this medicine, consult your doctor if you are taking any of the following medicines, 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 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 phlegm and mucus).

Consult your doctor or pharmacist before taking Normotus antitussive:

• If you are taking other medicines such as antidepressants or antipsychotics, Normotus antitussive may interact with these medicines, and you may experience changes in mental status (e.g., agitation, hallucinations, coma) and other effects such as body temperature above 38°C, increased heart rate, high blood pressure, and exaggerated reflexes, muscle stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).

Interactions of Normotus antitussive with food, beverages, 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.

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, drowsiness and dizziness may occur, so if you notice these symptoms, you should not drive vehicles or operate hazardous machinery.

Normotus antitussive contains maltitol, sodium benzoate, propylene glycol, glucose, and benzyl alcohol

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

Normotus antitussive contains 1 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).

Normotus antitussive contains 26.02 mg of propylene glycol per milliliter.

If the baby is under 4 weeks of age, consult your doctor or pharmacist, especially if the baby has been given other medicines that contain propylene glycol or alcohol.

Normotus antitussive contains glucose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine. It may cause cavities.

Normotus antitussive contains 0.00012 mg of benzyl alcohol per milliliter.

Benzyl alcohol may cause allergic reactions.

Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol can accumulate in your body and cause side effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol can accumulate in your body and cause side effects (metabolic acidosis).

Benzyl alcohol has been linked to the risk of serious side effects, including respiratory problems ("gasping syndrome") in children.

Do not administer this medicine to your newborn (up to 4 weeks of age) unless your doctor has recommended it.

This medicine should not be used for more than one week in children under 3 years of age unless your doctor or pharmacist has indicated it.

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

3. How to take Normotus antitussive

Follow the administration instructions for the medicine contained in this leaflet or as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents from 12 years of age: take 5 to 10 ml, depending on the intensity of the cough, every 4 hours if necessary. Do not exceed 6 doses in 24 hours.

If necessary, 15 ml can be taken every 6 or 8 hours as needed.

The maximum amount that can be taken in 24 hours is 60 ml, divided into several doses.

Use in children

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

Children between 6-11 years: take 2.5 to 5 ml, depending on the intensity of the cough, every 4 hours if necessary. Do not exceed 6 doses in 24 hours.

Also, 7.5 ml can be taken every 6 or 8 hours if necessary.

The maximum amount that can be taken in 24 hours is 30 ml, divided into several doses.

Children between 2-5 years: take 1.25 to 2.5 ml, depending on the intensity of the cough, every 4 hours if necessary. Do not exceed 6 doses in 24 hours. Also, 3.75 ml can be taken every 6-8 hours if necessary.

The maximum amount that can be taken in 24 hours is 15 ml, divided into several doses.

Children under 2 years:

This medicine is contraindicated in children under 2 years of age.

How to take

Normotus antitussive is taken orally.

Measure the amount of medicine to be taken with the dosing device included in the box. Drink directly from the dosing device. After each dose, wash the dosing device.

It can be taken with or without food.

Do not take with grapefruit or bitter orange juice or with alcoholic beverages (see section Interactions of Normotus antitussive with food, beverages, and alcohol).

If the cough worsens, if it 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 Normotus antitussive than you should:

If you take more Normotus antitussive than indicated, you may experience the following symptoms: nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, disorders of consciousness, rapid and 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 doses of this medicine can cause children to become drowsy, nervous, nauseous, vomit, or have changes in their gait.

There have been cases of abuse with medicines containing dextromethorphan, which can cause serious side effects such as tachycardia (accelerated heart rate), lethargy, hypertension or hypotension (high or low blood pressure), mydriasis (pupil dilation), agitation, vertigo, gastrointestinal discomfort, hallucinations, 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: 91 562 0420), indicating the medicine and the amount ingested.

If you forget to take Normotus antitussive:

If you forget to take Normotus antitussive, do not take a double dose to make up for the forgotten dose. If the symptoms continue, take the medicine again as indicated in section 3. How to take Normotus antitussive.

If you have any other doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Normotus antitussive can cause side effects, although not everyone will experience them.

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

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

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

5. Storage of Normotus antitussive

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

No special storage conditions are required.

Do not use this medicine after the expiration date that appears on the packaging after EXP. 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 that 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 that you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Normotus antitussive

• The active ingredient is dextromethorphan hydrobromide. Each milliliter contains 2 mg of dextromethorphan hydrobromide.

• The other components (excipients) are: sodium benzoate (E-211), citric acid, liquid maltitol (E-965), sodium saccharin (E-954), propylene glycol (E-1520), strawberry flavor (contains glucose and benzyl alcohol) and contramarum flavor, and purified water.

Appearance of the product and package contents:

Normotus antitussive is a colorless oral solution.

It is presented in packages containing 125 or 200 ml of solution with a dosing device with measurements for: 1.25, 2.5, and 5 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 leaflet:January 2023

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