Leaflet: information for the user

Normotus antitusivo 2 mg/ml oral solution

dextromethorphan hydrobromide

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

Follow exactly the administration instructions contained in this leaflet or those given 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 any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.
• You should consult a doctor if you get worse, if symptoms are accompanied by high fever, skin eruptions, or persistent headache, or if you do not improve after 7 days.

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

2. What you need to know before taking Normotus antitusivo

3. How to take Normotus antitusivo

4. Possible side effects

5. Storage of Normotus antitusivo

6. Contents of the pack and additional information

The dextromethorphan, active principle of this medication, is an antitussive that inhibits the cough reflex.

It is indicated for the symptomatic treatment of a cough not accompanied by expectoration (irritative cough, nervous cough). For adults and children 2 years of age and older.

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

Do not take Normotus antitusivo:

• If you are allergic to dextromethorphan or any of the other components of this medication (listed in section 6).
• Children under 2 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 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 used to quit smoking or with linezolid used as an antibacterial agent. (See Normotus antitusivo interaction with other medications section).

Warnings and precautions:

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

• Patients with persistent or chronic cough, such as that caused by smoking. Especially in children, chronic cough could be an early sign of asthma.
• Patients with liver disease.
• Patients with atopic dermatitis (inflammatory skin disease characterized by erythema, pruritus, exudation, crusts, and desquamation, which begins in childhood in individuals with hereditary allergic predisposition).
• Patients who are sedated, weakened, or bedridden.

Cases of abuse with dextromethorphan-containing medications have been reported in adolescents, therefore, this possibility should be taken into account, as it may lead to severe adverse effects (see section: If you take more Normotus antitusivo than you should).

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

Normotus antitusivo interaction with other medications:

Inform your doctor or pharmacist if you are using, have used recently, or may need to use 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, tranylcypromine) used to treat depression, Parkinson's disease, or other diseases.
• SSRIs (paroxetine, fluoxetine) used to treat depression.
• Bupropion used to quit smoking.
• Linezolid used as an antibacterial agent.
• Procarbazine used to treat cancer.
• Selegiline used to treat Parkinson's disease.

Before taking this medication, 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 discontinue treatment:

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

Consult your doctor or pharmacist before taking Normotus antitusivo:

• If you are taking other medications such as antidepressants or antipsychotics, Normotus antitusivo may interact with these medications and you may experience changes in 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).

Normotus antitusivo interaction with 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.

Pregnancy and lactation

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

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

Driving and operating machinery

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

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

Normotus antitusivo 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 medication.

Normotus antitusivo 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 old).

Normotus antitusivo contains 26.02 mg of propylene glycol per milliliter.

If the baby is less than 4 weeks old, consult your doctor or pharmacist, especially if the baby has been given other medications containing propylene glycol or alcohol.

Normotus antitusivo contains glucose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication. It may cause tooth decay.

Normotus antitusivo contains 0.00012 mg of benzyl alcohol per ml.

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 may accumulate in your body and cause adverse effects (metabolic acidosis).

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

Benzyl alcohol has been associated with the risk of severe adverse effects, including respiratory problems ("breathing difficulty") in children.

Do not administer this medication to your newborn (up to 4 weeks old) unless your doctor recommends it.

This medication should not be used for more than a week in children under 3 years old, unless your doctor or pharmacist recommends it.

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

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

The recommended dose is:

Adults and adolescents 12 years and older: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, you can take 15 ml 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 adverse effects may occur in children in case of overdose, including neurological alterations. 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.

You can also take 7.5 ml 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. You can also take 3.75 ml 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 medication is contraindicated in children under 2 years.

How to take

Normotus antitusivo is taken orally.

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

You can take it with or without food.

Do not take with orange or bitter lemon juice or with alcoholic beverages (See Normotus antitusivo interaction with foods, 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 eruptions, or persistent headache, consult your doctor.

If you take more Normotus antitusivo than you should:

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

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

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

Taking very high amounts 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 have been reported, which may lead to severe adverse effects such as: tachycardia (acceleration of heart rate), lethargy, hypertension or hypotension (high or low blood pressure), mydriasis (pupil dilation), agitation, vertigo, gastrointestinal discomfort, hallucinations, mumbling speech, nystagmus (uncontrolled and involuntary 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 Toxicological Information Service (phone: 91 562 0420), indicating the medication and the amount ingested.

If you forgot to take Normotus antitusivo:

If you forgot to take Normotus antitusivo, do not take a double dose to compensate for the missed dose. If symptoms persist, take the medication in the same way as indicated in the section 3. How to take Normotus antitusivo.

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

Like all medications, Normotus antitusivo may produce adverse effects, although not all people will experience them.

During the period of dextrometorfano use, the following adverse effects have been observed, although their frequency has not been established with precision:

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

If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in the prospectus.

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

No special storage conditions are required.

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

Medications should not be disposed of through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Normotus antitusivo

• 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 and blackcurrant flavors (contains glucose and benzyl alcohol) and purified water.

Appearance of the product and contents of the packaging:

Normotus antitusivo is an odorless oral solution.

It is presented in containers containing 125 or 200 ml of solution with a dosing device with measurements for: 1.25, 2.5, and 5 ml.

Holder of the marketing authorization and responsible for manufacturing:

Laboratorios Normon, S.A.

Ronda de Valdecarrizo,6

28760-Tres Cantos-Madrid (SPAIN)

Date of the last review of this leaflet:January 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/