NOTUS ANTITUSSIVE 2 mg/ml ORAL SOLUTION

Introduction

Leaflet: information for the user

Notus Antitusivo 2 mg/ml oral solution

Dextromethorphan hydrobromide

Read the entire 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. See section 4.

You should consult a doctor if it 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 leaflet

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

1. What Notus Antitusivo is and what it is used for

Dextromethorphan, the active ingredient of this medicine, is a cough suppressant that inhibits the cough reflex.

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

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

2. What you need to know before taking Notus Antitusivo

Do not take Notus Antitusivo:

• If you are allergic (hypersensitive) to dextromethorphan or to any of the other components of this medicine (listed in section 6)

Children under 2 years of age should not take this medicine

• If you have a severe lung disease
• If you have asthmatic cough
• If you have cough with 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 on use of other medicines).

Warnings and precautions

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

Consult your doctor or pharmacist before starting to take Notus Antitusivo:

• If you are taking other medicines such as antidepressants or antipsychotics, Notus Antitusivo may interact with these medicines 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, high blood pressure, and exaggerated reflexes, muscle stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).

Consult your doctor or pharmacist before starting to take Notus Antitusivo if you are a patient:

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

who is sedated, weakened, or bedridden.

There have been cases of abuse with medicines containing dextromethorphan by adolescents; therefore, this possibility should be taken into account, as serious side effects can occur (see section: If you take more Notus Antitusivo than you should).

Taking Notus Antitusivo with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or may take 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:

• Monoamine oxidase inhibitors (MAOIs) (moclobemide, tranilcipromine)

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 starting to take this medicine, consult your doctor if you are using 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).

Taking Notus Antitusivo with food, drinks, 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.

The rest of the food and drinks do not affect the efficacy of the medicine.

Pregnancy, 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; therefore, if you experience these symptoms, you should not drive vehicles or operate hazardous machinery.

This medicine contains maltitol (E-965)

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

This medicine contains propylene glycol

This medicine contains 25.9 mg of propylene glycol per milliliter.

If the child is under 5 years of age, consult your doctor or pharmacist, especially if they have been given other medicines that contain propylene glycol or alcohol.

If you are pregnant or breastfeeding, do not take this medicine unless it is recommended by your doctor. Your doctor may perform additional checks while you are taking this medicine.

If you have liver or kidney failure, do not take this medicine unless it is recommended by your doctor. Your doctor may perform additional checks while you are taking this medicine.

This medicine contains sodium

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

This medicine contains sodium benzoate

This medicine contains 1 mg of sodium benzoate (E211) per milliliter.

3. How to take Notus Antitusivo

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

The recommended dose is:

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

It can also be taken 15 ml every 6 or 8 hours if necessary.

The maximum amount that can be taken in 24 hours is 120 mg divided into several doses.

Always use the lowest effective dose.

Use in children and adolescents

Pediatric population

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 2.5-5 ml, depending on the intensity of the cough, every 4 hours if necessary. Do not exceed 6 doses in 24 hours

It can also be taken 7.5 ml every 6 or 8 hours if necessary.

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

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

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

Children under 2 years:

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

How to take

The medicine is taken orally.

Measure the amount of medicine to be taken with the measuring spoon included in the package. For correct dosing, a measuring spoon of 1.25, 2.5, and 5 ml is included.

Wash the spoon after each use.

Do not take with grapefruit or bitter orange juice or with alcoholic beverages.

Concomitant intake of this medicine with other foods or drinks does not affect its efficacy.

If it worsens, or if the cough persists for more than 7 days, or if it is accompanied by high fever, skin rash, or persistent headache, you should consult a doctor.

If you take more Notus Antitusivo than you should

If you take more Notus Antitusivo than indicated, you may experience the following symptoms: nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, disorders of consciousness, rapid 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.

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

4. Possible side effects

Like all medicines, this medicine can have side effects, although not everyone gets them.

During the use of dextromethorphan, the following side effects have been observed, whose frequency has not been established with certainty:

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

? In rarer cases: mental confusion and headache.

Reporting side effects:

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

5. Storage of Notus Antitusivo

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

Store in the original package. Do not freeze. Protect from light.

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

Medicines should not be thrown down the drain or into the trash. Deposit the packages and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medicines you no longer need. This way, you will help protect the environment.

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6. Package contents and additional information

Composition of Notus Antitusivo

• The active ingredient is dextromethorphan hydrobromide. Each milliliter of solution contains 2 milligrams of dextromethorphan as the active ingredient.

The other components (excipients) are sodium benzoate (E-211), anhydrous citric acid, maltitol (E-965), sodium saccharin, propylene glycol, strawberry and orange flavors, purified water, q.s.

Appearance of the product and package contents

Topaz-colored PET bottle closed with a high-density polyethylene cap containing 125 ml or 200 ml of solution.

Includes a measuring spoon of 1.25, 2.5, and 5 ml.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

Teva Pharma S.L.U.

Anabel Segura 11, Edificio Albatros B 1st floor

28108 Alcobendas, Madrid (Spain)

Manufacturer:

Teva Pharma S.L.U

C/C, n 4 Polígono Industrial Malpica

50016 Zaragoza (Spain)

or

FARMASIERRA MANUFACTURING S.L.

Irún road, km 26,200.

28700 San Sebastián de los Reyes (Madrid), Spain

Or

Edefarm, S.L.

Enchilagar del Rullo industrial estate, 117

4691 Villamarchante, Valencia, Spain

Or

Farmalider, S.A.

Aragoneses 2, 28108 Alcobendas, Madrid, Spain

Date of the last revision of this text:January 2022

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