NOTUS COUGH SUPPRESSANT 10 mg LOZENGES HONEY-LEMON FLAVORED

Introduction

Leaflet: Information for the user

Notus Antitusivo 10 mg lozenges with honey-lemon flavor

dextromethorphan hydrobromide

Read the entire leaflet carefully before starting to take this medication, as it

contains important information for you.

Follow the administration instructions of the medication 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 side effects not listed in this leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do 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

The active ingredient of this medication, dextromethorphan, 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), for adults and adolescents from 12 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 Notus Antitusivo

Do not take Notus Antitusivo

• If you are allergic to dextromethorphan or any of the other components of this medication (listed in section 6).
• Children under 12 years of age cannot take this medication.
• 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 any monoamine oxidase inhibitor (MAOI) medication used to treat depression, Parkinson's disease, or other diseases, as well as other serotonin reuptake inhibitor medications used to treat depression, such as fluoxetine and paroxetine; or also with bupropion, which is a medication used to quit smoking, or with linezolid, which is an antibacterial medication. (See section on use of other medications).

Warnings and precautions

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

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

Patient with the following conditions should consult a doctor before starting to take this medication:

• 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 are sedated, debilitated, or bedridden.

There have been cases of abuse with medications containing dextromethorphan by adolescents, so 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 medications

Inform your doctor or pharmacist if you are using, have recently used, 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 excitement, high blood pressure, and fever above 40°C (hyperpyrexia) can occur:

• Antidepressant monoamine oxidase inhibitors (MAOIs) (moclobemide, tranilcipromine)

paroxetine, fluoxetine

• 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 starting to take this medication, you should 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 interrupt treatment:

• Amiodarone and quinidine (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.)

diseases, allergy, 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 can cause side effects.

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

Pregnancy, breastfeeding, and fertility

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 medication.

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

Driving and using machines

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

Notus Antitusivo contains sucrose, glucose, and sodium

This medication contains sucrose and glucose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

It can harm teeth.

This medication contains 1.6 g of sucrose per lozenge, which should be taken into account in patients with diabetes mellitus.

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

3. How to take Notus Antitusivo

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

Adults and adolescents from 12 years of age: Dissolve 1 lozenge in the mouth when cough appears, up to a maximum of 2 lozenges every 4-6 hours as needed.

Do not exceed the dose of 12 lozenges (120 mg) in 24 hours, divided into several doses.

Always use the lowest effective dose.

Use in children

This medication is contraindicated in children under 12 years of age.

How to take:

This medication is taken orally. Suck the lozenge slowly in the mouth until it is completely dissolved. Do not chew or swallow.

Do not take with grapefruit or bitter orange juice or with alcoholic beverages (see section on taking Notus Antitusivo with food or drinks).

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 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, go to your doctor or call the Toxicology Information Service, phone: 915620420, 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, 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 side effects not listed in this leaflet.

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 leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Notus Antitusivo

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

No special storage conditions are required. Keep in the original packaging.

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

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Notus Antitusivo

• The active ingredient is dextromethorphan hydrobromide. Each lozenge contains 10 mg of dextromethorphan hydrobromide.
• The other components (excipients) are: cross-linked polyacrylic resin, liquid glucose, sucrose, sodium saccharin, citric acid monohydrate, sodium hydroxide, purified water, lemon flavor, and honey flavor.

Appearance of the product and package contents

This medication is presented in the form of honey-lemon flavored lozenges, round and yellow in color. It is available in packages containing 12 and 24 lozenges.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1ª Planta

Alcobendas 28108 Madrid.

Spain

Manufacturer

Farmalider S.A.

C/Aragoneses 2

28108- Alcobendas- Madrid

Spain

Date of the last revision of this leaflet:May 2023

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