Leaflet: information for the user

Notus Antitusivo 10 mg lozenges, lemon-honey flavor

dextromethorphan hydrobromide

Read this leaflet carefully before you start taking this medicine, because

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. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 7 days of treatment.

1. What is Notus Antitusivo 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. Contents of the pack and additional information

The dextromethorphan, active ingredient 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 adolescents 12 years of age and older.

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

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 old cannot take this medication

- If you have a serious lung disease

- If you have asthma cough

- 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 for the treatment of depression, Parkinson's disease, or other diseases, as well as other serotonin reuptake inhibitors used for the treatment of 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 may cause dependence. Therefore, treatment should be of short duration.

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

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

You should consult a doctor before starting to take this medication the following patients:

• 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 desquamation, which begins in childhood in individuals with hereditary allergic predisposition)
• Who are sedated, weakened, or bedridden.

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

Notus Antitusivo 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):

- Monoamine oxidase inhibitors (MAOI) antidepressants (moclobemide, tranilcipromina)

- Serotonin reuptake inhibitors (paroxetine, fluoxetine)

- Bupropion (used to quit smoking)

- Linezolid (used as an antibacterial)

- Procarbazin (used to treat cancer)

- Selegiline (used to treat Parkinson's disease)

You should consult your doctor before starting to take this medication 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)

- Expectorants and mucolytics (used to eliminate mucus and phlegm).

Notus Antitusivo with food, drinks, and alcohol

Do not consume alcoholic beverages during treatment, as it may cause adverse effects.

Do not take with orange or bitter lemon juice, as it may increase the adverse 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 operating machinery

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

Notus Antitusivo contains saccharose, glucose, and sodium

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

It may harm your teeth.

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

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

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Adults and adolescents 12 years and older:Dissolve 1 tablet in the mouth when coughing appears, up to a maximum of 2 tablets every 4-6 hours as needed.

Do not exceed a dose of 12 tablets (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.

How to take:

This medication is taken orally. Chew the tablet slowly in the mouth until it dissolves completely. Do not chew or swallow.

Do not take with grapefruit or bitter orange juice or with alcoholic beverages (see section Taking Notus Antitusivo 10 mg with food or drinks).

If the cough worsens, persists for more than 7 days of treatment, or is accompanied by high fever, skin eruptions, 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, altered consciousness, involuntary and rapid eye movements, cardiac disturbances (accelerated heart rate), coordination disturbances, psychosis with visual hallucinations, and hyperexcitability.

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

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

In case of overdose or accidental ingestion, visit your doctor or call the Toxicological Information Service, phone: 915620420, indicating the medication and the amount ingested.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

During the period of use of dextromethorphan, the following adverse effects have been observed, whose frequency has not been established with precision:

?Occasionally: drowsiness, dizziness, vertigo, constipation, gastrointestinal discomfort,

nausea, vomiting

?Rarely: mental confusion and headache.

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

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

Do not use this medication after the expiration date that appears on the blister and 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 in the trash. Dispose of the packaging and the

medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and the medications you no longer need. By doing so, you will help protect the environment.

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 polycarboxylate resin, liquid glucose, sucrose, sodium saccharin, citric acid monohydrate, sodium hydroxide, purified water, lemon flavor, and honey flavor.

Appearance of the product and contents of the packaging

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1st Floor

Alcobendas 28108 Madrid.

Spain

Responsible for manufacturing

Farmalider S.A.

C/Aragoneses 2

28108- Alcobendas- Madrid

Spain

Last review date of this leaflet:May 2023

The detailed information of this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/