Notus Antitussive 10 mg lozenges honey - lemon flavour

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Notus Antitussive 10 mg lozenges with honey-lemon flavour

dextromethorphan hydrobromide

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

Follow exactly the instructions for use provided 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 adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 7 days of treatment.

Contents of the leaflet

1. What Notus Antitussive is and what it is used for
2. What you need to know before taking Notus Antitussive
3. How to take Notus Antitussive
4. Possible side effects
5. How to store Notus Antitussive
6. Contents of the pack and other information

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

Dextromethorphan, the active ingredient in this medicine, is an antitussive that suppresses the cough reflex.

It is indicated for the symptomatic treatment of dry cough (non-productive cough, irritant cough, nervous cough) in adults and adolescents aged 12 years and older.

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

2. What you need to know before taking Notus Antitussive

Do not take Notus Antitussive

• If you are allergic to dextromethorphan or to any of the other ingredients of this medicine (listed in section 6).
• Children under 12 years of age must not take this medicine.
• If you have a severe lung disease.
• If you have asthmatic cough.
• If you have a productive cough with abundant secretions.
• If you are currently taking or have taken within the previous 2 weeks any monoamine oxidase inhibitor (MAOI) medicines used to treat depression, Parkinson's disease, or other conditions, as well as other serotonin reuptake inhibitors used for depression such as fluoxetine and paroxetine; or also bupropion, a medicine used to stop smoking, or linezolid, an antibacterial medicine. (See section on use with other medicines.)

Warnings and precautions

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

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

• If you are taking other medicines such as antidepressants or antipsychotics, Notus Antitussive 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 rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).

Patients should consult a doctor before starting this medicine if they:

• Have persistent or chronic cough, such as that caused by smoking. In children especially, chronic cough may be an early symptom of asthma.
• Have liver disease.
• Have atopic dermatitis (an inflammatory skin disease characterized by erythema, itching, exudation, crusting, and scaling, which begins in infancy in individuals with hereditary predisposition to allergy).
• Are sedated, weakened, or bedridden.

Cases of abuse have been reported with medicines containing dextromethorphan among adolescents; therefore, this possibility should be considered, as serious adverse effects may occur (see section: If you take more Notus Antitussive than you should).

Taking Notus Antitussive with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

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

• Monoamine oxidase inhibitor antidepressants (MAOIs) (moclobemide, tranilcipromine)
• Serotonin reuptake inhibitor antidepressants (paroxetine, fluoxetine)
• Bupropion (used to stop smoking)
• Linezolid (used as an antibacterial)
• Procarbazine (used to treat cancer)
• Selegiline (used to treat Parkinson's disease)

Before starting to take this medicine, you should consult your doctor if you are taking any of the following medicines, as it may be necessary to adjust the dose or interrupt treatment:

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

Taking Notus Antitussive with food, drinks, and alcohol

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

Do not take together with grapefruit juice or bitter orange juice, as they may increase the adverse effects of this medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Driving and use of machines

Rarely, drowsiness and mild dizziness may occur during treatment. If you experience these symptoms, you should not drive or operate dangerous machinery.

Notus Antitussive contains sucrose, glucose, and sodium

This medicine contains sucrose and glucose. If your doctor has informed you that you have an intolerance to certain sugars, consult him or her before taking this medicine.

May be harmful to teeth.

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

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

3. How to take Notus Antitussive

Follow exactly the dosage instructions provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Adults and adolescents aged 12 years and older: Allow 1 tablet to dissolve in the mouth when cough occurs, 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 medicine is contraindicated in children under 12 years of age.

How to take:

This medicine is taken by oral route. Slowly suck the tablet in the mouth until it dissolves completely. Do not chew or swallow it.

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

If cough worsens, persists for more than 7 days of treatment, or is accompanied by high fever, skin rash, or persistent headache, consult your doctor.

If you take more Notus Antitussive than you should

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

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

Contact your doctor or hospital immediately if you experience any of the symptoms listed above.

In case of overdose or accidental ingestion, go to your doctor or call the Toxicology Information Service at telephone number: 915620420, indicating the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

During the period of dextromethorphan use, the following adverse effects have been observed, although their frequency cannot be precisely determined:

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

? More rarely: mental confusion and headache.

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not mentioned in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Notus Antitussive

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

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

Do not use this medicine after the expiry date stated on the blister and on the container following EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and additional information

Composition of Notus Antitussive

• The active substance is dextromethorphan hydrobromide. Each lozenge contains 10 mg of dextromethorphan hydrobromide.
• The other components (excipients) are: cross-linked polycrylic 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 container

This medicine is presented as honey-lemon flavored lozenges, round and yellow in color. It is available in containers 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, 1st Floor

Alcobendas 28108 Madrid.

Spain

Manufacturer

Farmalider S.A.

C/Aragoneses 2

28108- Alcobendas- Madrid

Spain

Date of the most recent revision of this leaflet: May 2023

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