NOVAG TUSS 15 mg TABLETS

Introduction

Package Leaflet: Information for the User

NOVAG TUSS 15 mg Tablets

Dextromethorphan, hydrobromide

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse.

• Keep this package 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, pharmacist, or nurse, even if they are not listed in this package leaflet.
• You should consult a doctor if your symptoms worsen, if they are accompanied by high fever, skin rash, or persistent headache, or if they do not improve after 7 days.

Contents of the Package Leaflet:

1. What is NOVAG TUSS 15 mg Tablets and what is it used for
2. What you need to know before taking NOVAG TUSS 15 mg Tablets
3. How to take NOVAG TUSS 15 mg Tablets
4. Possible side effects
5. Storage of NOVAG TUSS 15 mg Tablets
6. Package Contents and Additional Information

1. What is NOVAG TUSS and what is it used for

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

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 forms that are not accompanied by expectoration (irritative cough, nervous cough) in adults, adolescents, and children from 6 years of age.

2. What you need to know before taking NOVAG TUSS

Do not take NOVAG TUSS:

• If you are allergic to dextromethorphan hydrobromide or any of the other components of this medication (listed in section 6).
• Children under 6 years of age cannot take this medication.
• If you have a severe 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 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 Interactions of NOVAG TUSS with other medications).

Warnings and precautions:

Consult your doctor, pharmacist, or nurse before starting to take NOVAG TUSSin the following cases:

• Patient with persistent or chronic cough, such as that caused by smoking. Especially in children, chronic cough could be an early symptom of asthma.

• Patient with liver disease.
• Patient 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).
• Patient who are sedated, debilitated, or bedridden.

There have been reports of abuse with medications containing dextromethorphan in adolescents, so this possibility should be taken into account, as serious side effects can occur (see section If you take more NOVAG TUSS than you should).

Children and adolescents:

Children under 6 years of age cannot take this medication.

Interactions of NOVAG TUSS with other medications:

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

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

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)
• 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)

Consult your doctor or pharmacist before taking NOVAG TUSS:

• If you are taking other medications such as antidepressants or antipsychotics, NOVAG TUSS 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, hypertension, and exaggerated reflexes, muscle stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).

Before taking 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.)

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

Interactions of NOVAG TUSS with food, beverages, 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 and lactation:

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.

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.

3. How to take NOVAG TUSS

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

The recommended dose is:

Adults and adolescents from 12 years of age:Take 1 tablet every 4 hours. Do not exceed 6 doses in 24 hours. If necessary, 2 tablets can be taken every 6 or 8 hours as needed.

The maximum amount that can be taken in 24 hours is 8 tablets divided into several doses.

Use in children:

Children between 6 and 11 years of age:Take 1 tablet every 8 hours. Depending on the intensity of the cough, 1 tablet can be taken every 6 hours.

The maximum amount that can be taken in 24 hours is 4 tablets divided into several doses.

Children under 6 years of age:Children under 6 years of age should not take this medication.

How to take:

This medication is taken orally.

The tablets can be swallowed whole, broken, or crushed, with the help of a liquid, preferably a glass of water.

It can be taken with or without food.

Do not take with grapefruit or bitter orange juice or with alcoholic beverages (see section Interactions of NOVAG TUSS with food, 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 rash, or persistent headache, consult a doctor.

Pediatric population

Severe side effects can occur in children in case of overdose, including neurological alterations. Caregivers should not exceed the recommended dose.

If you take more NOVAG TUSS than you should:

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

Taking very high amounts of this medication can cause children to become drowsy, nervous, nauseous, vomit, or have alterations in their gait.

There have been reports of abuse with medications containing dextromethorphan in adolescents, which can cause serious side effects such as tachycardia (accelerated heart rate), lethargy, hypertension or hypotension (high or low blood pressure), mydriasis (dilation of the eye pupil), agitation, vertigo, gastrointestinal discomfort, slurred speech, hallucinations, nystagmus (involuntary and uncontrolled eye movement), fever, tachypnea (shallow and rapid 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 Toxicology Information Service (telephone: 91.5620420), indicating the medication and the amount ingested.

If you forget to take NOVAG TUSS:

If you forget to take NOVAG TUSS, do not take a double dose to make up for the missed doses. If the symptoms continue, take the medication again as indicated in section 3. How to take NOVAG TUSS.

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

4. Possible side effects

Like all medications, NOVAG TUSScan 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 not listed in this package leaflet.

5. Storage of NOVAG TUSS

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 thrown away through the sewers or in the trash. Deposit the packaging and medications that are no longer needed at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications that are no longer needed. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of NOVAG TUSS

• The active ingredient is: dextromethorphan hydrobromide and contains 15 milligrams.
• The other components (excipients) are: microcrystalline cellulose, cornstarch, magnesium stearate.

Appearance of the product and package contents:

NOVAG TUSSare tablets, white, round, biconcave, scored on one side.

They are presented in a box with 20 tablets that are packaged in blisters.

Marketing Authorization Holder:

Tarbis Farma, S.L.U.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Manufacturer:

Laboratorios Alcalá Farma, S.L.

Avenida de Madrid 82

28802 Alcalá de Henares (Madrid)

Spain

This package leaflet was approved in: October 2019

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