Novag Tuss 15 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

NOVAG TUSS 15 mg tablets

Dextromethorphan, hydrobromide

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

Follow exactly the instructions for taking this medicine as described in this leaflet or as advised by your doctor, pharmacist, or nurse.

• 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, pharmacist, or nurse, even if they are effects not listed in this leaflet.
• You should consult a doctor if your condition worsens, if symptoms are accompanied by high fever, skin rash, or persistent headache, or if there is no improvement after 7 days.

Contents of the leaflet:

1. What NOVAG TUSS 15 mg tablets are and what they are 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 adverse effects
5. How to store NOVAG TUSS 15 mg tablets
6. Contents of the pack and other information

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

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

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

It is indicated for the symptomatic treatment of dry cough (non-productive cough), such as irritative cough or nervous cough, in adults, adolescents, and children aged 6 years and older.

2. What you need to know before starting NOVAG TUSS

Do not take NOVAG TUSS:

• If you are allergic to dextromethorphan hydrobromide or to any of the other ingredients of this medicine (listed in section 6).
• Children under 6 years of age must not take this medicine.
• If you have a serious lung disease.
• If you have asthmatic cough.
• If you have a cough accompanied by abundant secretions.
• If you are currently being treated or have been treated within the previous 2 weeks with a monoamine oxidase inhibitor (MAOI) used to treat depression, Parkinson's disease, or other conditions, 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 stop smoking, or with linezolid, which is an antibacterial medicine (see section "Interaction of NOVAG TUSS with other medicines").

Warnings and precautions:

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

• Patients with persistent or chronic cough, such as that caused by smoking. Particularly in children, chronic cough may be an early sign of asthma.

• Patients with liver disease.

• Patients with atopic dermatitis (an inflammatory skin disease characterized by erythema, itching, exudation, crusting, and scaling, which begins in childhood in individuals with hereditary predisposition to allergy).

• Patients who are sedated, weakened, or bedridden.

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

Children and adolescents:

Children under 6 years of age must not take this medicine.

Interaction of NOVAG TUSS with other medicines:

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

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

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

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

Consult your doctor or pharmacist before taking NOVAG TUSS:

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

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

• Amiodarone and quinidine (used to treat heart arrhythmias)

• Anti-inflammatory medicines (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 help eliminate phlegm and mucus).

Interaction of NOVAG TUSS with food, beverages and alcohol:

Alcoholic drinks should not be consumed during treatment, as they 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 and breastfeeding:

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.

Driving and use of machines:

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

3. How to take NOVAG TUSS

Follow exactly the dosing instructions for this medicine as described in this leaflet or as directed by your doctor, pharmacist, or nurse. If in doubt, consult your doctor or pharmacist.

The recommended dose is:

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

The maximum amount that may 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 may be taken every 6 hours.

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

Children under 6 years of age: This medicine must not be given to children under 6 years of age.

How to take:

This medicine is for oral use.

The tablets may be swallowed whole, split, or crushed, with liquid, preferably a glass of water.

It may be taken with or without food.

Do not take with grapefruit juice or bitter orange juice, or with alcoholic beverages (see section "Interaction of NOVAG TUSS with food, drinks and alcohol").

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

Paediatric population

Serious adverse effects may occur in children in case of overdose, including neurological disturbances. Caregivers must 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, 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.

Taking very high amounts of this medicine may cause drowsiness, restlessness, nausea, vomiting, or disturbances in gait in children.

Cases of abuse of medicines containing dextromethorphan have been reported in adolescents, potentially leading to serious adverse effects such as tachycardia (increased heart rate), lethargy, hypertension or hypotension (high or low blood pressure), mydriasis (dilation of the pupil), agitation, dizziness, gastrointestinal discomfort, slurred speech, hallucinations, nystagmus (involuntary and uncontrolled eye movements), fever, tachypnea (rapid and shallow breathing), brain damage, ataxia (uncoordinated movements), seizures, respiratory depression, loss of consciousness, arrhythmias (irregular heartbeats), and death.

In case of overdose or accidental ingestion, contact your doctor or call the Toxicology Information Service (telephone: 91.5620420), indicating the medicine 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 dose. If symptoms persist, take the medicine again as indicated in section 3. How to take NOVAG TUSS.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, NOVAG TUSS may cause adverse effects, although not everyone experiences them.

During the period of dextromethorphan use, the following adverse effects have been observed, for which the frequency could not be established accurately:

• In some cases: somnolence, dizziness, vertigo, constipation, gastrointestinal discomfort, nausea, vomiting.
• In rarer cases: mental confusion and headache.

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

5. Storage of NOVAG TUSS

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is 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 you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of NOVAG TUSS

• The active substance is: dextromethorphan hydrobromide, 15 milligrams.
• The other components (excipients) are: microcrystalline cellulose, corn starch, magnesium stearate.

Appearance of the product and contents of the pack:

NOVAG TUSS are white, round, biconcave tablets, scored on one side.

They are presented in a box containing 20 tablets, 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 leaflet was approved in: October 2019

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/