Package Insert: Information for the User

NOVAG TUSS 15 mg Tablets

Dextromethorphan hydrobromide

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

Follow exactly the administration instructions for the medication contained in this package insert or those indicated by your doctor, pharmacist, or nurse.

• Keep this package insert, as you may need to refer to 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 not listed in this package insert.
• You should consult a doctor if your symptoms worsen, are accompanied by high fever, skin rash, or persistent headache, or if they do not improve after 7 days.

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

The dextromethorphan, active ingredient of this medication, is an antitussive that inhibits the cough reflex.

It is indicated for the symptomatic treatment of forms of cough that are not accompanied by expectoration (irritative cough, nervous cough) in adults, adolescents, and children aged 6 years and above..

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 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 medications that inhibit serotonin reuptake 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 NOVAG TUSS interaction with other medications).

Warnings and precautions:

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

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

• Patients with liver disease.
• Patients with atopic dermatitis (inflammatory skin disease characterized by erythema, itching, exudation, crusts, and desquamation, which begins in childhood in individuals with hereditary allergic predisposition).
• Patients who are sedated, weakened, or bedridden.

Cases of abuse with medications containing dextromethorphan in adolescents have been described, therefore, this possibility should be taken into account, as it may produce severe adverse effects (see If you take moreNOVAG TUSSthan you should).

Children and adolescents:

Children under 6 years old cannot take this medication.

Interaction of NOVAG TUSS with other medications:

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

This medication may cause dependence. Therefore, treatment should be of short duration.

Do not take this medication during treatment, or in the 2 weeks following treatment with the following medications, as it may produce excitement, high blood pressure, and fever above40 °C(hyperpyrexia):

• Monamine oxidase inhibitors (MAOI) antidepressants (moclobemide, tranylcypromine)
• Selective 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 TUSSmay 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).

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 (used 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).

Interaction of NOVAG TUSS with food, drinks, and alcohol:

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

Do not take with orange or bitter lemon juice, as it may increase the adverse effects of this medication.

Pregnancy and breastfeeding:

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

Driving and operating machinery:

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

Follow exactly the administration instructions of the medication contained in this leaflet or those indicated by your doctor, pharmacist or nurse. In case of doubts, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents 12 years and older: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: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:Children under 6 years 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 orange or bitter lemon juice or with alcoholic beverages (see section Interaction of NOVAG TUSS with food, drinks and alcohol).

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

Pediatric population

Severe adverse effects may 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, 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.

Taking very high amounts of this medication may cause in children a state of drowsiness, nervousness, nausea, vomiting or alterations in gait.

Cases of abuse with medications containing dextromethorphan have been reported in adolescents, which may lead to severe adverse effects such as tachycardia (accelerated heart rate), lethargy, hypertension or hypotension (high or low blood pressure), mydriasis (pupil dilation), agitation, vertigo, gastrointestinal discomfort, mumbling speech, hallucinations, nystagmus (uncontrolled and involuntary eye movement), 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, consult your doctor or call the Toxicological Information Service (phone: 91.5620420), indicating the medication and the amount ingested.

If you forgot to take NOVAG TUSS:

If you forgot to takeNOVAG TUSS, do not take a double dose to compensate for the missed doses. If symptoms persist, take the medication in the same way as indicated in the section 3. How to take NOVAG TUSS.

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

Like all medications,NOVAG TUSSmay cause adverse effects, although not everyone will experience them.

During the period of dextromethorphan use, the following adverse effects have been observed, although their frequency cannot be established with precision:

• In some cases: drowsiness, dizziness, vertigo, constipation, gastrointestinal discomfort, nausea, vomiting.
• In rare instances: mental confusion and headache.

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

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.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

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 content of the packaging:

NOVAG TUSSare tablets, white, round, bicavous, scored on one face.

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

Holder of the marketing authorization:

Tarbis Farma, S.L.U.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Responsible for manufacturing:

Laboratorios Alcalá Farma, S.L.

Avenida de Madrid 82

28802 Alcalá de Henares (Madrid)

Spain

This leaflet was approved in: October 2019

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