NOVAG TUSS 10mg/5ml ORAL SOLUTION

Introduction

Leaflet: Information for the user

Novag tuss 10 mg/5 ml oral solution

Dextromethorphan hydrobromide

Read this leaflet carefully because it contains important information for you.

This medication can be obtained without a prescription. Nevertheless, to obtain the best results, it should be used properly.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If symptoms worsen or persist after 7 days or if they are accompanied by high fever, skin rash, or persistent headache, you should consult a doctor.
• If you consider that any of the adverse effects you are experiencing is serious or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Contents of the leaflet:

1. What is Novag tuss 10 mg/5 ml oral solution and what is it used for
2. Before taking Novag tuss 10 mg/5 ml oral solution
3. How to take Novag tuss 10 mg/5 ml oral solution
4. Possible side effects
5. Storage of Novag tuss 10 mg/5 ml oral solution
6. Additional information

1. What is Novag tuss 10 mg/5 ml oral solution and what is it used for

Dextromethorphan is an antitussive (cough medication). This medication is indicated for the symptomatic relief of all forms of cough that are not accompanied by expectoration (irritative cough, nervous cough).

2. Before taking Novag tuss 10 mg/5 ml oral solution

Do not take Novag tuss 10 mg/5 ml oral solution

• if you are allergic (hypersensitive) to dextromethorphan or to any of the other components of Novag tuss.
• if you have respiratory failure
• if you have asthmatic cough
• if you have cough accompanied by expectoration
• if you are being treated with certain antidepressant medications (see section "Use of other medications").

Be careful with Novag tuss 10 mg/5 ml oral solution

• if you have persistent or chronic cough, such as that caused by smoking, asthma, or emphysema (lung distension), or when the cough is accompanied by abundant secretions, you should consult a doctor
• if you have any liver disease, consult your doctor before taking this medication, as you may need to reduce the dose.

• Cases of abuse with medications containing dextromethorphan have been reported in adolescents, so this possibility should be taken into account, as serious adverse effects can occur (see section "If you take more Novag tuss 10 mg/5 ml oral solution than you should").

Use of other medications

Tell your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

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

Novag tuss 10 mg/5 ml oral solution should not be administered with:

• Quinidine, used for heart arrhythmias.

It should also not be used with the following medications, nor in the 2 weeks following the end of treatment with any of them:

• Antidepressants (of the monoamine oxidase inhibitor type, such as moclobemide)
• Furazolidone, isoniazid, and linezolid, used for infections
• Pargyline, used for the treatment of high blood pressure (hypertension)
• Procarbazine, used in cancer treatment
• Selegiline, used in the treatment of Parkinson's disease

If you are being treated with any of these, consult your doctor or pharmacist before taking this medication.

Consult your doctor or pharmacist before taking Novag tuss 10 mg/5 ml oral solution:

• If you are taking other medications such as antidepressants or antipsychotics, Novag tuss 10 mg/5 ml oral solution 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).

Taking Novag tuss 10 mg/5 ml oral solution with food and drinks

Alcoholic beverages should not be consumed during treatment with this medication (see point 4. POSSIBLE SIDE EFFECTS).

Use in children

Do not administer to children under 2 years of age.

Pregnancy

Consult your doctor or pharmacist before using any medication.

Important for women:

If you are pregnant or think you may be pregnant, consult your doctor before taking this medication. The use of medications during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

Breastfeeding

Consult your doctor or pharmacist before using any medication. Breastfeeding women should consult their doctor or pharmacist before taking this medication.

Driving and using machines

During treatment with Novag tuss 10 mg/5 ml oral solution, a decrease in reaction capacity or drowsiness may occasionally occur, which should be taken into account when driving vehicles or operating hazardous machinery.

Important information about some of the components of Novag tuss 10 mg/5 ml oral solution

This medication contains Liquid Maltitol (E-965). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication. It may have a slight laxative effect.

3. How to take Novag tuss 10 mg/5 ml oral solution

Follow these instructions exactly unless your doctor has given you different instructions.

Consult your doctor or pharmacist if you have any doubts.

This medication is taken orally. For correct dosing, a double-spoon measuring spoon with measures of 1.25 ml, 2.5 ml, and 5 ml is included. Wash the measuring spoon after each use.

The normal dose is:

Adults and children over 12 years:The usual dose is 1 to 2 teaspoons of 5 ml every 4-8 hours. Do not take more than 60 ml per day, which corresponds to 12 teaspoons of 5 ml.

Children 6 years to 12 years:The usual dose is 1 teaspoon of 2.5 ml to 1 teaspoon of 5 ml every 4-8 hours. Do not take more than 30 ml per day, which corresponds to 6 teaspoons of 5 ml.

Children 2 years to 6 years:The usual dose is 1 measure of 1.25 ml to 1 teaspoon of 2.5 ml every 4-8 hours. Do not take more than 15 ml per day, which corresponds to 6 teaspoons of 2.5 ml.

Do not exceed the recommended dose. Always use the lowest effective dose. If symptoms worsen or persist after 7 days of treatment, or if they are accompanied by high fever, skin rash, or persistent headache, you should consult your doctor. If you think the effect of Novag tuss 10 mg/5 ml oral solution is too strong or too weak, tell your doctor or pharmacist.

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

If you take more Novag tuss 10 mg/5 ml oral solution than you should

Signs of overdose are confusion, excitability, restlessness, nervousness, and irritability. Accidental ingestion of very high doses can cause a state of drowsiness or alterations in gait in children.

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

If you take more Novag tuss 10 mg/5 ml oral solution 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 include: coma, severe respiratory problems, and convulsions.

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

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service, tel.: 91-5620420, indicating the medication and the amount ingested.

If you forget to take Novag tuss 10 mg/5 ml oral solution

Do not take a double dose to make up for forgotten doses.

4. Possible side effects

Like all medications, Novag tuss 10 mg/5 ml oral solution can cause side effects, although not everyone experiences them.

Rarely (in less than 1 in 1,000 patients but in more than 1 in 10,000 patients), drowsiness, gastrointestinal discomfort, nausea, vertigo, and mental confusion may occur. In these cases, it is advisable to reduce the dose. Simultaneous consumption of alcohol during treatment may accentuate the appearance of side effects. Do not consume alcoholic beverages during treatment with this medication.

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

5. Storage of Novag tuss 10 mg/5 ml oral solution

Keep out of the reach and sight of children.

No special storage conditions are required.

Expiration date

Do not use Novag tuss 10 mg/5 ml oral solution after the expiration date that appears on the packaging after "Expiration date". The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or into the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Additional information

Composition of Novag tuss

Each dose unit (5 ml) contains 10 mg of dextromethorphan hydrobromide as the active ingredient.

The other components (excipients) are: Sodium benzoate (E-211), Anhydrous citric acid, Liquid Maltitol (E-965), Sodium saccharin (E-954), propylene glycol, strawberry and orange flavors, purified water.

Appearance of the product and packaging content

It is presented in 125 ml and 200 ml oral solution packages, including a double-spoon measuring spoon with measures of 1.25 ml, 2.5 ml, and 5 ml.

Marketing authorization holder and manufacturer

Marketing Authorization Holder:Tarbis Farma, S.L.U. Gran Vía Carlos III, 94 08028 – Barcelona - Spain

Manufacturer:Farmasierra Manufacturing, S.L. Ctra. Irún Km 26,200 28709 San Sebastián de los Reyes – Madrid Spain

This leaflet was approved in October 2019