Leaflet: information for the user

Novag tuss 10 mg/5 ml oral solution

Dextromethorphan hydrobromide

Read the entire leaflet carefully as it contains important information for you.

This medicine can be purchased without a prescription. However, for 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 are accompanied by high fever, skin eruptions, or persistent headache, you should consult a doctor.
• If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Dextromethorphan is a cough suppressant (medication for cough). This medication is indicated for the symptomatic relief of all forms of cough not accompanied by expectoration (irritative cough, nervous cough).

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 insufficiency

- If you have asthma cough

- If you have a cough accompanied by expectoration

- If you are being treated with certain antidepressant medications (See section “Use of other medications”).

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

• If you have persistent or chronic cough, such as that due to tobacco, asthma, or emphysema (lung distension), or when the cough is accompanied by abundant secretions, you must consult your doctor
• If you have any liver disease, consult your doctor before taking this medication, as you will need to reduce the dose.

- Cases of abuse with medications containing dextromethorphan in adolescents have been described, therefore this possibility should be taken into account, as it may cause severe adverse effects (see section “If you take more Novag tuss 10 mg/5 ml oral solution than you should”).

Use of other medications

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

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

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, or in the 2 weeks following the end of treatment with any of them:

• Antidepressants (of the type monoamine oxidase inhibitors, 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

Therefore, 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, high blood pressure, and exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).

Administration of Novag tuss 10 mg/5 ml oral solution with food and beverages

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

Use in children

Do not administer to children under 2 years.

Pregnancy

Consult your doctor or pharmacist before using any medication.

Lactation

Consult your doctor or pharmacist before using any medication. Women who are breastfeeding should consult their doctor or pharmacist before taking this medication.

Driving and operating machinery

During treatment with Novag tuss 10 mg/5 ml oral solution, a decrease in reaction time or drowsiness may 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 Maltitol liquid (E-965). If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication. It may have a mild laxative effect.

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 proper dosing, a double-ended spoon with measurements 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 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 to 6 years:The usual dose is 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. Use the smallest effective dose. If symptoms worsen or persist after 7 days of treatment, or if accompanied by high fever, skin eruptions, or persistent headache, consult your doctor. If you estimate that the action of Novag tuss 10 mg/5 ml oral solution is too strong or too weak, inform your doctor or pharmacist.

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 10 mg/5 ml oral solution than you should

The signs of overdose manifest with confusion, excitement, restlessness, nervousness, and irritability. Accidental ingestion of very high doses may cause children to become drowsy or experience gait disturbances.

Cases of abuse with dextromethorphan-containing medications have been reported in adolescents, potentially leading to severe adverse effects, such as tachycardia, lethargy, hypertension or hypotension, mydriasis, agitation, vertigo, gastrointestinal discomfort, hallucinations, mumbling speech, nystagmus, fever, tachypnea, cerebral damage, ataxia, seizures, respiratory depression, loss of consciousness, arrhythmias, 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, 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 include: coma, severe respiratory problems, and seizures.

Immediately contact your doctor or hospital if you experience any of the mentioned symptoms.

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

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

Do not take a double dose to compensate for the missed doses.

Like all medications, Novag tuss 10 mg/5 ml oral solution may produce adverse effects, although not all people will experience them.

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

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of 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 appearing on the packagingafter Expiration Date. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

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 counter-flavor aromas, Purified water.

Product appearance and packaging contents

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

Marketing authorization holder and responsible manufacturer

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

Responsible 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