Novag Tuss 10 mg/5 ml oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Novag tuss 10 mg/5 ml oral solution

Dextromethorphan hydrobromide

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

This medicine can be purchased without a prescription. However, to achieve the best results, it must be used correctly.

• 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 beyond 7 days, or if they are accompanied by high fever, skin rash, or persistent headache, you should consult a doctor.
• If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What Novag tuss 10 mg/5 ml oral solution is and what it is 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. How to store Novag tuss 10 mg/5 ml oral solution
6. Further information

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

Dextromethorphan is an antitussive (a medicine for cough). This medicine is indicated for the symptomatic relief of all forms of cough that are not accompanied by sputum production (irritant 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 insufficiency
• 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 medicines”).

Take special care 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 (pulmonary distension), or when cough is accompanied by abundant secretions, you should consult your doctor

• if you have any liver disease, consult your doctor before taking this medicine, as the dose should be reduced.

• Cases of abuse of medications containing dextromethorphan in adolescents have been reported; therefore, this possibility should be considered, as it may lead to serious adverse effects (see section “If you take more Novag tuss 10 mg/5 ml oral solution than you should”).

Use of other medicines

Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

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

Novag tuss 10 mg/5 ml oral solution must not be taken together with:

• Quinidine, used for heart arrhythmias.

It should also not be used together with the following medicines, or within 2 weeks after stopping treatment with any of them:

• Antidepressants (monoamine oxidase inhibitors, such as moclobemide)
• Furazolidone, isoniazid and linezolid, used for infections
• Pargyline, used for 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 medicines, consult your doctor or pharmacist before taking this medicine.

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

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

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

Alcoholic beverages must not be consumed during treatment with this medicine (see section 4. POSSIBLE ADVERSE EFFECTS).

Use in children

Do not administer to children under 2 years of age.

Pregnancy

Consult your doctor or pharmacist before using any medicine.

Important for women:

If you are pregnant or think you might be pregnant, consult your doctor before taking this medicine. Taking medicines during pregnancy may be dangerous for the embryo or fetus, and must be monitored by your doctor.

Breast-feeding

Consult your doctor or pharmacist before using any medicine. Women who are breast-feeding should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

During treatment with Novag tuss 10 mg/5 ml oral solution, a reduced reaction capacity or drowsiness may rarely occur; this should be taken into account when driving or operating dangerous machinery.

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

This medicine contains liquid maltitol (E-965). If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine. It may have a mild 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 medicine is taken orally. For accurate dosing, a double-ended spoon is included with measurements of 1.25 ml, 2.5 ml, and 5 ml. Wash the measuring spoon after each use.

The usual dose is:

Adults and children over 12 years of age: The usual dose is 1 to 2 teaspoons of 5 ml every 4–8 hours. Do not exceed 60 ml per day, equivalent to 12 teaspoons of 5 ml.

Children 6 to 12 years of age: The usual dose is 1 teaspoon of 2.5 ml to 1 teaspoon of 5 ml every 4–8 hours. Do not exceed 30 ml per day, equivalent to 6 teaspoons of 5 ml.

Children 2 to 6 years of age: The usual dose is 1.25 ml (one measure) to 1 teaspoon of 2.5 ml every 4–8 hours. Do not exceed 15 ml per day, equivalent to 6 teaspoons of 2.5 ml.

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

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 10 mg/5 ml oral solution than you should

Signs of overdose include confusion, excitability, restlessness, nervousness, and irritability. Accidental ingestion of very high doses may cause drowsiness or gait disturbances in children.

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

If you take more Novag tuss 10 mg/5 ml oral solution than recommended, you may experience the following symptoms: nausea and vomiting, involuntary muscle contractions, agitation, confusion, somnolence, disturbances in consciousness, involuntary and rapid eye movements, cardiac disorders (increased heart rate), coordination problems, psychosis with visual hallucinations, and hyperexcitability.

Other symptoms in case of massive overdose may include coma, severe breathing problems, and seizures.

Contact your doctor or go to the hospital immediately if you experience any of the symptoms listed above.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service at 91-5620420, indicating the medicine 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 missed doses.

4. Possible adverse effects

Like all medicines, Novag tuss 10 mg/5 ml oral solution may cause adverse effects, although not everyone experiences them.

Rarely (in less than 1 in 1,000 patients but more than 1 in 10,000 patients), somnolence, gastrointestinal discomfort, nausea, dizziness, and mental confusion may occur. In such cases, dose reduction is advisable. Concurrent consumption of alcohol during treatment may intensify the occurrence of adverse effects. Do not consume alcoholic beverages during treatment with this medicine.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed 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.

Expiry

Do not use Novag tuss 10 mg/5 ml oral solution after the expiry date stated on the packaging after Exp. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Information for the user

Composition of Novag tuss

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

The other components (excipients) are: Sodium benzoate (E-211), anhydrous citric acid, maltitol liquid (E-965), sodium saccharin (E-954), propylene glycol, strawberry and contramarum flavours, purified water.

Appearance of the medicine and contents of the pack

The product is presented in 125 ml and 200 ml bottles of oral solution, including a double-ended spoon with markings for 1.25 ml, 2.5 ml and 5 ml doses.

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

Edefarm, S.L.

Polígono Industrial Enchilagar del Rullo, 117, Villamarchante,

46191 Valencia

Spain

This leaflet was last approved in October 2019