Normotus Expectorante 2 mg/ml + 20 mg/ml oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Normotus Expectorant 2 mg/ml + 20 mg/ml oral solution

Dextromethorphan hydrobromide / Guaifenesin

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

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your doctor or pharmacist, even if these are effects not listed in this leaflet. See section 4.
• You should consult your doctor if your condition worsens, or if you also develop high fever, skin rash, persistent headache, or if you do not improve after 7 days of treatment.

Leaflet contents

1. What Normotus Expectorant is and what it is used for
2. What you need to know before taking Normotus Expectorant
3. How to take Normotus Expectorant
4. Possible side effects
5. How to store Normotus Expectorant
6. Contents of the pack and other information

1. What Normotus Expectorant is and what it is used for

It is a medicine containing dextromethorphan hydrobromide, which is a cough suppressant, and guaifenesin, which is an expectorant.

It is indicated for the relief of cough and to help loosen and expel excess mucus and phlegm in colds and flu in adults and children aged 6 years and older.

You should consult a doctor if symptoms worsen or do not improve after 7 days of treatment.

2. What you need to know before taking Normotus Expectorant

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

Do not take Normotus Expectorant:

• If you are allergic to guaifenesin or dextromethorphan hydrobromide or to any of the other ingredients of this medicine (listed in section 6).
• If you have asthma.
• If you have a cough with a large amount of mucus and phlegm.
• If you have a serious lung disease.
• If you are currently being treated or have been treated within the previous 2 weeks with monoamine oxidase inhibitors (MAOIs) used to treat depression, Parkinson's disease, or other conditions (see section “Other medicines and Normotus Expectorant”).

Warnings and precautions

Talk to your doctor or pharmacist before taking Normotus Expectorant if you are a patient:

• With liver disease.
• With atopic dermatitis (an inflammatory skin disease characterized by erythema, itching, exudation, crusting, and scaling, which begins in childhood in individuals with a hereditary predisposition to allergy).
• If you are taking other medicines such as antidepressants or antipsychotics, Normotus Expectorant 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).

Patients with persistent or chronic cough, such as that due to smoking, or who are sedated, weakened, or bedridden should not take this medicine.

Cases of abuse of medicines containing dextromethorphan have been reported, particularly among adolescents. This may lead to serious adverse effects (see section “If you take more Normotus Expectorant than you should”).

Interference with diagnostic tests

If you are scheduled to undergo any diagnostic tests (including blood and urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter test results.

Children and adolescents

This medicine is contraindicated in children under 2 years of age. Children aged 2–6 years should not take this medicine.

Other medicines and Normotus Expectorant

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Note that these instructions may also apply to medicines taken previously or that may be taken in the future.

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

• Medicines used to treat depression such as monoamine oxidase inhibitors (MAOIs) (moclobemide, tranylcypromine) and serotonin reuptake inhibitors (paroxetine, fluoxetine).
• Bupropion (used to stop smoking).
• Linezolid (used as an antibacterial agent).
• Procarbazine (used to treat cancer).
• Selegiline (used to treat Parkinson's disease).

If you are taking any of the following medicines, it may be necessary to adjust the dose or discontinue treatment:

• Amiodarone and quinidine (used to treat heart arrhythmias).
• Anti-inflammatory drugs (celecoxib, parecoxib, or valdecoxib).
• Central nervous system depressants (some of which are used to treat: mental disorders, allergies, Parkinson's disease, etc.).
• Expectorants and mucolytics (used to eliminate mucus and phlegm).
• Haloperidol (an antipsychotic).

Taking Normotus Expectorant with food, drinks, and alcohol

Do not consume alcoholic beverages during treatment with this medicine, as it may cause adverse reactions.

Do not take this medicine together with grapefruit juice or bitter orange juice, as they may increase the adverse effects of this medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

Driving and using machines

Rarely, drowsiness and mild dizziness may occur during treatment with this medicine. If you experience these symptoms, you should not drive or operate dangerous machinery.

Normotus Expectorant contains sodium, sodium benzoate, sorbitol, aspartame, and ethanol

This medicine contains less than 1 mmol of sodium (23 mg) per millilitre; therefore, it is essentially “sodium-free”.

This medicine contains 3.50 mg of sodium benzoate per millilitre.

Sodium benzoate may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

This medicine contains 400 mg of sorbitol per ml. Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

This medicine contains 4 mg of aspartame per ml. Aspartame contains a source of phenylalanine, which may be harmful in individuals with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

This medicine contains 0.99 mg of alcohol (ethanol) per millilitre, equivalent to 0.1% w/v. The amount in ml of this medicine is equivalent to less than 0.025 ml of beer or 0.010 ml of wine.

The small amount of alcohol contained in this medicine does not produce any noticeable effect.

3. How to take Normotus Expectorant

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults and adolescents aged 12 years and older: 5 ml or 10 ml every 4–6 hours as needed. Maximum dose: 60 ml / 24 hours.

Use in children

Children aged 6 to 12 years: 2.5 ml or 5 ml every 4–6 hours as needed. Maximum dose: 30 ml / 24 hours.

Serious adverse effects may occur in children in case of overdose, including neurological disturbances. Caregivers must not exceed the recommended dose.

Children aged 2 to 6 years: Other formulations are more suitable for this population. Administration should only occur under medical supervision due to the risk of paradoxical central nervous system (CNS) stimulation.

Children under 2 years of age: Contraindicated.

Patients with liver disease: The dose should be reduced by half the recommended amount for each population group, and must not exceed 4 doses per day under any circumstances.

This medicine is for oral use.

How to take:

Measure the required dose using the dosing cup provided with the bottle. After use, wash the dosing cup.

It is recommended to drink a glass of water after each dose and to maintain adequate fluid intake throughout the day. This medicine may be taken with or without food.

Do not take with grapefruit juice or bitter orange juice, or with alcoholic beverages (see section “Taking Normotus Expectorant with food, drinks and alcohol”).

Consult a doctor if symptoms worsen, or if you also experience high fever, skin rash, persistent headache, or if there is no improvement after 7 days of treatment.

If you take more Normotus Expectorant than you should

If you have taken more Normotus Expectorant than recommended, you may experience: confusion, excitability, restlessness, nervousness, irritability, nausea and vomiting.

Taking very high doses of this medicine may cause drowsiness, nervousness, nausea, vomiting, or unsteady gait in children.

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

If you take more Normotus Expectorant than indicated, you may experience the following symptoms: nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, disturbances in consciousness, involuntary and rapid eye movements, cardiac disorders (increased heart rate), coordination problems, psychosis with visual hallucinations, and hyperexcitability.

Other symptoms in cases of massive overdose may include coma, severe breathing difficulties, and seizures.

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

In case of overdose or accidental ingestion, contact your doctor or call the Toxicology Information Service (telephone: 91.5620420), indicating the name of the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

The following adverse effects have been observed during the period of use of dextromethorphan and guaifenesin, although their frequency cannot be precisely determined:

• In some cases: drowsiness, dizziness, vertigo, constipation, gastrointestinal discomfort, nausea, vomiting, headache, and skin itching (urticaria).
• In rarer cases: mental confusion.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Normotus Expectorant

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

No special storage conditions are required.

After opening the container, do not use beyond 12 months.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Normotus Expectorant

Each ml contains 2 mg of dextromethorphan hydrobromide and 20 mg of guaifenesin as active substances.

The other components (excipients) are: sodium benzoate (E-211), citric acid monohydrate, sorbitol (E-420), sodium saccharin, aspartame (E-951), povidone, orange flavour (containing ethanol), and purified water.

Appearance of the product and contents of the pack

Normotus Expectorant is a slightly coloured, transparent aqueous solution with an orange flavour.

The medicine is supplied in amber polyethylene terephthalate (PET) bottles with aluminium caps, containing 200 ml of oral solution.

Each pack includes a 15 ml dosing cup, marked with the following measurements: 1 ml, 2.5 ml, 5 ml, 7.5 ml, 10 ml and 15 ml.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 - 28760 Tres Cantos - Madrid (SPAIN)

Date of the most recent revision of this leaflet: July 2023

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