Normotus Antitussive 2 mg/ml oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Normotus antitussive 2 mg/ml oral solution

dextromethorphan hydrobromide

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 indicated 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 any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.
• You should consult a doctor if your condition worsens, if symptoms are accompanied by high fever, skin rash or persistent headache, or if there is no improvement after 7 days.

Leaflet contents

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

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

Dextromethorphan, the active substance in this medicine, is an antitussive that inhibits the cough reflex.

It is indicated for the symptomatic treatment of dry cough not accompanied by expectoration (irritative cough, nervous cough). For adults and children from 2 years of age.

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 antitussive

Do not take Normotus antitussive:

• If you are allergic to dextromethorphan or to any of the other components of this medicine (listed in section 6).
• Children under 2 years of age must not take this medicine.
• If you have a serious lung disease.
• If you have asthmatic cough.
• If you have a cough accompanied by abundant secretions.
• If you are currently being treated, or have been treated within the previous 2 weeks, with monoamine oxidase inhibitor (MAOI) medicines used to treat depression, Parkinson's disease, or other conditions, as well as other serotonin reuptake inhibitor medicines used to treat depression such as fluoxetine and paroxetine; or also with bupropion, a medicine used to stop smoking, or with linezolid, an antibacterial medicine. (See section: Interaction of Normotus antitussive with other medicines).

Warnings and precautions:

Talk to your doctor or pharmacist before taking Normotus antitussive if:

• You are a patient with persistent or chronic cough, such as that caused by smoking. In children especially, chronic cough may be an early sign of asthma.
• You have liver disease.
• You have 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).
• You are sedated, weakened, or bedridden.

Cases of abuse have been reported with medicines containing dextromethorphan in adolescents; therefore, this possibility should be considered, as serious adverse effects may occur (see section: If you take more Normotus antitussive than you should).

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

Interaction of Normotus antitussive with other medicines:

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.

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

• Monoamine oxidase inhibitor (MAOI) antidepressants (moclobemide, tranylcypromine).
• Serotonin reuptake inhibitor antidepressants (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).

Before taking this medicine, consult your doctor if you are taking any of the following medicines, as it may be necessary to adjust the dose or discontinue treatment:

• Amiodarone and quinidine (used to treat heart arrhythmias).
• Anti-inflammatory medicines (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 phlegm and mucus).

Talk to your doctor or pharmacist before taking Normotus antitussive:

• If you are taking other medicines such as antidepressants or antipsychotics, Normotus antitussive may interact with these medicines and you may experience changes in mental status (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).

Interaction of Normotus antitussive with food, drinks, and alcohol:

Do not consume alcoholic beverages during treatment, as this may cause adverse effects.

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

Pregnancy and breastfeeding

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

Pregnant or breastfeeding women should not take this medicine without first consulting their doctor.

Driving and use of machines

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

Normotus antitussive contains maltitol, sodium benzoate, propylene glycol, glucose, and benzyl alcohol

Normotus antitussive 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 medicine.

Normotus antitussive contains 1 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).

Normotus antitussive contains 26.02 mg of propylene glycol per millilitre.

If the baby is less than 4 weeks old, consult your doctor or pharmacist, especially if the baby has been given other medicines containing propylene glycol or alcohol.

Normotus antitussive contains glucose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine. It may cause dental caries.

Normotus antitussive contains 0.00012 mg of benzyl alcohol per ml.

Benzyl alcohol may cause allergic reactions.

Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Benzyl alcohol has been associated with the risk of serious adverse effects, including breathing problems ("gasping syndrome") in children.

Do not administer this medicine to your newborn (up to 4 weeks of age) unless recommended by your doctor.

This medicine should not be used for longer than one week in children under 3 years of age unless directed by your doctor or pharmacist.

Normotus antitussive contains less than 23 mg of sodium (1 mmol) per millilitre; thus, it is essentially “sodium-free”.

3. How to take Normotus antitussive

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

The recommended dose is:

Adults and adolescents aged 12 years and over: Take 5 to 10 ml, depending on the severity of the cough, every 4 hours if necessary. Do not exceed 6 doses in 24 hours.

If necessary, 15 ml may be taken every 6 or 8 hours as needed.

The maximum amount that can be taken in 24 hours is 60 ml, divided into several doses.

Use in children

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

Children aged 6–11 years: Take 2.5 to 5 ml, depending on the severity of the cough, every 4 hours if necessary. Do not exceed 6 doses in 24 hours.

Alternatively, 7.5 ml may be taken every 6 or 8 hours if needed.

The maximum amount that can be taken in 24 hours is 30 ml, divided into several doses.

Children aged 2–5 years: Take 1.25 to 2.5 ml, depending on the severity of the cough, every 4 hours if necessary. Do not exceed 6 doses in 24 hours.

Alternatively, 3.75 ml may be taken every 6–8 hours if needed.

The maximum amount that can be taken in 24 hours is 15 ml, divided into several doses.

Children under 2 years of age:

This medicine is contraindicated in children under 2 years of age.

How to take

Normotus antitussive is taken orally.

Measure the required amount of medicine using the dosing device provided in the package. Drink directly from the dosing device. After each dose, wash the dosing device.

It can be taken with or without food.

Do not take with grapefruit juice or bitter orange juice, or with alcoholic beverages (see section on interaction of Normotus antitussive with food, drinks, and alcohol).

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

If you take more Normotus antitussive than you should:

If you take more Normotus antitussive than recommended, you may experience the following symptoms: nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, disturbances of consciousness, involuntary and rapid 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 breathing difficulties, and seizures.

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

Taking very high amounts of this medicine may cause children to become drowsy, restless, nauseous, vomit, or experience disturbances in gait.

Cases of abuse have been reported with medications containing dextromethorphan, which may lead 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 and uncontrollable eye movements), 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, contact your doctor or call the Toxicology Information Service (telephone: 91 562 0420), indicating the medicine and the amount ingested.

If you forget to take Normotus antitussive:

If you forget to take Normotus antitussive, do not take a double dose to make up for the missed dose. If symptoms persist, resume taking the medicine as indicated in section 3. How to take Normotus antitussive.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Normotus antitussive may cause adverse effects, although not everybody will experience them.

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

• In some cases: somnolence, dizziness, vertigo, constipation, gastrointestinal discomfort, nausea, vomiting.
• In rarer cases: mental confusion and headache.

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

5. Storage of Normotus antitussive

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

No special storage conditions are required.

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 empty containers and unused medicines at the SIGRE collection point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Normotus antitussive

• The active substance is dextromethorphan hydrobromide. Each millilitre contains 2 mg of dextromethorphan hydrobromide.

• The other components (excipients) are: sodium benzoate (E-211), citric acid, maltitol liquid (E-965), sodium saccharin (E-954), propylene glycol (E-1520), strawberry flavour (containing glucose and benzyl alcohol), contramarum flavour, and purified water.

Appearance of the product and contents of the container:

Normotus antitussive is a colourless oral solution.

It is available in containers containing 125 ml or 200 ml of solution, with a dosing device marked for: 1.25, 2.5 and 5 ml.

Marketing Authorization Holder and Manufacturer:

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos-Madrid (SPAIN)

Date of the most recent review of this leaflet: January 2023

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