Notus Antitussive 2 mg/ml oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Notus 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 taking this medicine as described in this leaflet or as advised 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 effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens, or if you develop high fever, skin rash, persistent headache, or if there is no improvement after 7 days of treatment.

Contents of the leaflet

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

1. What Notus Antitussive is and what it is used for

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

It is indicated for the symptomatic treatment of dry cough (non-productive cough, irritative cough, nervous cough) in adults and children over 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 Notus Antitussive

Do not take Notus Antitussive:

• If you are allergic (hypersensitive) 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 severe lung disease
• If you have asthmatic cough
• If you have a cough accompanied by abundant secretions
• If you are currently taking or have taken within the previous 2 weeks any monoamine oxidase inhibitor (MAOI) medicine used to treat depression, Parkinson's disease, or other conditions, as well as other serotonin reuptake inhibitors used to treat depression such as fluoxetine and paroxetine; or also with bupropion, which is a medicine used to stop smoking, or with linezolid, which is an antibacterial medicine (see section on use of other medicines).

Warnings and precautions

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

Consult your doctor or pharmacist before starting to take Notus Antitussive:

• If you are taking other medicines such as antidepressants or antipsychotics, Notus Antitussive 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).

Consult your doctor or pharmacist before starting to take Notus Antitussive if you are a patient:

• With persistent or chronic cough, such as that due to smoking. Especially in children, chronic cough could be an early symptom of asthma.
• With liver disease
• With atopic dermatitis (an inflammatory skin disease characterized by erythema, itching, exudation, crusts, and scaling, which begins in childhood in individuals with hereditary predisposition to allergy)
• Who is sedated, weakened, or bedridden.

Cases of abuse of medicines containing dextromethorphan have been reported in adolescents; therefore, this possibility should be taken into account, as serious adverse effects may occur (see section: If you take more Notus Antitussive than you should).

Taking Notus Antitussive with other medicines

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

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

• Monoamine oxidase inhibitor (MAOI) antidepressants (moclobemide, tranilcypramine)
• Serotonin reuptake inhibitor antidepressants (paroxetine, fluoxetine)
• Bupropion (used to stop smoking)
• Linezolid (used as an antibacterial)
• Procarbazine (used to treat cancer)
• Selegiline (used to treat Parkinson's disease)

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

• Amiodarone and quinidine (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 phlegm and mucus).

Taking Notus 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.

Other foods and drinks do not affect the effectiveness of the medicine.

Pregnancy and breastfeeding

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

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

Driving and use of machines

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

This medicine contains maltitol (E-965)

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains propylene glycol

This medicine contains 25.9 mg of propylene glycol per millilitre.

If the child is under 5 years of age, consult your doctor or pharmacist, particularly if other medicines containing propylene glycol or alcohol have been administered.

If you are pregnant or breastfeeding, do not take this medicine unless recommended by your doctor. Your doctor may perform additional monitoring while you are taking this medicine.

If you have hepatic or renal impairment, do not take this medicine unless prescribed by your doctor. Your doctor may perform additional monitoring while you are taking this medicine.

This medicine contains sodium

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

This medicine contains sodium benzoate

This medicine contains 1 mg of sodium benzoate (E211) per millilitre.

3. How to take Notus Antitussive

Follow exactly the instructions for use provided in this leaflet or those indicated 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 5–10 ml, depending on the severity of cough, every 4 hours if necessary. Do not exceed 6 doses in 24 hours.

Alternatively, 15 ml may be taken every 6 or 8 hours if necessary.

The maximum daily dose is 120 mg, divided into several doses.

Always use the lowest effective dose.

Use in children and adolescents

Paediatric population

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 2.5–5 ml, depending on the severity of 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 necessary.

The maximum daily dose is 60 mg, divided into several doses.

Children aged 2–5 years: Under medical supervision, take 1.25–2.5 ml, depending on the severity of 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 necessary.

The maximum daily dose is 30 mg, divided into several doses.

Children under 2 years of age:

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

How to take it

The medicine is taken orally.

Measure the required dose using the dosing spoon provided in the package. A measuring spoon with markings for 1.25, 2.5, and 5 ml is included for accurate dosing.

Rinse the spoon after each use.

Do not take with grapefruit juice or bitter orange juice, or with alcoholic beverages.

Concomitant intake of this medicine with other foods or drinks does not affect its efficacy.

If symptoms worsen, or if cough persists for more than 7 days, or if it is accompanied by high fever, skin rash, or persistent headache, consult your doctor.

If you take more Notus Antitussive than you should

If you take more Notus Antitussive than recommended, you may experience the following symptoms: nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, disturbances of consciousness, rapid and involuntary 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 respiratory problems, 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, consult 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 have adverse effects, although not everyone experiences them.

During the period of use of dextromethorphan, the following adverse effects have been observed, whose frequency cannot be established with accuracy:

? In some cases: somnolence, dizziness, vertigo, constipation, gastrointestinal discomfort,
nausea, vomiting

? More rarely: mental confusion and headache.

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 Notus Antitussive

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

Store in the original container. Do not freeze. Protect from light.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to 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 Notus Antitussive

• The active substance is dextromethorphan hydrobromide. Each ml of solution contains 2

milligrams of dextromethorphan as the active substance.

• The other components (excipients) are sodium benzoate (E-211), anhydrous citric acid,

maltitol (E-965), sodium saccharin, propylene glycol, strawberry and contramarum flavors, purified water, q.s.

Appearance of the product and contents of the container

Topaz-colored PET bottle closed with a high-density polyethylene cap, containing 125 ml or 200 ml of solution.

Includes a measuring spoon with markings for 1.25, 2.5, and 5 ml.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Teva Pharma S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid (Spain)

Manufacturer:

Teva Pharma S.L.U.

C/C, n 4 Polígono Industrial Malpica

50016 Zaragoza (Spain)

or

FARMASIERRA MANUFACTURING S.L.

Ctra. Irún, km 26.200

28700 San Sebastián de los Reyes (Madrid), Spain

or

Edefarm, S.L.

Polígono Industrial Enchilagar del Rullo, 117

4691 Villamarchante, Valencia, Spain

or

Farmalider, S.A.

C/ Aragoneses 2, 28108 Alcobendas, Madrid, Spain

Date of the most recent review of this text: January 2022

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.es/