Leaflet: information for the user

Notus Antitusivo 2 mg/ml oral solution

Dextromethorphan Hydrobromide

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

Follow exactly the administration instructions for the medicine contained 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet (see section 4).

- You should consult a doctor if you get worse, or if you also have high fever, skin eruptions or persistent headache, or if you do not improve after 7 days of treatment.

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

2. What you need to know before starting to take Notus Antitusivo

3. How to take Notus Antitusivo

4. Possible side effects

5. Storage of Notus Antitusivo

6. Contents of the pack and additional information

The dextromethorphan, active principle of this medication, is an antitussive that inhibits the cough reflex.

It is indicated for the symptomatic treatment of a cough not accompanied by expectoration (irritative cough, nervous cough) in adults and children over 2 years old.

Consult a doctor if it worsens or does not improve after 7 days of treatment.

Do not take Notus Antitusivo:

- If you are allergic (hypersensitive) to dextromethorphan or to any of the other components of this medication (listed in section 6)

- Children under 2 years old cannot take this medication

- If you have a serious lung disease

- If you have asthma cough

- If you have a cough accompanied by abundant secretions

- If you are being treated or have been treated in the last 2 weeks with any monoamine oxidase inhibitor (MAOI) used for the treatment of depression, Parkinson's disease, or other diseases, as well as other medications inhibiting serotonin reuptake used for the treatment of depression such as fluoxetine and paroxetine; or also with bupropion, which is a medication used to quit smoking, or with linezolid, which is an antibacterial medication (See section on use of other medications).

Warnings and precautions

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

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

• If you are taking other medications such as antidepressants or antipsychotics, Notus Antitusivo may interact with these medications and you may experience changes in your mental state (e.g. agitation, hallucinations, coma) and other effects such as high body temperature, increased heart rate, high blood pressure, and exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).

Consult your doctor or pharmacist before starting to take Notus Antitusivo 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 sign of asthma.

- with liver disease

- with atopic dermatitis (inflammatory skin disease characterized by erythema, itching, exudation, crusts, and desquamation, which begins in childhood in individuals with hereditary allergic predisposition)

- who is sedated, weakened, or bedridden.

Cases of abuse with dextromethorphan-containing medications have been reported in adolescents. Therefore, this possibility should be taken into account, as it may lead to severe adverse effects (see section: If you take more Notus Antitusivo than you should).

Notus Antitusivo with other medications

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

Do not take this medication during treatment, or in the 2 weeks following treatment, with the following medications, as it may cause excitement, high blood pressure, and fever above 40°C (hyperpyrexia):

- Monoamine oxidase inhibitors (MAOIs) (moclobemide, tranylcypromine)

- Serotonin reuptake inhibitors (paroxetine, fluoxetine)

- Bupropion (used to quit smoking)

- Linezolid (used as an antibacterial)

- Procarbazine (used to treat cancer)

- Selegiline (used to treat Parkinson's disease)

Before starting to take this medication, consult your doctor if you are using any of the following medications, as it may be necessary to modify the dose of one of them or interrupt treatment:

- Amiodarone and quinidine (to treat heart arrhythmias)

- Anti-inflammatory medications (celecoxib, parecoxib, or valdecoxib)

- Central nervous system depressants (some of which are used to treat mental illnesses, allergies, Parkinson's disease, etc)

- Expectorants and mucolytics (used to eliminate mucus and phlegm).

Notus Antitusivo with food, drinks, and alcohol

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

Do not take this medication with orange or bitter lemon juice, as it may increase the adverse effects of this medication.

The rest of the food and drinks do not affect the efficacy of the medication.

Pregnancy, lactation

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

Driving and operating machinery

In rare cases, during treatment, you may experience mild drowsiness and dizziness. If you notice these symptoms, you should not drive cars or operate hazardous machinery.

This medication contains maltitol (E-965)

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains propylene glycol

This medication contains 25.9 mg of propylene glycol in each milliliter.

If the child is under 5 years old, consult your doctor or pharmacist, especially if other medications containing propylene glycol or alcohol have been administered.

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

If you have liver or kidney insufficiency, do not take this medication unless recommended by your doctor. Your doctor may perform additional checks while you are taking this medication.

This medication contains sodium

This medication contains less than 1 mmol of sodium (23 mg) in each milliliter; it is essentially "sodium-free".

This medication contains sodium benzoate

This medication contains 1 mg of sodium benzoate (E211) in each milliliter.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubts, ask your doctor or pharmacist.

The recommended dose is:

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

Also, 15 ml can be taken every 6 or 8 hours if necessary.

The maximum amount that can be taken in 24 hours is 120 mg divided into several doses.

Always use the smallest effective dose.

Use in children and adolescents

Pediatric population

Severe adverse effects can occur in children in case of overdose, including neurological alterations. Caregivers should not exceed the recommended dose.

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

Also, 7.5 ml can be taken every 6 or 8 hours if necessary.

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

Children 2-5 years:Under medical supervision, take 1.25-2.5 ml, depending on the severity of the cough, every 4 hours if necessary. Do not exceed 6 doses in 24 hours. Also, 3.75 ml can be taken every 6-8 hours if necessary.

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

Children under 2 years:

This medication is contraindicated in children under 2 years.

How to take

The medication is taken orally.

Measure the amount of medication to be taken with the spoon included in the package. For correct dosing, a measuring spoon of 1.25, 2.5, and 5 ml is included.

Wash the spoon after each use.

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

The concomitant intake of this medication with other foods or beverages does not affect its efficacy.

If it worsens, or if the cough persists for more than 7 days, or if it is accompanied by high fever, skin eruptions, or persistent headache, consult a doctor.

If you take more Notus Antitusivo than you should

If you take more Notus Antitusivo 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 be: 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, consult your doctor or call the Toxicological Information Service (phone: 91.5620420), indicating the medication and the amount ingested.

Like all medications, this medication may have adverse effects, although not everyone may experience them.

During the period of use of dextromethorphan, the following adverse effects have been observed, whose frequency has not been established with precision:

?In some cases: drowsiness, dizziness, vertigo, constipation, gastrointestinal discomfort,

nausea, vomiting

?In rare cases: mental confusion and headache.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is about possible adverse effects that do not appear in this leaflet. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

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Composition of Notus Antitusivo

- The active ingredient is dextromethorphan hydrobromide. Each milliliter of solution contains 2 milligrams of dextromethorphan as the active ingredient.

- The other components (excipients) are sodium benzoate (E-211), anhydrous citric acid, maltitol (E-965), sodium saccharin, propylene glycol, strawberry and counter-marum aromas, purified water, c.s

Appearance of the product and contents of the packaging

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

Includes a measuring spoon of 1.25, 2.5, and 5 ml.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization:

Teva Pharma S.L.U.

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

28108 Alcobendas. Madrid (Spain)

Responsible for manufacturing:

Teva Pharma S.L.U

C/C, n 4 Industrial Park Malpica

50016 Zaragoza (Spain)

or

FARMASIERRA MANUFACTURING S.L.

Irún Highway, km.26,200.

28700 San Sebastián de los Reyes (Madrid), Spain

or

Edefarm, S.L.

Industrial Park Enchilagar del Rullo, 117

4691 Villamarchante, Valencia, Spain

or

Farmalider, S.A.

C/ Aragoneses 2, 28108 Alcobendas, Madrid, Spain

Last review date of this text:January 2022

The detailed and updated information of this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/