Leaflet: information for the user

Notus Antitusivo y Expectorante 2 mg/ml + 20 mg/ml oral solution

Dextromethorphan hydrobromide / Guaifenesina

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

Follow exactly the administration instructions of 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.

- You should consult your doctor if you get worse or do not improve after 7 days of treatment.

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

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

3. How to take Notus Antitusivo y Expectorante

4. Possible side effects

5. Storage of Notus Antitusivo y Expectorante

6. Contents of the pack and additional information

It is a medication that contains dextromethorphan hydrobromide which is an antitussive and guaifenesin which is an expectorant.

It is indicated for the relief of cough and to facilitate the expulsion of excess mucus and phlegm in colds and flu for adults and children aged 6 years and above.

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

Do not take Notus Antitusivo y Expectorante

- If you are allergic (hypersensitive) to guaifenesin or to dextromethorphan hydrobromide, or to any of the other components of this medication

- Children under 2 years

- 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 being treated or have been treated in the past 2 weeks with any monoamine oxidase inhibitor (MAOI) medication used to treat depression or Parkinson's disease or other conditions (see the section on use of other medications)

If you have fructose intolerance (see the section on Important information about one of the components of Notus Antitusivo y Expectorante).

Warnings and precautions

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

Consult your doctor or pharmacist before taking Notus Antitusivo y Expectorante:

• If you are taking other medications such as antidepressants or antipsychotics, Notus Antitusivo y Expectorante 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).

Patients should consult their doctor before using this medication:

- 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).

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

Cases of abuse with dextromethorphan-containing medications have been reported in adolescents. This can cause serious adverse effects (see the section If you take more Notus Antitusivo y Expectorante than you should).

Interference with laboratory tests

If you are to undergo any laboratory test (including blood, urine, or skin tests that use allergens, etc.) inform your doctor that you are taking this medication, as it may alter the results.

Children and adolescents

This medication is contraindicated in children under 2 years. Children aged 2-6 years should not take this medication.

Taking Notus Antitusivo y Expectorante with other medications

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

Be aware that these instructions may also apply to medications that have been used before or may be used afterwards.

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):

- Medications used to treat depression such as monoamine oxidase inhibitors (MAOIs) (moclobemide, tranylcypromine) and

- selective 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)

- Sibutramine (used to treat obesity).

If you are taking any of the following medications, you may need to modify the dose of one of them or discontinue treatment:

- Amiodarone and quinidine (used 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).

- Haloperidol (antipsychotic).

Taking Notus Antitusivo y Expectorante with food and drinks:

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

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

Pregnancy and lactation and fertility:

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

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

Driving and operating machinery:

In rare cases, during treatment with this medication, you may experience a decrease in reaction time or mild drowsiness and dizziness, so if you notice these symptoms, you should not drive or operate machinery.

Notus Antitusivo y Expectorante contains aspartame, sorbitol, sodium benzoate, and sodium

This medication contains 7 mg of aspartame per milliliter.

Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

This medication contains 0.0575 mg of sorbitol (E-420) per milliliter.

This medication contains 3 mg of sodium benzoate per milliliter.

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

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is

Adults:take 5 ml measured with the dosing cup included in the box, every 6 hours. If necessary, it could be taken every 4 hours. If not sufficient, 10 ml can be taken every 4-6 hours as needed. In any case, the maximum amount of medication that can be taken in 24 hours is 60 ml divided into at least 6 doses.

Pediatric population

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

Children between 6 and 12 years:Take 2.5 ml measured with the dosing cup included in the box every 6 hours. If necessary, it could be taken every 4 hours. If not sufficient, 5 ml can be taken every 4-6 hours as needed. In any case, the maximum amount of medication that can be taken in 24 hours is 30 ml divided into at least 6 doses.

Children 2-6 years:Children under 6 years must not take this medication.

Children under 2 years:Children under 2 years cannot take this medication, it is contraindicated.

Patients with liver disease:Consult your doctor before taking this medication.

How to take

This medication is taken orally.

Use the dosing cup to measure the exact dose.

It is recommended to drink a glass of water after each dose and abundant liquid during the day.

It can be taken with or without food. Do not take with grapefruit or bitter orange juice or with alcoholic beverages (See Notus Antitusivo and Expectorante with food and drinks section).

If symptoms worsen, if they persist for more than 7 days, or if during treatment you notice skin eruptions, high fever, or persistent headache, discontinue treatment and consult your doctor.

If you take more Notus Antitusivo and Expectorante than you should:

If you take more Notus Antitusivo and Expectorante 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 pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Notus Antitusivo and Expectorante:

If you forgot to take Notus Antitusivo and Expectorante and symptoms continue, do not take a double dose to compensate for the missed dose. If necessary, take it as indicated in the section 3. How to take Notus Antitusivo and Expectorante.

Like all medications, Notus Antitusivo and Expectorante can produce adverse effects, although not all people may experience them.

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

- In some cases, the following have occurred: drowsiness, dizziness, vertigo, constipation, gastrointestinal discomfort, nausea, vomiting, headache, and skin itching (urticaria).

- In rare cases: mental confusion.

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

Keep out of the sight and reach of children.

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.

No special storage conditions are required.

Once the packaging is opened, it should not be used after 12 months.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and unused medicines at the SIGRE of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. In this way, you will help protect the environment.

Composition of Notus Antitusivo and Expectorante

Each milliliter of oral solution contains:

- As active principles: 2 mg of hydrobromide of destromethorphan and 20 mg of guaifenesin.

- The other components (excipients) are: sorbitol (E-420), povidone, sodium benzoate (E-211), anhydrous citric acid, strawberry flavor, purified water, and aspartame (E-951).

Appearance of the product and contents of the packaging

Bottles of 125 and 200 ml of transparent yellow-colored oral solution with strawberry flavor, containing a measuring cup with markings at 1 ml, 2.5 ml, 5 ml, 10 ml, 7.5 ml, and 15 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

Laboratorios Alcalá Farma, S.L.

Avenida de Madrid, 82

Alcalá de Henares, 28802 (Madrid) Spain

Last review date of this leaflet: January 2022

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