Notus Antitussive and Expectorant 2 mg/ml + 20 mg/ml oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Notus Antitussive and 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 administration 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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.
• You should consult your doctor if you worsen or do not improve after 7 days of treatment.

Leaflet contents

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

1. What Notus Cough Suppressant and 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 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 starting to take Notus Antitussive and Expectorant

Do not take Notus Antitussive and Expectorant

• If you are allergic (hypersensitive) to guaifenesin or dextromethorphan hydrobromide, or to any of the other components of this medicine
• Children under 2 years of age
• 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 a monoamine oxidase inhibitor (MAOI) medicine used to treat depression or Parkinson's disease or other conditions (see section on use with other medicines)

If you have fructose intolerance (see section Important information about some of the components of Notus Antitussive and Expectorant).

Warnings and precautions

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

Consult your doctor or pharmacist before taking Notus Antitussive and Expectorant:

• If you are taking other medicines such as antidepressants or antipsychotics, Notus Antitussive and 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 should consult a doctor before using this medicine if they have:

• Liver disease
• 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).

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 in adolescents. This may lead to serious adverse effects (see section If you take more Notus Antitussive and Expectorant than you should).

Interference with laboratory tests

If you are scheduled to undergo any laboratory 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.

Taking Notus Antitussive and Expectorant with other medicines

Inform your doctor or pharmacist if you are currently taking, or have recently taken, any other medicines, including those obtained without a prescription.

Please note that these instructions may also apply to medicines that have been used previously or may be used in the future.

Do not take this medicine during treatment with, or within 2 weeks after treatment with, the following medicines, as it may cause excitation, 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 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)
• Sibutramine (used to treat obesity)

If you are taking any of the following medicines, it may be necessary to adjust the dose or interrupt 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)
• Haloperidol (an antipsychotic)

Taking Notus Antitussive and Expectorant with food and drinks:

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

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

Pregnancy and breastfeeding and fertility:

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 women and those who are breastfeeding should not take this medicine without consulting their doctor.

Driving and using machines:

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

Notus Antitussive and Expectorant contains aspartame, sorbitol, sodium benzoate, and sodium

This medicine contains 7 mg of aspartame per milliliter.

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 eliminate it properly.

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

This medicine contains 3 mg of sodium benzoate per milliliter.

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

3. How to take Notus Antitussive and Expectorant

Follow exactly the instructions for use provided in this leaflet or as directed 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 provided in the package every 6 hours. If necessary, it may be taken every 4 hours. If this is not sufficient, 10 ml may 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.

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 to 12 years: Take 2.5 ml measured with the dosing cup provided in the package every 6 hours. If necessary, it may be taken every 4 hours. If this is not sufficient, 5 ml may 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 aged 2 to 6 years: Children under 6 years of age must not take this medicine.

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

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

How to take

This medicine is for oral use.

Use the dosing cup to measure the exact dose.

It is recommended to drink a glass of water after each dose and plenty of fluids 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 Notus Antitussive and Expectorant with food and drinks").

If symptoms worsen, persist for more than 7 days, or if during treatment you develop skin rashes, high fever, or persistent headache, you must stop treatment and consult your doctor.

If you take more Notus Antitussive and Expectorant than you should:

If you take more Notus Antitussive and Expectorant 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 hospital immediately if you experience any of the symptoms listed above.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Notus Antitussive and Expectorant:

If you forget to take Notus Antitussive and Expectorant and symptoms persist, do not take a double dose to make up for the missed dose. If necessary, resume taking it as indicated in section 3. How to take Notus Antitussive and Expectorant.

4. Possible adverse effects

Like all medicines, Notus Antitussive and Expectorant may produce adverse effects, although not everyone will experience them.

During the period of use of dextromethorphan and guaifenesin, the following adverse effects have been observed, whose frequency could not be established accurately:

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

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 Notus Antitussive and Expectorant

Keep out of the sight and reach of children.

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

No special storage conditions are required.

After opening the container, the product should not be used beyond 12 months.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Notus Antitussive and Expectorant

Each ml of oral solution contains:

• Active substances: 2 mg of dextromethorphan hydrobromide and 20 mg of guaifenesin.
• Other components (excipients): sorbitol (E-420), povidone, sodium benzoate (E-211), anhydrous citric acid, strawberry flavour, purified water and aspartame (E-951).

Description of the product and contents of the container

125 ml and 200 ml bottles of yellow, transparent oral solution with a strawberry flavour, supplied with a measuring cup marked at 1 ml, 2.5 ml, 5 ml, 10 ml, 7.5 ml and 15 ml.

Only certain pack sizes may be commercially available.

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

Laboratorios Alcalá Farma, S.L.

Avenida de Madrid, 82

Alcalá de Henares, 28802 (Madrid), Spain

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

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