NOTUS MUCOLYTIC 50 mg/ml ORAL SOLUTION

Introduction

Leaflet: information for the user

Notus mucolytic 50 mg/ml oral solution

carbocisteine

Contents of the leaflet

1. What is Notus mucolytic and what is it used for
2. What you need to know before taking Notus mucolytic
3. How to take Notus mucolytic 4. Possible side effects
4. Storage of Notus mucolytic
5. Package contents and additional information

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

It belongs to the group of medicines called mucolytics, which act by decreasing the viscosity of mucus, making it more fluid and facilitating its elimination.

It is indicated for the relief of excess mucus and phlegm that appear in grippe, catarrhal, or common cold processes.

You should consult a doctor if it worsens or does not improve after 5 days.

2. What you need to know before taking Notus Mucolytic

Do not take Notus mucolytic

• If you are allergic (hypersensitive) to carbocisteine and its derivatives, or to any of the other components of this medicine (included in section 6).

Warnings and precautions

• During the first days of treatment, you may observe an increase in mucus and phlegm that will decrease throughout the treatment.
• If you have stomach ulcers, duodenal ulcers, asthma, or any severe respiratory disease, as it may increase respiratory tract obstruction.

Children and adolescents

This medicine should not be administered to children between 2 and 12 years old.

Notus mucolytic 50 mg/ml oral solution is contraindicated in children under 2 years due to safety concerns.

Other medicines and Notus Mucolytic

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

Do not take this medicine with antitussives or substances that inhibit bronchial secretions, as it may cause an accumulation of fluidified mucus.

Pregnancy, breastfeeding, and fertility

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

3. How to take Notus Mucolytic

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again if you have doubts.

The normal dose is:

Adults and children over 12 years old

15 ml of oral solution measured with the measuring cup (750 mg of carbocisteine), 3 times a day.

Do not take more than 45 ml (3 measuring cups) in 24 hours.

Once you observe improvement, you can reduce the dose to 10 ml of oral solution (500 mg of carbocisteine) 3 times a day, equivalent to a maximum daily dose of 30 ml of the oral solution (1.5 mg of carbocisteine).

How to take

This medicine is taken orally.

It is recommended to drink a glass of water after each dose and a large amount of liquid throughout the day.

If it worsens, or if it does not improve after 5 days of treatment, or if fever, skin rash, persistent headache, or sore throat occurs, you should consult your doctor.

If you take more Notus mucolytic than you should

If you have taken more than you should, you may notice stomach pain, nausea, and diarrhea, itching, and skin rash.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 915 62 04 20, indicating the medicine and the amount taken.

If you forget to take Notus mucolytic

Do not take a double dose to make up for forgotten doses.

If necessary, take the medicine again as indicated in section 3. How to take Notus Mucolytic.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

During the use of carbocisteine, the following side effects have been observed:

Rare (may affect up to 1 in 1,000 people): Nausea, diarrhea

Very rare (may affect up to 1 in 10,000 people): Abdominal pain and allergic reactions such as rash, urticaria, and itching.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Notus Mucolytic

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

Do not store above 30°C.

Do not use this medicine after the expiration date shown on the packaging after the abbreviation CAD. The expiration date is the last day of the month indicated.

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

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need in the pharmacy's SIGRE. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Notus mucolytic

Each ml of oral solution contains:

• 50 mg of carbocisteine.
• The other components (excipients) are: sodium saccharin, methylparaben (E 218), raspberry flavor, red cochineal A (Ponceau 4R) (E-124), sodium carmellose, sodium hydroxide, purified water, sodium hydroxide solution 1N (to adjust the pH).

Sodium saccharin, sodium carmellose, sodium hydroxide, and sodium hydroxide solution 1N provide 7.38 mg of sodium per ml of oral solution.

Appearance of the product and package contents

200 ml package of red cherry-colored oral solution with a raspberry flavor, accompanied by a measuring cup with markings at 2.5 ml, 5 ml, 7.5 ml, 10 ml, 15 ml, and 20 ml.

Marketing authorization holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1ª planta, Alcobendas

28108 Madrid

Spain

Manufacturer

Laboratórios Basi - Indústria Farmacêutica, S.A

Parque Industrial Manuel Lourenço Ferreira, Lotes 15 e 16

3450-232 Mortagua

Portugal

Date of the last revision of this leaflet:January 2022

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/