Leaflet: information for the user

Notus mucolítico 50 mg/ml oral solution

carbocisteína

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

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

3. How to take Notus mucolítico

4. Possible side effects

5. Storage of Notus mucolítico

6. Contents of the pack and additional information

It belongs to the group of medications called mucolítics, which act by reducing the viscosity of mucus, liquefying it and facilitating its elimination.

It is indicated for the relief of excess mucus and phlegm that appears in gripal, catarrah, or common cold processes.

Consult a doctor if it worsens or does not improve after 5 days.

Do not take Notus mucolítico

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

Warnings and precautions

• You may observe an increase in mucus and phlegm during the first few days of treatment, which will decrease over time.
• If you have a stomach ulcer, duodenum, asthma, or any severe respiratory disease, as it may increase airway obstruction.

Children and adolescents

This medication should not be administered to children aged 2 to 12 years.

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

Other medications and Notus Mucolítico

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

Do not take this medication with antitussives or substances that inhibit bronchial secretions, as it may cause a buildup 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 medication.

Follow exactly the administration instructions of the medication contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again if you have any 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 oral solution (1.5 g of carbocisteine).

How to take

This medication is taken orally.

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

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

If you take more Notus mucolítico than you should

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

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

If you forgot to take Notus mucolítico

Do not take a double dose to compensate for the missed doses.

If necessary, take the medication again as indicated in section 3. How to Take Notus Mucolítico.How to Take Notus Mucolítico.

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

During the period of use of carbocisteine, the following adverse 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 Adverse Effects

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

Keepthis medicationout of the sight and reach of children.

Do not store at a temperature above 86°F (30°C).

Do not use this medication after the expiration date that appears 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 drains or in the trash. Dispose of packaging and unused medicines at the SIGREof the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Notus mucolytic

Each milliliter of oral solution contains:

- 50 mg of carbocisteine.

- The other components (excipients) are: sodium saccharin, methyl parahydroxybenzoate (E 218), raspberry flavor, cochineal red, A (Ponceau 4R) (E-124), sodium caramel, sodium hydroxide, purified water, 1N sodium hydroxide solution (to adjust the pH).

Sodium saccharin, sodium caramel, sodium hydroxide, and 1N sodium hydroxide solution contribute 7.38 mg of sodium per milliliter of oral solution.

Appearance of the product and contents of the packaging

200 ml oral solution packaging of cherry red color and 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.

Holder of the marketing authorization

Teva Pharma, S.L.U.

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

28108 Madrid

Spain

Responsible for manufacturing

Laboratórios Basi - Indústria Farmacêutica, S.A

Parque Industrial Manuel Lourenço Ferreira, Lots 15 and 16

3450-232 Mortagua

Portugal

Date of the last review 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/