Notus Mucolítico 50 mg/ml oral solution
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Notus mucolytic 50 mg/ml oral solution
carbocisteine
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you. Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.
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Package leaflet
- What Notus mucolytic is and what it is used for
- What you need to know before taking Notus mucolytic
- How to take Notus mucolytic
- Possible side effects
- Storage of Notus mucolytic
- Contents of the pack and other information
1. What Notus Mucolytic is and what it is used for
It belongs to a group of medicines called mucolytics, which work by reducing the viscosity of mucus, making it more fluid and facilitating its elimination.
It is indicated for the relief of excess mucus and phlegm occurring in flu-like conditions, catarrh, or the common cold.
You should consult a doctor if symptoms worsen or do not improve after 5 days.
2. What you need to know before starting to take Notus Mucolytic
Do not take Notus Mucolytic
- If you are allergic (hypersensitive) to carbocysteine and its derivatives, or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
- During the first days of treatment, you may notice an increase in mucus and phlegm, which will gradually decrease during the course of treatment.
- If you have a stomach or duodenal ulcer, asthma, or any other serious respiratory disease, as it may increase obstruction of the airways.
Children and adolescents
This medicine must not be given to children between 2 and 12 years of age.
Notus Mucolytic 50 mg/ml oral solution is contraindicated in children under 2 years of age due to safety concerns.
Other medicines and Notus Mucolytic
Inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including those obtained without a prescription.
Do not take this medicine with antitussives or with substances that inhibit bronchial secretions, as this may cause accumulation of liquefied mucus.
Pregnancy, 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 any medicine.
Pregnant women may only take this medication if considered necessary by their doctor. There are no data regarding the passage of carbocysteine into breast milk. Therefore, breastfeeding women may take this medication if considered necessary by their doctor. Driving and use of machines Effects on the ability to drive and use machines are not expected. Notus mucolytic contains carmine red A (Ponceau 4R) (E-124), methylparaben (E-218), and sodium This medicine may cause allergic-type reactions. It may cause allergic reactions (possibly delayed) and, exceptionally, bronchospasm. This medicine contains 110.76 mg of sodium per 15 ml, equivalent to 5.54% of the maximum daily intake of 2 g recommended by the WHO for an adult. |
3. How to take Notus Mucolytic
Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The usual dose is:
Adults and children over 12 years of age:
15 ml of oral solution measured with the dosing cup (750 mg of carbocisteine), 3 times a day.
Do not take more than 45 ml (3 dosing cups) in 24 hours.
Once improvement is observed, the dose may be reduced 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 (1,500 mg of carbocisteine).
How to take
This medicine is taken orally.
It is recommended to drink a glass of water after each dose and to consume plenty of fluids throughout the day.
If your symptoms worsen, or if you do not improve after 5 days of treatment, or if fever, skin rashes, persistent headache, or sore throat occur, you must consult your doctor.
If you take more Notus Mucolytic than you should
If you have taken more than the recommended dose, you may experience stomach pain, nausea and diarrhea, itching, and skin rashes.
In case of overdose or accidental ingestion, consult your doctor or pharmacist, or call the Toxicology Information Service at telephone number 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 missed doses.
If necessary, resume taking the medicine as indicated in section 3. How to take Notus Mucolytic.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.
The following adverse effects have been observed during the period of use of carbocysteine:
Rare (may affect up to 1 in 1,000 people): Nausea, diarrhoea
Very rare (may affect up to 1 in 10,000 people): Abdominal pain and allergic reactions such as rash, urticaria and pruritus.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish System of Pharmacovigilance of Human Medicines: http;//www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the packaging following the abbreviation EXP. The expiry date refers to the last day of the month indicated.
After opening the container, do not use beyond 12 months.
Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Notus mucolytic
Each ml of oral solution contains:
- 50 mg of carbocisteine.
- The other components (excipients) are: sodium saccharin, methylparahydroxybenzoate (E 218), raspberry flavour, cochineal red A (Ponceau 4R) (E-124), sodium carmellose, sodium hydroxide, purified water, 1N sodium hydroxide solution (to adjust pH).
Sodium saccharin, sodium carmellose, sodium hydroxide and 1N sodium hydroxide solution contribute 7.38 mg of sodium per ml of oral solution.
Appearance of the product and contents of the container
200 ml bottle of cherry-red oral solution with raspberry flavour, accompanied by a measuring cup marked 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, 1st floor, 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 most recent revision of this leaflet: January 2022
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/