NOTUS MUCOLYTIC 50 mg/ml ORAL SOLUTION
How to use NOTUS MUCOLYTIC 50 mg/ml ORAL SOLUTION
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
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Introduction
Leaflet: information for the user
Notus mucolytic 50 mg/ml oral solution
carbocisteine
Read this leaflet carefully before starting to take this medicine because it contains important information for you. Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.
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Contents of the leaflet
- What is Notus mucolytic and what is it used for
- What you need to know before taking Notus mucolytic
- How to take Notus mucolytic 4. Possible side effects
- Storage of Notus mucolytic
- 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.
Pregnant women should only take this medicine if their doctor considers it necessary. There is no data on the transfer of carbocisteine to breast milk. Therefore, breastfeeding women may take this medicine if their doctor considers it necessary. Driving and using machines No effects on the ability to drive and use machines are expected. Notus mucolytic contains red cochineal A (Ponceau 4R) (E-124), methylparaben (E-218), and sodium This medicine may cause allergic reactions. It can 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 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/
- Country of registration
- Active substance
- Prescription requiredNo
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to NOTUS MUCOLYTIC 50 mg/ml ORAL SOLUTIONDosage form: ORAL SOLUTION/SUSPENSION, 2 g carbocysteine / 100 mlActive substance: carbocisteineManufacturer: Almirall S.A.Prescription requiredDosage form: ORAL SOLUTION/SUSPENSION, 50 mg carbocysteine / mlActive substance: carbocisteineManufacturer: Laboratorios Cinfa S.A.Prescription not requiredDosage form: ORAL SOLUTION/SUSPENSION, 750 mgActive substance: carbocisteineManufacturer: Laboratorios Cinfa S.A.Prescription not required
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