MUCOSAN PEDIATRIC 3 mg/ml SYRUP
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How to use MUCOSAN PEDIATRIC 3 mg/ml SYRUP
Introduction
Leaflet:information for the user
Mucosan pediatric 3 mg/mlsyrup
Ambroxol hydrochloride
Read the entire leaflet carefully before starting to takethis medication, as it contains important information for you.
Follow the administration instructions of the medication contained in this leaflet or as 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
- You should consult a doctor if it worsens or does not improve after 5 days.
Contents of the leaflet
- What is Mucosan and what is it used for
- What you need to know before taking Mucosan
- How to take Mucosan
- Possible side effects
- Storage of Mucosan
- Package contents and additional information
1. What is Mucosan and what is it used for
Ambroxol, the active ingredient of this medication, belongs to a group of medications called mucolytics, which act by decreasing the viscosity of mucus, making it more fluid and facilitating its elimination.
This medication is indicated to facilitate the elimination of excess mucus and phlegm in colds and flu, for children from 2 to 12 years old.
You should consult a doctor if it worsens or does not improve after 5 days.
2. What you need to know before taking Mucosan
Do not take Mucosan
- If you are allergic to ambroxol hydrochloride or to any of the other components of this medication (listed in section 6).
- In children under 2 years of age.
Warnings and precautions
Consult your doctor or pharmacist before starting to take Mucosan.
If you have problems related to kidney or liver function, consult your doctor before using this medication.
There have been reports of severe skin reactions associated with the administration of ambroxol hydrochloride. If you develop a skin rash (including lesions of the mucous membranes, such as the mouth, throat, nose, eyes, and genitals), stop using Mucosan and consult your doctor immediately.
Children
Mucosan is contraindicated in children under 2 years of age.
In children from 2 to 6 years old, consult a doctor.
Other medications and Mucosan
Use of Mucosan with other medications
Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.
TakingMucosan with food and drinks
Mucosan can be taken with or without meals.
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 this medication.
No harmful effects have been observed during pregnancy. However, the usual precautions related to the use of medications during pregnancy should be followed.
The use of Mucosan is not recommended, especially during the first trimester of pregnancy.
Animal studies have shown that the active ingredient of this medication, ambroxol hydrochloride, passes into breast milk, and although no harmful effects are expected in the breastfed infant, its use should be avoided during breastfeeding.
Studies in animals do not indicate direct or indirect harmful effects on fertility.
No clinical data are available on fertility for ambroxol hydrochloride.
Driving and using machines
No effects on the ability to drive and use machines have been observed.
Mucosan contains benzoic acid
This medication contains 0.5 mg of benzoic acid per ml.
Benzoic acid may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks old).
Mucosan contains propylene glycol
This medication contains 5.2 mg of propylene glycol per ml.
If the baby is less than 4 weeks old, consult your doctor or pharmacist, especially if the baby has been given other medications that contain propylene glycol or alcohol.
3. How to take Mucosan
Follow the administration instructions of the medication contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.
The recommended dose is:
Children from 6 to 12 years old: 1 measure of 5 ml, 2-3 times a day, (every 8-12 hours, as needed), which means a maximum daily dose of 45 mg of ambroxol hydrochloride. After 2-3 days, once the patient improves, the dosage can be reduced to 2 times a day every 12 hours.
Children from 2 to 5 years old: 1 measure of 2.5 ml, 3 times a day (every 8 hours), which means a maximum daily dose of 22.5 mg of ambroxol hydrochloride. After 2-3 days, once the patient improves, the dosage can be reduced to 2 times a day every 12 hours.
How to take:
Mucosan is taken orally.
Measure the amount of medication to be taken with the measuring device included in the box.
It is recommended to drink a glass of water after each dose and plenty of liquid throughout the day.
You should consult a doctor if it worsens or does not improve after 5 days of treatment (3 days in children under 6 years old).
If you take more Mucosan than you should
If you have taken more Mucosan than you should, you may notice nausea, alteration of taste, sensation of numbness of the pharynx, sensation of numbness of the mouth, or any other side effect described in section 4 Possible side effects. In case of overdose or accidental ingestion, consult your doctor or pharmacist, or call the Toxicology Information Service, phone 915 620 420, indicating the medication and the amount ingested.
In case of massive accidental administration, symptomatic treatment is recommended.
4. Possible side effects
Like all medications, this medication can cause side effects, although not everyone experiences them.
The following side effects may occur:
- Frequent (may affect up to 1 in 10 people): nausea, alteration of taste, sensation of numbness of the pharynx, sensation of numbness of the mouth.
- Uncommon (may affect up to 1 in 100 people): vomiting, diarrhea, indigestion, abdominal pain, dry mouth.
- Rare (may affect up to 1 in 1,000 people): hypersensitivity reactions, exanthema, urticaria, dry throat.
- Frequency not known (cannot be estimated from available data): anaphylactic reactions, anaphylactic shock, angioedema (rapidly progressing swelling of the skin, subcutaneous tissues, mucous membranes, or submucosal tissues) and pruritus. Severe skin reactions (such as erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and acute generalized exanthematous pustulosis).
Reporting side effects:
If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.
5. Storage of Mucosan
Keep this medication out of sight and reach of children.
No special storage conditions are required.
Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.
Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.
6. Package contents and additional information
Composition of Mucosan
- The active ingredient is ambroxol hydrochloride. Each ml of syrup contains 3 mg of ambroxol hydrochloride.
- The other components are: hydroxyethylcellulose, sucralose, benzoic acid (E 210), wild berry flavor (contains propylene glycol), vanilla flavor (contains propylene glycol), and purified water.
Appearance of the product and package contents
Mucosan is presented in bottles of 125 ml or 200 ml of syrup with a child-resistant plastic cap. Its appearance is slightly viscous, clear, and practically colorless. It has a fruity aroma.
Marketing authorization holder:
Opella Healthcare Spain, S.L.
C/ Rosselló i Porcel, 21
08016 – Barcelona
Spain
Sanofi Group
Manufacturer:
- Nattermann & Cie. GmbH
Nattermannallee 1
50829 Köln
Germany
or
Delpharm Reims, S.A.S.
10 Rue Colonel Charbonneaux
51100 Reims
France
or
Opella Healthcare Italy, S.r.l.
viale Europa 11, 21040 Origgio (Va)
Italy
Date of the last revision of this leaflet: May 2022
You can access detailed and updated information about this medication by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:
https://cima.aemps.es/cima/dochtml/p/56156/P_56156.html
Detailed information about this medication 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 licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to MUCOSAN PEDIATRIC 3 mg/ml SYRUPDosage form: ORAL SOLUTION/SUSPENSION/PULMONARY INHALATION, 15 mg/2 mlActive substance: ambroxolManufacturer: Laboratorio Aldo Union S.L.Prescription requiredDosage form: ORAL SOLUTION/SUSPENSION, 15 mgActive substance: ambroxolManufacturer: Laboratorios Cinfa S.A.Prescription not requiredDosage form: ORAL SOLUTION/SUSPENSION, 6 mg/mlActive substance: ambroxolManufacturer: Laboratorios Cinfa S.A.Prescription not required
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