MUCOSAN RETARD 75 mg PROLONGED-RELEASE CAPSULES
Ask a doctor about a prescription for MUCOSAN RETARD 75 mg PROLONGED-RELEASE CAPSULES
How to use MUCOSAN RETARD 75 mg PROLONGED-RELEASE CAPSULES
Introduction
Leaflet:information for the user
Mucosan Retard 75 mg prolonged-release capsules
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, fluidizing it, and facilitating its elimination.
This medication is indicated to facilitate the elimination of excess mucus and phlegm in colds and flu, for adults.
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 any of the other components of this medication (listed in section 6).
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 experience 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
It is not indicated for use in children.
Other medications and Mucosan
Use of Mucosan with other medications
Inform 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 food.
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 regarding 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 have been observed on the ability to drive and use machinery.
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:
Adults: 1 capsule (75 mg of ambroxol hydrochloride) daily.
How to take:
Mucosan is taken orally.
The capsule should be swallowed whole with a little liquid, without opening and without chewing. It is recommended to drink a glass of water after administration and plenty of liquid during the day.
In exceptional cases, remnants of the excipient particles may be found in the feces, which no longer contain the active ingredient and are therefore of no importance.
You should consult a doctor if it worsens or does not improve after 5 days of treatment.
If you take more Mucosan than you should
If you have taken more Mucosan than you should, you may experience nausea 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.
- Uncommon (may affect up to 1 in 100 people): vomiting, diarrhea, indigestion, abdominal pain.
- Rare (may affect up to 1 in 1,000 people): hypersensitivity reactions, exanthema, urticaria.
- Frequency not known (cannot be estimated from the available data): anaphylactic reactions, anaphylactic shock, angioedema (rapidly progressing swelling of the skin, subcutaneous tissues, mucous membranes, or submucosal tissues) and pruritus. Severe cutaneous adverse reactions (such as erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and acute generalized exanthematous pustulosis).
Reporting of side effects:
If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects 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 medication.
5. Storage of Mucosan
Keep this medication out of the sight and reach of children.
Do not store above 30°C.
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 disposed of through wastewater or household waste. 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 prolonged-release capsule contains 75 mg of ambroxol hydrochloride in pellet form.
- The other ingredients are crospovidone, carnauba wax, stearic alcohol, and magnesium stearate. The capsule shell contains gelatin, purified water, titanium dioxide (E 171), red iron oxide (E 172), and yellow iron oxide (E 172). The white printing ink contains shellac, isopropyl alcohol, n-butyl alcohol, propylene glycol, and titanium dioxide (E 171).
Appearance of the product and package contents
Mucosan is available in boxes of 10 or 30 hard prolonged-release capsules.
They are hard gelatin capsules, elongated, with the upper part red and the lower part orange.
Marketing authorization holder
Opella Healthcare Spain, S.L.
C/ Rosselló i Porcel, 21
08016 – Barcelona
Spain
Sanofi Group
Manufacturer:
Delpharm Reims, S.A.S.
10 Rue Colonel Charbonneaux
51100 Reims
France
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/60102/Prospecto_60102.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 RETARD 75 mg PROLONGED-RELEASE CAPSULESDosage 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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