Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
ELIXIR
**(d) How to take Mucosolvan Liquid 30mg/5ml** The recommended dose for adults and children are stated below: Adult and children over 12 years: 10ml 2 times daily. For children under 12 years the following dosage regimen is recommended depending on severity of the disease. Children 6–12 years: 5ml 2–3 times daily. Children 2–5 years: 2.5 ml 3 times daily. Mucosolvan is not recommended for children under 2 years of age without medical advice. Mucosolvan can be taken with or without food. You should contact a doctor if your symptoms worsen or do not improve after 4 – 5 days. **If you take more Mucosolvan Liquid 30mg/5ml than you should** No specific symptoms of overdose have been reported to date. The symptoms observed in cases of accidental overdose or medication error are consistent with the side effects which may occur at recommended doses (see section e – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). In case of overdose, please consult a doctor as symptomatic treatment may be required. **If you forget to take Mucosolvan Liquid 30mg/5ml** If you forget to take Mucosolvan Liquid 30mg/5ml or take too small a dose, wait until it is time to take your next dose and then continue taking Mucosolvan Liquid 30mg/5ml as described in the dosage instructions above. **If you stop taking Mucosolvan Liquid 30mg/5ml** If you stop treatment early, your symptoms may get worse.
ORAL
Medical Information
**(b) What Mucosolvan Liquid 30mg/5ml is and what it is used for** Mucosolvan is used in conditions where there are a lot of thick secretions or mucus in your air passages. Mucosolvan contains ambroxol hydrochloride, which helps to clear the chest by thinning the mucus in your air passage.
**(c) What you need to know before you take Mucosolvan Liquid 30mg/5ml** **Do not take Mucosolvan Liquid 30mg/5ml:** - if you are allergic to the active substance, ambroxol hydrochloride, or any of the other ingredients of this medicine (listed in section a – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
R05CB06
ambroxol
Manufacturer Information
OPELLA HEALTHCARE SINGAPORE PTE. LTD.
Delpharm Reims
Active Ingredients
Documents
Patient Information Leaflets
Mucosolvan Liquid PIL.pdf
Approved: January 30, 2023