MUCOSOLVAN once-daily prolonged-release capsules are a medicine intended to improve mucus clearance in respiratory illnesses with viscous mucus (expectorant).
MUCOSOLVAN once-daily prolonged-release capsules are used as a treatment to improve mucus clearance in acute and chronic bronchial and lung disorders with viscous mucus.

MUCOSOLVAN once-daily prolonged-release capsules should not be taken:
• If you are hypersensitive (allergic) to the active substance ambroxol hydrochloride or to any of the other ingredients of this medicine listed in Section 6.
• By children younger than 12 years.

Warnings and Precautions
Talk to your doctor or pharmacist before taking this medicine.
There have been reports of severe skin reactions associated with the administration of ambroxol hydrochloride. If you develop a skin rash (including mucosal lesions in the mouth, throat, nose, eyes and genital region), stop taking MUCOSOLVAN once-daily prolonged-release capsules and seek medical advice immediately.
Patients with impaired kidney or liver function
If you suffer from impaired kidney function or a severe liver disease, MUCOSOLVAN once-daily prolonged-release capsules should only be used on medical advice. As with any medicine that is metabolised by the liver and then excreted via the kidneys, an accumulation of the metabolic products (metabolites) of ambroxol produced in the liver can be expected in patients with severe renal failure.
In some rare bronchial disorders that are associated with excessive accumulation of secretions (e.g. malignant ciliary syndrome), MUCOSOLVAN once-daily prolonged-release capsules should only be used under medical supervision due to possible secretion congestion.
Children
MUCOSOLVAN once-daily prolonged-release capsules are not suitable for children under 12 years of age due to the high active substance content. MUCOSOLVAN 30 mg/5 ml paediatric syrup and MUCOSOLVAN 30 mg/2 ml drops are available for use in this age group.
Taking MUCOSOLVAN once-daily prolonged-release capsules with other medicines
Please tell your doctor or pharmacist if you are taking/using any other medicines, have recently taken/used any other medicines, or are intending to take/use other medicines.
Ambroxol/Cough suppressants
Simultaneous use of MUCOSOLVAN once-daily prolonged-release capsules and cough suppressants (antitussives) may lead to the development of dangerous secretion congestion in patients with respiratory illnesses that are associated with an increased formation of mucus, such as cystic fibrosis or bronchiectasis, due to the reduction of the cough reflex.
Pregnancy, lactation and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Ambroxol reaches the unborn child. Clinical experience after the 28th week of gestation has produced no evidence of any harmful effects on the unborn child. Nonetheless, you should not take this medicine while you are pregnant, especially not during the first three months.
Breastfeeding
The active substance ambroxol has been shown to pass into breast milk in animal studies. Even if no harmful effects to the child are expected, use while breast-feeding is not recommended.
Fertility
Non-clinical studies have not provided any evidence of harmful effects with respect to fertility.

Driving and using machines
There is no evidence of an effect on the ability to drive or use machines; appropriate studies have not been performed.

Always take this medicine exactly as described in this package leaflet or exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
Adults and adolescents aged 12 years and over:
The usual dosage is one prolonged-release capsule (equivalent to 75 mg ambroxol hydrochloride/day) once daily.
Method and duration of treatment
MUCOSOLVAN once-daily prolonged-release capsules can be taken with or without food and should be swallowed whole with sufficient amounts of liquid (e.g., water, tea or fruit juice).
You should consult a doctor if your symptoms worsen or if there is no improvement after 4-5 days.
Please speak to your doctor or pharmacist if you feel that the effect of MUCOSOLVAN once-daily prolonged-release capsules is too strong or too weak.
If you take more MUCOSOLVAN once-daily prolonged-release capsules 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 at the recommended dose (see Chapter 4). In the event of an overdose, please consult a doctor as symptomatic treatment may be required.
If you forget to take MUCOSOLVAN once-daily prolonged-release capsules
If you forget to take MUCOSOLVAN once-daily prolonged-release capsules or have taken an insufficient amount, please continue to take MUCOSOLVAN once-daily prolonged-release capsules as described in the dosage instructions at the next scheduled time.
If you stop taking MUCOSOLVAN once-daily prolonged-release capsules
The symptoms may worsen if the treatment is discontinued prematurely.

Like all medicines, MUCOSOLVAN once-daily prolonged-release capsules can cause side effects, although not everybody gets them.
The following categories are used for stating the frequency of undesirable effects:

Reporting of side effects
If you notice any side effects, talk to your doctor or your pharmacist. This also applies for any side effects not listed in this leaflet.
- To reports any side effect(s):
• Saudi Arabia:
• The National Pharmacovigilance Centre (NPC):
• SFDA Call Center: 19999
• E-mail: npc.drug@sfda.gov.sa
• Website: https://ade.sfda.gov.sa/

• Other GCC States:
• Please contact the relevant competent authority.

Keep this medication out of reach of children.
Do not use this medicine after the expiry date which is stated after the words “Use by” on the outer package/blister pack. The expiry date refers to the last day of that month.
Storage conditions
Do not store above 30ºC.
Do not throw away any medicines via wastewater (e.g. not in the toilet or sink). Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. For more information, see www.bfarm.de/arzneimittelentsorgung.