Download MUCOSOLVAN Boehringer

MUCOSOLVAN
Boehringer
Composition
1 tablet contains 30 mg
5 ml liquid contains 15 mg or 30 mg
2 ml solution for oral or inhalation use contains 15 mg
trans-4-[(2-amino-3,5-dibromo-benzyl)amino]cyclohexanol hydrochloride (=ambroxol hydrochloride)
Side Effects
MUCOSOLVAN is generally well tolerated. Mild
upper gastro-intestinal side effects (primarily pyrosis, dyspepsia, and occasionally nausea, vomiting)
have been reported, principally following parenteral
administration. Allergic reactions have occured rarely, primarily skin rashes. There have been extremely
Excipients:
Tablets: lactose, maize starch, colloidal silica, mag- rare case reports of severe acute anaphylactic-type
reactions but their relationship to ambroxol is uncernesium stearate.
tain. Some of these patients have also shown allerLiquid: Hydroxyethylcellulose, sorbitol solution 70%,
gic reactions to other substances.
glycerin, benzoic acid, propyleneglycol, tartaric acid.
Solution: Citric acid, dibasic sodium phosphate, Pregnancy and Lactation
Preclinical studies as well as extensive clinical experisodium chloride, benzalkonium chloride.
ence after the 28th week have shown no evidence of
Properties
ill-effects during pregnancy. Nonetheless, the usual
Preclinically, ambroxol, the active ingredient of precautions regarding the use of drugs during pregMUCOSOLVAN, has been shown to increase respi- nancy, especially during the first trimester, should be
ratory tract secretion. It enhances pulmonary sur- observed. The drug enters breast milk, but is not likely
factant production and stimulates ciliary activity. to affect the infant when therapeutic doses are used.
These actions result in improved mucus flow and
Interactions
transport (mucociliary clearance). Improvement
Administration of ambroxol together with antibiotof mucociliary clearance has been shown in cliniics (amoxicilline, cefuroxime, erythromycin, doxycycal pharmacological studies. Enhancement of fluid cline) leads to higher antibiotic concentration in the
secretion and mucociliary clearance facilitates lung tissue. No clinically relevant unfavourable interexpectoration and eases cough.
action with other medications have been reported.
Indications
Dosage and Administration
Secretolytic therapy in acute and chronic bron- Tablets 30 mg
chopulmonary diseases associated with abnormal Adults
1 tablet 3 times daily
mucus secretion and impaired mucus transport.
The therapeutic effect may be enhanced by adminContraindications
istering 2 tablets 2 times daily.
MUCOSOLVAN should not be used in patients
known to be hypersensitive to ambroxol or other The tablets should be taken after meals with liquid.
components of the formulation.
Liquid (5 ml = 1 teaspoonful)
Adults and children over 12 years:
Special Precautions
Liquid 30 mg/5 ml
10 ml (2 tsps.) 2 times daily
MUCOSOLVAN solution contains the preservative
benzalkonium chloride. When inhaled this preser- This regimen is suitable for the therapy of acute
vative may cause bronchoconstriction in sensitive respiratory tract disorders and for the initial treatpatients with hyperreactive airways.
ment of chronic conditions up to 14 days.
Patients with bronchial asthma may be advised to
commencing inhalation after they have taken their
For the treatment of children under the age of 12 the regular bronchospasmolytic therapy.
following dosage regimen is recommended dependOverdosage
ing on the severity of the disease:
No symptoms of overdosage have been reported in
Liquid 30 mg/5 ml
man to date. If they occur, symptomatic treatment
Children 6 - 12 years
5 ml (1 tsp.) 2 - 3 times daily
should be provided.
Liquid 15 mg/5 ml
10 ml (2 tsps.) 3 times daily
Children 2 - 6 years
Children 1-2 years
2.5 ml (1/2 tsp.) 3 times daily
2.5 ml (1/2 tsp.) 2 times daily
Availability
Tablets 30 mg
This higher strength formula is for initial treatment, Liquid 15 mg/5 ml and 30 mg/5 ml
Solution for oral or inhalation use 15 mg/2 ml
the dosage may be halved after 14 days.
Storage instructions
Liquid 15 mg/5 ml
Store in a safe place out of the reach of children! Do
Children 6 - 12 years
5 ml (1 tsp.) 2 - 3 times daily
not take the medicine after the expiry date printed
Children 2 - 6 years
2.5 ml (1/2 tsp.) 3 times daily
on the pack.
Children under 2 years
2.5 ml (1/2 tsp.) 2 times daily
MUCOSOLVAN liquid should be taken at mealtimes.
Solution 15 mg/2 ml for oral and inhalation use
Oral (1 ml = 25 drops)
Adults
Children over 6 years
Children 2 - 6 years
Children under 2 years
at the initiation of treatment,
4 ml 3 times daily.
2 ml (= 50 drops) 2 - 3 times
daily
1 ml (= 25 drops) 3 times daily
1 ml (= 25 drops) 2 times daily
The drops should be taken with meals diluted with
tea, fruit juice, milk or water.
Inhalation
Adults and children over 6
years
Children under 6 years
1 - 2 inhalations of 2 - 3 ml
solution daily
1 - 2 inhalations of 2 ml solution daily
MUCOSOLVAN inhalant solution can be used in all
modern inhalation devices (excluding steam inhalers). It is miscible with physiological saline solution and may be diluted 1 : 1 in order to obtain optimal moisturisation of the air released by a respirator.
Since deep inhalation may provoke cough, the patient
should breathe normally during the inhalation treatment. It is generally recommended to warm inhalant solutions to body temperature before inhalation.