MUCOBROXOL Syrup Ref.[50692] Active ingredients: Ambroxol

In the case of disturbed brochomotoricity and excessive amount of secretion (e.g. in the rare malignant ciliary syndrome), because of possible secretory congestion MUCOBROXOL Syrup should be used with caution.

In impaired kidney function or a severe liver disease, MUCOBROXOL Syrup may be used only after consulting a physician. As for any medication with hepatic metabolism followed by renal elimination, accumulation of the metabolites of ambroxol generated in the liver can be expected in the presence of severe renal insufficiency.

There have been reports of severe skin reactions such as erythema multiforme, Stevens-Johnson Syndrome (SJS)/toxic epidermal necrolysis (TEN) and acute generalised exanthematous pustulosis (AGEP) associated with the administration of ambroxol hydrochloride.

If symptoms or signs of a progressive skin rash (sometimes associated with blisters or mucosal lesions) are present, ambroxol hydrochloride treatment should be discontinued immediately and medical advice should be sought.

With the combined use of MUCOBROXOL Syrup and antitussives (cough preparations) a dangerous congestion of the secretions can occur due to the suppressed coughing reflex, so that special care should be taken with the indication for this combined therapy.

Also, increased penetration of the antibiotics, amoxicillin, cefuroxim, erythromycin and doxycycline into the bronchial secretion when these were administered concomitantly with ambroxol has been reported.

Ambroxol hydrochloride crosses the placental barrier. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal evelopment, parturition or postnatal development. Extensive clinical experience after the 28th week of pregnancy has shown no evidence of harmful effects on the foetus.

Nonetheless, the usual precautions regarding the use of drugs during pregnancy should be observed. Especially during the first trimester, the use of Mucobroxol syrup is not recommended. Ambroxol hydrochloride is excreted in breast milk. Although unfavourable effects on breastfed infants would not be expected, Mucobroxol syrup is not recommended for use in breast feeding mothers.

There is no evidence for an effect on the ability to drive and use machines.

Studies on the effects on the ability to drive and use machines have not been performed.

The following frequencies are the basis for assessing undesirable effects: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), Not known (cannot be estimated from the available data).

Immune system disorders

Rare: Hypersensitivity reactions

Not known: Anaphylactic reactions including anaphylactic shock, Angioedema and pruritus

Skin and subcutaneous tissue disorders

Rare: Rash, Urticaria

Not known: Severe cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalized exanthematous pustulosis)

Gastrointestinal disorders

Common: Nausea, Oral hypoaesthesia

Uncommon: Vomiting, Diarrhoea, Dyspepsia, Abdominal pain, Dry mouth

Nervous System Disorders

Common: Dysgeusia

Respiratory, mediastinal and thoracic disorders

Common: Pharyngeal hypoaesthesia

Not known: Dry throat

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions to Pharmaceutical Services, Ministry of Health, CY-1475, www.moh.gov.cy/phs Fax: +357 22608649.

None known to date.