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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.