Composition
active ingredient Ambroxol Hydrochloride.
syrup: each 5 ml contains 15 mg.
oral drops : each 5 ml contains 7.5 mg.
Therapeutic Indications
Mucolytic therapy of acute or chronic bronchopulmonary diseases associated with abnormal mucous secretion and transport disturbances.
Posology And Method Of Administration
The following dosages are recommended:
| Age | Posology |
| Adults and children older than 12 years | 10 – 20 ml twice a day |
| Children 6-12 years | 5 – 10 ml 2 – 3 times a day |
| Children 2-5 years | 2.5 – 5 ml 3 times a day |
| Children under 2 years | 2.5 ml 2 times a day |
- These higher doses are suitable for initial dosing; after 14 days the doses may be reduced by half.
- A doctor should be consulted if symptoms are not improving or getting worse during treatment of acute respiratory disease.
- Renal impairment: No dosage adjustment is necessary.
- Hepatic impairment: No dosage adjustment is necessary.
Pregnancy And Lactation
Pregnancy:
- Ambroxol Hydrochloride crosses the placental barrier. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, parturition or postnatal development.
- Clinical experience after 28 weeks 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 Bronchopro is not recommended.
Breastfeeding:
Ambroxol Hydrochloride is excreted in breast milk in animals. As there are no adequate data from the use of Bronchopro in breastfeeding women, Bronchopro should be used by breastfeeding women only after careful evaluation of risk and benefit.
Fertility:
Animal studies do not indicate direct or indirect harmful effects on fertility.
Effects On Ability To Drive And Use Machines
The medicinal product has no or negligible influence on the ability to drive and use machines
Interactions With Other Medicinal Products And Other Forms Of Interaction
- Administration of Bronchopro with antibiotics (amoxicillin, cefuroxim, and erythromycin) leads to increase of antibiotics concentrations in bronchopulmonary mucus and sputum.
- Combination of Bronchopro with cough suppressants (e.g. codeine) can, due to suppressed cough reflex, cause serious obstruction of the airways. Concomitant use is thus not recommended.
- No clinically relevant unfavourable interactions with other medications have been reported.
Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Undesired Effects
- immune system disorders: there have been reports of anaphylactic reactions
- including anaphylactic shock, angioedema and pruritus.
- Nervous system disorders : Dysgeusia
- Skin and subcutaneous tissue disorders: there have been reports of skin rashes and allergic skin eruption. Severe cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalized exanthematous pustulosis)
- Gastrointestinal disorders: there have been rare reports of Nausea, Hypoesthesia in mouth Diarrhoea, Vomiting, Dyspepsia, Dry mouth, Abdominal pain.
- Respiratory, thoracic and mediastinal disorders: there have been rare reports of Hypoesthesia of pharynx.
Special Warnings And Precautions For Use
- Renal and hepatic impairment: In patients with renal or severe hepatic impairment Bronchopro syrup should be administered with caution.
- Caution is required in patients with history of peptic or duodenal ulcers.
- 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 Bronchopro. If symptoms or signs of a progressive skin rash (sometimes associated with blisters or mucosal lesions) are present, Bronchopro treatment should be discontinued immediately and medical advice should be sought.
Overdose
No specific symptoms of overdose have been reported in humans. Based on the reports of accidental overdose and/or mistakes in the treatment, observed signs are consistent with the known side effects of Bronchopro in recommended doses and may require appropriate symptomatic treatment.
