BROMHEXINA VS AMBROXOL PDF

Information for consumers and caregivers Information for healthcare professionals Review Summary What actions are Medsafe taking? How to report adverse events Further information. Bromhexine is a mucolytic, a medicine used to break up excessive or thick phlegm associated with a chesty cough. There is concern over the number of allergic reactions, including anaphylaxis, with the use of ambroxol to which bromhexine is metabolised. Codeine is a pain reliever occasionally used for the relief of pain and discomfort associated with cold and flu symptoms.

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Information for consumers and caregivers Information for healthcare professionals Review Summary What actions are Medsafe taking? How to report adverse events Further information. Bromhexine is a mucolytic, a medicine used to break up excessive or thick phlegm associated with a chesty cough.

There is concern over the number of allergic reactions, including anaphylaxis, with the use of ambroxol to which bromhexine is metabolised. Codeine is a pain reliever occasionally used for the relief of pain and discomfort associated with cold and flu symptoms.

Codeine is changed metabolised to morphine in the body. There is concern regarding morphine-induced respiratory depression due to differences in codeine metabolism, particularly in young patients. This risk has been highlighted previously in Prescriber Update [www. The MARC concluded that there was not enough evidence to support the use of these medicines in younger age groups. Medicines Adverse Reactions Committee minutes of the th meeting [www.

Medsafe is working with the sponsors of these products to ensure data sheets and Consumer Medicine Information appropriately outline the safety of bromhexine and codeine. In addition, Medsafe will be working with the sponsors of bromhexine-only products to update the package labelling to warn against the use of these medicines in children under six years of age. If you have any concerns about a medicine you are taking Medsafe encourages you to talk to your healthcare professional.

Cough and Cold Review [www. European Medicines Agency decision — Bromhexine [www. European Medicines Agency decision — Codeine [www. Information for consumers and caregivers Bromhexine-containing medicines used for cough and cold symptoms should only be used in adults and children six years of age and over. Codeine-containing products used for cough and cold symptoms should only be used in adults and children 12 years of age and over.

Use the lowest dose that works for you and stop as soon as you can. The medicine package will be updated with the new age restriction over the next few months. You should follow the advice that your pharmacist or doctor gives you. Report any adverse reactions to the Centre for Adverse Reactions Monitoring CARM Children with cough and colds should be allowed to rest, be made comfortable and be given plenty of fluids. Honey drinks can help to soothe a cough in children over one year of age.

This was a recommendation from the Cough and Cold Review Group. Information for healthcare professionals Bromhexine-containing medicines used for cough and cold symptoms are restricted to adults and children six years of age and over. Codeine-containing products used for cough and cold symptoms are restricted to adults and children 12 years of age and over. Use the lowest effective dose for the shortest possible duration. The package labelling for bromhexine-only containing products will be updated to include this new age restriction.

In the meantime, consumers and caregivers should be advised that bromhexine-only containing products are restricted for use in adults and children six years of age and over.

Discuss the benefits and risk of harms of bromhexine or codeine treatment before commencing therapy. The Cough and Cold Review Group recommended that children with cough and colds should be allowed to rest, be made comfortable and be given plenty of fluids. Submit a report to CARM Prescribers can submit using the online reporting tool available in patient management software.

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Start of review of ambroxol and bromhexine

Upper and lower respiratory tract infections are common conditions for which medical advice is sought, and their management relies on the use of prescription and over-the-counter OTC medicines. Ambroxol, bromhexine, carbocysteine, erdosteine, N -acetyl cysteine NAC , and sobrerol are mucoactive agents for which clinical trials have been conducted, have been awarded well-established status by regulatory authorities, and are available as OTC or prescription products. To briefly review the evidence-based efficacy and safety of these substances in the therapy of upper respiratory airways infections. We conducted searches in MEDLINE and other databases for clinical trials and reviews done on the efficacy and safety of ambroxol, bromhexine, carbocysteine, erdosteine, NAC, and sobrerol.

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Ambroxol and bromhexine expectorants: safety information to be updated

Ambroxol is a drug that breaks up phlegm , used in the treatment of respiratory diseases associated with viscid or excessive mucus. Recently, a hypothesis suggested that it may have a potential role in treatment of Paget's disease of bone , Parkinsonism , and other common diseases of aging-associated diseases involving dysfunction of autophagy. It was patented in and came into medical use in Ambroxol is indicated as "secretolytic therapy in bronchopulmonary diseases associated with abnormal mucus secretion and impaired mucus transport.

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Safety Information

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The European Medicines Agency has started a review of medicines containing ambroxol and bromhexine, which are widely used as expectorants medicines that help clear the airways , as well as to relieve sore throat. Some formulations are used to treat breathing disorders in premature and newborn babies. This follows concerns over an increased number of reports of allergic reactions, including anaphylactic severe allergic reactions with ambroxol. Medicines containing ambroxol have also been linked to severe skin adverse reactions. In addition, the AFMPS was concerned about the use of ambroxol as expectorant in children below 6 years of age and considered that the benefits of these medicines did not outweigh the risks in this population. Since bromhexine gets mainly converted into ambroxol in the body, and there are some reports linking the use of bromhexine with allergic reactions, the AFMPS considered that the review should also cover medicines containing bromhexine. The European Medicines Agency will now review the available data on the benefits and risks of medicines containing ambroxol and bromhexine, and issue an opinion on the marketing authorisations of these medicines across the European Union EU.

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