COMPOSITIONS :
Broxal® Elixir 30 mg/5 ml, each 5 ml (a measurement spoonful) elixir contains : Ambroxol HCl 30 mg, contains alcohol 5.0%.
DESCRIPTIONS :
Broxal® containing Ambroxol HCl is available in 15 mg/5 ml and 30 mg/5 ml elixir and 30 mg tablet.
INDICATIONS :
Broxal® is indicated as secretolytic in acute and chronic respiratory tract diseases particularly in chronic bronchitis exacerbation and asthmatic bronchitis.
DOSAGE AND ADMINISTRATIONS :
Broxal® Elixir 30 mg/5 ml :
- Adults and children over 12 years : 5 ml (1 measuring spoonful), 2 – 3 times daily.
- Children 6 – 12 years : 2.5 ml (½ measuring spoonful), 2 – 3 times daily.
OVERDOSAGE :
No symptoms of overdosage have been reported, if they occur, symptomatic treatment should be provided.
CONTRAINDICATIONS :
Patients known to be hypersensitive to Ambroxol.
WARNINGS AND PRECAUTIONS :
- Ambroxol can be administered during pregnancy (especially in the 1st trimester) and lactation only after careful risk/benefit assessment. Administration during pregnancy and lactation still needs further research.
- Ambroxol should not be used in the long term without physician’s consultation.
- In some cases of renal insufficiency, accumulation of Ambroxol metabolites takes place in the liver.
- There have been reports of severe skin reactions such as erythema multiforme, Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) and acute generalized exanthematous pustulosis (AGEP) associated with the administration of Ambroxol HCl. If symptoms or signs of a progressive skin rash (sometimes associated with blisters or mucosal lesions) are present, Ambroxol HCl treatment should be discontinued immediately and medical advice should be sought.
DRUG INTERACTIONS :
Administration of Ambroxol together with antibiotics (Amoxicillin, Cefuroxime, Erythromycin, Doxycycline) leads to higher antibiotic concentration in the lungs tissue.
ADVERSE REACTIONS :
- Intolerance reactions after Ambroxol administration have been reported in rare cases.
- Mild gastrointestinal side effects have been reported in some patients.
- Allergic reactions have been reported in rare cases and some of these patients have also shown allergic reactions to other substances. Some of the allergic reactions are : Skin rashes, swelling on the face, dyspnea, fever.
- It is not known whether Ambroxol has an impact in the ability to drive or operate machinery.
- Immune system disorder
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).
PRESENTATIONS :
Broxal® Elixir 30 mg/5 ml Box, 1 bottle @ 60 ml Reg. No. DKL9702323834A1
STORAGE :
STORE BELOW 30ºC, PROTECT FROM LIGHT
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
