Source: Health Products Regulatory Authority (IE) Publisher: UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A., 14th km National Road 1, GR-145 64 Kifissia, Greece
Trebon is indicated in adults as a mucolytic therapy in chronic bronchitis and other respiratory conditions associated with thick mucus hypersecretion.
In general the usual recommended dosage is: 600mg once daily.
The dosage may be increased according to the instructions of the treating doctor based on the assessment of treatment outcomes.
The duration of therapy is dependent on the nature and severity of the illness, and should be decided by the doctor.
The safety and efficacy of Trebon is not established in children aged 2 years and older and adolescents (see section 4.4). Other products with lower strengths of acetylcysteine are more suitable for this age group.
Trebon is contraindicated in children aged under 2 years (see section 4.3).
Limited data in patients over 65 years of age is available.
In patients with renal or hepatic impairment there is insufficient data on whether dosage adjustments are required. Renal and hepatic impairment can reduce clearance and increase acetylcysteine plasma levels which may result in an increase in adverse drug reactions due to drug accumulation (see section 5.2).
Dissolve the content of one sachet in half a glass of water. This produces a solution that should be consumed immediately.
There have been no cases of toxic overdose observed with orally-dosed acetylcysteine. Oral doses of up to 500mg/kg of acetylcysteine were tolerated without toxic effects.
The following symptoms have been reported after overdoses of intravenous acetylcysteine: anaphylactoid reaction, bronchospasm and gastro-intestinal symptoms such as nausea, vomiting and diarrhoea. Oral overdose may lead to gastrointestinal adverse effects, such as nausea, vomiting and diarrhoea.
Treatment of overdose is to be symptomatic and supportive treatment as indicated by the patient’s clinical condition.
3 years.
After preparation, the solution should be used immediately.
This medicinal product does not require any special temperature storage conditions.
Store in the original package in order to protect from moisture.
Sachets consisting of paper, aluminum foil, and polyethylene.
Pack size: 10, 20 or 30 sachets.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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