Presentation: Each sachet with powder used for the preparation of oral solution contains 600 mg of Acetylcysteine Indications: Trebon is indicated in adults as a mucolytic therapy in chronic bronchitis and other respiratory conditions associated with thick mucus hypersecretion Dosage and method of administration: Dosage: 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. Duration of treatment: The duration of therapy is dependent on the nature and severity of the illness and should be decided by the doctor. Paediatric population: Children older than 2 years of age and adolescents: The safety and efficacy of Trebon is not established in children aged 2 years and older and adolescents. Other products with lower strengths of acetylcysteine are more suitable for this age group. Children under 2 years of age: Trebon is contraindicated in children aged under 2 years. Elderly: Limited data in patients over 65 of age is available. Renal and hepatic impairment: 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 Administration: Dissolve the content of one sachet in half a glass of water. This produces a solution that should be consumed immediately. Contraindications:  Hypersensitivity to the active substance or to any of the excipients. The product should not be used in children under 2 years of age. Special warnings and precautions for use: Serious skin reactions have been reported whilst taking acetylcysteine, but these occur rarely. For this reason, medical advice should be sought immediately, and the patient should stop taking acetylcysteine in the event of new-onset changes to the skin and mucous membranes. This product should be used with caution by patients with a history of peptic ulcer disease. Acetylcysteine can, especially at the start of treatment, cause thinning and increased volume of bronchial secretions. If the patient is not able to expectorate this adequately, appropriate supportive measures should be implemented (such as postural drainage and suction removal). The medicine should be administered with caution to asthmatic patients, due to the risk of bronchospasm. In the event of bronchospasm, the drug should be discontinued immediately. This product should be used with caution by patients with histamine intolerance. They should avoid long-term therapy because Acetylcysteine affects the metabolism of histamine and can lead to symptoms of intolerance (e.g. headaches, rhinitis, itching). Renal and hepatic impairment: 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. There is no evidence of the efficacy of acetylcysteine in the management of cystic fibrosis. Paediatric population: Mucolytic drugs may obstruct the airways of children under 2 years of age, due to the physiological characteristics of the airways in this age group. The ability to cough up mucus may be limited. Therefore, the product must not be used in children under 2 years of age. The safety and efficacy of Trebon is not established in children aged 2 years and older and adolescents, due to the high content of acetylcysteine in this medicinal product. Other products with lower strengths of acetylcysteine are more suitable for this age group. Sorbitol: This medicinal product contains 2,167.9 mg sorbitol in each sachet. Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product. Sucrose: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicinal product. May be harmful to the teeth. Sodium: This medicinal product contains less than 1 mmol sodium per sachet, that is to say essentially ‘sodium-free’. Interactions: Antibiotics: In vitro experiments report an inactivation of certain antibiotics (tetracyclines, aminoglycosides, fluoroquinolones, carbapenem, cephalosporins, penicillins) due to acetylcysteine when the substances were directly mixed. Therefore, antibiotics should be administered separately and at an interval of at least 2 hours. Antitussives: Combined use of antitussives (cough-relieving agents) with acetylcysteine may cause dangerous secretory congestion due to the reduced cough reflex. Nitroglycerin: Administration of Trebon may lead to an increase in the vasodilatory and anti- platelet effect of glyceryl trinitrate. If the drugs are administered together the patient should be monitored for a hypotensive response. Activated charcoal: Co-administration with activated charcoal can reduce the effectiveness of acetylcysteine. Laboratory tests: Acetylcysteine may affect the recovery of salicylates in the colourimetric assay and also may give false-positive ketone bodies results in urinalysis (a biochemical parameter of the general urine test that is determined along with glucose in diabetic patients). This should be taken into account in patients having any blood or urine test, while taking acetylcysteine. Ability to drive/use machines: Acetylcysteine has no influence on the ability to drive and use machines. Fertility, pregnancy and lactation: Pregnancy: There are no or limited amount of data from the use of acetylcysteine in pregnant women. Animal studies are insufficient with respect to reproductive toxicity. Trebon is not recommended during pregnancy. Breast-feeding: It is unknown whether acetylcysteine /metabolites are excreted in human milk. A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Trebon therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman. Fertility: There are no human data from the use of acetylcysteine in fertility. Adverse reactions: For full list of adverse reactions consult SmPC. ‘Very Common’, ‘Common’ and ‘Serious’ side effects included in this prescribing information:  Serious: Anaphylactic shock, anaphylactic/anaphylactoid reaction, tachycardia, hypotension, haemorrhage, bronchospasm, dyspnoea. Acetylcysteine may have an undesirable effect on the gastric mucosa in patients with a history of peptic ulcer. Serious skin reactions have been reported whilst taking acetylcysteine, but these occur rarely. For this reason, in the event of new onset changes of the skin and mucous membranes medical advice should be sought immediately and the patient should stop taking acetylcysteine. MA number: PL 35533/0288 Cost: £112.50 (20 x 600mg sachets) MAH: Aspire Pharma Ltd, Unit 4, Rotherbrook Court, Bedford Road, Petersfield, Hampshire GU32 3QG Legal Category: POM Version number:  MAT-UK-TRE-0001-1 | March 2026