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
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. See also section 4.8.
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).
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).
There is no evidence of the efficacy of acetylcysteine in the management of cystic fibrosis.
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.
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.
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.
This medicinal product contains less than 1 mmol sodium per sachet, that is to say essentially ‘sodium-free’.
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.
Combined use of antitussives (cough-relieving agents) with acetylcysteine may cause dangerous secretory congestion due to the reduced cough reflex.
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.
Co-administration with activated charcoal can reduce the effectiveness of acetylcysteine.
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.
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 (see section 5.3). Trebon is not recommended during pregnancy.
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.
There are no human data from the use of acetylcysteine in fertility.
Acetylcysteine has no influence on the ability to drive and use machines.
In the evaluation of side effects following frequencies are defined as: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000); Not known (Cannot be estimated from the available data).
Uncommon: Hypersensitivity
Very rare: Anaphylactic shock, anaphylactic/anaphylactoid reaction
Uncommon: Headache
Uncommon: Tinnitus
Uncommon: Tachycardia
Uncommon: Hypotension
Very rare: Haemorrhage
Rare: Bronchospasm, dyspnoea
Uncommon: Vomiting, diarrhoea, stomatitis, abdominal pain, nausea
Rare: Dyspepsia
Uncommon: Urticaria, rash, angioedema, pruritus
Uncommon: Fever
Not known: Oedema
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.
A reduction of blood platelet aggregation in the presence of acetylcysteine has been confirmed by various studies. The clinical relevance is not yet understood.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance Website: www.hpra.ie.
Not applicable.
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