Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: ALTURiX Ltd, 287 Upper Fourth Street, Milton Keynes, MK9 1EH UK
Bronchospasms may occur with the use of acetylcysteine. If bronchospasm occur, the medicinal product should be discontinued immediately.
Caution is advised in patients with a history of peptic ulcer, especially when used concomitantly with other medicinal products known to irritate the mucous membrane of the gastrointestinal tract.
Serious skin reactions such as Stevens-Johnson syndrome and Lyell’s syndrome have very rarely been reported in temporal connection with the use of acetylcysteine. In most cases, at least one other suspect medicinal product, which was more likely the cause of the mucocutaneous syndrome could be identified. If cutaneous or mucosal alterations newly occur, immediate medical advice should be sought and the treatment with acetylcysteine should be discontinued immediately.
Bronchial secretions may become more fluid and increase in volume, in particular at the start of the treatment with acetylcysteine. When a patient is unable to cough up the secretions effectively, postural drainage and bronchoaspiration should be performed.
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, mucolytic drugs should not be used in children under 2 years of age.
The safety and efficacy is not established children aged 2 years and older and adolescents.
A mild sulfur odour does not indicate a change in the medicinal product, but is a property of the active substance itself.
NACSYS 600 mg effervescent tablets contain 115 mg of sodium per dose in the form of sodium hydrogen carbonate. Caution is advised in patients on a sodium-restricted diet.
Simultaneous solution of NACSYS 600 mg effervescent tablets with other medicinal products is not recommended.
To date, the inactivation of antibiotics by acetylcysteine has been reported only in in-vitro tests, whereby the relevant substances were mixed directly with each other. However, if oral antibiotics are required, it is advised that these should be taken two hours before or after Acetylcysteine.
Acetylcysteine should not be administered concomitantly with antitussive medicinal products.
Acetylcysteine may enhance the vasodilatory effects of nitroglycerin. Caution is advised.
Activated charcoal can decrease the effect of acetylcysteine due to reduced absorption.
Acetylcysteine may have an effect on the values of salicylates by colorimetric analysis.
There are limited data about the use of acetylcysteine in pregnant women. Animal studies do not indicate reproductive toxicity (see section 5.3). Acetylcysteine crosses the placenta. Available data do not indicate a risk to the child. If necessary, the use of NACSYS 600 mg effervescent tablets during pregnancy may be considered.
It is not known whether acetylcysteine passes into human milk, but at therapeutic doses no effects of acetylcysteine are expected on the infant. NACSYS 600 mg effervescent tablets may be used during breastfeeding.
Based on available preclinical experience, there are no indications for possible effects of the use of acetylcysteine on fertility.
There are no data on the effect of acetylcysteine on the ability to drive. An effect is, however, not likely.
The table below lists the undesirable effects recorded after systemic use of oral acetylcysteine according to system/organ class.
| System/organ class | Undesirable effect | |||
|---|---|---|---|---|
| Uncommon (≥1/1,000 to <1/100) | Rare (≥1/10.000 to <1/1,000) | Very rare (<1/10,000) | Not known | |
| Immune system disorder | Hypersensitivity* | Anaphylactic shock, anaphylactic/anaphylactoid reactions | ||
| Nervous system disorders | Headache | |||
| Ear and labyrinth disorders | Tinnitus | |||
| Vascular disorders | Haemorrhages | |||
| Gastrointestinal disorders | Stomatitis, abdominal pain, nausea, vomiting, diarrhoea | Dyspepsia | ||
| Skin and subcutaneous tissue disorders | Facial oedema | |||
| General disorders and administration site conditions | Pyrexia | |||
| Investigations | Low blood pressure | |||
A decrease in platelet aggregation in the presence of acetylcysteine has been confirmed in various studies. The clinical significance of this has not been determined.
* Hypersensitivity reactions include bronchospasm, dyspnoea, pruritus, urticaria, rash, angioedema and tachycardia.
Acetylcysteine may have an undesirable effect on the gastric mucosa in patients with a history of peptic ulcer or peptic ulcer [sic].
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 Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard.
Acetylcysteine can react with rubber and metal (e.g. iron, nickel, copper). Use of glass and/or plastic delivery systems is recommended when administering via nasogastric or nasointestinal tube.
Do not mix antibiotics and acetylcysteine prior to administration, due to the possibility of in-vitro inactivation of the antibiotics (mainly β-lactam antibiotics).
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