COMPOSITION: Each effervescent tablet contains: 200 mg N-acetylcysteine.
PHARMACOLOGICAL CLASSIFICATION: A/10.2.2 Medicines acting on the respiratory system - other.
PHARMACOLOGICAL ACTION: N-acetylcysteine is a mucolytic agent that reduces the viscosity of secretions probably by the splitting of disulphide bonds in mucoproteins. It limits hepatic toxicity in paracetamol overdosage by replenishing hepatic stores of glutathion.
INDICATIONS: N-acetylcysteine is used as a mucolytic, of non-infective secretions in cystic fibrosis and in respiratory conditions.
N-acetylcysteine is an effective antidote in paracetamol overdosage.
CONTRA-INDICATIONS: Hypersensitivity to N-acetylcysteine. Safety in pregnancy has not been established.
WARNINGS: N-acetylcysteine should be used with caution in asthmatic patients and since mucolytics may disrupt the gastric mucosal barrier, it should be used with caution in patients with a history of peptic ulceration.
DOSAGE AND DIRECTIONS FOR USE: The effervescent tablets should be dissolved in a glass of water before use. As a mucolytic:
Under 2 years 200 mg (1 effervescent tablet) once daily.
In paracetamol overdose: Initially 140 mg/kg, followed by 70 mg/kg every 4 hours for an additional 17 doses. As an antidote, N-acetylcysteine is reported to be very effective when administered within 8 hours of paracetamol overdose, with the protective effect diminishing after this time. Initiation of treatment after a lapse of 15 hours has previously thought to be ineffective, but recent studies suggest that beneficial results may still be obtained.
SIDE EFFECTS AND SPECIAL PRECAUTIONS: Adverse effects include bronchospasm, nausea, vomiting, stomatitis, rhinorrhoea, headache, tinnitus, urticaria, chills and fever. Anaphylaxis has less frequently been reported.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: See side-effects. Treatment would be symptomatic and supportive.
IDENTIFICATION: Smooth, round white tablets with a characteristic smell of blackberries.
PRESENTATION: Aluminium tubes of 25 effervescent tablets.
STORAGE INSTRUCTIONS: Store below 25°C in a cool dry place. Protect from light.
KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBER: 29/10.2.2/0753
NAME AND BUSINESS ADDRESS OF THE APPLICANT: Hexal Pharma (SA) (PTY) Ltd.
10 Fangio Road
DATE OF PUBLICATION OF THIS PACKAGE INSERT: November, 1996.