Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead 2191
TUSSMUCO is contraindicated in:
TUSSMUCO should be used with caution in asthmatic patients (see section 4.8).
Since mucolytics, such as TUSSMUCO may disrupt the gastric mucosal barrier, TUSSMUCO should be used with caution in patients with a history of peptic ulceration (see section 4.3).
Administration of TUSSMUCO, especially at the beginning of treatment, may liquefy bronchial secretions and, at the same time, increase their volume. If the patient is unable to expectorate efficiently, to avoid retention of secretions, postural drainage and tracheal suction should be used.
The occurrence of severe skin reactions such as Stevens-Johnson syndrome and Lyell’s syndrome has very rarely been reported in temporal connection with the use of acetylcysteine as contained in TUSSMUCO. If cutaneous and mucosal changes occur, the patient should seek medical advice without delay and the use of TUSSMUCO should be terminated (see section 4.8).
Caution is advised in patients with histamine intolerance. Treatment with TUSSMUCO for longer periods should be avoided in such patients as TUSSMUCO affects histamine metabolism and can result in symptoms of intolerance (e.g. headache, runny nose and itching) (see section 4.8).
Do not use TUSSMUCO continuously for more than 14 days without consulting a doctor (see section 4.2).
Mucolytics, such as TUSSMUCO, can result in blockage of the respiratory tract in children under 2 years of age due to the characteristics of their respiratory tract and their limited ability to cough up mucus. Therefore, TUSSMUCO must not be used in children under 2 years of age (see section 4.3).
Patients with rare glucose-galactose malabsorption should not take this medicine.
Tetracycline hydrochloride (with the exception of doxycycline) and other oral antibiotics such as cephalosporin cause a degree of antibiotic inactivation and must be administered separately from TUSSMUCO and with an interval of at least 2 hours.
Antitussive medicines and TUSSMUCO should not be administered concomitantly because reducing the cough reflex may lead to a build-up of bronchial secretions.
Activated charcoal may reduce the effect of TUSSMUCO.
Concurrent administration of nitroglycerin and TUSSMUCO causes significant hypotension and leads to temporal artery dilation with possible onset of headache.
If concurrent administration of nitroglycerin and TUSSMUCO is required, patients should be monitored and warned for hypotension that can be severe and accompanied by a headache.
TUSSMUCO can affect the colometric determination of salicylates.
In urine tests, TUSSMUCO can affect the results of determination of ketone bodies. The dissolution (mixing) of TUSSMUCO together with other medicines is not recommended.
Safety and efficacy has not been established (see section 4.3).
Safety has not been established. There is insufficient information on the excretion of N-acetylcysteine in human milk. A risk to the newborns/infants cannot be excluded.
No data available.
No studies on the effects on the ability to drive or use machines have been performed. TUSSMUCO has no known effect on the ability to drive and use machines.
Patients should not drive, use machinery or perform any tasks that require concentration until they are certain that TUSSMUCO do not adversely affect their ability to do so safely (see section 4.8).
| System organ class | Frequent | Less frequent | Frequency unknown (cannot be estimated from the available data) |
|---|---|---|---|
| Immune system disorders | Anaphylactic reactions up to shock, hypersensitivity (allergic reactions), anaphylactic/anaphylactoid reaction | ||
| Nervous system disorders | Headache | ||
| Ear and labyrinth disorders | Tinnitus | ||
| Cardiac disorders | Tachycardia | ||
| Vascular disorders | Haemorrhage, hypotension | ||
| Respiratory, thoracic and mediastinal disorders | Dyspnoea, bronchospasm - predominantly in patients with hyper reactive bronchial system in association with bronchial asthma | ||
| Gastrointestinal disorders | Stomatitis, abdominal pain, diarrhoea, vomiting, heartburn, nausea, dyspepsia | ||
| Skin and subcutaneous tissue disorders | Pruritus, urticaria, exanthema, rash, angioedema, Stevens- Johnson syndrome and toxic epidermal necrolysis (TEN). | ||
| General disorders and administrative site conditions | Fever | Oedema of the face |
The occurrence of serious skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in temporal association with the use of Nacetylcysteine, as contained in TUSSMUCO.
In case of recurrent skin and mucosal lesions, medical advice should be sought at once and the use of N-acetylcysteine terminated immediately.
A decreased blood platelet aggregation in the presence of N-acetylcysteine has been confirmed by various studies. The clinical relevance has not yet been clarified to date.
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare providers are asked to report any suspected adverse reactions to:
SAHPRA: https://www.sahpra.org.za/health-products-vigilance/
Aspen Pharmacare:
E-mail: Drugsafety@aspenpharma.com
Tel: 0800 118 088
In the absence of compatibility studies, this medicine must not be mixed with other medicines.
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