Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: Cipla Medpro (Pty) Ltd., Building 9, Parc du Cap, Mispel Street, Bellville, 7530, RSA Customer care: 080 222 6662
Hypersensitivity to any of the ingredients, including excipients listed in section 6.1.
Use in patients with active peptic ulceration.
MUCOSOLV CAPSULES must be used with caution in patients with a history of peptic ulcer or duodenal disease because of the risk that mucolytics may disrupt the gastric mucosal barrier.
No known interactions.
Safety in pregnancy and lactation has not been established.
MUCOSOLV CAPSULES have no or negligible influence on the ability to drive and use machines.
Frequency unknown: Anaphylactic reactions, allergic skin eruption and fixed drug eruption
Frequent: Nausea, diarrhoea, gastric discomfort
Less frequent: Gastro-intestinal bleeding
Frequency unknown: vomiting
Less frequent: Skin rashes
Frequency unknown: allergic skin eruptions. Isolated cases of dermatitis bullous such as Stevens-Johnson syndrome and erythema multiforme have also been reported.
Less frequent: Headache
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8 and to Cipla Medpro (Pty) Ltd at drugsafetysa@cipla.com or telephone 080 222 6662 (toll free).
Not applicable.
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