MUCOSOLV Capsule Ref.[50533] Active ingredients: Carbocisteine

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

4.3. Contraindications

Hypersensitivity to any of the ingredients, including excipients listed in section 6.1.

Use in patients with active peptic ulceration.

4.4. Special warnings and precautions for use

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.

4.5. Interaction with other medicinal products and other forms of interaction

No known interactions.

4.6. Pregnancy and lactation

Safety in pregnancy and lactation has not been established.

4.7. Effects on ability to drive and use machines

MUCOSOLV CAPSULES have no or negligible influence on the ability to drive and use machines.

4.8. Undesirable effects

Immune system disorders

Frequency unknown: Anaphylactic reactions, allergic skin eruption and fixed drug eruption

Gastrointestinal disorders

Frequent: Nausea, diarrhoea, gastric discomfort

Less frequent: Gastro-intestinal bleeding

Frequency unknown: vomiting

Skin and subcutaneous tissue disorders

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.

General disorders and administrative site conditions

Less frequent: Headache

Reporting of suspected adverse reactions

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).

6.2. Incompatibilities

Not applicable.

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