Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2022 Publisher: Neon Healthcare Ltd., 8 The Chase, John Tate Road, Hertford, SG13 7NN, United Kingdom
Hypersensitivity to the active substance(s), to other macrolide antibiotics, or to any of the excipients listed in section 6.1.
As with other macrolides, rare serious allergic reactions, including acute generalised exanthematous pustulosis (AGEP) have been reported. If an allergic reaction occurs, the drug should be discontinued and appropriate therapy should be instituted.
Physicians should be aware that reappearance of the allergic symptoms may occur when symptomatic therapy is discontinued.
Cross resistance may occur with other antibiotics of the macrolide group and also with lincomycin and clindamycin. Contact with the eyes or the mucous membranes of the nose and mouth should be avoided.
No interaction studies have been performed.
Zineryt can be used during pregnancy and during breast-feeding (but it should not be used on the chest).
None.
System Organ Class | Rare (≥1/10,000 to <1/1000) | Very rare (<1/10,000) | Not known (cannot be estimated from the available data) |
---|---|---|---|
Immune system disorders | Hypersensitivity | ||
Skin and subcutaneous tissue disorders | Pruritus, Erythema, Skin irritation, Skin burning sensation, Dry skin, Skin exfoliation | Acute generalised exanthematous pustulosis (AGEP) |
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 at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Not applicable.
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