ZINERYT Powder and solvent for solution Ref.[50535] Active ingredients: Erythromycin Zinc acetate

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

4.3. Contraindications

Hypersensitivity to the active substance(s), to other macrolide antibiotics, or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

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.

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

No interaction studies have been performed.

4.6. Fertility, pregnancy and lactation

Zineryt can be used during pregnancy and during breast-feeding (but it should not be used on the chest).

4.7. Effects on ability to drive and use machines

None.

4.8. Undesirable effects

Tabulated list of adverse reactions

System Organ ClassRare (≥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 of suspected adverse reactions

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.

6.2. Incompatibilities

Not applicable.

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