Zineryt 40 mg + 12 mg powder and solvent for cutaneous solution

Zineryt is indicated in children, adults and the elderly. It is used as topical treatment of acne vulgaris.

For cutaneous use. Apply twice daily over the whole of the affected area for a period of 10 to 12 weeks.

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 after systemic administration. 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.

Tabulated list of adverse reactions

*Reported after systemic administration

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.

It is not expected that overdosage would occur in normal use. Patients showing idiosyncratic hypersensitivity should wash the treated area with copious water and simple soap.

Pharmacotherapeutic group: Anti-acne, ATC code: D10A F52

Erythromycin is known to be efficacious, at 4%, in the topical treatment of acne vulgaris. Zinc, topically, is established as an aid to wound healing. The zinc acetate is solubilised by complexing with the erythromycin, and delivery of the complex is enhanced by the chosen vehicle.

Absorption

The complex does not survive in the skin, and erythromycin and zinc penetrate independently. The erythromycin penetrates, and is partially systemically absorbed (0 - 10% in vitro, 40 - 50% in animal studies); that portion absorbed is excreted in 24 – 72 hours. The zinc is not absorbed systemically.

Non-clinical data from repeated dose toxicity and reproduction and developmental toxicity studies reveal no additional hazard other than those described elsewhere in the SPC.

Di-isopropyl sebacate, ethanol.

Not applicable.

2 years

8 weeks after constitution

Do not store above 25° C.

Screw-capped HDPE bottles; an applicator assembly is fitted when dispensed. When constituted packs are of 30 ml and 90 ml.

No special requirements.