Zineryt
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zineryt
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Erythromycin-zinc complex containing the equivalent of 40 mg/ml erythromycin and 12 mg/ml zinc acetate (as the complex) on constitution.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder and solvent for cutaneous solution.
The packaging contains a bottle of powder, a bottle of solvent and an applicator in a plastic holder.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Zineryt is indicated in children, adults and the elderly. It is used as topical treatment of acne vulgaris.
4.2 Posology and method of administration
For cutaneous use. Apply twice daily over the whole of the affected area for a period of 10 to 12 weeks.
4.3 Contraindications
Hypersensitivity to the active substance(s), to other macrolide antibiotics, or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
4.4
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 Class |
Rare >1/10,000, <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 |
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.
4.9 Overdose
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.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
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.
5.2 Pharmacokinetic properties
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.
5.3 Preclinical safety data
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.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Di-isopropyl sebacate, ethanol.
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
2 years
8 weeks after constitution
6.4 Special precautions for storage
Do not store above 25oC.
6.5 Nature and contents of container
Screw-capped HDPE bottles; an applicator assembly is fitted when dispensed. When constituted packs are of 30 ml and 90 ml.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Astellas Pharma Ltd.
2000 Hillswood Drive
Chertsey
Surrey
KT16 0RS
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 00166/0109
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
Date of first authorisation: 07 March 1990 Date of latest renewal: 19 December 2008
10 DATE OF REVISION OF THE TEXT
31/03/2015