Zineryt

1. Name Of The Medicinal Product

Zineryt.

2. Qualitative And Quantitative Composition

Erythromycin 40 mg and zinc acetate 12 mg per ml on constitution.

3. Pharmaceutical Form

Dry powder bottle and solvent bottle to be admixed on dispensing.

4. Clinical Particulars

4.1 Therapeutic Indications

Topical treatment of acne vulgaris.

4.2 Posology And Method Of Administration

For children, adults, and the elderly. Apply twice daily over the whole of the affected area for a period of 10 to 12 weeks.

4.3 Contraindications

Zineryt is contraindicated in patients who are hypersensitive to erythromycin or other macrolide antibiotics, or to zinc, di-isopropyl sebacate or ethanol.

4.4 Special Warnings And Precautions For Use

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

None known.

4.6 Pregnancy And Lactation

There is no contraindication to the use of Zineryt in pregnancy or lactation.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

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

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

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

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

None known.

6.3 Shelf Life

2 years

8 weeks after constitution

6.4 Special Precautions For Storage

Do not store above 25^oC.

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 And Other Handling

None

Administrative Data

7. Marketing Authorisation Holder

Astellas Pharma Ltd

3^rd Floor

Future House

The Glanty

Egham

Surrey

TW20 9AH

United Kingdom

8. Marketing Authorisation Number(S)

0166/0109.

9. Date Of First Authorisation/Renewal Of The Authorisation

First authorisation granted 7 March 1990/ 29 March 2001

10. Date Of Revision Of The Text

16/06/2011

11. LEGAL CATEGORY

POM