Home | About the eMC | Help | Mobile
eMC - trusted, up to date and comprehensive information about medicines
Link to eMC medicine guides website
eMC homepage
Advanced search
Get Medicines Compendium UK app here

Astellas Pharma Ltd
3rd Floor, Future House, The Glanty, Egham, Surrey, TW20 9AH
Telephone: +44 (0)1784 419615
Fax: +44 (0)1784 419583
Medical Information Direct Line: 0800 783 5018
Medical Information e-mail: medinfo@gb.astellas.com

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Summary of Product Characteristics last updated on the eMC: 05/07/2011
SPC Zineryt


Go to top of the page
1. NAME OF THE MEDICINAL PRODUCT

Zineryt.


Go to top of the page
2. QUALITATIVE AND QUANTITATIVE COMPOSITION

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


Go to top of the page
3. PHARMACEUTICAL FORM

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


Go to top of the page
4. CLINICAL PARTICULARS

Go to top of the page
4.1 Therapeutic indications

Topical treatment of acne vulgaris.


Go to top of the page
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.


Go to top of the page
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.


Go to top of the page
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.


Go to top of the page
4.5 Interaction with other medicinal products and other forms of interaction

None known.


Go to top of the page
4.6 Pregnancy and lactation

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


Go to top of the page
4.7 Effects on ability to drive and use machines

None.


Go to top of the page
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

 


Go to top of the page
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.


Go to top of the page
5. PHARMACOLOGICAL PROPERTIES

Go to top of the page
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.


Go to top of the page
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.


Go to top of the page
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.


Go to top of the page
6. PHARMACEUTICAL PARTICULARS

Go to top of the page
6.1 List of excipients

Di-isopropyl sebacate, ethanol.


Go to top of the page
6.2 Incompatibilities

None known.


Go to top of the page
6.3 Shelf life

2 years

8 weeks after constitution


Go to top of the page
6.4 Special precautions for storage

Do not store above 25oC.


Go to top of the page
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.


Go to top of the page
6.6 Special precautions for disposal and other handling

None


Go to top of the page
Administrative Data

Go to top of the page
7. MARKETING AUTHORISATION HOLDER

Astellas Pharma Ltd

3rd Floor

Future House

The Glanty

Egham

Surrey

TW20 9AH

United Kingdom


Go to top of the page
8. MARKETING AUTHORISATION NUMBER(S)

0166/0109.


Go to top of the page
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

First authorisation granted 7 March 1990/ 29 March 2001


Go to top of the page
10. DATE OF REVISION OF THE TEXT

16/06/2011


Go to top of the page
11. LEGAL CATEGORY

POM



More information about this product

  • Patient Information Leaflets (PILs):

    Zineryt

Link to this document from your website: http://www.medicines.org.uk/emc/medicine/2268/SPC/


Active Ingredients/Generics

 
  erythromycin
  zinc acetate