Zipzoc 20% Impregnated Dressing
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zipzoc 20%, impregnated dressing
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
20% Zinc Oxide
Each stocking (80cm x 7cm) contains about 41.5g of ointment For a full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Impregnated dressing
Zipzoc is a sterile rayon stocking impregnated with an ointment containing Zinc Oxide
4. CLINICAL PARTICULARS
4.1. Therapeutic Indications
To be used as an aid in the treatment of chronic leg ulcers. Where chronic venous insufficiency exists the medicated stocking can be used as a primary contact layer under compression bandaging or hosiery.
4.2. Posology and Method of Administration
For cutaneous use.
Zipzoc should be applied to cover the lower leg from the base of the toes to below the knee. All folds should be smoothed out. To protect clothes from Zipzoc a suitable outer bandage should be worn. If chronic venous insufficiency exists, Zipzoc can be used as a primary contact layer under suitable compression bandaging.
The duration and frequency of application will depend on the clinical circumstances, but Zipzoc must be changed no less frequently than weekly.
4.3. Contra-Indications
Arterial leg ulcers.
Known hypersensitivity to zinc oxide or the excipients in the ointment.
4.4. Special Warnings and Special Precautions for Use
If outer bandage is inappropriate or the stocking is not changed with sufficient frequency it can cause the stocking to dry out.
4.5. Interaction with other Medicinal Products and other Forms of Interaction
None known.
4.6. Pregnancy and Lactation
There is no evidence to suggest Zipzoc should not be used during pregnancy or lactation.
4.7. Effects on Ability to Drive and Use Machines
It is unlikely to have an effect.
4.8. Undesirable Effects
General disorders & administration site conditions
Very rare: Application site pain Very rare: Oedema
Skin & subcutaneous tissue disorders
Very rare: Application site folliculitis Very rare: Erythema
4.9.
Overdose
None known
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic Properties
ATC-code: D09A B01
The stocking consists of a tubular rayon gauze impregnated with zinc oxide Ph. Eur. 20% in an ointment base. Zinc oxide has a soothing and protective effect. Zipzoc has no effect on the underlying condition of chronic venous leg ulcers but can be used under appropriate compression bandaging where chronic venous insufficiency is the problem.
5.2. Pharmacokinetic Properties
Not applicable.
5.3. Pre-clinical Safety Data
Nothing relevant to add to the prescribing information.
6. PHARMACEUTICAL PARTICULARS
6.1. List of Excipients
Ointment base consists of:
Liquid Paraffin White Soft Paraffin
6.2. Incompatibilities
Not applicable
3 years.
Nature and Content of Container
Polyethylene aluminium foil laminated pouches, each pouch containing a single stocking. The outer carton will contain 1, 4 or 10 pouches.
Each pouch contains a tubular rayon gauze stocking impregnated with about 41.5g of ointment.
Instructions for Use, Handling and Disposal
Zipzoc should be applied to cover the lower leg from the base of the toes to below the knee. All folds should be smoothed out. In the case of excessive calf size care should be taken to apply the stocking without constricting the lower leg. A suitable outer bandage or dressing should be used to prevent soiling of clothes. If chronic venous insufficiency exists, Zipzoc can be used as a primary contact layer under suitable compression and may be applied for one week.
7
Smith & Nephew Healthcare Limited Healthcare House 101 Hessle Road Hull,
HU3 2BN
8
PL 14038/0010
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
01/10/2006
10 DATE OF REVISION OF THE TEXT
05/10/2010