Zipzoc 20%, Impregnated Dressing
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
24-11-2020
Summary of Product characteristics
(SPC)
05-11-2020
Active ingredient:
Zinc oxide
Available from:
Evolan Pharma AB
ATC code:
D09AB; D09AB01
INN (International Name):
Zinc oxide
Dosage:
. percent volume/volume
Pharmaceutical form:
Impregnated dressing
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Zinc bandages; zinc bandage without supplements
Authorization status:
Marketed
Authorization date:
1998-07-13
Patient Information leaflet
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZIPZOC 20 % IMPREGNATED DRESSING (STOCKING)
zinc oxide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor, pharmacist or nurse
have told you.
•
Keep this leaflet. You may need to read it again
•
Ask you pharmacist or nurse if you need more information or advice.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not list in this leaflet. See section 4.
•
You must talk to a doctor if you do not feel better or if you feel
worse.
WHAT IS IN THIS LEAFLET
1.
What Zipzoc is and what it is used for
2.
What you need to know before you use Zipzoc
3.
How to use Zipzoc
4.
Possible side effects
5.
How to store Zipzoc
6.
Contents of the pack and other information
1.
WHAT ZIPZOC IS AND WHAT IT IS USED FOR
ZIPZOC is a sterile rayon stocking impregnated with an ointment
containing 20% w/w Zinc Oxide.
Zinc Oxide has a soothing and protective effect.
ZIPZOC IS USED:
•
as an aid in the treatment of chronic venous leg ulcers
•
if you have poor circulation in your veins (causing poor
return of circulating blood from the feet and legs to the heart, known
as chronic venous
insufficiency), as a primary contact layer under compression bandaging
or hosiery.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ZIPZOC
DO NOT USE ZIPZOC IF YOU:
-
are allergic to zinc oxide or any of the other ingredients of this
medicine (listed in section 6)
-
have used Zipzoc before and suffered a reaction to it
-
suffer from arterial leg ulcers (ulcers caused by poor circulation in
arteries rather than veins).
Consult your doctor, pharmacist or nurse immediately if you are unsure
what kind of ulcer you have.
WARNINGS AND PRECAUTIONS
If the outer bandage is inappropriate or the stocking is not changed
often enough it can cause the
stocking to dry out.
Do not smoke or go near naked flames - risk of severe
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
04 November 2020
CRN009TD5
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zipzoc 20%, Impregnated Dressing
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
20 % Zinc Oxide
Each stocking (80 cm x 7 cm) 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 venous leg ulcers.
Where chronic venous insufficiency exists the stocking can
be used as a primary contact layer under compression bandaging or
hosiery.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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 bandaging.
The duration and frequency of application will depend on the clinical
circumstances, but Zipzoc must be changed no less
frequently than weekly.
Method of administration
For cutaneous use.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1
Arterial leg ulcers.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If the 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
INTERACTIONS
None known
Health Products Regulatory Authority
04 November 2020
CRN009TD5
Page 2 of 3
4.6 FERTILITY, PREGNANCY AND LACTATION
There is no evidence to suggest Zipzoc should not be used during
pregnancy or lactation.
4.7 EFFECTS ON ABILITY TO DR
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