Zacin 0.025% w/w Cream

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Capsaicin

Available from:

Teva B.V.

ATC code:

M02AB

INN (International Name):

Capsaicin

Dosage:

0.025 percent weight/weight

Pharmaceutical form:

Cream

Therapeutic area:

Capsaicin and similar agents

Authorization status:

Marketed

Authorization date:

2010-03-26

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ZACIN
® 0.025% W/W CREAM
capsaicin 0.025% w/w
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
-
If you get any of the side effects, talk to your doctor or
pharmacist.This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Zacin Cream is and what it is used for
2.
What you need to know before you use Zacin Cream
3.
How to use Zacin Cream
4.
Possible side effects
5.
How to store Zacin Cream
6.
Contents of the pack and other information
1.
WHAT ZACIN CREAM IS AND WHAT IT IS USED FOR
The name of this medicine is Zacin Cream. The active ingredient in
this medicine is capsaicin which is a
naturally occurring substance found in plants.
Zacin Cream is used to relieve the pain from osteoarthritis.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ZACIN CREAM
DO NOT USE ZACIN CREAM
-
if you are allergic to capsaicin or any of the other ingredients of
this medicine (listed in section 6).
-
on broken or irritated skin.
This medicine is not suitable for use in children.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using
ZACIN CREAM
-
Keep away from the eyes, nose and mouth (if it does accidentally get
into your eyes, nose and mouth or
onto broken or irritated skin, wash off with plenty of water).
-
Wash your hands immediately after applying the cream, unless the hands
are the treated areas, in which
case, they should be washed 30 minutes after applying.
-
Avoid hot baths or showers immediately before or just after applying
Zacin Cream.
-
Do not apply tight bandages on top of Zacin Cream.
-
Avoid breathing in any vapours from the cream, as this can cause
irritation of the eyes

Summary of Product characteristics

Health Products Regulatory Authority
18 March 2021
CRN00C029
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zacin 0.025% w/w Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
capsaicin 0.025% w/w.
Excipient(s) with known effect
Each cream tube contains;
- 450 mg benzyl alcohol which is equivalent to 0.01 mg/mg
- 3.6g cetyl alcohol which is equivalent to 0.08 mg/mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream
A smooth white cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the symptomatic relief of pain associated with osteoarthritis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults and the elderly:
For topical administration to unbroken skin. Apply only a small amount
of cream (pea size) to affected area 3 or 4 times daily.
The cream should be gently rubbed in, there should be no residue left
on the surface. Zacin may cause transient burning on
application. The burning is observed more frequently when application
schedules of more than 4 times daily are used. Hands
should be washed immediately after application of Zacin unless hands
and fingers are being treated. Zacin should not be
applied near the eyes. Pain relief usually begins within the first
week of treatment and increases with continuing regular
application for the next two to eight weeks.
Not suitable for use in children.
4.3 CONTRAINDICATIONS
Zacin cream is contra-indicated on broken or irritated skin.
Zacin Cream is contra-indicated in patients with hypersensitivity to
the active substance or to any of the excipients listed in
section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Skin irritation has been reported following application of Zacin. The
hands should be washed immediately after application of
the cream, unless the hands are the treated areas, in which case, they
should be washed 30 minutes after application.
Contact with eyes and mucous membranes should be avoided.
Patients should avoid taking a hot bath or shower just before or after
applying Zacin, as it can enha