Zacin 0.025% w/w Cream

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Capsaicin

متاح من:

Cephalon UK Limited

ATC رمز:

M02AB; M02AB01

INN (الاسم الدولي):

Capsaicin

جرعة:

0.025 percent weight/weight

الشكل الصيدلاني:

Cream

نوع الوصفة الطبية :

Product subject to prescription which may be renewed (B)

المجال العلاجي:

Capsaicin and similar agents; capsaicin

الوضع إذن:

Marketed

تاريخ الترخيص:

1999-04-16

نشرة المعلومات

PACKAGE LEAFLET: INFORMATION FOR THE USER
ZACIN 0.025% W/W CREAM
CAPSAICIN 0.025%
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 is and what it is used for
2.
What you need to know before you use ZACIN
3.
How to use ZACIN
4.
Possible side effects
5.
How to store ZACIN
6.
Contents of the Pack and other information
1.
WHAT ZACIN 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 (hypersensitive) to capsaicin or any of the other
ingredients (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 immediaely 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 and breathing
difficulties (includi

خصائص المنتج

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.
Also contains Cetyl Alcohol 8.0% w/w
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 known
hypersensitivity to capsaicin 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.
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