Axsain 0.075% w/w Cream

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Capsaicin

Available from:

Cephalon UK Limited

ATC code:

M02AB; M02AB01

INN (International Name):

Capsaicin

Dosage:

0.075 percent weight/weight

Pharmaceutical form:

Cream

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Capsaicin and similar agents; capsaicin

Authorization status:

Marketed

Authorization date:

1994-06-14

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
AXSAIN 0.075% W/W CREAM
Capsaicin 0.075% 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 your 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 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 Axsain is and what it is used for
2.
What you need to know before you use Axsain
3.
How to use Axsain
4.
Possible side effects
5.
How to store Axsain
6.
Contents of the Pack and other information
1.
WHAT AXSAIN IS AND WHAT IT IS USED FOR
The name of this medicine is Axsain cream. The active ingredient in
this medicine is capsaicin which
is a naturally occurring substance found in plants.
Axsain cream is used to relive pain arising from nerves near to the
surface of the skin. This can
happen after having Shingles (Herpes Zoster).
Axsain cream is also used to relieve pain in patients who have nerve
damage to their hands or feet
caused by diabetes.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE AXSAIN CREAM
DO NOT USE AXSAIN 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 AXSAIN 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 treated areas, in
which case, they should be washed 30 minutes after applying.
-
Avoid hot baths or showers immediately before or

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Axsain 0.075% w/w Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Capsaicin 0.075% 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
1.
For the symptomatic relief of neuralgia associated with and following
Herpes Zoster infections
(post-herpetic neuralgia) after open skin lesions have healed.
2.
For the symptomatic management of painful diabetic peripheral
polyneuropathy.
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 the affected area 3 or 4
times daily. The cream should be gently rubbed in, there should be no
residue left on the surface. Axsain 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 Axsain with the fingers. Do not apply
near the eyes.
Patients using Axsain for the treatment of painful diabetic peripheral
polyneuropathy should only do so under the
direct supervision of a hospital consultant who has access to
specialist resources. The recommended duration of use in
the first instance is 8 weeks, since there is no clinical trial
evidence of efficacy for treatment of more than 8 weeks
duration. After this time, it is recommended that the patient's
condition should be fully clinically assessed prior to
continuation of treatment, and regularly re-evaluated thereafter, by
the supervising consultant.
Not suitable for use in children.
4.3 CONTRAINDICATIONS
Axsain cream is contra-indicated for use on broken or irritated skin.
Axsain Cream is contra-indicated in patients with known
hypersensitivity to capsaicin or to any of the excipients listed
in section 6.1.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
_