PanOxyl 5 cream

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Benzoyl peroxide

Available from:

Haleon UK Ltd

ATC code:

D10AE01

INN (International Name):

Benzoyl peroxide

Dosage:

50mg/1gram

Pharmaceutical form:

Cutaneous cream

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13060100; GTIN: 5011091100246

Patient Information leaflet

PanOxyl 5 Cream
PACKAGE LEAFLET: INFORMATION FOR THE USER
PANOXYL 5 CREAM
5% W/W BENZOYL PEROXIDE
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This medicine is available without prescription. However, you still
need to use
PanOxyl carefully to get the best results from it.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
You must see your doctor if your symptoms worsen or do not improve.
•
If any of the side effects gets serious, or if you notice any side
effects not listed
in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What PanOxyl is and what it is used for
2.
Before you use PanOxyl
3.
How to use PanOxyl
4.
Possible side effects
5.
How to store PanOxyl
6.
Further information
1.
WHAT PANOXYL IS AND WHAT IT IS USED FOR
The name of your medicine is PanOxyl 5 Cream (called PanOxyl in this
leaflet).
PanOxyl contains an active ingredient called benzoyl peroxide.
Benzoyl peroxide works by killing the bacteria on your skin that can
cause acne
PanOxyl is used to treat acne (spots).
PanOxyl is for use by adults and adolescents with acne. IT IS NOT FOR
USE BY
CHILDREN.
2.
BEFORE YOU USE PANOXYL
DO NOT USE PANOXYL IF:
•
you are allergic (_hypersensitive) _to benzoyl peroxide or any of the
other
ingredients (listed in Section 6).
Do not use PanOxyl if the above applies to you. If you are not sure,
ask your
pharmacist or doctor before you use this medicine.
TAKE SPECIAL CARE WITH PANOXYL
•
Only use PanOxyl on your skin. Avoid contact with the eyes, eyelids,
mouth, lips and inside the nose. If contact occurs, rinse with water.
•
TAKE CARE NOT TO USE PANOXYL ON AREAS OF BROKEN SKIN, such as cuts
or grazes. If contact with these areas occurs, wash the affected area
immediately with water.
•
Take care when applying this product to the neck and other sensitive
areas, since skin irritation is more likely to occur.
Page 1
STIEFEL CONFIDENTIAL
Page 1 of 5
PanOxyl 5 Cream
•
PanOxyl

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
PanOxyl 5 Cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Benzoyl peroxide 5.0% w/w
Also contains propylene glycol.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Cream for cutaneous use
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PanOxyl 5 Cream is indicated for the treatment of acne vulgaris.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Adults and adolescents _
Apply a thin film to the whole of the affected area once daily
preferably after
washing and drying the skin.
If excessive dryness or peeling occurs application should be
temporarily interrupted
as per physician instruction or patient tolerability.
Maximum lesion reduction may be expected after approximately eight to
twelve
weeks of drug use. Continued use is normally required to maintain a
clinical response.
_Elderly patients _
There are no specific recommendations for use in the elderly.
_ Paediatric Population _
Safety and effectiveness of topical benzoyl peroxide in children under
the age of 12
has not been established.
4.3
CONTRAINDICATIONS
Patients with a known hypersensitivity to any of the ingredients
should not use
the product.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Avoid
contact
with
the
eyes,
eyelids,
mouth,
lips
and
other
mucous
membranes. Contact with broken skin should be avoided. Care should be
taken
when applying the product to the neck and other sensitive areas.
During
the
first
weeks
of
treatment,
a
sudden
increase
in
peeling
and
reddening will occur in most patients and will normally subside in a
day or
two if treatment is temporarily discontinued.
Patients
should
be
advised
that
excessive
application
will
not
improve
efficacy, but may increase the risk of skin irritation.
Concomitant topical acne therapy should be used with caution because a
possible cumulative irritancy may occur, which sometimes may be
severe,
especially with the use of peeling, desquamating, or abrasive agents.
If severe local irritancy occurs (e.g. severe erythema,