Brevoxyl 4% cream

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Benzoyl peroxide

Beschikbaar vanaf:

Haleon UK Ltd

ATC-code:

D10AE01

INN (Algemene Internationale Benaming):

Benzoyl peroxide

Dosering:

40mg/1gram

farmaceutische vorm:

Cutaneous cream

Toedieningsweg:

Cutaneous

klasse:

No Controlled Drug Status

Prescription-type:

Valid as a prescribable product

Product samenvatting:

BNF: 13060100; GTIN: 5011091102523 5000123113941

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE
USER
BREVOXYL 4%
CREAM
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 Brevoxyl 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 contact a doctor if your symptoms worsen or do not improve.
-
If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please
tell your doctor or pharmacist.
IN THIS LEAFLET
:
1.
What Brevoxyl is and what it is used for
2.
Before you use Brevoxyl
3.
How to use Brevoxyl
4.
Possible side effects
5.
How to store Brevoxyl
6.
Further information
1.
WHAT BREVOXYL IS AND WHAT IT IS USED FOR
The name of your medicine is Brevoxyl 4% Cream (called Brevoxyl in
this leaflet). Brevoxyl contains an
active substance called
BENZOYL PEROXIDE
.
Benzoyl peroxide works by killing bacteria on your skin that cause
acne.
Brevoxyl is used to treat moderate acne (spots).
It helps to:
•
reduce the number of spots
•
stop new blackheads, whiteheads and spots from forming.
Brevoxyl is for use by adults and adolescents aged twelve years or
over.
2.
BEFORE YOU USE BREVOXYL
DO NOT USE BREVOXYL IF:
•
if you are allergic (hypersensitive) to benzoyl peroxide or any of the
other ingredients (listed in Section 6).
Do not use Brevoxyl 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 BREVOXYL
• Only use Brevoxyl on your skin. Keep it away from areas like your
eyes, eyelids, lips, mouth and inside the
nose. If contact with these areas occurs, immediately wash the
affected area with water.
•
TAKE CARE TO AVOID USING
Brevoxyl on broken skin; for example, if you have cuts or grazes.
•
TAKE CARE WHEN USING
Brevoxyl
ON AREAS OF SENSITIVE SKIN
such as your neck
• Brevoxyl can make your skin more sensitiv

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Brevoxyl 4% Cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Benzoyl peroxide 4% w/w as hydrous benzoyl peroxide Ph. Eur.
100 g cream contains 4 g benzoyl peroxide.
Also contains cetyl alcohol, stearyl alcohol and propylene glycol
alginate.
For a full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Cream.
A white to off white cream.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Brevoxyl is indicated for the treatment of moderate acne vulgaris.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adolescents and Adults_: _
Apply a thin film to the whole of the affected area once or twice
daily,
preferably after washing and drying the skin. The patient should start
with one
application daily, preferably in the evening, and then gradually
increase to two
times daily (morning and evening) if tolerated.
If excessive dryness or peeling occurs, frequency of application
should be
reduced or application temporarily interrupted at the physicians
instructions or
according to patient tolerability.
Improvement can generally be seen after 4-6 weeks of treatment.
However,
longer use may be necessary.
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.
Paediatric population_: _
The safety and efficacy of Brevoxyl has not been established in
children under
the age of 12 since acne vulgaris rarely presents in this age group.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Contact with the eyes, eyelids, mouth, lips, other mucous membranes
and
broken skin should be avoided. In case of accidental contact, rinse
well with
water. Care should be taken when applying the product to the neck and
other
sensitive areas.
This product contains propylene glycol alginate, stearyl alcohol and
cetyl
alcohol. Propylene glycol alginate may cause skin irritation. Stearyl
alcohol
and