Brevoxyl

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

BENZOYL PEROXIDE

Available from:

Beecham Group PLC 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

ATC code:

D10AE01

INN (International Name):

BENZOYL PEROXIDE 4 % (W/W)

Pharmaceutical form:

CREAM

Composition:

BENZOYL PEROXIDE 4 % (W/W)

Prescription type:

OTC

Therapeutic area:

ANTI-ACNE PREPARATIONS

Authorization status:

Withdrawn

Authorization date:

2005-07-25

Patient Information leaflet

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 a 
medicine called benzoyl peroxide. 
Benzoyl peroxide works by: 
  killing bacteria on your skin 
  having a peeling effect that makes your skin less greasy. 

Brevoxyl is used to treat moderate acne (spots). It helps to: 
  reduce the number of spots 
  stop new blackheads, whiteheads and spots from forming.  

2. 
BEFORE YOU USE BREVOXYL  

DO NOT USE BREVOXYL IF: 
  if you are allergic 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. 

USING OTHER MEDICINES 
Please tell your pharmacist or doctor if you are using or have
recently used any other medicines. This 
includes medicines you get without a prescription, such
as herbal medicines.  
In particular,

Summary of Product characteristics

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 

 100g cream contains 4g benzoyl peroxide. 

 For 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 to  the whole of the affected area once or twice daily. Wash with  soap 
and water prior to application. 

Paediatric use: 
The safety and efficacy of Brevoxyl has not been established in children since 
acne vulgaris rarely presents in this age group. 

Initial application of the product  may be varied at  the physicians instructions 
to reflect the patients skin type and to avoid undesirable
effects. 

Improvement can generally be seen after 4  - 6 weeks of treatment. However, 
longer use may be necessary. 

4.3 
CONTRAINDICATIONS 
Patients with 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,  mouth  and  other  mucous  membranes.    Care 
should  be  taken  when  applying  the  product  to  the  neck  and  other  sensitive 
areas. Propylene glycol alginate may cause skin irritation. Stearyl alcohol and 
cetyl alcohol may cause local skin reaction (e.g. contact
dermatitis). 

It is recommended that exposure to sun or sunlamps should be
minimised. 

Simultaneous  use  of  other  keratolytics  such  as  salicylates  or  sulphur  may 
increase occurrence of skin irritatio