Brevoxyl 40mg/g cream

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Benzoyl peroxide

Available from:

Avianta Pharma EU Limited

ATC code:

D10AE; D10AE01

INN (International Name):

Benzoyl peroxide

Pharmaceutical form:

Cream

Therapeutic area:

Peroxides; benzoyl peroxide

Authorization status:

Not marketed

Authorization date:

1995-11-13

Patient Information leaflet

LEAFLET
Brevoxyl ® 40mg/g Cream
Benzoyl peroxide
Read all of this leaflet carefully before you start using this
medicine because it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as
your doctor or pharmacist have
told you.
‐keep this leaflet You may need to read it again.
‐ask your pharmacist if you need more information or advice.
‐if you get any side effects, talk to your doctor or pharmacist. His
includes any possible side effects
not listed in this leaflet.
‐you must talk to your doctor if you do not feel better or if you
feel worse after 4 to 6 weeks
WHAT IS IN THIS LEAFLET:
1. What Brevoxyl is and what it is used for
2. what you need to know before you use Brevoxyl
3. How to use Brevoxyl
4. Possible side effects
5. How to store Brevoxyl
Contents of the pack and other information
1. What Brevoxyl is and what it is used for
The name of your medicine is Brevoxyl 40mg/g Vream (called Brevoxyl in
this leaflet). Brevoxyl
contains the active ingredient benzoyl peroxide which works by
fighting the bacteris that can cause
spots.
Brevoxyl is used to treat mild to moderate acne vulgaris in adults and
adolescents. It is not for use by
children. It helps to:
‐reduce the number of spots
‐stop new blackheads, whiteheads and spots from forming
2. What you need to know before you use Brevoxyl
Do not use Brevoxyl if you are allergic to benzoyl peroxide or any of
the other ingredients of this
medicine (listed in section 6). If you are not sure, ask your doctor
or pharmacist before you use this
medicine.
Warnings and precautions
‐avoid contact with the eyes, eyelids, moth, lips, other mucous
membranes and broken skin.
‐take care 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 reactions
(e.g.contact dematitis).
‐do not apply too much as this may icrease the risk of skin
irritation.
‐stop using Brevoxyl if severe local irr

Summary of Product characteristics

Health Products Regulatory Authority
10 June 2022
CRN00CTKH
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Brevoxyl 40mg/g cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of cream contains 40mg of benzoyl peroxide, as the hydrate.
Excipients with known effects:
Propylene glycol alginate 2.5mg/g
Cetyl alcohol 15mg/g
Stearyl alcohol (present in stearyl alcohol and macrogol cetostearyl
alcohol) >48mg/g
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 mild to moderate acne
vulgaris.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS AND ADOLESCENTS
Apply a thin layer to the whole of the affected area once or twice
daily. Wash with soap and water prior to application.
PAEDIATRIC POPULATION
The safety and efficacy of Brevoxyl in children under 12 years of age
has not been established since acne vulgaris rarely
presents in this age group.
ELDERLY PATIENTS
There are no specific recommendations for use in the elderly. Acne
vulgaris does not present in the elderly.
Initial application of the product may be varied at the physician’s
instructions to reflect the patient’s 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
Hypersensitivity to the active substance, benzoyl peroxide, or to any
of the excipients listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Contact with the eyes, eyelids, mouth, lips, other mucous membranes
and broken skin should be avoided.
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).
Health Products Regulatory Authority
10 June 2022
CRN00CTKH
Page 2 of 5
Patients should be advised that excessive applicat