BREVOXYL 4% CREAM

Active substance: BENZOYL PEROXIDE

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Brevoxyl 4% Cream – PL 19494/0067
Patient Information leaflet –
Sligo Manufacturing Site

v6

Package leaflet: Information for the user

6

Brevoxyl
Benzoyl peroxide

7333H

®

4% Cream

GSK-IRL-Sligo-IESLI
Stiefel; United Kingdom-GBR

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, 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 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 on your neck.

• Brevoxyl can make your skin more sensitive to the harmful
effects of the sun. Avoid the use of sunbeds/lamps and
minimise the time you spend in the sun. You should use
a sunscreen and wear protective clothing while using
Brevoxyl.
• Avoid contact with hair, dyed or coloured fabrics, (including
clothing, towels and bed linen) furniture or carpeting.
Brevoxyl can bleach these materials.
Children
Do not give this medicine to children under twelve years. It is
not known if it works or if it is safe for them.
Using other medicines
Tell your doctor or pharmacist if you are taking any other
medicines, if you’ve taken any recently, or if you start taking
new ones. This includes medicines bought without a prescription.
In particular, tell your doctor or pharmacist:
• if you are using any other acne treatment. If used at the
same time, it may make skin irritation worse
• if you are using other acne medicines containing tretinoin,
isotretinoin or tazarotene. If used at the same time, Brevoxyl
may make these treatments less effective
• if you are using sulphonamide-containing products such
as dapsone and sulfacetamide. If used at the same time as
Brevoxyl, your skin or facial hair may turn yellow or orange.
This will not be permanent.
Check with your doctor or pharmacist if you think any of
these may apply to you. Your doctor or pharmacist will decide if
you should take Brevoxyl with these medicines or you may need
to use your medicines at different times of the day (for example,
one in the morning and the other at bedtime).
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before using Brevoxyl
if you are pregnant or breast-feeding.
There is only limited information about the safety of Brevoxyl in
pregnant women.
• Tell your doctor or pharmacist if you are pregnant,
planning to become pregnant or become pregnant during
treatment with Brevoxyl.
It is not known whether benzoyl peroxide can pass into breast
milk. If you are breast-feeding, you must check with your doctor
or pharmacist before you use Brevoxyl.
• Do not use Brevoxyl on your breast if you are breastfeeding.
7333H

Brevoxyl Cream
1

K

S1LFLT-2D

FRONT PAGE
Page 1 of 2

Important information about some of the ingredients of
Brevoxyl
• Brevoxyl contains propylene glycol alginate. This may
cause skin irritation.
• Brevoxyl contains stearylalcohol and cetyl alcohol. These
may cause local skin reactions (e.g. contact dermatitis).
3. How to use Brevoxyl
Always use Brevoxyl exactly as your doctor or pharmacist has told
you to. Check with your doctor or pharmacist if you are not sure.
• Use Brevoxyl once or twice a day as instructed by your
doctor or pharmacist.
• Start with one application daily, preferably in the evening,
then gradually increase to twice daily (morning and evening),
as instructed.
• During the first weeks of treatment a sudden increase in
peeling and reddening of the skin will occur in most people.
If this causes you problems, try using Brevoxyl less often,
or stop using it for a few days until the irritation goes away
then start again. Stop using Brevoxyl if the irritation does
not go away.
• It may take 4 to 6 weeks before you see an improvement
of your skin. You may need to use this treatment for longer
before you see the full effects. This is normal for acne
treatments.
• After 6 to 8 weeks if your acne is no better or it gets worse,
talk to your doctor or pharmacist.
• Use Brevoxyl for as long as your doctor or pharmacist tells
you to. Continue using this medicine until the acne has gone.
• Do not stop using it without asking for advice. If you stop too
soon your acne may come back.
How to apply Brevoxyl
1. Completely remove any make-up.
2. Wash your hands and the affected area and gently dry.
3. Put a thin layer of Brevoxyl cream on the affected skin,
using your fingertips. If the cream does not rub into your
skin easily, you are using too much.
4. Apply to all of the area of your skin that has acne, not
just each spot. You may notice a mild burning sensation.
If this becomes severe, stop using Brevoxyl and see your
doctor.
5. Take care not to use too much Brevoxyl. Applying too
much, or more often than advised, will not help your acne
clear up more quickly and may cause skin irritation.
6. Wash your hands after using the cream.
If you forget to use Brevoxyl
• Do not use a double dose to make up for forgotten doses.
• Apply the next dose at the usual time.
If you accidentally swallow Brevoxyl
• Contact your doctor or pharmacist for advice. If you
accidentally get Brevoxyl in your mouth, rinse it with plenty
of water.
4. Possible side effects
Like all medicines, Brevoxyl can cause side effects, although not
everybody gets them.
Severe allergic reactions:
Severe allergic reactions have occurred in a very small number
of people but their exact frequency is not known. Signs include:
• raised and itchy rash (hives)
• swelling, sometimes of the face or mouth (angioedema),
causing difficulty in breathing
• collapse.

Contact a doctor immediately if you get these symptoms.
Stop taking Brevoxyl immediately
Other side effects include:
Very common: may affect more than 1 in 10
people
• peeling of the skin and redness at the site of application
Common: may affect up to 1 in 10 people
• dryness, itching or sensitivity of the skin at
the site of application
Uncommon: may affect up to 1 in 100 people:
• burning sensation.
Not known (cannot be estimated from the available data)
At site of application:
• rash
• discoloration of the skin
• other skin reactions such as irritation and pain.
Tell your doctor or pharmacist if any of these side effects
become severe or troublesome, or if you notice any side effects
not listed in this leaflet.
5. How to store Brevoxyl
• Keep out of the reach and sight of children.
• Do not store above 25°C.
• Do not use Brevoxyl after the expiry date which is printed on
the tube and carton.
• Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.
6. Further information
What Brevoxyl contains
• The active ingredient is benzoyl peroxide. Brevoxyl contains
4% w/w benzoyl peroxide.
• The other ingredients are: cetyl alcohol, stearyl alcohol,
macrogol cetostearyl ether, simethicone emulsion, propylene
glycol alginate, dimethyl isosorbide, fragrance (X-23304)
and water.
What Brevoxyl looks like and contents of the pack
Brevoxyl Cream is a white to off white cream and comes in
40 g tubes.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
GlaxoSmithKline UK Limited
Stockley Park West, Uxbridge,
Middlesex UB11 1BT, UK
Manufacturer:
Stiefel Laboratories (Ireland) Ltd.
Finisklin Business Park, Sligo, Ireland.
PL 19494/0067
MA 300/00601
Date of preparation:
January 2013

7333H

6
7333H
GSK-IRL-Sligo-IESLI
Stiefel; United Kingdom-GBR
Brevoxyl Cream
1

K

S1LFLT-2D

BACK PAGE
Page 2 of 2

Brevoxyl 4% Cream – PL 19494/0067
Patient Information leaflet –
Barnard Castle Manufacturing Site

Package leaflet: Information for the user

v6

6
10000000104364
GSK-GBR-Barnard Castle-UKBAR

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 see your 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, 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 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 sensitive
to the harmful effects of the sun. Avoid the

use of sunbeds/lamps and minimise the
time you spend in the sun. You should use
a sunscreen and wear protective clothing
while using Brevoxyl.
• Avoid contact with hair, dyed or coloured
fabrics (including clothing, towels and bed
linen) furniture or carpeting. Brevoxyl can
bleach these materials.
Children
Do not give this medicine to children under
twelve years. It is not known if it works or if it
is safe for them.
Using other medicines
Tell your doctor or pharmacist if you are
taking any other medicines, if you’ve taken
any recently, or if you start taking new ones.
This includes medicines bought without a
prescription.
In particular, tell your doctor or pharmacist:
• if you are using any other acne treatment.
If used at the same time, it may make skin
irritation worse
• if you are using other acne medicines
containing tretinoin, isotretinoin or
tazarotene. If used at the same time,
Brevoxyl may make these treatments less
effective
• if you are using sulphonamide-containing
products such as dapsone and
sulfacetamide. If used at the same time
as Brevoxyl, your skin or facial hair may
turn yellow or orange. This will not be
permanent.
Check with your doctor or pharmacist if
you think any of these may apply to you. Your
doctor or pharmacist will decide if you should
take Brevoxyl with these medicines or you may
need to use your medicines at different times
of the day (for example, one in the morning
and the other at bedtime).
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice
before using Brevoxyl if you are pregnant or
breast-feeding.
There is only limited information about the
safety of Brevoxyl in pregnant women.
Tell your doctor or pharmacist if you are
pregnant, planning to become pregnant
or become pregnant during treatment with
Brevoxyl.
It is not known whether benzoyl peroxide can
pass into breast milk. If you are breast-feeding,
you must check with your doctor or pharmacist
before you use Brevoxyl
• Do not use Brevoxyl on your breast if you
are breast-feeding.
Important information about some of the
ingredients of Brevoxyl
• Brevoxyl contains propylene glycol alginate.
This may cause skin irritation.
• Brevoxyl contains stearylalcohol and
cetyl alcohol. These may cause local skin
reactions (e.g. contact dermatitis).

Stiefel; United Kingdom-GBR
Brevoxyl Cream
1

K

JMF032

1000000
0104364

Front
Page 1 of 2

3. How to use Brevoxyl
Always use Brevoxyl exactly as your doctor or
pharmacist has told you to. Check with your
doctor or pharmacist if you are not sure.

• Use Brevoxyl once or twice a day as
instructed by your doctor or pharmacist
• Start with one application daily, preferably
in the evening, then gradually increase
to twice daily (morning and evening) as
instructed.
• During the first weeks of treatment a
sudden increase in peeling and reddening
of the skin will occur in most people. If this
causes you problems, try using Brevoxyl
less often, or stop using it for a few days
until the irritation goes away then start
again. Stop using Brevoxyl if the irritation
does not go away.
• It may take 4 to 6 weeks before you see an
improvement of your skin. You may need
to use this treatment for longer before you
see the full effects. This is normal for acne
treatments.
• After 6 to 8 weeks if your acne is no better
or it gets worse, talk to your doctor or
pharmacist.
• Use Brevoxyl for as long as your doctor or
pharmacist tells you to. Continue using this
medicine until the acne has gone.
• Do not stop using it without asking for
advice. If you stop too soon your acne may
come back.
How to apply Brevoxyl
1. Completely remove any make-up.
2. Wash your hands and the affected area and
gently dry.
3. Put a thin layer of Brevoxyl cream on the
affected skin using your fingertips. If the
cream does not rub into your skin easily,
you are using too much.
4. Apply to all of the area of your skin that
has acne, not just each spot. You may
notice a mild burning sensation. If this
becomes severe, stop using Brevoxyl and
see your doctor.
5. Take care not to use too much Brevoxyl.
Applying too much, or more often than
advised, will not help your acne clear up
more quickly and may cause skin irritation.
6. Wash your hands after using the cream.
If you forget to use Brevoxyl
• Do not use a double dose to make up for
forgotten doses.
• Apply the next dose at the usual time.
If you accidentally swallow Brevoxyl
• Contact your doctor or pharmacist for
advice. If you accidentally get Brevoxyl in
your mouth, rinse it with plenty of water.

Contact a doctor immediately if you get
these symptoms. Stop taking Brevoxyl
immediately.
Other side effects include:
Very common: may affect more than 1 in 10
people
• peeling of the skin and redness at the site
of application
Common: may affect up to 1 in 10 people
• dryness, itching or sensitivity of the skin at
the site of application
Uncommon: may affect up to 1 in 100 people:
• burning sensation.
Not known (cannot be estimated from the
available data)
At site of application:
• rash
• discoloration of the skin
• other skin reactions such as irritation and
pain.
Tell your doctor or pharmacist if any of these
side effects become severe or troublesome,
or if you notice any side effects not listed in
this leaflet.

5. How to store Brevoxyl
• Keep out of the reach and sight of children.
• Do not store above 25°C.
• Do not use Brevoxyl after the expiry date
which is printed on the tube and carton.
• Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

6
10000000104364
GSK-GBR-Barnard Castle-UKBAR
Stiefel; United Kingdom-GBR
Brevoxyl Cream
1

K

JMF032

6. Further information
What Brevoxyl contains
• The active ingredient is benzoyl peroxide.
Brevoxyl contains 4% w/w benzoyl peroxide.
• The other ingredients are: cetyl alcohol,
stearyl alcohol, macrogol cetostearyl ether,
simethicone emulsion, propylene glycol
alginate, dimethyl isosorbide, fragrance
(X-23304) and water.
What Brevoxyl looks like and contents of
the pack
Brevoxyl Cream is a white to off white cream
and comes in 50 g tubes.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
GlaxoSmithKline UK Limited
Stockley Park West, Uxbridge,
Middlesex
UB11 1BT, UK
Manufacturer:
Glaxo Operations UK Ltd
Harmire Road, Barnard Castle,
Co. Durham, DL12 8DT, UK
PL No 19494/0067
MA No 300/00601
Date of preparation:
January 2013

4. Possible side effects
Like all medicines, Brevoxyl can cause side
effects, although not everybody gets them.
Severe allergic reactions:
Severe allergic reactions have occurred in a
very small number of people but their exact
frequency is not known. Signs include:
• raised and itchy rash (hives)
• swelling, sometimes of the face or mouth
(angioedema), causing difficulty in breathing
• collapse.

1000000
0104364

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Page 2 of 2

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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