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DUAC ONCE DAILY 10MG/G + 50MG/G GEL

Active substance(s): CLINDAMYCIN PHOSPHATE / HYDROUS BENZOYL PEROXIDE

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United Kingdom
the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
Ireland
HPRA Pharmacovigilance, Earlsfort Terrace,
IRL - Dublin 2; Tel: +353 1 6764971;
Fax: +353 1 6762517. Website: www.hpra.ie;
E-mail: medsafety@hpra.ie

5. How to store DUAC ONCE DAILY GEL
Keep this medicine out of the sight and reach of
children.
Pharmacist: Store in a refrigerator (2°C-8°C). Do
not freeze.
Patient: After you have received DUAC ONCE
DAILY GEL from the pharmacist, do not store it
above 25°C and discard after 2 months.
Do not use this medicine after the expiry date which
is stated on the tube and carton (after “Exp:”). The
expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.

6. Contents of the pack and other
information
What DUAC ONCE DAILY GEL contains
· The active substances are: clindamycin
phosphate, equivalent to clindamycin 1 % w/w
(10 mg/g) and hydrous benzoyl peroxide,
equivalent to anhydrous benzoyl peroxide
5 % w/w (50 mg/g).
· The other ingredients are: carbomer,
dimeticone, disodium lauryl sulfosuccinate,
disodium edetate, glycerol, silica, colloidal
hydrated, poloxamer 182, purified water and
sodium hydroxide.
What DUAC ONCE DAILY GEL looks like and the
contents of the pack
· DUAC ONCE DAILY GEL comes in tubes
containing 5, 6, 15, 25, 30, 50, 55, 60 and
70 grams.
· The gel is off-white yellow in colour.
· Each carton contains one tube of DUAC ONCE
DAILY GEL.
· Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
GlaxoSmithKline UK Limited,
Stockley Park West,
Uxbridge, Middlesex UB11 1BT, UK

GlaxoSmithKline (Ireland) Limited,
12 Riverwalk, Citywest Business Campus,
Dublin 24, Ireland
PL 19494/0075 PA 1077/120/1 MA 300/01401
Manufacturer:
Stiefel Laboratories (Ireland) Ltd,
Finisklin Business Park,
Sligo,
Ireland
Other formats
To listen to or request a copy of this leaflet in
Braille, large print or audio please call, free of
charge:

Package leaflet: Information for the patient

clindamycin + anhydrous benzoyl peroxide
Read all of this leaflet carefully before you
start using this medicine because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your
doctor or pharmacist.
- This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What DUAC ONCE DAILY GEL is and what it is
used for
2. What you need to know before you use DUAC
ONCE DAILY GEL
3. How to use DUAC ONCE DAILY GEL
4. Possible side effects
5. How to store DUAC ONCE DAILY GEL
6. Contents of the pack and other information

0800 198 5000 (UK Only)
Please be ready to give the following information:
Product name: Duac Once Daily 10mg/g +
50mg/g Gel
Reference number: PL 19494/0075
This is a service provided by the Royal National
Institute of Blind People.
This medicinal product is authorised in the
Member States of the EEA under the following
names:
Austria, Denmark, Greece: Clindoxyl Gel
Cyprus: Indoxyl Gel
Czech Republic, Estonia, Hungary, Iceland, Italy,
Latvia, Portugal, Slovak Republic, Spain, Sweden:
Duac Gel
Finland: Clindoxyl Geeli
Germany: Duac Akne Gel
The Netherlands: Duac Acne Gel
Lithuania, Poland: Duac
Ireland, Malta, United Kingdom: Duac Once Daily Gel
This leaflet was last revised in December 2015.
Duac is a registered trade mark of Stiefel
Laboratories Inc.
© 2015 Stiefel Laboratories, Inc. All rights reserved.

1. What DUAC ONCE DAILY GEL is and
what it is used for
DUAC ONCE DAILY GEL contains two medicines:
clindamycin and benzoyl peroxide. DUAC ONCE
DAILY GEL belongs to a group of medicines known
as ‘anti-acne preparations’.
DUAC ONCE DAILY GEL is used for treating mild to
moderate acne on your skin.
· Clindamycin is an antibiotic which stops the
bacteria involved in acne from reproducing
· Benzoyl peroxide reduces blackheads and
whiteheads. It also kills the bacteria involved in
acne.
Used together in DUAC ONCE DAILY GEL, these
work by:
· fighting the bacteria that can cause acne
· treating existing blackheads, whiteheads, and
spots
· lowering the number of red, inflamed acne spots
DUAC ONCE DAILY GEL is for use by adults and
adolescents aged twelve years or over.

2. What you need to know before you use
DUAC ONCE DAILY GEL
Do not use DUAC ONCE DAILY GEL:
· if you are allergic to clindamycin, lincomycin,
benzoyl peroxide or any of the other ingredients
of DUAC ONCE DAILY GEL (listed in Section 6)
Do not use DUAC ONCE DAILY GEL if any of the
above apply to you. If you are not sure, talk to your
doctor or pharmacist before you start using DUAC
ONCE DAILY GEL.
Warnings and precautions
Talk to your doctor or pharmacist before using
DUAC ONCE DAILY GEL.
· Only use DUAC ONCE DAILY GEL on your
skin. Keep it away from areas like your eyes,
lips, mouth or inside your nose.
· Do not use the gel on any irritated areas of
your skin. For example, if you have cuts,
grazes, sunburn or broken skin.

If you accidently get DUAC ONCE DAILY GEL in
your eyes, mouth, lips, or inside your nose rinse
with plenty of water.
· Do not to use too much DUAC ONCE DAILY GEL
on sensitive areas of skin.
· Most patients will experience some skin
redness and peeling during the first few weeks
of treatment. If your skin becomes irritated,
you may need to use an oil-free moisturiser, use
DUAC ONCE DAILY GEL less often, or stop using
it for a short period to allow your skin to recover
and then re-start treatment.
· Stop treatment and see your doctor if skin
irritation is severe (severe redness, dryness,
itching, stinging, or burning) or does not
improve.
· Try not to let DUAC ONCE DAILY GEL come into
contact with coloured fabrics, including
clothing, towels, bed linen, furniture or
carpeting. DUAC ONCE DAILY GEL can bleach
these materials.
· DUAC ONCE DAILY GEL may bleach hair.
7523I

TEXT SIZE CONTAINED IN THIS ARTWORK
Body text size: 9pt
Leading: 9.5pt
Horizontal Scale: 100%
Smallest text size: 9pt
Microtext: Yes

7523I

GSK-IRL-Sligo-IESLI

Ireland-IRL; Stiefel; United Kingdom-GBR Duac Once Daily Gel

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· DUAC ONCE DAILY GEL 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 DUAC ONCE DAILY GEL.
Check with your doctor or pharmacist before
using this medicine if:
· you have ever had any of the following gut
problems: ‘regional enteritis’, ‘ulcerative colitis’,
or ‘antibiotic-associated colitis’.
· If you develop stomach cramps or diarrhoea
that does not improve or is severe, stop using
DUAC ONCE DAILY GEL and contact your
doctor immediately. Antibiotics may cause a
condition that results in severe diarrhoea and
stomach cramps. Although this is unlikely to
happen with antibiotics applied to the skin.
· If you have recently used other clindamycin or
erythromycin-containing medicines, there is an
increased chance that DUAC ONCE DAILY GEL
will not work as well as it should.

Tell your doctor or pharmacist if you have
used any other clindamycin or
erythromycin-containing medicines recently.
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.
Other medicines and DUAC ONCE DAILY GEL
Tell your doctor or pharmacist if you are using, have
recently used or might use any other medicines.
Tell your doctor or pharmacist if you are using any
of the following:
· any other acne treatments including antibiotics
used on your skin
· medicated or ‘abrasive’ soaps and cleansers
· soaps or cosmetics that have a strong drying effect
· products which contain large amounts of
alcohol or ‘astringents’
This is because when used together with
DUAC ONCE DAILY GEL, they may irritate your
skin over time.
DUAC ONCE DAILY GEL may make some acne
medicines less effective when used at the same
time. This includes:
· Some acne medicines that are applied to the
skin which contain tretinoin, isotretinoin or
tazarotene

Tell your doctor or pharmacist if you are also
using one of these medicines. You may need to
use the two products at different times of the day
(e.g. one in the morning and the other in the
evening). Using other acne medicines at the

same time as DUAC ONCE DAILY GEL can
increase the risk of skin irritation.

Stop treatment and see your doctor
if skin irritation becomes severe (severe
redness, dryness, itching, stinging or burning).
· DUAC ONCE DAILY GEL should not be used at the
same time as erythromycin-containing
medicines.
· Applying DUAC ONCE DAILY GEL at
the same time as medicines such as dapsone
and sulfacetamide can cause a temporary
colour-change of skin or facial hair (yellow/
orange colour). This will not be permanent.
· One of the medicines in DUAC ONCE DAILY GEL
can affect how certain general anaesthesia
medicines work (called “neuromuscular
blocking agents”).

Tell your doctor or pharmacist if you are
going to have surgery.
If you are not sure if any of the above apply to you,
talk to your doctor or pharmacist before using
DUAC ONCE DAILY GEL.
Pregnancy, breast-feeding and fertility
There is only limited information about the safety
of DUAC ONCE DAILY GEL in pregnant women.
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
using this medicine.
Your doctor will consider the benefit to you and
the risk to your baby of using DUAC ONCE DAILY
GEL while you’re pregnant.
It is not known whether the ingredients of DUAC
ONCE DAILY GEL can pass into breast milk. One of
the medicines in DUAC ONCE DAILY GEL is
clindamycin. When clindamycin is taken by mouth
or injection, it may pass into breast milk.
If you are breast-feeding, you must check with
your doctor before you use DUAC ONCE DAILY GEL.
Do not use DUAC ONCE DAILY GEL on your breast
if you are breast-feeding.

How to apply DUAC ONCE DAILY GEL
1. Completely remove any make-up.
2. Wash the affected area of skin well. Then rinse
with warm water and gently pat dry.
3. Put a thin film of gel on the entire area of
affected skin, using your fingertips.
4. Apply to all of the areas of your skin which have
acne, not just to the individual spots. If the gel
does not rub into your skin easily, you are using
too much.
· For your face only, use an amount of gel from
the tube which reaches from the tip of your
finger to the first joint (the first crease on
your finger). This is a ‘finger tip’.
· For your face and back, use two and a half
‘finger tips’ in total.
5. If you get a lot of dryness or skin peeling, you
can use an oil-free, fragrance free,
hypoallergenic moisturiser, use DUAC ONCE
DAILY GEL less frequently or stop treatment for
a short period, to allow your skin to adjust to
the treatment. This medicine may not work
properly if it is not applied every day.
6. Wash your hands after using the gel.
7. After it has dried, you can use a non-greasy
make-up.
Always use this medicine exactly as described in
this leaflet or as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if
you are not sure.
If you use more DUAC ONCE DAILY GEL than
you should
· Take care not to apply too much. Applying
too much gel or applying it more frequently will
not help your spots clear up more quickly, and
may cause skin irritation. If this does happen,
use the gel less often, or stop using it for a few
days and then start again.
If you accidentally swallow DUAC ONCE
DAILY GEL
· If you do accidentally swallow the gel, seek
medical advice. You may get symptoms similar
to when you take antibiotics by mouth (an upset
stomach).
If you forget to use DUAC ONCE DAILY GEL
· Do not use a double dose to make up for
forgotten individual doses.
· Apply the next dose at the usual time.
Don’t stop DUAC ONCE DAILY GEL without
advice
Don’t use the gel for more than 12 weeks at one
time, without talking to your doctor. Use
DUAC ONCE DAILY GEL for as long as your doctor
recommends. Don’t stop unless your doctor
advises you to.

3. How to use DUAC ONCE DAILY GEL
Always use this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.
· Use DUAC ONCE DAILY GEL once a day in the
evening.
· It may take 2 to 5 weeks before you see the
effect of DUAC ONCE DAILY GEL.
· Do not use for more than 12 weeks at one time.
Your doctor will tell you how long your
treatment will last.

It is important to continue to use the gel as
prescribed by your doctor. If you stop too soon,
your acne may return.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Stop using DUAC ONCE DAILY GEL and see a
doctor straight away if you notice any of the
following serious side effects – you may need
urgent medical treatment:
· signs of an allergic reaction (such as swelling of
your face, eyes, lips or tongue, nettle rash or
difficulty breathing, collapse)
· severe or prolonged diarrhoea, or abdominal cramps
· severe burning, peeling or itching.
Other possible side effects:
If you notice any of these side effects, try using
DUAC ONCE DAILY GEL less often, or stop using it
for one or two days and then start again.
Very common side effects
(at least 1 in 10 people are affected )
At site of application:
· Redness, peeling, dryness
These side effects are generally mild.
Common side effects
(less than 1 in 10 people are affected )
· Headache
At site of application:
· Burning, pain, sensitivity to sunlight
Uncommon side effects
(less than 1 in 100 people affected)
· Tingling (paraesthesia), worsening acne, red,
itchy skin, rash (dermatitis, erythematous rash).
Other side effects
Other side effects with frequencies that cannot be
estimated from the available data include:
· Allergic reactions
· Inflammation of the intestine, diarrhoea,
including bloody diarrhoea, stomach pain
At the site of application:
· Skin reactions, discoloration of the skin
· Raised itchy rash (hives)
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via (see details below). By reporting
side effects you can help provide more information
on the safety of this medicine.
7523I

TEXT SIZE CONTAINED IN THIS ARTWORK
Body text size: 9pt
Leading: 9.5pt
Horizontal Scale: 100%
Smallest text size: 9pt
Microtext: Yes

7523I

GSK-IRL-Sligo-IESLI

Ireland-IRL; Stiefel; United Kingdom-GBR Duac Once Daily Gel

N/A

S6LFLT-2D

White paper

Offset
K

1

0

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1

Page 2 of 2

10000000138127

Package leaflet: Information for the patient

clindamycin + anhydrous benzoyl peroxide
Read all of this leaflet carefully before
you start using this medicine because it
contains important information for you.
- Keep this leaflet. You may need to read
it again.
- If you have any further questions, ask
your doctor or pharmacist.
- This medicine has been prescribed for
you only. Do not pass it on to others. It
may harm them, even if their signs of
illness are the same as yours.
- If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet:
1. What DUAC ONCE DAILY GEL is and
what it is used for
2. What you need to know before you use
DUAC ONCE DAILY GEL
3. How to use DUAC ONCE DAILY GEL
4. Possible side effects
5. How to store DUAC ONCE DAILY GEL
6. Contents of the pack and other
information

1. What DUAC ONCE DAILY GEL is
and what it is used for
DUAC ONCE DAILY GEL contains two
medicines: clindamycin and benzoyl
peroxide. DUAC ONCE DAILY GEL belongs
to a group of medicines known as
‘anti-acne preparations’.
DUAC ONCE DAILY GEL is used for treating
mild to moderate acne on your skin.
• Clindamycin is an antibiotic which
stops the bacteria involved in acne
from reproducing

• If you develop stomach cramps or
diarrhoea that does not improve or is
severe, stop using DUAC ONCE DAILY
GEL and contact your doctor
immediately. Antibiotics may cause a
condition that results in severe
diarrhoea and stomach cramps.
Although this is unlikely to happen with
antibiotics applied to the skin.
• If you have recently used other
clindamycin or erythromycincontaining medicines, there is an
increased chance that DUAC ONCE
DAILY GEL will not work as well as it
should.
 Tell your doctor or pharmacist if you
have used any other clindamycin or
erythromycin-containing medicines
recently.
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.
Other medicines and DUAC ONCE DAILY
GEL
Tell your doctor or pharmacist if you are
using, have recently used or might use any
other medicines.
Tell your doctor or pharmacist if you are
using any of the following:
• any other acne treatments including
antibiotics used on your skin
• medicated or ‘abrasive’ soaps and
cleansers
• soaps or cosmetics that have a strong
drying effect
• products which contain large amounts
of alcohol or ‘astringents’

1
10000000138127
GSK-GBR-Barnard Castle-UKBAR
Ireland-IRL; Stiefel; United Kingdom-GBR
Duac Once Daily Gel
N/A
JMF036

Offset
White paper
1
K

0

0

2. What you need to know before
you use DUAC ONCE DAILY GEL
Do not use DUAC ONCE DAILY GEL:
• if you are allergic to clindamycin,
lincomycin, benzoyl peroxide or any of
the other ingredients of DUAC ONCE
DAILY GEL (listed in Section 6)
Do not use DUAC ONCE DAILY GEL if any of
the above apply to you. If you are not sure,
talk to your doctor or pharmacist before
you start using DUAC ONCE DAILY GEL.
Warnings and precautions
Talk to your doctor or pharmacist before
using DUAC ONCE DAILY GEL.
• Only use DUAC ONCE DAILY GEL on
your skin. Keep it away from areas like
your eyes, lips, mouth or inside your
nose.
• Do not use the gel on any irritated
areas of your skin. For example, if you
have cuts, grazes, sunburn or broken
skin.
 If you accidently get DUAC ONCE DAILY
GEL in your eyes, mouth, lips, or inside
your nose rinse with plenty of water.
• Do not to use too much DUAC ONCE
DAILY GEL on sensitive areas of skin.
• Most patients will experience some
skin redness and peeling during the
first few weeks of treatment. If your
skin becomes irritated, you may need
to use an oil-free moisturiser, use DUAC
ONCE DAILY GEL less often, or stop
using it for a short period to allow your
skin to recover and then re-start
treatment.
• Stop treatment and see your doctor if
skin irritation is severe (severe redness,
dryness, itching, stinging, or burning) or
does not improve.
• Try not to let DUAC ONCE DAILY GEL
come into contact with coloured
fabrics, including clothing, towels, bed
linen, furniture or carpeting. DUAC
ONCE DAILY GEL can bleach these
materials.
• DUAC ONCE DAILY GEL may bleach hair.
• DUAC ONCE DAILY GEL 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 DUAC ONCE DAILY GEL.
Check with your doctor or pharmacist
before using this medicine if:
• you have ever had any of the following
gut problems: ‘regional enteritis’,
‘ulcerative colitis’, or
‘antibiotic-associated colitis’.

This is because when used together with
DUAC ONCE DAILY GEL, they may irritate
your skin over time.
DUAC ONCE DAILY GEL may make some
acne medicines less effective when used
at the same time.
This includes:
• Some acne medicines that are applied
to the skin which contain tretinoin,
isotretinoin or tazarotene
 Tell your doctor or pharmacist if you
are also using one of these medicines.
You may need to use the two products
at different times of the day (e.g. one in
the morning and the other in the
evening). Using other acne medicines
at the same time as DUAC ONCE DAILY
GEL can increase the risk of skin
irritation.
 Stop treatment and see your doctor
if skin irritation becomes severe
(severe redness, dryness, itching,
stinging or burning).
• DUAC ONCE DAILY GEL should not be
used at the same time as
erythromycin-containing medicines.
• Applying DUAC ONCE DAILY GEL at the
same time as medicines such as
dapsone and sulfacetamide can
cause a temporary colour-change of
skin or facial hair (yellow/orange colour).
This will not be permanent.
• One of the medicines in DUAC ONCE
DAILY GEL can affect how certain
general anaesthesia medicines work
(called “neuromuscular blocking
agents”).
 Tell your doctor or pharmacist if you
are going to have surgery.
If you are not sure if any of the above
apply to you, talk to your doctor or
pharmacist before using DUAC ONCE
DAILY GEL.
Pregnancy, breast-feeding and fertility
There is only limited information about the
safety of DUAC ONCE DAILY GEL in
pregnant women.
If you are pregnant or breast-feeding, think
you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist
for advice before using this medicine.
Your doctor will consider the benefit to you
and the risk to your baby of using DUAC
ONCE DAILY GEL while you’re pregnant.
It is not known whether the
ingredients of DUAC ONCE
DAILY GEL can pass into breast
milk. One of the medicines in
DUAC ONCE DAILY GEL is
clindamycin. When clindamycin
is taken by mouth or injection, it
may pass into breast milk.
If you are breast-feeding, you
must check with your doctor
before you use DUAC ONCE
DAILY GEL.
Do not use DUAC ONCE DAILY
GEL on your breast if you are
breast-feeding.

9.0pt

Pharma code Ref. No. 7121

• Benzoyl peroxide reduces blackheads
and whiteheads. It also kills the
bacteria involved in acne.
Used together in DUAC ONCE DAILY GEL,
these work by:
• fighting the bacteria that can cause acne
• treating existing blackheads,
whiteheads, and spots
• lowering the number of red, inflamed
acne spots
DUAC ONCE DAILY GEL is for use by adults
and adolescents aged twelve years or over.

9.8pt
95%
9.0pt
Y

Page 1 of 2

Pharma code Ref. No. 7121
3. How to use DUAC ONCE DAILY
GEL
Always use this medicine exactly as your
doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.
• Use DUAC ONCE DAILY GEL once a day
in the evening.
• It may take 2 to 5 weeks before you see
the effect of DUAC ONCE DAILY GEL.
• Do not use for more than 12 weeks at
one time. Your doctor will tell you how
long your treatment will last.
How to apply DUAC ONCE DAILY GEL
1. Completely remove any make-up.
2. Wash the affected area of skin well. Then
rinse with warm water and gently pat dry.
3. Put a thin film of gel on the entire area
of affected skin, using your fingertips.
4. Apply to all of the areas of your skin
which have acne, not just to the individual
spots. If the gel does not rub into your
skin easily, you are using too much.
• For your face only, use an amount of
gel from the tube which reaches
from the tip of your finger to the first
joint (the first crease on your finger).
This is a ‘finger tip’.
• For your face and back, use two and
a half ‘finger tips’ in total.
5. If you get a lot of dryness or skin
peeling, you can use an oil-free,
fragrance free, hypoallergenic
moisturiser, use DUAC ONCE DAILY GEL
less frequently or stop treatment for a
short period, to allow your skin to
adjust to the treatment. This medicine
may not work properly if it is not
applied every day.
6. Wash your hands after using the gel.
7. After it has dried, you can use a
non-greasy make-up.
Always use this medicine exactly as
described in this leaflet or as your doctor or
pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.

Pharma code Ref. No. 7121
Other side effects
Other side effects with frequencies that cannot
be estimated from the available data include:
• Allergic reactions
• Inflammation of the intestine, diarrhoea,
including bloody diarrhoea, stomach pain
At the site of application:
• Skin reactions, discoloration of the skin
• Raised itchy rash (hives)
Reporting of side effects
If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. You can also report side effects
directly via (see details below). By reporting
side effects you can help provide more
information on the safety of this medicine.
United Kingdom
the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
Ireland
HPRA Pharmacovigilance, Earlsfort Terrace,
IRL - Dublin 2; Tel: +353 1 6764971;
Fax: +353 1 6762517. Website: www.hpra.ie;
E-mail: medsafety@hpra.ie

5. How to store DUAC ONCE DAILY
GEL
Keep this medicine out of the sight and
reach of children.
Pharmacist: Store in a refrigerator
(2°C-8°C). Do not freeze.
Patient: After you have received DUAC ONCE
DAILY GEL from the pharmacist, do not store
it above 25°C and discard after 2 months.
Do not use this medicine after the expiry
date which is stated on the tube and carton
(after “Exp:”). The expiry date refers to the
last day of that month.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
you no longer use. These measures will
help protect the environment.

1
10000000138127
GSK-GBR-Barnard Castle-UKBAR
Ireland-IRL; Stiefel; United Kingdom-GBR
Duac Once Daily Gel
N/A
JMF036

Offset
White paper
1
K

0

0

If you use more DUAC ONCE DAILY GEL
than you should
• Take care not to apply too much.
Applying too much gel or applying it
more frequently will not help your spots
clear up more quickly, and may cause
skin irritation. If this does happen, use
the gel less often, or stop using it for a
few days and then start again.
If you accidentally swallow DUAC ONCE
DAILY GEL
• If you do accidentally swallow the
gel, seek medical advice. You may get
symptoms similar to when you take
antibiotics by mouth (an upset stomach).
If you forget to use DUAC ONCE DAILY GEL
• Do not use a double dose to make up
for forgotten individual doses.
• Apply the next dose at the usual time.
Don’t stop DUAC ONCE DAILY GEL
without advice
Don’t use the gel for more than 12 weeks
at one time, without talking to your doctor.
Use DUAC ONCE DAILY GEL for as long as
your doctor recommends. Don’t stop
unless your doctor advises you to.
It is important to continue to use the gel
as prescribed by your doctor. If you stop
too soon, your acne may return.
If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist.

6. Contents of the pack and other
information

What DUAC ONCE DAILY GEL contains
• The active substances are: clindamycin
phosphate, equivalent to clindamycin
1 % w/w (10 mg/g) and hydrous benzoyl
peroxide, equivalent to anhydrous
benzoyl peroxide 5 % w/w (50 mg/g).
• The other ingredients are: carbomer,
dimeticone, disodium lauryl
sulfosuccinate, disodium edetate,
glycerol, silica, colloidal hydrated,
poloxamer 182, purified water and
sodium hydroxide.
What DUAC ONCE DAILY GEL looks like
and the contents of the pack
• DUAC ONCE DAILY GEL comes in tubes
containing 5, 6, 15, 25, 30, 50, 55,
60 and 70 grams.
• The gel is off-white yellow in colour.
• Each carton contains one tube of
DUAC ONCE DAILY GEL.
• Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
GlaxoSmithKline UK Limited,
Stockley Park West, Uxbridge,
Middlesex UB11 1BT, UK
GlaxoSmithKline (Ireland) Limited,
12 Riverwalk, Citywest Business Campus,
Dublin 24, Ireland
PL 19494/0075
PA 1077/120/1
4. Possible side effects
MA 300/01401
Like all medicines, this medicine can cause Manufacturer:
side effects, although not everybody gets
Glaxo Operations UK Ltd,
them.
Harmire Road, Barnard Castle
Stop using DUAC ONCE DAILY GEL and
Co. Durham, DL12 8DT, UK
see a doctor straight away if you notice Other formats
any of the following serious side
To listen to or request a copy of this leaflet
effects – you may need urgent medical
in Braille, large print or audio please call,
treatment:
free of charge:
• signs of an allergic reaction (such as
0800 198 5000 (UK Only)
swelling of your face, eyes, lips or
Please be ready to give the following
tongue, nettle rash or difficulty
information:
breathing, collapse)
• severe or prolonged diarrhoea, or
Product name: Duac Once Daily
abdominal cramps

10mg/g + 50mg/g Gel
• severe burning, peeling or itching.
Reference number: PL 19494/0075
Other possible side effects:
This is a service provided by the
If you notice any of these side effects, try
Royal National Institute of Blind People.
using DUAC ONCE DAILY GEL less often, or
This medicinal product is authorised in
stop using it for one or two days and then
the Member States of the EEA under the
start again.
following names:
Very common side effects
Austria, Denmark, Greece: Clindoxyl Gel
(at least 1 in 10 people are
Cyprus: Indoxyl Gel
affected )
Czech Republic, Estonia, Hungary, Iceland,
At site of application:
Italy, Latvia, Portugal, Slovak Republic,
• Redness, peeling, dryness
Spain, Sweden: Duac Gel
Finland: Clindoxyl Geeli
These side effects are generally
Germany: Duac Akne Gel
mild.
The Netherlands: Duac Acne Gel
Common side effects
Lithuania, Poland: Duac
(less than 1 in 10 people are
Ireland, Malta, United Kingdom: Duac Once
affected)
Daily Gel
• Headache
This leaflet was last revised in
At site of application:
December 2015
• Burning, pain, sensitivity to
sunlight
Duac is a registered trade mark of
Stiefel Laboratories Inc.
Uncommon side effects
(less than 1 in 100 people affected )
© 2015 Stiefel Laboratories, Inc.
• Tingling (paraesthesia), worsening
All rights reserved.
acne, red, itchy skin, rash (dermatitis,
1000000
erythematous rash).
0138127

9.0pt
9.8pt
95%
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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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