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DUAC ONCE DAILY 10MG/G + 30MG/G GEL

Active substance: HYDROUS BENZOYL PEROXIDE

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Package leaflet: Information for the patient

4

Duac Once Daily 10 mg/g + 30 mg/g Gel
®

clindamycin + anhydrous benzoyl peroxide

10000000111133

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.
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.
• 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

Stiefel; United Kingdom-GBR
Duac Once Daily Gel
1

➔ 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

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➔ 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.

128 Code - 111133

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, or inside your nose rinse with plenty of
water.
• Do not 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’.

GSK-CAN-Mississauga-CAMIS

• 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.

3. How to use DUAC ONCE DAILY GEL

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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 2-5 weeks before you see the effect of
DUAC ONCE DAILY GEL.

Mississauga - Additional Artwork Information Panel
Specification Number:
(Does NOT include Specification version number)

TYPE SIZE: 8.0/9.0
HORIZONTAL SCALE: 100%

GSLFLT032

Replaces Item Code:

N/A

Component Basic Dimensions:

324 x 140

(in mm)

• 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.
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.
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:
• Skin burning sensation, peeling, itching, dry skin
• Redness of your skin, especially during the first few
weeks of use
These side effects are generally mild.
Common side effects
(less than 1 in 10 people are affected)
• Headache
At the site of application:
• Sensitivity to sunlight, skin pain
• Red, itchy skin, rash (dermatitis)
Uncommon side effects
(less than 1 in 100 people affected)
At the site of application:
• Tingling (paraesthesia), worsening of acne

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Other side effects
Other side effects have occurred in a very small number of
people but their exact frequency is unknown:
• 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)
If you get any side effects, talk to your doctor or
pharmacist. This includes any side effects not listed in this
leaflet.

10000000111133
GSK-CAN-Mississauga-CAMIS
Stiefel; United Kingdom-GBR
Duac Once Daily Gel

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 2 months after opening.
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.

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6. Contents of the pack and other information
What DUAC ONCE DAILY GEL contains
• The active substances are: clindamycin and hydrous
benzoyl peroxide. 1 g of gel contains 10 mg (1 % w/w)
clindamycin as clindamycin phosphate and 30 mg
(3 % w/w) anhydrous benzoyl peroxide as hydrous
benzoyl peroxide.
• The other ingredients are: carbomer, dimeticone,
disodium lauryl sulfosuccinate, disodium edetate,
glycerol, silica (dental type), poloxamer 182, purified
water and sodium hydroxide
What DUAC ONCE DAILY GEL looks like and contents
of the pack
DUAC ONCE DAILY GEL is a white to slightly
yellow-coloured gel and is supplied in tubes of 30 g.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
GlaxoSmithKline UK Limited
Stockley Park West,
Uxbridge
Middlesex
UB11 1BT
UK
GlaxoSmithKline (Ireland) Limited
Stonemasons Way
Rathfarnham
Dublin 16
Ireland.
Manufacturer:
Glaxo Operations UK Ltd.
Harmire Road, Barnard Castle
Co. Durham, DL12 8DT, UK
Other formats:
To listen to or request a copy of this leaflet in Braille, large
print or audio please call, free of charge:
0800 198 5000 (UK Only)
Please be ready to give the following information:
Product name
Duac Once Daily 10 mg/g + 30 mg/g gel
Reference number 19494/0251
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:
Cyprus, Greece: Indoxyl 10 mg/g + 30 mg/g Gel
Bulgaria, Czech Republic, Germany, Italy, Romania,
Slovenia, Spain: Duac 10 mg/g + 30 mg/g Gel
Latvia: Duac 10 mg/30 mg/g Gels
Lithuania: Duac 10 mg/30 mg/g Gelis
Poland: Duac 10 mg/g + 30 mg/g zel
Ireland, Malta, United Kingdom: Duac Once Daily
10 mg/g + 30 mg/g Gel
This leaflet was last revised in February 2013.
Duac is a registered trademark of Stiefel Laboratories,
Inc.
© 2013 Stiefel Laboratories, Inc.

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A111133

Mississauga - Additional Artwork Information Panel
Specification Number:
(Does NOT include Specification version number)

TYPE SIZE: 8.0/9.0
HORIZONTAL SCALE: 100%

GSLFLT032

Replaces Item Code:

N/A

Component Basic Dimensions:

324 x 140

(in mm)

Expand view ⇕

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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