DUAC ONCE DAILY GEL

Active substance: HYDROUS BENZOYL PEROXIDE

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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.

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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’.

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.

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 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.

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APPROVED:

PROOF HISTORY:
v.3 - waymade - 22/04/14

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)

DATE:
22/04/14
DATE OF PROOF:

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.

UK PIL DATED AUGUST 2013
REPORTING OF SIDE EFFECTS

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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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Duac Once Daily Gel
PRODUCT:

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PRE-PRESS NO.:

Tell your doctor or pharmacist if you have used
any other clindamycin or erythromycin-containing medicines recently.

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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’.
• 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 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.

WARNING!

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

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

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.

WARNING!

27mm

DUAC® ONCE DAILY GEL
(clindamycin phosphate/benzoyl peroxide)
Patient Information leaflet

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

000-0000F

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.

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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 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.

PROOF HISTORY:
v.3 - waymade - 22/04/14

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

WARNING!

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.

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

27mm

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.

These side effects are generally mild.
Common side effects
(less than 1 in 10 people are affected)
• Headache

Uncommon side effects
(less than 1 in 100 people affected)
DATE:

At the site of application:
• Tingling (paraesthesia), worsening acne, red, itchy skin, rash (dermatitis, erythematous rash).

22/04/14

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)

DATE OF PROOF:

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ARTWORKER:

PRE-PRESS NO.:

04-1957

Q.A.
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At the site of application:
• Skin burning sensation, pain, sensitivity to sunlight

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

UK PIL DATED AUGUST 2013
REPORTING OF SIDE EFFECTS

6464/2520F

5. How to store Duac Once Daily Gel
Do not use after the expiry date printed on the carton or tube label.

CODE:

Duac Once Daily Gel
PRODUCT:

CUSTOMER:

Waymade

By reporting side effects you can help provide more information on the safety of this medicine.

Pharmacist:
Duac Once Daily Gel should be stored in a refrigerator (2-8°C). Do not freeze.
Patient:
Do not store above 25°C. After 2 months discard and use a new tube.
If your doctor tells you to stop using Duac Once Daily Gel, please take any remaining medicine back to the pharmacist for safe
disposal. Only keep the medicine if your doctor tells you to.
If your medicine becomes discoloured you should consult your pharmacist who will advise you what to do.
6. Contents of the pack and other information
Your medicine is called Duac Once Daily Gel. The active substances in Duac Once Daily Gel are clindamycin phosphate
1.28%w/w equivalent to clindamycin 1%w/w (10mg/g) and hydrous benzoyl peroxide 6.67%w/w equivalent to anhydrous benzoyl
peroxide 5%w/w (50mg/g) in a white opaque gel.
Duac Once Daily Gel also contains the following inactive ingredients:
carbomer, dimeticone, disodium lauryl sulfosuccinate, glycerol, disodium edetate, colloidal hydrated silica, poloxamer 182, sodium
hydroxide and purified water.
Duac Once Daily Gel is available in tubes of 25 grams.
POM

PL No: 6464/2520

This product is manufactured by Stiefel Laboratories (Ireland) Ltd., Finiskin Industrial Estate, Sligo, Ireland and procured from
within the EU and repackaged by the Product Licence holder:
Waymade Plc, Miles Gray Road, Basildon, Essex, SS14 3FR
Leaflet revision and issue date (Ref.) 22.4.2014
Duac Once Daily Gel is a registered trademark of Stiefel Laboratories Ltd

WARNING!

At site of application:
• Redness, peeling, drying

DATE:

CUSTOMER
APPROVED:

Very common side effects
(at least 1 in 10 people are affected)

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

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.

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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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