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CLINDAMYCIN 1% + BENZOYL PEROXIDE 3% GEL

Active substance(s): ANHYDROUS BENZOYL PEROXIDE / CLINDAMYCIN / ANHYDROUS BENZOYL PEROXIDE / CLINDAMYCIN

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Duac® Once Daily 10mg/g + 30mg/g Gel
Clindamycin 1% + benzoyl peroxide 3% Gel
(clindamycin phosphate + benzoyl peroxide)
Your medicine is known by any of the above names but will be referred to
as Duac Once Daily Gel throughout this
Patient Information Leaflet
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

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.

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

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).

1) What Duac Once Daily Gel is and what it is used for

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.

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, 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’.
• 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.

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.

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 2-5 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.

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.

6) Contents of the pack and other information
What Duac Once Daily Gel contains:
1g of gel contains 10mg (1% w/w) clindamycin as clindamycin phosphate
and 30mg (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 gel.
It is available in tubes of 30g or 60g.
PL 10383/2214

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.

Duac Once Daily 10mg/g + 30mg/g Gel
Clindamycin 1% + benzoyl peroxide 3% Gel

POM

Who makes and repackages your medicine?
Your medicine is manufactured by Glaxo Operations UK Ltd., Harmire
Road, Barnard Castle Co. Durham, DL12 8DT, UK. Procured from within
the EU and repackaged by Product Licence Holder: Primecrown Ltd, 4/5
Northolt Trading Estate, Belvue Road, Northolt, Middlesex UB5 5QS.
Leaflet date: 22.12.2016
Duac® is a registered trademark of Stiefel Laboratories, Inc., USA.

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

5) How to store Duac Once Daily Gel
• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the
carton and tube. The expiry date refers to the last day of the month.
• 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 above 25°C and discard after 2 months.
• If your medicine shows any visible signs of deterioration, consult your
pharmacist who will advise you what to do.
• 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.

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 020 8839 3000 to obtain the leaflet in a format suitable
for you.

Expand Transcript

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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