Duac Once Daily 10 mg/g + 50 mg/g Gel

Ireland - English - HPRA (Health Products Regulatory Authority)

Buy It Now

Active ingredient:
Clindamycin; Anhydrous Benzoyl Peroxide
Available from:
PCO Manufacturing Ltd.
ATC code:
D10AF; D10AF51
INN (International Name):
Clindamycin; Anhydrous Benzoyl Peroxide
Dosage:
10+50 milligram(s)/gram
Pharmaceutical form:
Gel
Therapeutic area:
Antiinfectives for treatment of acne; clindamycin, combinations
Authorization number:
PPA0465/457/001
Authorization date:
2020-11-13

Read the complete document

Package leaflet: Information for the user

Duac

®

Once Daily 10 mg/g + 50 mg/g Gel

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:

What DUAC ONCE DAILY GEL is and what it is used for

What you need to know before you use DUAC ONCE DAILY

How to use DUAC ONCE DAILY GEL

Possible side effects

How to store DUAC ONCE DAILY GEL

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

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’.

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.

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

Completely remove any make-up.

Wash the affected area of skin well. Then rinse with warm

water and gently pat dry.

Put a thin film of gel on the entire area of affected skin, using

your fingertips.

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.

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.

Wash your hands after using the gel.

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

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 HPRA Pharmacovigilance,

Website: www.hpra.ie.

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 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 30 grams.

The gel is off-white yellow in colour.

Each carton contains one tube of DUAC ONCE DAILY GEL.

Manufacturer

Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, Co.

Durham, DL12 8DT, UK

Product procured from within the EU, repackaged and

distributed by the PPA Holder: PCO Manufacturing Ltd., Unit 10,

Ashbourne Business Park, Rath, Ashbourne, Co. Meath, Ireland.

PPA Number: PPA0465/457/001

Duac is a registered trademark of Stiefel Laboratories, Inc.

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 October 2020

Read the complete document

Health Products Regulatory Authority

13 November 2020

CRN00C00Y

Page 1 of 2

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Duac Once Daily 10 mg/g + 50 mg/g Gel

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

1 g of gel contains:

10 mg clindamycin as clindamycin phosphate

50 mg anhydrous benzoyl peroxide as hydrous benzoyl peroxide

For the full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Gel.

Product imported from Greece:

White to slightly yellow homogeneous gel

4 CLINICAL PARTICULARS

As per PA1077/120/001

5 PHARMACOLOGICAL PROPERTIES

As per PA1077/120/001

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Carbomer

Dimeticone

Disodium lauryl sulfosuccinate

Disodium edetate

Glycerol

Silica, colloidal hydrated

Poloxamer 182

Purified water

Sodium hydroxide

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

The shelf life expiry date of this product shall be the date shown on the tube and outer package of the product on the market

in the country of origin.

Shelf life of medicinal product after dispensing 2 months.

6.4 Special precautions for storage

Store in a refrigerator (2° C - 8° C). Do not freeze.

Health Products Regulatory Authority

13 November 2020

CRN00C00Y

Page 2 of 2

Storage conditions after dispensing

Do not store above 25° C.

6.5 Nature and contents of container

Tube in an outer carton.

Pack size: 30 g

6.6 Special precautions for disposal

No special requirements.

7 PARALLEL PRODUCT AUTHORISATION HOLDER

PCO Manufacturing Ltd.

Unit 10, Ashbourne Business Park

Rath

Ashbourne

Co. Meath

Ireland

8 PARALLEL PRODUCT AUTHORISATION NUMBER

PPA0465/457/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 13

November 2020

10 DATE OF REVISION OF THE TEXT

Similar products

Search alerts related to this product

View documents history

Share this information