Duac

Leaflet attached to the packaging: patient information

DUAC

(10 mg + 50 mg)/g, gel
(Clindamycin + Benzoyl peroxide)

You should read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• You should consult a doctor or pharmacist if you have any further doubts.
• The medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm another person, even if the symptoms of the disease are the same.
• If any of the side effects worsen or if any side effects not mentioned in the leaflet occur, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is DUAC and what is it used for
• 2. Important information before using DUAC
• 3. How to use DUAC
• 4. Possible side effects
• 5. How to store DUAC
• 6. Contents of the packaging and other information

1. What is DUAC and what is it used for

DUAC contains two active substances: clindamycin and benzoyl peroxide. DUAC is a topical acne treatment.
DUAC is used to treat mild to moderate acne.

• Clindamycin is an antibiotic that inhibits the growth of bacteria that cause acne.
• Benzoyl peroxide reduces the number of blackheads (open and closed), has a bactericidal effect on bacteria that cause acne. Clindamycin and benzoyl peroxide in DUAC:
• fight the bacteria that cause acne,
• treat open and closed blackheads and pimples,
• reduce the number of red, inflamed pimples.

DUAC is intended for use in adults and adolescents over 12 years of age.

2. Important information before using DUAC

When not to use DUAC:

• If the patient is allergic to clindamycin, lincomycin, benzoyl peroxide, or any of the other ingredients of the medicine (listed in section 6 of this leaflet), do not use DUAC. If in doubt, consult a doctor or pharmacist.

Warnings and precautions

Before starting treatment with DUAC, consult a doctor or pharmacist.

• DUAC should only be used on the skin. Avoid contact with eyes, lips, mouth, or nostrils.

Do not use the medicine on irritated skin, such as cuts, abrasions, sunburn, or damaged skin.
➔ If DUAC accidentally gets into the eyes, mouth, or nostrils, rinse these areas thoroughly with water.

• Do not use too much DUAC on sensitive skin areas.
• Most people being treated may experience redness and peeling of the skin during the first few weeks of treatment. If the skin becomes irritated,it may be necessary to use a non-greasy moisturizer, reduce the frequency of application of DUAC, or stop using it until the skin condition improves.
• If skin irritation is severe (severe redness, dryness, itching, stinging, or burning), stop using DUAC and consult a doctor.
• Be careful not to let the medicine come into contact with colored materials, including clothing, towels, bedding, furniture, or carpets, as DUAC may cause discoloration of these materials.
• DUAC may bleach hair.
• DUAC may make the skin more sensitive to the harmful effects of sunlight. Avoid using sunlamps and minimize exposure to the sun. During treatment with DUAC, use UV filters and protective clothing.

You should consult a doctor or pharmacist before using the medicine if:

• the patient has or has had any of the following gastrointestinal diseases: enteritis, ulcerative colitis, antibiotic-associated colitis.
• if abdominal pain or diarrhea occur, which do not go away or worsen, then stop using DUAC and consult a doctor immediately. Antibiotics can cause diseases characterized by severe diarrhea and abdominal pain, but their occurrence is unlikely after using antibiotics on the skin.
• the patient has recently used medicines containing clindamycin or erythromycin, as there is an increased risk that DUAC may not work as well as it should.

➔ You should consult a doctor or pharmacist ifthe patient has used any other medicine containing clindamycin or erythromycin recently.

Children

This medicine should not be used in children under 12 years of age. It is not known if it is safe for them and if it will work properly.

Other medicines and DUAC

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, and about any medicines you plan to take.
Tell your doctor or pharmacist if you are using any of the following medicines:

• other acne treatments, including antibiotics used on the skin,
• medicated soaps and cleansers with exfoliating properties,
• soaps and cosmetics with strong drying effects,
• medicines containing large amounts of alcohol or astringents. Using these medicines and DUAC at the same time may cause skin irritation.

DUAC may make some medicines used at the same time less effective. These include:

• some topical acne treatments containing tretinoin, isotretinoin, or tazarotene.

➔ Tell your doctor or pharmacistif you are using any of these medicines.
It may be necessary to use them at different times of the day (e.g., one in the morning and the other in the evening). Using other acne treatments with DUAC at the same time may increase the risk of skin irritation.
➔ Stop using the medicine and consult a doctorif skin irritation is severe (severe redness, dryness, itching, stinging, or burning).

• Do not use DUAC at the same time as other medicines containing erythromycin.
• Using DUAC at the same time as medicines such as dapsoneor sulfacetamidemay cause temporary changes in skin or hair color on the face (yellow/orange color). This is not a permanent effect.
• One of the ingredients of the medicine may affect the action of medicines used in general anesthesia (called "muscle relaxants").

➔ Tell your doctor or pharmacistabout any planned surgery.
If in doubt whether any of the above situations apply to you, consult a doctor or pharmacist.

Pregnancy, breastfeeding, and fertility

Information on the safety of using DUAC in pregnant women is limited.
If you are pregnant or breastfeeding, or 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 decide whether the benefits of using DUAC during pregnancy outweigh the risks to the baby.
It is not known whether the ingredients of DUAC pass into breast milk.
One of the ingredients of DUAC is clindamycin. If clindamycin is taken orally or by injection, it may pass into breast milk.
If you are breastfeeding, you must consult a doctorbefore using DUAC.
Do not use DUAC on the breast during breastfeeding.

3. How to use DUAC

This medicine should always be used as directed by your doctor or pharmacist. If you are unsure, consult a doctor or pharmacist.

• DUAC should be used once a day, in the evening.
• The effect of DUAC may only be visible after 2 to 5 weeks of use.
• Do not use the medicine for more than 12 weeks in a row. Your doctor will decide how long the treatment should last.

How to apply DUAC:

• 1. Remove all makeup.
• 2. Wash the affected skin thoroughly, rinse with warm water, and gently pat dry with a towel.
• 3. A small amount of gelshould be applied with your fingertips to the entire affected skin.
• 4. The gel should be applied to the entiresurface of the affected skin, not just individual acne lesions. If the gel does not absorb easily, it means you have used too much gel.
• To cover the face, use an amount of gel that fits on the tip of your finger up to the first joint (first bend of the finger) - this is the "finger tip" amount.
• To cover the face and back, use an amount equivalent to a maximum of two and a half "finger tip" amounts.
• 5. If the skin becomes severely dry or starts to peel, you can use a non-greasy moisturizer, use DUAC less often, or stop using it for a while to allow the skin to adjust to the treatment. This medicine may not work properly if it is not used every day.
• 6. After using the gel, wash your hands.
• 7. Once the gel has dried, you can apply a non-greasy makeup.

This medicine should always be used as described in the patient information leaflet or as directed by your doctor or pharmacist. If you are unsure, consult a doctor or pharmacist.

Using more DUAC than recommended

• Do not use more gel than recommended. Using more gel than recommended or using it more often than recommended will not speed up the healing of pimples and may cause skin irritation. If you have used too much gel, reduce the frequency of application or stop using it for a few days and then resume treatment.

If DUAC is accidentally swallowed

• If you swallow the gel, consult a doctor. Side effects similar to those that occur when antibiotics are taken orally (stomach upset) may occur.

Missing a dose of DUAC:

• Do not use a double dose to make up for a missed dose,
• Use the next scheduled dose as usual.

Do not stop using DUAC unless your doctor tells you to.

Do not use the gel for more than 12 weeks in a row without consulting your doctor.
Use DUAC for as long as your doctor has prescribed. Do not stop treatment unless your doctor decides to.
It is important to use the gel exactly as your doctor has prescribed. If you stop using this medicine too soon, acne may come back.
If you have any further questions about using this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, DUAC can cause side effects, although not everybody gets them.

If you experience any of the following severe side effects, stop using the medicine and consult a doctor immediately – you may need urgent medical attention:

• allergic reaction symptoms (such as: swelling of the face, eyes, lips, or tongue, hives, or difficulty breathing, fainting),
• severe or persistent diarrhea or abdominal cramps,
• severe burning, peeling, or itching.

Other possible side effects

If you notice any of the following symptoms, reduce the frequency of application of DUAC or stop using it for 1 or 2 days and then resume treatment.
Very common(may affect more than 1 in 10 people):

• at the application site: redness, peeling, dry skin. These side effects are usually mild.

Common(may affect up to 1 in 10 people):

• -headache,
• at the application site: burning, pain, increased sensitivity to sunlight:

Uncommon(may affect up to 1 in 100 people):

• tingling sensation (paresthesia), worsening of acne, redness and itching of the skin, rash (skin inflammation, erythematous rash).

Other side effects

Other side effects that have occurred in a very small number of people, frequency not known:

• allergic reactions,
• enteritis, diarrhea, including bloody diarrhea, abdominal pain,
• at the application site: skin reactions, skin discoloration, raised, itchy rash (hives).

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301; fax: +48 22 49 21 309; website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help provide more information on the safety of this medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store DUAC

Keep out of sight and reach of children.
Store in a refrigerator at 2°C - 8°C. Do not freeze.
After opening the container, store at a temperature not above 25°C.
Shelf life after opening the container: 2 months.
Do not use this medicine after the expiry date stated on the packaging after "EXP".
The expiry date refers to the last day of the month.
The "Lot" abbreviation means the batch number of the product.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What DUAC contains

The active substances of the medicine are:

• clindamycin in the form of clindamycin phosphate,
• benzoyl peroxide in the form of benzoyl peroxide with water. 1 g of gel contains 10 mg of clindamycin and 50 mg of benzoyl peroxide.

The medicine also contains:

• carbomer (50,000 mPa.s), dimethicone (100 mm².s), disodium lauryl sulfosuccinate, disodium edetate, glycerol, colloidal silicon dioxide, poloxamer 182, sodium hydroxide, purified water.

What DUAC looks like and what the pack contains

DUAC is a white to light yellow, homogeneous gel.
DUAC is available in tubes containing 5 g, 6 g, 15 g, 25 g, 30 g, 50 g, 55 g, 60 g, or 70 g of gel, packaged in a cardboard box.
Each cardboard box contains one tube of DUAC.
Not all pack sizes may be marketed.
If you have any doubts about using DUAC or about the information in this leaflet, consult a doctor or pharmacist.

Marketing authorization holder:

Stiefel Laboratories Legacy (Ireland) Ltd.
Unit 2, Building 2500, Avenue 2000,
Cork Airport Business Park, Cork
Ireland

Importer:

GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland
To obtain more detailed information, please contact the representative of the marketing authorization holder:
GSK Services Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warsaw
tel. (22) 576-90-00

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Denmark: Clindoxyl Gel
Cyprus, Greece: Indoxyl Gel
Estonia, Iceland, Italy, Latvia, Portugal, Slovakia, Spain, Sweden: DUAC Gel
Finland: Clindoxyl Geeli
Germany: DUAC Akne Gel
Netherlands: DUAC Acne Gel
Czech Republic, Lithuania, Poland: DUAC
Ireland, Malta, United Kingdom (Northern Ireland): DUAC Once Daily Gel
Date of last revision of the leaflet:June 2022