Duac

Leaflet accompanying the packaging: patient information

Duac

10 mg/g + 30 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 that 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 specifically for one 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 belongs to anti-acne medicines.
Duac is used to treat mild to moderate common 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 occur in acne. Clindamycin and benzoyl peroxide in Duac:
• fight bacteria that cause acne,
• treat open and closed blackheads, as well as pimples and nodules,
• reduce the number of red, inflamed pimples and nodules that occur in acne.

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 this medicine (listed in section 6 of this leaflet), do not use Duac if this applies to the patient. In case of any doubts, consult a doctor or pharmacist.

Warnings and precautions

Before starting to use Duac, consult a doctor or pharmacist.

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

Do not use the medicine on irritated skin, e.g., if there are 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.
• In most treated patients, redness and peeling of the skin may occur 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 using Duac, or stop using it until the skin condition improves.
• If skin irritation is severe (strong redness, dryness, itching, stinging, or burning), stop using Duac and contact a doctor.
• Be careful not to let the medicine come into contact with colored materials, including clothing, towels, bedding, furniture, and carpets or upholstery. Duac may discolor these materials.
• Duac may discolor hair.
• Duac may make the skin more sensitive to the harmful effects of sunlight. Avoid using sunbeds and minimize exposure to the sun. During treatment with Duac, use UV filters and protective clothing.

Consult a doctor or pharmacist before using the medicine if:

• the patient has or has had the following gastrointestinal diseases: enteritis, ulcerative colitis, antibiotic-associated colitis.
• if abdominal pain or diarrhea occur, which do not pass or worsen, then stop using Duac and contact 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.

Consult a doctor or pharmacist if the patient has usedany 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 the patient is taking now or has taken recently, as well as about medicines the patient plans to take.
Tell your doctor or pharmacist about using any of the following medicines:

• other anti-acne medicines, including antibiotics used on the skin,
• medicated soaps and cleansers with therapeutic and exfoliating properties,
• soaps and cosmetics with strong drying properties,
• 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:

• certain anti-acne medicines used on the skin, containing tretinoin, isotretinoin, or tazarotene.

Tell your doctor or pharmacistabout 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 anti-acne medicines at the same timeas Duac may increase the risk of skin irritation.
Stop using the medicine and consult a doctorif skin irritation is severe (strong 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 and/or orange). 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 planned surgery.
In case of any doubts whether any of the above situations apply to the patient using Duac, consult a doctor or pharmacist.

Pregnancy, breastfeeding, and fertility

Information on the safety of using Duac in pregnant women is limited.
If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
The doctor will decide whether the benefits of using Duac during pregnancy outweigh the risks to the child.
It is not known whether the ingredients of Duac pass into breast milk.
One of the ingredients of Duac is clindamycin. If clindamycin is used orally or by injection, it may pass into breast milk.
If the patient is breastfeeding, she must consult a doctorbefore using Duac.
Do not use Duac on the breast skin during breastfeeding.

3. How to use Duac

This medicine should always be used as directed by a doctor or pharmacist. In case of any doubts, consult a doctor or pharmacist.

• Duac should be used on affected skin 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. The doctor will determine how long the treatment should last.

How to apply Duac:

• 1. Completely remove makeup from the treated skin surface.
• 2. Wash the treated skin thoroughly, rinse with warm water, and gently pat dry with a towel.
• 3. A small amount of gelshould be applied with fingertips to the entire treated skin.
• 4. The gel should be applied to the entiresurface of the treated skin, not just individual acne lesions. If the gel does not absorb easily, it means that too much gel has been used.
• To cover the face, use an amount of gel that fits between the tip of the finger and the first joint (first bend of the finger) - this is an amount equivalent to a "finger tip".
• For the face and back, use an amount equivalent to a maximum of two and a half "finger tips".
• 5. If the skin becomes strongly dry or starts to peel, a non-greasy moisturizer can be used, Duac can be used less frequently, or its use can be stopped for some time 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, a non-greasy makeup can be applied.

This medicine should always be used as described in the patient information leaflet or as directed by a doctor or pharmacist. In case of any doubts, consult a doctor or pharmacist.

Using more Duac than recommended

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

If Duac is accidentally swallowed

• In case of swallowing 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 recommended dose as scheduled.

Do not stop using Duac unless a doctor decides to do so.

Do not use the gel for more than 12 weeks in a row without a doctor's recommendation.
Use Duac for as long as the doctor has prescribed. Do not stop treatment unless the doctor decides to do so.
It is important to use the gel exactly as the doctor has prescribed. If treatment is stopped too early, acne may recur.
In case of any further doubts about using this medicine, consult a doctor or pharmacist.

4. Possible side effects

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

If any of the following severe side effects occur, stop using the medicine and seek medical help immediately:

• allergic reaction symptoms (such as: swelling of the face, eyes, lips, or tongue, hives, or difficulty breathing, fainting),
• severe or prolonged 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 using Duac or stop using it for 1 or 2 days, then resume treatment.
Very common(may affect more than 1 in 10 people):

• burning sensation on the skin, peeling of the skin, itching of the skin, dryness of the skin,
• at the site of application: redness of the skin, especially in the first few weeks of use. These side effects are usually mild.

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

• -headache,
• at the site of application: increased sensitivity to sunlight, skin pain, redness, itching of the skin, rash (skin inflammation).

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

• tingling sensation (paresthesia), worsening of acne.

Other side effects

Other side effects that have occurred in a very small number of treated patients, with a frequency that is not known:

• allergic reactions,
• enteritis, diarrhea, including bloody diarrhea, abdominal pain,
• at the site of application: 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 Monitoring of the 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.
Reporting side effects will help gather more information on the safety of the medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Duac

The medicine should be stored out of sight and reach of children.
Pharmacist:Store in a refrigerator at a temperature of 2°C - 8°C. Do not freeze.
Patient: After receiving from a pharmacist, do not store above 25°C and discard after 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 stated.
The abbreviation "Lot" 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 that are no longer needed. 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 30 mg of benzoyl peroxide.

The medicine also contains:
glycerol, carbomer 980, dimethicone, colloidal silica, poloxamer 182, sodium hydroxide, disodium edetate, disodium lauryl sulfosuccinate, purified water.

What Duac looks like and what the pack contains

Duac is a white to light yellow gel, available in tubes containing 30 g or 60 g of gel.
Not all pack sizes may be marketed.

Marketing authorization holder:

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

Manufacturer:

GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland
Marathon Distributors Ltd
35, Kilkis Street
2234 Latsia
Nicosia, Cyprus
To obtain more detailed information, 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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Cyprus
Indoxyl 10 mg/g + 30 mg/g Gel
Greece
Indoxyl 10 mg/g + 30 mg/g Gel
Germany
Duac 10 mg/g + 30 mg/g Gel
Italy
Duac 10 mg/g + 30 mg/g Gel
Romania
Duac 10 mg/g + 30 mg/g Gel
Spain
Duac 10 mg/g + 30 mg/g Gel
Lithuania
Duac 10 mg/30 mg/g Gelis
Poland
Duac 10 mg/g + 30 mg/g gel
Malta
Duac Once Daily 10 mg/g + 30 mg/g Gel
United Kingdom (Northern Ireland)
Duac Once Daily 10 mg/g + 30 mg/g Gel
Date of last revision of the leaflet:10/2024