Duac

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

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 necessary.
• You should consult a doctor or pharmacist if you have any further doubts.
• The medicine has been prescribed for a specific person. It should not be given 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, pharmacist, or nurse. 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 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 old.

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 you. If you have 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.You should avoid contact with the eyes, lips, or mouth, or the inside of the nose.

Do not use the medicine on irritated skin, e.g., if there are cuts, abrasions, sunburn, or if the skin is damaged.
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If Duac accidentally gets into the eyes, mouth, or inside the nose, these areas should be rinsed 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 (severe redness, dryness, itching, stinging, or burning), you should 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 floor coverings. Duac may cause discoloration of these materials.
• Duac may discolor hair.
• Duac may make the skin more sensitive to the harmful effects of sunlight. You should avoid using sunlamps and minimize exposure to the sun. During treatment with Duac, you should use UV filters and protective clothing.

You should 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 go away or worsen, you should 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 will not work as well as it should.

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You should consult a doctor or pharmacistif you have used any other medicine containing clindamycin or erythromycin recently.
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 time as Duac may increase the risk of skin irritation.
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You should stop using the medicine and consult a doctorif skin irritation is severe (severe redness, dryness, itching, stinging, or burning).

• Duac should not be used at the same time as other medicines containing erythromycin.
• Using Duac at the same time as medicines such as dapsoneor sulfacetamidemay cause a temporary change 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").

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You should consult a doctor or pharmacistif you are planning to have surgery.
If you are unsure whether any of the above situations apply to you while using Duac, you should 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, think you may be pregnant, or plan to have a child, you 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 you are breastfeeding, you must consult a doctorbefore using Duac.
Do not use Duac on the breast skin while breastfeeding.

3. How to use Duac

This medicine should always be used as directed by a doctor or pharmacist. If you have 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. You should completely remove makeup from the surface of the skin to be treated.
• 2. The skin to be treated should be washed thoroughly, rinsed with warm water, and gently dried with a towel.
• 3. A small amount of gelshould be applied with the fingertips to the entire affected skin.
• 4. The gel should be applied to the entiresurface of the skin to be treated, not just to individual acne lesions. If the gel does not absorb easily, it means that too much gel has been applied.
• To cover the face, you should use an amount of gel that fits on the tip of the finger up to the first joint (the first bend of the finger) - this is the "finger-tip" amount.
• To cover the face and back, you should 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, so that the skin can get used to the treatment. This medicine may not work properly if it is not used every day.
• 6. After using the gel, you should 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 a doctor or pharmacist. If you have any doubts, 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 more gel than recommended, you should reduce the frequency of using the gel or stop using it for a few days and then resume treatment.

If Duac is accidentally swallowed

• If the gel is swallowed, you should 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,
• You should use the next recommended dose, according to the previous dosing schedule.

Do not stop using Duac unless a doctor tells you to.

Do not use the gel for more than 12 weeks in a row without a doctor's recommendation.
Duac should be used for as long as the doctor has recommended. Do not stop treatment unless the doctor decides otherwise.
It is important to use the gel exactly as the doctor has recommended.If you stop using the medicine too early, acne may come back again.
If you have any further doubts about using this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

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

If any of the following severe side effects occur, you should stop using the medicine and contact 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, you should reduce the frequency of using Duac or stop using it for 1 or 2 days and then resume treatment.
Very common(may affect more than 1 in 10 people):

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

Common(may affect less than 1 in 10 people):

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

Uncommon(may affect less than 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 any not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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.

5. How to store Duac

The medicine should be kept out of sight and reach of children.
Pharmacist:Store in a refrigerator (2°-8°C). Do not freeze.
Patient:After receiving from the pharmacist, do not store above 25°C and discard 2 months after first opening the tube.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should 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 (anhydrous 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 940, dimethicone, colloidal hydrated silica, poloxamer 182, sodium hydroxide, disodium edetate, disodium lauryl sulfosuccinate, purified water.

What Duac looks like and what the packaging contains

Duac is a white to light yellow gel, available in tubes containing 30 g of gel.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, the country of export:

GlaxoSmithKline Trading Services Limited
12 Riverwalk, Citywest Business Campus
Dublin 24
Ireland

Manufacturer:

GlaxoSmithKline Trading Services Limited
12 Riverwalk, Citywest Business Campus
Dublin 24
Ireland

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Authorization number in Romania, the country of export: 10957/2018/01

Parallel import authorization number: 245/23

This medicinal product is authorized for sale 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 approval of the leaflet: 27.10.2023

[Information about the trademark]