Duac

Package leaflet: Information for the patient

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Duac (Indoxyl), (10 mg + 50 mg)/g, gel
Clindamycinum + Benzoylis peroxidum
Duac and Indoxyl are different trade names of the same medicinal product.
Please read the entire leaflet before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• Consult your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If any of the adverse effects worsen or if you notice any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents:

1. What Duac is and what it is used for
2. What you need to know before using Duac
3. How to use Duac
4. Possible side effects
5. How to store Duac
6. Contents of the pack and other information

1. What Duac is and what it is used for

Duac contains two active substances: clindamycin and benzoyl peroxide. Duac belongs to a group of medicines used to treat acne.
Duac is used to treat mild to moderate acne vulgaris.

• Clindamycin is an antibiotic that inhibits the growth of bacteria responsible for acne.
• Benzoyl peroxide reduces comedones (closed and open), and has bactericidal activity against bacteria associated with acne.
  The combination of clindamycin and benzoyl peroxide in Duac:
• fights the bacteria involved in acne,
• treats open and closed comedones and pimples,
• reduces the number of red, inflamed pimples associated with acne.

Duac is intended for use in adults and adolescents above the age of 12.

2. Important information before using Duac

When not to use Duac:

• Do not use Duac if you are allergic to clindamycin, lincomycin, benzoyl peroxide, or any of the ingredients of this medicine (listed in section 6 of this leaflet). If in doubt, consult your doctor or pharmacist.

Warnings and precautions
Talk to your doctor or pharmacist before using Duac.
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• Duac should only be applied to the skin. Avoid contact with the eyes, lips, mouth, or inside of the nose.

Do not apply Duac to irritated skin, such as skin with cuts, abrasions,
sunburn, or damaged skin.
➔ If Duac accidentally gets into the eyes, mouth, or inside the nose, rinse the area thoroughly with water.

• Do not apply too much Duac to sensitive areas of skin.
• 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 moisturiser, reduce the frequency of application of Duac, or stop using it temporarily until the skin condition improves.
• If skin irritation is severe (intense redness, dryness, itching, stinging, or burning), stop using Duac and contact your doctor.
• Take care to avoid contact of the medicine with coloured fabrics, including clothing, towels, bed linen, furniture, carpets, or rugs. Duac may cause discolouration of these materials.
• Duac may bleach hair.
• Duac may make your skin more sensitive to the harmful effects of sunlight. Avoid using sunbeds and limit sun exposure as much as possible. While using Duac, use sunscreen products with UV filters and protective clothing.

Contact your doctor or pharmacist before using Duac if:

• you have or have had any of the following gastrointestinal disorders: intestinal inflammation, ulcerative colitis, or antibiotic-associated colitis.
• if you experience abdominal pain or diarrhoea that does not go away or worsens, you should stop using Duac and contact your doctor immediately. Antibiotics may cause conditions characterised by severe diarrhoea and abdominal pain, although this is unlikely with topical antibiotics.
• you have recently used medicines containing clindamycin or erythromycin, as there may be an increased risk that Duac will not work as effectively.

➔ Talk to your doctor or pharmacist if you have recently used any other medicine containing clindamycin or erythromycin.
Children
Duac should not be used in children under 12 years of age. It is not known whether it is safe or effective in this age group.
Other medicines and Duac
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Inform your doctor or pharmacist if you are using any of the following:

• other acne treatments, including topical antibiotics,
• medicated soaps and cleansing agents with exfoliating properties,
• soaps and cosmetics with strong drying effects,
• medicines containing high concentrations of alcohol or astringents. Using these products together with Duac may lead to skin irritation. Duac may also reduce the effectiveness of certain other medicines used at the same time. These include:
• certain topical acne treatments containing tretinoin, isotretinoin, or tazarotene. Page 2 of 6

➔ Inform your doctor or pharmacist if 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 simultaneously with Duac may increase the risk of skin irritation.
➔ Stop using Duac and contact your doctor if skin irritation is severe (intense redness, dryness, itching, stinging, or burning).

• Do not use Duac at the same time as other medicines containing erythromycin.
• Using Duac together with medicines such as dapsone or sulfacetamide may cause temporary discolouration of the skin or facial hair (yellow/orange colour). This effect is not permanent.
• One of the ingredients of Duac may affect the action of medicines used in general anaesthesia (called "muscle relaxants").

➔ Inform your doctor or pharmacist if you are scheduled for surgery.
If you are unsure whether any of the above situations apply to you while using Duac, contact your doctor or pharmacist.
Pregnancy, breastfeeding, and fertility
Information on the safety of using Duac during pregnancy is limited.
During pregnancy, while breastfeeding, if you suspect you may be pregnant, or if you are planning a pregnancy, consult your doctor or pharmacist before using this medicine.
Your doctor will decide whether the benefits of using Duac during pregnancy outweigh the risks to the unborn child.
It is not known whether the ingredients of Duac pass into breast milk.
One of the ingredients of Duac is clindamycin. When clindamycin is administered orally or by injection, it may pass into breast milk.
If you are breastfeeding, you must contact your doctor before using Duac.
Do not apply Duac to the skin of the breasts during breastfeeding.

3. How to use Duac

This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt,
please consult your doctor or pharmacist.

• Duac should be applied once daily, in the evening.
• The effect of Duac may not become apparent until after 2 to 5 weeks of treatment.
• Do not use the medicine for longer than 12 consecutive weeks. Your doctor will determine how long treatment should continue.

How to apply Duac:

1. Remove all makeup completely.
2. Wash the affected skin thoroughly, rinse with warm water, and gently pat dry with a towel.
3. A small amount of gel should be applied with fingertips to the entire affected area.
4. The gel should be applied to the whole treated skin surface, not only to individual acne lesions. If the gel does not absorb easily, this indicates that too much gel has been applied.
   • To cover the face, use an amount of gel that fits between the fingertip and the first joint (first finger bend)—this amount corresponds to a "fingertip unit".

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• To cover both face and back, use a maximum of two and a half "fingertip units". 5. If the skin becomes excessively dry or starts to peel, a non-greasy moisturizer may be used, or Duac may be applied less frequently or temporarily discontinued to allow the skin to adjust to treatment. This medicine may not work properly if not used daily. 6. After applying the gel, wash your hands. 7. Once the gel has dried, non-greasy makeup may be applied. This medicine should always be used as described in the patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Use of more Duac than recommended

• Do not apply excessive amounts of gel. Applying too much gel or using it more often than recommended will not speed up healing of acne lesions and may cause skin irritation. If too much gel has been applied, reduce the frequency of application or discontinue use for a few days, then resume treatment.

If Duac is accidentally swallowed

• If the gel is swallowed, contact your doctor immediately. Adverse effects may occur similar to those seen with oral antibiotics (stomach irritation).

Missed dose of Duac:

• Do not use a double dose to make up for a missed dose.
• Apply the next recommended dose according to your usual dosing schedule.

Do not stop using Duac unless instructed by your doctor.
Do not use the gel for longer than 12 consecutive weeks without medical advice.
Duac should be used for as long as your doctor recommends. Do not stop treatment unless your doctor
decides otherwise.
It is important to use the gel exactly as prescribed by your doctor. If you stop using this
medicine too early, acne may return.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following serious adverse symptoms occur, stop using the medicine and contact a doctor immediately – urgent medical assistance may be required:

• signs of allergic reactions (such as swelling of the face, eyes, lips or tongue, hives or difficulty breathing, fainting),
• severe or persistent diarrhoea or abdominal cramps,
• severe burning, peeling or itching.

Other possible adverse reactions
If any of the following symptoms are noticed, reduce the frequency of application of the medicine Duac or discontinue use for 1 or 2 days, then resume treatment.
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Very common ( may affect more than 1 in 10 patients ):

• at the application site: redness, peeling, dryness of the skin. These adverse reactions are usually mild.

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

• headache,
• at the application site: burning, pain, increased sensitivity to sunlight.
  Uncommon ( may affect less than 1 in 100 patients ):
• tingling sensation (paraesthesia), worsening of acne, redness and itching of the skin, rash (skin inflammation, erythematous rash).

Other adverse reactions
Other adverse reactions that occurred in a very small number of treated individuals; frequency unknown:

• allergic reactions,
• intestinal inflammation, diarrhoea (including bloody diarrhoea), abdominal pain,
• at the application site: skin reactions, skin depigmentation, raised, itchy rash (urticaria).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions 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 adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Duac

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

6. Contents of the pack and other information

What Duac contains
The active substances are:

• clindamycin as clindamycin phosphate,
• benzoyl peroxide (anhydrous benzoyl peroxide) as benzoyl peroxide with water. Each 1 g of gel contains 10 mg of clindamycin and 50 mg of benzoyl peroxide.

Other ingredients are:
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• carbomer (50,000 mPa.s), dimethicone (100 mm.s), disodium lauryl sulfosuccinate, disodium edetate, glycerol, colloidal anhydrous silica, poloxamer 182, sodium hydroxide, purified water.

What Duac looks like and contents of the pack
Duac is a white to pale yellow, homogeneous gel.
Duac is available in a tube containing 30 g of gel, packed in a cardboard box.
Each cardboard box contains one tube of Duac.
If you have any questions regarding the use of Duac or the information contained in this leaflet, consult your doctor or pharmacist.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Greece, country of export:
GlaxoSmithKline Monoprosopi A.E.B.E., Leof. Kifisias 266, 152 32 Chalandri, Greece
Manufacturer:
GlaxoSmithKline Trading Services Limited, 12 Riverwalk, Citywest Business Campus, D24 YK11, Dublin, Ireland
Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing Authorisation number in Greece, country of export: 90510/18-7-2019
Parallel Import Licence Number: 289/25
This medicinal product is authorised in the European Economic Area and 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
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