Duac

Patient Information Leaflet

Warning! Keep this leaflet! 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 brand names for the same medicine.
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. The medicine may harm someone else, even if their symptoms are identical.
• If any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Duac is and what it is 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 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 in the treatment of mild to moderate acne vulgaris.

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

Warnings and precautions
Before starting to use Duac, speak to your doctor or pharmacist.

• Duac should only be applied to the skin. Avoid contact with the eyes, lips, mouth, or inside the nose.

Do not use the medicine on 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 treated individuals 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 (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 discoloration of these materials.
• Duac may bleach hair.
• Duac may make the skin more sensitive to the harmful effects of sunlight. Avoid using sunbeds and minimize exposure to sunlight. While using Duac, use sunscreen products with UV filters and protective clothing.

Contact your doctor or pharmacist before using Duac if:

• the patient has or has had any of the following gastrointestinal disorders: intestinal inflammation, ulcerative colitis, or antibiotic-associated colitis;
• if abdominal pain or diarrhoea occurs and does not go away or worsens, then stop using Duac and contact your doctor immediately. Antibiotics may cause diseases characterized by severe diarrhoea and abdominal pain, although this is unlikely when antibiotics are applied to the skin;
• the patient has recently used medicines containing clindamycin or erythromycin, as there is an increased risk that Duac may not work as effectively. ➔ Consult your doctor or pharmacist if the patient has 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 medicines:

• other anti-acne medicines, including topical antibiotics,
• medicated and exfoliating soaps and cleansers,
• soaps and cosmetics with strong drying effects,
• medicines containing high amounts of alcohol or astringents. Using these medicines together with Duac may lead to skin irritation.

Duac may cause some concurrently used medicines to be less effective. These include:

• certain topical anti-acne medicines containing tretinoin, isotretinoin, or tazarotene. ➔ Tell 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 anti-acne medicines simultaneously with Duac may increase the risk of skin irritation.

➔ Stop using the medicine 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 skin or hair discoloration on the face (yellow/orange colour). This is not a permanent effect.
• One of the ingredients of Duac may affect the action of medicines used in general anaesthesia (called "muscle relaxants").

➔ Tell your doctor or pharmacist about any planned 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 in pregnant women is limited.
During pregnancy, breastfeeding, if pregnancy is suspected, or when planning pregnancy, consult your doctor or pharmacist before using this medicine.
Your doctor will decide whether the benefits to the patient from 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 the patient is breastfeeding, she must contact her 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 you are unsure,
you should consult your doctor or pharmacist.

• Duac should be applied once daily, in the evening.
• The effect of Duac may not become noticeable 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 the treatment should last.

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 entire 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".
   • To cover the face and back, use up to a maximum of two fingertip units.
5. If the skin becomes excessively dry or starts to peel, you may use a non-greasy moisturizer, apply Duac less frequently, or temporarily discontinue use to allow the skin to adapt to treatment. This medicine may not work properly if not used daily.
6. After applying the gel, you must 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 information leaflet or as directed by your doctor
or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Use of more than the recommended dose of Duac

• Do not use excessive amounts of gel. Applying more gel than recommended or applying it more frequently than directed will not speed up healing of acne lesions and may cause skin irritation. If excessive gel has been used, reduce the frequency of application or discontinue use for several days, then resume treatment.

If Duac is accidentally swallowed:

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

Missed dose of Duac:

• Do not apply a double dose to make up for a missed dose.
• Apply the next recommended dose according to your regular 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.
Use Duac exactly as prescribed by your doctor. Do not stop treatment unless your doctor advises otherwise.
It is important to use the gel exactly as directed 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 experiences them.
If any of the serious adverse reactions listed below occur, stop using the medicine and contact a doctor immediately – immediate medical assistance may be required:

• symptoms of allergic reactions (such as: swelling of the face, eyes, lips or tongue, urticaria or
  breathing difficulties, 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 Duac or discontinue use for 1 or 2 days, then resume treatment.
Very common (may affect more than 1 in 10 patients):

• at the application site: redness of the skin, skin 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 sensation, 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 (dermatitis, 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 or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Reactions of Medicinal Products at 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 this medicine.

5. How to store Duac

Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2°C–8°C). Do not freeze.
Storage conditions after first opening the tube: Do not store above 25°C.
Shelf life after first opening the tube: 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 month indicated.
Medicines must 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 pack and other information

What Duac contains
The active substances 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 clindamycin and 50 mg benzoyl peroxide.

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

What Duac looks like and contents of the pack
Duac is a white to pale yellow gel.
Duac is available in an aluminium tube containing 30 g of gel, packed in a cardboard box.

For further information, contact the responsible party or the parallel importer.

Responsible party 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing authorisation number in Greece, country of export: 90510/18-7-2019
Parallel import authorisation number: 327/25

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