Duac

Patient Information Leaflet

DUAC 10 mg/g + 30 mg/g Gel

clindamycin + anhydrous benzoyl peroxide
Please read all of this leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What DUAC Gel is and what it is used for

DUAC Gel contains two medicinal substances: clindamycin and benzoyl peroxide.
DUAC Gel belongs to a group of medicines known as "anti-acne preparations".
DUAC Gel is used to treat mild to moderate acne of the skin.

• Clindamycin is an antibiotic that prevents the growth of bacteria involved in acne.
• Benzoyl peroxide reduces blackheads and pimples. It also kills the bacteria involved in acne.

The combined use of these two ingredients in DUAC Gel works by:

• fighting the bacteria that cause acne
• treating existing blackheads, pimples, and pustules
• reducing the number of inflamed, red acne pustules

DUAC Gel is indicated for use in adults and adolescents aged 12 years and older.

2. What you should know before using Duac Gel

Do not use DUAC Gel

• if you are allergic to clindamycin, lincomycin, benzoyl peroxide, or any of the other ingredients of DUAC Gel (listed in section 6). Do not use DUAC Gel if any of the above apply to you. If you are unsure, speak to your doctor or pharmacist before starting to use DUAC Gel.

Warnings and precautions
Talk to your doctor or pharmacist before using Duac Gel

• Use DUAC Gel on the skin only. Keep away from areas such as eyes, lips, mouth, or inside the nose.
• Do not use the gel on irritated areas of skin. For example, if there are cuts, abrasions, sunburns, or damaged skin. → If DUAC Gel accidentally gets into the eyes, mouth, or nose, rinse thoroughly with plenty of water.
• Do not apply too much DUAC Gel on sensitive areas of skin.
• Most patients experience some redness and peeling of the skin during the first few weeks of treatment. If your skin becomes irritated, you may need to use an oil-free moisturizer, use DUAC Gel less frequently, or stop using it temporarily to allow your skin to recover, then restart treatment.
• Stop treatment and consult your doctor if skin irritation is severe (severe redness, dryness, itching, stinging pain, or burning) or does not improve.
• Try to avoid contact between DUAC Gel and coloured fabrics, including clothing, towels, linen sheets, furniture, or carpets. DUAC Gel may bleach these materials.
• DUAC Gel may bleach hair.
• DUAC Gel may make your skin more sensitive to the harmful effects of sunlight. Avoid using sunbeds/lamps and minimize exposure to sunlight. You should use sunscreen and wear protective clothing while using DUAC Gel.

Before using this medicine, talk to your doctor or pharmacist if:
→ you have ever had the following intestinal problems: "regional enteritis", "ulcerative colitis", or "antibiotic-associated colitis".
→ If you experience stomach cramps or diarrhoea that does not improve or worsens, stop using
DUAC Gel and contact your doctor immediately. Antibiotics can cause a condition leading to severe diarrhoea and stomach cramps, although this is unlikely with antibiotics applied to the skin.
→ If you have recently used other medicines containing clindamycin or erythromycin, there is an increased chance that DUAC Gel may not work as effectively as it should.
→ Inform your doctor or pharmacist if you have recently used any other medicine containing clindamycin or erythromycin.

Children
Do not give this medicine to children under twelve years of age. It is not known whether it is effective or safe for them.

Other medicines and Duac Gel
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor or pharmacist if you are using any of the following:

• Any acne treatment containing antibiotics applied to the skin
• Medicated or "abrasive" soaps and cleansers
• Soaps or cosmetics that are too drying
• Products containing high amounts of alcohol or "astringent substances"

Because these products, when used together with DUAC Gel, may irritate the skin over time.
DUAC Gel may make some anti-acne medicines less effective when used at the same time.
This includes:

• certain anti-acne medicines applied to the skin containing tretinoin, isotretinoin, or tazarotene. → Inform your doctor or pharmacist if you are also using any of these medicines. It may be necessary to use the two products at different times of the day (for example, one in the morning and the other in the evening).

Using other anti-acne medicines together with DUAC Gel may increase the risk of skin irritation.
→ Stop treatment and consult your doctor if skin irritation becomes severe (severe redness, dryness, itching, stinging pain, or burning).

• DUAC Gel must not be used at the same time as medicines containing erythromycin.
• Applying DUAC Gel at the same time as medicines such as dapsone and sulfacetamide may cause a temporary skin or facial hair discoloration (yellow/orange). This will not be permanent.
• One of the medicines in DUAC Gel may affect the action of certain medicines used during general anaesthesia (so-called "neuromuscular blocking agents").
• Inform your doctor or pharmacist if you are scheduled for surgery.

If you are unsure whether any of these conditions apply to you, talk to your doctor or pharmacist before using DUAC Gel.

Pregnancy, breastfeeding, and fertility
There is limited information available on the safety of Duac Gel in pregnant women.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Your doctor will assess the benefit to the mother and the potential risk to the unborn child of using Duac Gel during pregnancy.
It is not known whether the components of DUAC Gel pass into breast milk. One of the medicines in DUAC Gel is clindamycin. When clindamycin is taken by mouth or by injection, it can pass into breast milk.
If you are breastfeeding, consult your doctor before using DUAC Gel.
Do not apply DUAC Gel to the breast area if you are breastfeeding.

3. HOW TO USE DUAC GEL

Use this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.

• Use DUAC Gel once daily in the evening.
• It may take 2 to 5 weeks before you see the effect of DUAC Gel.
• Do not use for longer than 12 weeks at a time. Your doctor will tell you how long your treatment should last.

How to apply DUAC GEL

1. Remove all makeup completely.
2. Wash the affected area thoroughly. Then rinse with lukewarm water and gently pat dry with a towel.
3. Apply a thin layer of gel to the entire affected skin area, using the tip of your finger.
4. Apply to all acne-prone areas of the skin, not just individual spots. If the gel does not absorb easily, this means too much has been applied.

• For the face only, use an amount of gel that, when squeezed from the tube, reaches from the fingertip to the first joint (the first crease on the finger). This is known as a "fingertip unit".
• For both face and back, use a total of two and a half fingertip units. 5. If you experience excessive dryness or peeling of the skin, you may use an oil-free, fragrance-free, hypoallergenic moisturizer, use DUAC Gel less frequently, or stop treatment temporarily to allow your skin to adjust. This medicine may not work properly if not applied daily. 6. Wash your hands after applying the gel. 7. Once the gel is dry, you may apply non-comedogenic, non-oily makeup.

Always use this medicine exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
If you use more DUAC Gel than you should

• Be careful not to apply too much. Applying too much gel or applying it more often will not clear acne faster and may cause skin irritation. If this occurs, use the gel less frequently or stop using it for a few days, then restart treatment.

If you accidentally swallow DUAC Gel

• If the gel is accidentally swallowed, consult a doctor. You may experience symptoms similar to those seen when taking oral antibiotics (such as stomach upset).

If you forget to use DUAC Gel

• Do not use a double dose to make up for missed doses.
• Apply the next dose at your usual time.

Do not stop using DUAC Gel without medical advice.
Do not use the gel for longer than 12 weeks at a time without speaking to your doctor. Use DUAC Gel for the duration recommended by your doctor. Do not stop unless your doctor advises you to do so.
It is important to continue using the gel as prescribed by your doctor. If you stop too early, acne may return.
If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using DUAC Gel and contact a doctor immediately if you experience any of the following
serious side effects – you may need urgent medical treatment:

• Signs of an allergic reaction (such as swelling of the face, eyes, lips or tongue, hives, breathing difficulties, collapse)
• Severe or prolonged diarrhoea, or abdominal cramps
• Severe burning, peeling or itching.

Other possible side effects:
If you notice any of these side effects, try using DUAC Gel less frequently, or stop using it for one or two days and then resume treatment.
Very common side effects
(affects at least 1 in 10 people)
At the application site:

• Skin burning sensation, peeling, itching, dry skin
• Skin redness, especially during the very first weeks of use. These side effects are usually mild in intensity.

Common side effects
(affects less than 1 in 10 people)

• Headache

At the application site:

• Light sensitivity, skin pain
• Red, itchy, raised skin ( dermatitis )

Uncommon side effects
(affects less than 1 in 100 people)
At the application site:

• Tingling (paresthesia), worsening of acne.

Other side effects
Other side effects have occurred in a very small number of people, but their exact frequency is unknown:

• Allergic reactions
• Inflammation of the intestine, diarrhoea (including bloody diarrhoea), stomach ache

At the application site:

• Skin reactions, skin discoloration
• Itchy, raised skin rash (urticaria)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the website of the Italian Medicines Agency (Agenzia Italiana del Farmaco): https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Duac Gel

Keep DUAC Gel out of the sight and reach of children.
Pharmacist: store in a refrigerator (2°C–8°C). Do not freeze.
Patient: after receiving DUAC Gel from the pharmacist, do not store above 25°C and discard 2 months after opening.
Do not use this medicine after the expiry date stated on the tube and label (after "EXP.:"). The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What DUAC Gel contains

• The active substances are clindamycin phosphate and benzoyl peroxide hydrate. One gram of gel contains 10 mg (1% w/w) of clindamycin as clindamycin phosphate and 30 mg (3% w/w) of anhydrous benzoyl peroxide as benzoyl peroxide hydrate.
• The other components are: carbomer 980, dimethicone, disodium lauryl sulfosuccinate, disodium edetate, glycerol, silica (hydrated colloidal), poloxamer 182, purified water and sodium hydroxide.

Description of the appearance of DUAC Gel and contents of the pack
DUAC Gel is a white to yellowish gel supplied in tubes of 30 grams and 60 grams.

• Each pack contains one tube of DUAC Gel.
• Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Stiefel Laboratories Legacy (Ireland) Limited – Unit 2, Building 2500, Avenue 2000, Cork Airport
Business Park, Cork - Ireland
Local Representative: GlaxoSmithKline S.p.A. Viale dell’Agricoltura, 7 37135 Verona, Italy
Manufacturer and batch release:
GlaxoSmithKline Trading Services Limited
12 Riverwalk,
Citywest Business Campus
Dublin 24,
Ireland

This medicinal product has been authorised in the European Union Member States under the following names:
Cipro 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 zel
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

This Patient Information Leaflet was last approved in May 2021