DUAC 1% + 5% Gel

Зміст інструкції

1. DUAC 10 mg/g + 30 mg/g Gel
   1. What is DUAC Gel and what is it 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. Package contents and other information

DUAC 10 mg/g + 30 mg/g Gel

clindamycin + anhydrous benzoyl peroxide

Read this leaflet carefully before 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you use 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 is DUAC Gel and what is it used for

DUAC Gel contains two medicinal products: 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 blocks the reproduction of bacteria involved in acne.
• Benzoyl peroxide reduces blackheads and pimples. It also kills the bacteria involved in acne.

Their use in combination in DUAC Gel works by:

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

Duac Gel is indicated for use in adults and adolescents aged 12 years and over.

2. What you need to 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 applies to you. If you are not sure, talk 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 only on the skin. Keep away from areas such as eyes, lips, mouth or inside the nose.
• Do not use the gel on irritated skin. For example if there are cuts, abrasions, sunburns, or damaged skin. → If Duac Gel accidentally gets into your eyes, mouth or nose, rinse thoroughly with water.
• Do not use too much DUAC Gel on sensitive skin areas.
• Most patients experience some redness and peeling of the skin during the first few weeks of treatment. If the skin becomes irritated, it may be necessary to use an oil-free moisturizer, use Duac Gel less often, or stop using it for a short period to allow the skin to recover and then start treatment again.
• Stop treatment and consult your doctor if skin irritation is severe (severe redness, dryness, itching, stinging pain, or burning) or if it does not improve.
• Try to avoid contact between DUAC Gel and colored fabrics, including clothing, towels and linen, furniture or carpets. DUAC Gel may bleach these materials.
• DUAC Gel may bleach hair.
• DUAC Gel may make the skin more sensitive to the harmful effects of the sun. Avoid the use of sunbeds/lamps and minimize exposure to the sun. It is necessary to 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 “colitis
associated with the use of antibiotics”.
→ If you experience stomach cramps or diarrheathat does not improve or worsens, stop using
DUAC Gel and contact your doctor immediately. Antibiotics can cause a
condition that causes severe diarrhea and stomach cramps, although this is unlikely to
occur with antibiotics applied to the skin.
→ If you have recently used other medicines containing clindamycin or erythromycin, there is a
greater likelihood that DUAC Gel will not work as well as it should.
→ Tell your doctor or pharmacist if you have recently usedany other medicine based
on clindamycin or erythromycin.

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

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

• Any acne treatment that contains antibiotics used on the skin
• Medicated or “abrasive” soaps and cleansers
• Soaps or cosmetics that have a too drying effect
• Products that contain a lot of alcohol or “astringent substances”.

This is because when used together with DUAC Gel, over time they can irritate the skin.

DUAC Gel can make some anti-acne medicines less effective when used at the
same time.
This includes:

• some anti-acne medicines that are applied to the skin and contain tretinoin,isotretinoin or tazarotene.→ Tell your doctor or pharmacistif 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).

The use of other anti-acne medicines together with DUACGel may increase the risk of skin irritation.
→ Stop treatment and consult your doctorif skin irritation becomes severe
(severe redness, dryness, itching, stinging pain, or burning).

• DUACGel should not be used at the same time as medicines containingerythromycin.
• Applying DUAC Gel at the same time as medicines such as dapsone and sulfacetamide may cause a temporary change in skin or facial hair color (yellow / orange). This will not be permanent.
• One of the medicines present in DUAC Gel may affect the functioning of certain medicines used in general anesthesia (so-called "neuromuscular blocking agents").
• Tell your doctor or pharmacistif you are to undergo surgery .

If you are not sure if any of these conditions apply to you, talk to your doctor or pharmacist before using DUAC Gel.
Pregnancy, breastfeeding and fertility
There is only limited informationon the safety of Duac Gel in pregnant women .
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.

The doctorwill assess the benefit for the mother and the risk to the child of using Duac Gel in
pregnancy.

It is not knownwhether the ingredients of DUAC Gel can pass into breast milk. One of the medicines
contained in DUAC Gel is clindamycin. When clindamycin is taken by mouth or
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 if you are breastfeeding.

3. HOW TO USE DUAC GEL

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.

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

How to apply DUAC GEL

• 1. Remove makeup completely.
• 2. Wash the affected area thoroughly. Then rinse with lukewarm water and gently pat dry with a towel.
• 3. Apply a thin layerof gel to the entireaffected skin area, using your fingertips.
• 4. Apply to all areas of skin with acne, not just on individual pimples. If the gel is not easily absorbed, this means that an excessive amount has been applied.
• For the face only, use the amount of gel that, when emerging from the tube, reaches the fingertip at first contact (the first crease on the finger). This is a “fingertip unit”.
• For the face and back, use a total of two and a half “fingertip units”.
• 5. In case of excessive dryness and scaling of the skin, it is possible to use an oil-free, fragrance-free and hypoallergenic moisturizer, use DUAC Gel less frequently or interrupt the treatment for a short period, to allow the skin to adjust to the treatment. This medicinemay not work properly if it is not applied every day.
• 6. Wash your handsafter using the gel.
• 7. After it has dried, you can use non-oily makeup.

Use this medicine following exactly as stated in this leaflet or the instructions
of 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 frequently will not clear up pimples more quickly, and may cause skin irritation. If this should happen, use the gel less often, or stop using it for a few days and then start again.

If you accidentally swallow DUAC Gel

• If you accidentally swallow the gel, consult a doctor. You may experience symptoms similar to those when taking antibiotics orally (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 the usual time.

Do not stop using DUAC Gel without advice.
Do not use the gel for more than 12 weeks at a time, without talking to your doctor. Use DUAC
Gel for the time recommended by your doctor. Do not stop unless your doctor tells you to.

It is important to continue using the gel as prescribed by your doctor.If you stop too soon,
acne may return.
If you have any further questions on the use of 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 consult a doctor immediately if you experience any of the following
serious side effects – you may need urgent medical attention:

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

Other possible side effects:
If you experience any of these side effects, try using DUAC Gel less frequently, or
stop using it for one or two days and then resume.

Very common side effects

(affects at least 1 in 10 people)

At the application site:

• Burning sensation of the skin, peeling, itching, skin dryness
• Redness of the skin, especially during the very first weeks of use. These side effects are usually mild.

Common side effects

(affects less than 1 in 10 people)

• Headache

At the application site:

• Light sensitivity, skin pain
• Red, itchy and 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 been reported in a very limited number of people, but their exact
frequency is unknown:

• Allergic reactions
• Inflammation of the intestine, diarrhea, including bloody diarrhea, stomach pain

At the application site:

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.
You can also report side effects directly through 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 it at a temperature above
25°C and discard 2 months after opening.
Do not use this medicine after the expiry date which is stated on the tube and the label (after
”EXP.:”). The expiry date refers to the last day of that month.
Do not dispose of any medicine in 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 ingredients are clindamycin phosphate and benzoyl peroxide hydrate. One gram of gel contains 10 mg (1% weight/weight) of clindamycin as clindamycin phosphate and 30 mg (3% weight/weight) of anhydrous benzoyl peroxide as benzoyl peroxide hydrate.
• The other ingredients 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 package contents
DUAC Gel is a yellowish-white gel and is 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 Member States of the European Union with 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