DUAC 10 mg/g + 50 mg/g GEL

Introduction

Package Leaflet: Information for the Patient

Duac 10 mg/g + 50 mg/ggel

clindamycin + benzoyl peroxide anhydrous

Read the package leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

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

1. What is Duac gel and what is it used for

Duac gel contains two active substances: clindamycin and benzoyl peroxide.

Duac gel belongs to a group of medicines known as anti-acne preparations.

Antibiotics are used to treat bacterial infections and will not work for viral infections such as the common cold or flu.

It is important that you follow the instructions regarding dose, administration interval, and treatment duration indicated by your doctor.

Do not store or reuse this medicine. If you have any leftover antibiotic after finishing treatment, return it to the pharmacy for proper disposal. Do not throw away medicines via wastewater or household waste.

Duac gel is indicated for the treatment of mild to moderate acne vulgaris.

• Clindamycin is an antibiotic that prevents the bacteria involved in acne from reproducing.
• Benzoyl peroxide acts by reducing comedones (blackheads and whiteheads) and also eliminates the bacteria involved in acne.

When these active substances are used together in Duac gel, they help to:

• fight the bacteria that cause acne

• treat blackheads, whiteheads, and pimples
• reduce the number of red and inflamed acne pimples.

Duac gel is indicated for adults and adolescents from 12 years of age onwards.

2. What you need to know before you use Duac gel

Do not use Duac gel:

• if you are allergic to clindamycin, lincomycin, benzoyl peroxide, or any of the other ingredients of this medicine (listed in section 6).

Do not use Duac gel if any of the above applies to you. If you are not sure, consult your doctor or pharmacist before using Duac gel.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Duac gel.

• Use Duac gel only on the skin.Avoid contact of the gel with the eyes, lips, mouth, or inside of the nose.
• Do not use the gel on irritated skin areas.For example, if you have cuts, scratches, sunburns, or damaged skin.

• If Duac gel accidentally comes into contact with the eyes, mouth, or inside of the nose, rinse with plenty of water.

• Do not use too much Duac gel on sensitive skin areas.
• Most patients experience 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 moisturizing cream, use Duac gel less frequently, or stop using it for a short period to allow your skin to recover and then restart treatment.
• If severe irritation occurs (severe redness, dryness, itching, stinging, or burning) or irritation does not improve, discontinue treatment and consult your doctor.
• Avoid getting Duac gel into contact with colored tissues, including colored clothing, towels, bedding, furniture, or carpets. Duac gel may bleach these materials.
• Duac gel may discolor hair.
• Duac gel may increase the sensitivity of your skin to the harmful effects of the sun. Avoid using sunbeds/lamps and minimize the time you spend exposed to the sun. While using Duac gel, you should use a sunscreen and wear protective clothing to protect you from sun radiation.

Consult your doctor or pharmacist before using this medicine:

• if you have ever had any of the following intestinal problems: “regional enteritis”, “ulcerative colitis”, or “antibiotic-associated colitis”.

If you have stomach cramps or diarrheathat does not improve or is severe, stop using Duac gel and contact your doctor immediately.Antibiotics can cause a change that leads to severe diarrhea and stomach cramps, although this is unlikely to occur with antibiotics applied to the skin.

• if you have recently used other medicines that contain clindamycin or erythromycin, there is a greater chance that Duac gel may not work as well as it should.

• Tell your doctor or pharmacistif you have recently used other medicines that contain clindamycin or erythromycin.

Children

Do not use this medicine in children under 12 years of age, as it is not known if it works or is safe for them.

Using Duac gel with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Tell your doctor or pharmacist if you are using any of the following:

• any other acne treatment, including antibiotics applied to the skin
• medicated soaps or cleansers or “abrasive” soaps
• soaps or cosmetics that have a strong drying effect
• products that contain high amounts of alcohol or “astringents”.

This is because when Duac gel is used with these products, your skin may become irritated over time.

Duac gel may make some acne medicines less effective when used at the same time, such as:

• some acne medicines applied to the skin that contain tretinoin, isotretinoin, or tazarotene.

• Tell your doctor or pharmacistif you are using any of these medicines. You may need to use the two products at different times of the day (e.g., one in the morning and the other at night). Using other acne medicines at the same time as Duac gel may increase the risk of skin irritation.

• If severe irritation occurs (severe redness, dryness, itching, stinging, or burning), stop treatment and consult your doctor.

• Duac gel should not be used at the same time as other medicines that contain erythromycin.

• Applying Duac gel at the same time as medicines such as dapsone and sulfacetamidemay cause a temporary change in skin or facial hair color (turning it yellow/orange). This effect is not permanent.

• One of the components of Duac gel may affect the way certain general anesthetics (called “neuromuscular blockers”) work.

• Tell your doctor or pharmacistif you are going to have surgery.

If you are not sure if any of the above applies to you, consult your doctor or pharmacist before using Duac gel.

Pregnancy, breastfeeding, and fertility

There is limited information on the safety of Duac gel in pregnant women.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Your doctorwill assess the benefit for you and the risk for your baby of using Duac gel during pregnancy.

It is not knownif the components of Duac gel are excreted in breast milk. One of the active substances in Duac gel is clindamycin. When clindamycin is given orally or injected, it may appear in breast milk.

If you are breastfeeding, consult your doctorbefore using Duac gel.

Do not useDuac gel on the breast if you are breastfeeding.

3. How to use Duac gel

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If you are not sure, consult your doctor or pharmacist again.

• Use Duac gel once a day, in the evening.
• It may take between 2 and 5 weeks before you see the effect of Duac gel.
• Do not use Duac gel for more than 12 weeks in a row. Your doctor will tell you the duration of treatment.

How to apply Duac gel

1. Remove any makeup.
2. Wash the affected skin area well. Rinse with lukewarm water and pat dry.
3. Apply a thin layerof gel to allof the affected skin area using your fingertips.
4. Apply the product to all areas of skin that have acne, not just individual pimples. If the gel does not absorb easily, you are using too much product.

• For the face, use the amount of gel that fits on the tip of the finger up to the first joint (the first fold of the finger). This is about the size of a pea.
• For the face and back, use two and a half fingertips in total.

1. If you have a lot of dryness or peeling of the skin, use an oil-free moisturizing cream, use Duac gel less frequently, or stop applying the treatment for a short period to allow your skin to adapt to the treatment. This medicine may not work properly if it is not applied every day.
2. Wash your handsafter applying the gel.
3. Once the product has dried, you can use a non-greasy makeup.

Use this medicine as your doctor or pharmacist has told you or as indicated in the package leaflet. If you are not sure, consult your doctor or pharmacist.

If you use more Duac gel than you should

• Be careful not to apply too much product.Applying too much gel or applying it more frequently will not help your acne improve more quickly and may cause skin irritation. If this happens, use the gel less frequently or stop using it for a few days and then start using it again.
• There is no experience of overdose with Duac gel. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you accidentally swallow Duac gel

• If you accidentally swallow the gel, consult your doctor. You may have symptoms similar to those when taking oral antibiotics (stomach upset).

If you forget to use Duac gel

• Do not apply a double dose to make up for forgotten doses.
• Apply the next dose at the usual time.

If you stop treatment with Duac gel

Do not use Duac gel for more than 12 weeks in a row without consulting your doctor. Use Duac gel for as long as your doctor recommends. Do not stop using Duac gel unless your doctor tells you to.

It is important that you continue using the gel as your doctor has told you. If you stop treatment too soon, it is likely that your acne will come back.

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.

If you notice any of the following serious side effects, stop using Duac gel and consult your doctor immediately – you may need urgent medical attention:

• signs of an allergic reaction (such as swelling of the face, eyes, lips, or tongue, hives, difficulty breathing, collapse)
• severe or prolonged diarrhea, or stomach cramps
• severe stinging, 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 start treatment again.

Very common side effects

(affect at least 1 in 10 people)

At the application site:

• Redness, peeling, dryness.

These side effects are usually mild.

Common side effects

(affect less than 1 in 10 people)

• Headache.

At the application site:

• Stinging, pain, sensitivity to sunlight.

Uncommon side effects

(affect less than 1 in 100 people)

• Tingling (paresthesia), worsening of acne, redness, itching of the skin, rash (dermatitis, erythematous rash).

Other side effects

A small number of people have had other side effects, although the exact frequency is unknown:

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

At the application site:

• Skin reactions, skin discoloration.
• Inflammatory rash that causes itching (hives).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency via the website: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Duac gel

Keep this medicine out of the sight and reach of children.

Pharmacist:Store in a refrigerator (between 2°C and 8°C). Do not freeze.

Patient:Once the pharmacist has dispensed Duac gel to you, do not store it above 25°C and discard it after 2 months.

Do not use this medicine after the expiry date which is stated on the packaging (after EXP). The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. If you are unsure, ask your pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Duac gel

• The active substances are: clindamycin phosphate, equivalent to clindamycin 1% w/w (10 mg/g) and benzoyl peroxide hydrated, equivalent to anhydrous benzoyl peroxide 5% w/w (50 mg/g).

• The other ingredients (excipients) are: carbomer, dimethicone, lauryl sulfosuccinate disodium, disodium edetate, glycerol, hydrated colloidal silica, poloxamer 182, purified water, and sodium hydroxide.

Appearance of the product and pack contents

• Duac gel is available in packs of 5, 6, 15, 25, 30, 50, 55, 60, and 70 g.

The gel is white to slightly yellowish in color.

• Each pack contains a tube of Duac gel.
• Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

GlaxoSmithKline, S.A.

P.T.M. C/ Severo Ochoa, 2

28760 Tres Cantos (Madrid)

Tel: + 34 900 202 700

[email protected]

Manufacturer

GlaxoSmithKline Trading Services Limited

12 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Denmark: Clindoxyl Gel

Cyprus, Greece: Indoxyl Gel

Estonia, Iceland, Italy, Latvia, Portugal, Slovak Republic, 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

Date of last revision of this leaflet:August 2021.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es.