DUAC 10 mg/g + 30 mg/g GEL

Introduction

Package Leaflet: Information for the Patient

Duac 10 mg/g + 30 mg/ggel

clindamycin + benzoyl peroxide anhydrous

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

• Keep this 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 pack

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. Storage of 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 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 as indicated by your doctor.

Do not keep or reuse this medicine. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not throw medicines down the drain or in the trash.

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 blackheads and whiteheads. It also eliminates the bacteria involved in acne.

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

• combat the bacteria that can cause acne
• treat blackheads, whiteheads, and pimples
• reduce the number of red and inflamed acne pimples.

Duac gel is indicated for adults and adolescents aged 12 years and above.

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 with the eyes, lips, mouth, or inside 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 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, fragrance-free, and hypoallergenic moisturizer, use Duac gel less frequently, or stop using it for a short period of time to allow your skin to recover and then restart treatment.
• If severe irritation occurs (severe redness, dryness, itching, stinging, or burning), or the irritation does not improve, discontinue treatment and consult your doctor.
• Avoid getting Duac gel into contact with colored tissues, including 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 yourself from the sun.

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 diarrhea that 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 contained clindamycin or erythromycin, there is an increased chance that Duac gel may not work as well as it should.

Tell your doctor or pharmacistif you have recently usedother medicines that contained clindamycin or erythromycin.

Children

Do not use this medicine in children under 12 years old, 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), discontinue 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 sulfacetamide may 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 limitedsafety information on the use of Duac gel in pregnant women.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

It is not knownif the components of Duac gel are excreted in breast milk. One of the medicines that Duac gel contains 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 use Duac gel on the breast if you are breastfeeding.

3. How to use Duac gel

For external use only.

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

• Use Duac gel once a day, at night.
• It may take between 2 and 5 weeks before you notice the effect of Duac gel.
• Do not use Duac gel for more than 12 weeks in a row. Your doctor will indicate 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 gently pat dry.
3. Apply a thin layer of gel to the entire affected skin area using your fingertips.
4. Apply the product to all areas of the 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 your finger to the first joint (the first fold of the finger). This is the fingertip.
• For the face and back, use two and a half fingertips in total.
5. If you have a lot of dryness or peeling of the skin, use an oil-free, fragrance-free, and hypoallergenic moisturizer, use Duac gel less frequently, or stop applying the treatment for a short period of time to allow your skin to adapt to the treatment. This medicine may not work properly if it is not applied every day.
6. Wash your hands after applying the gel.
7. Once the product has dried, you can use a non-greasy makeup if you wish.

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 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 restart treatment.
• There is no experience with overdose of 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 using 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 indicated.If you stop treatment too soon, it is likely that the acne will return.

If you have any further questions on the use of this product, 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 restart treatment.

Very common side effects(may affect more than 1 in 10 people)

At the application site:

• stinging, peeling, itching, dryness of the skin.
• redness of the skin, especially during the first few weeks of treatment.

These side effects are usually mild.

Common side effects(may affect up to 1 in 10 people)

• headache.

At the application site:

• sensitivity to sunlight, pain in the skin.
• redness, itching of the skin, rash (dermatitis).

Uncommon side effects(may affect up to 1 in 100 people)

At the application site:

• tingling (paresthesia), worsening of acne.

Other side effects:

A small number of people have had other side effects, but 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.
• elevated itchy rash (hives).

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency (AEMPS) 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:After the pharmacist has dispensed Duac gel to you, do not store it above 25°C. Discard after two months.

Write the dispensing date on the outer packaging.

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 indicated.

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

6. Contents of the pack and other information

Composition of Duac gel

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

Appearance of the product and packaging contents

Duac gel is a white to slightly yellowish gel supplied in 30 and 60 gram tubes.

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 under the following names:

Date of last revision of this leaflet:October 2024.

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