Patient Information: Package Insert

Duac 10 mg/g + 30 mg/ggel

clindamicina + peróxido de benzoílo anhidro

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

-Keep this package insert, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1.What is Duac gel and how is it used

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

3.How to use Duac gel

4.Possible side effects

5.Storage of Duac gel

6.Contents of the package and additional information

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

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

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, and also eliminates the bacteria involved in acne.

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

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

Duac gel is indicated for use in adults and adolescents 12 years of age and older.

No use Duac gel:

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

Do not use Duac gel if you have any of the above conditions. If you are unsure, consult your doctor or pharmacist before using Duac gel.

Advertencias y precauciones

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

·Use Duac gel only on the skin.Avoidcontact of the gel 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, sunburn, or damaged skin.

?If Duac gel accidentally enterscontact 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 skin redness and peeling during the first weeks of treatment.If your skin becomes irritated,you may need to use a non-comedogenic 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 (severe redness, dryness, itching, stinging, or burning) occurs, or if irritation does not improve, discontinue treatment and consult your doctor.

·Avoid Duac gel coming into contact with colored fabrics, including clothing, towels, bedding, furniture, or carpets.Duac gel may discolor these materials.

·Duac gel may cause hair discoloration.

·Duac gel may increase your skin's sensitivity to the damaging effects of the sun. Avoid the use of sunbeds/lamp UV and minimize the time you spend exposed to the sun. While using Duac gel, you must use a sunscreen and wear protective clothing.

Consult your doctor or pharmacist before using this medication:

·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 condition that leads to severe diarrhea and stomach cramps, although this is unlikely to occur with topical antibiotics.

·if you have recently used other medications that contained clindamycin or erythromycin, there is an increased possibility that Duac gel may not work as well as it should.

?Inform your doctor or pharmacistif you have recently usedother medications that contained clindamycin or erythromycin.

Children

Do not use this medication in children under 12 years of age, andit is unknown whether it works or is safe for them.

Use of Duac gel with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

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

·any other acne treatment, including topical antibiotics

·soaps or medicated cleansers or "exfoliants"

·soaps or cosmetics that have a strong drying effect

·products that contain large amounts of alcohol or "astringents".

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

Duac gel may make some acne medications less effective when used together,such as:

·some acne medications that are applied to the skin and containtretinoin, isotretinoin, or tazarotene.

?Inform your doctor or pharmacistif you are using any of these medications. You may need to use the two products at different times of the day (for example, one in the morning and the other at night).

Using other acne medications at the same time as Duac gel, may increase the risk of skin irritation.

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

·Duac gel should not be administered at the same time as other medications that contain erythromycin.

·The application of Duac gel at the same time as medications such as dapsone and sulfacetamida may cause a temporary change in the color of the skin or facial hair (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.

?Inform your doctor or pharmacistif you are to be operated on.

If you are unsure about any of the above points, consult your doctor or pharmacist before using Duac gel.

Pregnancy, breastfeeding, and fertility

The safety information on the use of Duac gel in pregnant womenis limited.

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

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

It is unknownwhether the components of Duac gel are excreted in breast milk. One of the medications in Duac gel is clindamycin. When clindamycin is administered orally or injected, it may appear in breast milk.

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

Do not use Duac gel on the breast if you arebreastfeedingyour baby.

Instructions for External Use.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

·Use Duac gel once a day, at night.

·It may take between 2 and 5 weeks to observe the effect of Duac gel.

·Do not use Duac gel for more than 12 consecutive weeks. Your doctor will indicate the duration of treatment.

How to Apply Duac Gel

1.Remove any remaining makeup.

2.Wash the affected skin area well. Rinse with warm water and pat dry.

3.Applya thin layerof gel toallthe affected skin area using the fingertips.

4.Apply the product to all areas of skin with acne, not just on the pimples. If the gel does not absorb easily, it is because you are using too much product.

·For the face, use the amount of gel that comes out of the tube and reaches from the tip of the finger to the first joint (the first crease of the finger). That is, the fingertip.

·For the face and back, use two and a half fingertips in total.

5.If you have a lot of dryness in the skin, or the skin is peeling, use an oil-free moisturizer (oil-free), fragrance-free and hypoallergenic, use Duac gel less frequently, or stop applying the treatment for a short period of time to allow the skin to adapt to the treatment. This medication may not work properly if it is not applied every day.

6.Wash your handsafter applying the gel.

7.Once the product has dried, you can use a non-greasy makeup if you wish.

Use this medication as directed by your doctor or pharmacist or as indicated in the package insert. If you are unsure, consult your doctor or pharmacist.

If You Use More Duac Gel Than You Should

·Be careful not to apply too much product.The application of too much gel or applying it more frequently will not help the acne improve faster, and could 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.

·No experience of overdose with Duac gel. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If You Accidentally Ingest Duac Gel

·If you accidentally ingest the gel, consult your doctor.You may experience symptoms similar to those when taking oral antibiotics (stomach discomfort).

If You Forget to Use Duac Gel

·Do not apply a double dose to compensate for the missed doses.

·Apply the next dose at the usual time.

If You Interrupt Treatment with Duac Gel

Do not use Duac gel for more than 12 consecutive weeks without consulting your doctor. Use Duac gel for the entire time recommended by your doctor. Do not stop using Duac gel unless your doctor recommends it.

It is essential to continue using the gel as directed by your doctor.If you stop the treatment too soon, it is likely that the acne will return.

If you have any questions about the use of this medication, ask your doctor or pharmacist.

Just like all medications, this medication can produce adverse effects, although not all people will experience them.

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

·Signs of allergic reaction (such as facial swelling, eye, lip, or tongue swelling, hives, difficulty breathing, collapse)

·Severe or prolonged diarrhea, or abdominal cramps

·Severe itching, peeling, or burning.

Other possible adverse effects:

If you notice any of these adverse effects, try using Duac gel less frequently, or stop using it for one or two days and then start the treatment again.

Frequent adverse effects(may affect more than 1 in 10 people)

At the application site:

·Itching, peeling, burning, dryness of the skin.

·Redness of the skin, especially during the first weeks of treatment.

These adverse effects are usually mild.

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

·Headache.

At the application site:

·Sensitivity to sunlight, skin pain.

·Redness, itching, or rash (dermatitis).

Rare adverse effects(may affect up to 1 in 100 people)

At the application site:

·Tickling (paresthesia), worsening of acne.

Other adverse effects:

A reduced number of people have experienced other adverse effects, but the exact frequency is unknown:

·Allergic reactions.

·Intestinal inflammation, diarrhea, including bloody diarrhea, stomach pain.

At the application site:

·Reactions on the skin, skin discoloration.

·Rash with elevated lesions that cause itching (hives).

Reporting adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keepthismedicationoutofsightandreachofchildren.

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

Patient:After thepharmacist dispenses Duac gel,do not storeat a temperature above 25°C.Donot usefor two months.

Indicate the dispensing date of the packaging on the outer packaging.

Do not use this medication after the expiration date that appears on the packaging (after CAD). The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. In this way, you will help protect the environment.

Composition of Duac gel

·The active ingredients are: clindamycin and aqueous benzoyl peroxide. 1 gram of gel contains 10 mg (1% p/p) of clindamycin as clindamycin phosphate and 30 mg (3 % p/p) of anhydrous benzoyl peroxide as aqueous benzoyl peroxide.

·The other components are: carbomer980, dimethicone, lauril sulfosuccinate sodium, disodium edetate, glycerol, colloidal hydrated silica, poloxamer 182, purified water, and sodium hydroxide.

Appearance of the product and contents of the package

Duac gel is a white to slightly yellowish gel that is supplied in tubes of 30 and 60 grams.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

GlaxoSmithKline, S.A.

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

28760 Tres Cantos(Madrid)

Tel: + 34 900 202 700

[email protected]

Responsible for manufacturing

GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublín 24

Irlanda

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:October 2024.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es