Package Insert: Information for the Patient

Duac 10 mg/g + 50 mg/g Gel

clindamicina + peróxido de benzoílo anhidro

Read this entire package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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 common acne.

• 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:

• fight the bacteria that causes acne

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

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

Do not use Duac gel:

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

Do not use Duac gel if you have any of the above circumstances. If you are unsure, 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 the 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 enters the eyes, mouth, or the inside of 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 irritates,you may need to use a non-oil moisturizing cream, use Duac gel less frequently, or stop using it for a short period of time to allow your skin to recover and then resume treatment.
• If severe irritation (severe redness, dryness, itching, stinging, or burning) occurs or irritation does not improve, discontinue treatment and consult your doctor.
• Avoid Duac gel from coming into contact with colored tissues, including colored 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 on treatment with 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 containing clindamycin or erythromycin, there is a higher probability that Duac gel will not work as well as it should.

• Inform your doctor or pharmacist if you have usedrecently other medications containing clindamycin or erythromycin.

Children

Do not use this medication in children under 12 years of age, as its safety and effectiveness in this age group are unknown.

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
• medicated soaps or cleansers or "abrasives"
• cosmetics that have a strong drying effect
• products containing 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 topical acne medications that 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,discontinue treatment and consult your doctor.

• Duac gel should not be administered at the same time as other medications containing erythromycin.

• The application of Duac gel at the same time as medications such asdapsone and sulfacetamidamay cause a temporary change in skin or 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.

• 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 women is 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 benefits for you and the risks 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 active ingredients 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 useDuac gel on the breast if you are breastfeeding your baby.

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 skin areas 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.

1. If you have a lot of dryness in the skin, or the skin is flaking, use an oil-free moisturizing cream, 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.
2. Wash your handsafter applying the gel.
3. Once the product has dried, you can use a non-greasy makeup.

Use this medication as indicated 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.
• There are no experiences 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 have symptoms similar to 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 the 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 indicated by your doctor.If you stop treatment too soon, it is likely that the acne will return.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

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

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 the 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:

• Itching, pain, sensitivity to sunlight.

Uncommon side effects
(affect less than 1 in 100 people)

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

Other side effects

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

• Allergic reactions.
• Intestinal inflammation, diarrhea, including bloody diarrhea, stomach pain.

At the application site:

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

Reporting side effects

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

Keepthis medication out of the sight and reach of children.

Pharmacist:Store in refrigerator (between2°Cand 8°C). Do not freeze.

Patient:Once the pharmacist has dispensed Duac gel to you,do not store it at a temperature above25°Cand dispose of it after 2 months.

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.

Medications should not be disposed of through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Duac gel

• The active principles are: clindamicina fosfate, equivalent to clindamicina 1% p/p (10 mg/g) and peróxido de benzoílo hidratado, equivalent to peróxido de benzoílo anhidro 5% p/p (50 mg/g).

• The other components (excipients) are: carbómero, dimeticona, l auril sulfosuccinato de disodio, edetato de disodio, glicerol, sílice coloidal hidratada, poloxámero 182, agua purificada e hidróxido de sodio.

Appearance of the product and contents of the packaging

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

The gel is white to slightly yellowish in color.

• Each packaging contains a tube of Duac gel.
• Only some packaging sizes may be marketed.

Marketing authorization holder and responsible 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]

Responsible manufacturer

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 and in the United Kingdom (Northern Ireland) with the following names:

Dinamarca: Clindoxyl Gel

Chipre, Grecia: Indoxyl Gel

Estonia, Islandia, Italia, Letonia, Portugal, República Eslovaca, España, Suecia: Duac Gel

Finlandia: Clindoxyl Geeli

Alemania: Duac Akne Gel

Países Bajos: Duac Acne Gel

República Checa, Lituania, Polonia: Duac

Irlanda, Malta, Reino Unido (Irlanda del Norte): Duac Once Daily Gel

Last review date of this leaflet: August 2021.

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