Duac 10 mg/g + 30 mg/g gel

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Duac 10 mg/g + 30 mg/g gel

clindamycin + anhydrous benzoyl peroxide

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

• Keep this leaflet, as 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Duac gel is and what it is 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. 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 are not effective against viral infections such as the flu or the common cold.

It is important that you follow the instructions regarding dose, dosing interval, and duration of treatment as directed by your doctor.

Do not store or reuse this medicine. If you have any antibiotic left over after completing treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via the sink or in household waste.

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

• Clindamycin is an antibiotic that prevents the growth of the bacteria involved in acne.
• Benzoyl peroxide works by reducing blackheads and whiteheads. It also kills the bacteria involved in acne.

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

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

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

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 this medicine (listed in section 6).

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

Warnings and precautions

Talk to 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 the nose.
• Do not use the gel on irritated areas of skin. For example, if you have cuts, scratches, sunburn, or damaged skin.

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

• Do not use too much Duac gel on sensitive areas of skin.
• 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 moisturizer, use Duac gel less frequently, or stop using it temporarily to allow your skin to recover, then restart treatment.
• If severe irritation occurs (severe redness, dryness, itching, stinging, or burning), or if irritation does not improve, stop treatment and contact your doctor.
• Avoid letting Duac gel come into contact with colored fabrics, including clothing, towels, bed linen, furniture, or carpets. Duac gel may bleach these materials.
• Duac gel may bleach hair.
• Duac gel may increase the sensitivity of your skin to the harmful effects of sunlight. Avoid using sunbeds or UV lamps and minimize your exposure to sunlight. While using Duac gel, you should use a sunscreen and wear protective clothing against solar 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 diarrhea that does not improve or is severe, stop using Duac gel and contact your doctor immediately. Antibiotics can cause a disturbance leading to severe diarrhea and stomach cramps, although this is unlikely with antibiotics applied to the skin
• if you have recently used other medicines containing clindamycin or erythromycin, there may be an increased chance that Duac gel will not work as well as expected.

? Tell your doctor or pharmacist if you have recently used other medicines containing clindamycin or erythromycin.

Children

Do not use this medicine in children under 12 years of age, as it is unknown whether it is effective or safe for them.

Use of Duac gel with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

• any other acne treatments, including topical antibiotics
• medicated soaps or cleansers or “abrasive” products
• soaps or cosmetics with a strong drying effect
• products containing high amounts of alcohol or “astringents”.

This is because using Duac gel together with these products may irritate your skin over time.

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

• some topical acne medicines containing tretinoin, isotretinoin, or tazarotene.

? Tell your doctor or pharmacist if 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 one 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 containing erythromycin.

• Applying Duac gel at the same time as medicines such as dapsone and sulfacetamide 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 action of certain general anesthetics (called “neuromuscular blockers”).

? Inform your doctor or pharmacist if you are scheduled for surgery.

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

Pregnancy, breastfeeding, and fertility

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 medicine.

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

It is unknown whether the components of Duac gel are excreted in breast milk. One of the medicines contained in Duac gel is clindamycin. When clindamycin is administered orally or by injection, it may appear in breast milk.

If you are breastfeeding, you should consult your doctor before using Duac gel.

Do not use Duac gel on the breasts if you are breastfeeding your baby.

3. How to use Duac gel

F or external use only.

Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• Use Duac gel once daily, in the evening.
• It may take between 2 and 5 weeks before you notice the effect of Duac gel.
• Do not use Duac gel for longer than 12 consecutive weeks. Your doctor will determine the duration of treatment.

How to apply Duac gel

1. Remove any traces of makeup.
2. Wash the affected skin area thoroughly. Rinse with lukewarm water and gently dry.
3. Apply a thin layer of gel over the entire affected area using your fingertip.
4. Apply the product to all acne-prone areas of skin, not just on individual spots. If the gel does not absorb easily, you are using too much product.
   • For the face, use the amount of gel that covers from the fingertip to the first joint (the first crease of the finger)—that is, one fingertip unit.
   • For the face and back, use a total of two and a half fingertip units.
5. If your skin becomes very dry or starts to peel, use an oil-free, fragrance-free, hypoallergenic moisturizer, use Duac gel less frequently, or stop treatment temporarily to allow your skin to adapt. This medicine may not work properly if not applied daily.
6. Wash your hands after applying the gel.
7. Once the product has dried, you may apply non-comedogenic makeup, if desired.

Use this medicine as directed by your doctor or pharmacist, or as described in the package leaflet. 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. Applying more gel or applying it more frequently will not make acne improve faster and may cause skin irritation. If this occurs, use the gel less frequently or stop using it for a few days, then resume treatment.
• There is no experience of overdose with Duac gel. In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If Duac gel is accidentally ingested

• If you accidentally swallow the gel, consult your doctor. You may experience symptoms similar to those seen with oral antibiotics (stomach discomfort).

If you forget to use Duac gel

· Do not apply a double dose to make up for a missed dose.

· Apply the next dose at your usual time.

If you stop treatment with Duac gel

Do not use Duac gel for longer than 12 consecutive weeks without consulting your doctor. Use Duac gel for as long as your doctor recommends. Do not stop using Duac gel unless your doctor advises you to do so.

It is important that you continue using the gel as directed by your doctor. If you stop treatment too early, acne is likely to return.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

If you notice any of the following serious adverse 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 diarrhoea, or abdominal cramps
• severe stinging, peeling or itching.

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 resume treatment.

Very common adverse 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 weeks of treatment.

These adverse effects are generally mild.

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

• Headache.

At the application site:

• Sensitivity to sunlight, skin pain.
• Redness, itching of the skin, rash (dermatitis).

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

At the application site:

• Tingling (paraesthesia), worsening of acne.

Other adverse effects:

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

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

At the application site:

• Skin reactions, skin discolouration.
• Itchy raised rash (wheals).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse 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 the refrigerator (between 2°C and 8°C). Do not freeze.

Patient: After the pharmacist dispenses Duac gel, do not store above 25°C. Discard after two months.

Indicate the dispensing date on the outer packaging.

Do not use this medicine after the expiry date stated on the container (after EXP). The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Duac gel

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

Appearance of the product and contents of the container

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

Only some package 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 medicinal product is authorized in the European Economic Area (EEA) member states under the following names:

Date of the 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 Health Products (AEMPS) http://www.aemps.gob.es