Duac 10 mg/g + 50 mg/g gel

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Duac 10 mg/g + 50 mg/g gel

clindamycin + anhydrous benzoyl peroxide

Read the entire leaflet carefully before you start using this medicine, as 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 other people, 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 influenza or the common cold.

It is important that you follow the instructions regarding dose, frequency, 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 wastewater or 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 comedones (blackheads and whiteheads) and also kills the bacteria associated with 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 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 on skin only. Avoid contact of the gel with the eyes, lips, mouth, or inside of 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 of the nose, rinse thoroughly with plenty of water.

• Do not use excessive amounts of 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 moisturiser, 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 irritation does not improve, stop treatment and contact your doctor.

• Avoid letting Duac gel come into contact with coloured fabrics, including coloured 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/tanning lamps and minimise the time spent in direct sunlight. While using Duac gel, you should use a sunscreen and wear protective clothing to shield your skin from 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 diarrhoea that does not improve or is severe, stop using Duac gel and contact your doctor immediately. Antibiotics may cause a condition leading to severe diarrhoea 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 is an increased chance that Duac gel may not work as well as expected.

• Inform 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.

Using Duac gel with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might need to use 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 “abrasives”
• 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:

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

• Inform 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 (for example, 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 skin or facial hair colour (turning it yellow/orange). This effect is not permanent.

• One of the components of Duac gel may affect the action of certain general anaesthetics (known as “neuromuscular blockers”).

• Inform your doctor or pharmacist if you are due to have 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

Information on the safety of using Duac gel in pregnant women is limited.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 active ingredients 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

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

• Use Duac gel once daily, at night.
• 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 advise you on the duration of treatment.

How to apply Duac gel

1. Remove any traces of makeup.
2. Wash the affected area of skin thoroughly. Rinse with lukewarm water and dry gently.
3. Apply a thin layer of gel to the entire affected area of skin using the tips of your fingers.
4. Apply the product to all acne-prone areas of skin, not only on individual pimples. If the gel does not absorb easily, you are using too much product.

• For the face, use the amount of gel that comes out of the tube and reaches from the fingertip to the first joint (the first crease of the finger)—that is, the fingertip.
• For the face and back, use a total of two and a half fingertip units.

1. If you experience excessive 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. This medicine may not work properly if not applied every day.
2. Wash your hands after applying the gel.
3. Once the product has dried, you may use non-comedogenic (non-greasy) makeup.

Use this medicine as directed by your doctor or pharmacist, or as indicated in this 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 are no reported cases 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, stating the medicine and the amount ingested.

If you accidentally swallow Duac gel

• 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 missed doses.
• Apply the next dose at the 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 any further questions about how to use 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 restart treatment.

Very common adverse effects

(affect at least 1 in 10 people)

At the application site:

• Redness, peeling, dryness.

These adverse effects are usually mild.

Common adverse effects

(affect less than 1 in 10 people)

• Headache.

At the application site:

• Stinging, pain, sensitivity to sunlight.

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

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

Other adverse effects

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

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

At the application site:

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: 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 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 at temperatures above 25°C and discard it after 2 months.

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 medicines and their containers at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Duac gel

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

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

Appearance of the medicine and contents of the pack

• 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 colour.

• Each pack contains one tube of Duac gel.
• Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 authorised in 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, Slovakia, 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 the most recent review of this leaflet: August 2021.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios - AEMPS) http://www.aemps.gob.es.