DUOCLIN 10 mg/g + 50 mg/g GEL

Introduction

Leaflet: Information for the user

Duoclin 10 mg/g + 50 mg/g gel

clindamycin + benzoyl peroxide anhydrous

Read the entire leaflet carefully before starting to use 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 to you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Duoclin and what is it used for
2. What you need to know before starting to use Duoclin
3. How to use Duoclin
4. Possible side effects
5. Storage of Duoclin
6. Package contents and additional information

1. What is Duoclin and what is it used for

Duoclin contains two active substances: clindamycin and benzoyl peroxide. Duoclin belongs to the group of medicines known as 'anti-acne preparations'.

Antibiotics are used to treat bacterial infections and are not used to treat viral infections such as the flu or the common cold.

It is essential that you follow the instructions regarding dosage, administration interval, and treatment duration indicated by your doctor.

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

This medicine is used for the treatment of mild to moderate acne on your skin.

• 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 this medicine, they help to:

• Combat the bacteria that cause acne
• Treat existing blackheads, whiteheads, and pimples
• Reduce the number of red and inflamed acne pimples

Duoclin is for use in adults and adolescents aged 12 and above.

2. What you need to know before starting to use Duoclin

Do not use Duoclin:

• if you are allergic to clindamycin, lincomycin, benzoyl peroxide, or any of the other components of this medicine (listed in Section 6).

Do not use this medicine if any of the above circumstances apply to you. If you are unsure, consult your doctor or pharmacist before using Duoclin.

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medicine

• Consult your doctor or pharmacist before using this medicine ifyou 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 Duoclinand contact your doctor immediately. Antibiotics can cause a disruption that leads to severe diarrhea and stomach cramps. Although this is unlikely to occur with antibiotics applied to the skin.

• Use Duoclinonly on the skin. Avoid contact 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, sunburns, or damaged skin.

• If Duoclin accidentally comes into contact with the eyes, mouth, lips, or inside the nose, rinse with plenty of water.

• Do not use too much Duoclin on sensitive skin areas.
• Most patients experience redness and peeling during the first few weeks of treatment. If your skin becomes irritated, you may need to use an oil-free moisturizing cream, use this medicine less frequently, or stop using it for a short period 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, interrupt treatment and consult your doctor.

• Duoclin may increase the sensitivity of your skin to the harmful effects of the sun. Avoid using sunbeds/UV lamps and minimize the time you spend exposed to the sun. While using Duoclin, you should use a sun protection product and wear protective clothing.

• If you have recently used other medicines that contained clindamycin or erythromycin, there is an increased chance that Duoclin may not work as well as it should.

• Tell your doctor or pharmacist if you have recently usedother medicines that contained clindamycin or erythromycin.

• Try to avoid this medicine coming into contact with colored tissues, including colored clothing, towels, bedding, furniture, or carpets. Duoclin may discolor these materials.
• Duoclin gel may discolor hair.

Children

Do not use this medicine in children under 12 years of age. It is not known if it works or is safe for them.

Using Duoclin 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' products
• soaps or cosmetics that have a strong drying effect
• products that contain large amounts of alcohol or 'astringents'

This is because when Duoclin is used with these products, your skin may become irritated over time.

This medicine may make some acne medicines less effective when used at the same time. This includes:

• Some acne medicines applied to the skin that contain 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 Duoclin may increase the risk of skin irritation.

• Interrupt treatment and consult your doctorif severe irritation occurs (severe redness, dryness, itching, stinging, or burning).

Duoclin should not be used at the same time as other medicines that contain erythromycin.

Applying Duoclin at the same time as medicines such as dapsoneand sulfacetamidemay cause a temporary change in skin or facial hair color (yellow/orange color). This effect is not permanent.

One of the components in this medicine may affect the way certain general anesthetics (called 'neuromuscular blocking agents') work.

• Tell your doctor or pharmacistif you are going to have surgery.

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

Pregnancy, breastfeeding, and fertility

There is limited information on the safety of using Duoclin 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 doctor will assess the benefit to you and the risk to the baby of using Duoclin during pregnancy.

It is not known if the components of this medicine are excreted in breast milk. One of the medicines contained in Duoclin is clindamycin. When clindamycin is given orally or injected, it may appear in breast milk. If you are breastfeeding, consult your doctorbefore using Duoclin.

Do not use this medicine on the breast if you are breastfeeding.

3. How to use Duoclin

Follow the instructions for using this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

• Use Duoclin once a day at night.
• It may take between 2 and 5 weeks to see the effect of this medicine.
• Do not use Duoclin for more than 12 weeks in a row. Your doctor will indicate the duration of treatment.

How to apply Duoclin

1. Completely 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 skin areas that have acne, not just individual pimples. If the gel does not apply easily, you are using too much product.
   • For the face only, use the amount of gel that comes out of the tube and reaches from the tip of your finger to the first joint (the first fold of your finger). This is the 'finger tip'.
   • For the face and back, use two and a half 'finger tips' in total.

1. If you have a lot of dryness or peeling of the skin, use an oil-free, fragrance-free, hypoallergenic moisturizing cream, use Duoclin less frequently, or stop applying the treatment for a short period to allow your skin to adapt to the treatment. This medicine may not work properly if it is not applied every day.
2. Wash your hands after applying the gel.
3. Once the product has dried, you can use a non-greasy makeup if you wish.

Use this medicine as your doctor or pharmacist has indicated or as described in the leaflet. If you are unsure, consult your doctor or pharmacist.

If you use more Duoclin 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 start using it again.

If you accidentally swallow Duoclin

• If you accidentally swallow the gel, consult your doctor. You may have symptoms similar to those experienced when taking oral antibiotics (stomach upset).

In case of overdose or accidental ingestion, consult your doctor or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested or used.

If you forget to use DuoclinDo not apply a double dose to make up for forgotten doses.

• Apply the next dose at the usual time.

If you stop treatment with Duoclin

Do not use the gel for more than 12 weeks in a row without consulting your doctor. Use Clindamycin/Benzoyl peroxide for as long as your doctor recommends. Do not stop using this medicine unless your doctor advises you to do so.

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

If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Stop using Duoclin and consult your doctor immediately if you notice any of the following serious side effects – 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 abdominal cramps
• severe stinging, peeling, or itching.

Very common side effects

(may affect more than 1 in 10 people)

At the application site:

• redness, peeling, dryness

These side effects are usually mild.

Common side effects

(may affect up to 1 in 10 people)

• headache

At the application site:

• stinging, pain, sensitivity to sunlight

Uncommon side effects

(may affect up to 1 in 100 people)

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

Other side effects

Other side effects with frequency not known (frequency cannot be estimated from available data) include:

• allergic reactions
• inflammation of the intestine, diarrhea, including bloody diarrhea, stomach pain

At the application site:

• skin reactions, skin discoloration
• inflammatory rash that causes itching (urticaria)

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Duoclin

Keep this medicine out of the sight and reach of children.

Store in a refrigerator (2°C – 8°C).

After the first opening of Duoclin, do not store above 25°C and discard after 2 months.

Do not use this medicine after the expiry date stated on the packaging after 'EXP'.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Duoclin

• The active substances are: clindamycin and benzoyl peroxide anhydrous. 1 g of gel contains 10 mg of clindamycin (as clindamycin phosphate) and 50 mg of benzoyl peroxide anhydrous (as hydrated benzoyl peroxide).
• The other components are: carbomer 980, dimethicone, sodium lauryl sulfosuccinate, disodium edetate, glycerol, poloxamer (poloxamer 182), hydrated colloidal silica, sodium hydroxide 2N, purified water.

Appearance of the product and package contents

Homogeneous gel, white to slightly yellowish in color, with fine visible particles.

25 g, 30 g, 50 g, or 60 g of gel in a closed aluminum tube with a white plastic cap, in a cardboard box.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Industrial Farmacéutica Cantabria, S.A.

Ctra. Cazoña-Adarzo s/n, 39011 Santander

Spain

Manufacturer

Jadran-Galenski laboratorij d.d.

Svilno 20

51000 Rijeka

Croatia

This medicine is authorized in the Member States of the European Economic Area under the following names:

Slovenia: Klindamicin/benzoilperoksid JGL 10mg/50mg in 1 g gel

Spain: Duoclin 10mg/g + 50 mg/g gel

Italy: DUOCLIN

Portugal: DUOCLIN 10 mg/g + 50 mg/g Gel

Date of the last revision of this leaflet:06/2021

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