Product Information for the User

Duoclin 10 mg/g + 50 mg/g gel

clindamicina + peróxido de benzoilo anhidro

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

• Keep this product information, 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 product information. See section 4.

Duoclin contains two active ingredients: clindamicina and peróxido de benzoilo. Duoclin belongs to a group of medications known as ‘anti-acne preparations’.

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

• Clindamicina is an antibiotic that prevents the bacteria involved in acne from reproducing.
• Peróxido de benzoilo acts by reducing blackheads and whiteheads. It also eliminates the bacteria involved in acne.

When these active ingredients are used together in this medication, they help to:

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

Duoclin is for use in adults and adolescents 12 years of age and older.

No use Duoclin:

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

Do not use this medication if you apply any of the above circumstances. 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 medication

• Consult your doctor or pharmacist before using this medication ifyou have ever had any of the followingintestinal 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 condition that leads to severe diarrhea and stomach cramps. Although this is unlikely to occur with topical antibiotics.

• 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 enters 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 weeks of treatment.If your skin irritates, you may need to use a non-oil moisturizing cream, use this medication 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.

• Duoclin 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 Duoclin, you must use a sunscreen and wear protective clothing.

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

• Inform your doctor or pharmacist if you have recently usedother medications containing clindamycin or erythromycin.

• Try to avoid this medication 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 medication in children under 12 years of age. Its safety and effectiveness in this age group are unknown.

Use of Duoclin 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’
• soaps or cosmetics that have a strong drying effect
• products containing large amounts of alcohol or ‘astringents’

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

This medication may make some acne medications less effective when used together. This includes:

• Some topical acne medications that containtretinoin, isotretinoinortazarotene.

• Inform your doctor or pharmacist if you are also 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 Duoclin may increase the risk of skin irritation.

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

Duoclin should not be administered at the same time as other medications that contain erythromycin.

The application of Duoclin at the same time as medications such asdapsoneandsulfacetamidamaycause a temporary change in skin or facial hair color (yellow/orange color). This effect is not permanent.

One of the components in this medication may affect the way certain general anesthetics (called ‘neuromuscular blocking agents’) 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 this medication.

Pregnancy, breastfeeding, and fertility

The safety of Duoclin in pregnant women is limited.

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

Your doctor will evaluate the benefits for you and the risks to the baby of using Duoclin during pregnancy.

It is unknown whether the components of this medication are excreted in breast milk. One of the medications in Duoclin is clindamycin. When clindamycin is administered orally or injected, it may appear in breast milk.Consult your doctorif you are breastfeeding before using Duoclin.

Do not use this medication 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.

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

How to applyDuoclin

1. Completely remove any remaining makeup.

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

3. Apply a fine layer of gel to all affected skin, using the fingertips.

4. Apply the product to all skin areas with acne, not just individual pimples. If the gel does not apply easily, it is because 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 fingertip tip to the first joint (the first finger fold). This is 'fingertip tip'.
• For the face and back, use two 'fingertip tips' and a half in total.

5. If you have a lot of dry skin or the skin is peeling, use an oil-free, fragrance-free, hypoallergenic moisturizing cream. Use Duoclin less frequently or stop applying the treatment for a short period 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 desired.

Use this medication as indicated by your doctor or pharmacist or as indicated in the package insert. If 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 using it more frequently will not help the acne improve faster, 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 ingest Duoclin

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

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

If you forgot to use DuoclinDo 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 Duoclin

Do not use the gel for more than 12 consecutive weeks without consulting your doctor. Use Clindamicina/Peróxido de benzoilo for the time recommended by your doctor. Do not stop using this medication 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 any doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Stop using Duoclin and consult your doctor immediately if you notice any of the severe effects listed below – 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.

Very Common Adverse Effects

(may affect more than 1 in 10 people)

At the application site:

• Redness, peeling, dryness

These adverse effects are usually mild.

Common Adverse Effects

(may affect up to 1 in 10 people)

• Headache

At the application site:

• Itching, pain, sensitivity to sunlight

Uncommon Adverse Effects

(may affect up to 1 in 100 people)

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

Other Adverse Effects

Other adverse effects with unknown frequency (frequency cannot be estimated from available data) include:

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

At the application site:

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

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Store in refrigerator (2°C – 8°C).

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

Do not use this medication after the expiration date that appears on the packaging after "CAD?".

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

Composition of Duoclin

• The active principles are:clindamicina and anhydrous benzoil peroxide.1 g of gel contains 10 mg of clindamicina (as clindamicina phosphate) and 50 mg of anhydrous benzoil peroxide (as benzoil peroxide hydrate).
• The other components are:carbomer980, dimethicone,sodium lauryl sulfosuccinate, disodium edetate, glycerol, poloxamer (poloxamer 182), hydrated colloidal silica, sodium hydroxide 2N, purified water.

Appearance of the product and content of the container

Homogeneous gel of white to slightly yellowish color with visible fine 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.

Only some container sizes may be commercially marketed.

Holder of the Marketing Authorization and Responsible for Manufacturing

Holder of the Marketing Authorization

Industrial Farmacéutica Cantabria, S.A.

Ctra. Cazoña-Adarzo s/n, 39011 Santander

Spain

Responsible for Manufacturing

Jadran-Galenski laboratorij d.d.

Svilno 20

51000 Rijeka

Croatia

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

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

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

Italy: DUOCLIN

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

Last review date of this leaflet:06/2021

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.