Duoclin 10 mg/g + 50 mg/g gel
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
Duoclin 10 mg/g + 50 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 reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Contents of the leaflet
- What Duoclin is and what it is used for
- What you need to know before using Duoclin
- How to use Duoclin
- Possible adverse effects
- How to store Duoclin
- Contents of the pack and other information
1. What Duoclin is and what it is used for
Duoclin contains two active substances: clindamycin and benzoyl peroxide. Duoclin 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 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 after completing treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.
This medicine is used for the treatment of mild to moderate acne on the skin.
- Clindamycin is an antibiotic that prevents the bacteria involved in acne from multiplying.
- Benzoyl peroxide works by reducing blackheads and whiteheads. It also kills the bacteria involved in acne.
When these active substances are used together in this medicine, they help to:
- Fight 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 years and older.
2. What you need to know before using Duoclin
Do not use Duoclin:
- 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 this medicine if any of the above apply to you. If you are unsure, consult your doctor or pharmacist before using Duoclin.
Warnings and precautions
Talk to your doctor or pharmacist before starting to use this medicine
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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'.
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If you have stomach cramps or diarrhoea that does not improve or is severe, stop using Duoclin and contact your doctor immediately. Antibiotics can cause a disturbance leading to severe diarrhoea and stomach cramps. Although this is unlikely with antibiotics applied to the skin.
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Use Duoclin only on the skin. Avoid contact of the gel with the eyes, lips, mouth, or inside the nose.
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Do not use the gel on irritated areas of skin. For example, if you have cuts, scratches, sunburn, or damaged skin.
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If Duoclin accidentally comes into contact with the eyes, mouth, lips, or inside the nose, rinse thoroughly with plenty of water.
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Do not use too much Duoclin on sensitive areas of skin.
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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 moisturiser, use this medicine less frequently, or stop using it temporarily to allow your skin to recover, then restart treatment.
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If severe irritation occurs (severe redness, dryness, itching, stinging, or burning), discontinue treatment and consult your doctor.
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Duoclin may increase the sensitivity of your skin to the harmful effects of sunlight. Avoid using sunbeds/lamps emitting UV radiation and minimize the time spent exposed to sunlight. While being treated with Duoclin, you should use sunscreen and wear protective clothing.
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If you have recently used other medicines containing clindamycin or erythromycin, there is an increased possibility that Duoclin may not work as well as expected.
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Inform your doctor or pharmacist if you have used other medicines containing clindamycin or erythromycin recently.
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Try to avoid letting this medicine come into contact with coloured fabrics, including coloured clothing, towels, bed linen, furniture, or carpets. Duoclin may bleach these materials.
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Duoclin gel may bleach hair.
Children
Do not use this medicine in children under 12 years of age. It is unknown whether it is effective or safe for them.
Using Duoclin 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 or 'abrasive' soaps or cleansers
- soaps or cosmetics with a strong drying effect
- products containing large amounts of alcohol or 'astringents'
This is because when Duoclin is used together with these products, your skin may become irritated over time.
This medicine may make some acne treatments less effective when used at the same time. This includes:
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Some topical acne treatments containing tretinoin, isotretinoin, or tazarotene.
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Inform your doctor or pharmacist if you are also 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 treatments at the same time as Duoclin may increase the risk of skin irritation.
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Stop treatment and consult your doctor if severe irritation occurs (severe redness, dryness, itching, stinging, or burning).
Duoclin should not be used at the same time as other medicines containing erythromycin.
Applying Duoclin at the same time as medications such as dapsone and sulfacetamide may cause a temporary change in skin or facial hair colour (yellow/orange). This effect is not permanent.
One of the components in this medicine may affect the action of certain general anaesthetics (known as "neuromuscular blocking agents").
- Inform your doctor or pharmacist if you are going to have surgery.
If you are unsure whether any of the above points apply to you, consult your doctor or pharmacist before using this medicine.
Pregnancy, breastfeeding, and fertility
Safety information on the use of Duoclin 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 Duoclin during pregnancy.
It is unknown whether the components of this medicine are excreted in breast milk. One of the medicines contained in Duoclin is clindamycin. When clindamycin is administered orally or by injection, it may appear in breast milk. If you are breastfeeding, you must consult your doctor before using Duoclin.
Do not use this medicine on the breast if you are breastfeeding your baby.
3. How to use Duoclin
Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
- Use Duoclin once daily at night.
- It may take between 2 and 5 weeks before you notice the effect of this medicine.
- Do not use Duoclin for more than 12 consecutive weeks. Your doctor will determine the duration of treatment.
How to apply Duoclin
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Completely remove any traces of makeup.
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Wash the affected skin area thoroughly. Rinse with lukewarm water and gently dry.
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Apply a thin layer of gel to the entire affected area of skin, using the fingertips.
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Apply the product to all areas of skin affected by acne, not only on individual pimples. If the gel does not spread 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 fingertip to the first joint (the first crease of the finger). This is referred to as a "fingertip unit".
- For the face and back, use a total of two and a half fingertip units.
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If you experience significant skin dryness or peeling, use an oil-free, fragrance-free, hypoallergenic moisturizing cream, use Duoclin less frequently, or temporarily stop treatment to allow your skin to adapt. This medication may not work properly if not applied daily.
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Wash your hands after applying the gel.
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Once the product has dried, you may apply non-comedogenic makeup, if desired.
Use this medicine exactly as prescribed by your doctor or pharmacist, or as described in this 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 excessive gel or using 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.
If you accidentally swallow Duoclin
- If you accidentally swallow the gel, consult your doctor. You may experience symptoms similar to those seen with oral antibiotics (stomach discomfort).
In case of overdose or accidental ingestion, consult your doctor or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested or used.
If you forget to use Duoclin Do not apply a double dose to make up for missed doses.
- Apply the next dose at the usual time.
If you interrupt treatment with Duoclin
Do not use the gel for more than 12 weeks consecutively 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 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 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.
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 burning, peeling, or itching.
Very common adverse effects
(may affect more than 1 in 10 people)
At the application site:
- Redness, peeling, dryness
These adverse effects are generally mild.
Common adverse effects
(may affect up to 1 in 10 people)
- Headache
At the application site:
- Burning, pain, sensitivity to sunlight
Uncommon adverse effects
(may affect up to 1 in 100 people)
- Tingling (paresthesia), worsening of acne, redness, skin itching, rash (dermatitis, erythematous rash).
Other adverse effects
Other adverse effects with unknown frequency (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, itchy rash (urticaria)
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 Duoclin
Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2°C – 8°C).
After 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 container following "EXP".
Medicines should not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.
6. Contents of the pack and other information
Composition of Duoclin
- The active substances are: clindamycin and anhydrous benzoyl peroxide. 1 g of gel contains 10 mg of clindamycin (as clindamycin phosphate) and 50 mg of anhydrous benzoyl peroxide (as hydrated benzoyl peroxide).
- The other components are: carbomer 980, dimethicone, disodium lauryl sulfosuccinate, disodium edetate, glycerol, poloxamer (poloxamer 182), hydrated colloidal silica, sodium hydroxide 2N, purified water.
Appearance of the product and contents of the pack
Homogeneous gel, white to slightly yellowish in colour, with fine visible particles.
25 g, 30 g, 50 g or 60 g of gel in an aluminium tube closed with a white plastic cap, packed in a cardboard box.
Only some pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Industrial Farmacéutica Cantabria, S.A.
Barrio Solía 30, La Concha de Villaescusa
39690 Cantabria
Spain
Manufacturer
Jadran-Galenski laboratorij d.d.
Svilno 20
51000 Rijeka
Croatia
This medicinal product is authorised in the European Economic Area member states under 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
Date of the most recent review of this leaflet: 06/2021
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es.