Duocutan

Package leaflet: Information for the patient

Duocutan, 10 mg/g + 50 mg/g, gel
Clindamycinum + Benzoylis peroxidum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Duocutan is and what it is used for
2. Important information before using Duocutan
3. How to use Duocutan
4. Possible side effects
5. How to store Duocutan
6. Contents of the pack and other information

1. What Duocutan is and what it is used for

Duocutan contains two active substances: clindamycin and benzoyl peroxide. Duocutan belongs to a group of medicines used to treat acne.
Duocutan is applied to the skin for the treatment of mild to moderate acne vulgaris.

• Clindamycin is an antibiotic that inhibits the growth of bacteria responsible for acne development.
• Benzoyl peroxide reduces open and closed comedones. It also has a bactericidal effect on bacteria involved in acne formation.

These two substances, when used together in Duocutan:

• combat the bacteria responsible for acne,
• treat open and closed comedones and pimples,
• reduce the number of red, inflamed pimples associated with acne.
  Duocutan is intended for use in adults and adolescents aged 12 years and older.

2. Important information before using Duocutan

When not to use Duocutan

• Do not use Duocutan if the patient is allergic to clindamycin, lincomycin, benzoyl peroxide, or any of the other ingredients of this medicine (listed in section 6). Do not use Duocutan if any of the above situations apply. If in doubt, consult a doctor or pharmacist.

Warnings and precautions
Before starting treatment with Duocutan, discuss it with your doctor or pharmacist.

• Duocutan is for topical use only. Avoid contact with the eyes, lips, mouth, or inside the nose.
• Do not apply the medicine to irritated skin, for example if there are cuts, abrasions, sunburns, or other skin damage.
• If Duocutan accidentally gets into the eyes, mouth, or inside the nose, rinse thoroughly with plenty of water.
• Do not apply excessive amounts of Duocutan to sensitive areas of the skin.
• In most treated individuals, redness and peeling of the skin may occur during the first few weeks of treatment. If skin irritation develops, it may be necessary to use an oil-free moisturizer, reduce the frequency of application of Duocutan, or temporarily discontinue treatment until the skin condition improves, after which treatment may be resumed.
• If skin irritation is severe (intense redness, dryness, itching, stinging, or burning) or does not resolve, stop using Duocutan and contact your doctor.
• Take care to avoid contact of the medicine with colored fabrics, including clothing, towels, bed linens, furniture, and carpets. Duocutan may cause discoloration of these materials.
• Duocutan may bleach hair.
• Duocutan may make the skin more sensitive to the harmful effects of sunlight. Avoid using sunlamps or tanning beds and minimize exposure to sunlight. If sun exposure cannot be avoided, use sunscreen products with UV filters and wear protective clothing during treatment with Duocutan.

Contact your doctor or pharmacist before using Duocutan:

• if the patient has had or currently has any of the following gastrointestinal disorders: regional enteritis, ulcerative colitis, or antibiotic-associated colitis.
• if cramping abdominal pain or diarrhoea develops and persists or worsens, stop using Duocutan and contact your doctor immediately. Antibiotics may cause diseases characterized by severe diarrhoea and abdominal pain, although this is unlikely when antibiotics are applied to the skin.
• if the patient has recently used medicines containing clindamycin or erythromycin, there may be an increased risk that Duocutan will not work as effectively.

Consult your doctor or pharmacist if the patient has recently used any other medicine containing clindamycin or erythromycin.

Children
Duocutan must not be used in children under 12 years of age. It is not known whether it is safe or effective in this age group.

Duocutan and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently using, has recently used, or plans to use.

Inform your doctor or pharmacist if any of the following medicines are being used:

• other acne treatments, including topical antibiotics,
• medicated soaps and cleansing agents with exfoliating properties,
• soaps and cosmetics with strong drying effects,
• products containing high concentrations of alcohol or astringents.

Using the above products together with Duocutan may cause skin irritation.

Duocutan may reduce the effectiveness of certain concomitantly used medicines. These include:

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

Inform your doctor or pharmacist if any of these medicines are being used. It may be necessary to apply them at different times of the day (e.g. one in the morning and the other in the evening).

Using other acne treatments simultaneously with Duocutan may increase the risk of skin irritation. Discontinue use and contact your doctor if skin irritation is severe (intense redness, dryness, itching, stinging, or burning).

• Do not use Duocutan at the same time as other medicines containing erythromycin.
• Using Duocutan together with medicines such as dapsone or sulfacetamide may temporarily change the color of the skin or facial hair (yellow and/or orange). This effect is not permanent.
• One of the ingredients of Duocutan may affect the action of certain medicines used in general anaesthesia (called muscle relaxants).

Inform your doctor or pharmacist if surgery is planned.

If in doubt whether any of the above situations apply, consult your doctor or pharmacist before using Duocutan.

Pregnancy and breastfeeding

Information on the safety of using Duocutan during pregnancy is limited. If the patient is pregnant, suspects she may be pregnant, plans to become pregnant, or is breastfeeding, she should consult her doctor or pharmacist before using this medicine.

The doctor will decide whether the benefits of using Duocutan during pregnancy outweigh the risks to the unborn child.

It is not known whether the components of Duocutan pass into human milk. One of the components of Duocutan is clindamycin. When clindamycin is administered orally or by injection, it may pass into human milk.

If the patient is breastfeeding, she must consult her doctor before using Duocutan. Do not apply Duocutan to the skin of the breasts during breastfeeding.

Driving and operating machinery
Not applicable

3. How to use Duocutan

This medicine should always be used exactly as directed by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist.

• Duocutan should be applied once daily, in the evening.
• The effect of Duocutan may not become noticeable until after 2 to 5 weeks of treatment.
• Do not use the medicine for longer than an additional 12 weeks. Your doctor will determine how long the treatment should continue.

Method of administration
This medicine is for topical use on the skin only.
How to apply Duocutan gel

1. Remove all makeup completely.
2. Wash the affected skin thoroughly, rinse with warm water, and gently pat dry with a towel.
3. Apply a small amount of gel with your fingertips to the entire affected area.
4. Apply the gel to the entire treated skin surface, not only to individual acne lesions. If the gel does not absorb easily, this indicates that too much has been applied.
   • For the face, use an amount of gel extending from the fingertip to the first joint (first finger crease) – this quantity corresponds to a "fingertip unit".
   • For the face and back, use up to two and a half "fingertip units".
5. If the skin becomes excessively dry or starts to peel, you may use a non-greasy, fragrance-free, hypoallergenic moisturizer. Alternatively, apply Duocutan less frequently or discontinue use temporarily to allow the skin to adapt to treatment. This medicine may not work properly if not used daily.
6. Wash your hands after applying the gel.
7. Once the gel has dried, non-greasy makeup may be applied.

Use of more than the recommended dose of Duocutan
Do not use excessive amounts of gel. Applying more gel than recommended or using it more frequently than advised will not speed up healing of acne lesions and may cause skin irritation. If too much gel has been applied, reduce the frequency of application or discontinue use for several days, then resume treatment.

If Duocutan is accidentally swallowed
If the gel is swallowed, contact your doctor immediately. Adverse effects similar to those seen with oral antibiotics (such as stomach irritation) may occur.

Missed dose of Duocutan

• Do not apply a double dose to make up for a missed dose.
• Apply the next recommended dose as scheduled, following the previous dosing regimen.

Stopping treatment with Duocutan
Do not stop using Duocutan unless instructed by your doctor.
Do not use the gel for longer than 12 consecutive weeks without medical advice.
Continue using Duocutan for as long as your doctor recommends. Do not stop treatment unless your doctor advises otherwise.
It is important to use the gel exactly as directed by your doctor. Stopping treatment too early may result in recurrence of acne.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the following serious adverse effects occur, stop using the medicine immediately and contact a doctor urgently – immediate medical assistance may be required:

• symptoms of allergic reactions (such as: swelling of the face, eyes, lips or tongue, hives or difficulty breathing, fainting),
• severe or persistent diarrhoea or abdominal cramps,
• severe burning, peeling or itching of the skin.

Other possible adverse effects:
If any of the following symptoms are noticed, reduce the frequency of application of Duocutan or discontinue use for 1 or 2 days, then resume treatment.

Very common (may affect more than 1 in 10 patients):
At the application site:

• redness of the skin, skin peeling, dry skin. These adverse effects are usually mild.

Common (may affect less than 1 in 10 patients):

• headache
  At the application site:
• burning sensation, skin pain, increased sensitivity to sunlight

Uncommon (may affect less than 1 in 100 patients):
At the application site:

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

Frequency not known (cannot be estimated from available data):

• allergic reactions
• intestinal inflammation, diarrhoea, including bloody diarrhoea, abdominal pain

At the application site:

• skin reactions, skin discolouration,
• raised, itchy rash (urticaria).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warszawa
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Duocutan

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the tube and the cardboard box after "EXP". The expiry date refers to the last day of the specified month.
Store in a refrigerator (2°C - 8°C). Do not freeze.
Keep the tube tightly closed after each use.
Shelf-life after first opening of the tube: 2 months. After first opening, do not store above 25 ° C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Duocutan contains
The active substances are:
clindamycin and benzoyl peroxide. 1 g of gel contains 10 mg (1% w/w) clindamycin in the form of
clindamycin phosphate and 50 mg (5% w/w) benzoyl peroxide in the form of benzoyl peroxide with
water.
The other ingredients are:
carbomer, dimethicon 100, disodium lauryl sulfosuccinate, disodium edetate, glycerol 85% (E 422),
colloidal anhydrous silica, poloxamer 182, purified water, sodium hydroxide (E524) (for pH adjustment).

What Duocutan looks like and contents of the pack
Duocutan is a white gel, available in aluminium tubes containing 30 g, 50 g, and 60 g of gel,
packaged in a cardboard carton.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki
tel. +48 22 350 66 69

Manufacturer
mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany

SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki

This medicinal product is authorised in the European Economic Area countries under the following names:
Germany: Clindaderm comp. 10 mg/g + 50 mg/g Gel
Croatia: Acnemine 10 mg/g + 50 mg/g gel
Italy: Aknecutan
Poland: Duocutan
Spain: Mibac 10 mg/g + 50 mg/g gel