Duocutan

Package Leaflet: Information for the Patient

Duocutan, 10 mg/g + 30 mg/g, Gel

Clindamycin + Benzoyl Peroxide

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Duocutan and what is it 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 is Duocutan and what is it used for

Duocutan contains two active substances: clindamycin and benzoyl peroxide. Duocutan belongs to a group of anti-acne medicines.
Duocutan is used on the skin to treat mild to moderate common acne.

• Clindamycin is an antibiotic that inhibits the growth of bacteria that cause acne.
• Benzoyl peroxide reduces open and closed comedones. It also has a bactericidal effect on bacteria that cause acne.

These substances used together in Duocutan:

• fight the bacteria that cause acne,
• treat open and closed comedones and pimples,
• reduce the number of red, inflamed pimples that occur in acne.

Duocutan is intended for use in adults and adolescents from 12 years of age.

2. Important information before using Duocutan

When not to 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 to the patient. If in doubt, consult a doctor or pharmacist.

Warnings and precautions

Before starting to use Duocutan, discuss it with your doctor or pharmacist.

• Duocutan should only be used on the skin. Avoid contact with the eyes, lips, mouth, or inside the nose.
• Do not use the medicine on irritated skin, e.g., if there are cuts, abrasions, sunburn, or if the skin is damaged.
• If Duocutan accidentally gets into the eyes, mouth, or inside the nose, rinse these areas thoroughly with water.
• Do not use too much Duocutan on sensitive skin areas.
• In most treated patients, redness and peeling of the skin may occur during the first few weeks of treatment. If the skin becomes irritated ,it may be necessary to use a non-greasy moisturizer, reduce the frequency of application of Duocutan, or stop using it until the skin condition improves, and then resume treatment.
• If skin irritation is severe (strong redness, dryness, itching, stinging, or burning) or does not improve, stop using Duocutan and contact a doctor.
• Be careful not to let the medicine come into contact with colored materials, including clothing, towels, bedding, furniture, and carpets. Duocutan may discolor these materials.
• Duocutan may discolor hair.
• Duocutan may make the skin more sensitive to the harmful effects of sunlight. Avoid using sunlamps and minimize exposure to the sun. If exposure to sunlight cannot be avoided, use UV filters and protective clothing during Duocutan treatment.

Consult a doctor or pharmacist before using Duocutan:

• if the patient has or has had any of the following gastrointestinal diseases: segmental enteritis, ulcerative colitis, antibiotic-associated colitis.
• if abdominal cramps or diarrhea occur that do not go away or worsen, stop using Duocutan and contact a doctor immediately. Antibiotics can cause diseases characterized by severe diarrhea and abdominal pain, but their occurrence is unlikely after using antibiotics on the skin.
• if the patient has recently used medicines containing clindamycin or erythromycin, there is an increased risk that Duocutan may not work as well as it should.

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

Children

This medicine should not be used in children under 12 years of age. It is not known if it is safe and effective for them.

Duocutan and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently using or has recently used, as well as any medicines the patient plans to use.
Tell your doctor or pharmacist about using any of the following medicines:

• other anti-acne medicines, including antibiotics used on the skin,
• medicinal soaps and cleansers with drying properties,
• soaps and cosmetics with strong drying effects,
• products containing large amounts of alcohol or astringents.

Using these medicines and Duocutan at the same time may cause skin irritation.
Duocutan may make some of the medicines used at the same time less effective.
These medicines include:

• certain anti-acne medicines used on the skin, containing tretinoin, isotretinoin, or tazarotene.

Tell your doctor or pharmacist about using any of these medicines. It may be necessary to use them at different times of the day (e.g., one in the morning and the other in the evening).
Using other anti-acne medicines at the same time as Duocutan may increase the risk of skin irritation.
Stop using the medicine and consult a doctor if skin irritation is severe (strong redness, dryness, itching, stinging, or burning).

• Duocutan should not be used at the same time as other medicines containing erythromycin.
• Using Duocutan at the same time as medicines such as dapsone or sulfacetamide may cause temporary discoloration of the skin or hair on the face (yellow and/or orange color). This is not a permanent effect.
• One of the ingredients of Duocutan may affect the action of certain medicines used in general anesthesia (called muscle relaxants).

Tell your doctor or pharmacist about planned surgery.
If in doubt whether any of the above situations apply to the patient, consult a doctor or pharmacist before using Duocutan.

Pregnancy and breastfeeding

Information on the safety of using Duocutan in pregnant women is limited.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this medicine.
The doctor will decide whether the benefits of using Duocutan during pregnancy outweigh the risks to the baby.
It is not known whether the ingredients of Duocutan pass into breast milk. One of the ingredients of Duocutan is clindamycin. If clindamycin is used orally or by injection, it may pass into breast milk.
If the patient is breastfeeding, they must consult a doctor before using Duocutan.
Do not use Duocutan on the breast skin during breastfeeding.

3. How to use Duocutan

This medicine should always be used as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

• Duocutan should be used once a day, in the evening.
• The effect of Duocutan may only be visible after 2 to 5 weeks of use.
• Do not use the medicine for more than 12 weeks in a row. The doctor will determine how long the treatment should last.

Method of administration
The medicine is intended for use on the skin.
How to apply Duocutan

• 1. Remove all makeup
• 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 skin.
• 4. Apply the gel to the entire surface of the affected skin, not just individual acne lesions. If the gel does not absorb easily, it means too much gel has been applied.
• To cover the face, use an amount of gel that fits on the tip of the finger up to the first joint (first fold of the finger) - this is the "finger-tip" amount.
• To cover the face and back, use an amount equivalent to a maximum of two and a half "finger-tip" amounts.
• 5. If the skin becomes strongly dry or starts to peel, you can use a non-greasy, fragrance-free, hypoallergenic moisturizer, use Duocutan less often, or stop using it for a while to allow the skin to adjust to the treatment. This medicine may not work properly if it is not used every day.
• 6. After using the gel, wash your hands.
• 7. Once the gel has dried, you can apply a non-greasy makeup.

Using more Duocutan than recommended

Do not use more gel than recommended. Using too much gel or using it more often than recommended will not speed up the healing of pimples and may cause skin irritation. If too much gel is used, reduce the frequency of application or stop using it for a few days and then resume treatment.

If Duocutan is accidentally swallowed

If the gel is swallowed, consult a doctor. Side effects similar to those that occur when antibiotics are taken orally (stomach upset) may occur.

Missing a dose of Duocutan

• Do not use a double dose to make up for a missed dose.
• Use the next scheduled dose as directed by the previous dosing schedule.

Stopping use of Duocutan

Do not stop using Duocutan unless the doctor decides to.
Do not use the medicine for more than 12 weeks in a row without the doctor's recommendation.
Use Duocutan for as long as the doctor recommends. Do not stop treatment unless the doctor decides otherwise.
It is essential to use the gel exactly as the doctor recommends. If treatment is stopped too early, acne may recur.
If you have any further doubts about using this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Duocutan can cause side effects, although not everybody gets them.
If any of the following severe side effects occur, stop using the medicine immediately and seek medical help - you may need urgent medical attention:

• allergic reaction symptoms (such as: face, eye, lip, tongue, or throat swelling, hives, or difficulty breathing, fainting),
• severe or persistent diarrhea or abdominal cramps,
• severe burning, peeling, or itching of the skin.

Other possible side effects:
If you notice any of the following symptoms, reduce the frequency of application of Duocutan or stop using it for 1 or 2 days and then resume treatment.
Very common(may affect more than 1 in 10 people):
At the application site:

• skin burning sensation, peeling, itching, dryness,
• skin redness, especially during the first weeks of use.

These side effects are usually mild.
Common(may affect up to 1 in 10 people):

• headache

At the application site:

• sensitivity to sunlight, skin pain,
• redness, itching, rash (skin inflammation).

Uncommon(may affect up to 1 in 100 people):
At the application site:

• tingling sensation (paresthesia), worsening of acne

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

• allergic reactions
• enteritis, diarrhea, including bloody diarrhea, abdominal pain

At the application site:

• skin reactions, skin discoloration,
• raised, itchy rash (hives).

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Duocutan

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the tube and carton after "EXP". The expiry date refers to the last day of the month.
Store in a refrigerator (2°C - 8°C). Do not freeze.
Shelf life after first opening the tube: 2 months. After first opening the tube, 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. This will help protect the environment.

6. Contents of the pack and other information

What Duocutan contains

The active substances of Duocutan are:
clindamycin and benzoyl peroxide. 1 g of gel contains 10 mg (1% w/w) of clindamycin in the form of clindamycin phosphate and 30 mg (3% w/w) of benzoyl peroxide in the form of benzoyl peroxide with water.
The other ingredients are:
carbomer, dimethicone 100, disodium lauryl sulfosuccinate, disodium edetate, glycerol 85% (E 422),
silica, colloidal, anhydrous, poloxamer 182, purified water, sodium hydroxide (E 524) (for pH adjustment).

What Duocutan looks like and contents of the pack

Duocutan is a white gel, available in aluminum tubes containing 30 g, 50 g, and 60 g of gel, in a carton.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki
phone: +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 medicine is authorized in the Member States of the European Economic Area under the following names:

Germany:
Clindaderm comp. 10 mg/g + 30 mg/g Gel
Poland:
Duocutan
Spain:
Mibac 10 mg/g + 30 mg/g gel

Date of last revision of the leaflet: