Benzacne Duo

Package Leaflet: Information for the Patient

Benzacne Duo, 10 mg/g + 50 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, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Benzacne Duo and what is it used for

Benzacne Duo contains two active substances: clindamycin and benzoyl peroxide. Benzacne Duo belongs to a group of medicines called "anti-acne preparations". Benzacne Duo is used for the treatment of mild to moderate acne on the skin.

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

These substances, used together in Benzacne Duo:

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

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

2. Important information before using Benzacne Duo

When not to use Benzacne Duo:

• 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 Benzacne Duo if any of the above applies to you. If you are unsure, consult your doctor or pharmacist before using Benzacne Duo.

Warnings and precautions

Before using Benzacne Duo, consult your doctor or pharmacist.

• Before using this medicine, you should contact your doctor or pharmacist if you have or have hadthe following gastrointestinal diseases: chronic inflammation of the intestine, ulcerative colitis, antibiotic-associated colitis.
• If you experience abdominal cramps or diarrhea, which do not go away or worsen, stop using Benzacne Duoand contact your doctor immediately. Antibiotics can cause diseases characterized by severe diarrhea and abdominal cramps, but their occurrence is unlikely after using antibiotics on the skin.
• Benzacne Duo should only be used on the skin. Avoid contact with the eyes, lips, mouth, or nostrils.
• Do not use the medicine on irritated skin, such as cuts, abrasions, sunburn, or damaged skin.
• If Benzacne Duo accidentally gets into your eyes, mouth, or nostrils, rinse the area thoroughly with water.
• Do not use too much Benzacne Duo on sensitive skin areas.
• Most treated patients may experience redness and peeling of the skin 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 Benzacne Duo, or stop using it until the skin condition improves.
• If skin irritation is severe (severe redness, dryness, itching, stinging, or burning) or does not go away, stop using the medicine and consult your doctor.
• Benzacne Duo may make your skin more sensitive to the harmful effects of sunlight. Avoid using sunlamps and minimize exposure to the sun. During treatment with Benzacne Duo, use sunscreens and protective clothing.
• If you have recently used medicines containing clindamycin or erythromycin, there is an increased risk that Benzacne Duo may not work as well as it should.
• You should consult your doctor or pharmacist if you have usedany other medicine containing clindamycin or erythromycin recently.
• Be careful not to let the medicine come into contact with colored materials, including clothing, towels, bedding, furniture, and carpets. Benzacne Duo may cause discoloration of these materials.
• Benzacne Duo may discolor hair.

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.

Other medicines and Benzacne Duo

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Tell your doctor or pharmacist if you are using any of the following products:

• other anti-acne medicines, including antibiotics used on the skin,
• medicated soaps and cleansers or exfoliating products,
• soaps and cosmetics with a strong drying effect,
• products containing high amounts of alcohol and/or astringents. Using these products and Benzacne Duo at the same time may lead to skin irritation over time. Benzacne Duo may cause some medicines used at the same time to be less effective. These include:
• Some anti-acne medicines used on the skin, containing tretinoin, isotretinoin, or tazarotene.
• Tell your doctor or pharmacist if you are 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 Benzacne Duo may increase the risk of skin irritation.
• Stop using the medicine and consult your doctorif skin irritation is severe (severe redness, dryness, itching, stinging, or burning).

Do not use Benzacne Duo at the same time as other medicines containing erythromycin.
Using Benzacne Duo at the same time as medicines such as dapsoneor sulfacetamidemay cause a temporary change in skin or hair color on the face (yellow/orange color). This is not permanent.
One of the ingredients of the medicine may affect the action of medicines used in general anesthesia (called "muscle relaxants").

• Tell your doctor or pharmacist aboutany planned surgery.

If you are unsure whether any of the above situations apply to you, consult your doctor or pharmacist before using Benzacne Duo.

Pregnancy, breastfeeding, and fertility

Information on the safety of using Benzacne Duo in pregnant women is limited.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Your doctor will decide whether the benefits of using Benzacne Duo during pregnancy outweigh the risks to your baby.
It is not known whether the ingredients of Benzacne Duo pass into breast milk. One of the ingredients of Benzacne Duo is clindamycin. If clindamycin is taken orally or by injection, it may pass into breast milk. If you are breastfeeding, you must consult your doctorbefore using Benzacne Duo.
Do not use Benzacne Duo on the breast skin during breastfeeding.

3. How to use Benzacne Duo

Always use this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.

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

How to apply Benzacne Duo:

• 1. Remove all makeup.
• 2. Wash the affected skin area thoroughly, rinse with warm water, and gently pat dry.
• 3. Apply a thin layer of gelwith your fingertips to the entireaffected skin area.
• 4. Apply the gel to the entire skin surface affected by acne, not just individual pimples. If the gel does not absorb easily, it means you have used too much.
• To cover just the face, use an amount that fits on the tip of your finger to the first joint (the first bend of the finger) – this is the "finger-tip" amount.

Fingertip is the amount of gel that fits on the tip of the finger to the first joint.

• To cover the face and back, use up to two and a half "finger-tip" amounts.
• 5. If your skin becomes severely dry or starts to peel, you can use a non-greasy, fragrance-free, hypoallergenic moisturizer, use Benzacne Duo less often, or stop using it for a while to allow your 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.

Always use this medicine exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

Using more than the recommended dose of Benzacne Duo

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

If Benzacne Duo is accidentally swallowed

• In case of accidental swallowing of the gel, seek medical advice.Side effects similar to those that occur when antibiotics are taken orally (stomach upset) may occur.

Missing a dose of Benzacne Duo:

• Do not use a double dose to make up for a missed dose,
• Use the next scheduled dose as usual.

Stopping treatment with Benzacne Duo

Do not use the gel for more than 12 weeks in a row without consulting your doctor. Use Benzacne Duo for as long as your doctor has prescribed. Do not stop treatment unless your doctor decides to.
It is important to use the gel exactly as your doctor has prescribed. If you stop using this medicine too early, acne may come back again.
If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Benzacne Duo can cause side effects, although not everybody gets them.

If you experience any of the following serious side effects, stop using the medicine and seek medical help immediately:

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

Very common

(may affect more than 1 in 10 people)
At the application site:

• Redness, peeling, dryness of the skin.

These side effects are usually mild.

Common

(may affect up to 1 in 10 people)

• Headache

At the application site:

• Burning, pain, increased sensitivity to sunlight

Uncommon

(may affect up to 1 in 100 people)

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

Other side effects

Other side effects, with frequency not known (frequency cannot be estimated from the available data)

• Allergic reactions
• Colitis, diarrhea, including bloody diarrhea, abdominal pain

At the application site:

• Skin reactions, skin discoloration
• Itchy rash (hives)

Reporting side effects

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

5. How to store Benzacne Duo

Keep the medicine out of the sight and reach of children.
Store in a refrigerator (2°C - 8°C).
After first opening the tube: 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. 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 Benzacne Duo contains

• 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 benzoyl peroxide with water.
• Excipients: carbomer 980, dimethicone, sodium lauryl sulfate, disodium edetate, glycerol, silica colloidal anhydrous, poloxamer 182, sodium hydroxide, purified water.

What Benzacne Duo looks like and contents of the pack

White to light yellow homogeneous gel with visible small particles.
The gel is available in aluminum tubes with a white plastic screw cap containing 25 g, 30 g, 50 g, or 60 g of gel, packaged in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder:

Orifarm Healthcare A/S
Energivej 15
5260 Odense S
Denmark
[email protected]

Manufacturer:

Jadran - Galenski Laboratorij d.d.
Svilno 20
51000 Rijeka
Croatia
Orifarm Generics A/S
Energivej 15
5260 Odense S
DenmarkOrifarm Healthcare Sp. z o.o.
Przyokopowa 31
01-208 Warsaw
Poland
[email protected]

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

Denmark: Clindonix
Estonia: Irexime
Finland: Clindonix
Latvia: Irexime 10 mg/g + 50 mg/g gels
Lithuania: Irexime 10 mg/g / 50 mg/g gelis
Poland: Benzacne Duo
Slovenia: Clinelin 10mg/50 mg v 1g gel

Date of last revision of the leaflet: 14.06.2024