Benzacne duo

Package leaflet: Information for the user

Benzacne Duo, 10 mg/g + 50 mg/g, gel
Clindamycinum + Benzoylis peroxidum
Please read all of this leaflet carefully before 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

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

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

• Clindamycin is an antibiotic that inhibits the growth of bacteria responsible for acne development.
• Benzoyl peroxide reduces both open and closed comedones (blackheads and whiteheads). It has a bactericidal effect on bacteria associated with acne.

These substances, when used together in Benzacne Duo:

• combat bacteria responsible for acne,
• treat open and closed comedones and pimples,
• reduce the number of red, inflamed pimples associated with acne.

Benzacne Duo is intended for use in adults and adolescents aged 12 years and older.

2. Important information before using Benzacne Duo

When not to use Benzacne Duo:

• If the patient is allergic to clindamycin, lincomycin, benzoyl peroxide, or any of the other ingredients of this medicine (listed in section 6 of this leaflet).

Do not use Benzacne Duo if any of the above apply to you. If in doubt, consult your doctor or pharmacist before starting to use Benzacne Duo.

Warnings and precautions

Before using Benzacne Duo, speak to your doctor or pharmacist.

• Contact your doctor or pharmacist before using this medicine if the patient has or has had any of the following intestinal diseases: chronic bowel inflammation, ulcerative colitis, or antibiotic-associated colitis.
• If abdominal cramps or diarrhoea occur and do not go away or worsen, stop using Benzacne Duo and contact your doctor immediately. Antibiotics may cause conditions characterised by severe diarrhoea and abdominal cramps, although such conditions are unlikely after topical antibiotic use.
• Benzacne Duo is for topical use only. Avoid contact with eyes, lips, mouth, or inside the nose.
• Do not apply the medicine on irritated skin, such as skin with cuts, abrasions, sunburn, or other skin damage.
  • If Benzacne Duo accidentally gets into the eyes, mouth, or inside the nose, rinse the area thoroughly with plenty of water.
• Do not apply excessive amounts of Benzacne Duo to sensitive skin areas.
• Redness and peeling of the skin may occur in most treated patients during the first few weeks of treatment. If skin becomes irritated, it may be necessary to use a non-greasy moisturiser, reduce the frequency of application of Benzacne Duo, or discontinue use until the skin condition improves.
• If skin irritation is severe (intense redness, dryness, itching, stinging, or burning) or persists, discontinue use and contact your doctor.
• Benzacne Duo may make the skin more sensitive to the harmful effects of sunlight. Avoid using sunbeds and limit sun exposure as much as possible. During treatment with Benzacne Duo, use sunscreen products and protective clothing.
• If the patient has recently used medicines containing clindamycin or erythromycin, there is an increased risk that Benzacne Duo may not work as well as expected.
  • Consult your doctor or pharmacist if the patient has recently used any other medicine containing clindamycin or erythromycin.
• Take care to avoid contact of the medicine with coloured fabrics, including clothing, towels, bed linen, furniture, and carpeting. Benzacne Duo may cause fading or bleaching of these materials.
• Benzacne Duo may bleach hair.

Children

This medicine should not be used in children under 12 years of age. It is not known whether it is safe or effective in this age group.

Other medicines and Benzacne Duo

Tell your doctor or pharmacist about all medicines you are currently using, have recently used, or plan to use.

Inform your doctor or pharmacist if you are using any of the following products:

• Other acne medicines, including topical antibiotics,
• Medicinal or exfoliating soaps and cleansers,
• Soaps and cosmetics with strong drying effects,
• Products containing high amounts of alcohol and/or astringents.

Using any of the above products together with Benzacne Duo may lead to skin irritation over time. Benzacne Duo may reduce the effectiveness of certain concomitant medicines. These include:

• Certain topical acne medicines containing tretinoin, isotretinoin, or tazarotene.
  • Inform your doctor or pharmacist if you are using any of these medicines. It may be necessary to use them at different times of day (e.g. one in the morning and the other in the evening). Using other topical acne medicines together with Benzacne Duo may increase the risk of skin irritation.
  • Stop using the medicine and contact your doctor if skin irritation is severe (intense redness, dryness, itching, stinging, or burning).

Do not use Benzacne Duo at the same time as other medicines containing erythromycin.

Using Benzacne Duo together with medicines such as dapsone or sulfacetamide may temporarily change the colour of the skin or facial hair to yellow/orange. This effect is not permanent.

One of the ingredients of this medicine may affect the action of drugs 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 Benzacne Duo.

Pregnancy, breastfeeding, and fertility

Information on the safety of using Benzacne Duo during pregnancy is limited. If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

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

It is not known whether the ingredients of Benzacne Duo pass into breast milk. One of the components of Benzacne Duo is clindamycin. When clindamycin is administered orally or by injection, it may pass into breast milk. If the patient is breastfeeding, she must consult her doctor before using Benzacne Duo.

Do not apply Benzacne Duo to the skin of the breasts during breastfeeding.

3. How to use Benzacne Duo

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

• Benzacne Duo should be applied once daily, in the evening.
• The effect of Benzacne Duo may not become apparent until 2 to 5 weeks after starting treatment.
• Do not use the medicine for longer than 12 consecutive weeks. Your doctor will determine how long the treatment should last.

How to apply Benzacne Duo:

1. Remove all makeup completely.
2. Wash the affected skin thoroughly, rinse with warm water, and gently pat dry.
3. Apply a thin layer of gel with fingertips to the entire affected area.
4. The gel should be applied to the entire skin surface affected by acne, not only to individual pimples. If the gel does not absorb easily, this indicates that too much has been applied.
   • For the face alone, use an amount of gel that fits between the fingertip and the first joint of the finger (first finger crease) – this amount corresponds to a "fingertip unit".

• For the face and back together, use a maximum of two and a half "fingertip units". 5. If the skin becomes excessively dry or starts to peel, a fragrance-free, hypoallergenic, non-greasy moisturizer may be used. Alternatively, apply Benzacne Duo 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. After applying the gel, wash your hands. 7. Once the gel has dried, non-greasy makeup may be applied.

This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Using more than the recommended dose of Benzacne Duo

• Do not apply excessive amounts of gel. Applying too much gel or using it more often than recommended will not speed up healing of pimples 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 Benzacne Duo is accidentally swallowed

• In case of accidental ingestion of the gel, seek medical advice. Adverse effects similar to those seen with oral antibiotics (e.g. stomach irritation) may occur.

Missed dose of Benzacne Duo:

• Do not apply a double dose to make up for a missed dose.
• Apply the next recommended dose as scheduled.

Stopping treatment with Benzacne Duo
Do not use the gel for longer than 12 consecutive weeks without medical advice. Benzacne
Duo should be used for as long as directed by your doctor. Do not stop treatment unless
your doctor advises otherwise.
It is important to use the gel exactly as directed by your doctor. If treatment is stopped
too early, acne may recur.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in every patient.
If any of the following serious adverse symptoms 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, mouth or tongue, urticaria, or difficulty breathing, fainting),
• severe or persistent diarrhoea or abdominal cramps,
• severe burning, peeling or itching.

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

• Redness, peeling, dryness of the skin.

These adverse reactions are usually mild in nature.
Common
(may affect less than 1 in 10 patients)

• Headache

At the site of application:

• Burning, pain, increased sensitivity to sunlight

Uncommon
(may affect less than 1 in 100 patients)

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

Other adverse reactions
Other adverse reactions with unknown frequency (frequency cannot be determined from available data)

• Allergic reactions
• Intestinal inflammation, diarrhoea, including bloody diarrhoea, abdominal pain

At the site of application:

• Skin reactions, skin depigmentation
• Itchy rash (urticaria)

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions 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 Warsaw
Tel.: +48 22 4921301
Fax: +48 22 4921309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions allows further information on the safety of the medicine to be collected.
Adverse reactions can also be reported to the marketing authorization holder.

5. How to store Benzacne Duo

Keep this medicine out of sight and reach of children.
Store in a refrigerator (2°C - 8°C).
After first opening the tube: do not store at temperatures above 25°C and discard after 2
months.
Do not use this medicine after the expiry date stated on the packaging after "EXP".
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Benzacne Duo contains

• The active substances are: clindamycin and benzoyl peroxide anhydrous. 1 g of gel contains 10 mg clindamycin as clindamycin phosphate and 50 mg benzoyl peroxide anhydrous as benzoyl peroxide with water.
• Other components: carbomer 980, dimethicone, disodium lauryl sulfosuccinate, disodium edetate, glycerol, colloidal hydrated silica, poloxamer 182, sodium hydroxide, purified water.

What Benzacne Duo looks like and contents of the pack
White to pale yellow homogeneous gel with visible fine particles.
The gel is available in aluminium tubes closed with a white plastic cap, containing 25 g, 30 g, 50 g or 60 g of gel, packed in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation 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
Denmark
For further information regarding this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Orifarm Healthcare Sp. z o.o.
ul. Przyokopowa 31
01-208 Warsaw
Poland
[email protected]
This medicinal product is authorised 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