Aknetcutan

Patient Information Leaflet

Aknecutan 10 mg/g + 50 mg/g gel

clindamycin + benzoyl peroxide
Equivalent medicine
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leafleaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet
1 What Aknecutan is and what it is used for

2. What you need to know before using Aknecutan
3. How to use Aknecutan
4. Possible side effects
5. How to store Aknecutan
6. Contents of the pack and other information

1. What Aknecutan is and what it is used for

Aknecutan contains two active substances: clindamycin and benzoyl peroxide. Aknecutan belongs to a group of medicines known as "anti-acne preparations".
Aknecutan is used for the treatment of mild to moderate acne of the skin. Aknecutan is intended for use in adults and adolescents aged twelve years and older.

• Clindamycin is an antibiotic that prevents the reproduction of bacteria involved in acne.
• Benzoyl peroxide reduces blackheads and pimples. It also kills the bacteria involved in acne.

Their combined use in Aknecutan works by:

• fighting the bacteria that can cause acne;
• treating existing blackheads, pimples, and pustules;
• reducing the number of red, inflamed acne pustules;

2. What you need to know before using Aknecutan

Do not use Aknecutan

• 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 Aknecutan if you have any of the conditions listed above.
If you are in any doubt, consult your doctor or pharmacist before starting to use Aknecutan.
Warnings and precautions
Talk to your doctor or pharmacist before using Aknecutan.

• Use Aknecutan only on your skin. Keep it away from areas such as eyes, lips, mouth, or inside the nose.
• Do not apply the gel to irritated areas of skin. For example, if you have cuts, scrapes, sunburn, or damaged skin.
• If Aknecutan accidentally gets into your eyes, mouth, or nose, rinse thoroughly with plenty of water.
• Do not use excessive amounts of Aknecutan on sensitive areas of skin.
• Most patients will experience redness and peeling of the skin during the first few weeks of treatment. If your skin becomes irritated, you may need to use an oil-free moisturizer and use Aknecutan less frequently, or stop using it temporarily to allow the skin to heal before resuming treatment.
• Stop treatment and consult your doctor if skin irritation is severe (severe redness, dryness, itching, stinging, or burning) or does not improve.
• Try to avoid Aknecutan coming into contact with coloured fabrics, including clothing, towels, bed linen, furniture, or carpets. Aknecutan may bleach these materials.
• Aknecutan may bleach hair.
• Aknecutan may make your skin more sensitive to the harmful effects of sunlight. Avoid using sunbeds/lamps and minimize your time in the sun. While using Aknecutan, if exposure to strong sunlight cannot be avoided, you must use sunscreen and wear protective clothing.

Talk to your doctor or pharmacist before using this medicine if:

• You have ever had any of the following intestinal conditions: "Crohn's disease", "ulcerative colitis", or "antibiotic-associated colitis".
• If you experience stomach cramps or diarrhoea that do not improve or are severe, stop using Aknecutan and contact your doctor immediately. Antibiotics can cause a condition leading to severe diarrhoea and stomach cramps, although this is unlikely with antibiotics applied to the skin.
• If you have recently used other medicines containing clindamycin or erythromycin, there is an increased chance that Aknecutan may not work as effectively.

Inform your doctor or pharmacist if you have recently used any other medicine containing clindamycin or erythromycin.
Children
Do not give this medicine to children under twelve years of age. It is not known whether it is effective or safe for them.
Other medicines and Aknecutan
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
Inform your doctor or pharmacist if you are using any of the following treatments:

• Any other acne treatments, including topical antibiotics
• Medicated or "abrasive" soaps and cleansers
• Soaps or cosmetics with a strong drying effect
• Products containing high amounts of alcohol or "astringents"

These may irritate the skin over time when used together with Aknecutan.
Aknecutan may reduce the effectiveness of certain acne medicines if used at the same time. This includes:

• Certain topical acne medicines containing tretinoin, isotretinoin, or tazarotene

Inform your doctor or pharmacist if you are also taking any of these medicines. You may need to use the two products at different times of the day (e.g. one in the morning and the other in the evening).
Using other acne medicines at the same time as Aknecutan may increase the risk of skin irritation.
Stop treatment and consult your doctor if skin irritation becomes severe (severe redness, dryness, itching, stinging, or burning).

• Aknecutan must not be used at the same time as medicines containing erythromycin.
• Applying Aknecutan together with medicines 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 active substances in Aknecutan may affect the action of certain medicines used for general anaesthesia (called "neuromuscular blockers").

Inform your doctor or pharmacist if you are scheduled for surgery.
If you are unsure whether any of the conditions listed above apply to you, consult your doctor or pharmacist before using Aknecutan.
Pregnancy and breastfeeding
There is limited information on the safety of Aknecutan in pregnant women.
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Your doctor will consider the benefit to you and the potential risk to your baby of using Aknecutan during pregnancy.
It is not known whether the components of Aknecutan pass into breast milk. One of the active substances in Aknecutan is clindamycin. It has been reported that clindamycin passes into breast milk when taken orally or by injection.
If you are breastfeeding, you must consult your doctor before using Aknecutan.
Do not use Aknecutan on the breasts if you are breastfeeding.
Driving and using machines
Not applicable.

3. How to use Aknecutan

Use this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.

• Use Aknecutan once daily, in the evening.
• It may take 2–5 weeks before you see the effect of Aknecutan.
• Do not use this medicine for more than 12 consecutive weeks. Your doctor will tell you how long your treatment should last.

Method of administration
This medicine is for topical use only.
How to apply Aknecutan

1. Completely remove any makeup.
2. Wash the affected area of skin thoroughly. Then rinse with lukewarm water and gently pat dry.
3. Apply a thin layer of gel to the entire affected area of skin, using your fingertips.
4. Apply the medicine to all areas of skin affected by acne, not only on individual spots. If the gel does not spread and absorb easily, you are using too much.
   • For the face only, use an amount of gel that, when squeezed from the tube, reaches the tip of your finger up to the first crease (first finger joint). This amount is referred to as a "fingertip unit".
   • For face and back, use a total of two and a half fingertip units.
5. If you experience excessive dryness or peeling of the skin, you may use a hypoallergenic, oil-free, fragrance-free moisturizer; you may also use Aknecutan less frequently or interrupt treatment briefly to allow your skin to adapt. This medicine may not work properly if not applied daily.
6. Wash your hands after applying the gel.
7. After the gel has dried, you may apply non-comedogenic, non-oily makeup.

If you use more Aknecutan than you should
Be careful not to apply too much. Applying too much gel or applying it more often than recommended will not help clear acne faster and may cause skin irritation. If this occurs, use the gel less frequently or stop using it for a few days, then restart treatment.

If you accidentally ingest Aknecutan
In case of accidental ingestion of the gel, consult a doctor. Symptoms may occur similar to those seen with oral antibiotics (stomach upset).

If you forget to use Aknecutan

• Do not apply a double dose to make up for the missed dose.
• Apply the next dose at your usual time.

If you stop using Aknecutan
Do not stop using Aknecutan without medical advice.
Do not use the gel for more than 12 consecutive weeks without consulting your doctor. Use Aknecutan for the entire duration recommended by your doctor. Do not stop using this medicine unless your doctor advises you to do so.
It is important to continue using the gel as prescribed by your doctor. If you stop treatment too early, acne may return.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Stop using Aknecutan and consult a doctor immediately if you notice any of the following serious side effects – you may need urgent medical treatment:

• signs of an allergic reaction (such as swelling of the face, eyes, lips or tongue, hives or breathing difficulties, collapse)
• severe or prolonged diarrhoea or abdominal cramps
• severe burning, peeling or itching of the skin

Other possible side effects:
If you notice any of these side effects, try using Aknecutan less frequently, or stop using it for one or two days and then resume.
Very common side effects (may affect more than 1 in 10 people)
At the application site:

• redness, peeling, dryness
  These side effects are usually mild in intensity.

Common side effects (may affect up to 1 in 10 people)

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

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

• tingling ( paraesthesia ), worsening of acne, red and itchy skin, skin rash ( dermatitis , erythematous skin eruption )

Not known (frequency cannot be estimated from available data)

• allergic reactions
• inflammation of the intestine, diarrhoea, including diarrhoea with blood, stomach ache
  At the application site:
• skin reactions, skin discolouration
• raised itchy skin rash ( urticaria )

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. This includes any possible side effects not listed in this patient information leaflet. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Aknecutan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the tube and the carton (after "Exp."). The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C-8 °C). Do not freeze.
After first opening, this medicine can be used for 2 months if stored below 25 °C.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Aknecutan contains
The active substances are: clindamycin and benzoyl peroxide.
1 gram of gel contains 10 mg (1% w/w) of clindamycin, as clindamycin phosphate, and
50 mg (5% w/w) of benzoyl peroxide, as benzoyl peroxide hydrate.
The other components are:
carbomers, dimethicone, disodium lauryl sulfosuccinate, disodium edetate, glycerol 85% (E 422), hydrated colloidal silica, poloxamer 182, purified water and sodium hydroxide (E 524).

Description of the appearance of Aknecutan and contents of the pack
Aknecutan is a white gel supplied in aluminium tubes containing 30 g, 50 g or 60 g of gel.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
mibe pharma Italia S.r.l.
via Leonardo da Vinci 20/B
39100 Bolzano, BZ
Italy

Manufacturer
mibe GmbH Arzneimittel
Münchener Strasse 15
06796 Brehna
Germany
or
Sun-Farm Sp. z o.o.
Ul. Dolna 21
05-092 Łomianki
Poland

This medicinal product is authorised in the European Economic Area Member States 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 10 mg/g + 50 mg/g gel
Poland: Duocutan
Spain: Mibac 10 mg/g + 50 mg/g gel