AKNECUTAN 10 mg /G + 50 Mg/G Gel

Зміст інструкції

1. Aknecutan 10 mg/g + 50 mg/g gel
   1. What is Aknecutan and what is it 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

Aknecutan 10 mg/g + 50 mg/g gel

clindamycin + benzoyl peroxide
Generic medicine

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you use 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 is Aknecutan and what is it 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 skin acne. Aknecutan is intended
for use by adults and adolescents aged twelve years or 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 use in association in Aknecutan works by:

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

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 have any doubts, ask 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 the inside of your nose.
• Do not use the gel on areas of irritated skin. For example, if you have cuts, scrapes, sunburns or damaged skin.
• If Aknecutan accidentally gets into your eyes, mouth or nose, rinse with plenty of water.
• Do not use an excessive amount of Aknecutan on sensitive areas of the 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 often or stop using it for a short period to allow the skin to heal and then restart treatment.
• Stop treatment and consult your doctor if skin irritation is severe (severe redness, dryness, itching, stinging or burning pain) or if it does not improve.
• Try to avoid getting Aknecutan in contact with colored fabrics, including clothes, towels, bed linen, furniture or carpets. Aknecutan can bleach these materials.
• Aknecutan can discolor hair.
• Aknecutan can make the skin more sensitive to the harmful effects of the sun. Avoid using sunbeds/lamps and minimize your time in the sun. While using Aknecutan, if you cannot avoid exposure to strong sunlight, 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 problems: "Crohn's disease", "ulcerative colitis" or "antibiotic-associated colitis".
• If you experience stomach cramps or diarrhea that does not improve or is severe, stop using Aknecutan and contact your doctor immediately. Antibiotics can cause a condition that causes severe diarrhea 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 a greater likelihood that Aknecutan will not work as well as it should.

Tell 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 the age of twelve. It is not known whether it works or is
safe for them.

Other medicines and Aknecutan
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicine.
Tell your doctor or pharmacist if you are using any of the following treatments:

• Any other treatment for acne, including antibiotics used on the skin
• Medicated or “abrasive” soaps and cleansers
• Soaps or cosmetics that have a strong drying effect
• Products that contain large amounts of alcohol or “astringents”

If used together with Aknecutan, they can irritate the skin over time.
Aknecutan can reduce the effectiveness of some medicines for acne if they are used
at the same time. This includes:

• Some acne medications applied to the skin that contain tretinoin, isotretinoin or tazarotene

Tell 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 (for example, one in the morning and
the other in the evening).
Using other acne medications at the same time as Aknecutan can 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 should not be used at the same time as medicines containing erythromycin.
• Applying Aknecutan together with medicines such as dapsone and sulfacetamide can cause a temporary change in the color of the skin or facial hair (yellow/orange color). This effect will not be permanent.
• One of the active substances in Aknecutan may affect the action of some general anesthetic drugs (called "neuromuscular blocking agents").

Tell your doctor or pharmacist if you are about to undergo surgery.
If you are not sure whether any of the conditions listed above apply to you, ask 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, suspect you are pregnant, are planning to become pregnant or are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
The doctor will consider the benefit to you and the risk to the 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. Clindamycin
has been reported to pass into breast milk if taken orally or by injection.
If you are breastfeeding, you should consult your doctor before using Aknecutan.
Do not use Aknecutan on the breast if you are breastfeeding.

Driving and using machines
Not applicable.

3. How to use Aknecutan

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts, consult your doctor or pharmacist.

• Use Aknecutan once a day, 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 the treatment should last.

Route of administration
The medicine is for external use.
How to apply Aknecutan

• 1. Remove any makeup completely.
• 2. Wash the affected area of skin thoroughly. Then rinse with lukewarm water and dry gently.
• 3. Apply a thin layer of gel to the entire affected skin area, using your fingertips.
• 4. Apply the medicine to all areas of skin that have acne, and not just to individual pimples. If the gel is not easily absorbed into the skin, you are using too much.
• For the face only, use the amount of gel that, when exiting the tube, reaches the tip of your finger on first contact (the first crease on your finger). This amount is a “finger tip unit”.
• For the face and back, use two and a half “finger tip units” in total.
• 5. If you experience excessive dryness or flaking of the skin, you can use a hypoallergenic, oil-free, fragrance-free moisturizer; use Aknecutan less frequently or interrupt the treatment for a short period, to allow your skin to adjust to the treatment. This medicine may not work properly if it is not applied every day.
• 6. Wash your hands after using the gel.
• 7. After the gel has dried, you can apply oil-free makeup.

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

If you accidentally ingest Aknecutan
If you accidentally ingest the gel, consult a doctor. Symptoms similar to
those that occur when taking oral antibiotics may occur (stomach ache).

If you forget to use Aknecutan

• Do not use a double dose to make up for a missed dose.
• Apply the next dose at the 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 talking to your doctor. Use Aknecutan for
the time recommended by your doctor. Do not stop using this medicine unless your doctor
tells you to do so.
It is important to continue using the gel as prescribed by your doctor. If you stop the treatment
too soon, acne may return.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using Aknecutan and consult your doctor immediately if you notice any of the following serious side
effects - you may need urgent medical attention:

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

Other possible side effects:
If you notice any of these side effects, try to use 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, flaking, dryness These side effects are usually mild.

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 ( paresthesia), worsening of acne, red and itchy skin, rash ( dermatitis, erythematous rash)

Not known(frequency cannot be estimated from the available data)

• allergic reactions
• inflammation of the intestine, diarrhea, including diarrhea with the presence of blood, stomach pain At the application site:
• skin reactions, skin discoloration
• itchy raised rash ( urticaria)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly through 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 which is stated on the tube and the packaging (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 at a
temperature below 25 °C.
Do not dispose of any medicine in wastewater. Ask your pharmacist how to dispose of medicines you
no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Aknecutan contains
The active ingredients are: clindamycin and benzoyl peroxide.
1 gram of gel contains 10 mg (1% w/w) of clindamycin, in the form of clindamycin phosphate and
50 mg (5% w/w) of benzoyl peroxide in the form of benzoyl peroxide hydrate.
The other ingredients 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 and is 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 Member States of the European Economic Area with the
following denominations:
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