DUOCLIN 10 mg /G + 50 Mg/G Żel

Treść ulotki

1. Duoclin 10 mg/g + 50 mg/g gel
   1. What Duoclin is and what it is used for
   2. What you need to know before using Duoclin
   3. How to use Duoclin
   4. Possible side effects
   5. How to store Duoclin
   6. Contents of the pack and other information

Duoclin 10 mg/g + 50 mg/g gel

clindamycin + anhydrous benzoyl peroxide
equivalent 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 they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Duoclin is and what it is used for
• 2. What you need to know before you use Duoclin
• 3. How to use Duoclin
• 4. Possible side effects
• 5. How to store Duoclin
• 6. Contents of the pack and other information

1. What Duoclin is and what it is used for

Duoclin contains two medicinal products: clindamycin and benzoyl peroxide.
Duoclin belongs to a group of medicines known as “anti-acne preparations”.
Duoclin is used to treat mild to moderate acne of the skin.

• Clindamycin is an antibiotic that blocks the reproduction of bacteria involved in acne.
• Benzoyl peroxide reduces blackheads and pimples. It also kills the bacteria involved in acne. Their use in combination in Duoclin works by:
• fighting the bacteria that cause acne
• treating existing blackheads, pimples and pustules
• reducing the number of red and inflamed acne pustules

Duoclin is indicated for use in adults and adolescents aged 12 years and over.

2. What you need to know before using Duoclin

Do not use Duoclin

• 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 Duoclin if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before starting to
use Duoclin.

Warnings and precautions
Talk to your doctor or pharmacist before using Duoclin

• Before using this medicine, talk to your doctor or pharmacist ifyou have ever had the following intestinal problems: “regional enteritis”, “ulcerative colitis” or “antibiotic-associated colitis”.
• If you experience stomach cramps or diarrheathat does not improve or gets worse, stop using

Duoclin andcontact your doctor immediately. Antibiotics can cause a
condition that causes severe diarrhea and stomach cramps. Although this is unlikely
to happen with antibiotics applied to the skin.

• Use Duoclin only on the skin. Keep away from areas such as eyes, lips, mouth or inside the nose.
• Do not use the gel on irritated skin. For example if there are cuts, abrasions, burns, or damaged skin. If Duoclin accidentally gets into your eyes, mouth or nose, rinse thoroughly with plenty of water.
• Do not use too much Duoclin on sensitive skin areas.
• Most patients show some redness and skin flaking during the first few weeks of treatment. If the skin becomes irritated,you may need to use an oil-free moisturizer, use Duoclin less often, or stop using it for a short period to allow the skin to recover and then start treatment again.
• Stop treatment and consult your doctor if skin irritation is severe (severe redness, dryness, itching, stinging pain, or burning) or if it does not improve.
• Duoclin may make the skin more sensitive to the harmful effects of the sun. Avoid the use of sunbeds/lamps and minimize exposure to the sun. You should use sunscreen and wear protective clothing while using Duoclin.
• If you have recently used other medicines containing clindamycin or erythromycin, there is a greater likelihood that Duoclin will not work as well as it should. Tell your doctor or pharmacist if you have recently usedany other medicine containing clindamycin or erythromycin.
• Try to avoid contact between Duoclin and colored items, including clothing, towels and sheets, furniture or carpets. Duoclin can bleach these materials.
• Duoclin can bleach hair.

Children
Do not give this medicine to children under twelve years of age. It is not known if it works or is safe
for them.

Other medicines and Duoclin
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:

• Any acne treatment containing antibiotics used on the skin
• Medicated or “abrasive” soaps and cleansers
• Soaps or cosmetics that have a too drying effect
• Products that contain a lot of alcohol or “astringent substances”. This is because when used together with Duoclin, they can irritate the skin over time.

Duoclin can make some anti-acne medicines less effective when used
at the same time. This includes:

• some anti-acne medicines that are applied to the skin and contain tretinoin,isotretinoinor tazarotene.Tell your doctor or pharmacist if you are also using 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 anti-acne medicines together with Duoclin may increase the risk of skin irritation.

Stop treatment and consult your doctorif skin irritation becomes
severe
(severe redness, dryness, itching, stinging pain, or
burning).
Duoclin should not be used at the same time as medicines containing erythromycin.
Applying Duoclin at the same time as medicines such as dapsoneand sulfacetamidecan
cause a temporary change in the color of the skin or hair on the face (yellow/orange).
This will not be permanent.
One of the medicines present in Duoclin can affect the functioning of certain medicines
that are used in general anesthesia (so-called “neuromuscular blocking agents”).

Tell your doctor or pharmacistif you are going to have
surgery.
If you are not sure if any of these conditions apply to you, talk to
your doctor or pharmacist before using Duoclin.

Pregnancy and breastfeeding
There is limited information on the safety of Duoclin in pregnant women.
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.
The doctor will assess the benefit for the mother and the risk to the child of using Duoclin
during pregnancy.
It is not known whether the ingredients of Duoclin can pass into breast milk. One of the medicines
contained in Duoclin is clindamycin. When clindamycin is taken by mouth or
by injection, it can pass into breast milk. If you are breastfeeding, you should consult your
doctor before usingDuoclin.
Do not apply Duoclin to the breast if you are breastfeeding.

3. How to use Duoclin

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

• Use Duoclin once a day in the evening.
• It may take 2 to 5 weeks to see the effect of Duoclin.
• Do not use for more than 12 consecutive weeks. Your doctor will tell you how long the treatment should last.

How to apply Duoclin

• 1. Remove makeup completely.
• 2. Wash the affected area thoroughly. Then rinse with lukewarm water and gently pat dry with a towel.
• 3. Apply a thin layerof gel to the entireaffected skin area, using your fingertips.
• 4. Apply to all areas of skin with acne, not just on individual pimples. If the gel is not easily absorbed, this means that too much has been applied.
• For the face only, use the amount of gel that, when exiting the tube, reaches the fingertip at first contact (the first wrinkle on the finger). This is a “fingertip unit”.
• For the face and back, use a total of two and a half “fingertip units”.
• 5. In case of excessive dryness and flaking of the skin, you can use a hypoallergenic, oil-free, fragrance-free moisturizer, use Duoclin less frequently, or interrupt the treatment for a short period, to allow the skin to adjust to the treatment.

This medicine may not work properly if it is not applied every day.

• 6. Wash your handsafter using the gel.
• 7. After it has dried, you can use non-oily makeup.

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

If you use more Duoclin than you should

• Be careful not to apply too much. Applying too much gel or applying it more frequently will not clear up pimples faster, and may cause skin irritation. If this happens, use the gel less often, or stop using it for a few days and then start again.

If you accidentally ingest Duoclin

• If you accidentally swallow the gel, consult a doctor. You may experience symptoms similar to those when taking oral antibiotics (stomach upset).

If you forget to use Duoclin

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

Do not stop treatment with Duoclin.
Do not use the gel for more than 12 weeks at a time without talking to your doctor. Use
Duoclin for the time recommended by your doctor. Do not stop unless your doctor advises you to.

It is important to continue using the gel as prescribed by your doctor. If you stop too
soon, acne may return.
If you have any further questions on the use of 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 Duoclin and consult your doctor immediately if you experience 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 diarrhoea, or abdominal cramps
• Severe burning, peeling or itching.

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.

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

• Headache

At the application site:

• Burning, pain, light sensitivity

Uncommon side effects
(may affect up to 1 in 100 people)

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

Other side effects
Other side effects with unknown frequency (frequency cannot be estimated based on available data) include:

• Allergic reactions
• Inflammation of the intestine, diarrhoea, including bloody diarrhoea, 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. 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 Duoclin

Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2 °C-8 °C).
After the first opening of Duoclin, do not store it at a temperature higher than 25 °C and discard after
2 months.
Do not use this medicine after the expiry date which is stated on the packaging after “EXP.:”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. 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 Duoclin contains

• The active ingredients are: clindamycin and benzoyl peroxide anhydrous. 1 g of gel contains 10 mg of clindamycin (as clindamycin phosphate) and 50 mg of benzoyl peroxide anhydrous (as benzoyl peroxide hydrate).
• The other excipients are: carbomer 980, dimethicone, disodium lauryl sulfosuccinate, disodium edetate, glycerol, poloxamer (poloxamer 182), hydrated colloidal silica, 2N sodium hydroxide and purified water.

Description of the appearance of Duoclin and contents of the pack
Homogeneous gel from white to slightly yellow with visible fine particles.
25 g, 30 g, 50 g or 60 g of gel in an aluminum tube closed with a white plastic screw cap, in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Difa Cooper S.p.A.
Via Milano 160
21042 Caronno P. (Va)
Italy

Manufacturer
JADRAN - Galenski laboratorij d.d.
Svilno 20
51000 Rijeka
Croatia

This medicinal product is authorised in the Member States of the European Union with the following names:
Spain: Duoclin 10 mg/g + 50 mg/g gel
Portugal: Duoclin {Name of the medicinal product}
{Name of the Member State} {Name of the medicinal product}
[Complete with national data]