SICLEA 1 mg /G + 25 Mg/G Гель

Содержание инструкции

1. What is Siclea and what is it used for
2. What you need to know before using Siclea
3. How to use Siclea
4. Possible side effects
5. How to store Siclea
6. Package Contents and Other Information
7. What Siclea is and what it is used for
8. What you need to know before using Siclea
9. How to use Siclea
10. Possible side effects
11. How to store Siclea
12. Package Contents and Other Information

Siclea 1 mg/g + 25 mg/g gel
adapalene/benzoyl peroxide
Generic medicine

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

1. What is Siclea and what is it used for

Siclea is used for the treatment of acne.
The gel combines two active ingredients, adapalene and benzoyl peroxide, which act
together but in different ways:
Adapalene belongs to a group of substances known as retinoids and acts specifically on the skin processes
that cause acne.
Benzoyl peroxide, the other active ingredient, acts as an antibacterial agent and exerts a soothing
and exfoliating action on the outermost layer of the skin.

2. What you need to know before using Siclea

Do not use Siclea

• if you are allergic to adapalene or benzoyl peroxide or to any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant
• if you are planning a pregnancy

Warnings and precautions
Talk to your doctor or pharmacist before using this medicine.
Do not use this gel on areas where there are cuts, abrasions, sunburn or eczema.
Make sure the gel does not come into contact with your eyes, mouth or nostrils, and other very sensitive areas of the
body. If it comes into contact with any of these areas, immediately rinse the affected area with
plenty of lukewarm water.
Avoid excessive exposure to sunlight and UV lamps.
Avoid contact of the gel with your hair or colored fabrics as it may discolor them.
Wash your hands thoroughly after using this medicine.

Other medicines and Siclea
Do not use other acne products (containing benzoyl peroxide and/or retinoids) at the same time as
this gel.
Avoid using Siclea at the same time as cosmetic products that irritate, dry or exfoliate the skin.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.

Pregnancy and breastfeeding
Pregnancy
DO NOT USESiclea if you are pregnant or planning a pregnancy. Your doctor will be able to give you
more information.
If you become pregnant while using this medicine, stop treatment and inform your doctor
as soon as possible for further monitoring.

Breastfeeding
This gel can be used during breastfeeding. In order to avoid contact exposure to the
infant, application of this medicine to the chest area should be avoided.
Consult your doctor or pharmacist before taking any medicine.

Driving and using machines
Not applicable.

Siclea contains propylene glycol which can cause skin irritation
This medicine contains 40 mg of propylene glycol (E1520) in each gram of gel, which is equivalent to
4.00% w/w.

Siclea contains polysorbates which can cause allergic reactions
This medicine contains 3 mg of polysorbate 80 in each gram of gel, which is equivalent to 0.3% w/w.

Siclea contains benzoic acid, a degradation product of benzoyl peroxide, which can
cause local irritation.

3. How to use Siclea

Use this medicine following the instructions of your doctor exactly. If you have any doubts, ask your
doctor or pharmacist.
This medicine is indicated exclusively for use in adults, adolescents and children aged 9 years or
older. This medicine is for external use only.
Apply a thin layer of gel evenly to the areas affected by acne, once a day in the evening before bedtime,
avoiding contact with the eyes, lips and nostrils. The skin must be clean and dry before application. Wash
your hands thoroughly after applying this gel.
Your doctor will tell you how long you should use this medicine.
If you should feel that the effect of Siclea is too strong or too weak, consult your doctor or
pharmacist.
If persistent skin irritation occurs while using this medicine, contact your
doctor. Your doctor may ask you to apply a moisturising cream, to use the gel less
frequently, to temporarily suspend therapy or to discontinue it.

If you use more Siclea than you should
If you apply more gel than you should to the skin, your acne will not disappear faster but your
skin may become irritated and reddened.
Contact your doctor or hospital:

• If you have used more Siclea than you should;
• If a child has accidentally taken this medicine;
• If you have accidentally ingested this medicine.

The doctor will advise you on the measures to be taken.

If you forget to use Siclea
Do not apply a double dose to compensate for a missed application.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using the medicine and seek medical attention immediately if you experience tightness of the throat
or swelling of the eyes, face, lips or tongue, if you feel faint or have difficulty breathing.
Stop using the medicine if you develop hives or feel an itching sensation on your face or
body. The frequency with which these side effects can occur is not known.
Common side effects (may affect up to 1 in 10 people):

• dry skin
• local skin rash (irritant contact dermatitis)
• burning sensation
• skin irritation
• redness
• scaling

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

• skin itching
• sunburn

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

• facial swelling, allergic contact reactions
• eyelid swelling
• constriction of the throat
• skin pain (stinging pain)
• blisters (vesicles)
• difficulty breathing
• change in skin color
• burning at the application site

If skin irritation occurs following application of this medicine, it is generally mild or moderate, with local signs such as redness, dryness, scaling,
burning and skin pain (stinging pain), which reach their peak during the first week
and then disappear without additional treatment.
Cases of burning at the application site have been reported, mostly superficial but also
more severe cases with blisters.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any 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 Siclea

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 pack and the tube. The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
After first opening the tube, use the medicine within 3 months.
Do not dispose of any medicine in waste water or household waste.
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 Siclea contains

• The active ingredients are: adapalene and benzoyl peroxide. 1 g of gel contains 1 mg of adapalene (0.1% w/w) and benzoyl peroxide, hydrate, equivalent to 25 mg (2.5% w/w) of anhydrous benzoyl peroxide.
• The other ingredients are: propylene glycol (E1520); glycerol; Sepineo P600 (acrylamide and sodium acryloyldimethyl taurate (1:1) copolymer, isohexadecane, polysorbate 80, sorbitan oleate); poloxamer 124; disodium edetate; sodium docusate; purified water.

Description of the appearance of Siclea and package contents
Opaque, homogeneous gel ranging in color from white to very pale yellow.
Packages: 1 tube containing 30 g, 45 g or 60 g.
The gel is packaged in white HDPE/LLDPE plastic tubes with a white HDPE cap, equipped with a
removable aluminum seal and closed with a white polypropylene screw cap.
Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Zentiva Italia S.r.l.
Via P. Paleocapa 7
20121 Milan, Italy

Manufacturer
Adalvo Limited
Malta Life Sciences Park, Building 1, Level 4,
Sir Temi Zammit Buildings, San Gwann, SGN 3000, Malta
BELTAPHARM SPA
Via STELVIO 66
20095 Cusano Milanino
Milan, Italy

This medicinal product is authorised in the Member States of the European Economic Area and in the
United Kingdom (Northern Ireland) under the following denominations:
Netherlands: Adapaleen/Benzoylperoxide Zentiva 1 mg/g + 25 mg/g, gel
Germany: Adapalen/Benzoylperoxid Zentiva 1 mg/g + 25 mg/g Gel
Spain: Siclea 1 mg/g + 25 mg/g gel
France ADAPALENE/PEROXYDE DE BENZOYLE ZENTIVA 0.1%/2.5%, gel
Italy: Siclea

Siclea 3 mg/g + 25 mg/g gel
adapalene/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 may 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 Siclea is and what it is used for
• 2. What you need to know before you use Siclea
• 3. How to use Siclea
• 4. Possible side effects
• 5. How to store Siclea
• 6. Contents of the pack and other information

1. What Siclea is and what it is used for

Siclea gel belongs to a group of medicines called “topical anti-acne preparations”,
meaning it is used for the treatment of common acne, when comedones (blackheads,
whiteheads), numerous papules and pustules (inflamed pimples) are present.
This gel combines two active ingredients, adapalene and benzoyl peroxide, which act
together but in different ways:

• adapalene belongs to a group of substances known as retinoids and acts specifically on skin processes that cause acne.
• benzoyl peroxide acts as an antibacterial agent and exerts a soothing and exfoliating action on the outermost layer of the skin.

This medicine should only be used in adult patients and adolescents aged 12
years or older.

2. What you need to know before using Siclea

Do not use Siclea

• if you are allergic to adapalene or benzoyl peroxide or to any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant
• if you are planning a pregnancy

Warnings and precautions
Consult your doctor or pharmacist before using this medicine.
Do not use this gel on areas where there are cuts, abrasions, sunburn or eczema.
Make sure the gel does not come into contact with your eyes, mouth or nostrils, and other very sensitive areas of the
body. If it comes into contact with any of these areas, immediately rinse the affected area with
plenty of lukewarm water.
Avoid excessive exposure to sunlight and UV lamps.
Avoid contact of the gel with your hair or colored fabrics as it may discolor them.
Wash your hands thoroughly after using this medicine.
If you experience persistent skin irritation as soon as you start treatment with this gel, contact your
doctor (see Section 3 - How to use Siclea).

Other medicines and Siclea
Do not use other acne products (containing benzoyl peroxide and/or retinoids) at the same time as
this gel.
Avoid using Siclea at the same time as cosmetic products that irritate, dry or exfoliate the skin.
Other medicines may affect your gel treatment, tell your doctor or pharmacist if you are
using, have recently used or might use any other medicine.

Pregnancy and breastfeeding
Pregnancy
DO NOT USESiclea if you are pregnant or planning a pregnancy. Your doctor can give you
more information.
If you become pregnant while using this medicine, stop treatment and inform your doctor
as soon as possible for further monitoring.

Breastfeeding
If you are breastfeeding, ask your doctor for advice before using this medicine. The
doctor will advise you whether to stop breastfeeding or to refrain from treatment with this
gel.
If your doctor advises you to continue treatment, do not apply the gel to the chest in order to avoid
contact exposure to the infant.

Driving and using machines
Siclea gel has no or negligible effects on the ability to drive and use machines.

Siclea contains propylene glycol which can cause skin irritation
This medicine contains 40 mg of propylene glycol (E1520) in each gram of gel, which is equivalent to
4.00% w/w.

Siclea contains polysorbates which can cause allergic reactions
This medicine contains 3 mg of polysorbate 80 in each gram of gel, which is equivalent to 3.00% w/w.

Siclea contains benzoic acid, a degradation product of benzoyl peroxide, which can
cause local irritation.

3. How to use Siclea

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.
This medicine is indicated exclusively for use in adults and adolescents aged 12 years or older.
This medicine is only for external use.
The doctor will decide which concentration of gel you need, depending on the severity and appearance of your
acne. The doctor will also decide if you need additional treatment.

• The skin must be clean and dry before application.
• Apply a thin layer of gel evenly to the entire area affected by acne on the face and/or trunk, once a day in the evening before going to bed. Avoid contact with eyes, lips, nostrils and mucous membranes.
• If used on the face: wash and dry your face and use an amount equal to the size of a pea and apply it to each part of the face (e.g. forehead, chin, each of the two cheeks).
• Wash your hands thoroughly immediately after applying the gel.

The doctor will tell you how long you should use this medicine. If you do not see any
improvement after 4-8 weeks, contact your doctor to discuss the benefit of continuing the
treatment.
If persistent skin irritation occurs during the first weeks of using Siclea gel,
contact your doctor. The doctor may ask you to apply a moisturizing cream, to use
the medicine less frequently, to temporarily suspend therapy or to discontinue it.
Do not apply cosmetics (such as face creams or make-up products) before
the daily application of the gel. These products can be used after the gel has
dried.

Use in children
This medicine should not be used in children under 12 years of age.

If you use more Siclea than you should
If you apply more gel than you should to the skin, your acne will not disappear faster but your
skin may become irritated and reddened.
Contact your doctor or hospital:

• If you have used more Siclea than you should have;
• If a child has accidentally taken this medicine;
• If you or someone else has accidentally ingested this medicine.

The doctor will advise you on the measures to be taken.

If you forget to use Siclea
Do not apply a double dose to compensate for a missed application.
Pimples (comedones, papules and pustules) will only be reduced after several applications of this
medicine. Continue to use this treatment for the period prescribed by your doctor.
If you have any doubts about 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 everyone gets them.
Approximately 1 in 10 patients using this medicine may experience adverse skin reactions.
Stop using this medicine and seek immediate medical attention if you experience tightness of the
throat or swelling of the eyes, face, lips or tongue, if you feel faint or have difficulty
breathing. Stop using the medicine if hives develop or you feel an itchy sensation on the
face or body. The frequency with which these side effects can occur is unknown.
Common side effects (may affect up to 1 in 10 people):

• burning sensation of the skin
• skin irritation
• eczema
• redness
• scaling

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

• redness of the eyelid
• tingling or pins and needles sensation at the application site
• itchy skin, allergic skin reaction
• rash
• dry skin

In addition to the side effects described above, the following side effects have been reported with a
lower dosage of adapalene/ benzoyl peroxide gel (1 mg/g + 25 mg/g):
Uncommon side effects (may affect up to 1 in 100 people):

• sunburn

Not known(frequency cannot be estimated based on available data):

• swelling of the eyelids
• constriction of the throat
• allergic contact reaction
• swelling of the face
• skin pain (stinging pain)
• blisters (vesicles)
• difficulty breathing
• alteration of skin color
• burning sensation at the application site

Adverse reactions typically associated with the use of Siclea include reactions at the application site ranging
from mild to moderate, such as skin irritation with redness, dryness, scaling, tingling
and/or burning sensation of the skin.
Cases of burning at the application site have been reported, mostly superficial but also
more severe cases with blisters.
If you experience persistent skin irritation during the first few weeks when using this medicine,
contact your doctor. Skin adverse reactions, for example skin irritation, are more frequent with
the higher dosage of the gel compared to the lower dosage (adapalene/ benzoyl peroxide 1 mg/g + 25
mg/g gel). You may be asked to apply a moisturizer, use the gel less
frequently, suspend treatment for a short period of time or discontinue it. These
reactions usually occur at the beginning of treatment, and tend to decrease gradually over time.

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 Siclea

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 package and the tube. The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
After first opening of the tube, use the medicine within 3 months.
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. Package Contents and Other Information

What Siclea contains

• The active ingredients are: adapalene and benzoyl peroxide. 1 g of gel contains 3 mg of adapalene (0.3% w/w) and benzoyl peroxide, hydrate, equivalent to 25 mg (2.5% w/w) of anhydrous benzoyl peroxide.
• The other ingredients are: propylene glycol (E1520); glycerol; Sepineo P600 (acrylamide and sodium acryloyldimethyl taurate (1:1) copolymer, isohexadecane, polysorbate 80, sorbitan oleate); poloxamer 124; disodium edetate; sodium docusate; purified water.

Description of the appearance of Siclea and package contents
Opaque, homogeneous gel ranging in color from white to very pale yellow.
The gel is packaged in white HDPE/LLDPE plastic tubes with a white HDPE cap, equipped with a
removable aluminum seal and closed with a white polypropylene screw cap.
One tube containing 30 g
One tube containing 45 g
One tube containing 60 g
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Zentiva Italia S.r.l.
Via P. Paleocapa 7
20121 Milano, Italy

Manufacturer
Adalvo Limited
Malta Life Sciences Park, Building 1, Level 4,
Sir Temi Zammit Buildings, San Gwann, SGN 3000, Malta
BELTAPHARM SPA
Via STELVIO 66
20095 Cusano Milanino
Milano, Italy

This medicinal product is authorised in the Member States of the European Economic Area and in the
United Kingdom (Northern Ireland) under the following denominations:
Netherlands: Adapaleen/Benzoylperoxide Zentiva 3 mg/g + 25 mg/g, gel
Germany: Adapalen/Benzoylperoxid Zentiva 3 mg/g + 25 mg/g Gel
Spain: Siclea Forte 3 mg/g + 25mg/g gel
France ADAPALENE/PEROXYDE DE BENZOYLE ZENTIVA 0.3%/2.5%, gel
Italy: Siclea