Siclea
ItalyTable of Contents
Package leaflet: Information for the user
Siclea 1 mg/g + 25 mg/g gel
adapalene/benzoyl peroxide
Generic medicine
Please read all of this leaflet carefully before you start using this medicine, because 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
- If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
Contents of this leaflet
- What Siclea is and what it is used for
- What you need to know before using Siclea
- How to use Siclea
- Possible side effects
- How to store Siclea
- Contents of the pack and other information
1. What Siclea is and what it is used for
Siclea is used for the treatment of acne.
The gel combines two active substances, adapalene and benzoyl peroxide, which work 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 effect 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 of skin with cuts, abrasions, sunburn, or eczema.
Make sure that the gel does not come into contact with your eyes, mouth, nostrils, or other highly sensitive areas of the body. If contact occurs, rinse the affected area immediately with plenty of lukewarm water.
Avoid excessive exposure to sunlight and UV lamps.
Avoid contact of the gel with your hair or coloured fabrics, as it may cause bleaching.
Wash your hands thoroughly after using this medicine.
Other medicines and Siclea
Do not use other acne treatments (containing benzoyl peroxide and/or retinoids) concurrently with this gel.
Avoid using Siclea together with cosmetic products that irritate, dry out, or exfoliate the skin.
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Pregnancy and breastfeeding
Pregnancy
DO NOT USE Siclea if you are pregnant or planning to become pregnant. Your doctor can provide further information.
If you become pregnant while using this medicine, stop treatment immediately and inform your doctor as soon as possible for further evaluation.
Breastfeeding
This gel may be used during breastfeeding. To avoid contact exposure to the infant, application of this medicine on 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 may cause skin irritation
This medicine contains 40 mg of propylene glycol (E1520) in each gram of gel, equivalent to 4.00% w/w.
Siclea contains polysorbates which may cause allergic reactions
This medicine contains 3 mg of polysorbate 80 in each gram of gel, equivalent to 0.3% w/w.
Siclea contains benzoic acid, a degradation product of benzoyl peroxide, which may cause local irritation.
3. How to use Siclea
Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
This medicine is intended for use only in adults, adolescents, and children aged 9 years and older. This medicine is for external use only.
Apply a thin, even layer of gel once daily in the evening before going to bed to the acne-affected areas, avoiding contact with the eyes, lips, and nostrils. The skin should 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 feel that the effect of Siclea is too strong or too weak, consult your doctor or pharmacist.
If you experience persistent skin irritation while using this medicine, contact your doctor. Your doctor may advise you to use a moisturizing cream, to apply the gel less frequently, or to temporarily suspend or discontinue treatment.
If you use more Siclea than you should
If you apply more gel than recommended, your acne will not clear up faster, but your skin may become irritated and red.
Contact your doctor or hospital:
- If you have used more Siclea than you should have;
- If a child has accidentally ingested this medicine;
- If you have accidentally swallowed this medicine.
Your doctor will advise you on the necessary steps to take.
If you forget to use Siclea
Do not apply a double dose to make up for a missed application.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Stop using the medicine and contact your doctor immediately if you experience throat tightness 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 experience itching of the face or body. The frequency with which these side effects may occur is unknown.
Common side effects (may affect up to 1 in 10 people):
- Dry skin
- Localised skin rash (irritant contact dermatitis)
- Burning sensation
- Skin irritation
- Redness
- Peeling
Uncommon side effects (may affect up to 1 in 100 people):
- Skin itching
- Sunburn
Not known (frequency cannot be estimated from the available data):
- Facial swelling, allergic contact reactions
- Eyelid swelling
- Throat constriction
- Skin pain (pricking pain)
- Blisters (vesicles)
- Breathing difficulty
- Skin colour change
- 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, peeling, burning and skin pain (pricking pain), which usually peak during the first week and then resolve without additional treatment.
Cases of burning at the application site have been reported, mostly superficial, but also more severe cases with blistering.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. 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 Siclea
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and tube. The expiry date refers to the last day of that month.
Do not store above 30°C.
After first opening the tube, use the medicine within 3 months.
Do not dispose of any medicine via 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 substances 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 components are: propylene glycol (E1520); glycerol; Sepineo P600 (copolymer of acrylamide and sodium acryloyldimethyl taurate (1:1), isohexadecane, polysorbate 80, sorbitan oleate); poloxamer 124; disodium edetate; sodium docusate; purified water.
Description of the appearance of Siclea and contents of the pack
Homogeneous, opaque gel, white to very pale yellow in colour.
Pack sizes: 1 tube of 30 g, 45 g or 60 g.
The gel is packed in white HDPE/LLDPE plastic tubes with a white HDPE cap, sealed with an aluminium seal and closed with a white polypropylene screw cap.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva Italia S.r.l.
Via P. Paleocapa 7
20121 Milano, Italy
Manufacturers
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 European Economic Area and the United Kingdom (Northern Ireland) under the following names:
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
Package leaflet: information for the user
Siclea 3 mg/g + 25 mg/g gel
adapalene/benzoyl peroxide
Equivalent medicinal product
Please read this leaflet carefully before using this medicine because 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
- If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
Contents of this leaflet
- What Siclea is and what it is used for
- What you need to know before using Siclea
- How to use Siclea
- Possible side effects
- How to store Siclea
- 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 "anti-acne topical preparations".
It is used for the treatment of acne vulgaris when comedones (blackheads,
whiteheads) and numerous papules and pustules (inflamed pimples) are present.
This gel combines two active substances, 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 acts as an antibacterial agent and exerts a soothing and exfoliating effect on the outermost layer of the skin.
This medicine should only be used in adult and adolescent patients aged 12 years and 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
Talk to your doctor or pharmacist before using this medicine.
Do not use this gel on areas of skin with cuts, abrasions, sunburn or eczema.
Make sure that the gel does not come into contact with your eyes, mouth, nostrils, or other highly sensitive areas of the body. If contact occurs, rinse the affected area immediately with plenty of lukewarm water.
Avoid excessive exposure to sunlight and UV lamps.
Avoid contact of the gel with your hair or coloured fabrics, as it may cause bleaching.
Wash your hands thoroughly after using this medicine.
If you experience persistent skin irritation soon after starting treatment with this gel, contact your doctor (see Section 3 - How to use Siclea).
Other medicines and Siclea
Do not use other acne treatments (containing benzoyl peroxide and/or retinoids) concurrently with this gel.
Avoid using Siclea at the same time as cosmetic products that irritate, dry or exfoliate the skin.
Other medicines may affect your treatment with this gel. Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pregnancy and breastfeeding
Pregnancy
DO NOT USE Siclea if you are pregnant or planning to become pregnant. Your doctor can provide further information.
If you become pregnant while using this medicine, stop treatment immediately and inform your doctor as soon as possible for further advice.
Breastfeeding
If you are breastfeeding, consult your doctor before using this medicine. Your doctor will advise whether you should stop breastfeeding or avoid treatment with this gel.
If your doctor advises you to continue treatment, do not apply the gel on the chest area to avoid exposing the infant to contact with the product.
Driving and using machines
Siclea gel has no or negligible effects on the ability to drive and use machinery.
Siclea contains propylene glycol which may cause skin irritation
This medicine contains 40 mg of propylene glycol (E1520) in each gram of gel, equivalent to 4.00% w/w.
Siclea contains polysorbates which may cause allergic reactions
This medicine contains 3 mg of polysorbate 80 in each gram of gel, equivalent to 3.00% w/w.
Siclea contains benzoic acid, a degradation product of benzoyl peroxide, which may cause local irritation.
3. How to use Siclea
Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
This medicine is intended for use in adults and adolescents aged 12 years and older only. This medicine is for external use only.
Your doctor will decide which gel concentration is appropriate for you, depending on the severity and type of your acne. Your doctor will also determine whether you need additional treatment.
- The skin must be clean and dry before application.
- Apply a thin, even layer of gel once daily in the evening before going to bed, over the entire acne-affected area of the face and/or trunk. Avoid contact with the eyes, lips, nostrils, and mucous membranes.
- When used on the face: wash and dry your face, then apply an amount of gel the size of a pea to each area of the face (for example, forehead, chin, each cheek).
- Wash your hands thoroughly immediately after applying the gel.
Your doctor will inform you how long you should use this medicine. If you do not see any improvement after 4–8 weeks, consult your doctor to discuss whether continuing treatment is beneficial.
If persistent skin irritation occurs during the first weeks of using Siclea gel, contact your doctor. Your doctor may recommend using a moisturizing cream, applying the medicine less frequently, temporarily stopping treatment, or discontinuing it altogether.
Do not apply cosmetics (such as facial creams or makeup products) before the daily application of the gel. These products may be used after the gel has dried.
Use in children
This medicine must not be used in children under 12 years of age.
If you use more Siclea than you should
If you apply more gel than recommended, your acne will not clear up faster, but your skin may become irritated and red.
Contact your doctor or hospital:
- If you have used more Siclea than intended;
- If a child has accidentally ingested this medicine;
- If you or someone else has accidentally swallowed this medicine.
Your doctor will advise you on the necessary steps to take.
If you forget to use Siclea
Do not apply a double dose to make up for a missed application.
Pimples (comedones, papules, and pustules) will only begin to improve after several applications of this medicine. Continue using this treatment for the duration prescribed by your doctor.
If you have any doubts 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 everybody gets them.
Approximately 1 in 10 patients using this medicine may experience adverse skin reactions.
Stop using this medicine and contact your doctor immediately if you experience throat tightness or swelling of the eyes, face, lips or tongue, if you feel faint or have difficulty breathing. Discontinue use of the medicine if you develop hives or experience itching of the face or body. The frequency of these side effects is unknown.
Common side effects (may affect up to 1 in 10 people):
- burning sensation of the skin
- skin irritation
- eczema
- redness
- peeling
Uncommon side effects (may affect up to 1 in 100 people):
- eyelid redness
- stinging or prickling sensation at the application site
- skin itching, skin allergic reaction
- skin rash
- dry skin
In addition to the side effects described above, the following side effects have been reported with a lower strength of adapalene/benzoyl peroxide gel (1 mg/g + 25 mg/g):
Uncommon side effects (may affect up to 1 in 100 people):
- sunburn
Frequency not known (frequency cannot be estimated from the available data):
- swelling of the eyelids
- throat tightness
- contact allergic reaction
- facial swelling
- skin pain (stinging pain)
- blisters (vesicles)
- difficulty breathing
- change in skin colour
- burning at the application site
Adverse reactions typically associated with the use of Siclea include mild to moderate reactions at the application site, such as skin irritation with redness, dryness, peeling, stinging and/or burning of the skin.
Cases of burning at the application site have been reported, mostly superficial, but also more severe cases with blistering.
If persistent skin irritation occurs during the first few weeks of using this medicine, contact your doctor. Cutaneous adverse reactions, such as skin irritation, are more frequent with the higher strength gel compared to the lower strength (adapalene/benzoyl peroxide 1 mg/g + 25 mg/g gel). You may be advised to apply a moisturising cream, to use the gel less frequently, to interrupt treatment for a short period or to stop treatment altogether. These reactions usually occur at the beginning of treatment and tend to gradually diminish over time.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. 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 Siclea
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. The expiry date refers to the last day of that month.
Do not store above 30°C.
After first opening of the tube, use the medicine within 3 months.
Do not dispose of any medicine via 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 substances 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 components are: propylene glycol (E1520); glycerol; Sepineo P600 (acrylamide/sodium acryloyldimethyl taurate copolymer (1:1), isohexadecane, polysorbate 80, sorbitan oleate); poloxamer 124; disodium edetate; sodium docusate; purified water.
Description of the appearance of Siclea and contents of the pack
Homogeneous, opaque gel, white to very pale yellow in colour.
The gel is packaged in white HDPE/LLDPE plastic tubes with a white HDPE cap, fitted with an aluminium removable seal and closed with a white polypropylene screw cap.
30 g tube
45 g tube
60 g tube
It is possible that not all pack sizes are marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva Italia S.r.l.
Via P. Paleocapa 7
20121 Milano, Italy
Manufacturers
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 European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
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 + 25 mg/g gel
France: ADAPALENE/PEROXYDE DE BENZOYLE ZENTIVA 0,3%/2,5%, gel
Italy: Siclea