ADALAIN 1 mg /G + 25 Mg/G Żel

Treść ulotki

1. Adalain 1 mg/g + 25 mg/g gel
   1. What is Adalain and what is it used for
   2. What you need to know before using Adalain
   3. How to use Adalain
   4. Possible side effects
   5. How to store Adalain
   6. Contents of the pack and other information
2. Adalain 3 mg/g + 25 mg/g gel
   1. What is Adalain and what is it used for
   2. What you need to know before using Adalain
   3. How to use Adalain
   4. Possible side effects
   5. How to store Adalain
   6. Contents of the pack and other information

Adalain 1 mg/g + 25 mg/g gel

Adapalene/benzoyl peroxide
Generic medicine

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

1. What is Adalain and what is it used for

Adalain is indicated for the treatment of acne.
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 the processes
of the skin 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 Adalain

Do not use Adalain

• 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 one 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 with colored fabrics as it may discolor them.
Wash your hands thoroughly after using this medicine.

Other medicines and Adalain
Do not use other acne products (containing benzoyl peroxide and/or retinoids) at the same time as
the gel.
Avoid using Adalain 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 useAdalain if you are pregnant or if you are 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
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 operating machinery
Not applicable.

Adalain 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.

Adalain 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.

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

3. How to use Adalain

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, adolescents and in 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 experience that the effect of Adalain is too strong or too weak, consult your doctor or
pharmacist.
If persistent skin irritation occurs when using this medicine, contact your doctor.
Your doctor may ask you to apply a moisturising cream, to use the gel less frequently, to
suspend therapy temporarily or to discontinue it.

If you use more Adalain 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 Adalain than you should have.
• If a child has accidentally taken this medicine.
• If you have accidentally ingested this medicine.

The doctor will advise you on the measures to take.

If you forget to use Adalain
Do not apply a double dose to compensate for missing an application.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
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 you develop hives or feel an itching sensation
on your 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):

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

In the event that skin irritation occurs following application of this medicine, this
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 serious cases with blisters.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell 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 Adalain

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 after Exp..
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. Contents of the pack and other information

What Adalain 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 Adalain and contents of the pack
Opaque, homogeneous gel from white to very pale yellow in color.
Pack sizes: 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 pack sizes may be marketed.

Marketing Authorisation Holder
Aristo Pharma GmbH
Wallenroder Straße 8 – 10
13435
Berlin, Germany

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 with the
following denominations:
Netherlands Adapaleen/benzoylperoxide Aristo 1 mg/g + 25 mg/g Gel
Croatia Arelma
Italy Adalain
Poland Adalain

Adalain 3 mg/g + 25 mg/g gel

Adapalene/benzoyl peroxide
Generic medicine

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

1. What is Adalain and what is it used for

Adalain 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, the other active ingredient, 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 adults and adolescents aged 12 years or older.

2. What you need to know before using Adalain

Do not use Adalain

• 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 contact occurs with one 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 Adalain).

Other medicines and Adalain
Do not use other acne products (containing benzoyl peroxide and/or retinoids) at the same time as
this gel.
Avoid using Adalain 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
taking, have recently taken or might take any other medicine.

Pregnancy and breastfeeding
Pregnancy
DO NOT useAdalain if you are pregnant or if you are 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 your chest in order to avoid
contact exposure to the infant.

Driving and operating machinery
Adalain gel has no or negligible effects on the ability to drive and operate machinery.

Adalain 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.

Adalain 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.

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

3. How to use Adalain

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 in adults and adolescents aged 12 years or older.
This medicine is for external use only.
The doctor will decide which gel concentration 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 over the entire area affected by acne on the face and/or trunk, once a day in the evening before bedtime. 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 this gel,
contact your doctor. The doctor may ask you to apply a moisturizer, use the medicine less
frequently, temporarily suspend therapy or discontinue it.
Do not apply cosmetics (such as face creams or makeup 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 the age of 12.

If you use more Adalain 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 red.
Contact your doctor or hospital:

• If you have used more Adalain than you should.
• 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 Adalain
Do not apply a double dose to compensate for a missed application.
Pimples (comedones, papules and pustules) will only decrease 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 everybody gets them.
About 1 in 10 patients using this medicine may experience adverse skin reactions.
Stop using this medicine and see your doctor 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 itchy
sensation on your 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 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
• change in skin color
• burning at the application site.

Adverse reactions typically associated with the use of Adalain include application site reactions
from mild to moderate, such as skin irritation with redness, dryness, scaling,
tingling and/or burning 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 of using this
medicine, contact your doctor. Skin adverse reactions, for example 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 asked to apply a moisturizer, to use the
gel less frequently, to suspend treatment for a short period of time or to
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, even those not listed in this leaflet, tell 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 Adalain

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 after Expiry..
The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
After the 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 eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Adalain 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 copolymer (1:1), isohexadecane, polysorbate 80, sorbitan oleate); poloxamer 124; disodium edetate; sodium docusate; purified water.

Description of the appearance of Adalain and contents of the pack
Opaque, homogeneous gel from white to very pale yellow in colour.
The gel is packaged in white HDPE/LLDPE plastic tubes with a white HDPE cap, equipped with a
removable aluminium seal and closed with a white polypropylene screw cap.
One tube of 15 g
One tube of 30 g
One tube of 45 g
One tube of 60 g
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aristo Pharma GmbH
Wallenroder Straße 8 – 10
13435
Berlin, Germany

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 with the
following denominations:
Netherlands Adapaleen/benzoylperoxide Aristo 3 mg/g + 25 mg/g Gel
Croatia Arelma
Italy Adalain
Poland Adalain