BERATES 1 mg /G + 25 Mg/G Gel

Зміст інструкції

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

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

1. What is Berates and what is it used for

Berates 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 Berates

Do not use Berates

• if you are allergic to adapalene or benzoyl peroxide or to any other ingredient 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 with colored fabrics as it may discolor them.
Wash your hands thoroughly after using this medicine.

Other medicines and Berates
Do not use other acne products (containing benzoyl peroxide and/or retinoids) at the same time as this gel.
Avoid using Berates 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 USEBerates 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
This gel can be used during breastfeeding. In order to avoid exposure to the
infant through contact, 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.

Berates 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.

Berates 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.

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

3. How to use Berates

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 children of
age 9 years or older. This medicine is only for external use.
Apply a thin layer of gel evenly to the areas affected by acne, once a day in the evening before
going to bed, 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 Berates 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 temporarily suspend therapy or to
discontinue it.

If you use more Berates 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 Berates than you should have;
• If a child has accidentally taken this medicine;
• If you have accidentally swallowed this medicine.

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

If you forget to use Berates
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 the 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
itchy sensation on your face or body. The frequency with which these side effects
may 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):

• itchy skin
• sunburn

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

• facial swelling, allergic contact reactions
• eyelid swelling
• tightening 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, 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 treatments.
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, 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 Berates

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 to
protect the environment.

6. Package contents and other information

information
What Berates 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 Berates and package contents
Opaque, homogeneous gel from white to very pale yellow in color.
Package sizes: 1 tube of 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
Adalvo Limited
Malta Life Science Park,
Level 4, Building 1,
Sir Temi Zammit Buildings,
San Gwann, SGN 3000,
Malta

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

This medicinal product is authorised in the Member States of the European Economic Area
and in the United Kingdom (Northern Ireland) with the following denominations:
Netherlands: Berates 1 mg/g + 25 mg/g Gel

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

1. What Berates is and what it is used for

Berates 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 Berates

Do not use Berates

• if you are allergic to adapalene or benzoyl peroxide or to any other ingredient 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.
If you experience persistent skin irritation as soon as you start treatment with this gel
contact your doctor (see Section 3 - How to use Berates).

Other medicines and Berates
Do not use other acne products (containing benzoyl peroxide and/or retinoids) in
conjunction with this gel.
Avoid using Berates in conjunction with 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 USEBerates 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. Your 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
Berates gel has no or negligible effects on the ability to drive and use machines.

Berates 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.

Berates 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.

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

3. How to use Berates

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 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 treatment.
If persistent skin irritation occurs during the first few weeks of using
Berates gel, contact your doctor. The doctor may ask you to apply a
moisturizing cream, use the medicine less frequently, temporarily stop therapy
or 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 Berates 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 Berates than you should have;
• If a child has accidentally taken this medicine;
• If you or someone else has accidentally swallowed this medicine.

The doctor will advise you on the measures to take.

If you forget to use Berates
Do not apply a double dose to make up for a missed application.
Pimples (comedones, papules and pustules) will only reduce 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 skin adverse 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 hives occur or you feel
an itching sensation on your face or body. The frequency with which these side effects
can occur is unknown.
Side effects common(may affect up to 1 in 10 people):

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

Side effects uncommon(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):
Side effects uncommon(may affect up to 1 in 100 people):

• sunburn

Not known(frequency cannot be estimated based on the 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 Berates include reactions at the
application site ranging 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 when 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
moisturizing cream, to use the gel less frequently, to suspend treatment for a
short period of time or to stop 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. 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 Berates

Keep this medicine out of 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 Berates 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 Berates and package contents
Opaque, homogeneous gel from white to very pale yellow in color.
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 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 and Manufacturer

Marketing Authorisation Holder
Adalvo Limited
Malta Life Science Park,
Level 4, Building 1,
Sir Temi Zammit Buildings,
San Gwann, SGN 3000,
Malta

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

This medicinal product is authorised in the Member States of the European Economic Area
and in the United Kingdom (Northern Ireland) with the following denominations:
Netherlands: Berates 3 mg/g + 25 mg/g Gel