DIPROSONE 0.05 % Cream

Зміст інструкції

1. Diprosone 0.05% cream
   1. What Diprosone is and what it is used for
   2. What you need to know before using Diprosone
   3. How to use Diprosone
   4. Possible side effects
   5. How to store Diprosone
   6. Contents of the pack and other information
2. Diprosone 0.05% ointment
   1. What Diprosone is and what it is used for
   2. What you need to know before using Diprosone
   3. How to use Diprosone
   4. Possible side effects
   5. How to store Diprosone
   6. Contents of the pack and other information
3. Diprosone 0.05% cutaneous solution
   1. What is Diprosone and what is it used for
   2. What you need to know before using Diprosone
   3. How to use Diprosone
   4. Possible side effects
   5. How to store Diprosone
   6. Contents of the pack and other information

Diprosone 0.05% cream

betamethasone dipropionate

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

1. What Diprosone is and what it is used for

Diprosone contains the active ingredient betamethasone dipropionate, which belongs to a class of
medicines called corticosteroids.
Corticosteroids are hormones that perform numerous activities, with an important function in
controlling inflammation.
Diprosone is indicated in the treatment of the following skin diseases (dermatoses):

• Contact eczema, characterized by redness, scaling, small blisters, vesicles, small superficial wounds and caused by contact with certain substances such as detergents, cosmetics or substances used for work;
• Constitutional eczema, characterized by redness and vesicles, often accompanied by severe itching;
• Seborrheic eczema of adults and infants (cradle cap), characterized by yellowish and oily scales, redness, small crusts and sometimes itching that affects the scalp, face, ears and chest;
• Stasis eczema, characterized by darker areas of the skin, with red, thin, sometimes thickened spots, with the presence of itching and pain;
• Dyshidrosis, characterized by small vesicles often itchy, containing a transparent liquid;
• Generalized and anogenital itching;
• Intertrigo, characterized by redness, scaling, irritation and itching due to the rubbing of two close parts of the body;
• Solar erythema, characterized by itching, pain, burning sensation and the presence of blisters;
• Irritative forms caused by plants, chemicals, insect bites;
• Psoriasis, characterized by red patches, thickenings, silvery-white scaling and sometimes itching;
• Other inflammatory skin diseases such as Vidal-Brocq simple lichen characterized by severe itching and thickening of the skin and lichen ruber planus characterized by itchy skin elevations of a dark red, rounded or polygonal shape;
• Dermatoses in which bacteria are also present. In this case, you must associate Diprosone with a specific antibiotic.

2. What you need to know before using Diprosone

Do not use Diprosone

• if you are allergic to betamethasone dipropionate, to other corticosteroids or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from cutaneous tuberculosis, a form of tuberculosis that affects the skin;
• if you have localized viral diseases of the skin (herpes simplex, smallpox, chickenpox). If you have atopic dermatitis, characterized by itching, redness, scaling and skin elevations, do not use an occlusive (non-breathable, e.g. polyethylene) bandage with Diprosone.

Warnings and precautions
Consult your doctor or pharmacist before using Diprosone.
Do not allow Diprosone to come into contact with your eyes.
The doctor will pay particular attention in cases where Diprosone is used for long periods, on
a large area of skin and especially if it is applied under an occlusive bandage (non-
breathable, e.g. polyethylene). This is because the medicine in these cases can pass into the blood and
can affect some hormones, blood sugar and urine values, and the decrease
in the elimination of some hormones with urine (17-KS and 17-OHCS).
If you develop irritation following application of the medicine, discontinue treatment and inform
your doctor immediately, who will prescribe appropriate therapy.
If you develop a skin infection during the use of Diprosone, consult your doctor who will advise you on
suitable treatment. If the treatment is not effective, the doctor will suspend therapy
with Diprosone, until the infection is resolved.
The use, especially if prolonged, of medicines applied to the skin can cause allergic reactions. In
this case, the doctor will suspend the treatment and prescribe suitable therapy.
As with all potent topical corticosteroids, the doctor will interrupt the
treatment with Diprosone as soon as the disease is under control.
Any maintenance therapy will be carried out with Diprosone creamor by alternating Diprosone
ointmentwith Diprosone cream.
Given the characteristics of Diprosone cream, application with an occlusive bandage is not recommended.
All adverse effects that are reported after systemic use of corticosteroids (administered
for example orally) can also occur with corticosteroids applied locally to the skin
(topical use), especially in infants and children.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents
In early infancy, the medicine should be administered only when absolutely necessary.
All adverse effects, including the influence on some hormones, can occur especially
in infants and children, including growth retardation with repercussions on both height and
body weight.
In newborns, the diaper can act as an occlusive bandage.

Other medicines and Diprosone
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
The effectiveness of Diprosone is reduced by:

• barbiturates (medicines used mainly for the treatment of anxiety and to induce sleep);
• antihistamines (medicines used for the treatment of allergies);
• diphenylhydantoin (medicines used for the treatment of epilepsy). The effectiveness of Diprosone is increased by:
• salicylates and phenylbutazone (medicines used for the treatment of inflammation).

Diprosone reduces the effectiveness of:

• oral hypoglycemic agents and insulin (medicines used for the treatment of diabetes).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy:
If you are pregnant, use this medicine only if absolutely necessary and under the direct
supervision of your doctor.

Breastfeeding:
It is not known whether the medicine passes into breast milk. The doctor will decide whether to discontinue Diprosone,
taking into account how important the treatment is for you.

Driving and using machines
This medicine does not affect the ability to drive vehicles and use machines.

Diprosone cream contains:

• cetostearyl alcoholwhich can cause skin reactions (for example, contact dermatitis);
• chlorocresolwhich can cause allergic reactions.

3. How to use Diprosone

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any
doubts, consult your doctor or pharmacist.
Apply Diprosone cream 1–2 times a day.
Spread a sufficient amount to cover the entire affected area and gently massage until
complete absorption.

If you use more Diprosone than you should
In case of ingestion/accidental application of an excessive dose of Diprosone, immediately
inform your doctor or go to the nearest hospital.
Avoid excessive and prolonged use of Diprosone, as it may cause adrenal gland dysfunction, generally reversible. In this case, your doctor will advise you to stop the
treatment, reduce the frequency of applications, or replace Diprosone with another medicine.

If you forget to use Diprosone
Do not use a double dose to make up for a missed dose.

If you stop using Diprosone
If you have any doubts about the use of 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.
During cortisone therapy on the skin, especially for intensive and prolonged treatments, some of the
following side effects may occur:

• burning sensation;
• itching;
• irritation;
• dryness of the skin;
• thinning of the skin (skin atrophy);
• acne;
• alteration of skin color (hypopigmentation);
• inflammation with red skin rashes around the mouth (perioral dermatitis);
• skin reaction due to contact (contact dermatitis);
• maceration of the skin;
• fungal, bacterial and viral infections;
• atrophy, itchy rash with sweat retention (miliaria) and streaks localized to areas rubbed for long
  periods of time with occlusive bandages.

The following effects may occur with unknown frequency (frequency cannot be defined on the basis of
available data):

• blurred vision.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform 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 Diprosone

This medicine does not require any particular storage conditions.
After first opening, Diprosone cream is valid for 3 months.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is reported on the package after “Scad.”
The expiry date refers to the last day of that month.
The indicated expiry date refers to the product in intact packaging, correctly
stored.
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 contains Diprosone

• The active ingredient for 100 g of cream is betamethasone 17,21-dipropionate 0.064 g equivalent to betamethasone alcohol 0.05 g.
• The other components are: chlorocresol, sodium phosphate monobasic dihydrate, phosphoric acid, white petrolatum, liquid paraffin, polyethylene glycol monocetyl ether (Cetomacrogol 1000), cetostearyl alcohol, purified water.

Description of the appearance of Diprosone and contents of the pack
Diprosone cream 0.05% - tube of 30 g.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:
Organon Italia S.r.l.
Piazza Carlo Magno, 21
00162 Roma

Manufacturer:
Schering-Plough Labo N.V. - Industriepark 30, B – 2220 Heist-op-den-Berg – Belgium

Diprosone 0.05% ointment

betamethasone dipropionate

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

1. What Diprosone is and what it is used for

Diprosone contains the active ingredient betamethasone dipropionate, which belongs to a class of
medicines called corticosteroids.
Corticosteroids are hormones that perform numerous activities, with an important function in
controlling inflammation.
Diprosone is indicated in the treatment of the following skin diseases (dermatoses):

• Psoriasis, characterized by red patches, thickening, silvery-white scaling and sometimes itching;
• Lichenified eczema, characterized by patches, sometimes itchy, of thickened skin with well-defined edges and a scaly surface;
• Lichen ruber planus, characterized by itchy skin elevations of a dark red color, rounded or polygonal in shape;
• Contact eczema, characterized by redness, scaling, small blisters, bubbles, superficial small wounds and caused by contact with certain substances such as detergents, cosmetics or substances used at work;
• Constitutional eczema, characterized by redness and blisters often accompanied by severe itching;
• Stasis eczema, characterized by darker areas of skin, with red, thin, sometimes thickened spots, with the presence of itching and pain;
• Dyshidrosis, characterized by small blisters often itchy, containing a clear liquid;
• Anogenital pruritus;
• Solar erythema, characterized by itching, pain, burning sensation and the presence of blisters;
• Irritative forms caused by plants, chemicals, insect bites;
• Dermatoses in which bacteria are also present. In this case, you must associate Diprosone with a specific antibiotic.

2. What you need to know before using Diprosone

Do not use Diprosone

• if you are allergic to betamethasone dipropionate, to other corticosteroids or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from cutaneous tuberculosis, a form of tuberculosis that affects the skin;
• if you have localized viral diseases of the skin (herpes simplex, smallpox, chickenpox). If you have atopic dermatitis, characterized by itching, redness, scaling and skin elevations, do not use an occlusive (non-breathable, e.g. polyethylene) dressing with Diprosone.

Warnings and precautions
Consult your doctor or pharmacist before using Diprosone.
Do not allow Diprosone to come into contact with your eyes.
The doctor will pay particular attention in cases where Diprosone is used for long periods, on
a large area of skin and especially if it is applied under an occlusive dressing (non-
breathable, e.g. polyethylene). This is because the medicine in these cases can pass into the blood and
can affect some hormones, blood sugar and urine values, and the decrease
in the elimination of some hormones with urine (17-KS and 17-OHCS).
If, following application of the medicine, you develop irritation, stop treatment and inform
your doctor immediately, who will prescribe appropriate therapy.
If you develop a skin infection during the use of Diprosone, consult your doctor who will advise you on
suitable treatment. If the treatment is not effective, the doctor will suspend therapy
with Diprosone, until the infection resolves.
The use, especially if prolonged, of medicines applied to the skin can cause allergic reactions. In
this case, the doctor will suspend the treatment and prescribe suitable therapy.
As with all potent topical corticosteroids, the doctor will interrupt the
treatment with Diprosone as soon as the disease is under control.
Any maintenance therapy will be carried out with Diprosone creamor by alternating Diprosone
ointmentwith Diprosone cream.
Given the characteristics of Diprosone ointment, application with an occlusive dressing is not recommended.
All adverse effects that are reported after systemic use of corticosteroids (administered
for example by mouth) can also occur with corticosteroids applied locally to the skin
(topical use), especially in infants and children.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents
In early infancy, the medicine should be administered only when absolutely necessary.
All adverse effects, including the influence on some hormones, can occur especially
in infants and children, including growth retardation with repercussions on both height and
body weight.
In newborns, the diaper can act as an occlusive dressing.

Other medicines and Diprosone
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
The effectiveness of Diprosone is reduced by:

• barbiturates (medicines used mainly for the treatment of anxiety and to induce sleep);
• antihistamines (medicines used for the treatment of allergies);
• diphenylhydantoin (medicines used for the treatment of epilepsy).

The effectiveness of Diprosone is increased by:

• salicylates and phenylbutazone (medicines used for the treatment of inflammation).

Diprosone reduces the effectiveness of:

• oral hypoglycemic agents and insulin (medicines used for the treatment of diabetes).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy:
If you are pregnant, use this medicine only if absolutely necessary and under the direct
supervision of your doctor.

Breastfeeding:
It is not known whether the medicine passes into breast milk. The doctor will decide whether to stop Diprosone,
taking into account how important the treatment is for you.

Driving and using machines
This medicine does not affect the ability to drive vehicles and use machines.

3. How to use Diprosone

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts, consult your doctor or pharmacist.
Apply Diprosone ointment 1–2 times daily.
Spread a sufficient amount to cover the entire affected area and massage gently until
complete absorption.

If you use more Diprosone than you should
In case of ingestion/accidental application of an excessive dose of Diprosone, immediately
inform your doctor or go to the nearest hospital.
Avoid excessive and prolonged use of Diprosone, as it may cause malfunction of the
adrenal glands, generally reversible. In such cases, your doctor will advise you to stop the
treatment, reduce the frequency of applications, or replace Diprosone with another medicine.

If you forget to use Diprosone
Do not use a double dose to make up for a missed dose.

If you stop using Diprosone
If you have any doubts about using 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.
During cortisone therapy on the skin, especially for intensive and prolonged treatments, some of the
following side effects may occur:

• burning sensation;
• itching;
• irritation;
• dryness of the skin;
• thinning of the skin (skin atrophy);
• acne;
• alteration of skin color (hypopigmentation);
• inflammation with red skin rashes around the mouth (perioral dermatitis);
• skin reaction due to contact (contact dermatitis);
• maceration of the skin;
• fungal, bacterial and viral infections;
• atrophy, itchy rash with sweat retention (miliaria) and streaks localized to areas rubbed for long periods of time with an occlusive bandage.

The following effects may occur with unknown frequency (frequency cannot be defined on the
basis of available data):

• blurred vision.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform
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 Diprosone

This medicine does not require any particular storage conditions.
After first opening, Diprosone ointment is valid for 3 months.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the package after “Scad.”
The expiry date refers to the last day of that month.
The expiry date indicated refers to the product in intact packaging, correctly
stored.
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 Diprosone contains

• The active substance for 100 g of ointment is betamethasone 17,21-dipropionate 0.064 g equivalent to betamethasone alcohol 0.05 g.
• The other ingredients are: liquid paraffin, white petrolatum.

Description of the appearance of Diprosone and contents of the pack
Diprosone ointment 0.05% - tube of 30 g.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:
Organon Italia S.r.l.
Piazza Carlo Magno, 21
00162 Roma

Manufacturer:
Schering-Plough Labo N.V. - Industriepark 30, B – 2220 Heist-op-den-Berg - Belgium

Diprosone 0.05% cutaneous solution

betamethasone dipropionate

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

1. What is Diprosone and what is it used for

Diprosone contains the active ingredient betamethasone dipropionate, which belongs to a class of
medicines called corticosteroids.
Corticosteroids are hormones that perform numerous activities, with an important function in
controlling inflammation.
Diprosone is indicated in the treatment of the following skin diseases (dermatoses):

• Scalp dermatoses: or seborrheic eczema, characterized by yellowish and greasy scales, redness, small crusts and sometimes itching affecting the scalp, face, ears and chest; or microbial eczema, characterized by round or oval itchy lesions; or dry or oily pityriasis, characterized by scales and itching; or psoriasis, characterized by red patches, thickening, silvery-white scaling and sometimes itching;
• Intertrigo, characterized by redness, scaling, irritation and itching due to the rubbing of two adjacent parts of the body, including areas covered with hair;
• Other inflammatory skin diseases sensitive to treatment with cortisone-based medicines;
• Dermatoses in which bacteria or fungi are also present. In this case, you must combine Diprosone with a specific antibiotic or antifungal.

2. What you need to know before using Diprosone

Do not use Diprosone

• if you are allergic to betamethasone dipropionate, to other corticosteroids or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from cutaneous tuberculosis, a form of tuberculosis that affects the skin;
• if you have localised viral diseases of the skin (herpes simplex, chickenpox, shingles). If you have atopic dermatitis, characterised by itching, redness, scaling and skin elevations, do not use an occlusive (non-breathable, e.g. polyethylene) dressing with Diprosone.

Warnings and precautions
Consult your doctor or pharmacist before using Diprosone.
Do not allow Diprosone to come into contact with your eyes.
Diprosone cutaneous solution contains flammable substances.
The doctor will pay particular attention in cases where Diprosone is used for long periods, on
a large area of skin and especially if it is applied under an occlusive dressing (non-
breathable, e.g. polyethylene). This is because the medicine in these cases can pass into the blood and
can affect some hormones, blood sugar and urine levels, and the decrease
in the elimination of some hormones with urine (17-KS and 17-OHCS).
If you develop irritation following application of the medicine, stop treatment and inform
your doctor immediately, who will prescribe appropriate therapy.
If you develop a skin infection during use of Diprosone, consult your doctor who will advise you on
suitable treatment. If the treatment is not effective, the doctor will suspend therapy
with Diprosone until the infection resolves.
The use, especially if prolonged, of medicines applied to the skin can cause allergic reactions. In
this case, the doctor will suspend treatment and prescribe suitable therapy.
As with all topical corticosteroids with high activity, the doctor will interrupt the
treatment with Diprosone as soon as the disease is under control.
Any maintenance therapy will be carried out with Diprosone cream, or by alternating Diprosone
ointmentwith Diprosone cream.
Given the characteristics of Diprosone cutaneous solution, application with an occlusive
dressing is not recommended.
All adverse effects that are reported after systemic use of corticosteroids (administered
for example by mouth) can also occur with corticosteroids applied locally to the skin
(topical use), especially in infants and children.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents
In early infancy, the medicine should be administered only when absolutely necessary.
All adverse effects, including the influence on some hormones, can occur especially
in infants and children, including delayed growth with repercussions on both height and
body weight.
In newborns, the diaper can act as an occlusive dressing.

Other medicines and Diprosone
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
The effectiveness of Diprosone is reduced by:

• barbiturates (medicines used mainly for the treatment of anxiety and to induce sleep);
• antihistamines (medicines used for the treatment of allergies);
• diphenylhydantoin (medicines used for the treatment of epilepsy).

The effectiveness of Diprosone is increased by:

• salicylates and phenylbutazone (medicines used for the treatment of inflammation). Diprosone reduces the effectiveness of:
• oral hypoglycemic agents and insulin (medicines used for the treatment of diabetes).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy:
If you are pregnant, use this medicine only if absolutely necessary and under the direct
supervision of your doctor.

Breastfeeding:
It is not known whether the medicine passes into breast milk. The doctor will decide whether to stop Diprosone,
taking into account how important the treatment is for you.

Driving and using machines
This medicine does not affect the ability to drive vehicles and operate machinery.

3. How to use Diprosone

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any
doubts, consult your doctor or pharmacist.
Apply Diprosone cutaneous solution 1–2 times daily.
Apply a few drops of cutaneous solution, in a quantity sufficient to cover the entire affected area and
gently massage until completely absorbed.

If you use more Diprosone than you should
In case of ingestion/accidental application of an excessive dose of Diprosone, immediately notify
your doctor or go to the nearest hospital.
Avoid excessive and prolonged use of Diprosone, as it may cause malfunction of the
adrenal glands, generally reversible. In this case, your doctor will advise you to stop the
treatment, reduce the frequency of applications, or replace Diprosone with another medicine.

If you forget to use Diprosone
Do not use a double dose to make up for a missed dose.

If you stop using Diprosone
If you have any doubts about the use of 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.
During cortisone therapy on the skin, especially for intensive and prolonged treatments, some of the
following side effects may occur:

• burning sensation;
• itching;
• irritation;
• dryness of the skin;
• thinning of the skin (skin atrophy);
• acne;
• alteration of skin color (hypopigmentation);
• inflammation with red skin rashes around the mouth (perioral dermatitis);
• skin reaction due to contact (contact dermatitis);
• maceration of the skin;
• fungal, bacterial and viral infections;
• atrophy, itchy rash with sweat retention (miliaria) and streaks localized to areas rubbed for long
  periods of time with an occlusive bandage.

The following effects may occur with unknown frequency (frequency cannot be defined on the basis of
available data):

• blurred vision.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform 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 Diprosone

Keep the bottle in the outer packaging to protect the medicine from light.
After first opening, Diprosone cutaneous solution is valid for 3 months.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “Exp.”
The expiry date refers to the last day of that month.
The expiry date indicated refers to the product in intact packaging, correctly
stored.
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 Diprosone contains

• The active ingredient per 100 g of cutaneous solution is betamethasone 17,21-dipropionate 0.064 g equivalent to betamethasone alcohol 0.05 g.
• The other ingredients are: carbopolimetilene, isopropyl alcohol, purified water.

Description of the appearance of Diprosone and contents of the pack
Diprosone cutaneous solution 0.05% - bottle of 30 g.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:
Organon Italia S.r.l.
Piazza Carlo Magno, 21
00162 Roma

Manufacturer:
Cenexi HSC - 2, rue Louis Pasteur - 14200 Hérouville Saint-Clair, France