Diprostone: detailed information

Patient Information Leaflet

Diprosone 0.05% cream

betamethasone dipropionate
Please read all of this leaflet carefully before you use 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 they have the same symptoms as yours, because 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 Diprosone is and what it is used for
What you need to know before using Diprosone
How to use Diprosone
Possible side effects
How to store Diprosone
Contents of the pack and other information

1. What Diprosone is and what it is used for

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

Contact eczema, characterized by redness, scaling, small blisters, vesicles, and superficial sores 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 intense itching;
Seborrheic eczema in adults and infants (cradle cap), characterized by yellowish, greasy scales, redness, small crusts, and sometimes itching affecting the scalp, face, ears, and chest;
Stasis eczema, characterized by darker areas of skin, red spots, thin or sometimes thickened skin, accompanied by itching and pain;
Dyshidrotic eczema (dyshidrosis), characterized by small, often itchy blisters containing a clear fluid;
Generalized and anogenital pruritus;
Intertrigo, characterized by redness, scaling, irritation, and itching due to friction between adjacent body parts;
Sunburn (solar erythema), characterized by itching, pain, burning sensation, and blistering;
Irritative conditions caused by plants, chemicals, or insect stings;
Psoriasis, characterized by red patches, thickening of the skin, silvery-white scaling, and sometimes itching;
Other inflammatory skin diseases such as Vidal-Brocq lichen simplex, characterized by intense itching and skin thickening, and lichen ruber planus, characterized by itchy, dark red, round or polygonal skin papules;
Dermatoses associated with bacterial infection. In such cases, Diprosone should be used in combination 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 have cutaneous tuberculosis, a form of tuberculosis affecting the skin;
if you have viral skin infections (herpes simplex, smallpox, varicella). If you have atopic dermatitis, characterized by itching, redness, scaling, and skin elevations, do not use an occlusive dressing (non-breathable, e.g. polyethylene) with Diprosone.

Warnings and precautions
Talk to your doctor or pharmacist before using Diprosone.
Do not let Diprosone come into contact with your eyes.
Your doctor will pay particular attention if Diprosone is used for long periods, over a large skin surface, and especially if it is applied under an occlusive dressing (non-breathable, e.g. polyethylene). This is because the medicine may then pass into the bloodstream and may affect certain hormones, blood and urine sugar levels, and reduce the urinary excretion of certain hormones (17-KS and 17-OHCS).
If you develop irritation after applying the medicine, stop treatment immediately and inform your doctor, who will prescribe appropriate therapy.
If you develop a skin infection while using Diprosone, consult your doctor, who will recommend suitable treatment. If the treatment is not effective, your doctor will discontinue Diprosone therapy until the infection resolves.
The use, especially if prolonged, of topical medicines applied to the skin may cause allergic reactions. In such cases, your doctor will discontinue treatment and prescribe appropriate therapy.
As with all potent topical corticosteroid preparations, your doctor will discontinue Diprosone treatment as soon as the condition is under control.
Any maintenance therapy will be carried out using Diprosone cream or by alternating Diprosone ointment with Diprosone cream.
Due to the characteristics of Diprosone cream, application under an occlusive dressing is not recommended.
All adverse effects reported after systemic use of corticosteroids (e.g. administered orally) may 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 very young infants, this medicine should only be administered when strictly necessary.
All adverse effects, including effects on certain hormones, may occur especially in infants and children, including growth retardation affecting both height and body weight.
In newborns, diapers may act as an occlusive dressing.

Other medicines and Diprosone
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
The effectiveness of Diprosone is reduced by:

barbiturates (medicines used mainly to treat anxiety and to induce sleep);
antihistamines (medicines used to treat allergies);
phenytoin (medicines used to treat epilepsy).

The effectiveness of Diprosone is increased by:

salicylates and phenylbutazone (medicines used to treat inflammation).

Diprosone reduces the effectiveness of:

oral hypoglycemics and insulin (medicines used to treat diabetes).

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy:
Use this medicine during pregnancy only if clearly needed and under the direct supervision of your doctor.
Breastfeeding:
It is not known whether the medicine passes into breast milk. Your 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 your ability to drive or operate machinery.

Diprosone cream contains:

cetostearyl alcohol, which may cause skin reactions (e.g. contact dermatitis);
chlorocresol, which may cause allergic reactions.

3. How to use Diprosone

Use this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Apply Diprosone cream 1–2 times a day.
Apply a sufficient amount to cover the entire affected area and gently massage until
completely absorbed.
If you use more Diprosone than you should
In case of accidental ingestion or excessive application, contact your doctor immediately or go to the nearest hospital.
Avoid excessive and prolonged use of Diprosone, as it may cause adrenal gland dysfunction, which is usually reversible. In such cases, your doctor will advise you to stop treatment, reduce the frequency of applications, or switch to another medicine.
If you forget to use Diprosone
Do not apply a double dose to make up for a missed dose.
If you stop treatment with 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 will experience them.
During corticosteroid treatment on the skin, especially with intensive and prolonged therapy, some of the following side effects may occur:

burning sensation;
itching;
irritation;
dry skin;
thinning of the skin (cutaneous atrophy);
acne;
changes in skin color (hypopigmentation);
inflammation with red skin rashes around the mouth (perioral dermatitis);
skin reaction due to contact (contact dermatitis);
skin maceration;
fungal, bacterial, and viral infections;
atrophy, itchy rash with sweat retention (miliaria), and localized streaking in areas repeatedly rubbed and treated over long periods with occlusive bandaging.

The following side effects may occur with unknown frequency (frequency cannot be estimated from the available data):

blurred vision.

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 Diprosone

This medicine does not require any special storage conditions.
After first opening, Diprosone cream remains valid for 3 months.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp.".
The expiry date refers to the last day of that month.
The stated expiry date refers to the product in its original, unopened packaging, correctly stored.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Diprosone contains

The active substance is betamethasone 17,21-dipropionate 0.064 g per 100 g of cream, equivalent to 0.05 g of betamethasone alcohol.
The other components are: chlorocresol, sodium dihydrogen phosphate dihydrate, phosphoric acid, white soft paraffin, liquid paraffin, polyethylene glycol monostearate (Cetomacrogol 1000), cetostearyl alcohol, purified water.

Description of the appearance of Diprosone and contents of the pack
Diprosone cream 0.05% - 30 g tube.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Organon Italia S.r.l.
Piazza Carlo Magno, 21
00162 Rome
Manufacturer:
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium

Patient information leaflet

Diprosone 0.05% ointment

betamethasone dipropionate
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 they have the same symptoms as you, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Diprosone is and what it is used for
What you need to know before using Diprosone
How to use Diprosone
Possible side effects
How to store Diprosone
Contents of the pack and other information

1. What Diprosone is and what it is used for

Diprosone contains the active substance betametasone dipropionate, which belongs to a class of medicines called corticosteroids.
Corticosteroids are hormones that perform numerous functions, playing an important role in controlling inflammation.
Diprosone is indicated for 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 borders and scaly surface;
Lichen planus, characterized by itchy, raised lesions of dark red color, round or polygonal in shape;
Contact eczema, characterized by redness, scaling, small blisters, vesicles, and small superficial wounds 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 intense itching;
Stasis eczema, characterized by darker areas of skin, red spots, thin or sometimes thickened skin, with presence of itching and pain;
Dyshidrosis, characterized by small, often itchy blisters containing clear fluid;
Anogenital pruritus;
Sunburn, characterized by itching, pain, burning sensation, and presence of blisters;
Irritative conditions caused by plants, chemical substances, or insect bites;
Dermatoses in which bacteria are also present. In this case, Diprosone must be used in combination 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 have cutaneous tuberculosis, a form of tuberculosis affecting the skin;
if you have viral skin infections (herpes simplex, smallpox, varicella). If you have atopic dermatitis, characterized by itching, redness, scaling, and skin elevations, do not use an occlusive dressing (non-breathable, e.g. polyethylene) with Diprosone.

Warnings and precautions
Talk to your doctor or pharmacist before using Diprosone.
Do not let Diprosone come into contact with your eyes.
Your doctor will pay particular attention when Diprosone is used for long periods, over 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 may pass into the bloodstream and may affect certain hormones, blood and urine sugar levels, and reduce the urinary excretion of certain hormones (17-KS and 17-OHCS).
If you develop irritation after applying the medicine, stop treatment immediately and inform your doctor, who will prescribe appropriate therapy.
If you develop a skin infection while using Diprosone, consult your doctor, who will recommend suitable treatment. If the treatment is not effective, your doctor will discontinue therapy with Diprosone until the infection resolves.
The use, especially prolonged, of topical skin medications may cause allergic reactions. In such cases, your doctor will discontinue treatment and prescribe appropriate therapy.
As with all potent topical corticosteroid preparations, your doctor will discontinue treatment with Diprosone as soon as the condition is under control.
Any maintenance therapy will be carried out with Diprosone cream or by alternating Diprosone ointment with Diprosone cream.
Due to the characteristics of Diprosone ointment, application under an occlusive dressing is not recommended.
All adverse effects reported after systemic use of corticosteroids (e.g. administered orally) may 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 very early infancy, this medicine should be administered only when strictly necessary.
All adverse effects, including effects on certain hormones, may occur especially in infants and children, including growth retardation affecting both height and body weight.
In newborns, diapers may act as occlusive dressings.

Other medicines and Diprosone
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
The effectiveness of Diprosone is reduced by:

barbiturates (medicines used mainly to treat anxiety and to induce sleep);
antihistamines (medicines used to treat allergies);
phenytoin (medicines used to treat epilepsy).

The effectiveness of Diprosone is increased by:

salicylates and phenylbutazone (medicines used to treat inflammation).

Diprosone reduces the effectiveness of:

oral hypoglycemics and insulin (medicines used to treat diabetes).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy:
Use this medicine during pregnancy only if strictly necessary and under direct medical supervision.
Breastfeeding:
It is not known whether the medicine passes into breast milk. Your doctor will decide whether to discontinue Diprosone, taking into account how important treatment with this medicine is for you.

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

3. How to use Diprosone

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Apply Diprosone ointment 1–2 times a day.
Apply a sufficient amount to cover the entire affected area and gently massage until
completely absorbed.
If you use more Diprosone than you should
In case of accidental ingestion/over-application of an excessive dose of Diprosone, inform your
doctor immediately or go to the nearest hospital.
Avoid excessive and prolonged use of Diprosone, as it may cause adrenal gland dysfunction,
which is usually reversible. In such a case, your doctor will advise you to stop 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 forgotten dose.
If you stop using Diprosone
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

burning sensation;
itching;
irritation;
dryness of the skin;
thinning of the skin (cutaneous atrophy);
acne;
changes in 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 localized striae in areas rubbed repeatedly over long periods of time under occlusive bandaging.

The following side effects may occur with unknown frequency (frequency cannot be estimated from the available data):

blurred vision.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult 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 special storage conditions.
After first opening, Diprosone ointment remains valid for 3 months.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
The stated expiry date refers to the product in its original, unopened packaging, stored correctly.
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 Diprosone contains

The active substance: per 100 g of ointment, betamethasone 17,21-dipropionate 0,064 g equivalent to betamethasone alcohol 0,05 g.
The other components are: liquid paraffin, white soft paraffin.

Description of the appearance of Diprosone and contents of the pack
Diprosone ointment 0.05% - tube of 30 g.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Organon Italia S.r.l.
Piazza Carlo Magno, 21
00162 Rome
Manufacturer:
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium

Patient information leaflet: information for the patient

Diprosone 0.05% cutaneous solution

betamethasone dipropionate
Please 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, consult 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 adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Diprosone is and what it is used for
What you need to know before using Diprosone
How to use Diprosone
Possible side effects
How to store Diprosone
Contents of the pack and other information

1. What Diprosone is and what it is used for

Scalp dermatoses: such as seborrhoeic eczema, characterized by yellowish, greasy scales, redness, small crusts, and sometimes itching affecting the scalp, face, ears, and chest; or microbial eczema, characterized by itchy, round or oval lesions; or dry or oily pityriasis, characterized by scaling 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 friction between two adjacent body areas, including hairy areas;
Other inflammatory skin diseases responsive to corticosteroid treatment;
Dermatoses associated with bacterial or fungal infection. In such cases, Diprosone should be used in combination with a specific antibiotic or antifungal agent.

2. What you should 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 have cutaneous tuberculosis, a form of tuberculosis affecting the skin;
if you have viral skin infections (herpes simplex, smallpox, chickenpox). If you have atopic dermatitis, characterized by itching, redness, scaling, and skin elevations, do not use an occlusive dressing (non-breathable, e.g. polyethylene) with Diprosone.

Warnings and precautions
Talk to your doctor or pharmacist before using Diprosone.
Do not let Diprosone come into contact with your eyes.
Diprosone cutaneous solution contains flammable ingredients.
Your doctor will pay particular attention when Diprosone is used for prolonged periods, over 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 may be absorbed into the bloodstream and may affect certain hormones, blood and urine sugar levels, and reduce the urinary excretion of certain hormones (17-KS and 17-OHCS).
If you develop irritation after applying the medicine, stop treatment and contact your doctor immediately, who will prescribe appropriate therapy.
If you develop a skin infection while using Diprosone, consult your doctor, who will recommend suitable treatment. If the treatment is not effective, your doctor will discontinue therapy with Diprosone until the infection resolves.
The use, especially if prolonged, of topical skin medications may cause allergic reactions. In such cases, your doctor will discontinue treatment and prescribe appropriate therapy.
As with all potent topical corticosteroid preparations, your doctor will discontinue Diprosone treatment as soon as the condition is under control.
Any maintenance therapy will be carried out using Diprosone cream, or by alternating Diprosone ointment with Diprosone cream.
Due to the characteristics of Diprosone cutaneous solution, application under occlusive dressing is not recommended.
All adverse effects reported after systemic use of corticosteroids (e.g. administered orally) may also occur with locally applied corticosteroids (topical use), especially in infants and children.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents
In very early infancy, this medicine should be administered only when strictly necessary.
All adverse effects, including effects on certain hormones, may occur especially in infants and children, including growth delay with consequences on both height and body weight.
In infants, diapers may 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 to treat anxiety and to induce sleep);
antihistamines (medicines used to treat allergies);
phenytoin (medicines used to treat epilepsy).

The effectiveness of Diprosone is increased by:

salicylates and phenylbutazone (medicines used to treat inflammation).

Diprosone reduces the effectiveness of:

oral hypoglycemics and insulin (medicines used to treat diabetes).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy:
Use this medicine during pregnancy only if clearly needed and under direct medical supervision.
Breastfeeding:
It is not known whether the medicine passes into breast milk. Your doctor will decide whether to discontinue Diprosone, taking into account how important treatment with this medicine is for you.

Driving and using machines
This medicine has no effect on the ability to drive vehicles or operate machinery.

3. How to use Diprosone

Use this medicine exactly as prescribed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Apply Diprosone cutaneous solution 1–2 times a day.
Apply a few drops of the cutaneous solution, in sufficient quantity to cover the entire affected area,
and gently massage until completely absorbed.
If you use more Diprosone than you should
In case of accidental ingestion/over-application of an excessive dose of Diprosone, contact
your doctor immediately or go to the nearest hospital.
Avoid excessive and prolonged use of Diprosone, as it may cause adrenal gland dysfunction,
which is usually reversible. In such a case, your doctor will advise you to stop treatment,
reduce the frequency of applications, or replace Diprosone with another medicine.
If you forget to use Diprosone
Do not apply 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 experiences them.
During corticosteroid treatment on the skin, especially with intensive and prolonged use, some of the following side effects may occur:

burning sensation;
itching;
irritation;
dryness of the skin;
thinning of the skin (cutaneous atrophy);
acne;
changes in skin color (hypopigmentation);
inflammation with red skin rash 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 localized striae in areas repeatedly rubbed and treated over long periods with occlusive bandaging.

The following side effects may occur with unknown frequency (frequency cannot be estimated from the available data):

blurred vision.

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 the website 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 remains valid for 3 months.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp.".
The expiry date refers to the last day of that month.
The stated expiry date applies to the product stored in its original, undamaged packaging and
correctly stored.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Diprosone contains

The active substance in 100 g of cutaneous solution is betamethasone 17,21-dipropionate 0.064 g, equivalent to 0.05 g of betamethasone alcohol.
The other components are: carbopol, isopropyl alcohol, purified water.

Description of the appearance of Diprosone and contents of the package
Diprosone cutaneous solution 0.05% - 1 bottle of 32.25 mL in HDPE.
Diprosone cutaneous solution 0.05% - 1 bottle of 30 mL in LDPE.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Organon Italia S.r.l.
Piazza Carlo Magno, 21
00162 Rome, Italy

Manufacturer:
Cenexi HSC - 2, rue Louis Pasteur - 14200 Hérouville Saint-Clair, France
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium