Diprosalic

Package leaflet: Information for the patient

Diprosalic 0,05%+3% ointment

betamethasone dipropionate and salicylic acid
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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Diprosalic is and what it is used for

Diprosalic contains betamethasone dipropionate and salicylic acid.
Betamethasone belongs to a class of medicines called corticosteroids.
Corticosteroids are hormones that perform numerous functions, playing an important role in controlling inflammation.
Salicylic acid softens the outermost layer of the skin (keratolytic effect), limits bacterial growth (bacteriostatic effect), and kills fungi (fungicidal effect) at the skin level.
Diprosalic ointment is indicated for the treatment of the following skin conditions:

• chronic eczema, characterized by scaling, thickened skin and deep fissures that are slow to heal;
• neurodermatitis, characterized by itching and desquamation;
• verrucous and pruritic psoriasis, characterized by white, thickened scales, red patches and itching.

2. What you should know before using Diprosalic

Do not use Diprosalic

• if you are allergic to betamethasone, to other corticosteroids, to salicylic acid, to other salicylates, or to any of the other ingredients of this medicine (listed in section 6);
• if you have vaccinal pustules, characterized by raised skin lesions of various sizes containing pus;
• if you have infectious diseases such as chickenpox, Herpes simplex, or cutaneous tuberculosis.

Warnings and precautions
Talk to your doctor or pharmacist before using Diprosalic.
Do not let Diprosalic come into contact with your eyes or mucous membranes (mouth or genitals). If you use Diprosalic in the presence of skin infections, your doctor will prescribe an appropriate antibacterial or antifungal therapy. Your doctor will discontinue treatment with Diprosalic if it proves ineffective.
All adverse effects reported after systemic use of corticosteroids (for example, taken orally) may also occur with corticosteroids applied locally to the skin (topical use), especially in infants and children.
Do not use under occlusive dressings (non-breathable, e.g., polyethylene).
The use, especially if prolonged, of products applied to the skin may cause allergic reactions. In such cases, your doctor will discontinue treatment and prescribe appropriate therapy.
Your doctor will exercise particular caution if you use Diprosalic over extensive skin areas, under occlusive dressings (non-breathable, e.g., polyethylene), or for long-term treatment, especially in infants and children.
If during treatment you notice that your skin becomes excessively dry or further irritated, discontinue therapy with Diprosalic.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children
When Diprosalic is used in children, harmful effects may be greater than those observed in adults.
Locally applied corticosteroids in children may affect certain hormones (suppression of the hypothalamic-pituitary-adrenal axis and Cushing's syndrome), cause growth retardation, weight gain, and increased intracranial pressure (intracranial hypertension), characterized by bulging fontanelles and severe headache. Manifestations of adrenal suppression in children include low plasma cortisol levels and lack of response to ACTH stimulation.

Other medicines and Diprosalic
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
Betamethasone dipropionate and salicylic acid, when applied to the skin at recommended doses, do not interact significantly with other medicines.
However, if you need to apply Diprosalic over large skin areas or for prolonged periods, interactions with other medicines may occur.

The effectiveness of betamethasone is reduced by:

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

The effectiveness of betamethasone is increased by:

• salicylates and phenylbutazone (medicines used to treat inflammation).

Betamethasone reduces the effect of:

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

Salicylic acid increases the effect of:

• oral antidiabetics;
• sulfonamides (medicines used to treat bacterial infections);
• methotrexate (a medicine used to treat certain types of cancer and autoimmune diseases);
• probenecid (a medicine used to treat gout).

Additionally, an interaction between salicylic acid and heparin (a medicine used to thin the blood) and naproxen (a medicine used to treat inflammation and fever) has been reported. In the first case, bleeding tendency was induced; in the second, increased elimination of the medicine through the kidneys.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy
Use Diprosalic during pregnancy only if your doctor considers that the potential benefit to you justifies the possible risk to the fetus.
Do not use Diprosalic over extensive areas of the body, in large quantities, or for prolonged periods.

Breastfeeding
It is not known whether the medicine passes into breast milk. Your doctor will decide whether to discontinue breastfeeding or to discontinue treatment with Diprosalic, taking into account how important therapy with this medicine is for you.
As with any similar medicine, if you are pregnant or breastfeeding, your doctor will prescribe Diprosalic only when strictly necessary and will monitor you closely.

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

3. How to use Diprosalic

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Apply Diprosalic ointment twice daily.
Apply a sufficient amount to cover the entire affected area and gently massage until
completely absorbed.
If you use more Diprosalic than you should
Avoid excessive and prolonged use over large areas of skin, as this may cause
impaired adrenal gland function (symptoms due to overactivity of the adrenal glands, including Cushing's syndrome) and may cause symptoms due to excess salicylic acid (increased breathing, liver damage, nausea, vomiting, stomach burning, ringing in the ears, excessive drowsiness, and confusion). In such cases, your doctor will advise you to stop treatment, reduce the frequency of application, or replace Diprosalic with another medicine.
If you forget to use Diprosalic
Do not use a double dose to make up for the missed dose.
If you stop using Diprosalic
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 everyone experiences them.
Systemic side effects (affecting the whole body) are very rare; however, their occurrence may be favored when the medicine is applied to large areas of skin, using high doses and for prolonged periods of time, especially when used in infants and children.
At the application site, the following may occur:

• burning sensation;
• irritation;
• dry skin;
• infection affecting the upper part of the hair follicle (folliculitis);
• acne-like lesions;
• increased hair growth (hypertrichosis);
• changes in skin color (hypopigmentation);
• thinning of the skin (cutaneous atrophy);
• inflammation with red skin eruptions around the mouth (perioral dermatitis);
• skin allergy due to contact (allergic contact dermatitis);
• skin inflammation (dermatitis).

The following side effects may be more frequent when using occlusive dressings:

• skin maceration;
• infection;
• thinning of the skin (cutaneous atrophy);
• skin streaks (striae);
• itchy rash with sweat retention (miliaria).

The following side effects may occur with unknown frequency:

• blurred vision.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You may 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 Diprosalic

This medicinal product does not require any special storage conditions.
After first opening, Diprosalic ointment is valid for three months.
Keep this medicine out of the sight and reach of children.
Do not use this medicinal product after the expiry date which is stated on the carton after "Exp.".
The expiry date refers to the last day of that month.
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 Diprosalic contains

• The active substances are betametasone dipropionate and salicylic acid. 100 g of ointment contain betametasone dipropionate 0.064 g and salicylic acid 3 g;
• The other components are: liquid paraffin and white soft paraffin.

Description of the appearance of Diprosalic and contents of the pack
Diprosalic ointment, tube of 30 g.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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

Diprosalic 0.05%+2% topical solution

betamethasone dipropionate and salicylic acid
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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Diprosalic is and what it is used for

Diprosalic contains betametasone dipropionate and salicylic acid.
Betamethasone belongs to a class of medicines called corticosteroids.
Corticosteroids are hormones that perform numerous functions, including an important role in controlling inflammation.
Salicylic acid softens the outermost layer of the skin (keratolytic action), limits bacterial growth (bacteriostatic action), and kills fungi (fungicidal action) at the skin level.
Diprosalic topical solution is indicated for the treatment of the following scalp and hairy area conditions:

• psoriasis, characterized by red patches, thickening, silvery-white scaling, and sometimes itching;
• seborrhoeic dermatitis, characterized by a skin rash affecting areas rich in sebaceous glands such as the scalp and hairy regions.

2. What you should know before using Diprosalic

Do not use Diprosalic

• if you are allergic to betamethasone, to other corticosteroids, to salicylic acid, to other salicylates, or to any of the other ingredients of this medicine (listed in section 6);
• if you have vaccinal pustules, characterized by raised skin lesions of various sizes containing pus;
• if you have infectious diseases such as chickenpox, Herpes simplex, or cutaneous tuberculosis.

Warnings and precautions
Talk to your doctor or pharmacist before using Diprosalic.
Do not allow Diprosalic to come into contact with the eyes or mucous membranes (mouth or genitals). If you use Diprosalic in the presence of skin infections, your doctor will prescribe an appropriate antibacterial or antifungal therapy. Your doctor will discontinue treatment with Diprosalic if it proves ineffective.
All adverse effects reported after systemic use of corticosteroids (for example, administered orally) may also occur with corticosteroids applied locally to the skin (topical use), especially in infants and children.
Do not use under occlusive dressing (non-breathable, e.g., polyethylene).
The use, especially prolonged, of topical skin products may cause allergic reactions. In such cases, your doctor will discontinue treatment and prescribe appropriate therapy.
Your doctor will pay particular attention if you use Diprosalic over large areas of skin, under occlusive dressings (non-breathable, e.g., polyethylene), or for long-term treatment, especially in infants and children.
If during treatment you notice that your skin becomes excessively dry or further irritated, stop therapy with Diprosalic.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children
When Diprosalic is used in children, harmful effects may be greater than those observed in adults.
Locally applied corticosteroids in children may affect certain hormones (suppression of the hypothalamic-pituitary-adrenal axis and Cushing's syndrome), cause growth retardation, weight gain, and increased intracranial pressure (intracranial hypertension), characterized by bulging of the fontanelles and severe headache. Signs of adrenal suppression in children include low plasma cortisol levels and lack of response to ACTH stimulation.

Other medicines and Diprosalic
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicine.
Betamethasone dipropionate and salicylic acid, when applied to the skin at recommended doses, do not interact significantly with other medicines.
However, if you need to apply Diprosalic over large areas of skin or for prolonged periods, interactions with other medicines may occur.

The effectiveness of betamethasone is reduced by:

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

The effectiveness of betamethasone is increased by:

• salicylates and phenylbutazone (medicines used to treat inflammation).

Betamethasone reduces the effect of:

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

Salicylic acid increases the effect of:

• oral antidiabetics;
• sulfonamides (medicines used to treat bacterial infections);
• methotrexate (a medicine used to treat certain types of cancer and autoimmune diseases);
• probenecid (a medicine used to treat gout).

Additionally, an interaction between salicylic acid and heparin (a medicine used to thin the blood) and naproxen (a medicine used to treat inflammation and fever) has been reported. In the first case, bleeding tendency was induced; in the second, increased renal elimination of the medicine occurred.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy
If you are pregnant, use Diprosalic only if your doctor considers that the potential benefit to you justifies the possible risk to the fetus.
Do not use Diprosalic over large areas of the body, in large quantities, or for prolonged periods.

Breastfeeding
It is not known whether this medicine passes into breast milk. Your doctor will decide whether to discontinue breastfeeding or to stop treatment with Diprosalic, taking into account how important therapy with this medicine is for you.
As with any other similar medicine, if you are pregnant or breastfeeding, your doctor will prescribe Diprosalic only when strictly necessary and will monitor you closely.

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

3. How to use Diprosalic

Use this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Apply Diprosalic topical solution twice daily.
Apply a few drops of the solution, using enough quantity to cover the entire affected area, and gently
massage until completely absorbed.
In some cases, adequate maintenance therapy may be achieved with once-daily application.
If you use more Diprosalic than you should
Avoid excessive and prolonged use of Diprosalic over large areas of skin, as this may cause improper
functioning of the adrenal glands (symptoms due to overactivity of the adrenal glands, including Cushing's syndrome) and symptoms due to excess salicylic acid (increased breathing, liver damage, nausea, vomiting, stomach burning, ringing in the ears, excessive sleepiness, and confusion). 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 Diprosalic
Do not apply a double dose to make up for the missed dose.
If you stop using Diprosalic
If you have any questions 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.
Systemic side effects (affecting the whole body) are very rare; however, their occurrence may be more likely when the medicine is applied over large areas of skin, at high doses, and for prolonged periods, especially when used in infants and children.

The following may occur at the application site:

• burning sensation;
• irritation;
• dryness of the skin;
• infection involving the upper part of the hair follicle (folliculitis);
• acne-like eruptions;
• increased hair growth (hypertrichosis);
• changes in skin color (hypopigmentation);
• thinning of the skin (cutaneous atrophy);
• inflammation with red skin rashes around the mouth (perioral dermatitis);
• allergic skin reaction due to contact (allergic contact dermatitis);
• skin inflammation (dermatitis).

The following side effects may be more frequent when using occlusive dressings:

• skin maceration;
• infection;
• thinning of the skin (cutaneous atrophy);
• skin streaks;
• itchy rash due to sweat retention (miliaria).

The following side effects may occur with unknown frequency:

• 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 help provide more information on the safety of this medicine.

5. How to store Diprosalic

Do not store above 25°C.
Keep the bottle in the outer packaging to protect the medicine from light.
After first opening, Diprosalic topical solution remains stable for 6 weeks.
As this is a hydroalcoholic solution, the preparation is flammable.
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.
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 Diprosalic contains

• The active substances are betamethasone dipropionate and salicylic acid. 100 g of cutaneous solution contain 0.064 g of betamethasone dipropionate and 2 g of salicylic acid;
• The other components are: edetate disodium, hypromellose, sodium hydroxide, isopropyl alcohol, purified water.

Description of the appearance of Diprosalic and contents of the pack
Diprosalic cutaneous solution, 32.25 ml HDPE bottle with LDPE dropper and PP screw cap
Diprosalic cutaneous solution, 30 ml bottle with LDPE dropper and PP screw cap

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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