Advantan

Package leaflet: Information for the patient

ADVANTAN 0.1% cutaneous solution

methylprednisolone aceponate
Please read all of this leaflet carefully before you start 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 their symptoms are the same as yours, as it may be dangerous.
• 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:

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

1. What Advantan is and what it is used for

Advantan contains methylprednisolone aceponate, a potent corticosteroid.
Advantan is used for the treatment of inflammatory dermatoses of the scalp associated with itching, such as:

• constitutional eczema (atopic dermatitis, neurodermatitis),
• seborrheic eczema,
• contact eczema,
• nummular eczema,
• common eczema.

The Advantan cutaneous solution formulation is particularly suitable for dermatoses of the scalp and hairy areas, as it allows uniform distribution and, consequently, penetration of the active substance.

2. What you need to know before using Advantan

Do not use Advantan

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if the area to be treated is affected by tuberculosis or syphilis;
• if you have viral infections (e.g. chickenpox or herpes zoster);
• if you have skin diseases associated with bacterial or fungal infections;
• if you have rosacea (redness and scaling affecting certain areas of the face);
• if you have skin inflammation around the mouth (perioral dermatitis);
• if you have ulcers, acne vulgaris, or atrophic dermatitis;
• if there are skin reactions to vaccinations (redness) in the area to be treated.

Warnings and precautions
Corticosteroids should be administered only at the lowest possible dose, especially in children, and only for the shortest duration necessary to achieve and maintain the desired therapeutic effect.
The use, particularly if prolonged, of topical products may lead to sensitization phenomena and cause adverse effects. In such cases, treatment must be discontinued and a doctor should be consulted.
As with all corticosteroids, inappropriate use may mask clinical symptoms.
Consult your doctor or pharmacist before using Advantan

• if you have skin diseases associated with bacterial or fungal infections requiring specific therapy;
• if you have local skin infections, as they may worsen with the use of corticosteroids applied to the skin;
• if you have glaucoma, inform your doctor. As known for corticosteroids that affect the entire organism (systemic corticosteroids), the use of corticosteroids applied locally to the affected area (topical corticosteroids) may also lead to glaucoma (e.g. after excessive dosing or application over large areas for prolonged periods, with occlusive bandaging techniques, or after application around the eyes);
• if you use Advantan to treat large body surface areas or for prolonged periods, especially under occlusive bandaging, the treatment duration should be as short as possible, since the risk of systemic absorption and the occurrence of systemic adverse effects cannot be completely ruled out.

Advantan must not come into contact with eyes, open wounds, or mucous membranes.
Occlusive bandaging should be avoided unless specifically indicated. Note that diapers as well as intertriginous areas may act as occlusive dressings.
Advantan cutaneous solution is flammable: do not apply near open flames.
Contact your doctor if you experience blurred vision or other visual disturbances.
Children
Do not use Advantan with diapers, as diapers may act as occlusive dressings.
Advantan should not be used under occlusive bandaging.
In children aged between 4 months and 3 years, careful medical assessment of the risk/benefit ratio is required.
Other medicines and Advantan
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
No interactions with other medicines are currently known.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
As a general rule, corticosteroids should be avoided during the first trimester of pregnancy. In particular, treatment over large skin areas, prolonged use, and occlusive bandaging should be avoided during pregnancy (see "Warnings and precautions").
Some epidemiological studies suggest a possible, although limited, increased risk of cleft palate (palate malformation) in newborns whose mothers were treated with systemic corticosteroids during the first trimester of pregnancy.
Therefore, during pregnancy, Advantan should only be used if, according to the doctor, the benefits outweigh the risks.
Breastfeeding
It is not known whether topical administration of Advantan may lead to sufficient systemic absorption of methylprednisolone aceponate to result in detectable levels in breast milk.
For this reason, caution should be exercised when Advantan is administered to breastfeeding women.
Breastfeeding women should not be treated on the breast area.
During breastfeeding, treatment of large skin areas, prolonged use, or occlusive bandaging should be avoided (see "Warnings and precautions").
Fertility
No information is available regarding the influence of methylprednisolone aceponate on fertility.
Driving and using machines
Advantan does not impair the ability to drive or operate machinery.

3. How to use Advantan

Use this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Unless otherwise prescribed by a physician, Advantan should be applied drop by drop, once daily,
to the affected areas, with gentle massage.
The duration of treatment should not exceed 4 weeks in adults.
Use in children
The safety of Advantan in children and adolescents under 18 years of age has not been established.
No data are available.
If you use more Advantan than you should
If cases of cutaneous atrophy (more or less marked thinning of the skin and subcutaneous tissues) occur due to using Advantan in excessive amounts, treatment must be discontinued. Symptoms usually resolve within 10–14 days.
Results from acute toxicity studies with methylprednisolone aceponate have not indicated any risk
of acute intoxication following single excessive topical application (application over a large surface area under conditions favoring absorption).
Following accidental ingestion of Advantan cutaneous solution, effects related to isopropyl alcohol, a component of the vehicle, may occur. These effects may manifest as symptoms of central nervous system depression, even after ingestion of only a few milliliters of the product.
In case of accidental ingestion/overdose of an excessive dose of Advantan, contact your doctor immediately or go to the nearest hospital.
IF YOU HAVE ANY DOUBT ABOUT THE USE OF ADVANTAN, CONSULT YOUR DOCTOR OR
PHARMACIST.
If you forget to use Advantan
Do not use a double dose to make up for the missed dose.
If you stop treatment with Advantan
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.
The assessment of side effects is generally based on the following frequency conventions:
Very common: affects more than 1 in 10 users.
Common: affects 1 to 10 in 100 users.
Uncommon: affects 1 to 10 in 1,000 users.
Rare: affects 1 to 10 in 10,000 users.
Very rare: affects more than 1 in 10,000 users.
Not known: frequency cannot be estimated from the available data.

Systemic disorders and administration site conditions:

• Common: burning sensation.
• Uncommon: itching, pain, folliculitis (inflammation of hair follicles), localized feeling of warmth, dryness, irritation, eczema.
• Not known: blisters, erythema, hypertrichosis.

Skin and subcutaneous tissue disorders:

• Uncommon: seborrhoea of the scalp, hair loss.
• Not known: acne, telangiectasia (permanent dilation of capillaries), skin atrophy, skin striae, perioral dermatitis (inflammation around the mouth), skin discoloration, skin allergic reaction.

Eye disorders:

• Not known: blurred vision.

Systemic effects may occur due to absorption when topical preparations containing corticosteroids are applied.

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 following address: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Advantan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
The stated expiry date applies to the product in its original, unopened packaging and properly stored.
Store below 30°C.
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 Advantan contains

• The active substance is methylprednisolone aceponate.
• 1 ml of cutaneous solution contains 1 mg of methylprednisolone aceponate (0.1%).

The other ingredients are: isopropyl myristate, isopropyl alcohol.
Description of the appearance of Advantan and contents of the pack
Cutaneous solution, 20 ml bottle.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
LEO Pharma A/S, Industriparken 55, DK-2750 Ballerup, Denmark
Manufacturer
Berlimed SA c/o Francisco Alonso s/n 28806 Alcalá de Henares - Madrid, Spain.
Authorized distributor in Italy: LEO Pharma S.p.A., Via Elio Vittorini 129 - 00144 Rome

Patient information leaflet

ADVANTAN 0.1% ointment

methylprednisolone aceponate
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 side effect, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Advantan is and what it is used for

Advantan contains methylprednisolone aceponate, a potent corticosteroid.
Advantan is used for the treatment of eczemas (inflammatory, non-contagious dermatitis affecting the skin surface), such as:

• constitutional eczema (atopic dermatitis, neurodermatitis),
• common eczema,
• allergic and irritant contact eczema,
• dyshidrotic eczema,
• eczema in children.

The Advantan ointment formulation, with its anhydrous base and occlusive effect, helps retain skin moisture, softens thickened skin layers, and enhances penetration of the active ingredient.
Therefore, Advantan ointment is particularly suitable for dry forms and chronic stages.

2. What you need to know before using Advantan

Do not use Advantan

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if the area to be treated is affected by tuberculosis or syphilis;
• if you have viral infections (e.g. chickenpox or herpes zoster);
• if you have skin diseases associated with bacterial or fungal infections;
• if you have rosacea (redness and scaling affecting certain areas of the face);
• if you have perioral dermatitis (skin inflammation around the mouth);
• if you have ulcers, acne vulgaris, or atrophic dermatitis;
• if there are skin reactions to vaccinations (redness) in the area to be treated.

Warnings and precautions
Corticosteroids should be administered only at the lowest possible dose, especially in children, and only for the shortest duration necessary to achieve and maintain the desired therapeutic effect.
The use, particularly if prolonged, of topical products may lead to sensitization reactions and cause adverse effects. In such cases, treatment should be discontinued and a doctor consulted.
As with all corticosteroids, inappropriate use may mask clinical symptoms.
Consult your doctor or pharmacist before using Advantan:

• if you have skin diseases associated with bacterial and/or fungal infections requiring specific treatment;
• if you have local skin infections, as these may worsen with the use of corticosteroids applied to the skin;
• if you have glaucoma, inform your doctor. As known for corticosteroids that affect the entire body (systemic corticosteroids), even with topical corticosteroids applied locally to the affected area, glaucoma may occur (e.g. after excessive dosing or application over large areas for prolonged periods, with occlusive bandaging techniques, or after application around the eyes);
• if you use Advantan to treat large body surface areas or for prolonged periods, especially under occlusive dressing, the treatment duration should be as short as possible, since the risk of systemic absorption and occurrence of systemic adverse effects cannot be completely ruled out.

Advantan must not come into contact with eyes, open wounds, or mucous membranes.
Avoid treatment under occlusive dressing unless specifically indicated. Note that diapers as well as intertriginous areas may act as occlusive dressings.
Contact your doctor if blurred vision or other visual disturbances occur.
Children
Do not use Advantan with diapers, as diapers may act as occlusive dressings.
Advantan should not be used under occlusive dressing.
In children aged between 4 months and 3 years, careful medical evaluation of the risk\benefit ratio is required.
Other medicines and Advantan
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
No interactions with other medicines are currently known.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
As a general rule, corticosteroids should be avoided during the first trimester of pregnancy. In particular, during pregnancy, treatment over large skin areas, prolonged use, or occlusive bandaging should be avoided (see "Warnings and precautions").
Some epidemiological studies suggest a possible, albeit limited, increased risk of cleft palate (palate malformation) in newborns whose mothers were treated with systemic corticosteroids during the first trimester of pregnancy.
Therefore, during pregnancy, Advantan should only be used if, in the opinion of the doctor, the benefits outweigh the risks.
Breastfeeding
It is not known whether topical administration of Advantan may lead to sufficient systemic absorption of methylprednisolone aceponate to result in measurable quantities in breast milk.
For this reason, caution should be exercised when Advantan is administered to breastfeeding women.
Breastfeeding women should not be treated on the breast area.
During breastfeeding, avoid treatment of large skin areas, prolonged use, or occlusive dressings (see "Warnings and precautions").
Fertility
No information is available regarding the influence of methylprednisolone aceponate on fertility.
Driving and using machines
Advantan does not impair the ability to drive vehicles or operate machinery.

3. How to use Advantan

Use this medicinal product exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Unless otherwise prescribed by your doctor, Advantan should be applied in a thin layer once daily to the affected skin area, with gentle massage.
When treatment involves extensive skin areas, the duration of therapy must be appropriately limited by the doctor.
The treatment duration must not exceed 12 weeks in adults and 4 weeks in children.

Use in children
The safety of Advantan in infants under 4 months of age has not been established.

If you use more Advantan than you should
If signs of cutaneous atrophy (more or less marked thinning of the skin and subcutaneous tissues) occur due to excessive use of Advantan, treatment must be discontinued. Symptoms usually resolve within 10–14 days.
Results from acute toxicity studies with methylprednisolone aceponate have not indicated any risk of acute intoxication following a single excessive topical application (application over a large surface area under conditions favoring absorption) or accidental ingestion of Advantan.
In case of accidental ingestion/overdose of Advantan, contact your doctor immediately or go to the nearest hospital.

IF YOU HAVE ANY DOUBT ABOUT THE USE OF ADVANTAN, CONSULT YOUR DOCTOR OR
PHARMACIST.

If you forget to use Advantan
Do not apply a double dose to make up for the missed dose.

If you stop treatment with Advantan
If you have any doubts about using this medicinal product, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The assessment of side effects is generally based on the following frequency conventions:
Very common: affects more than 1 in 10 people.
Common: affects 1 to 10 people in 100.
Uncommon: affects 1 to 10 people in 1,000.
Rare: affects 1 to 10 people in 10,000.
Very rare: affects more than 1 in 10,000 people.
Not known: frequency cannot be estimated from the available data.

Immune system disorders

• Not known: allergy to the medicine.

Systemic and administration site conditions:

• Common: folliculitis (inflammation of hair follicles), burning sensation.
• Uncommon: pustules, blisters, itching, pain, erythema, papules.
• Not known: hypertrichosis (increased hair growth).

Skin and subcutaneous tissue disorders:

• Uncommon: skin fissures, telangiectasias (permanent dilation of capillaries).
• Not known: skin atrophy, skin striae, perioral dermatitis (inflammation of the skin around the mouth), skin discoloration, allergic skin reaction, acne.

Eye disorders

• Not known: blurred vision.

Systemic effects due to absorption may occur when topical preparations containing corticosteroids are applied.

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 following website: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Advantan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
The indicated expiry date applies to the product stored in its original intact packaging and kept under proper storage conditions.
Store below 30°C.
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

The active substance is methylprednisolone aceponate.
1 g of ointment contains 1 mg of methylprednisolone aceponate (0.1%).
The other components are white petrolatum, liquid paraffin, microcrystalline wax, hydrogenated castor oil.

• Description of the appearance of Advantan and package contents Ointment, tube of 20 g.
• Marketing Authorization Holder and Manufacturer Marketing Authorization Holder LEO Pharma A/S, Industriparken 55, DK-2750 Ballerup, Denmark.

Manufacturer
LEO Pharma Manufacturing Italy S.r.l
Via E. Schering 21 - 20090 Segrate (MI), Italy.
Authorized distributor in Italy: LEO Pharma S.p.A., Via Elio Vittorini 129 - 00144 Rome

Patient information leaflet

ADVANTAN 0.1% cream

methylprednisolone aceponate
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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Advantan is and what it is used for

Advantan contains methylprednisolone aceponate, a potent corticosteroid.
Advantan is used to treat eczema (inflammatory, non-contagious dermatitis affecting the skin surface), such as:

• constitutional eczema (atopic dermatitis, neurodermatitis),
• nummular eczema,
• allergic and irritant contact eczema,
• dyshidrotic eczema,
• eczema in children.

Due to its high water content, Advantan cream allows drainage of exudates (inflammatory fluids) and is therefore particularly suitable for the treatment of oozing eczematous lesions in the acute phase, especially on skin areas prone to maceration, whether exposed or covered with hair.

2. What you need to know before using Advantan

Do not use Advantan

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if the area to be treated is affected by tuberculosis or syphilis;
• if you have viral infections (e.g. chickenpox or herpes zoster);
• if you have skin diseases associated with bacterial or fungal infections;
• if you have rosacea (redness and scaling affecting certain areas of the face);
• if you have inflammation of the skin around the mouth (perioral dermatitis);
• if you have ulcers, acne vulgaris, or atrophic dermatitis;
• if you have skin reactions to vaccinations (redness) in the area to be treated.

Warnings and precautions
Corticosteroids should be administered only at the lowest possible dose, especially in children, and only for the shortest period necessary to achieve and maintain the desired therapeutic effect.
The use, particularly if prolonged, of topical products may lead to sensitization phenomena and cause adverse effects. In such cases, treatment must be discontinued and you should consult your doctor.
As with all corticosteroids, inappropriate use may mask clinical symptoms.
Consult your doctor or pharmacist before using Advantan:

• if you have skin diseases associated with bacterial or fungal infections requiring specific treatment;
• if you have local skin infections, as they may worsen with the use of corticosteroids applied to the skin;
• if you notice excessive skin dryness during prolonged use of Advantan cream, switch to a formulation with higher fat content (Advantan hydrophobic cream or ointment);
• if you have glaucoma, inform your doctor. As known for corticosteroids acting systemically (systemic corticosteroids), the use of corticosteroids applied locally to the affected area (topical corticosteroids) may also lead to glaucoma (e.g. after excessive dosing or application over large areas for prolonged periods, under occlusive dressing, or after application to the skin around the eyes);
• if you use Advantan to treat large body surface areas or for prolonged periods, particularly under occlusive dressing, the treatment duration should be as short as possible, since the risk of systemic absorption and occurrence of systemic adverse effects cannot be completely ruled out.

Advantan must not come into contact with eyes, open wounds, or mucous membranes.
Avoid treatment under occlusive dressing unless specifically indicated. Note that diapers as well as intertriginous areas may act as occlusive dressings.
Contact your doctor if blurred vision or other visual disturbances occur.
Children
Do not use Advantan with diapers, as diapers may act as occlusive dressings.
Indeed, Advantan must not be used under occlusive dressing.
In children aged between 4 months and 3 years, careful medical evaluation of the risk/benefit ratio is required.
Other medicines and Advantan
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
No interactions with other medicines are currently known.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
As a general rule, corticosteroids should be avoided during the first trimester of pregnancy. In particular, treatment over extensive skin areas, prolonged use, or occlusive dressing should be avoided during pregnancy (see "Warnings and precautions").
Some epidemiological studies suggest a possible, although limited, increased risk of cleft palate (palatal malformation) in infants born to women treated with systemic corticosteroids during the first trimester of pregnancy.
Therefore, during pregnancy, Advantan should only be used if, in the doctor's opinion, the benefits outweigh the risks.
Breastfeeding
It is not known whether topical administration of Advantan may lead to sufficient systemic absorption of methylprednisolone aceponate to result in detectable quantities in breast milk.
For this reason, caution should be exercised when Advantan is administered to breastfeeding women.
Breastfeeding women should not be treated on the breast area.
During breastfeeding, avoid treatment of large skin areas, prolonged use, or occlusive dressings (see "Warnings and precautions").
Fertility
No information is available regarding the influence of methylprednisolone aceponato on fertility.
Driving and using machines
Advantan does not impair the ability to drive or use machinery.
Advantan cream contains cetyl stearyl alcohol. It may cause local skin reactions (e.g. contact dermatitis).
Advantan cream contains butylated hydroxytoluene. It may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.

3. How to use Advantan

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Unless otherwise prescribed by a physician, Advantan should be applied in a thin layer with gentle massage once daily to the affected skin area.
When treating extensive skin areas, the duration of therapy should be appropriately limited by the doctor.
The treatment duration should not exceed 12 weeks in adults and 4 weeks in children.

Use in children
The safety of Advantan in infants under 4 months of age has not been established.

If you use more Advantan than you should
If cases of cutaneous atrophy (more or less marked thinning of the skin and subcutaneous tissues) occur due to excessive use of Advantan, treatment must be discontinued. Symptoms usually resolve within 10–14 days.
Toxicity studies with methylprednisolone aceponate have not indicated any risk of acute intoxication following a single excessive topical application (application over a large surface area under conditions favoring absorption) or accidental ingestion of Advantan.
In case of accidental ingestion/overdose of Advantan, inform your doctor immediately or go to the nearest hospital.

IF YOU HAVE ANY DOUBT ABOUT THE USE OF ADVANTAN, CONSULT YOUR DOCTOR OR PHARMACIST.

If you forget to use Advantan
Do not apply a double dose to make up for the missed dose.

If you stop treatment with Advantan
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 gets them.
The assessment of side effects is generally based on the following frequency conventions:
Very common: affects more than 1 in 10 people.
Common: affects 1 to 10 in 100 people.
Uncommon: affects 1 to 10 in 1,000 people.
Rare: affects 1 to 10 in 10,000 people.
Very rare: affects more than 1 in 10,000 people.
Not known: frequency cannot be estimated from the available data.

Infections and infestations

• Rare: fungal skin infections.

Systemic and administration site conditions

• Common: burning, itching.
• Uncommon: dryness, erythema, blisters, folliculitis (inflammation of hair follicles), rash, paresthesia (tingling).
• Rare: cellulitis, swelling, irritation.
• Not known: hypertrichosis (increased hair growth).

Immune system disorders:

• Uncommon: allergy to the medicine.

Skin and subcutaneous tissue disorders

• Rare: pyoderma (skin disease with ulcerative characteristics), skin fissures, telangiectasia (permanent dilation of capillaries), skin atrophy, acne.
• Not known: skin striae, perioral dermatitis (inflammation of the skin around the mouth), skin discoloration, skin allergic reaction.

Eye disorders

• Not known: blurred vision.

Systemic effects due to absorption may occur when topical preparations containing corticosteroids are applied.

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 http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Advantan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. 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.
Store below 25°C.
Usable duration after first opening: 3 months.
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 Advantan contains

• The active substance is methylprednisolone aceponate. 1 g of cream contains 1 mg of methylprednisolone aceponate (0.1%).
• The other components are: decyl oleate, glycerol monostearate 40-55, cetyl alcohol, semi-synthetic solid glycerides, triglycerides of saturated vegetable fatty acids, polyoxyl 40 stearate, glycerol 85%, disodium edetate, benzyl alcohol, butylated hydroxytoluene, purified water.

Description of the appearance of Advantan and pack contents
Cream, tube of 20 g.
Cream, tube of 50 g.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
LEO Pharma A/S, Industriparken 55, DK-2750 Ballerup, Denmark.
Manufacturer
LEO Pharma Manufacturing Italy S.r.l., Via E. Schering 21 - 20090 Segrate (MI), Italy.
Local representative in Italy: LEO Pharma S.p.A., Via Elio Vittorini 129 - 00144 Rome.

Package leaflet: information for the patient

ADVANTAN 0.1% hydrophobic cream

methylprednisolone aceponate
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 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, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Advantan is and what it is used for

Advantan contains methylprednisolone aceponate, a potent corticosteroid.
Advantan is used to treat eczema (non-contagious inflammatory dermatitis affecting the skin surface), such as:

• constitutional eczema (atopic dermatitis, neurodermatitis),
• nummular eczema,
• allergic and irritant contact eczema,
• dyshidrotic eczema,
• childhood eczema.

The formulation of Advantan hydrophobic cream ensures an appropriate lipid supply to the skin without blocking transpiration and heat exchange. Due to these characteristics, Advantan hydrophobic cream has a broad range of use, from skin conditions that are not excessively exudative to those that are not particularly dry.

2. What you need to know before using Advantan

Do not use Advantan

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if the area to be treated is affected by tuberculosis or syphilis;
• if you have viral infections (e.g. chickenpox or herpes zoster);
• if you have skin diseases associated with bacterial or fungal infections;
• if you have rosacea (redness and scaling affecting certain areas of the face);
• if you have perioral dermatitis (skin inflammation around the mouth);
• if you have ulcers, acne vulgaris, or atrophic dermatitis;
• if there are cutaneous reactions to vaccinations (redness) in the area to be treated.

Warnings and precautions
Corticosteroids should be administered only at the lowest possible dose, especially in children, and only for the shortest duration necessary to achieve and maintain the desired therapeutic effect.
The use, particularly if prolonged, of topical products may lead to sensitization phenomena and cause adverse effects. In such cases, treatment should be discontinued and medical advice sought.
As with all corticosteroids, inappropriate use may mask clinical symptoms.
Consult your doctor or pharmacist before using Advantan:

• if you have skin diseases associated with bacterial or fungal infections requiring specific treatment;
• if you have local skin infections, as these may worsen with the use of topical corticosteroids;
• if you have glaucoma, inform your doctor. As known for corticosteroids acting systemically (systemic corticosteroids), even with topical corticosteroids applied locally to the affected area, glaucoma may develop (e.g. after excessive dosing, application over large areas for prolonged periods, use under occlusive dressing, or application around the eyes);
• if you use Advantan to treat large body surface areas or for prolonged periods, especially under occlusive dressing, treatment duration should be as short as possible, since the risk of systemic absorption and occurrence of systemic adverse effects cannot be completely ruled out.

Advantan must not come into contact with eyes, open wounds, or mucous membranes.
Occlusive dressing should be avoided unless specifically indicated. Note that diapers and intertriginous areas may act as occlusive dressings.
Following application of Advantan 0.1% hydrophilic cream over 60% of the body surface under occlusive dressing for 22 hours, suppression of plasma cortisol levels and disruption of circadian rhythm have been observed in healthy adult volunteers; therefore, treatment duration in such circumstances should be kept to the minimum necessary.
Contact your doctor if blurred vision or other visual disturbances occur.
Children
Do not use Advantan with diapers, as diapers may act as occlusive dressings.
Advantan should not be used under occlusive dressing.
In children between 4 months and 3 years of age, careful medical assessment of the risk-benefit ratio is required.
Other medicines and Advantan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions with other medicines are currently known.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
As a general rule, corticosteroid use in pregnant women should be avoided during the first trimester. In particular, treatment over extensive skin areas, prolonged use, or occlusive dressing should be avoided during pregnancy (see "Warnings and precautions").
Some epidemiological studies suggest a possible, albeit limited, increased risk of cleft palate (palatal malformation) in newborns of women treated with systemic corticosteroids during the first trimester of pregnancy.
Therefore, during pregnancy, Advantan should be used only if, in the doctor's opinion, the benefits outweigh the risks.
Breastfeeding
It is not known whether topical administration of Advantan leads to sufficient systemic absorption of methylprednisolone aceponate to result in detectable levels in breast milk.
For this reason, caution should be exercised when Advantan is administered to breastfeeding women.
Breastfeeding women should not be treated on the breast area.
During breastfeeding, treatment of large skin areas, prolonged use, or occlusive dressings should be avoided (see "Warnings and precautions").
Fertility
No data are available regarding the effect of methylprednisolone aceponate on fertility.
Driving and using machines
Advantan does not impair the ability to drive or operate machinery.

3. How to use Advantan

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Unless otherwise prescribed by your doctor, Advantan should be applied in a thin layer once daily, with gentle massage, to the affected skin area.
When treating extensive skin areas, the duration of therapy should be appropriately limited by the doctor.
The treatment duration should not exceed 12 weeks in adults and 4 weeks in children.

Use in children
The safety of Advantan in infants below 4 months of age has not been established.

If you use more Advantan than you should
If signs of cutaneous atrophy (more or less marked thinning of the skin and subcutaneous tissues) occur due to using more Advantan than necessary, treatment must be discontinued. Symptoms usually resolve within 10–14 days.
Toxicity studies with methylprednisolone aceponate have shown no risk of acute intoxication following a single excessive topical application (application over a large surface area under conditions favoring absorption) or accidental ingestion of Advantan.
In case of accidental ingestion/overdose of Advantan, contact your doctor immediately or go to the nearest hospital.

IF YOU HAVE ANY DOUBT ABOUT THE USE OF ADVANTAN, CONSULT YOUR DOCTOR OR PHARMACIST.

If you forget to use Advantan
Do not apply a double dose to make up for the missed dose.

If you stop treatment with Advantan
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The assessment of adverse reactions is generally based on the following frequency conventions:
Very common: affects more than 1 in 10 users.
Common: affects 1 to 10 in 100 users.
Uncommon: affects 1 to 10 in 1,000 users.
Rare: affects 1 to 10 in 10,000 users.
Very rare: affects more than 1 in 10,000 users.
Not known: frequency cannot be estimated from the available data.

Systemic disorders and administration site conditions:

• Common: burning, itching.
• Uncommon: dryness, erythema, blisters, irritation, eczema, peripheral edema.
• Not known: folliculitis (inflammation of hair follicles), hypertrichosis (excessive hair growth).

Immune system disorders:

• Not known: allergy to the medicine.

Skin and subcutaneous tissue disorders:

• Uncommon: skin atrophy, bruising, impetigo (superficial skin infection), oily skin.
• Not known: telangiectasia (permanent dilation of capillaries), striae of the skin, perioral dermatitis (inflammation of the skin around the mouth), skin discoloration, skin allergic reaction, acne.

Eye disorders:

• Not known: blurred vision.

Systemic effects due to absorption may occur when topical preparations containing corticosteroids are applied.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa . By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store Advantan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. 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 kept under proper storage conditions.
Store below 25°C.
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 Advantan contains
The active substance is methylprednisolone aceponate.
1 g of hydrophobic cream contains 1 mg of methylprednisolone aceponate (0.1%). The other ingredients are:
white vaseline, liquid paraffin, white wax, high molecular weight aliphatic esters, purified water.
Description of the appearance of Advantan and package contents
Hydrophobic cream, tube of 20 g.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
LEO Pharma A/S, Industriparken 55, DK-2750 Ballerup, Denmark.
Manufacturer
LEO Pharma Manufacturing Italy S.r.l., Via E. Schering 21 - 20090 Segrate (MI), Italy.
Licensee in Italy: LEO Pharma S.p.A., Via Elio Vittorini 129 - 00144 Rome

PATIENT LEAFLET: INFORMATION FOR THE USER

Advantan 0.1% Cutaneous Emulsion

Methylprednisolone aceponate
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 others, even if their symptoms are the same as yours, as it could 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 Advantan cutaneous emulsion is and what it is used for
2. What you need to know before using Advantan cutaneous emulsion
3. How to use Advantan cutaneous emulsion
4. Possible side effects
5. How to store Advantan cutaneous emulsion
6. Contents of the pack and other information

1. What Advantan cutaneous emulsion is and what it is used for

Advantan cutaneous emulsion contains the active substance methylprednisolone aceponate.
Advantan cutaneous emulsion is a topical anti-inflammatory medicinal product (corticosteroid).
Advantan cutaneous emulsion reduces inflammation and allergic reactions of the skin, as well as reactions associated with excessive skin cell replication (hyperproliferation). It relieves redness (erythema), fluid accumulation (edema), and leakage from inflamed skin. It also provides relief from itching, burning sensation, or pain.
Advantan cutaneous emulsion is used for the treatment of acute conditions such as:

• Mild to moderate skin rashes (eczema) caused by external agents, such as:
• allergy to substances that have come into contact with your skin (allergic contact dermatitis),
• allergic reaction to everyday substances, e.g. soaps (irritant contact dermatitis),
• skin rash with coin-shaped spots (nummular eczema),
• itchy rash on hands and feet (dyshidrotic eczema);
• non-specific eczema (common eczema);
• Eczema due to internal causes (endogenous eczema), such as atopic dermatitis or neurodermatitis;
• Scaly and inflamed skin rash (seborrheic eczema).

2. What you need to know before using Advantan emulsion

Do not use Advantan emulsion

• if you are allergic to the active substance, methylprednisolone aceponate (MPA), or to any of the excipients of this medicine (see also section 6 “Contents of the pack and other information”);
• if you suffer from tuberculosis, syphilis, or viral infections, such as herpes or varicella;
• on skin areas affected by red/rosy skin inflammation (rosacea), ulcers, inflammatory skin diseases of the sebaceous glands (acne vulgaris), or skin conditions associated with skin thinning (cutaneous atrophy);
• on skin areas showing vaccine reactions, i.e. red or inflamed areas following vaccination;
• on specific inflammations around the upper lip or chin (perioral dermatitis);
• in case of bacterial or fungal skin infections (unless treated with an appropriate medication);

Warnings and precautions
Talk to your doctor before using Advantan emulsion.
Be cautious with Advantan emulsion if your doctor has diagnosed a concurrent bacterial or fungal skin infection. In such cases, you may need to take additional prescribed medications to treat the infection, which might otherwise worsen.
Anti-inflammatory drugs (corticosteroids), such as the active substance MPA contained in Advantan emulsion, may have significant effects on the body. The use of Advantan emulsion over large body surface areas or for prolonged periods is not recommended, to avoid increasing the risk of adverse effects.
To reduce the risk of adverse effects:

• limit the use of the medicine as much as possible;
• use only for the shortest time necessary to relieve the skin condition;
• avoid contact of Advantan emulsion with the eyes, mouth, deep open wounds, or mucous membranes (e.g. anal and genital areas);
• do not use Advantan emulsion over extensive body surfaces (more than 40% of the body surface area);
• do not use Advantan emulsion under non-breathable or impermeable materials, including plasters, non-breathable bandages, clothing, or diapers, unless specifically prescribed by a doctor.

Using Advantan emulsion to treat conditions different from those for which it was prescribed may mask symptoms and interfere with proper diagnosis and treatment.
Contact your doctor if you experience blurred vision or other visual disturbances.
Children
Limit the use of the medicine as much as possible to reduce the risk of side effects.
Advantan emulsion must not be used under non-breathable or impermeable materials such as diapers, unless specifically prescribed by a doctor.
Advantan emulsion may be used in children between 4 months and 3 years of age only if prescribed by a doctor.
The use of Advantan emulsion is not recommended in children under 4 months of age.
Other medicines and Advantan emulsion
No interactions between Advantan emulsion and other medicines are currently known.
Inform your doctor if you are taking or have recently taken any other medicines, including those without a prescription.
Pregnancy and breastfeeding
To avoid risks to your baby's health, you must not use Advantan emulsion if you are pregnant or breastfeeding, unless otherwise directed by your doctor.
If your doctor recommends using Advantan emulsion during breastfeeding, do not apply it on the breast. Avoid contact between the treated areas and the baby.
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Driving and using machines
The use of Advantan emulsion does not affect the ability to drive or operate machinery.

3. How to use Advantan cutaneous emulsion

Always use this medicine exactly as directed by your doctor. If you have any doubts,
you must consult your doctor.
Unless otherwise prescribed by your doctor, the general dosage is as follows:

• apply a thin layer of Advantan cutaneous emulsion once daily to the affected areas, gently massaging it in;
• generally, the duration of treatment with Advantan cutaneous emulsion should not exceed two weeks. Always keep the treatment period as short as possible.
• when using Advantan cutaneous emulsion for desquamative and inflamed skin eruptions (seborrheic eczema) on the face, treatment should not last longer than one week;
• if excessive skin dryness occurs, consult your doctor; it may be necessary to apply an additional liporeplenishing ointment.

Advantan cutaneous emulsion may be used in children between 4 months and 3 years of age, if prescribed by
a doctor. Dose adjustments are not required.
The use of Advantan cutaneous emulsion is not recommended in children under 4 months of age due to
the lack of safety data.
If you use more Advantan cutaneous emulsion than you should
No risks are expected following a single application of an excessive amount of Advantan
cutaneous emulsion (excessive quantity, application over too large an area, or too frequent use). Repeated overdosing may cause undesirable effects (see section 4. "Possible side effects").
If you forget to use Advantan cutaneous emulsion
Do not use a double dose at the next application; instead, continue using it as prescribed by your doctor or as described in the package leaflet.
If you stop treatment with Advantan cutaneous emulsion
If you stop treatment with Advantan cutaneous emulsion too early, the initial symptoms of the skin disease may recur. Before stopping treatment with
Advantan cutaneous emulsion, consult your doctor or pharmacist.
If you have further questions about the use of this product, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Advantan cutaneous emulsion can cause side effects, although not
everyone experiences them.
The assessment of side effects is generally based on the following frequency conventions:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Not known: frequency cannot be estimated from the available data.

• Common:
• Local skin irritation (e.g., burning sensation)
• Uncommon:
• Pain
• Itching
• Blisters and pustules
• Desquamation
• Superficial skin lesions (erosion)
• Worsening or recurrence of eczema; skin fissures

The topical use of anti-inflammatory drugs, the so-called corticosteroids (such as the active substance in Advantan cutaneous emulsion), may cause the following adverse events (frequency not known):

• Thinning of the skin (atrophy)
• Dry skin
• Redness (erythema)
• Appearance of red spots
• Inflammation of hair follicles (folliculitis)
• Striae
• Acne
• Specific skin inflammation around the upper lip or chin (perioral dermatitis)
• Allergic skin reactions (contact dermatitis)
• Changes in skin pigmentation
• Abnormal hair growth on the body

Side effects may occur not only in the treated area but also in other parts of the body. This may happen if the active substance (a corticosteroid) is absorbed into the body through the skin. This could, for example, increase intraocular pressure (glaucoma).

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 following address:
. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Advantan skin emulsion

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Do not use Advantan skin emulsion after the expiry date stated on the tube and packaging after EXP. The expiry date refers to the last day of the month.
The product is valid for 3 months after first opening of the tube.
Do not dispose of medicines 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 Advantan cutaneous emulsion contains

• The active substance is: methylprednisolone aceponate (MPA). The excipients are: medium-chain triglycerides, triglycerides of caprylic-capric-miristic-stearic acids, macrogol-2 stearyl ether, macrogol-21 stearyl ether, benzyl alcohol, disodium edetate, glycerol (85%) and purified water.

Description of the appearance of Advantan cutaneous emulsion and contents of the pack
Advantan cutaneous emulsion is a white emulsion for cutaneous application (creamy consistency) and is available in tubes of:

• 20 g
• 50 g

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: LEO Pharma A/S, Industriparken 55, DK-2750 Ballerup, Denmark

Manufacturer:
LEO Pharma Manufacturing Italy S.r.l., Via E. Schering 21
20090 Segrate (Milan)
Italy
Local representative in Italy:
LEO Pharma S.p.A., Via Elio Vittorini 129 - 00144 Rome

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria, Finland, Germany, Italy, Portugal: Advantan
Spain: Adventan

This Patient Information Leaflet was last approved on