ADVANTAN 0.1% Cream

Зміст інструкції

1. ADVANTAN 0,1% cutaneous solution
   1. What is Advantan and what is it 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
2. ADVANTAN 0,1% ointment
   1. What is Advantan and what is it 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
3. ADVANTAN 0,1% cream
   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
4. ADVANTAN 0.1% hydrophobic cream
   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
5. Advantan 0.1% cutaneous emulsion
   1. What is Advantan cutaneous emulsion and what is it 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
6. Advantan cutaneous emulsion is a white emulsion for cutaneous application (of creamy consistency) and is available in tubes of:

ADVANTAN 0,1% cutaneous solution

methylprednisolone aceponate
Read this leaflet carefully before you start using this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Advantan is and what it is used for
• 2. What you need to know before you use 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 is Advantan and what is it used for

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

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

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

2. What you need to know before using Advantan

Do not use Advantan

• if you are allergic to the active ingredient 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 accompanied by bacterial or fungal infections;
• if you have rosacea (redness and scaling that characterize certain areas of the face);
• if you have inflammation of the skin around the mouth (perioral dermatitis);
• if you have ulcers, acne vulgaris and atrophic dermatitis;
• if there are skin reactions to vaccinations (redness) in the area to be treated.

Warnings and precautions
Corticosteroids must be administered only at the lowest possible dose, especially in children, and
only for the period strictly necessary to achieve and maintain the desired therapeutic effect.
The use, especially if prolonged, of products for external use can give rise to sensitization phenomena
and cause undesirable effects. In this case, stop treatment and consult your
doctor.
As with all corticosteroids, inappropriate use can mask clinical symptoms.
Consult your doctor or pharmacist before using Advantan

• if you have skin diseases accompanied by bacterial or fungal infections for which treatment with a specific therapy is required;
• if you have local skin infections because they may worsen with the use of corticosteroids applied to the skin;
• if you have glaucoma, inform your doctor. As is known for corticosteroids that have an effect on the whole body (systemic corticosteroids), even with the use of corticosteroids applied locally to the area to be treated (topical corticosteroids), it is possible for glaucoma to occur (e.g. after use at excessive doses or on large areas for prolonged periods, with occlusive dressing techniques or after application to the skin around the eyes);
• if you use Advantan for the treatment of large areas of the body or for prolonged periods of time, in particular under occlusive dressing, the duration of treatment must be as short as possible since the risk of absorption and the occurrence of systemic undesirable effects cannot be completely excluded.

Advantan must not come into contact with eyes, open wounds and mucous membranes.
Treatment with occlusive dressing should be avoided unless indicated. Note that the diaper as well as
intertriginous areas can act as an occlusive dressing.
Advantan cutaneous solution is flammable: it must not be applied near open flames.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children
Do not use Advantan with a diaper as the diaper can act as an occlusive dressing.
Advantan should in fact not be used with occlusive dressing.
In the case of children between 4 months and 3 years of age, a careful evaluation of the risk/benefit ratio is necessary by the doctor.

Other medicines and Advantan
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
No interactions with other medicines are known to date.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
As a general rule, the use of corticosteroids should be avoided in pregnant women during the first trimester. In particular, during pregnancy, treatment on
extensive areas of skin, prolonged use and occlusive dressing should be avoided (see “Warnings and precautions”).
Some epidemiological studies suggest that there may be a possible increased risk, albeit
limited, of cleft palate (palatal malformation) in newborns from women treated with systemic corticosteroids
during the first trimester of pregnancy.
Consequently, during pregnancy, Advantan should be used only if, according to the doctor, the
benefits outweigh the risks.

Breastfeeding
It is not known whether topical administration of Advantan can lead to sufficient systemic absorption of methylprednisolone aceponate to determine detectable amounts 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.
During breastfeeding, treatment of large areas of skin, prolonged use or occlusive dressings should be avoided (see “Warnings and precautions”).

Fertility
No information is available regarding the influence of methylprednisolone aceponate on fertility.

Driving and operating machinery
Advantan does not impair the ability to drive vehicles or operate machinery.

3. How to use Advantan

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts, consult your doctor or pharmacist.
Unless otherwise prescribed by your doctor, Advantan should be applied drop by drop, once a day, to the areas affected by the condition, with a light 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
Should cases of skin atrophy (more or less marked thinning of the skin and subcutaneous tissues) occur due to use of Advantan in a quantity greater than necessary, treatment should be discontinued. Normally the symptoms regress within 10 – 14 days.
The results of acute toxicity studies with methylprednisolone aceponate have not indicated any risk of acute poisoning following single cutaneous application of an excessive quantity (application to a large surface area under conditions that favor absorption).
Following accidental ingestion of Advantan cutaneous solution, effects related to isopropyl alcohol, a component of the base, may occur. These effects may present as symptoms of depression of the central nervous system even with only a few milliliters of product.
In case of accidental ingestion/intake of an excessive dose of Advantan, inform your doctor immediately or go to the nearest hospital.
IF YOU HAVE ANY DOUBTS ABOUT THE USE OF ADVANTAN, ASK YOUR DOCTOR OR PHARMACIST.

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

If you stop using Advantan
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
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 10,000 people.

Very rare: may affect up to 1 in 10,000 people.

Not known:frequency cannot be estimated from the available data.

Systemic conditions and conditions related to the site of administration:

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

Skin and subcutaneous tissue disorders:

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

Eye disorders

• Not known: Blurred vision.

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

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through 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 which is stated on the packaging. The expiry date refers to the last day of that month.
The expiry date indicated refers to the product in intact packaging, correctly
stored.
Store at a temperature not exceeding 30°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Advantan contains

• The active ingredient 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, bottle of 20 ml.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
LEO Pharma A/S, Industriparken 55, DK-2750 Ballerup, Denmark

Manufacturer
Berlimed SA c/o Francisco Alonso s/n 28806 Alcalà de Henares - Madrid, Spain.
Distributor in Italy: LEO Pharma S.p.A., Via Elio Vittorini 129 - 00144 Rome

ADVANTAN 0,1% ointment

methylprednisolone aceponate
Read this leaflet carefully before you start using this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Advantan is and what it is used for
• 2. What you need to know before you use 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 is Advantan and what is it used for

Advantan contains methylprednisolone aceponate, a potent corticosteroid.
Advantan is used for the treatment of eczema (inflammatory skin conditions, non-contagious,
that affect the surface of the skin) 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 with an occlusive effect, maintains skin
moisture softening the thickened skin layer and facilitating the penetration of the active ingredient.
Therefore Advantan ointment is particularly indicated in 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 ingredient 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 accompanied by bacterial or fungal infections;
• if you have rosacea (redness and scaling that characterize certain areas of the face);
• if you have inflammation of the skin around the mouth (perioral dermatitis);
• if you have ulcers, acne vulgaris and atrophic dermatitis;
• if there are skin reactions to vaccinations (redness) in the area to be treated.

Warnings and precautions
Corticosteroids must be administered only at the lowest possible dose, especially in children, and
only for the period strictly necessary to achieve and maintain the desired therapeutic effect.
The use, especially if prolonged, of products for external use can give rise to sensitization phenomena
and cause undesirable effects. In this case, stop treatment and consult your
doctor.
As with all corticosteroids, inappropriate use can mask clinical symptoms.
Consult your doctor or pharmacist before using Advantan:

• if you have skin diseases accompanied by bacterial and/or fungal infections for which treatment with a specific therapy is required;
• if you have local skin infections because they may worsen with the use of corticosteroids applied to the skin;
• if you have glaucoma, inform your doctor. As is known for corticosteroids that affect the whole body (systemic corticosteroids), the appearance of glaucoma is also possible with the use of corticosteroids applied locally to the area to be treated (topical corticosteroids) (e.g. after use at excessive doses or on extensive areas for prolonged periods, with occlusive dressing techniques or after application to the skin around the eyes);
• if you use Advantan for the treatment of large areas of the body or for prolonged periods of time, in particular under occlusive dressing, the duration of treatment must be as short as possible, since the risk of absorption and the occurrence of systemic undesirable effects cannot be completely excluded.

Advantan must not come into contact with eyes, open wounds and mucous membranes.
Treatment with occlusive dressing should be avoided unless indicated. Note that the diaper as well as
intertriginous areas can act as an occlusive dressing.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children
Do not use Advantan with a diaper as the diaper can act as an occlusive dressing.
Advantan in fact must not be used under occlusive dressing.
In the case of children between 4 months and 3 years of age, a careful assessment of the
risk/benefit ratio is necessary.

Other medicines and Advantan
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
No interactions with other medicines are known to date.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
As a general rule, the use of corticosteroids should be avoided in pregnant women during the first trimester. In particular, treatment on
extensive areas of skin, prolonged use or occlusive dressing should be avoided during pregnancy (see “Warnings and precautions”).
Some epidemiological studies suggest that there may be a possible increased risk, albeit
limited, of cleft palate (malformation of the palate) in newborns from women treated with systemic corticosteroids during the first trimester of pregnancy.
Consequently, 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 can lead to sufficient systemic absorption of methylprednisolone aceponate to determine detectable amounts 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.
During breastfeeding, treatment of large areas of skin, prolonged use or occlusive dressings 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 vehicles or operate machinery.

3. How to use Advantan

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

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

If you use more Advantan than you should
Should cases of skin atrophy (more or less marked thinning of the skin and subcutaneous tissues) occur due to use of Advantan in quantities greater than necessary, treatment should be discontinued. Normally the symptoms regress within 10 – 14 days.
The results of acute toxicity studies with methylprednisolone aceponate have not indicated any
risk of acute poisoning following single cutaneous application of an excessive amount
(application to a large surface in conditions that favor absorption) or accidental ingestion
of Advantan.
In case of ingestion/accidental intake of an excessive dose of Advantan, inform your
doctor immediately or go to the nearest hospital.
IF YOU HAVE ANY DOUBTS ABOUT THE USE OF ADVANTAN, ASK YOUR DOCTOR OR
PHARMACIST.

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

If you stop using Advantan
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The assessment of side effects is generally based on the following frequency conventions:

Very common:present in more than 1 user out of 10.

Common:present in 1 to 10 users out of 100.

Uncommon:present in 1 to 10 users out of 1000.

Rare:present in 1 to 10 users out of 10,000.

Very rare:present in more than 1 user out of 10,000.

Not known:frequency cannot be estimated based on the available data.

Immune system disorders

• Not known:allergy to the medicine.

Systemic and conditions related to the site of administration:

• 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, cutaneous allergic reaction, acne.

Eye disorders

• Not known:Blurred vision.

Systemic effects may occur due to absorption if topical corticosteroid preparations are applied to
large areas.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through 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 which is stated on the packaging. The expiry date refers to the last day of that month.
The expiry date indicated refers to the product in intact packaging, correctly
stored.
Store at a temperature not exceeding 30°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

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

• Description of the appearance of Advantan and contents of the packOintment, tube containing 20 g.
• Marketing Authorisation Holder and ManufacturerMarketing Authorisation HolderLEO 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.
Distributor in Italy: LEO Pharma S.p.A., Via Elio Vittorini 129 - 00144 Rome

ADVANTAN 0,1% cream

methylprednisolone aceponate
Read this leaflet carefully before you start using this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Advantan is and what it is used for
• 2. What you need to know before you use 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 skin conditions, non-contagious,
that affect the surface of the skin) such as:

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

The formulation of Advantan cream, due to its high water content, allows the flow of
exudates (inflammatory fluids) and is therefore particularly suitable for the treatment of
weeping eczematous forms in the acute phase of skin areas subject to maceration, exposed and covered by
hair.

2. What you need to know before using Advantan

Do not use Advantan

• if you are allergic to the active ingredient 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 accompanied by bacterial or fungal infections;
• if you have rosacea (redness and scaling that characterize certain areas of the face);
• if you have inflammation of the skin around the mouth (perioral dermatitis);
• if you have ulcers, acne vulgaris and atrophic dermatitis;
• if there are skin reactions to vaccinations (redness) in the area to be treated.

Warnings and precautions
Corticosteroids must be administered only at the lowest possible dose, especially in children, and
only for the period strictly necessary to achieve and maintain the desired therapeutic effect.
The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena
and cause undesirable effects. In this case, stop treatment and consult your
doctor.
As with all corticosteroids, inappropriate use can mask clinical symptoms.
Consult your doctor or pharmacist before using Advantan:

• if you have skin diseases accompanied by bacterial or fungal infections for which treatment with a specific therapy is required;
• if you have local skin infections because they may worsen with the use of corticosteroids applied to the skin;
• if you notice excessive skin dryness when applying Advantan cream for prolonged periods, switch to a formulation with a higher fat content (Advantan hydrophobic cream or ointment);
• if you have glaucoma, inform your doctor. As is known for corticosteroids that affect the whole body (systemic corticosteroids), the appearance of glaucoma is also possible with the use of corticosteroids applied locally to the area to be treated (topical corticosteroids) (e.g. after use at excessive doses or on large areas for prolonged periods, with occlusive dressing techniques or after application to the skin around the eyes);
• if you use Advantan for the treatment of large areas of the body or for prolonged periods of time, in particular under occlusive dressing, the duration of treatment must be as short as possible, since the risk of absorption and the occurrence of systemic undesirable effects cannot be completely excluded.

Advantan must not come into contact with eyes, open wounds and mucous membranes.
Treatment with occlusive dressing should be avoided unless indicated. Note that the diaper as well as
intertriginous areas can act as an occlusive dressing.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children
Do not use Advantan with a diaper as the diaper can act as an occlusive dressing.
Advantan must not be used under occlusive dressing.
In the case of children between 4 months and 3 years of age, a careful evaluation of the risk/benefit ratio is necessary by the doctor.

Other medicines and Advantan
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
No interactions with other medicines are known to date.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
As a general rule, the use of corticosteroids should be avoided in pregnant women during the first trimester. In particular, treatment on
extensive skin areas, prolonged use or occlusive dressing should be avoided during pregnancy (see “Warnings and precautions”).
Some epidemiological studies suggest that there may be a possible increased risk, albeit
limited, of cleft palate (palatal malformation) in newborns from women treated with systemic corticosteroids during the first trimester of pregnancy.
Consequently, 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 can lead to sufficient systemic absorption of methylprednisolone aceponate to determine detectable amounts in breast milk.
Therefore, caution should be exercised when Advantan is administered to breastfeeding women.
Breastfeeding women should not be treated on the breast.
During breastfeeding, treatment of large areas of skin, prolonged use or occlusive dressings should be avoided (see “Warnings and precautions”).

Fertility
No information is available regarding the influence of methylprednisolone aceponate on fertility.

Driving and operating machinery
Advantan does not impair the ability to drive vehicles or operate machinery.

Advantan cream contains cetostearyl alcohol. It may cause local skin reactions (e.g.
contact dermatitis).

Advantan cream contains butylhydroxytoluene. 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 following the instructions of your doctor or pharmacist exactly. If you have any
doubts, consult your doctor or pharmacist.
Unless otherwise prescribed by your doctor, Advantan should be applied in a thin layer with a light
massage, once a day, to the affected skin area.
In case of treatment on extensive skin areas, the duration of therapy should be appropriately
limited by the doctor.
The duration of treatment should not exceed 12 weeks in adults and 4 weeks in children.

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

If you use more Advantan than you should
If cases of skin atrophy (more or less marked thinning of the skin and subcutaneous tissues) occur due to
use of Advantan in quantities greater than necessary, treatment should be discontinued. Normally the
symptoms regress within 10 – 14 days.
The results of acute toxicity studies with methylprednisolone aceponate have not indicated any
risk of acute poisoning following single cutaneous application of an excessive amount
(application to a large surface under conditions that favor absorption) or accidental ingestion
of Advantan.
In case of ingestion/accidental intake of an excessive dose of Advantan, immediately inform
your doctor or go to the nearest hospital.
IF YOU HAVE ANY DOUBTS ABOUT THE USE OF ADVANTAN, ASK YOUR DOCTOR OR
PHARMACIST.

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

If you stop using Advantan
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
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:the frequency cannot be estimated from the available data.

Infections and infestations

• Rare:fungal skin infections.

Systemic disorders and conditions related to the administration site

• Common:burning sensation, itching.
• Uncommon:dryness, erythema, vesicles, folliculitis (inflammation of hair follicles), rash, paraesthesia (tingling).
• Rare:cellulitis, oedema, 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 ulcer-like characteristics), skin fissures, telangiectasias (permanent dilation of capillaries), skin atrophy, acne.
• Not known:skin striae, perioral dermatitis (inflammation of the skin around the mouth), skin discolouration, allergic skin reaction.

Eye disorders

• Not known:Blurred vision.

Systemic effects may occur due to absorption if topical corticosteroids are applied to large areas of the body.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through 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 sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
The expiry date indicated refers to the product in intact packaging, correctly
stored.
Store at a temperature not exceeding 25°C.
Validity after first opening: 3 months.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Advantan contains

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

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

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 (MI), Italy.
Distributor in Italy: LEO Pharma S.p.A., Via Elio Vittorini 129 - 00144 Roma.

ADVANTAN 0.1% hydrophobic cream

methylprednisolone aceponate
Read this leaflet carefully before you start using this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Advantan is and what it is used for
• 2. What you need to know before you use 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 skin conditions,
that affect the surface of the skin) such as:

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

The formulation of Advantan hydrophobic cream ensures the skin an appropriate lipid supply without
blocking perspiration and heat exchange. Due to its characteristics, Advantan hydrophobic cream
has a rather wide range of applications, from skin conditions that are not excessively
secreting 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 ingredient 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 accompanied by bacterial or fungal infections;
• if you have rosacea (redness and scaling that characterize certain areas of the face);
• if you have inflammation of the skin around the mouth (perioral dermatitis);
• if you have ulcers, acne vulgaris and atrophic dermatitis;
• if there are skin reactions to vaccinations (redness) in the area to be treated.

Warnings and precautions
Corticosteroids must be administered only at the lowest possible dose, especially in children, and
only for the period strictly necessary to achieve and maintain the desired therapeutic effect.
The use, especially if prolonged, of products for external use can give rise to sensitization phenomena
and cause undesirable effects. In this case, stop treatment and consult your
doctor.
As with all corticosteroids, inappropriate use can mask clinical symptoms.
Consult your doctor or pharmacist before using Advantan:

• if you have skin diseases accompanied by bacterial or fungal infections for which treatment with a specific therapy is required;
• if you have local skin infections because they may worsen with the use of corticosteroids applied to the skin;
• if you have glaucoma, inform your doctor. As is known for corticosteroids that have an effect on the whole body (systemic corticosteroids), the appearance of glaucoma is also possible with the use of corticosteroids applied locally to the area to be treated (topical corticosteroids) (e.g. after use at excessive doses or on large areas for prolonged periods, with occlusive dressing techniques or after application to the skin around the eyes);
• if you use Advantan for the treatment of large areas of the body or for prolonged periods of time, in particular under occlusive dressing, the duration of treatment must be as short as possible, since the risk of absorption and the appearance of systemic undesirable effects cannot be completely excluded.

Advantan must not come into contact with eyes, open wounds and mucous membranes.
Treatment with occlusive dressing should be avoided unless indicated. Note that the diaper as well as
intertriginous areas can act as an occlusive dressing.
Following the application of Advantan 0.1% hydrophobic cream on 60% of the body surface under
occlusive dressing for 22 hours, suppression of plasma cortisol levels and
an influence on the circadian rhythm were observed in healthy adult volunteers, therefore it is necessary to limit
the period of treatment in such situations to the minimum necessary.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children
Do not use Advantan with a diaper as the diaper can act as an occlusive dressing.
Advantan must not be used under occlusive dressing.
In the case of children between 4 months and 3 years of age, a careful evaluation of the
risk/benefit ratio is necessary.

Other medicines and Advantan
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
No interactions with other medicines are known to date.

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

Pregnancy
As a general rule, the use of corticosteroids should be avoided in pregnant women during the first trimester. In particular, treatment on
extensive areas of skin, prolonged use or occlusive dressing should be avoided during pregnancy (see “Warnings and precautions”).
Some epidemiological studies suggest that there may be a possible increased risk, albeit
limited, of cleft palate (palatal malformation) in newborns from women treated with systemic corticosteroids
during the first trimester of pregnancy.
Consequently, during pregnancy, Advantan should be used only if, according to the doctor, the
benefits outweigh the risks.

Breastfeeding
It is not known whether topical administration of Advantan can lead to sufficient systemic absorption of methylprednisolone aceponate to determine detectable amounts 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.
During breastfeeding, treatment of large areas of skin, prolonged use or occlusive dressings should be avoided (see “Warnings and precautions”).

Fertility
No information is available regarding the influence of methylprednisolone aceponate on fertility.

Driving and operating machinery
Advantan does not impair the ability to drive vehicles or operate machinery.

3. How to use Advantan

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

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

If you use more Advantan than you should
Should cases of skin atrophy (more or less marked thinning of the skin and subcutaneous
tissues) due to use of Advantan in quantities greater than necessary occur, treatment should be discontinued. Normally the symptoms regress within 10 – 14 days.
The results of acute toxicity studies with methylprednisolone aceponate have not indicated any
risk of acute intoxication following single cutaneous application of an excessive amount
(application to a large surface under conditions that favor absorption) or accidental ingestion
of Advantan.
In case of ingestion/accidental intake of an excessive dose of Advantan, inform
your doctor immediately or go to the nearest hospital.
IF YOU HAVE ANY DOUBTS ABOUT THE USE OF ADVANTAN, ASK YOUR DOCTOR OR
PHARMACIST.

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

If you stop using Advantan
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The assessment of side effects is generally based on the following frequency conventions:

Very common: present in more than 1 out of 10 users.

Common:present in 1 to 10 users out of 100.

Uncommon:present in 1 to 10 users out of 1000.

Rare:present in 1 to 10 users out of 10,000.

Very rare: present in more than 1 out of 10,000 users.

Not known:the frequency cannot be estimated based on available data.

Systemic conditions and conditions related to the site of administration :

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

Immune system disorders:

• Not known:allergy to the medicine.

Skin and subcutaneous tissue disorders:

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

Eye disorders

• Not known:blurred vision.

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system, at 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 sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
The expiry date indicated refers to the product in intact packaging, correctly
stored.
Store at a temperature not exceeding 25°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Advantan contains
The active ingredient is methylprednisolone aceponate.
1 g of hydrophobic cream contains 1 mg of methylprednisolone aceponate (0.1%). The other components are:
white petrolatum, liquid paraffin, white wax, aliphatic esters with high molecular weight, purified water.

Description of the appearance of Advantan and contents of the pack
Hydrophobic cream, tube containing 20 g.

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 (MI), Italy.
Distributor in Italy: LEO Pharma S.p.A., Via Elio Vittorini 129 - 00144 Roma

Advantan 0.1% cutaneous emulsion

Methylprednisolone aceponate

Read this leaflet carefully before using this medicineas it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Advantan cutaneous emulsion is and what it is used for
• 2. What you need to know before you use 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 is Advantan cutaneous emulsion and what is it used for

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

• 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 (eczema vulgare);
• Eczema due to internal causes in the patient (endogenous eczema), such as atopic dermatitis or neurodermatitis;
• Skin rash with scaling and inflammation (seborrheic eczema).

2. What you need to know before using Advantan cutaneous emulsion

Do not use Advantan cutaneous emulsion

• if you are allergic to the active ingredient 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, e.g. herpes or chickenpox;
• on skin areas characterized by redness/rosacea, on ulcers, in case of inflammatory diseases of the sebaceous glands (acne vulgaris) or skin diseases accompanied by thinning of the skin (skin atrophy);
• on skin areas characterized by vaccination reactions, i.e. reddened or inflamed areas after vaccination;
• on specific inflammation in the area of the upper lip or chin (perioral dermatitis);
• in the presence of bacterial or fungal skin infections (unless treated with an appropriate medication);

Warnings and precautions
Consult your doctor before using Advantan cutaneous emulsion.
Be careful with Advantan cutaneous emulsion if your doctor has diagnosed you with
a concomitant skin infection (bacterial or fungal). In this case, it will be necessary to take the
additional medications prescribed to treat the infection, which could otherwise worsen.
Anti-inflammatory drugs (corticosteroids), such as the active ingredient MPA contained in Advantan
cutaneous emulsion, appear to have significant effects on the body. The use of
Advantan cutaneous emulsion on extensive areas of the body or for prolonged periods is not recommended, in order to reduce the
risk of undesirable effects.
To reduce the risk of undesirable effects:

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

The use of Advantan cutaneous emulsion for the treatment of disorders other than those for which it has been
prescribed may mask symptoms and hinder accurate diagnosis and therapy.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children
Limit the use of the drug as much as possible, to reduce the risk of side effects.
Advantan cutaneous emulsion should not be used under non-breathable or waterproof materials,
such as diapers, unless prescribed by your doctor.
Advantan cutaneous emulsion may be used in children between 4 months and 3 years of age, only if
prescribed by your doctor.
The use of Advantan cutaneous emulsion is not recommended in children under 4 months of age.

Other medicines and Advantan cutaneous emulsion
To date, no interactions of Advantan cutaneous emulsion with other medicines are known.
Inform your doctor if you are taking or have recently taken any other medicines, including those
available over the counter.

Pregnancy and breastfeeding
To avoid risks to your baby's health, do not use Advantan cutaneous emulsion if you are
pregnant or breastfeeding, unless otherwise prescribed by your doctor.
If your doctor recommends the use of Advantan cutaneous emulsion during breastfeeding, do not apply it
to the breast. Avoid contact of the baby with the treated areas of the body.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.

Driving and operating machinery
The use of Advantan cutaneous emulsion does not affect the ability to drive or operate machinery.

3. How to use Advantan cutaneous emulsion

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

• apply a thin layer of Advantan cutaneous emulsion once a day to the affected areas, massaging gently;
• in general, the duration of treatment with Advantan cutaneous emulsion should not exceed two weeks. Always limit the period of use as much as possible.
• in case of using Advantan cutaneous emulsion for flaky and inflamed skin rashes (seborrheic eczema) on the face, the treatment should not last more than one week;
• if excessive skin dryness occurs, consult your doctor; it may be necessary to apply an additional liporestoring ointment.

Advantan cutaneous emulsion can be used in children between 4 months and 3 years of age, if prescribed by the
doctor. No dosage adjustments are 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 to too large areas or too frequent use). Repeated overdoses may cause undesirable effects (see section 4. “Possible
undesirable effects”).

If you forget to use Advantan cutaneous emulsion
Do not use a double dose of Advantan cutaneous emulsion at the next application, but continue
package.

If you stop using Advantan cutaneous emulsion
If you stop treatment with Advantan cutaneous emulsion too early, the primary symptoms of the skin disease may reappear.
Before stopping treatment with
Advantan cutaneous emulsion, ask your doctor or pharmacist.
If you have further questions about the use of this product, please contact your doctor or pharmacist.

4. Possible side effects

Like all medicines, Advantan cutaneous emulsion may cause side effects, although not everyone will experience 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 1000 people
Very rare: may affect up to 1 in 10000 people
Not known: frequency cannot be estimated based on available data.

• Common:
• local skin irritation (for example, burning sensation):
• Uncommon:
• pain;
• itching;
• vesicles and pustules;
• scaling
• superficial wounds (erosion);
• worsening or recurrence of eczema; skin cracks. Topical use of anti-inflammatory drugs, so-called corticosteroids (like the active ingredient in Advantan cutaneous emulsion) may cause the following adverse events (frequency not known)
• Thinning of the skin (atrophy)
• skin dryness,
• redness (erythema),
• appearance of red spots,
• inflammation of hair follicles (folliculitis),
• stretch marks,
• acne,
• specific skin inflammation in the area of the upper lip or chin (perioral dermatitis);
• allergic skin reactions (contact dermatitis),
• changes in skin color,
• abnormal hair growth on the body,
• side effects may occur not only in the treated area, but also in other areas of the body. This happens if the active ingredient (a corticosteroid) is absorbed by the body through the skin. This may, for example, increase intraocular pressure (glaucoma),

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through the
national reporting system, at the address:
. By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Advantan cutaneous emulsion

Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 30° C.
Do not use Advantan cutaneous emulsion after the expiry date indicated on the tube and the packaging
after EXP. The expiry date refers to the last day of the month.
The validity after first opening of the tube is 3 months.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Advantan cutaneous emulsion contains

• The active ingredient is: methylprednisolone aceponate (MPA). The excipients are: medium chain triglycerides, triglycerides of caprylic-capric-myristic-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 (of creamy consistency) and is available in tubes of:

creamy) and is available in tubes of:

• 20 g
• 50 g Not all pack sizes may be marketed. Marketing Authorisation Holder and ManufacturerMarketing 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
Distributor in Italy:
LEO Pharma S.p.A., Via Elio Vittorini 129 - 00144 Rome

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Austria, Finland, Germany, Italy, Portugal: Advantan
Spain: Adventan