ELOCON 0.1% Krem

Treść ulotki

1. Elocon 0.1% cream, 0.1% ointment
   1. What Elocon is and what it is used for
   2. What you need to know before using Elocon
   3. How to use Elocon
   4. Possible side effects
   5. How to store Elocon
   6. Contents of the pack and other information
2. Elocon 0.1% cutaneous solution
   1. What Elocon is and what it is used for
   2. What you need to know before using Elocon
   3. How to use Elocon
   4. Possible side effects
   5. How to store Elocon
   6. Contents of the pack and other information

Elocon 0.1% cream, 0.1% ointment

mometasone furoate

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

1. What Elocon is and what it is used for

Elocon contains mometasone furoate, which belongs to a class of medicines called
corticosteroids.
Corticosteroids are hormones that perform numerous activities, with an important function in
controlling inflammation.
Elocon is indicated in the treatment of the following skin diseases (dermatoses) that respond to
corticosteroid therapy in adults and children:

• Psoriasis, characterized by red patches, thickening, silvery-white scaling and sometimes itching;
• Atopic dermatitis, characterized by itching, redness, scaling and skin elevations;
• Contact dermatitis, characterized by redness, scaling, small blisters, bullae, superficial small wounds and crusts that occur when coming into contact with certain substances;
• Seborrheic dermatitis, a skin rash that affects areas rich in sebaceous glands such as the scalp, face, chest and ears;
• Irritant dermatitis, characterized by vesicles, scaling, crusts, itching and thickening of the skin;
• Neurodermatitis, characterized by itching and scaling;
• Stasis eczema, characterized by darker areas, with red, thin, sometimes thickened spots, with the presence of itching and pain;
• Dyshidrosis, characterized by small vesicles often itchy, containing a clear liquid;
• Solar erythema, characterized by itching, pain, burning sensation and the presence of blisters.

2. What you need to know before using Elocon

Do not use Elocon

• if you are allergic to mometasone furoate, to other corticosteroids or to any of the other ingredients of this medicine (listed in section 6);
• if you have other skin conditions such as rosacea, which manifests with widespread redness in the central part of the face;
• if you have juvenile acne (acne vulgaris);
• if you have skin atrophy (thinning of the skin);
• if you have perioral dermatitis (red skin rashes around the mouth);
• if you have itching in the genital area and around the anus;
• if your child has diaper rash;
• if you have impetigo or pyoderma, bacterial skin infections characterized by blisters filled with clear fluid, which subsequently fill with pus, taking on a bright yellow color;
• if you have viral skin infections (for example herpes simplex, herpes zoster and varicella, common warts, acuminata condyloma, contagious molluscum);
• if you have candida or dermatophytes, skin diseases caused by parasites or fungi;
• if you suffer from tuberculosis, a disease that usually affects the lungs;
• if you suffer from syphilis, a sexually transmitted infectious disease;
• if you have skin reactions following vaccinations;
• if you suffer from scabies, a contagious skin infection caused by mites;
• on wounds or skin ulcerations.

Warnings and precautions
Consult your doctor or pharmacist before using Elocon.
The doctor will pay particular attention in cases where Elocon is used for long periods, on
a large surface of skin, in the folds and lesions and especially if it is applied under an
occlusive dressing (non-breathable, e.g. polyethylene). This is because the medicine in these cases
can pass into the blood and can affect some hormones and blood sugar and urine levels.
Regardless of age, you should avoid continuous therapy for a prolonged period of time.
If you apply the medicine to the face, do not use occlusive dressings and limit the duration of treatment to
5 days.
The medicine may alter the appearance of some lesions, creating difficulties in diagnosis for
the doctor, resulting in a slowing of healing.
If you suffer from psoriasis, the doctor will carefully monitor the use of Elocon.
Do not allow Elocon to come into contact with the eyes, including the eyelids, due to the risk, albeit very
rare, of increased pressure in the eye (glaucoma) and cataracts.
If you develop irritation or an excessive response with the use of Elocon, stop treatment and
immediately inform your doctor.
If you develop an infection during the use of Elocon, consult your doctor, who will advise you on appropriate
treatment. It may be necessary to stop using Elocon until the infection is
adequately controlled.
All adverse effects that are reported after systemic use of corticosteroids (administered
for example by mouth) can also occur with corticosteroids applied locally to the skin
(topical use), especially in infants and children.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children
Continuous administration for a prolonged period of time can interfere with the growth and
development of the child, therefore the doctor will prescribe the smallest amount of medicine capable of
achieving an effective therapeutic response. Using doses equivalent to those of
adults in children can manifest greater adverse effects than those that manifest in
adults.
Occlusive dressings should not be used in children. The diaper can act as an occlusive
dressing.
Use Elocon with caution in children aged two years or older.
The use of Elocon is not recommended in children under two years of age.

Other medicines and Elocon
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
To date, no interactions of other medicines with Elocon are known.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.
If you are pregnant or breastfeeding, use this medicine only if absolutely
necessary and under the direct supervision of your doctor. Also avoid application to large areas of
the body surface or for prolonged periods of time.
There is no adequate evidence on the safety of using Elocon in pregnant women, and therefore the
risk of some effects on the human fetus is unknown. As with other corticosteroids applied
locally, the possibility that fetal growth may be affected by the passage of the corticosteroid through the placenta should be considered.
If you are pregnant, your doctor will prescribe Elocon only if the potential benefit justifies the potential risk
for you or the fetus.
It is not known whether the medicine passes into breast milk. If you are breastfeeding, your doctor will carefully
assess whether to prescribe you Elocon. Stop breastfeeding in cases of prolonged or high-dose treatment.

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

Elocon 0.1% ointment contains stearyl propylene glycol (E477)
Propylene glycol can cause skin irritation. Since this medicine contains propylene
glycol, do not use it on open wounds or large areas of damaged skin (such as burns) without having
spoken to your doctor or pharmacist.

3. How to use Elocon

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Apply Elocon once a day.
Spread a thin layer of cream or ointment, in sufficient quantity to cover the entire
affected area, massaging gently until completely absorbed.
In most cases, an occlusive dressing is not required.
Your doctor will inform you about the duration of treatment.

If you use more Elocon than you should
Avoid excessive and prolonged use of Elocon, as it may cause malfunction of the
adrenal glands, generally reversible. In such cases, your doctor will advise you to stop the
treatment, reduce the frequency of applications or replace Elocon with another medicine.
The amount of corticosteroids contained in each package is so low as to have little or no harmful
effect in the unlikely event of accidental oral ingestion.
In case of accidental intake of an excessive dose of Elocon, immediately inform your doctor
or go to the nearest hospital.

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

If you stop using Elocon
Do not abruptly stop therapy, as you may develop symptoms such as skin redness,
stinging pain and burning. Discontinue treatment gradually, for example by continuing in
an intermittent manner before stopping it.
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.

Rare side effects (may affect up to 1 in 1,000 people)

• dry skin
• skin irritation
• skin inflammation (dermatitis)
• skin inflammation with red rashes around the mouth (perioral dermatitis)
• maceration of the skin
• acute skin inflammation with itching and sweat retention in the layers under the skin (miliaria)
• dilatation of superficial blood vessels (telangiectasia)

Very rare side effects (may affect up to 1 in 10,000 people)

• infection involving the upper part of the hair follicle (folliculitis)
• burning sensation
• itching

Side effects with unknown frequency (frequency cannot be estimated based on available data)

• infections
• cluster of boils (furunculosis)
• altered sensitivity of the limbs or other parts of the body frequently accompanied by tingling (paresthesia)
• skin reaction due to contact (contact dermatitis)
• loss of skin color (hypopigmentation)
• increased hair growth (hypertrichosis)
• skin striae
• appearance of acne (acneiform dermatitis)
• thinning of the skin (atrophy)
• pain and reactions at the site where the medicine has been applied
• blurred vision. The medicine used for a prolonged period of time, may affect some hormones. In children, who are more sensitive, chronic therapy with corticosteroids can interfere with growth and development.

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
adverse-reactions. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Elocon

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 pack after “Exp.”
The expiry date refers to the last day of that month.

Elocon 0,1% cream: do not store at a temperature above 25°C.

Elocon 0,1% ointment: this medicine does not require any special storage conditions.
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 Elocon 0.1% cream contains

• The active ingredient is mometasone furoate: 1 g of cream contains 1 mg of mometasone furoate.
• The other ingredients are: hexylene glycol, white wax, soft white paraffin, purified water, hydrogenated phosphatidylcholine, titanium dioxide, aluminium starch octenylsuccinate.

What Elocon 0.1% ointment contains

• The active ingredient is mometasone furoate: 1 g of ointment contains 1 mg of mometasone furoate.
• The other ingredients are: hexylene glycol, propylene glycol stearate (E477), white wax, white petrolatum, purified water.

Description of the appearance of Elocon and contents of the pack
Elocon 0.1% cream - tube of 30 g
Elocon 0.1% ointment - tube of 30 g

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Organon Italia S.r.l.
Piazza Carlo Magno, 21
00162 Roma

Manufacturer:
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium

Elocon 0.1% cutaneous solution

mometasone furoate

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

1. What Elocon is and what it is used for

Elocon contains mometasone furoate, which belongs to a class of medicines called
corticosteroids.
Corticosteroids are hormones that perform numerous activities, with an important function in
controlling inflammation.
Elocon is indicated in the treatment of the following skin diseases (dermatoses), which respond to
corticosteroid therapy in adults and children:

• Psoriasis, characterized by red patches, thickening, silvery-white scaling and sometimes itching;
• Atopic dermatitis, characterized by itching, redness, scaling and skin lesions;
• Contact dermatitis, characterized by redness, scaling, small blisters, bubbles, superficial small wounds and scabs that appear when coming into contact with certain substances;
• Seborrheic dermatitis, a skin rash that affects areas rich in sebaceous glands such as the scalp, face, chest and ears;
• Irritant dermatitis, characterized by vesicles, scaling, scabs, itching and thickening of the skin;
• Neurodermatitis, characterized by itching and scaling;
• Stasis eczema, characterized by darker areas, with red, thin, sometimes thickened spots, with the presence of itching and pain;
• Dyshidrosis, characterized by small, often itchy vesicles containing a clear liquid;
• Solar erythema, characterized by itching, pain, burning sensation and the presence of blisters. Elocon 0.1% cutaneous solution is specifically indicated for the treatment of the scalp and other hairy areas.

2. What you need to know before using Elocon

Do not use Elocon

• if you are allergic to mometasone furoate, to other corticosteroids or to any of the other ingredients of this medicine (listed in section 6);
• if you have other skin conditions such as rosacea, which manifests with widespread redness in the central part of the face;
• if you have teenage acne (acne vulgaris);
• if you have skin atrophy (thinning of the skin);
• if you have perioral dermatitis (red skin rashes around the mouth);
• if you have itching in the genital area and around the anus;
• if your baby has diaper rash;
• if you have impetigo or pyoderma, bacterial skin infections characterized by blisters filled with clear fluid, which subsequently fill with pus, thus taking on a bright yellow color;
• if you have viral skin infections (for example herpes simplex, herpes zoster and varicella, common warts, acuminata condyloma, contagious molluscum);
• if you have candida or dermatophytes, skin diseases caused by parasites or fungi;
• if you suffer from tuberculosis, a disease that usually affects the lungs;
• if you suffer from syphilis, a sexually transmitted infectious disease;
• if you have skin reactions following vaccinations;
• if you suffer from scabies, a contagious skin infection caused by mites;
• on wounds or skin ulcerations.

Warnings and precautions
Talk to your doctor or pharmacist before using Elocon.
The doctor will pay particular attention in cases where Elocon is used for long periods, on
a large area of skin, in the folds and lesions and especially if it is applied under an
occlusive dressing (non-breathable, e.g. polyethylene). This is because the medicine in these cases
can pass into the blood and can affect some hormones and blood sugar and urine levels.
Regardless of age, you should avoid continuous therapy for a prolonged period of time.
If you apply the medicine to the face, do not use occlusive dressings and limit the duration of treatment to
5 days.
The medicine may alter the appearance of some lesions, creating difficulties in diagnosis for the
doctor, resulting in delayed healing.
If you suffer from psoriasis, the doctor will carefully monitor the use of Elocon.
Do not allow Elocon to come into contact with your eyes, including the eyelids, due to the risk, albeit very
rare, of increased eye pressure (glaucoma) and cataracts.
If you develop irritation or an excessive response with the use of Elocon, stop treatment and
immediately inform your doctor.
If you develop an infection during the use of Elocon, consult your doctor, who will advise you on appropriate
treatment. It may be necessary to stop using Elocon until the infection is
adequately controlled.
All side effects that are reported after systemic use of corticosteroids (administered
for example by mouth) can also occur with corticosteroids applied locally to the skin
(topical use), especially in infants and children.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children
Continuous administration for a prolonged period of time can interfere with the growth and
development of the child, therefore the doctor will prescribe the smallest amount of medicine capable of
achieving an effective therapeutic response. Using a dose equivalent to that of
adults in children can manifest greater adverse effects than those that manifest in
adults.
Occlusive dressings should not be used in children. The diaper can act as an occlusive
dressing.
Use Elocon with caution in children aged two years or older.
The use of Elocon is not recommended in children under two years of age.

Other medicines and Elocon
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
To date, no interactions of other medicines with Elocon are known.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.
If you are pregnant or breastfeeding, use this medicine only if absolutely
necessary and under the direct supervision of your doctor. Avoid, however, application to large areas of
the body surface or for prolonged periods.
There is no adequate evidence on the safety of using Elocon in pregnant women, and therefore the
risk of some effects on the human fetus is unknown. As with other corticosteroids applied
locally, the possibility that fetal growth may be affected by the passage of the corticosteroid through the placenta should be considered.
If you are pregnant, your doctor will prescribe Elocon only if the potential benefit justifies the potential risk
for you or the fetus.
It is not known whether the medicine passes into breast milk. If you are breastfeeding, the doctor will carefully
assess whether to prescribe you Elocon. Stop breastfeeding in cases of prolonged or high-dose treatment.

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

Elocon 0.1% cutaneous solution contains propylene glycol (E1520)
Propylene glycol can cause skin irritation. Since this medicine contains propylene
glycol, do not use it on open wounds or large areas of damaged skin (such as burns) without having
spoken to your doctor or pharmacist.

3. How to use Elocon

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have any
doubts, consult your doctor or pharmacist.
Apply Elocon once a day.
Apply a few drops of cutaneous solution, in an amount sufficient to cover the entire affected area,
massaging gently until completely absorbed.
In most cases, an occlusive bandage is not required.
Your doctor will inform you about the duration of treatment.

If you use more Elocon than you should
Avoid excessive and prolonged use of Elocon, as it may cause malfunction of the
adrenal glands, generally reversible. In such cases, your doctor will advise you to discontinue the
treatment, reduce the frequency of applications, or replace Elocon with another medicine.
The amount of corticosteroids contained in each package is so low as to have little or no harmful
effect in the unlikely event of accidental oral ingestion.
In case of accidental intake of an excessive dose of Elocon, immediately inform your doctor
or go to the nearest hospital.

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

If you stop using Elocon
Do not abruptly stop therapy, as you may develop symptoms such as skin redness,
stinging pain and burning. Discontinue treatment gradually, for example by continuing in
an intermittent manner before stopping it.
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.

Rare side effects (may affect up to 1 in 1,000 people)

• dry skin
• skin irritation
• skin inflammation (dermatitis)
• skin inflammation with red rashes around the mouth (perioral dermatitis)
• maceration of the skin
• acute skin inflammation with itching and sweat retention in the layers under the skin (miliaria)
• dilatation of superficial blood vessels (telangiectasia)

Very rare side effects (may affect up to 1 in 10,000 people)

• infection involving the upper part of the hair follicle (folliculitis)
• burning sensation
• itching

Side effects with unknown frequency (frequency cannot be estimated based on available data)

• infections
• cluster of boils (furunculosis)
• altered sensitivity of the limbs or other parts of the body frequently accompanied by tingling (paresthesia)
• skin reaction due to contact (contact dermatitis)
• loss of skin color (hypopigmentation)
• increased hair growth (hypertrichosis)
• skin striae
• appearance of acne (acneiform dermatitis)
• thinning of the skin (atrophy)
• pain and reactions at the site where the medicine has been applied
• blurred vision. The medicine used for a prolonged period of time can affect some hormones. In children, who are more sensitive, chronic therapy with corticosteroids can interfere with growth and development.

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
adverse-reactions.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Elocon

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 pack after “Exp.”
The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Elocon 0.1% cutaneous solution contains

• The active ingredient is mometasone furoate: 1 g of cutaneous solution contains 1 mg of mometasone furoate.
• The other ingredients are: isopropyl alcohol, propylene glycol (E1520), hydroxypropylcellulose, disodium phosphate monohydrate, dilute phosphoric acid, purified water.

Description of the appearance of Elocon and contents of the pack
Elocon 0.1% cutaneous solution - bottle of 30 g.

Marketing authorisation holder and manufacturer

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

Manufacturer:
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium