Elocon

PACKAGE LEAFLET

Package leaflet: information for the patient

Elocon 0.1% cream, 0.1% ointment

mometasone furoate
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, talk to 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 using 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 functions, with an important role in controlling inflammation.
Elocon is indicated for 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, vesicles, small superficial wounds, and crusts that appear following contact with certain substances;
• Seborrheic dermatitis, a skin eruption affecting areas rich in sebaceous glands such as the scalp, face, chest, and ears;
• Irritant dermatitis, characterized by blisters, scaling, crusting, itching, and skin thickening;
• Neurodermatitis, characterized by itching and scaling;
• Stasis eczema, characterized by darker areas, red spots, thin or sometimes thickened patches, with itching and pain;
• Dyshidrotic eczema (dyshidrosis), characterized by small, often itchy blisters containing a clear fluid;
• Sunburn (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 disorders such as facial rosacea, which manifests as widespread redness in the central part of the face;
• if you have acne vulgaris (common acne);
• if you have cutaneous atrophy (thinning of the skin);
• if you have perioral dermatitis (red skin eruptions around the mouth);
• if you have genital or perianal pruritus (itching);
• if your baby has diaper rash;
• if you have impetigo or pyoderma, bacterial skin infections characterized by small blisters filled with clear fluid, which later become filled with pus and appear bright yellow;
• if you have viral skin infections (e.g. herpes simplex, herpes zoster, varicella, common warts, genital warts, molluscum contagiosum);
• if you have candidiasis or dermatophytosis, 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.
Your doctor will pay particular attention if Elocon is used for prolonged periods, over a large area of skin, in skin folds or on lesions, and especially if it is applied under occlusive dressings (non-breathable, e.g. polyethylene). This is because the medicine may then pass into the bloodstream and may affect certain hormones and blood and urinary sugar levels.
Regardless of age, prolonged continuous therapy should be avoided.
If you apply the medicine to the face, do not use occlusive dressings and limit treatment duration to 5 days.
The medicine may alter the appearance of certain skin lesions, making diagnosis more difficult for the doctor and potentially delaying healing.
If you have psoriasis, your doctor will monitor the use of Elocon carefully.
Do not let Elocon come into contact with the eyes, including the eyelids, due to the risk—although very rare—of increased intraocular pressure (glaucoma) and cataract formation.
If you develop irritation or an excessive reaction while using Elocon, stop treatment immediately and contact your doctor.
If you develop an infection while using Elocon, consult your doctor, who will recommend appropriate treatment. You may need to stop using Elocon until the infection is adequately controlled.
All adverse effects reported after systemic use of corticosteroids (e.g. taken orally) may also occur with corticosteroids applied locally to the skin (topical use), especially in infants and children.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children
Prolonged continuous administration may interfere with a child's growth and development. Therefore, the doctor will prescribe the smallest amount of medicine capable of achieving an effective therapeutic response. When using a dose equivalent to that used in adults, children may experience more pronounced adverse effects than adults.
Occlusive dressings must not be used in children. Diapers may act as occlusive dressings.
Use Elocon with caution in children aged two years and older.
The use of Elocon is not recommended in children under two years of age.

Other medicines and Elocon
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
To date, no interactions with other medicines are known for Elocon.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are pregnant or breastfeeding, use this medicine only if strictly necessary and under direct medical supervision. Avoid application over large areas of the body or for prolonged periods.
There are insufficient data on the safety of Elocon use in pregnant women, and therefore the risk of potential effects on the human fetus is unknown. As with other topically applied corticosteroids, it is possible that corticosteroid passage through the placenta may affect fetal growth.
If you are pregnant, your doctor will prescribe Elocon only if the potential benefit justifies the potential risk to you or the fetus.
It is not known whether the medicine passes into breast milk. If you are breastfeeding, your doctor will carefully evaluate whether to prescribe Elocon. Discontinue breastfeeding during prolonged treatment or high-dose therapy.

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

Elocon 0.1% ointment contains propylene glycol stearate (E477)
Propylene glycol may cause skin irritation. Since this medicine contains propylene glycol, do not use it on open wounds or extensive areas of damaged skin (such as burns) without first consulting your doctor or pharmacist.

3. How to use Elocon

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Apply Elocon once daily.
Apply a thin layer of cream or ointment, in sufficient quantity to cover the entire affected area, and gently massage until fully absorbed.
In most cases, occlusive dressings are not required.
Your doctor will advise you on the duration of treatment.
If you use more Elocon than you should
Avoid excessive and prolonged use of Elocon, as it may cause adrenal gland dysfunction, which is generally reversible. In such cases, your doctor will advise you to stop treatment, reduce the frequency of applications, or switch to another medicine.
The amount of corticosteroids contained in each package is so low that accidental oral ingestion is unlikely to cause any harmful effects.
If a large amount of Elocon is accidentally ingested, contact your doctor immediately or go to the nearest hospital.
If you forget to use Elocon
Do not apply a double dose to make up for a missed application.
If you stop using Elocon
Do not stop treatment abruptly, as you may develop symptoms such as skin redness, stinging, and burning. Discontinue treatment gradually, for example by applying intermittently before stopping completely.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

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

• dry skin
• skin irritation
• skin inflammation (dermatitis)
• skin inflammation with red rash around the mouth (perioral dermatitis)
• skin maceration
• acute skin inflammation with itching and sweat retention under the skin layers (miliaria)
• dilation 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 from the available data)

• infections
• clusters of boils (furunculosis)
• altered sensation in limbs or other body parts, often accompanied by tingling (paraesthesia)
• skin reaction due to contact (contact dermatitis)
• loss of skin colour (hypopigmentation)
• increased hair growth (hypertrichosis)
• skin streaks
• development of acne (acneiform dermatitis)
• thinning of the skin (atrophy)
• pain and reactions at the site where the medicine was applied
• blurred vision

If used for a prolonged period, this medicine may affect certain hormones. In children, who are more sensitive, chronic therapy with corticosteroids may interfere with growth and development.

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. 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 stated on the packaging after "Expiry".
The expiry date refers to the last day of that month.
Elocon 0.1% cream: do not store above 25°C.
Elocon 0.1% ointment: this medicine requires no special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Elocon 0.1% cream contains

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

What Elocon 0.1% ointment contains

• The active substance is mometasone furoate: 1 g of ointment contains 1 mg of mometasone furoate.
• The other components are: xylityl glycol, stearate glycol propylene (E477), white wax, white soft paraffin, purified water.

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

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

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

Patient information leaflet

Elocon 0.1% cutaneous solution

mometasone furoate
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to 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 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

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 functions, with an important role in controlling inflammation.
Elocon is indicated for 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, vesicles, small superficial wounds, and crusts that appear upon contact with certain substances;
• Seborrheic dermatitis, a skin eruption affecting areas rich in sebaceous glands such as the scalp, face, chest, and ears;
• Irritant dermatitis, characterized by blisters, scaling, crusts, itching, and skin thickening;
• Neurodermatitis, characterized by itching and scaling;
• Stasis eczema, characterized by darker areas, red spots, thin or sometimes thickened skin, with itching and pain;
• Dyshidrosis, characterized by small, often itchy blisters containing clear fluid;
• Sunburn (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 disorders such as facial rosacea, which manifests as widespread redness in the central area of the face;
• if you have common acne (acne vulgaris);
• if you have cutaneous atrophy (thinning of the skin);
• if you have perioral dermatitis (red skin eruptions around the mouth);
• if you have genital or perianal itching;
• if your child has diaper rash;
• if you have impetigo or pyoderma, bacterial skin infections characterized by small blisters filled with clear fluid, which later become filled with pus and turn bright yellow;
• if you have viral skin infections (e.g. herpes simplex, herpes zoster, chickenpox, common warts, genital warts, molluscum contagiosum);
• if you have candidiasis or dermatophytosis, 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.
Your doctor will pay particular attention if Elocon is used for prolonged periods, over large areas of skin, in skin folds and creases, or especially if it is applied under occlusive dressings (non-breathable, e.g. polyethylene). This is because the medicine may pass into the bloodstream and may affect certain hormones and blood and urine sugar levels.
Regardless of age, prolonged continuous therapy should be avoided.
If you apply the medicine to the face, do not use occlusive dressings and limit treatment duration to 5 days.
The medicine may alter the appearance of certain skin lesions, making diagnosis more difficult for the doctor and potentially delaying healing.
If you have psoriasis, your doctor will monitor the use of Elocon carefully.
Avoid contact of Elocon with the eyes, including the eyelids, due to the risk—although very rare—of increased eye pressure (glaucoma) and cataract formation.
If you develop irritation or an excessive reaction while using Elocon, stop treatment immediately and inform your doctor.
If you develop an infection while using Elocon, consult your doctor, who will recommend appropriate treatment. You may need to stop using Elocon until the infection is adequately controlled.
All adverse effects reported after systemic use of corticosteroids (e.g. taken orally) may also occur with corticosteroids applied locally to the skin (topical use), especially in infants and children.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children
Prolonged continuous treatment may interfere with a child's growth and development. Therefore, the doctor will prescribe the smallest amount of medicine needed to achieve an effective therapeutic response. When using doses equivalent to those in adults, children may experience more pronounced adverse effects than adults.
Occlusive dressings must not be used in children. Diapers may act as occlusive dressings.
Use Elocon with caution in children aged two years and 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 with other medicines are known for Elocon.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are pregnant or breastfeeding, use this medicine only if strictly necessary and under direct medical supervision. Avoid application over large areas of the body or for prolonged periods.
There are insufficient data on the safety of Elocon use in pregnant women, and therefore the risk of potential effects on the human fetus is unknown. As with other topically applied corticosteroids, the possibility that fetal growth may be affected by 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 to you or the fetus.
It is not known whether the medicine passes into breast milk. If you are breastfeeding, your doctor will carefully evaluate whether to prescribe Elocon. Discontinue breastfeeding during prolonged treatment or when high doses are used.

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

Elocon 0.1% cutaneous solution contains propylene glycol (E1520)
Propylene glycol may 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 first consulting your doctor or pharmacist.

3. How to use Elocon

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply Elocon once daily.
Apply a few drops of the topical solution, in sufficient quantity to cover the entire affected area, gently massaging 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 adrenal gland dysfunction, which is usually reversible. In such a case, your doctor will advise you to stop treatment, reduce the frequency of applications, or switch to another medicine.
The amount of corticosteroids contained in each package is so low that accidental oral ingestion is unlikely to have any harmful effect.
If a large amount of Elocon is accidentally ingested, contact your doctor immediately or go to the nearest hospital.

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

If you stop using Elocon
Do not stop treatment abruptly, as you may develop symptoms such as skin redness, stinging, and burning. Discontinue treatment gradually, for example by using it intermittently before stopping completely.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Rare side effects (may affect up to 1 in 1,000 people)

• dry skin
• skin irritation
• skin inflammation (dermatitis)
• skin inflammation with red rash around the mouth (perioral dermatitis)
• skin maceration
• acute skin inflammation with itching and sweat retention under the skin layers (miliaria)
• dilation 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 from the available data)

• infections
• clusters of boils (furunculosis)
• altered sensation in limbs or other body parts, often accompanied by tingling (paraesthesia)
• skin reaction due to contact (contact dermatitis)
• loss of skin colour (hypopigmentation)
• increased hair growth (hypertrichosis)
• skin streaks
• acne-like eruptions (acneiform dermatitis)
• thinning of the skin (atrophy)
• pain and reactions at the site of application
• blurred vision

Prolonged use of this medicine may affect certain hormones. In children, who are more sensitive, chronic therapy with corticosteroids may interfere with growth and development.
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 appropriate reporting system.
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 stated on the carton 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 via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Elocon 0.1% cutaneous solution contains

• The active substance is mometasone furoate: 1 g of cutaneous solution contains 1 mg of mometasone furoate.
• The other components are: isopropyl alcohol, propylene glycol (E1520), hydroxypropylcellulose, monobasic sodium phosphate dihydrate, diluted phosphoric acid, purified water.

Description of the appearance of Elocon and contents of the pack
Elocon 0.1% cutaneous solution – 30 mL bottle.
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