ECOVAL 1 mg /G Ointment

Зміст інструкції

1. ECOVAL 1 mg/g cream, 1 mg/g ointment
   1. What Ecoval is and what it is used for
   2. What you need to know before using Ecoval
   3. How to use Ecoval
   4. Possible side effects
   5. How to store Ecoval
   6. Contents of the pack and other information
2. ECOVAL 1 mg/g cutaneous emulsion
   1. What Ecoval is and what it is used for
   2. What you need to know before using Ecoval
   3. How to use Ecoval
   4. Possible side effects
   5. How to store Ecoval
   6. Contents of the pack and other information
3. ECOVAL 0,5 mg/g Cutaneous Solution
   1. What is Ecoval and what is it used for
   2. What you need to know before you take Ecoval
   3. How to use Ecoval
   4. Possible side effects
   5. How to store Ecoval
   6. Contents of the pack and other information

ECOVAL 1 mg/g cream, 1 mg/g ointment

betamethasone valerate

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

1. What Ecoval is and what it is used for

Ecoval contains a medicine called betamethasone valerate. Betamethasone valerate belongs to a
group of medicines called corticosteroids, which help to reduce swelling and irritation caused by
skin problems such as:

• eczema (atopic dermatitis)
• seborrheic dermatitis (itching that develops on the face, scalp, chest and back with red, scaly formations)
• allergic contact or irritant dermatitis
• lichen (skin disease characterized by skin lesions of a dry, crusty and scaling appearance)
• psoriasis (thickened patches of red inflamed skin, often covered with silvery scales)
• neurodermatitis (skin condition characterized by chronic itching or scaling)
• treatment of itching

2. What you need to know before using Ecoval

Do not use Ecoval cream and ointment:

• if you are allergic (hypersensitive) to betamethasone valerate or any of the other ingredients of Ecoval (listed in section 6)
• in children under one year of age
• to treat any of the following skin problems:
• untreated skin infections
• viral skin infections (herpes simplex, chickenpox)
• tuberculous infections (caused by fungi or bacteria)
• acne
• severe redness of the skin, particularly in the central area of the face (rosacea)
• red spots and rash around the mouth (perioral dermatitis)
• itching in the anal and genital area
• itching of the skin without inflammation
• skin lesions (skin ulcers)

Do not use this medicine if any of these conditions apply to you. If you are not sure, talk to your doctor or
pharmacist before using Ecoval.

Warnings and precautions
Talk to your doctor or pharmacist before using this medicine if:

• you have had a previous allergic reaction to other steroids;
• you are applying cream or ointment with an occlusive bandage (in children, a diaper can act as an occlusive bandage). The bandage may facilitate the passage of the active ingredient through the skin, in this way you may accidentally use too much medicine;
• you have psoriasis, your doctor will want to visit you more frequently;
• you are applying cream or ointment to a chronic leg ulcer. In this case, it may increase the risk of local allergic reactions or infections;
• you want to apply the cream or ointment to a large area;
• you are applying cream or ointment to broken skin or in skin folds;
• you are applying cream or ointment near the eyes or eyelids, repeated entry of the cream or ointment into the eyes can cause cataracts and glaucoma;
• you are applying cream or ointment to thin skin such as the face or in children who have thinner skin than adults and may therefore absorb higher amounts of medicine;
• you are elderly and/or suffer from reduced kidney/liver function. In this case, it is advisable to use the smallest amount of medicine for the shortest time required to achieve the desired clinical benefit. Do not use dressings or bandages on the face of children where you have applied cream or ointment, use in children or on the face should be limited to 5 days.

Contact your doctor if you experience blurred vision or other visual disturbances.
If you are not sure whether any of the above conditions apply to you or your child, talk to your doctor
or pharmacist before using this medicine.

Other medicines and Ecoval
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicine.
In particular, be careful if you are taking ritonavir and itraconazole because these medicines
increase the effect of the medicine.

Pregnancy and breastfeeding
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
The administration of betamethasone valerate during pregnancy should be considered only in
cases of real necessity and under the direct control of the doctor.
Use the minimum amount of medicine for the shortest possible time.
Breastfeeding
Topical administration of betamethasone valerate during breastfeeding should be considered in
cases of real necessity.
If you use betamethasone valerate during breastfeeding, avoid applying it to the breast to prevent the
baby from ingesting it.

Driving and using machines
No adverse effects on these activities are known.

Ecoval cream contains chlorocresol and cetostearyl alcohol and liquid paraffin
Ecoval cream contains chlorocresolwhich may cause allergic reactions and cetostearyl alcoholwhich may
cause localized skin reactions (e.g. contact dermatitis).
ECOVAL cream and ointment contain paraffin. During use, avoid smoking or approaching
open flames due to the risk of serious burns. Fabric (clothing, bedding, dressings,
etc.) that has come into contact with this product burns more easily and constitutes a serious fire hazard.
Washing clothes and bedding may reduce the build-up of product but not remove it
completely.

3. How to use Ecoval

Always use Ecoval following the doctor's instructions exactly. If you have any doubts, consult your doctor or
pharmacist.
Cream - Application of the cream is indicated in lesions of any location and is preferable in the
treatment of delicate and moist skin surfaces.
Ointment - Skin irritations of a dry type benefit more from the application
of the ointment.

• Gently apply a small amount of cream or ointment to the surface to be treated 2-3 times a day. When you notice a significant improvement, you can reduce the applications until stopping them.

If your condition worsens or does not resolve within four weeks, consult your doctor who will re-evaluate the
treatment and diagnosis.
Therapy with topical corticosteroids should be gradually discontinued when the disease is
under control and treatment should continue with an emollient cream as maintenance therapy.
Following the sudden interruption of the application of topical corticosteroids, particularly those
potent, a relapse of pre-existing dermatoses may occur.

Use in children
Do not use the treatment for more than 5 days in children without medical supervision and do not use occlusive
bandaging.

Application on the face
Apply Ecoval to the face only if recommended by your doctor. Applications to the face cannot be prolonged
for a long time because the skin of the face thins easily. Do not apply the cream or ointment
to the eyes.

If you use more Ecoval than you should
If, by mistake, you use more Ecoval than you should on some occasions, do not worry. If you accidentally ingest
the medicine, you may feel unwell. Contact your doctor or go to hospital as soon as
possible.

If you forget to use Ecoval

• If you forget to use Ecoval, apply it as soon as you remember, then continue as before.
• Do not apply an extra dose to make up for the missed one.

If you stop using Ecoval
If you use Ecoval regularly, be sure to talk to your doctor 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.
manifest.

Stop using Ecoval and contact your doctor immediately if:

• your skin condition worsens, a widespread rash develops or your skin swells during treatment. You may be allergic to Ecoval, have an infection or need other treatments.
• you have psoriasis with pus under the skin. This can happen very rarely during or after treatment and is known as pustular psoriasis.

Other side effects you may experience when using Ecoval:
Common(may affect up to 1 in 10 people)

• a burning, painful, irritating or itchy sensation when applying the product

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

• an increased risk of infection
• allergic skin reactions in the treated area (local hypersensitivity)
• rash, irregular skin itching or redness of the skin
• thinning and dryness of the skin which can make wrinkles appear more easily
• stretch marks
• thinning of the skin which can make underlying veins more visible
• increased or decreased hair growth or hair loss and changes in skin colour
• weight gain, rounding of the face (moon face)
• delayed weight gain or slowed growth in children
• thinning of the bones which can become weaker and break
• cataracts or increased pressure in the eye (glaucoma)
• increased levels of sugar in the blood and urine
• increased blood pressure
• irritation and pain at the application site

Not known(frequency cannot be estimated from available data)

• blurred vision

The following side effects may also occur locally:
redness, swelling, skin peeling, acne-like eruptions, dilation of small blood vessels in the
skin (capillaries) especially on the face, fragility of blood vessels, purpura, dermatitis with pustules.
Prolonged and/or high-dose use may lead to high blood pressure, feeling tired and weak,
heart rhythm disturbances, low potassium levels in the blood, metabolic alkalosis.

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: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting
side effects you can help provide more information on the safety of this medicine.
Reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Ecoval

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 Exp. The expiry date refers to the last day of that month.
Cream: Do not store at a temperature above 30°C
Ointment: No 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 Ecoval contains
The active ingredient is betamethasone valerate

Cream

• 1 g contains 1.22 mg of betamethasone valerate equivalent to betamethasone 1 mg (0.1% w/w). The other components are: Chlorocresol, Polyoxyethylene cetyl stearyl ether, Cetostearyl alcohol, White petrolatum, Liquid paraffin, Sodium phosphate monobasic, Phosphoric acid or Sodium hydroxide, Purified water.

Ointment

• 1 g contains 1.22 mg of betamethasone valerate equivalent to betamethasone 1 mg (0.1% w/w). The other components are: liquid paraffin, white petrolatum.

Description of the appearance of Ecoval and contents of the pack
Cream in a tube of 30 g.
Ointment in a tube of 30 g.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – Verona

Manufacturer
Cream
Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations)
Harmire Road - Barnard Castle - County Durham - DL12 8DT– United Kingdom
GlaxoSmithKline Pharmaceuticals S.A., ul. Grunwaldzka 189 60-322 Poznan Poland

Ointment
Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations)
Harmire Road - Barnard Castle - County Durham - DL12 8DT– United Kingdom
Aspen Bad Oldesloe GmbH - Industriestrasse 32-36 - 23843 Bad Oldesloe -Germany

Other sources of information
More detailed information on this medicine is available on the AIFA website

ECOVAL 1 mg/g cutaneous emulsion

betametasone valerato

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

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

Contents of this leaflet:

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

2. What Ecoval is and what it is used for

Ecoval contains a medicine called betamethasone valerate. Betamethasone valerate belongs to a
group of medicines called corticosteroids, which help to reduce swelling and irritation caused by
skin problems such as:

• eczema (atopic dermatitis)
• seborrheic dermatitis (itching that develops on the face, scalp, chest and back with red scaly formations)
• allergic or irritant contact dermatitis
• lichen (skin disease characterized by skin lesions of a dry, crusty and scaling appearance).
• psoriasis (thickened patches of red inflamed skin, often covered with silvery scales)
• neurodermatitis (skin condition characterized by chronic itching or scaling)
• treatment of itching

4. What you need to know before using Ecoval

Do not use Ecoval cutaneous emulsion:

• if you are allergic (hypersensitive) to betamethasone valerate or any of the other ingredients of Ecoval (listed in section 6)
• in children under one year of age
• to treat any of the following skin problems:
• untreated skin infections
• viral skin infections (herpes simplex, chickenpox)
• tuberculous infections (caused by fungi or bacteria)
• acne
• severe redness of the skin, especially in the central area of the face (rosacea)
• red spots and rash around the mouth (perioral dermatitis)
• itching in the anal and genital area
• itching of the skin without inflammation
• skin lesions (skin ulcers)

Do not use this medicine if any of these cases apply to you. If you are not sure, talk to your doctor or
pharmacist before using Ecoval.

Warnings and precautions
Talk to your doctor or pharmacist before using this medicine if:

• you have had a previous allergic reaction to other steroids;
• you are applying the emulsion with an occlusive bandage (in children, the diaper can act as an occlusive bandage). The bandage may facilitate the passage of the active ingredient through the skin, in this way you may accidentally use too much medicine;
• you have psoriasis, your doctor will want to visit you more frequently;
• you are applying the emulsion to a chronic leg ulcer. In this case, it may increase the risk of local allergic reactions or infections;
• you want to apply it to a large area;
• you are applying the emulsion to broken skin or in skin folds;
• you are applying the emulsion near the eyes or eyelids, repeated entry of the emulsion into the eyes may cause cataracts and glaucoma;
• you are elderly and/or suffer from reduced kidney/liver function. In this case, the use of the smallest amount of medicine for the shortest time required to achieve the desired clinical benefit is recommended. Do not use dressings or bandages on children's faces where you have applied the emulsion, use in children or on the face should be limited to 5 days.

Contact your doctor if you experience blurred vision or other visual disturbances.
If you are not sure whether any of the above conditions apply to you or your child, talk to your doctor
or pharmacist before using this medicine.

• Due to the flammable nature of Ecoval cutaneous emulsion, you should avoid smoking or being near open flames if you are applying the product, and immediately after use

Other medicines and Ecoval
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
In particular, be careful if you are taking ritonavir and itraconazole because these medicines
increase the effect of the drug.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding, ask
your doctor or pharmacist for advice before using this medicine.
Pregnancy
The administration of betamethasone valerate during pregnancy should only be considered in
cases of real necessity and under the direct control of the doctor.
Use the minimum amount of medicine for the shortest possible time.
Breastfeeding
Topical administration of betamethasone valerate during breastfeeding should be considered in
cases of real necessity.
If you are using betamethasone valerate during breastfeeding, avoid applying it to the breast to avoid the
baby ingesting it.

Driving and using machines
No adverse effects on these activities are known
Ecoval 1mg/g Cutaneous Emulsion contains E218 methyl hydroxybenzoate and cetostearyl alcohol and liquid paraffin
Ecoval 1mg/g Cutaneous Emulsion contains E218 methyl hydroxybenzoate, which may cause allergic reactions
(even delayed).
Ecoval 1mg/g Cutaneous Emulsion contains cetostearyl alcohol, which may cause localized skin reactions
(e.g. contact dermatitis).
ECOVAL lotion contains paraffin. During use avoid smoking or approaching open flames
due to the risk of serious burns. Fabric (clothing, bedding, dressings etc.) that has been in
contact with this product burns more easily and poses a serious fire hazard. Washing of
clothing and bedding may reduce the accumulation of product but not remove it completely.

5. How to use Ecoval

Always use Ecoval following exactly the doctor's instructions. If you have any doubts, consult your doctor or
pharmacist.
The preparation in the form of an emulsion is indicated when small amounts of product need to be applied to
large skin areas or for application in hard-to-reach areas such as, for example, hairy areas. Pay
attention during application due to the flammable nature of the product.
Apply a small amount of emulsion gently to the area to be treated 2-3 times a day.
When you notice a significant improvement, you can reduce the applications until they are discontinued.
If your condition worsens or does not resolve within four weeks, consult your doctor who will re-evaluate the
treatment and diagnosis.
Therapy with topical corticosteroids should be gradually discontinued when the disease is
under control and treatment should continue with an emollient cream as maintenance therapy.
Following the sudden interruption of the application of topical corticosteroids, particularly those
potent, a relapse of pre-existing dermatoses may occur.

Use in children
Do not use the treatment for more than 5 days in children without medical supervision and do not use an occlusive
bandage.

Application to the face
Apply Ecoval to the face only if recommended by your doctor. Applications to the face should not be prolonged
for a long time because the skin of the face thins easily. Do not apply the emulsion to the eyes.

If you use more Ecoval than you should
If, by mistake, you use more Ecoval than you should on some occasions, do not worry. If you accidentally ingest
the medicine, you may feel unwell. Seek your doctor's advice or go to hospital as soon as
possible.

If you forget to use Ecoval

• If you forget to use Ecoval, apply it as soon as you remember, then continue as before
• Do not apply an extra dose to make up for the missed one

If you stop using Ecoval
If you use Ecoval regularly, make sure you talk to your doctor 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.

Stop using Ecoval and contact your doctor immediately if:

• your skin condition gets worse, a widespread rash develops or your skin swells during treatment. You may be allergic to Ecoval, have an infection or need other treatments.
• you have pus-filled psoriasis under the skin. This can happen very rarely during or after treatment and is known as pustular psoriasis.

Other side effects you may notice when using Ecoval:

Common(may affect up to 1 in 10 people)

• a burning, stinging, painful or itchy sensation when applying the product

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

• an increased risk of infection
• allergic skin reactions in the treated area (local hypersensitivity)
• rash, irregular itchy skin or redness of the skin
• thinning and dryness of the skin which can make wrinkles appear more easily
• stretch marks
• thinning of the skin which can make underlying veins more visible
• increased or decreased hair growth or hair loss and changes in skin colour
• weight gain, rounding of the face (moon face)
• delayed weight gain or slowed growth in children
• thinning of the bones which can become weaker and break more easily
• cataracts or increased pressure in the eye (glaucoma)
• increased levels of sugar in the blood and urine
• increased blood pressure
• irritation and pain at the application site

Not known(frequency cannot be estimated from available data)

• blurred vision

The following side effects may also occur locally:
redness, swelling, skin peeling, acne-like eruptions, dilation of small blood vessels in the
skin (capillaries) especially on the face, fragility of blood vessels, purpura, dermatitis with pustules.
Prolonged and/ or high-dose use can lead to high blood pressure, feeling tired and weak,
irregular heartbeat, low potassium levels in the blood, metabolic alkalosis.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national
reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Ecoval

• 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 Scad. The expiry date refers to the last day of that month
• Do not store at a temperature above 25°C
• Keep the container tightly closed when not in use. Flammable content. Keep away from fire, flames or heat. Do not leave the emulsion in direct sunlight.
• 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 Ecoval contains

• The active ingredient is betamethasone valerate: 1 g of cutaneous emulsion contains 1.22 mg of betamethasone valerate equivalent to 1 mg of betamethasone (0.1% w/w)
• The other ingredients are: E218 methyl hydroxybenzoate, xanthan gum, cetostearyl alcohol, liquid paraffin, isopropyl alcohol, glycerol, polyoxyethylene cetyl stearyl ether, citric acid monohydrate, sodium citrate, purified water.

Description of the appearance of Ecoval and contents of the pack
Cutaneous emulsion in 30 g bottle.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – Verona

Manufacturer
Aspen Bad Oldesloe GmbH - Industriestrasse, 32-36 – 23843 Bad Oldesloe - Germany

Other sources of information
More detailed information on this medicinal product is available on the AIFA website

ECOVAL 0,5 mg/g Cutaneous Solution

betamethasone valerate

Read this leaflet carefully before taking 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 experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

3. What is Ecoval and what is it used for

called betamethasone valerate. It belongs to a group of medicines called corticosteroids, which
help to reduce swelling and irritation.
Ecoval is used to reduce redness and itching caused by some scalp problems, such as:

• eczematous dermatitis (allergic inflammation);
• seborrheic eczema (skin inflammation that affects areas rich in sebaceous glands such as the scalp);
• psoriasis (thickened patches of inflamed, red skin, often covered with silvery scales), excluding widespread plaque psoriasis;
• alopecia areata (patchy hair loss);
• dry pityriasis (the scalp is covered with very fine, easily removable scales);
• dandruff (the scalp is covered with larger, greasy, yellowish scales).

6. What you need to know before you take Ecoval

Do not use Ecoval:

• if you are allergic (hypersensitive) to betamethasone valerate or to any of the other ingredients of Ecoval (listed in section 6)
• if you have a scalp infection
• in children under one year of age
• if you have viral infections (herpes simplex)
• if you have skin infections caused by bacteria or fungi (cutaneous tuberculosis)

If any of these apply to you, do not use Ecoval. If you are not sure, talk to your doctor or pharmacist before using Ecoval

Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine if:

• you have had a previous allergic reaction to other steroids
• you are applying the product with an occlusive bandage. The bandage may facilitate the passage of the active ingredient through the skin, in this way you may accidentally use too much medicine.
• you have psoriasis, your doctor will want to see you more frequently;
• you are applying the liquid to broken skin or in the folds of the skin;
• you want to apply it to a large area;
• you are applying the liquid to non-intact skin or in the folds of the skin;
• you are applying the liquid to thin skin such as the face or in children who have thinner skin than adults and may therefore absorb higher amounts of medicine;
• you are elderly and/or suffer from reduced kidney/liver function. In such cases, it is advisable to use the smallest amount of medicine for the shortest time necessary to achieve the desired clinical benefit. Do not use occlusive dressings or bandages in children where you have applied the product, use in children should be limited to 5 days.

Contact your doctor if you experience blurred vision or other visual disturbances.

Other medicines and Ecoval
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Be particularly careful if you are taking ritonavir and itraconazole because these medicines increase the effect of the drug.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
The administration of betamethasone valerate during pregnancy should be considered only in cases of real necessity and under the direct control of the doctor.
Use the minimum amount of medicine for the shortest possible time.
Breastfeeding
Topical administration of betamethasone valerate during breastfeeding should be considered only in cases of real necessity.
If you use betamethasone valerate during breastfeeding, avoid applying it to the breast to avoid the baby ingesting it.

Driving and operating machinery
No adverse effects on these activities are known .

7. How to use Ecoval

Always use Ecoval following the doctor's instructions exactly. If you have any doubts, consult your doctor or
pharmacist.
Apply a small amount of ECOVAL 0.5 mg/g Cutaneous solution 2-3 times a day to the affected area, massaging gently until a visible improvement is achieved; to prolong and
complete the effect, a single daily application or at longer intervals will suffice.
In the treatment of dandruff, the preparation can be applied immediately after washing your hair.
Ecoval cutaneous solution does not grease and does not leave a trace on the hair.

If you use more Ecoval than you should
If you apply too much or ingest it, it may harm you. Talk to your doctor or go to hospital as
soon as possible.

If you forget to use Ecoval

• If you forget to apply Ecoval, apply it immediately as soon as you remember, then continue as before
• Do not apply an extra dose to make up for the missed one

If you stop using Ecoval
If you use Ecoval regularly, make sure to talk to your doctor before stopping its use.
If you have any further questions on 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.
manifest.

Stop taking Ecoval and contact your doctor immediately if:

• your skin condition worsens, a widespread rash develops or your skin swells during treatment. You may be allergic to Ecoval, have an infection or need other treatments.
• you have psoriasis with pus under the skin. This can happen very rarely during or after treatment and is known as pustular psoriasis.

Other side effects you may notice when using Ecoval:

Common(may affect up to 1 in 10 people)

• sensations of burning, pain, irritation or itching when applying the product

Very Rare(may affect up to 1 in 10,000 people)

• an increased risk of infection
• allergic skin reactions in the treated area (local hypersensitivity)
• rash, irregular skin itching or redness of the skin
• thinning and dryness of the skin which can make wrinkles appear more easily
• stretch marks
• thinning of the skin which can make underlying veins more visible
• increased or decreased hair growth or hair loss and change in skin color
• weight gain, rounding of the face (moon face).
• delayed weight gain or slowed growth in children
• thinning of the bones which can become weaker and break
• cataracts or increased pressure in the eye (glaucoma)
• increased levels of sugar in the blood and urine
• increased blood pressure
• irritation and pain at the application site

Not known(frequency cannot be estimated from available data)

• blurred vision

The following side effects may also occur locally:
redness, swelling, skin scaling, acne-like eruptions, dilation of small blood vessels in the
skin (capillaries) especially on the face, fragility of blood vessels, purpura, dermatitis with pustules.
Prolonged and/ or high-dose use may lead to high blood pressure, feeling tired and weak,
heart rhythm disturbances, decreased levels of potassium in the blood, metabolic alkalosis.

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 www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Ecoval

• 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 (exp). The expiry date refers to the last day of that month.
• Do not store at a temperature above 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.
• Keep the container tightly closed when not in use.
• Keep away from fire, flames or heat.
• Do not expose the solution to direct sunlight.

6. Contents of the pack and other information

What Ecoval contains
The active ingredient is betamethasone valerate
100 g of solution contains 0.061 g of betamethasone valerate, equivalent to 0.05 g of betamethasone.
The other ingredients are: carbopol 980, isopropyl alcohol, sodium hydroxide, purified water.

Description of the appearance of Ecoval and contents of the pack
Cutaneous solution - bottle of 30 g

Marketing Authorisation Holder
GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – Verona

Manufacturer
Aspen Bad Oldesloe GmbH – Industriestrasse, 32-36 – 23843 Bad Oldesloe – Germany

Other sources of information
More detailed information on this medicine is available on the AIFA website