ETACORTILEN 1,5 MG/ML Eye drops, solution

Зміст інструкції

1. Etacortilen 1.5 mg/ml Ophthalmic Gel
   1. What Etacortilen is and what it is used for
   2. What you need to know before using Etacortilen
2. Etacortilen does not affect the ability to drive vehicles or use machinery.
   1. How to use Etacortilen
   2. Possible side effects
   3. How to store Etacortilen
   4. Contents of the pack and other information
3. Etacortilen 1.5 mg/ml Eye Drops, solution
   1. What is Etacortilen and what is it used for
   2. What you need to know before using Etacortilen
   3. How to use Etacortilen
4. Etacortilen to avoid irritation, lesions or sudden increase in pressure
   1. Possible side effects
   2. How to store Etacortilen
   3. Package Contents and Other Information

Etacortilen 1.5 mg/ml Ophthalmic Gel

Desametasone sodium phosphate

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

1. What Etacortilen is and what it is used for

Etacortilen contains the active ingredient desametasone sodium phosphate, a
corticosteroid with anti-inflammatory activity.
Etacortilen is indicated in the treatment of spring conjunctivitis, allergic,
blepharitis and allergic blepharoconjunctivitis, allergic keratoconjunctivitis, scleritis,
episcleritis and uveitis.
Contact your doctor if you do not notice an improvement or if you notice a worsening at the end of the prescribed therapy.

2. What you need to know before using Etacortilen

Do not use Etacortilen
Do not use Etacortilen if you are allergic to desamethasone sodium phosphate or any
of the other ingredients of this medicine (listed in section 6).
Also do not use Etacortilen in case of: increased intraocular pressure, Herpes simplex,
corneal viral infections in acute ulcerative phase, conjunctivitis with ulcerative keratitis
even in the initial phase (positive fluorescein test), tuberculosis and
fungal infections of the eye, acute purulent ophthalmias, purulent conjunctivitis, purulent and herpetic blepharitis, hordeolum, corneal lesions or abrasions.
It is contraindicated in children under three years of age; it is also generally
contraindicated in pregnancy and breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before using Etacortilen.
Prolonged use of corticosteroids can cause an increase in intraocular pressure. Ask your doctor to check your intraocular pressure if you are using
corticosteroids for more than two weeks. Prolonged use over time (1 to 4
years) and high doses of corticosteroids for ophthalmic use can
lead to clouding of the lens (posterior subcapsular cataract)
(see section 4).
The use of corticosteroids in the presence of viral infections or in the presence of
bacterial, viral or fungal conjunctivitis may worsen the
disease or mask the signs of infection progression (see section
2 “Do not use Etacortilen”).
The use of corticosteroids is permitted in herpetic keratitis only under strict
supervision of the ophthalmologist.
The use of corticosteroids in the presence of lesions delays tissue healing,
promoting the onset and spread of any infections.
In all these cases, consult your doctor before using Etacortilen.
This medicine contains 0.12 mg of phosphates per drop equivalent to 2.43
mg/ml.
If you have severe damage to the outermost transparent layer of the eye (the cornea), the
phosphates may, in very rare cases, cause opaque spots on the cornea due to
calcium accumulation during treatment.
Contact your doctor if you feel swelling and weight gain around the trunk and on
the face, as these are usually the first manifestations of a
syndrome called Cushing's syndrome. Suppression of adrenal gland function may develop after discontinuation of prolonged or intensive treatment with Etacortilen. Contact your doctor before stopping
treatment on your own. These risks are particularly important in children and in
patients treated with a medicine called ritonavir or cobicistat.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents
Etacortilen is contraindicated in children under 3 years of age. In children from 3 to
12 years of age, the product should be administered only when absolutely necessary and under the direct
control of the doctor.

Other medicines and Etacortilen
Tell your doctor or pharmacist if you are taking, have recently taken or
may take any other ophthalmic products or other medicines, including
over-the-counter medicines.
Consult your doctor if you are using ritonavir or cobicistat, as they may
increase the level of desamethasone in the blood.

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.
Use during pregnancy
This medicine should be administered during pregnancy only when absolutely
necessary and under the direct control of the doctor.
Use during breastfeeding
Etacortilen is generally contraindicated during breastfeeding.

Driving and operating machinery

Etacortilen does not affect the ability to drive vehicles or use machinery.

As with any ophthalmic drug, if transient blurred vision occurs during use, wait for vision to return to clarity before driving or using machinery.

3. How to use Etacortilen

Use this medicine following exactly the instructions of your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one drop of ophthalmic gel 3 - 4 times a day or as prescribed by your doctor.

Use in children and adolescents
Etacortilen should be administered to children from 3 to 12 years of age only when absolutely necessary and under the direct control of the doctor.

Instructions for use

• 1) Wash your hands thoroughly.
• 2) Make sure the single-dose container is intact.
• 3) Detach the single-dose container from the strip.
• 4) Hold the single-dose container by the base.
• 5) Shake downwards.
• 6) Open by twisting the top and pulling.
• 7) Apply the gel, taking care not to touch the eye, eyelid or any other surface with the tip of the single-dose container; this can avoid contamination.

If you use more Etacortilen than you should
In case of overdose, temporarily and gradually discontinue the use of Etacortilen to avoid irritation, injury or a sudden increase in intraocular pressure (acute glaucoma). Contact your doctor or pharmacist immediately.

If you accidentally ingest the product, immediately notify your doctor or go to the nearest hospital, and drink fluids to dilute it.

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

If you stop using Etacortilen
You should not stop treatment without consulting your doctor.
If you have any doubts 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 everyone will experience them.
The following side effects may occur with the use of Etacortilen:
Effects on the body:

• Allergic reactions (hypersensitivity)

The following side effects have been reported with medicines belonging to the same
group of medicines as Etacortilen (corticosteroids):
Effects on the eye:

• opacity of the lens that alters vision (subcapsular cataract)
• eye infection (including bacterial, fungal and viral infections)
• eye irritation
• perforation of the eye (scleral or corneal perforation)
• increased pressure in the eye
• eye disease due to increased pressure inside the eye (glaucoma)
• burning sensation in the eye
• blurred vision (frequency not known)

In very rare cases, some patients with severe damage to the clear layer in the front
part of the eye (cornea) have developed opaque spots on the cornea due to
calcium accumulation during treatment.
Unknown side effects (frequency cannot be defined based on available data):
Hormonal problems: increased hair growth on the body (especially in
women), weakness and muscle atrophy, purple stretch marks on the skin of the body,
increased blood pressure, irregular or absent menstrual cycle, changes in
protein and calcium levels in the body, delayed growth in children and
adolescents, and swelling and weight gain of the body and face (called “Cushing’s
syndrome”) (see section 2 “Special warnings”).
In all these cases, it is appropriate to discontinue treatment and seek adequate
therapy.

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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can contribute to providing more
information on the safety of this medicine.

5. How to store Etacortilen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the
package after EXP.
The expiry date refers to the last day of that month and to the product
intact, correctly stored.
Do not store at a temperature above 25°C.
Single-dose containers must be used immediately after their
opening; any remaining medicine must be discarded.
After opening the aluminium sachet, the containers must be used
within 28 days: after this period, any remaining containers must be
discarded.
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 to
protect the environment.

6. Contents of the pack and other information

What Etacortilen contains

• The active ingredient is desamethasone sodium phosphate; 1 ml of gel contains 1.5 mg of desamethasone sodium phosphate.
• The other ingredients are: sodium citrate, sodium phosphate monobasic monohydrate, disodium phosphate dodecahydrate, xanthan gum, purified water.

How Etacortilen looks and contents of the pack
Etacortilen is an ophthalmic gel available in 5 single-dose containers of 0.4 ml of
gel inside an aluminum sachet.
Packs of 20 single-dose containers.

Marketing Authorisation Holder and Manufacturer:
SIFI S.p.A. - Via Ercole Patti, 36 – 95025 Aci S. Antonio (CT)
Detailed and updated information for this product is available by
scanning the QR code, reported on the product packaging, with a
smartphone. The same information is also available at the following URL:
http://qr.sifigroup.com/1g103130/ ”.
[QR code pictogram]

Etacortilen 1.5 mg/ml Eye Drops, solution

Desametasone sodium phosphate

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 could 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

• 7. What is Etacortilen and what it is used for
• 8. What you need to know before using Etacortilen
• 9. How to use Etacortilen
• 10. Possible side effects
• 11. How to store Etacortilen
• 12. Contents of the pack and other information

7. What is Etacortilen and what is it used for

Etacortilen contains the active ingredient desametasone sodium phosphate, a
corticosteroid with anti-inflammatory activity.
Etacortilen is indicated in the treatment of spring conjunctivitis, allergic,
blepharitis and allergic blepharoconjunctivitis, allergic keratoconjunctivitis, scleritis,
episcleritis and uveitis.
Contact your doctor if, at the end of the prescribed therapy, you do not notice an
improvement or if you notice a worsening.

8. What you need to know before using Etacortilen

Do not use Etacortilen
Do not use Etacortilen if you are allergic to desamethasone sodium phosphate or to any
of the other ingredients of this medicine (listed in section 6).
Also, do not use Etacortilen in case of: ocular hypertension, Herpes simplex,
corneal viral infections in an acute ulcerative stage, conjunctivitis with ulcerative
keratitis even in the early stages (positive fluorescein test), tuberculosis and
fungal infections of the eye, acute purulent ophthalmitis, purulent conjunctivitis,
purulent and herpetic blepharitis, hordeolum, corneal lesions or abrasions.
It is contraindicated in children under three years of age; it is also generally
contraindicated during pregnancy and breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before using Etacortilen.
Prolonged use of corticosteroids can cause an increase in intraocular pressure.
Ask your doctor to check your intraocular pressure if you are using
corticosteroids for more than two weeks. Prolonged use over time (1 to 4
years) and high doses of corticosteroids for ophthalmic use can
lead to clouding of the lens (posterior subcapsular cataract)
(see section 4).
The use of corticosteroids in the presence of viral infections or in the presence of
bacterial, viral or fungal conjunctivitis can promote worsening of the
disease or mask the signs of infection progression (see section
2 “Do not use Etacortilen”).
The use of corticosteroids is permitted in herpetic keratitis only under strict
supervision of the ophthalmologist.
The use of corticosteroids in the presence of lesions delays the healing of damaged tissues,
promoting the onset and spread of any infections.
In all these cases, consult your doctor before using Etacortilen.
This medicine contains 0.18 mg of phosphates per drop, equivalent to 3.66
mg/ml.
If you have severe damage to the outermost transparent layer of the eye (the cornea), the
phosphates may, in very rare cases, cause opaque spots on the cornea due to
calcium accumulation during treatment.
See your doctor if you feel swelling and weight gain around the trunk and on
your face, as these are usually the first signs of a
syndrome called Cushing's syndrome. Suppression of adrenal gland function can develop after discontinuation of prolonged or intensive treatment with Etacortilen. See your doctor before stopping
treatment on your own. These risks are particularly important in children and in
patients treated with a medicine called ritonavir or cobicistat.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents
Etacortilen is contraindicated in children under 3 years of age.
In children from 3 to 12 years of age, the product should be administered only in cases of actual
need and under the direct control of the doctor.

Other medicines and Etacortilen
Tell your doctor or pharmacist if you are taking, have recently taken or
may take any other ophthalmic products or other medicines, including
over-the-counter medicines.
See your doctor if you are using ritonavir or cobicistat, as they may
increase the level of desamethasone in the blood.

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.
Use during pregnancy
This medicine should be administered during pregnancy only in cases of
actual need and under the direct control of the doctor.
Use during breastfeeding
Etacortilen is generally contraindicated during breastfeeding.

Driving and using machines
Etacortilen does not affect the ability to drive vehicles or use machines.
As with any eye medicine, if you experience transient blurred vision during use,
wait until your vision is clear before driving or
using machines.

9. How to use Etacortilen

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one eye drop 3 - 4 times a day or as prescribed by your doctor.

Use in children and adolescents
Etacortilen should be administered to children from 3 to 12 years of age only when absolutely necessary and under the direct supervision of a doctor.

Instructions for use

• 8) Wash your hands thoroughly.
• 9) Make sure the single-dose container is intact.
• 10) Detach the single-dose container from the strip.
• 11) Open by twisting the top without pulling.

• 12) Instill the eye drops, taking care not to touch the eye, eyelid, or any other surface with the tip of the single-dose container; this will help avoid contamination.

If you use more Etacortilen than you should
In case of overdose, temporarily and gradually discontinue use of

Etacortilen to avoid irritation, lesions or sudden increase in pressure

ocular (acute glaucoma). Contact your doctor or pharmacist immediately.
If you accidentally ingest the product, immediately notify your doctor or go to the nearest hospital, and drink fluids to dilute it.

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

If you stop treatment with Etacortilen
Do not stop treatment without consulting your doctor.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

10. Possible side effects

Like all medicines, this medicine can cause side effects, although
not everyone experiences them.
The following side effects may occur with the use of Etacortilen:
Effects on the body:

• Allergic reactions (hypersensitivity)

The following side effects have occurred with drugs belonging to the same
group of medicines as Etacortilen (corticosteroids):
Effects on the eye:

• opacity of the lens that alters vision (subcapsular cataract)
• eye infection (including bacterial, fungal and viral infections)
• eye irritation
• perforation of the eye (scleral or corneal perforation)
• increased pressure in the eye
• eye disease due to increased pressure inside the eye (glaucoma)
• burning sensation in the eye
• blurred vision (frequency not known)

In very rare cases, some patients with severe damage to the clear layer in the front
part of the eye (cornea) have developed opaque spots on the cornea due to
calcium accumulation during treatment.
Unknown side effects (frequency cannot be defined based on available
data):
Hormonal problems: increased hair growth on the body (especially in
women), weakness and muscle atrophy, purple stretch marks on the skin of the body,
increased blood pressure, irregular or absent menstrual cycle, changes in
protein and calcium levels in the body, delayed growth in children and
adolescents, and swelling and weight gain of the body and face (called “Cushing’s
syndrome”) (see section 2 “Special warnings”).
In all these cases, it is appropriate to discontinue treatment and seek adequate
therapy.

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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can contribute to providing more
information on the safety of this medicine.

11. How to store Etacortilen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the
pack after SCAD.
The expiry date refers to the last day of that month and to the product
intact, correctly stored.
Do not store at a temperature above 25°C.
Single-dose containers must be used immediately after their
opening; any remaining medicine must be discarded.
After opening the aluminium sachet, the containers must be used
within 28 days: after this period any remaining containers must be
discarded.
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 to
protect the environment.

12. Package Contents and Other Information

What Etacortilen contains

• The active ingredient is desamethasone sodium phosphate; 1 ml of solution contains 1.5 mg of desamethasone sodium phosphate .
• The other ingredients are: sodium citrate, monobasic sodium phosphate monohydrate, disodium phosphate dodecahydrate, purified water.

How Etacortilen looks and package contents
Etacortilen is an eye drop, solution, available in 5 single-dose containers of 0.3
ml of eye drops within an aluminum sachet.
Packs of 10 or 20 single-dose containers.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
SIFI S.p.A. - Via Ercole Patti, 36 – 95025 Aci S. Antonio (CT)
“Detailed and up-to-date information for this product is available by
scanning the QR code, reported on the product packaging, with a
smartphone. The same information is also available at the following URL:
http://qr.sifigroup.com/1g103110 .
[QR code pictogram]