Etacortilen

Package leaflet: Information for the patient

Etacortilen 1.5 mg/ml Ophthalmic Gel

Dexamethasone sodium phosphate
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, contact 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 substance dexamethasone sodium phosphate, a
corticosteroid with anti-inflammatory activity.
Etacortilen is indicated for the treatment of vernal conjunctivitis, allergic conjunctivitis,
blepharitis and allergic blepharoconjunctivitis, allergic keratoconjunctivitis, scleritis,
episcleritis, and uveitis.
If you do not notice any improvement or if your condition worsens after completing the prescribed treatment, please consult your doctor.

2. What you need to know before using Etacortilen

Do not use Etacortilen
Do not use Etacortilen if you are allergic to dexamethasone sodium phosphate or to any of the other ingredients of this medicine (listed in section 6).
Also, do not use Etacortilen if you have: elevated intraocular pressure, herpes simplex, acute ulcerative viral infections of the cornea, conjunctivitis with ulcerative keratitis even in the initial phase (positive fluorescein test), tuberculosis or fungal infections of the eye, acute purulent ophthalmia, purulent conjunctivitis, purulent and herpetic blepharitis, styes, or 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 may increase intraocular pressure. Ask your doctor to monitor your intraocular pressure if you use corticosteroids for more than two weeks. Prolonged use over time (from 1 to 4 years) and high doses of ophthalmic corticosteroids may lead to clouding of the lens (posterior subcapsular cataract) (see section 4).
The use of corticosteroids in the presence of viral infections or bacterial, viral, or fungal conjunctivitis may worsen the disease or mask signs of infection progression (see section 2 "Do not use Etacortilen").
The use of corticosteroids in herpetic keratitis is permitted only under strict supervision by an ophthalmologist.
The use of corticosteroids in the presence of tissue damage may delay healing and favor the onset and spread of possible 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), phosphates may very rarely cause opaque corneal deposits due to calcium accumulation during treatment.
Contact your doctor if you experience swelling and weight gain around the trunk and face, as these are usually the first signs of a condition called Cushing's syndrome. Suppression of adrenal gland function may develop after discontinuation of prolonged or intensive treatment with Etacortilen. Consult 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 aged 3 to 12 years, the product should be administered only when strictly necessary and under direct medical supervision.

Other medicines and Etacortilen
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other ophthalmic products or other medicines, including those without a prescription.
Talk to your doctor if you are taking ritonavir or cobicistat, as they may increase the level of dexamethasone in the blood.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.

Use during pregnancy
This medicine should be administered during pregnancy only when clearly needed and under direct medical supervision.

Use during breastfeeding
Etacortilen is generally contraindicated during breastfeeding.

Driving and using machines
Etacortilen does not affect the ability to drive or operate machinery. However, as with any eye medication, if transient blurred vision occurs during use, wait until your vision clears before driving or operating machinery.

3. How to use Etacortilen

Use this medicine exactly as directed by 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 aged 3 to 12 years only when
strictly necessary and under direct medical supervision.
Instructions for use

1. Wash your hands thoroughly.
2. Ensure 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 part 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 helps prevent contamination.

If you use more Etacortilen than you should
In case of overdose, temporarily discontinue and gradually reduce the use of
Etacortilen to avoid irritation, lesions, or sudden increase in intraocular pressure (acute glaucoma). Contact your doctor or pharmacist immediately.
If you accidentally ingest the product, inform your doctor immediately 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 the missed dose.
If you stop using Etacortilen
Do not stop treatment without consulting your doctor.
If you have any doubts about how to use this medicine, consult your doctor or
pharmacist.

4. 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:
Systemic effects:

• Allergic reactions (hypersensitivity)

The following side effects have been reported with medicines belonging to the same
pharmacological group as Etacortilen (corticosteroids):
Eye-related effects:

• Clouding of the lens affecting vision (subcapsular cataract)
• Eye infection (including bacterial, fungal, and viral infections)
• Eye irritation
• Perforation of the eye (scleral or corneal perforation)
• Increased intraocular pressure
• Eye disease due to elevated 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 at the front
of the eye (cornea) have developed opaque spots on the cornea due to calcium
deposition during treatment.
Side effects with unknown frequency (frequency cannot be estimated from the
available data):
Hormonal problems: increased body hair growth (especially in women), muscle
weakness and atrophy, purple stretch marks on the skin, 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 with weight gain in the
body and face (called “Cushing's syndrome”) (see section 2 “Special warnings”).
In all these cases, treatment should be discontinued and appropriate therapy
initiated.
Reporting of side effects
If you experience any side effect, including those not listed in
this leaflet, consult your doctor or pharmacist. You may also report side
effects directly via the national reporting system at the website
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 Etacortilen

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 and to the product kept unopened and properly stored.
Do not store above 25°C.
Single-dose containers must be used immediately after opening; any remaining medicine must be discarded.
After opening the aluminium foil sachet, the containers must be used within 28 days: after this period, any remaining containers must be discarded.
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. Contents of the pack and other information

What Etacortilen contains

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

What Etacortilen looks like and contents of the pack
Etacortilen is an ophthalmic gel available in 5 single-dose containers containing 0.4 ml of gel each, packed in an aluminium pouch.
Pack sizes: 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 on this product is available by scanning the QR code on the product packaging with a smartphone. The same information is also available at the following URL:
http://qr.sifigroup.com/1g103130/ ”.
[QR symbol]

Patient Information Leaflet

Etacortilen 1.5 mg/ml Eye Drops, solution

Sodium dexamethasone phosphate
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 may 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

7. What Etacortilen is 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 Etacortilen is and what it is used for

Etacortilen contains the active substance dexamethasone sodium phosphate, a
corticosteroid with anti-inflammatory activity.
Etacortilen is indicated for the treatment of vernal conjunctivitis, allergic conjunctivitis,
blepharitis and allergic blepharoconjunctivitis, allergic keratoconjunctivitis, scleritis,
episcleritis and uveitis.
If you do not notice improvement or if you notice worsening after completing the prescribed course of treatment, consult your doctor.

8. What you need to know before using Etacortilen

Do not use Etacortilen
Do not use Etacortilen if you are allergic to sodium phosphate dexamethasone or to any of the other ingredients of this medicine (listed in section 6).
Additionally, do not use Etacortilen if you have:

• elevated intraocular pressure (endocular hypertension),
• Herpes simplex,
• active ulcerative viral infections of the cornea,
• ulcerative keratoconjunctivitis even in the early stage (positive fluorescein test),
• tuberculosis or fungal infections of the eye,
• acute purulent ophthalmia,
• purulent or herpetic conjunctivitis,
• purulent or herpetic blepharitis,
• styes,
• corneal lesions or abrasions.

Etacortilen 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 may lead to increased intraocular pressure. Ask your doctor to monitor your intraocular pressure if you use corticosteroids for more than two weeks. Long-term use (from 1 to 4 years) and high doses of ophthalmic corticosteroids may cause clouding of the lens (posterior subcapsular cataract) (see section 4).

Using corticosteroids in the presence of viral infections, or in cases of bacterial, viral, or fungal conjunctivitis, may worsen the disease or mask signs of infection progression (see section 2 "Do not use Etacortilen").

The use of corticosteroids in herpetic keratitis is permitted only under strict supervision by an ophthalmologist.

The use of corticosteroids in the presence of tissue lesions may delay healing and promote the onset and spread of possible 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), phosphates may very rarely cause opaque corneal spots due to calcium accumulation during treatment.

Contact your doctor if you experience swelling and weight gain around the trunk and face, as these are usually the first signs of a condition called Cushing's syndrome. Suppression of adrenal gland function may develop after discontinuation of prolonged or intensive treatment with Etacortilen. Consult 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 aged 3 to 12 years, the product should be administered only when strictly necessary and under direct medical supervision.

Other medicines and Etacortilen
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other ophthalmic products or other medicines, including those not requiring a prescription.

Consult your doctor if you are using ritonavir or cobicistat, as these may increase the level of dexamethasone in the blood.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

Use during pregnancy
This medicine should be administered during pregnancy only when strictly necessary and under direct medical supervision.

Use during breastfeeding
Etacortilen is generally contraindicated during breastfeeding.

Driving and using machines
Etacortilen does not affect the ability to drive or operate machinery.
However, as with any eye medication, if transient blurred vision occurs during use, wait until your vision clears before driving or operating machinery.

9. How to use Etacortilen

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one drop of eye drops 3–4 times daily, or as otherwise prescribed by your doctor.

Use in children and adolescents
Etacortilen should be administered to children aged 3 to 12 years only when clearly necessary and under direct medical supervision.

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. Open by twisting the top part without pulling.
5. Instill the eye drops, taking care not to touch the eye, eyelid, or any other surface with the tip of the single-dose container, to 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 intraocular pressure (acute glaucoma). Contact your doctor or pharmacist immediately.
If you accidentally swallow the product, inform your doctor immediately 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 the missed dose.

If you stop treatment with Etacortilen
Do not stop treatment without first consulting your doctor.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

10. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although
not everyone experiences them.
The following adverse reactions may occur with the use of Etacortilen:
Systemic reactions:

• Allergic reactions (hypersensitivity)

The following adverse reactions have occurred with medicines belonging to the same
drug class as Etacortilen (corticosteroids):
Eye-related reactions:

• Lens opacity affecting vision (subcapsular cataract)
• Eye infection (including bacterial, fungal, and viral infections)
• Eye irritation
• Perforation of the eye (scleral or corneal perforation)
• Increased intraocular pressure
• 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 at the front
of the eye (cornea) developed opaque corneal deposits due to calcium accumulation
during treatment.
Adverse reactions with unknown frequency (frequency cannot be determined from
available data):
Hormonal disorders: increased body hair growth (especially in women), muscle
weakness and atrophy, purple striae on the skin, increased blood pressure,
irregular or absent menstrual cycle, changes in levels of proteins and calcium in the
body, delayed growth in children and adolescents, and swelling with weight gain in
the body and face (called "Cushing's syndrome") (see section 2 "Special warnings").
In all these cases, treatment should be discontinued and appropriate therapy
initiated.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in
this leaflet, consult your doctor or pharmacist. You may also report adverse
reactions directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting adverse reactions, you can help provide 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 stated on the
packaging after EXP.
The expiry date refers to the last day of that month and to the product
in its original, unopened form, correctly stored.
Do not store above 25°C.
Single-dose containers must be used immediately after opening;
any remaining medicinal product must be discarded.
After opening the aluminium foil sachet, the containers must be used
within 28 days: after this period, any remaining containers must be
discarded.
Do not dispose of any medicine via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer in use.
This will help protect the environment.

12. Package contents and other information

What Etacortilen contains

• The active substance is sodium phosphate of dexamethasone; 1 ml of solution contains 1.5 mg of dexamethasone sodium phosphate.
• The other components are: sodium citrate, monobasic sodium phosphate monohydrate, dodecahydrated disodium phosphate, purified water.

What Etacortilen looks like and contents of the pack
Etacortilen is an eye drop solution, available in 5 single-dose containers of 0.3 ml of eye drops inside an aluminum sachet.
Packs containing 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 on this product is available by scanning the QR code shown on the product packaging with a smartphone. The same information is also available at the following URL:
http://qr.sifigroup.com/1g103110 .
[QR symbol]