Label: information for the user

EtaCortilen 1.5 mg/mL eye drops solution

dexamethasone sodium phosphate

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

-This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist,even if they are not listed in this label. See section 4.

1.What is EtaCortilen and how it is used

2.What you need to know before starting to use EtaCortilen

3.How to use EtaCortilen

4.Possible adverse effects

5.Storage of EtaCortilen

6.Contents of the package and additional information

Eatocortilen contains a substance called dexamethasone. It is a corticosteroid that inhibits inflammatory symptoms.

It is indicated for the treatment of non-infectious eye inflammations, such as conjunctivitis, blepharitis, and/or uveitis.

Inform your doctor if the disease does not improve or worsens after the prescribed duration for your treatment.

Do not use Etacortilen:

• If you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6).
• If you have high pressure in the eye (ocular hypertension).
• If you have an eye infection such as Herpes simplex, viral corneal infections in ulcerative stage, tuberculosis, or fungal eye infections, acute purulent conjunctivitis, purulent blepharitis, or Hordeolum.
• If you have conjunctivitis with inflammation and ulcers on the surface of the cornea of the eye (keratitis) even if it is in an early stage.
• If you have corneal damage (corneal lesions and abrasions)

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medication.

It is necessary to closely monitor the eyes during the use of this medication and in particular:

• If the treatment is used for two weeks or more, due to the risk of increased eye pressure.
• If long-term use of ocular corticosteroids (1–4 years) is used, especially at high doses, as they may cause cataract formation (see section 4).
• If you have a viral infection, as the use of corticosteroids may worsen/exacerbate the condition, which may lead to irreversible corneal opacification.
• If you have a condition associated with corneal thinning.
• In case of herpes-related corneal inflammation (keratitis herpética). The use of corticosteroids may delay the healing of the damaged tissue and increase the incidence and spread of infections.
• In case of bacterial, viral, or fungal conjunctivitis, as the topical administration of corticosteroids may mask the evidence of infection progression.
• If you are using other eye drops that contain phosphates (see section 4).

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

Consult 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 occur after interrupting intensive or long-term treatment with this medication. Consult your doctor before stopping treatment on your own. These risks are especially important in children and patients treated with a medication called ritonavir or cobicistat.

In all the cases mentioned above and in case of hypersensitivity to any of the components of the medication, your doctor will discontinue the use of the eye drop and initiate appropriate treatment.

Contact lenses

Your doctor will ask you to remove your contact lenses before applying the eye drop. There is no information on the effect of this product on contact lenses. Therefore, do not use contact lenses until the effects of the eye drop have completely disappeared.

Children and adolescents

The safety and efficacy of this medication have not been established in children.

Long-term use of corticosteroids should be avoided in children.

Other medications and Etacortilen

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including medications obtained without a prescription.

You should inform your doctor if you are taking other medications that contain phosphates. Your ophthalmologist will closely monitor your cornea at regular intervals.

The following medications may reduce the effects of Etacortilen:

• Medications used to treat epilepsy (barbiturates, phenytoin)
• Medications used to help you sleep or reduce anxiety (sedatives)
• Medications used to treat various bacterial infections (rifampicin)
• Medications used to treat low blood pressure or nasal congestion (epinephrine)

Etacortilen may reduce the effects of:

• Medications such as anticholinesterases (indicated for reduced intestinal motility and myasthenia gravis)
• Medications used to treat viral eye infections
• Medications similar to aspirin called salicylates (indicated for inflammation, pain, fever, and preventing blood clot formation)

Inform your doctor if you are taking ritonavir or cobicistat, as this may increase the amount of dexamethasone in the blood and its effects, such as Cushing's syndrome.

Inform your doctor if you are taking atropine or related products, as used together may increase eye pressure.

This medication may be used with other eye medications, but it is essential to follow the instructions included in section 3.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.

Use during pregnancy

The use of this medication during pregnancy is not recommended except if your doctor considers it necessary and under strict supervision.

Use of this medication during breastfeeding

The use of this medication during breastfeeding is not recommended.

Driving and operating machinery

As with all eye drops, you may experience blurred vision after applying the eye drop. Wait until your vision is clear before driving or operating machinery.

Etacortilen contains phosphates

This medication contains 0.13 mg of phosphates in each drop equivalent to 3.66 mg/ml.

If you have severe corneal damage (the transparent layer at the front of the eye), treatment with phosphates, in rare cases, may cause blurred vision due to calcium accumulation.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is one drop in the affected eye or eyes 3 or 4 times a day or as indicated by your doctor.

Usage Instructions

1. Wash your hands thoroughly before applying the eye drops.
2. Ensure the single-use container is intact.
3. Remove a single-use container from the strip.

1. To open, turn the cap of the container without stretching it.

1. Sit or lie down and tilt your head back and look upwards. Gently and carefully pull your lower eyelid down with your thumb and index finger.
2. Do not allow the tip of the single-use container to touch the eye or eyelids or any other surface to avoid possible contamination.

Since once opened the individual single-use container cannot maintain sterility, discard the remaining contents after administration.

Use in Children and Adolescents

This medication is not recommended for use in children.

If You Use More Etacortilen Than You Should

No cases of overdose have been described with the use of this medication.

If you accidentally instill more drops than you should, rinse thoroughly. Apply the next dose as usual.

If you accidentally ingest the product, your doctor may consider a stomach wash.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Use Etacortilen

Do not apply a double dose to compensate for the missed dose.

If You Interrupt Treatment with Etacortilen

Patients with pre-existing severe damage to their cornea, which threatens vision, should not interrupt treatment without consulting their doctor. Always inform your doctor if you plan to interrupt treatment.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Using Etacortilen with Other Ophthalmic Medications

If you are using any other ophthalmic medication, leave 5 minutes between the use of each medication.

Ophthalmic creams should be used last.

Like all medicines, this medication may cause side effects, although not everyone will experience them. Most people treated with this eye drop do not experience any side effects.

The possible unwanted effects due to the use of corticosteroids are as follows:

Very common: may affect more than 1 in 10 people

•increase in intraocular pressure after 15-20 days of topical administration in susceptible individuals and in patients with glaucoma.

Common: may affect up to 1 in 10 people

•discomfort, irritation, burning, itching, stinging, and blurred vision after application. These symptoms are usually mild and short-lived.

Uncommon: may affect up to 1 in 100 people

•cataract formation (clouding of the lens) after long-term use of corticosteroids;

•exacerbation of herpes simplex or fungal infections;

•delayed wound healing.

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

•corneal perforation;

•corneal calcification.

Unknown frequency: the frequency cannot be estimated from the available data.

•Endocrine problems: excessive body hair growth (particularly in women), muscle weakness and wasting, purple skin discoloration on the body, increased blood pressure, irregular or absent menstrual periods, changes in protein and calcium levels in the body, delayed growth in children and adolescents, and facial and body swelling and weight gain (known as‘Cushing's syndrome’) (see“Warnings and precautions”section).

In all the cases mentioned above, patients should discontinue use of the eye drop and initiate appropriate treatment.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the bottom of each container, on the outer packaging, and on the box after“CAD”. The expiration date is the last day of the month indicated on the product without opening and properly stored.

This medication does not require special storage conditions.

The eye drops are for single use and are presented in single-dose containers. Once the single-dose container is opened, use immediately and discard any unused product.

After the first opening of the aluminum bag, the remaining single-dose containers in the bag must be used within 28 days; after this period, unused single-dose containers must be discarded.

Medications should not be disposed of through the drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medications. By doing so, you will help protect the environment.

Composition of Etacortilen

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

Appearance of the product and content of the container

Etacortilen 1.5 mg/ml eye drops in solution is an colorless solution that is presented in 5 single-dose containers that contain 0.3 ml of eye drops in an aluminum bag and conditioned within a box. Each single-dose container contains 0.45 mg of dexamethasone sodium phosphate in 0.3 ml of solution.

The box contains 2 or 4 aluminum bags.

Each box contains 10 or 20 single-dose containers.

Some container sizes may only be marketed.

Holder of the marketing authorization and responsible for manufacturing

SIFI S.p.A.

Via Ercole Patti 36

95025 Aci Sant'Antonio (CT)

Italy

Local representative:

SIFI IBÉRICA S.L.

C/ Poeta Joan Maragall, 47

Planta 4, Puerta 402

28020 Madrid - Spain

Last review date of this prospectus: November 2021 .

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) www.aemps.gob.es