ETACORTILEN 1.5 mg/ml EYE DROPS SOLUTION

2. What you need to know before you use Etacortilen

Do not use Etacortilen:

• If you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• If you have high pressure inside the eye (ocular hypertension).
• If you have an eye infection such as Herpes simplex, corneal infections caused by viruses in the ulcerative stage, tuberculosis, or fungal eye infections, acute purulent ophthalmia, purulent conjunctivitis, herpetic 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 medicine.

It is necessary to closely monitor the eyes during the use of this medicine, particularly:

• If treatment is used for two weeks or more, due to the risk of increased eye pressure.
• If long-term ocular corticosteroids are used (1-4 years), especially at high doses, as they can cause clouding of the lens (see section 4).
• If you have a viral infection, as the use of corticosteroids can worsen/exacerbate the condition, which can lead to irreversible clouding of the cornea.
• If you have a disorder associated with thinning of the cornea.
• In the case of corneal inflammation caused by herpes (herpetic keratitis). The use of corticosteroids can delay the healing of damaged tissue and increase the incidence and spread of infections.
• In the case of bacterial, viral, or fungal conjunctivitis, as the topical administration of corticosteroids can mask the evidence of infection progression.
• If you are using other eye drops that contain phosphate (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 manifestations of a syndrome called Cushing's syndrome. Suppression of adrenal gland function can occur after intensive or long-term treatment with this medicine. Consult your doctor before stopping treatment on your own. These risks are especially important in children and patients treated with a medicine called ritonavir or cobicistat.

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

Tell your doctor if you are taking atropine or related products, as they can increase eye pressure when used at the same time.

This medicine can be used with other eye medicines, but it is essential to follow the instructions included in section 3.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Use during pregnancy

The use of this medicine is not recommended during pregnancy unless your doctor considers it necessary and under strict supervision.

Use of this medicine during breastfeeding

The use of this medicine is not recommended during breastfeeding.

Driving and using machines

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

Etacortilen contains phosphates

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

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

3. How to use Etacortilen

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one drop in the affected eye(s) 3 or 4 times a day or as directed by your doctor.

Instructions for use

1. Wash your hands well before applying the eye drops.
2. Make sure the single-dose container is intact.
3. Remove a single-dose container from the strip.

1. To open, twist the tab of the container without stretching.

1. Sit or lie down and tilt your head back and look up. With your thumb and index finger, gently and carefully pull the lower eyelid down.
2. Do not let the tip of the single-dose container touch the eye or eyelids or any other surface to avoid possible contamination.

Since once the single-dose container is opened, sterility cannot be maintained, the remaining contents should be discarded after administration.

Use in children and adolescents

The use of this medicine is not recommended in children.

If you use more Etacortilen than you should

No cases of overdose have been reported with the use of this medicine.

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

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

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 medicine and the amount ingested.

If you forget to use Etacortilen

Do not apply a double dose to make up for the forgotten dose.

If you stop treatment with Etacortilen

Patients with severe pre-existing corneal damage that threatens vision should not stop treatment without consulting their doctor. Always inform your doctor if you think you want to stop treatment.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

If you use Etacortilen with other eye medicines

If you are using any other eye medicine, wait 5 minutes between using each medicine.

Eye ointments should be used last.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 subjects and in patients with glaucoma.

Common: may affect up to 1 in 10 people

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

Uncommon: may affect up to 1 in 100 people

• clouding of the lens (cataract formation) after long-term use of corticosteroids;
• worsening/exacerbation of Herpes simplex or fungal infections;
• delayed healing of wounds.

Rare: may affect up to 1 in 10,000 people

• corneal perforation;
• corneal calcification.

Frequency not known: frequency cannot be estimated from the available data.

• Hormonal problems: excessive body hair growth (particularly in women), weakness and muscle wasting, purple striae on the skin of the body, increased blood pressure, irregular or absent menstrual periods, changes in body protein and calcium levels, delayed growth in children and adolescents, and swelling and weight gain of the body and face (called Cushing's syndrome) (see section "Warnings and precautions").

In all the above cases, patients should stop using the eye drops and start appropriate treatment.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Etacortilen

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

Do not use this medicine after the expiry date which is stated on the bottom of each container, on the outer packaging, and on the carton after "EXP". The expiry date is the last day of the month shown on the unopened and properly stored product.

This medicine does not require any special storage conditions.

The eye drops are for single use and come in single-dose containers. Once the single-dose container is opened, use immediately and discard any unused remaining 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, any unused single-dose containers must be discarded.

Medicines should not be disposed of via wastewater or household waste. Place the containers and medicines you no longer need in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Etacortilen

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

Appearance and pack contents

Etacortilen 1.5 mg/ml Eye Drops Solution is a colorless solution presented in 5 single-dose containers containing 0.3 ml of eye drops in an aluminum bag and packaged in a carton. Each single-dose container contains 0.45 mg of dexamethasone sodium phosphate in 0.3 ml of solution.

The carton contains 2 or 4 aluminum bags.

Each carton contains 10 or 20 single-dose containers.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

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

Date of last revision of this package leaflet:November 2021.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) www.aemps.gob.es