Etafri

Package Leaflet: Information for the Patient

Etafry, 1.5 mg/mL, Eye Drops, Solution
Dexamethasone Sodium Phosphate

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Etafry and what is it used for
• 2. Important information before using Etafry
• 3. How to use Etafry
• 4. Possible side effects
• 5. How to store Etafry
• 6. Contents of the pack and other information

1. What is Etafry and what is it used for

Etafry contains the active substance dexamethasone. It is a corticosteroid that suppresses inflammation symptoms.
This medicine is indicated for the treatment of non-infectious inflammatory eye conditions, such as conjunctivitis, blepharitis, or uveitis.
If there is no improvement or the patient feels worse after the prescribed treatment period, they should consult a doctor.

2. Important information before using Etafry

When not to use Etafry:

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
• if the patient has high intraocular pressure (glaucoma);
• if the patient has an eye infection such as herpes simplex, corneal ulcers, tuberculosis, or fungal infections of the eye, acute purulent conjunctivitis, or purulent blepharitis;
• if the patient has corneal ulcers or abrasions;

Warnings and precautions

Before starting treatment with Etafry, the patient should discuss it with their doctor or pharmacist.
During treatment with Etafry, close ophthalmological monitoring is required, especially:

• if the medicine is used for more than two weeks, as this is associated with an increased risk of elevated intraocular pressure;
• in cases of chronic (1-4 years) use of corticosteroids for the eye, especially in high doses, as they may cause cataracts (see section 4);
• if the patient has a viral infection, as corticosteroids may worsen the condition, leading to irreversible corneal clouding;
• if the patient has a condition associated with corneal thinning;
• in cases of herpes simplex keratitis, as corticosteroids may delay wound healing and increase the frequency and extent of infections;
• in patients with bacterial, viral, or fungal conjunctivitis, as corticosteroid administration may mask symptoms of infection progression;
• when using other eye drops containing phosphates (see section 4).

If the patient experiences blurred vision or other visual disturbances, they should contact their doctor.
The patient should consult their doctor if they experience swelling and weight gain, particularly on the trunk and face, as these are usually the first symptoms of Cushing's syndrome. Adrenal insufficiency may occur after discontinuation of long-term or intensive treatment with Etafry. The patient should consult their doctor before stopping treatment. This risk is particularly important in children and patients treated with ritonavir or cobicistat.
In all the above cases and in case of hypersensitivity to any of the ingredients of the medicine, the doctor will advise the patient to stop using the eye drops and initiate appropriate treatment.

Contact Lenses

The doctor will advise the patient to remove contact lenses before using the medicine. There is no information on the effect of this medicine on contact lenses. Therefore, the patient should not wear contact lenses immediately after administration.

Children and Adolescents

The safety and efficacy of Etafry in children have not been established.
In any case, the patient should avoid continuous, long-term use of corticosteroids.

Etafry and Other Medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription.
The patient should inform their doctor about taking other medicines containing phosphates. The ophthalmologist will closely and regularly monitor the condition of the cornea.
The effect of Etafry may be reduced by the following medicines:

• medicines used to treat epilepsy (barbiturates, phenytoin)
• medicines used to treat sleep disorders or anxiety (sedatives and hypnotics)
• medicines used to treat various bacterial infections (rifampicin)
• medicines used to treat low blood pressure or decongestants (ephedrine)

Etafry may reduce the effect of the following medicines:

• medicines such as anticholinesterases (used in cases of slowed intestinal peristalsis and myasthenia);
• medicines used to treat viral eye infections;
• salicylates, i.e., medicines similar to aspirin (used to combat inflammation, pain, and fever, as well as to thin the blood).

The patient should inform their doctor about taking ritonavir or cobicistat, as these medicines may increase the concentration of dexamethasone in the blood and enhance its effects, e.g., Cushing's syndrome.
The patient should inform their doctor about taking atropine or similar products, as their concurrent use with Etafry may increase intraocular pressure.
Etafry can be used with other ophthalmic medicines, but it is essential to follow the instructions in section 3.

Pregnancy, Breast-feeding, and Fertility

If the patient is pregnant or breast-feeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Use during pregnancy
This medicine is not recommended during pregnancy, unless the doctor considers it necessary. In this case, it can only be used under close medical supervision.
Use during breast-feeding
Etafry is not recommended during breast-feeding.

Driving and Using Machines

Like all eye drops, they may cause blurred vision. The patient should not drive or operate machinery until their vision returns to normal.

Etafry Contains Phosphates

The medicine contains 0.13 mg of phosphates in each drop, which corresponds to 3.66 mg/ml.
If the patient has suffered a severe injury to the transparent layer in the front of the eye (cornea), phosphates may, in very rare cases, lead to the formation of cloudy spots on the cornea due to calcium accumulation during treatment.

3. How to Use Etafry

This medicine should always be used exactly as the doctor or pharmacist has told the patient. If the patient is not sure, they should ask their doctor or pharmacist.
The recommended dose is one drop into the affected eye 3 to 4 times a day or as advised by the doctor.
Instructions for use

• 1) Before administering the medicine, the patient should wash their hands thoroughly.
• 2) Check that the single-dose container is intact.
• 3) Tear off the single-dose container from the strip.

• 4) Open by twisting the top without pulling.

• 5) Sit or lie down and tilt the head back, looking up. With the thumb and index finger, gently and carefully pull the lower eyelid down.

• 6) Do not touch the tip of the single-dose container to the eye, eyelid, or any other surface to avoid contamination.

Since it is impossible to maintain sterility after opening the single-dose container, any remaining medicine should be discarded after administration.

Use in Children and Adolescents

Etafry is not recommended for use in children.

Using More Than the Recommended Dose of Etafry

There have been no reports of overdose with Etafry.
In case of accidental administration of more drops than recommended, the patient should rinse their eye thoroughly. The next dose should be administered as usual.
In case of accidental ingestion of the product, the doctor may consider gastric lavage.

Missing a Dose of Etafry

The patient should not take a double dose to make up for a forgotten dose.

Stopping Treatment with Etafry

Patients with existing severe corneal damage threatening vision loss should not stop treatment without consulting their doctor.
The patient should always consult their doctor if they are considering stopping treatment.
If the patient has any further questions about the use of this medicine, they should ask their doctor or pharmacist.

Using Etafry with Other Ophthalmic Medicines

If more than one ophthalmic medicine is used, the patient should wait at least 5 minutes between administering the different medicines. Eye ointments should be used last.

4. Possible Side Effects

Like all medicines, Etafry can cause side effects, although not everybody gets them. Most people using these eye drops do not experience any side effects.
Possible side effects associated with the use of corticosteroids are as follows:
Very common: occur in more than 1 in 10 people

• increased intraocular pressure after 15-20 days of administration in the eye in predisposed patients and patients with glaucoma.

Common: occur in less than 1 in 10 people

• discomfort, irritation, burning, stinging, itching, and visual disturbances after administration. These symptoms are usually transient and mild.

Uncommon: occur in less than 1 in 100 people

• cataract formation (as a result of chronic corticosteroid use);
• worsening/exacerbation of herpes simplex infection or fungal infections;
• delayed wound healing.

Rare: occur in less than 1 in 10,000 people

• corneal perforation;
• corneal calcification.

Frequency not known: cannot be estimated from the available data
Hormonal disorders: increased hair growth on the body (especially in women), muscle weakness, and muscle mass loss, purple striae on the skin, increased blood pressure, irregular menstrual periods or amenorrhea, changes in protein and calcium levels in the body, growth retardation in children and adolescents, and swelling and weight gain, particularly on the trunk and face (Cushing's syndrome) (see section 2 "Warnings and precautions").
In all the above cases, the patient should stop using the eye drops and initiate appropriate treatment.

Reporting Side Effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, PL-02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, the patient can help provide more information on the safety of this medicine.

5. How to Store Etafry

The medicine should be stored out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottom of each single-dose container, on the protective packaging, and on the carton after EXP. The expiry date refers to the last day of the month stated.
There are no special precautions for storage of the medicinal product.
The eye drops are for single use and are supplied in single-dose containers.
After opening the single-dose container, the medicine should be used immediately; any unused medicine should be discarded.
After the first opening of the aluminum sachet, the shelf life of the single-dose containers is 28 days; after this period, any unused single-dose containers should be discarded.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the Pack and Other Information

What Etafry Contains

• 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.

What Etafry Looks Like and Contents of the Pack

Etafry is a colorless solution in single-dose containers containing 0.3 mL of eye drops, packaged in aluminum sachets and placed in a cardboard box. Each single-dose container contains 0.45 mg of dexamethasone sodium phosphate in 0.3 mL of solution.
The cardboard box contains 2 or 4 aluminum sachets.
Each cardboard box 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 S. Antonio (CT)
Italy

Date of Last Revision of the Package Leaflet 29.11.2023