Etafry

Package leaflet: Information for the patient

Etafry, 1.5 mg/mL, eye drops, solution
Dexamethasoni natrii phosphas
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

1. What Etafry is and what it is 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 Etafry is and what it is used for

Etafry contains a substance called dexamethasone. It is a corticosteroid that suppresses inflammatory symptoms.
This medicine is indicated for the treatment of non-infectious inflammatory eye conditions, such as conjunctivitis, blepharitis, or scleritis.
If there is no improvement after the recommended treatment period, or if your condition worsens, consult your doctor.

2. Important information before using Etafry
When not to use Etafry:

• 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 intraocular pressure (intraocular hypertension);
• if you have an eye infection such as herpes virus infection, herpetic keratitis with corneal ulceration, tuberculous or fungal eye infection, acute purulent conjunctivitis, purulent conjunctivitis, herpetic blepharitis with purulent discharge, or hordeolum;
• if you have conjunctivitis with corneal ulceration, even in its early stage;
• corneal lesions and abrasions;

Warnings and precautions
Before starting Etafry, discuss it with your doctor or pharmacist.
Ophthalmological monitoring is required during treatment with Etafry, particularly:

• if the medicine is used for two weeks or longer, due to the risk of elevated intraocular pressure;
• in chronic (1-4 years) use of ocular corticosteroids, especially at high doses, as they may cause lens opacity (see section 4);
• if you have a viral infection, as corticosteroid use may worsen or intensify the condition, potentially leading to irreversible corneal opacity;
• if you have a condition associated with corneal thinning;
• in cases of herpetic keratitis (caused by herpes virus), as corticosteroid use may delay wound healing and increase the frequency and extent of infections;
• in patients with bacterial, viral, or fungal conjunctivitis, as ocular corticosteroid administration may mask signs of infection progression;
• when using other eye drops containing phosphates (see section 4).

If you experience blurred vision or other visual disturbances, contact your doctor.
Contact your doctor if you develop swelling and weight gain, particularly in the trunk and face, as these are usually the first signs of Cushing's syndrome. Adrenal suppression may occur following discontinuation of prolonged or intensive treatment with Etafry. Consult your doctor before deciding to stop treatment. This risk is particularly relevant in children and patients treated with ritonavir or cobicistat.
In all the above cases, and in case of hypersensitivity to any ingredient of the medicine, your doctor will recommend discontinuation of the eye drops and initiate appropriate treatment.

Contact lenses
Your doctor will advise removing contact lenses before using this medicine. There is no information available on the effect of this medicine on contact lenses. Therefore, do not insert contact lenses immediately after instillation.

Children and adolescents
The safety and efficacy of Etafry in children have not been established.
Continuous, long-term use of corticosteroids should be avoided in all cases.

Etafry and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those available without prescription.
Inform your doctor if you are using other medicines containing phosphates. An ophthalmologist will closely and regularly monitor the corneal status.
The following medicines may reduce the effect of Etafry:

• antiepileptic drugs (barbiturates, phenytoin);
• drugs used for sleep disorders or anxiety (sedatives and hypnotics);
• drugs used to treat various bacterial infections (rifampicin);
• drugs used for low blood pressure or nasal decongestion (ephedrine).

Etafry may reduce the effect of the following medicines:

• drugs such as anticholinesterases (indicated for intestinal motility disorders and myasthenia gravis);
• drugs used for viral eye infections;
• salicylates, i.e., drugs similar to aspirin (used to treat inflammation, pain, fever, and for blood thinning).

Inform your doctor if you are taking ritonavir or cobicistat, as these drugs may increase blood levels of dexamethasone and intensify related effects, such as Cushing's syndrome.
Inform your doctor if you are taking atropine or similar products, as their concurrent use with this medicine may increase intraocular pressure.
Etafry may be used with other ophthalmic medicines, but it is important to follow the instructions in section 3.

Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, suspect you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Use during pregnancy
This medicine is not recommended during pregnancy unless your doctor considers its use necessary. In such cases, it should only be used under strict medical supervision.

Use during breastfeeding
Etafry is not recommended during breastfeeding.

Driving and operating machinery
As with all eye drops, blurred vision may occur. Do not drive or operate machinery until normal vision returns.

Etafry contains phosphates.
This medicine contains 0.13 mg of phosphates per drop, equivalent to 3.66 mg/mL.
If you have suffered a severe injury to the transparent front layer 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
Always use this medicine exactly as prescribed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is one drop into the affected eye 3 to 4 times daily, or as directed by your doctor.

Instructions for use

1. Wash your hands thoroughly before instillation.
2. Check that 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. Sit or lie down, tilt your head backward, look upward, and gently pull down the lower eyelid with your thumb and index finger.
6. Do not touch the eye, eyelid, or any other surface with the tip of the single-dose container to avoid contamination.
   Since sterility cannot be maintained after opening the single-dose container, any remaining medicine must be discarded after administration.

Use in children and adolescents
Etafry is not recommended for use in children.

Use of more than the recommended dose of Etafry
Cases of Etafry overdose have not been reported.
If an excessive number of drops is accidentally administered, thoroughly rinse the eye. Apply the next dose as usual.
In case of accidental ingestion, the doctor may consider gastric lavage.

Missed dose of Etafry
Do not use a double dose to make up for a missed dose.

Stopping Etafry treatment
Patients with existing severe corneal damage threatening vision loss should not discontinue treatment without consulting their treating physician. Always consult your doctor if you are considering stopping treatment.

If you have any further questions about using this medicine, consult your doctor or pharmacist.

Using Etafry with other ophthalmic medicines
If using more than one ophthalmic medicine, wait at least 5 minutes between administering each medicine. Ophthalmic ointments should be used last.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
Most people using these eye drops do not experience any adverse reactions.
Possible adverse reactions associated with corticosteroid use are as follows:

Very common: occurs in more than 1 in 10 people

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

Common: occurs in no more than 1 in 10 people

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

Uncommon: occurs in no more than 1 in 100 people

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

Very rare: occurs in no more than 1 in 10,000 people

• corneal perforation;
• corneal calcification.

Frequency not known: frequency cannot be estimated from the available data
Endocrine disorders: excessive body hair growth (particularly in women), muscle weakness and loss of muscle mass, purple striae on the skin, increased blood pressure, irregular menstruation or amenorrhea, changes in protein and calcium levels in the body, growth suppression in children and adolescents, and edema with increased body weight, particularly noticeable on the trunk and face (a condition known as Cushing's syndrome) (see section 2 "Warnings and precautions").

In all of the above cases, eye drop use should be discontinued and appropriate treatment initiated.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration 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
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Etafry

Keep this medicine out of 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 stated month for unopened medicine stored under recommended conditions.
No special storage conditions apply for this medicinal product.
The drops are intended for single use and are supplied in single-dose containers.
After opening the single-dose container, the medicine should be used immediately; any unused portion must be discarded.
After first opening the aluminium sachet, the single-dose containers remain suitable for use for 28 days; any unused single-dose containers must be discarded after this period.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package 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, monosodium phosphate monohydrate, disodium phosphate dodecahydrate, purified water.

What Etafry looks like and contents of the pack
Etafry is a clear solution in single-dose containers containing 0.3 ml of eye drops,
packaged in aluminium sachets of 5 units each 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 aluminium sachets.
Each cardboard package contains 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)
Italy