Dexafree

Leaflet attached to the packaging: information for the user

DEXAFREE, 1 mg/ml, eye drops, solution in a single-dose container

Dexamethasone phosphate

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

• Keep this 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 a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. WHAT IS DEXAFREE AND WHAT IS IT USED FOR

Dexafree is an eye drop in single-dose containers, which contains a substance called dexamethasone. This substance is a corticosteroid that inhibits the symptoms of inflammation. Dexafree is indicated for the treatment of inflammatory conditions of the eye. The eye should not be infected (redness of the eye, discharge, tearing, ...), otherwise, specific anti-infective treatment should be applied at the same time (see section 2).

2. IMPORTANT INFORMATION BEFORE USING DEXAFREE

When NOT to use Dexafree

If the patient has an eye infectionthat may be bacterial (acute purulent infection), fungal, viral (herpes virus, cowpox virus (VACV), chickenpox virus (VZV)), or caused by amoebas, if the patient has corneal damage(perforation, ulceration, or pathological changes associated with incomplete healing (regeneration)), if the patient has been diagnosed with increased intraocular pressurecaused by glucocorticoids (a group of corticosteroids), if the patient is allergic(hypersensitive) to dexamethasone sodium phosphateor any of the other ingredients of Dexafree.

Warnings and precautions

Before starting to use Dexafree, the patient should discuss it with their doctor or pharmacist. DO NOT INJECT, DO NOT SWALLOWDo not touch the tip of the dropper to the eye or eyelids.During the use of Dexafree, strict ophthalmological control is required, especially:

• in children and the elderly. It is recommended to have more frequent detailed ophthalmological examinations,
• if the patient has an eye infection. Dexafree can only be used if anti-infective treatment has been applied at the same time,
• if the patient has a corneal ulcer. Local treatment with dexamethasone or Dexafree should not be used unless the inflammatory condition is the main cause of delayed healing.
• if the patient has increased intraocular pressure. If the patient has previously experienced side effects caused by locally applied steroids, resulting in increased intraocular pressure, there is a risk of increased intraocular pressure if they use Dexafree,
• if the patient has glaucoma. Children: prolonged, continuous use should be avoided. Acute allergic conjunctivitis: if the patient has acute allergic conjunctivitis and standard therapy is not effective, Dexafree can only be used for a short period. Patients with diabetes: if the patient has diabetes, they should inform their ophthalmologist. Red eye: if the patient has a red eye and the cause of the symptoms is not diagnosed, Dexafree should not be used. Contact lenses: the patient should avoid wearing contact lenses during therapy with Dexafree.

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 a condition called Cushing's syndrome. Suppression of adrenal function may occur as a result of discontinuing prolonged or intensive use of Dexafree. The patient should consult their doctor before deciding to stop treatment. This risk is particularly important in children and patients treated with ritonavir or cobicistat. If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.

Dexafree and other medicines

If it is necessary to use other eye drops, the patient should wait 15 minutes before administering the next dose. The patient should tell their doctor if they are taking ritonavir or cobicistat, as these medicines may increase the levels of dexamethasone in the blood. Calcium phosphate precipitation on the surface of the corneal stroma has been observed in cases of concurrent use of local corticosteroids and beta-adrenergic receptor blockers. The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take.

Pregnancy and breastfeeding

There is insufficient data on the use of Dexafree in pregnant women. The potential risk to humans is unknown. Therefore, it is not recommended to use Dexafree during pregnancy. It is not known whether the medicine is excreted in breast milk. However, the total dose of dexamethasone is low. Therefore, Dexafree can be used during breastfeeding. If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.

Driving and using machines

As with all eye drops, transient blurred vision or other visual disturbances may affect the ability to drive or operate machinery. The patient should not drive or operate machinery until their vision has returned to normal.

DEXAFREE contains phosphates

The medicine contains 80 micrograms of phosphates in each drop.

3. HOW TO USE DEXAFREE

Dose

This medicine should always be used exactly as prescribed by the doctor. If the patient is unsure, they should consult their doctor or pharmacist. The recommended dose is 1 drop into the affected eye 4 to 6 times a day. In severe cases, treatment can be started with 1 drop every hour, and after improvement, the dose can be reduced to 1 drop every 4 hours. It is recommended to gradually reduce the dose to avoid relapse.

• in elderly patients: there is no need to change the dose.
• in children: prolonged, continuous treatment should be avoided.

Method of administration

Administration to the eye: this medicine is intended for use in the eyes.
1. Before using the medicine, wash your hands thoroughly.
2. Looking up and gently pulling down the lower eyelid with your finger, put one drop into the eye that needs treatment.
3. Immediately after instillation, gently pressthe inner corner of the treated eye with your finger for a few minutes (to reduce the risk of systemic reactions and increase the penetration of the active substance into the eye).
After use, discardthe single-dose container. Do not store it for later use.

Frequency of administration

4 to 6 times a day.

Duration of treatment

The treatment period usually ranges from a few days to a maximum of 14 days.

Using a higher dose of Dexafree than recommended

In case of administration of too high a dose to the eye and prolonged irritation, the eye should be rinsed with sterile water. The patient should immediately contact their doctor or pharmacist.

Missing a dose of Dexafree

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

Stopping the use of Dexafree

The patient should not suddenly stop treatment. They 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.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Hormonal disorders:

Unknown: frequency cannot be estimated from the available data

• increased body hair growth (especially in women), muscle weakness, and muscle mass loss, purple striae on the skin, increased blood pressure, irregular menstrual periods or absence of menstruation, 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").

Eye disorders:

Very common: (occurring in more than 1 in 10 people):
increased intraocular pressure, after 2 weeks of treatment
Common: (occurring in 1 to 10 people in 100):
discomfort, irritation, burning, stinging, itching, and visual disturbances after instillation. These symptoms are usually transient and mild.
Uncommon: (occurring in 1 to 10 people in 1,000):
allergic reactions or hypersensitivity to one of the ingredients of the eye drops, delayed healing, cataract (clouding of the lens), inflammation, glaucoma.
Rare: (occurring in less than 1 in 10,000 people):
conjunctivitis, mydriasis (pupil dilation), facial edema, ptosis (drooping eyelid), uveitis (inflammation of the uvea), corneal calcification, keratopathy (corneal disease), changes in corneal thickness, corneal edema, corneal ulceration, corneal perforation.
In patients with severe damage to the transparent, anterior part of the eye (cornea), phosphates may, in very rare cases, cause corneal clouding due to calcium deposition during treatment.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: [email protected]
Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. HOW TO STORE DEXAFREE

The medicine should be stored out of sight and reach of children. Do not use Dexafree after the expiry date stated on the single-dose container after EXP. The expiry date refers to the last day of the month. After opening the sachet: use the contents of the single-dose containers within 15 days. After opening the single-dose container: use immediately and discard the single-dose container after use. Store the single-dose containers in the sachet to protect them from light. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. CONTENTS OF THE PACKAGING AND OTHER INFORMATION

What Dexafree contains

• The active substance of Dexafree is dexamethasone sodium phosphate. One milliliter of solution contains 1 mg of dexamethasone phosphate (as dexamethasone sodium phosphate).
• The other ingredients are: disodium edetate, disodium phosphate dodecahydrate, sodium chloride, and water for injections.

What Dexafree looks like and contents of the pack

Dexafree is a clear, colorless to light brown solution for eye drops, available in single-dose containers. Each single-dose container contains 0.4 ml of solution. The box contains 20, 30, 50, or 100 single-dose containers packed in sachets.

Marketing authorization holder

LABORATOIRES THEA
12, rue Louis Blériot
63017 CLERMONT-FERRAND Cedex 2
FRANCE

Manufacturer

EXCELVISION
27, rue de la Lombardière
ZI la Lombardière
07100 ANNONAY
FRANCE
Laboratoire UNITHER
1 rue de l’Arquerie
50200 COUTANCES
FRANCE