Dexafree

Package Leaflet: Information for the User

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

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

Dexamethasone phosphate

You should carefully read the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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 pack and other information

1. WHAT IS DEXAFREE AND WHAT IS IT USED FOR

Dexafree is an eye drop in single-dose containers, which contains the substance called dexamethasone. This substance is a corticosteroid, which suppresses 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 used 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, you should discuss it with your 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 monitoring is required, especially:
• in children and the elderly. More frequent detailed ophthalmological examination is recommended,
• if the patient has an eye infection. Dexafree can only be used in cases where anti-infective treatment has been used 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 adverse reactions to locally used 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 causes of the symptoms are not recognized, Dexafree should not be used.
• Contact lenses: wearing contact lenses should be avoided during therapy with Dexafree.

You should consult a doctor if the patient experiences swelling and weight gain, particularly on the trunk and face, as these are usually the first symptoms of a disease called Cushing's syndrome. Adrenal insufficiency may occur as a result of discontinuing prolonged or intensive use of Dexafree. You should consult a doctor before the patient decides to discontinue 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

In case of the need to use other eye medicines, you should wait 15 minutes before administering the next medicine. You should tell your doctor about taking ritonavir or cobicistat, as these medicines may increase the content of dexamethasone in the blood. Calcium phosphate precipitation on the corneal surface has been observed with the concomitant use of topical corticosteroids and beta-adrenergic receptor blockers. You should tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.

Pregnancy and breastfeeding

• There is insufficient data on the use of Dexafree in pregnant women. The potential risk to humans is not known. Therefore, the use of Dexafree during pregnancy is not recommended.
• It is not known whether the medicine is excreted in breast milk. However, the total dose of dexamethasone is low. Therefore, Dexafree may 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. You should not drive or operate machinery until normal vision has returned.

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 as directed by your doctor. If you are unsure, you should consult your 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. Gradual reduction of the dose is recommended 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 to be treated.
• 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).
• 4. After use, the single-dose container should be discarded. It should not be stored for later use.

Frequency of administration

4 to 6 times a day.

Duration of treatment

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

Use of a higher than recommended dose of Dexafree

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

Missing a dose of Dexafree

A double dose should not be used to make up for a missed dose.

Stopping the use of Dexafree

Treatment should not be stopped abruptly. You should always consult a doctor if the patient is considering stopping treatment. If you have any further doubts about the use of the medicine, you should consult a 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 hair growth on the body (especially in women), muscle weakness, and loss of muscle mass, 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").

Eye disorders:

Very common (affecting more than 1 in 10 people):

• increased intraocular pressure, after 2 weeks of treatment.

Common (affecting 1 to 10 people in 100):

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

Uncommon (affecting 1 to 10 people in 1,000):

• allergic reactions or hypersensitivity to one of the ingredients of the eye drops,
• delayed healing,
• cataract (lens opacity),
• inflammatory conditions,
• glaucoma.

Rare (affecting less than 1 in 10,000 people):

• conjunctivitis,
• pupil dilation (mydriasis),
• facial swelling,
• ptosis (drooping eyelid),
• uveitis (inflammation of the uvea),
• corneal calcification,
• crystalline keratopathy,
• 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 opacification during treatment due to calcium deposition.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309; website: https://smz.ezdrowie.gov.pl. By reporting side effects, you can help provide more information on the safety of this 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 packaging. The expiry date refers to the last day of the month stated. 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. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Dexafree contains

• The active substance of the medicine is dexamethasone sodium phosphate. One milliliter of the solution contains 1 mg of dexamethasone phosphate (as dexamethasone sodium phosphate).
• The other ingredients of the medicine 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. For more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in France, the country of export:

Laboratoires THEA
12, rue Louis Blériot
63017 Clermont-Ferrand Cedex 2
France

Manufacturer:

EXCELVISION
Rue de la Lombardiere
07100 Annonay
France
Laboratoire UNITHER
1 Rue de la L’arquerie
50200 Coutances
France

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Authorization number in France, the country of export:374 776-8
34009 374 776 8 0

Parallel import authorization number: 367/18

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Bulgaria, Cyprus, France, Greece, Ireland, Poland, Portugal, Spain, and the United Kingdom ……………….. DEXAFREE
Belgium, Luxembourg, and the Netherlands ......................................................... MONOFREE DEXAMETHASONE
Austria and Germany ................................................................................................................... MONODEX
Italy and Slovenia ............................................................................................................. DEXAMONO
Denmark, Finland, and Norway .................................................................................................. MONOPEX

Date of leaflet approval: 12.12.2023

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