Dexafree

Leaflet accompanying the packaging: information for the user

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

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

Dexamethasone phosphate

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. 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 that contains a substance called dexamethasone. This substance is a corticosteroid that 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 related to 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 treatment with Dexafree, the doctor or pharmacist should be consulted. DO NOT INJECT, DO NOT SWALLOWDo not touch the tip of the dropper to the eye or eyelids.

• During treatment with Dexafree, close 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 inflammation is the main cause of delayed healing.
• if the patient has increased intraocular pressure. If the patient has previously experienced side effects of topical steroid treatment resulting in increased intraocular pressure, there is a risk of increased intraocular pressure if they use Dexafree,
• if the patient has glaucoma.
• Children: continuous, prolonged 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 treatment with Dexafree.

The doctor should be consulted 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 treatment with Dexafree. The doctor should be consulted 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

If other eye drops need to be used, a 15-minute interval should be observed between administrations. The doctor should be informed about the use of ritonavir or cobicistat, as these medicines may increase the dexamethasone content in the blood. Calcium phosphate precipitation on the corneal surface has been observed with the concomitant use of topical corticosteroids and beta-blockers. The doctor or pharmacist should be informed about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take.

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 can be used during breastfeeding.

If the patient is pregnant or breastfeeding, suspects 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 per drop.

3. How to use Dexafree

Dose

This medicine should always be used as directed by the doctor. In case of doubts, the doctor or pharmacist should be consulted. 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: no dose adjustment is necessary.
• in children: continuous, prolonged 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, hands should be washed thoroughly.
• 2. Looking up and gently pulling down the lower eyelid with a finger, one drop should be instilled into the eye that needs treatment.
• 3. Immediately after instillation, the inner corner of the treated eye should be gently pressedwith a 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 treatment duration 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. The doctor or pharmacist should be contacted immediately.

Missed administration of Dexafree

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

Discontinuation of Dexafree

Treatment should not be stopped abruptly. The doctor should always be consulted if the patient is considering stopping treatment. In case of any further doubts about the use of the medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Dexafree 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 muscle mass loss, purple stretch marks 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 (lens opacity),
• inflammatory conditions,
• glaucoma.

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

• conjunctivitis,
• pupil dilation (mydriasis),
• facial swelling,
• eyelid ptosis,
• 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 due to calcium deposition during treatment.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, 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, 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. Dexafree should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month. Single-dose containers should be stored in a sachet to protect them from light. After opening the sachet: the contents of the single-dose containers should be used within 15 days. After opening the single-dose container: it should be used immediately and discarded after use. Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer used. 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 the solution contains 1 mg of dexamethasone phosphate (as dexamethasone sodium phosphate).
• Other ingredients of the medicine are: disodium edetate, disodium phosphate dodecahydrate, sodium chloride, and water for injections.

What Dexafree looks like and what the packaging contains

Dexafree is a clear, colorless to slightly brownish solution for eye drops, available in single-dose containers. Each single-dose container contains 0.4 ml of the solution. The box contains 20, 30, 50, or 100 single-dose containers packaged in sachets. For more detailed information, the marketing authorization holder or parallel importer should be consulted.

Marketing authorization holder in France, the country of export:

Laboratoires THEA, 12, rue Louis Blériot, 63017 CLERMONT-FERRAND CEDEX 2, France

Manufacturer:

Laboratoire UNITHER, 1 Rue de l’Arquerie, 50200 Coutances, France

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
French marketing authorization number, in the country of export: 374 774-5
34009 374 774 5 1
374 775-1
34009 374 775 1 2
374 776-8
34009 374 776 8 0
374 777-4
34009 374 777 4 1
569 031-1
34009 569 031 1 5

Parallel import authorization number: 250/19

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

Countries:

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

Date of leaflet approval: 20.06.2024

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