DEXAFREE

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Dexafree, 1 mg/ml, eye drops, solution in single-dose container
Dexamethasoni phosphas
Please read this leaflet carefully before using this medicine, because 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. This medicine may harm other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of Contents

1. What Dexafree is and what it is 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 DEXAFREE IS AND WHAT IT IS USED FOR

Dexafree is an eye drop solution in single-dose containers containing a substance called
dexamethasone. This substance is a corticosteroid which suppresses inflammatory symptoms.
Dexafree is indicated for the treatment of inflammatory conditions of the eye(s).
The eye should not be infected (redness, discharge, tearing, etc.); otherwise, appropriate anti-infective treatment must be administered concomitantly (see section 2).

2. IMPORTANT INFORMATION BEFORE USING DEXAFREE

When NOT to use Dexafree

• If the patient has an eye infection, which may be bacterial (acute purulent infection), fungal, viral (herpes simplex virus, vaccinia virus (VACV), varicella-zoster virus (VZV)) or caused by amoebae,
• If the patient has corneal damage (perforation, ulceration or pathological changes associated with incomplete healing (regeneration)),
• If the patient has been diagnosed with glucocorticoid-induced elevated intraocular pressure (a group of corticosteroids),
• If the patient is allergic (hypersensitive) to dexamethasone sodium phosphate or any of the other components of Dexafree.

Warnings and precautions
Before starting treatment with Dexafree, discuss it with your doctor or pharmacist.
DO NOT INJECT, DO NOT SWALLOW
Do not touch the eye or eyelids with the dropper tip.

• Strict ophthalmological monitoring is required during treatment with Dexafree, especially:
• in children and elderly patients. More frequent detailed eye examinations are recommended,
• if the patient has an eye infection. Dexafree may only be used if anti-infective treatment is administered concomitantly,
• 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 elevated intraocular pressure. If the patient previously experienced adverse effects from topical steroid treatment leading to increased intraocular pressure, there is a risk of elevated intraocular pressure recurring during treatment with 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 ineffective, Dexafree may be used only 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 symptoms is unknown, Dexafree should not be used.
• Contact lenses: wearing contact lenses should be avoided during treatment with Dexafree.

Seek medical advice if the patient develops swelling and weight gain, particularly noticeable
in the trunk and face, as these are usually the first signs of a condition known as
Cushing's syndrome. Adrenal suppression may occur following discontinuation
of prolonged or intensive treatment with Dexafree. Consult a doctor before
deciding to stop treatment. This risk is particularly significant in children and in patients
receiving ritonavir or cobicistat.
If the patient experiences blurred vision or other visual disturbances, contact a
doctor.
Dexafree and other medicines
If other eye medications are required, wait 15 minutes before administering the next medication.
Inform the doctor if the patient is taking ritonavir or cobicistat, as these medicines may
increase blood levels of dexamethasone.
Precipitation of calcium phosphate on the corneal surface has been observed when
corticosteroids and beta-adrenergic receptor blocking agents are used concomitantly.
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to use.
Pregnancy and breastfeeding

• There are insufficient data on the use of Dexafree in pregnant women. The potential risk to humans is unknown. Therefore, Dexafree is not recommended during pregnancy.
• It is not known whether the drug 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, suspects she may be pregnant, or is planning to become pregnant,
she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
As with all eye drops, transient blurred vision or other visual disturbances may affect
the ability to drive or operate machinery. Do not drive or operate machinery until
normal vision returns.
Dexafree contains phosphates
The medicine contains 80 micrograms of phosphates per drop.

3. HOW TO USE DEXAFREE MEDICINAL PRODUCT

Dosage
This medicinal product should always be used as prescribed by the physician. In case of doubt, consult
your doctor or pharmacist.
The recommended dose is 1 drop into the affected eye 4 to 6 times daily. In severe cases, treatment may
be initiated with 1 drop every hour; once improvement is observed, the dose should be reduced to
1 drop every 4 hours. Gradual dose reduction is recommended to prevent recurrence.

• In elderly patients: no dosage adjustment is required.
• In children: prolonged, continuous treatment should be avoided.

Administration method
Ocular administration: this medicinal product is intended for ophthalmic use only.

1. Wash hands thoroughly before applying the medicine.
2. Look upward and gently pull down the lower eyelid with a finger, then instill one drop into the eye requiring treatment.
3. Immediately after instillation, gently press with a finger on the inner corner of the treated eye for several minutes (to reduce the risk of systemic adverse reactions and to enhance penetration of the active substance into the eye).
4. After use, the single-dose container must be discarded. Do not store for future use.

Frequency of administration
4 to 6 times daily.
Duration of treatment
Treatment duration usually ranges from several days up to a maximum of 14 days.
Use of a higher than recommended dose of Dexafree
If an excessive dose has been administered into the eye and prolonged irritation occurs, the eye should be rinsed with sterile water.
Contact your physician or pharmacist immediately.
Missed dose of Dexafree
Do not use a double dose to make up for a missed dose.
Discontinuation of Dexafree treatment
Do not stop treatment abruptly. Always consult your doctor if considering discontinuation of treatment.
In case of any further doubts regarding the use of this medicinal product, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.

Endocrine disorders:
Unknown frequency: cannot be estimated from available data

• Excessive growth of body hair (especially in women), muscle weakness and loss of muscle mass, purple skin stretch marks, increased blood pressure, irregular menstruation or absence of menstruation, changes in protein and calcium levels in the body, growth suppression in children and adolescents, and swelling with weight gain particularly noticeable in the trunk and face (a condition known as Cushing's syndrome) (see section 2 "Warnings and precautions").

Eye disorders:
Very common (affects more than 1 in 10 people):

• Elevated intraocular pressure, after 2 weeks of treatment.

Common (affects 1 to 10 people in 100):

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

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

• Allergic reactions or hypersensitivity to one of the ingredients of the eye drops,
• Delayed wound healing,
• Cataract,
• Inflammatory conditions,
• Glaucoma.

Very rare (affects less than 1 in 10,000 people):

• Conjunctivitis,
• Pupil dilation (mydriasis),
• Facial swelling,
• Drooping of the eyelid,
• Iritis (inflammation of the uvea),
• Corneal calcification,
• Corneal inflammation (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, lead during treatment to corneal clouding due to calcium deposition.

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 of Monitoring Adverse Reactions of Medicinal Products at 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; website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. HOW TO STORE DEXAFREE

Keep the medicine out of the 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 stated month.
After opening the sachet: use the contents of the single-dose containers within 5 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 from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Dexafree contains

• The active substance is dexamethasone sodium phosphate. Each millilitre of solution contains 1 mg of dexamethasone phosphate (as dexamethasone sodium phosphate).
• 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, colourless to slightly brown solution for eye drops available in single-dose containers.
Each single-dose container contains 0.4 ml of solution. The pack contains 20, 30, 50 or 100 single-dose containers packed in sachets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation 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
Poland

Repackaged in:
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Poland
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation Number in France, the country of export: 374 776-8
34009 374 776 8 0

Parallel Import Authorisation Number: 367/18

This medicinal product is authorised in the European Economic Area countries under the following names:
Bulgaria, Cyprus, France, Greece, Ireland, Poland, Portugal, Spain and United Kingdom…………….
................................................................................................................................................DEXAFREE
Belgium, Luxembourg and the Netherlands ..................................MONOFREE DEXAMETHASONE
Austria and Germany ...................................................................................................................MONODEX
Italy and Slovenia .............................................................................................................DEXAMONO
Denmark, Finland and Norway ..................................................................................................MONOPEX