Dexafree

Package leaflet: Information for the user

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Dexafree, 1 mg/ml, eye drops, solution in single-dose container
Dexamethasoni phosphas
Please read all of this leaflet carefully before using this medicine because it contains
important information for the patient.

• Keep this leaflet to be able to read it again if necessary.
• If you have any doubts, 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 the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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 that suppresses inflammatory symptoms.
Dexafree is indicated for the treatment of inflammatory conditions of the eye(s).
The eye should not be infected (eye redness, discharge, tearing, ...); otherwise, appropriate anti-infective treatment should 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 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 steroid-induced ocular hypertension (glucocorticoids being a group of corticosteroids),
• If the patient is allergic (hypersensitive) to dexamethasone sodium phosphate or any of the other ingredients of Dexafree.

Warnings and precautions
Before starting treatment with Dexafree, discuss this with a 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 in all cases 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 leading to increased intraocular pressure during topical steroid treatment, there is a risk of elevated intraocular pressure occurring when using 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.
  • Diabetic patients: 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 not diagnosed, Dexafree should not be used.
  • Contact lenses: wearing contact lenses should be avoided during treatment with Dexafree.

Patients should consult a doctor if they experience swelling and weight gain, particularly noticeable
on 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. Patients should 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, they should contact a
doctor.
Dexafree and other medicines
If other eye medications need to be used, 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 topical corticosteroids and β-adrenergic receptor blockers are used concomitantly.
Patients should inform their doctor or pharmacist about all medicines they are currently taking,
have recently taken, or plan to take.
Pregnancy and breastfeeding

• There are insufficient data on the use of Dexafree in pregnant women. The potential risk to humans is unknown. Therefore, the use of Dexafree during pregnancy is not recommended.
• 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 plans 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. Patients should 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

Dosage
This medicine should always be used as directed 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, and once improvement is observed, the dose should be
reduced to 1 drop every 4 hours. Gradual reduction of the dose is recommended to avoid relapse.

• In elderly patients: no dosage adjustment is necessary.
• In children: continuous, long-term treatment should be avoided.

Method of administration
Ocular administration: this medicine is intended for ophthalmic use only.

1. Wash hands thoroughly before using the medicine.
2. Tilt the head back, gently pull down the lower eyelid with a finger and instill one drop into the affected eye.
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 reactions and enhance penetration of the active substance into the eye).
4. After use, the single-dose container should be discarded. Do not store for later 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 to the eye and prolonged irritation occurs, rinse the eye with sterile water.
Seek immediate advice from your physician or pharmacist.
Missed dose of Dexafree
Do not administer a double dose to make up for a missed dose.
Discontinuation of Dexafree
Do not stop treatment abruptly. Always consult your doctor if considering discontinuation of treatment.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience 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 stretch marks on the skin, 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):

• Increased 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,
• Clouding of the lens (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, front part of the eye (cornea), phosphates may, very rarely, during treatment, lead to corneal clouding due to calcium deposition.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, telephone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Dexafree

Keep Dexafree 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.
Store single-dose containers in the sachet to protect them from light.
After opening the sachet: use the contents of the single-dose containers within 15 days.
After opening a single-dose container: use immediately and discard the single-dose container after use.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the package and other information

What Dexafree contains

• The active substance is dexamethasone sodium phosphate. One millilitre of solution contains 1 mg of dexamethasone phosphate (as dexamethasone sodium phosphate).
• Other components 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, colourless to slightly brown solution for eye drops available in single-dose containers.
Each single-dose container holds 0.4 ml of solution. The package 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:
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, Poland

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

Marketing Authorisation Numbers in France, 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 Licence Number: 250/19

This medicinal product is authorised in the European Economic Area countries under the following names:
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