Darazur

Package Leaflet: Information for the User

DARAZUR, 1 mg/ml, Eye Drops, Solution

Dexamethasone phosphate

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

• Keep this package 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 you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What is DARAZUR and what is it used for

DARAZUR is an eye drop solution in a multidose container, which contains the active substance dexamethasone. This substance is a corticosteroid that suppresses the symptoms of inflammation. DARAZUR is indicated for the treatment of eye inflammation. The eye should not be infected (redness of the eye, discharge, tearing, etc.), otherwise, anti-infective treatment should be used at the same time (see section 2).

2. Important information before using DARAZUR

When not to use DARAZUR:

• 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 pressure(increased pressure in the eye) caused by glucocorticoids (a group of corticosteroids),
• if the patient is allergic(hypersensitive) to dexamethasone sodium phosphateor any of the other ingredients of this medicine (listed in section 6)

Warnings and precautions

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

• During treatment with DARAZUR, strict ophthalmological control is required, especially:
• in children and the elderly. More frequent detailed ophthalmological examination is recommended.
• if the patient has an eye infection. DARAZUR can only be used in cases where

anti-infective treatment has been used at the same time.

• if the patient has corneal ulceration. Local treatment with dexamethasone or DARAZUR 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 adverse effects of topical steroid treatment resulting in increased intraocular pressure, there is a risk of increased intraocular pressure if DARAZUR is used.
• 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, DARAZUR can be used for a short period only.
• 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, DARAZUR should not be used.
• Contact lenses: contact lenses should be avoided during treatment with DARAZUR.
• Patients with a history of contact hypersensitivity to silver should not use DARAZUR, as the drops may contain trace amounts of silver.

You should consult your doctor if you 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. Adrenal insufficiency may occur as a result of discontinuation of prolonged or intensive treatment with DARAZUR. You should consult your doctor before deciding to stop treatment. This risk is particularly important in children and patients treated with ritonavir or cobicistat.
If you experience blurred vision or other vision disturbances, you should contact your doctor.

DARAZUR and other medicines

If you need to use other eye drops, wait 15 minutes before administering the next drop.
You should tell your doctor about taking ritonavir or cobicistat, as these medicines may increase the levels 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 you are taking, have recently taken, or plan to take.

Pregnancy and breastfeeding

• There are no sufficient data on the use of DARAZUR in pregnant women. The potential risk to humans is not known. Therefore, DARAZUR should not be used during pregnancy.
• It is not known whether the medicine is excreted in breast milk. However, the total dose of dexamethasone is low. Therefore, DARAZUR can be used during breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

As with all eye drops, temporary blurred vision or other visual disturbances may affect the ability to drive or operate machinery. You should not drive or operate machinery until your vision is normal.

DARAZUR contains phosphates

This medicine contains 2.177 mg of phosphates in each ml of solution.
If the patient has severe damage to the transparent layer on the front of the eye (cornea), phosphates may rarely cause cloudy spots on the cornea due to calcium accumulation during treatment.

3. How to use DARAZUR

Dose

This medicine should always be used exactly as your doctor has told you. If you are not sure, ask 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. It is recommended to gradually reduce the dose to avoid relapse.

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

Method of administration

Administration into the eye: this medicine is intended for use in the eyes.
 Before using the medicine, wash your hands thoroughly.
 Looking up and gently pulling down the lower eyelid with your finger, put one drop into the eye that needs treatment.
 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 and before closing, the multidose container should be shaken once in a downward direction, without touching the dropper tip, to remove any remaining liquid from the tip.
This is necessary to ensure the administration of subsequent drops.

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 DARAZUR

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

Missed dose of DARAZUR

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

Stopping treatment with DARAZUR

Treatment should not be stopped abruptly. You should always consult your doctor if you are considering stopping treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Hormonal disorders:

Uncommon (may affect up to 1 in 100 people)

• with frequent use, the kidneys may not produce enough hormones (suppression of adrenocortical function). This may manifest as low blood sugar, dehydration, weight loss, and disorientation.
• Hormonal problems: excessive 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: (may affect more than 1 in 10 people):

• increased intraocular pressure, after 2 weeks of treatment

Common: (may affect up to 1 in 10 people):

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

Uncommon: (may affect up to 1 in 100 people):

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

Rare: (may affect up to 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.

Reporting of side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store DARAZUR

Keep this medicine out of the sight and reach of children.
Do not use DARAZUR after the expiry date which is stated on the multidose container after EXP. The expiry date refers to the last day of that month.
Shelf life after first opening of the multidose container: 28 days.
There are no special precautions for storage of the medicinal product.
Medicines should 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 pack and other information

What DARAZUR contains

• The active substance of DARAZUR is dexamethasone phosphate. Each milliliter of solution contains 1 mg of dexamethasone phosphate (as dexamethasone sodium phosphate).
• The other ingredients are disodium phosphate dodecahydrate, sodium chloride, disodium edetate, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), and water for injections.

What DARAZUR looks like and contents of the pack

DARAZUR, eye drops, is a clear, colorless solution supplied in a multidose container in a cardboard box.
Each multidose container is a white HDPE bottle with a capacity of 11 ml (with a dropper and screw cap) containing 6 ml of solution. The pack contains 1 or 3 multidose containers.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Pharmaselect International Beteiligungs GmbH
Ernst-Melchior-Gasse 20
1020 Vienna, Austria
Phone: (+43) 17860386-0

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

Austria, Bulgaria, Denmark, Germany, Netherlands: Dexanova
Belgium: Darazon
Croatia, Hungary, Czech Republic: Darazur
Italy, Portugal: Amexzur
Spain, Slovakia: Amexxine
Date of last revision of the leaflet:October 2024
Detailed information on this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: www.urpl.gov.pl