Darazur

Package leaflet: Information for the user

DARAZUR, 1 mg/ml, eye drops, solution
Dexamethasoni phosphas
Please read all of this leaflet carefully before using this medicine because it contains
important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What DARAZUR is and what it is 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 DARAZUR is and what it is used for

DARAZUR is a multi-dose container of eye drops containing a substance called dexamethasone. This substance is a corticosteroid which suppresses inflammatory symptoms.
DARAZUR 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 should be administered concomitantly (see section 2).

2. Information before using DARAZUR

When not to use DARAZUR:

• 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 elevated intraocular pressure caused by glucocorticoids (a group of corticosteroids),
• if the patient has hypersensitivity (allergy) to dexamethasone sodium phosphate or any of the other ingredients of this medicine (listed in section 6)

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

• Close ophthalmological monitoring is required in all cases during treatment with DARAZUR, especially:

  • in children and elderly patients. More frequent detailed ophthalmic examinations are recommended.
  • if the patient has an eye infection. DARAZUR may only be used if anti-infective treatment is administered concomitantly.

• 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 elevated intraocular pressure. If the patient previously experienced adverse effects leading to increased intraocular pressure during treatment with locally applied steroids, there is a risk of increased intraocular pressure when using DARAZUR.

• 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, DARAZUR 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, DARAZUR should not be used.
  • Contact lenses: wearing 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.

Seek medical advice if the patient develops swelling and weight gain, particularly noticeable on the trunk and face, as these are usually the first signs of a condition called Cushing's syndrome. Adrenal suppression may occur following discontinuation of prolonged or intensive treatment with DARAZUR. Consult a doctor before deciding to stop treatment. This risk is particularly significant in children and in patients treated with ritonavir or cobicistat.
If the patient experiences blurred vision or other visual disturbances, contact a doctor.

DARAZUR and other medicines
If other eye medications are required, wait 15 minutes before administering the next product.
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 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 DARAZUR in pregnant women. The potential risk to humans is unknown. Therefore, the use of DARAZUR 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, DARAZUR may be used during breastfeeding.

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, 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.

DARAZUR contains phosphates
This medicine contains 2.177 mg of phosphates per ml of solution.
If the patient has severe damage to the transparent front layer of the eye (cornea), phosphates may, in very rare cases, cause corneal clouding due to calcium deposits during treatment.

3. How to use the medicine DARAZUR

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 dose reduction is recommended to prevent relapse.

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

Method of administration
Ocular administration: this medicine is intended for ophthalmic use only.
 Wash hands thoroughly before using the medicine.
 While looking upward and gently pulling down the lower eyelid with a finger, instill one drop into the eye requiring treatment.
 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 increase penetration of the active substance into the eye).
After use and before replacing the cap, shake the multidose container once downward, without touching the tip of the dropper, to remove any residual liquid from the tip.
This is necessary to ensure proper delivery of subsequent doses.

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.

Accidental overdose of DARAZUR
In case of overdose in the eye with prolonged irritation, rinse the eye with sterile water.
Seek immediate advice from your doctor or pharmacist.

Missed dose of DARAZUR
Do not administer a double dose to make up for a missed dose.

Discontinuation of DARAZUR
Do not stop treatment abruptly. Always consult your doctor if you are considering discontinuing 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:
Uncommon (may occur in up to 1 in 100 people):

• With frequent use, the kidneys may fail to produce sufficient hormones (suppression of corticoadrenal function). This may manifest as low blood sugar levels, dehydration, weight loss, and disorientation regarding the patient's location.
• Hormonal problems: excessive body hair growth (particularly 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 (may occur in more than 1 in 10 people):

• Elevated intraocular pressure, after 2 weeks of treatment.

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

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

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

• Allergic reactions or hypersensitivity symptoms to one of the ingredients of the eye drops,
• Delayed healing,
• Lens opacity (cataract),
• Infections,
• Glaucoma.

Very rare (may occur in up to 1 in 10,000 people):

• Conjunctivitis,
• Pupil dilation (mydriasis),
• Facial swelling,
• Drooping of the eyelids,
• Iritis (inflammation of the uvea),
• Corneal calcification,
• Keratitis (crystalline keratopathy),
• Changes in corneal thickness,
• Corneal edema,
• Corneal ulceration,
• Corneal perforation.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store DARAZUR

Keep this medicine out of sight and reach of children.
Do not use DARAZUR after the expiry date stated on the multidose container after EXP. The expiry date refers to the last day of the stated month.
Shelf life after first opening the multidose container: 28 days.
No special storage requirements for this medicinal product.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Darazur contains

• The active substance is dexamethasone sodium phosphate. Each millilitre of solution contains 1 mg of dexamethasone sodium 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 are a clear, colourless solution supplied in a multidose container within a cardboard box.
Each multidose container is a white 11 ml bottle made of low-density polyethylene (HDPE) (with dropper and cap) containing 6 ml of solution. The pack contains 1 or 3 multidose containers.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Pharmaselect International Beteiligungs GmbH
Ernst-Melchior-Gasse 20
1020 Vienna, Austria
Tel: (+43) 17860386-0

This medicinal product is authorised in the following European Economic Area countries under the following names:
Austria, Bulgaria, Denmark, Germany, Netherlands: Dexanova
Belgium: Darazon
Croatia, Hungary, Czech Republic: Darazur
Italy, Portugal: Amexzur
Spain, Slovakia: Amexxine

Detailed information about this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: www.urpl.gov.pl