Dexamitrex

Package Leaflet: Information for the User

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.

Dexamytrex

(5 mg + 1 mg)/ml, eye drops, solution
Gentamicin sulfate + Dexamethasone sodium phosphate

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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 side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

1. What is Dexamytrex and what is it used for

Dexamytrex contains the active substances: gentamicin sulfate - an antibiotic from the aminoglycoside group and dexamethasone sodium phosphate - a glucocorticosteroid.
The medicine is used in infections of the anterior segment of the eye, caused by microorganisms sensitive to gentamicin, such as: bacterial conjunctivitis, keratitis - without corneal epithelial damage and eyelid margin damage with severe inflammatory symptoms, and in secondary infected allergic conjunctivitis and blepharitis.

2. Important information before using Dexamytrex

When not to use Dexamytrex:

Warnings and precautions

Before starting to use Dexamytrex, the patient should discuss it with their doctor or pharmacist, especially in the case of:

• if the patient is using other eye drops or ointments;
• if the patient is using contact lenses. It is not recommended to use contact lenses during treatment with Dexamytrex.

The patient should contact their doctor immediately if, during treatment with Dexamytrex:

• partial or complete hearing loss or dizziness occurs;
• the amount of purulent discharge, inflammation, or pain increases;
• sudden, very severe eye and head pain occurs, accompanied by nausea, vomiting, sudden blurred vision, and decreased visual acuity. These may be symptoms of increased intraocular pressure;
• blurred vision or other vision disturbances occur;
• blurred vision and difficulty seeing in bright light occur. These may be symptoms of a disease called cataract;
• any other eye problems occur (pain, redness, tearing, photophobia). These may be symptoms of eye damage.

The patient should consult their doctor if they experience swelling and weight gain, especially 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 long-term or intensive use of Dexamytrex. The patient should consult their doctor before deciding to stop treatment. This risk is particularly important in children and patients treated with ritonavir or cobicistat.
The medicine should not be used for a long time, as gentamicin-resistant bacteria or secondary eye infections (bacterial, fungal, or viral) may develop.

Children and adolescents

The safety and efficacy of Dexamytrex in children have not been established.

Dexamytrex and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, including those available without a prescription.
In particular, the patient should tell their doctor if they are taking:

• amphotericin B, heparin, sulfadiazine, cefalotin, and cloxacillin, administered topically to the eye. Concurrent administration of Dexamytrex with any of these medicines may lead to the formation of visible precipitates in the conjunctival sac;
• other eye drops or ointments. If Dexamytrex is used concurrently with other eye drops or ointments, a 15-minute interval should be maintained between the administration of the medicines. Eye ointments should always be used last;
• ritonavir or cobicistat, as these medicines may increase the dexamethasone content in the blood.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Dexamytrex should not be used during pregnancy and breastfeeding.

Driving and using machines

Even when used as recommended, Dexamytrex may temporarily disturb vision after administration. Therefore, the patient should not drive or operate machines until the symptoms have completely resolved.

Dexamytrex contains disodium phosphate dodecahydrate and potassium dihydrogen phosphate

The medicine contains 0.20 mg of phosphates in each drop, which corresponds to 6.52 mg/ml.
In patients with severe damage to the transparent, anterior part of the eye (cornea), phosphates may, in very rare cases, cause corneal clouding during treatment due to calcium deposition.

3. How to use Dexamytrex

This medicine should always be used as directed by the doctor. If in doubt, the patient should consult their doctor or pharmacist.
Recommended dose
If not otherwise prescribed, 1 drop into the conjunctival sac of the infected eye 4-6 times a day.
Pull down the lower eyelid and instill 1 drop into the conjunctival sac. The treatment duration should not exceed 2 weeks.

Warning!

Administration instructions

Before instilling the medicine, the patient should wash their hands thoroughly.
Tilt their head back and gently pull down the lower eyelid with their index finger. With the other hand, hold the bottle vertically over the eye, without touching the eye, and instill one drop into the conjunctival sac by gently squeezing the bottle wall.
The patient should try to keep their eye open and move it so that the solution is distributed evenly.
Then, they should gently press the area of the eye corner near the nose with their finger for 2 minutes. This can help limit the absorption of the medicine into the entire body.
Dexamytrex eye drops are sterile. To avoid contaminating the eye drops, the patient should not touch the dropper tip with their fingers or touch it to the eye surface or any other surface. Using contaminated drops can lead to serious eye damage, including vision loss.
After using the medicine, the patient should put on the protective cap and carefully close the bottle.
If the patient feels that the effect of Dexamytrex is too strong or too weak, they should consult their doctor or pharmacist.
Warning:
If Dexamytrex is used concurrently with other eye drops or ointments, a 15-minute interval should be maintained between the administration of the medicines. Eye ointments should always be used last.

Using a higher than recommended dose of Dexamytrex

Since the medicine is used in the eye, overdose is not expected.

Missing a dose of Dexamytrex

The patient should take the missed dose as soon as possible. They should not take a double dose to make up for the missed dose. If they have missed several doses, they should inform their doctor and follow their recommendations.

4. Possible side effects

Like all medicines, Dexamytrex can cause side effects, although not everybody gets them.
The frequency of possible side effects is defined as follows:
Very common - occurs in more than 1 in 10 patients
Common - occurs in 1 to 10 in 100 patients
Uncommon - occurs in 1 to 10 in 1,000 patients
Rare - occurs in 1 to 10 in 10,000 patients

Very rare - occurs in less than 1 in 10,000 patients
Unknown frequency - cannot be estimated from the available data
Possible side effects:
Rare:
Mild, transient, and short-term vision disturbances.
Very rare:
Pupil dilation in the treated eye.
Unknown frequency:
Difficulty in wound healing (if the medicine is used after corneal injuries), cataract (after long-term use), glaucoma (after long-term use), eye irritation, corneal deposits, hypersensitivity (including eyelid and conjunctival edema, itching, conjunctival hyperemia, contact dermatitis).
Fungal keratitis developing particularly easily as secondary infections during long-term local use of corticosteroid-containing medicines. After using corticosteroids, fungal infection should always be considered if persistent corneal ulceration occurs.
Bacterial eye infection.
Secondary infections with pathogens: bacterial, viral (including herpes simplex virus).
Increased intraocular pressure (which may be associated with optic nerve damage, decreased visual acuity, and visual field defects).
Subcapsular cataract.
Perforation (perforation) of the cornea.
Hormonal disorders: increased body hair growth (especially in women), muscle weakness, and muscle mass loss, purple striae on the skin, increased blood pressure, irregular menstrual periods or amenorrhea, changes in protein and calcium levels in the body, growth retardation in children and adolescents, and swelling and weight gain, especially on the trunk and face (Cushing's syndrome) (see section 2 "Warnings and precautions").
Blurred vision.
Other side effects reported in connection with the use of eye drops containing phosphates
In patients with severe damage to the transparent, anterior part of the eye (cornea), phosphates may, in very rare cases, cause corneal clouding during treatment due to calcium deposition.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Dexamytrex

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Do not store above 25°C. Protect from light.
Any remaining solution should be discarded 30 days after opening the bottle.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Dexamytrex contains

• The active substances of the medicine are: gentamicin (as gentamicin sulfate) and dexamethasone (as dexamethasone sodium phosphate). 1 ml of the eye drops contains 5 mg of gentamicin sulfate and 1 mg of dexamethasone sodium phosphate.
• The other ingredients are: cetrimide, disodium phosphate dodecahydrate, potassium dihydrogen phosphate, sodium metabisulfite, glycerol 85%, povidone, hypromellose, disodium edetate, water for injections.

What Dexamytrex looks like and contents of the pack

Dexamytrex is available as eye drops.
It is available in a bottle with a dropper and screw cap, in a cardboard box.
Pack size: 5 ml.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Greece, the country of export:

Bausch+Lomb Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, Ireland

Manufacturer:

Dr. Gerhard Mann Chem.-Pharm. Fabrik GmbH
Brunsbütteler Damm 165-173
13581 Berlin
Germany

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
Marketing authorization number in Greece, the country of export: 75842/24-12-2015
39494/10/23-05-2011

Parallel import authorization number: 43/24

Date of leaflet approval: 29.01.2024

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