Dexamitrex

Package Leaflet: Information for the User

Dexamytrex

(5 mg + 1 mg)/ml, eye drops, solution
(Gentamicin sulfate + Dexamethasone sodium 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 those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Package Leaflet Contents

• 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. Package contents 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, as well as in secondary infected allergic conjunctivitis and eyelid margin inflammation.

2. Important information before using Dexamytrex

When not to use Dexamytrex:

Warnings and precautions

Before starting treatment with Dexamytrex, discuss it with your doctor or pharmacist, especially if:

• you are using other eye drops.
• you are using contact lenses. It is not recommended to use contact lenses during treatment with Dexamytrex.

You should immediately contact your doctor if, during treatment with Dexamytrex:

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

You should consult your doctor if you 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 discontinuation of long-term or intensive treatment with Dexamytrex. You should consult your doctor before deciding to discontinue treatment. This risk is particularly important in children and patients treated with ritonavir or cobicistat.
Do not use the medicine 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

Tell your doctor about all the medicines you are taking, or have recently taken, including those obtained without a prescription.
Especially, tell your doctor if you are using:

• 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 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.
Dexamytrex should not be used during pregnancy and breastfeeding.

Driving and using machines

Even when used as recommended, Dexamytrex may cause temporary blurred vision after administration. Therefore, do not drive or operate machinery 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 accumulation.

3. How to use Dexamytrex

This medicine should always be used exactly as your doctor has instructed. If you are unsure, ask your 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.
Treatment should not last longer than 2 weeks.

Warning!

Administration instructions

Before instilling the medicine, wash your hands thoroughly.
Tilt your head back and gently pull down the lower eyelid with your index finger. With your 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.
Try to keep your eye open and move it so that the solution is evenly distributed.
Then, gently press the area of the eye corner near the nose with your finger for 2 minutes. This will help limit the absorption of the medicine into the entire body.
Dexamytrex eye drops are sterile. To avoid contamination of the eye drops, do not touch the dropper tip with your fingers or touch it to the eye surface or any other surface. Using contaminated eye drops can lead to serious eye damage, including vision loss.
After using the medicine, replace the protective cap and close the bottle carefully.
If you feel that the effect of Dexamytrex is too strong or too weak, talk to your doctor or pharmacist.
Warning:
If Dexamytrex is used concurrently with other eye drops or ointments, maintain a 15-minute interval between the administration of the medicines. Eye ointments should always be used last.

Using a higher dose of Dexamytrex than recommended

Since the medicine is used in the eye, overdose is unlikely.

Missing a dose of Dexamytrex

Take the missed dose as soon as possible. Do not take a double dose to make up for the missed dose. If you miss several doses, inform your doctor and follow their instructions.

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 - occur in more than 1 in 10 patients
Common - occur in 1 to 10 in 100 patients
Uncommon - occur in 1 to 10 in 1,000 patients
Rare - occur in 1 to 10 in 10,000 patients
Very rare - occur 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 (penetration) of the eye surface membrane.
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 cycles 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 accumulation.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Dexamytrex

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expiry date (EXP)".
Store in a temperature not exceeding 25°C.
Discard the remaining eye drops 28 days after first opening the container.
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. Package contents and other information

What Dexamytrex contains

• The active substances are: gentamicin (as gentamicin sulfate) and dexamethasone (as dexamethasone sodium phosphate). 1 ml of 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 K 25, hypromellose, disodium edetate, water for injections.

What Dexamytrex looks like and package contents

Dexamytrex is available as eye drops.
It is available in a polyethylene (LDPE) bottle with a dropper (LDPE) and a polyethylene (HDPE) cap, in a cardboard box.
Package size: 5 ml.

Marketing authorization holder and manufacturer

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

Date of last revision of the package leaflet: May 2025