Dexamytrex

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
Gentamicini sulfas + Dexamethasoni natrii phosphas
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so you can read it again if necessary.
• If you have any doubts, please 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 identical.
• If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Dexamytrex is and what it is 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 Dexamytrex is and what it is 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 epithelial damage, eyelid margin infections with severe inflammatory symptoms, and in secondarily infected allergic conjunctivitis and eyelid margin inflammation.

2. Important information before using Dexamytrex

When not to use Dexamytrex:

• if the patient is allergic to gentamicin, dexamethasone, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has acute, purulent disease of the anterior segment of the eye;
• if the patient has superficial herpetic keratitis or corneal erosions and ulcers;
• if the patient has tuberculous infection of the eyeball;
• if the patient has fungal infection of the eye;
• if the patient has narrow-angle or open-angle glaucoma.

Warnings and precautions
Before starting treatment with Dexamytrex, consult a doctor or pharmacist,
especially if:

• the patient is using other medicines applied locally to the eye;
• the patient wears contact lenses. Wearing contact lenses during treatment with Dexamytrex is not recommended.

Contact a 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, severe eye and head pain occurs, accompanied by nausea, vomiting, sudden blurred vision, and reduced visual acuity. These may be symptoms of increased intraocular pressure;
• blurred vision or other visual disturbances occur;
• hazy vision and difficulty seeing in bright light occur. These may be symptoms of cataract;
• any other eye problems occur (pain, eye redness, tearing, photophobia). These may be symptoms of damage to parts of the eye.

Consult a doctor if the patient develops swelling and weight gain, particularly noticeable
in 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 Dexamytrex. Consult a doctor before
deciding to stop treatment. This risk is particularly relevant in children and in patients
receiving ritonavir or cobicistat.
Do not use the medicine for prolonged periods, as resistant bacteria to gentamicin
may develop or secondary eye infections (bacterial, fungal, or viral) may occur.

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

Dexamytrex and other medicines
Inform the doctor about all medicines currently or recently taken by the patient, including those
obtained without a prescription.
Especially inform the doctor if the patient is using:

• amphotericin B, heparin, sulfadiazine, cephalothin, or cloxacillin, applied locally to the eye. Concurrent administration of Dexamytrex with any of these medicines may result in the formation of visible precipitates in the conjunctival sac;
• other eye drops or ointments. If Dexamytrex is used simultaneously with other eye drops or ointments, a 15-minute interval should be maintained between administrations. Eye ointments should always be applied last;
• ritonavir or cobicistat, as these medicines may increase blood levels of dexamethasone.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant,
she should consult a doctor or pharmacist before using this medicine.
Dexamytrex should not be used during pregnancy or breastfeeding.

Driving and operating machinery
Even when used as directed, Dexamytrex may temporarily impair vision after administration; therefore,
driving and operating machinery should be avoided until these symptoms have completely resolved.

Dexamytrex contains disodium phosphate dodecahydrate and potassium dihydrogen phosphate
The medicine contains 0.20 mg of phosphates per drop, equivalent to 6.52 mg/ml.
In patients with severe damage to the transparent, anterior part of the eye (cornea), phosphates
may very rarely cause corneal clouding due to calcium deposition during treatment.

3. How to use Dexamytrex

This medicine should always be used exactly as directed by the physician. If in doubt, consult a doctor or pharmacist.
Recommended dose
Unless otherwise advised, instill 1 drop into the conjunctival sac of the affected eye 4–6 times daily.
Pull the lower eyelid downwards and instill 1 drop into the conjunctival sac.
The duration of treatment should not exceed 2 weeks.

Caution!
Instructions for administration
Wash hands thoroughly before instilling the drops.
Tilt the head backwards and gently pull down the lower eyelid with the index finger.
With the other hand, hold the bottle vertically above the eye and instill one drop into the conjunctival sac by gently squeezing the bottle, taking care not to touch the eye with the dropper tip.
Try to keep the eye open and move it gently to ensure even distribution of the solution. Then gently press with a finger on the inner corner of the eye (near the nose) for 2 minutes. This helps reduce absorption of the medicine into the systemic circulation.
Dexamytrex eye drops are sterile. To avoid contamination, do not touch the dropper tip with fingers or allow it to touch the eye surface or any other surface. Using contaminated eye drops may lead to serious eye damage, including vision loss.
After using the medicine, replace and tightly close the protective cap on the bottle.
If you feel that the effect of Dexamytrex is too strong or too weak, consult your doctor or pharmacist.
Note:
If Dexamytrex is used together with other eye drops or eye ointments, a 15-minute interval should be maintained between the applications. Eye ointments should always be used last.
Use of a higher than recommended dose of Dexamytrex
Since this medicine is administered into the eye, overdose is not expected.
Missed dose of Dexamytrex
Apply the missed dose as soon as possible. Do not use a double dose to make up for the missed dose. If several doses have been missed, inform your treating physician and follow their instructions.

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, although not everyone will experience them.
The frequency of possible adverse reactions is defined as follows:
Very common – occurs in more than 1 in 10 people.
Common – occurs in 1 to 10 in 100 people.
Uncommon – occurs in 1 to 10 in 1,000 people.
Rare – occurs in 1 to 10 in 10,000 people.
Very rare – occurs in fewer than 1 in 10,000 people.
Frequency not known – cannot be estimated from available data.

Possible adverse reactions:
Rare:
Mild, transient and short-term visual disturbances.

Very rare:
Dilation of the pupil in the treated eye.

Frequency not known:
Impaired wound healing (if the medicine is used after corneal injury), cataract (after prolonged use), glaucoma (after prolonged use), eye irritation, corneal deposits, hypersensitivity (including eyelid and conjunctival swelling, itching, conjunctival hyperaemia, contact dermatitis).

Fungal infections of the cornea, particularly prone to develop as secondary infections during prolonged local use of corticosteroid-containing medicines. Fungal infection should always be considered after corticosteroid use if persistent corneal ulceration occurs.

Bacterial eye infections.
Secondary infections by pathogens: bacterial, viral (including herpes simplex virus).
Increased intraocular pressure (which may be associated with optic nerve damage, worsening of visual acuity, and visual field defects).
Posterior subcapsular cataract.
Perforation (puncturing) of the membrane on the surface of the eye.
Hormonal disorders: excessive body hair growth (especially in women), muscle weakness and loss of muscle mass, purple skin striae, 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 oedema with increased body weight, particularly noticeable in the trunk and face (a condition known as Cushing's syndrome) (see section 2 "Warnings and precautions").
Blurred vision.

Other adverse reactions reported with the use of eye drops containing phosphates:
In patients with severe damage to the transparent, front part of the eye (cornea), phosphates may very rarely cause corneal calcification (clouding) due to calcium accumulation during treatment.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of 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.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store the medicine Dexamytrex

The medicine should be stored in a place inaccessible and not visible to children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Do not store above 25°C. Store in the outer carton to protect from light.
Any remaining drops should be discarded 30 days after first opening the bottle.
Medicines must 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 package and other information

What Dexamytrex contains

• The active substances in this medicine 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.
• Other components are: cetylpyridinium chloride, disodium phosphate dodecahydrate, potassium dihydrogen phosphate, sodium metabisulfite, glycerol, povidone, hypromellose, disodium edetate, water for injections.

What Dexamytrex looks like and contents of the pack
Dexamytrex is available as eye drops, solution.
It is available in a bottle with a dropper, packed in a cardboard box.
Pack size: 5 ml.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Greece, the country of export:
Bausch + Lomb Ireland Limited
3013 Lake Drive
Citywest Business Campus 24
Dublin, Ireland
Manufacturer:
Dr. Gerhard Mann Chem. Pharma Fabrik GmbH
Brunsbütteler Damm 165-173
13581 Berlin, Germany
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in Greece, the country of export: 75842/24-12-2015
39494/10/23-05-2011
Parallel Import Authorisation Number: 208/24