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 this medicine, as it contains
important information for the patient.

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

Table of contents of the leaflet

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 aminoglycoside antibiotic, 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, and eyelid margin inflammation with severe inflammatory signs, as well as 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 ulcers and erosions;
• if the patient has tuberculosis 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, discuss it with your doctor or pharmacist,
especially if:

• the patient is using other medicines administered locally to the eye;
• the patient wears contact lenses. The use of contact lenses is not recommended during treatment with Dexamytrex.

Seek immediate medical advice if, during treatment with Dexamytrex:

• partial or complete hearing loss or dizziness occurs;
• the amount of purulent discharge increases, or inflammation or pain worsens;
• sudden, severe eye and headache occur, 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 a condition called cataract;
• any other eye problems occur (pain, eye redness, tearing, photophobia). These may indicate 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 called
Cushing's syndrome. Adrenal suppression may occur following discontinuation
of prolonged or intensive treatment with Dexamytrex. Consult a doctor before
discontinuing treatment. This risk is particularly significant 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
Safety and efficacy have not been established in children.
Dexamytrex with other medicines
Inform your doctor about all medicines the patient is currently taking or
has recently taken, including those available without a prescription.
In particular, inform the doctor if the patient is using:

• amphotericin B, heparin, sulfadiazine, cephalothin, or cloxacillin, administered locally 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 simultaneously with other eye drops or ointments, a 15-minute interval should be maintained between administrations. 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 or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her 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, until these symptoms have completely resolved, the patient should not drive or operate machinery.
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 opacities due to calcium deposition during treatment.

3. How to use Dexamytrex

This medicine should always be used as directed by the physician. In case of doubt, consult a
physician 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 downward 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 medicine.
Tilt the head backward and gently pull down the lower eyelid
with the index finger. With the other hand, hold the bottle in an
upright position above the eye, without touching the eye, and
instill one drop into the conjunctival sac by gently squeezing the
bottle wall.
Try to keep the eye open and move it so that the solution spreads evenly.
Then gently press the area at the inner corner of the eye near the nose with a finger for 2 minutes. This
can help reduce the 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 contact 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 the protective cap and close the bottle carefully.
If you feel that the effect of Dexamytrex is too strong or too weak, consult your physician or pharmacist.
Note:
If Dexamytrex is used simultaneously 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 the medicine is applied to 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 can 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 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 fewer than 1 in 10,000 patients
Frequency not known – cannot be estimated based on available data

Possible adverse reactions:
Rare:
Mild, transient and short-lived disturbances in vision.

Very rare:
Pupil dilation in the treated eye.

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

Fungal corneal infections, which may particularly easily 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 caused 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 (corneal melt) of the ocular surface membrane.

Endocrine 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 edema 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, in very rare cases, during treatment, lead to corneal opacification due to calcium deposition.

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

5. How to store Dexamytrex

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the stated month.
Do not store above 25°C. Protect from light.
Discard any remaining drops 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 in use. This will help protect the environment.

6. Contents of the pack and other information

What Dexamytrex contains

• The active substances are: gentamicin (in the form of gentamicin sulfate) and dexamethasone (in the form of dexamethasone sodium phosphate). Each 1 ml of eye drops contains 5 mg of gentamicin sulfate and 1 mg of dexamethasone sodium phosphate.
• Other components: cetylpyridinium chloride, disodium phosphate dodecahydrate, potassium dihydrogen phosphate, sodium pyrosulfite, 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 supplied in a bottle with a dropper and a screw cap, packed in a cardboard box.
Pack size: 5 ml.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Greece, 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 in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing Authorisation Number in Greece, country of export: 75842/24-12-2015
39494/10/23-05-2011
Parallel Import Licence Number: 43/24