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 use, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm others, even if their symptoms are identical.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform your 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 antibiotic of the aminoglycoside class, and dexamethasone sodium phosphate – a glucocorticosteroid.
Dexamytrex 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 infections 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;
• 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 this with your doctor or pharmacist,
especially if:

• the patient is using other medicines applied 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, inflammation, or pain increases;
• sudden, severe eye or headache occurs, accompanied by nausea, vomiting, sudden blurred vision, and decreased 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 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 called 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 significant in children and in patients treated with ritonavir or cobicistat. Do not use the medicine long-term, as resistant bacteria to gentamicin may develop or secondary eye infections (bacterial, fungal, or viral) may occur.

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

Dexamytrex with other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription.

Especially inform your 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 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 the administration of the medicines. 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 or 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 and while 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 clouding due to calcium accumulation during treatment.

3. How to use Dexamytrex

This medicine should always be used as directed by your doctor. If in doubt, consult your doctor or pharmacist.

Recommended dose
Unless otherwise advised, the recommended dose is 1 drop into the conjunctival sac of the affected eye 4 to 6 times daily.
Pull the lower eyelid downward and instill 1 drop into the conjunctival sac.
The treatment duration should not exceed 2 weeks.

Caution!
Instructions for administration
Wash your hands thoroughly before instilling the drops.
Tilt your head backward and gently pull down the lower eyelid with your 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. Try to keep the eye open and move it around to spread the solution evenly.
After instillation, gently press the inner corner of the eye (near the nose) with your finger for 2 minutes. This helps reduce the amount of medicine absorbed into the systemic circulation.

Dexamytrex eye drops are sterile. To avoid contamination, do not touch the dropper tip with your fingers or allow it to contact the eye surface or any other surface. Using contaminated eye drops may lead to serious eye damage, including loss of vision.
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 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 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 doctor and follow their instructions.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will get 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 less than 1 in 10,000 people.
Frequency not known – cannot be estimated from the available data.

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

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 corneal infections, which may develop particularly easily 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 lead to 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 disturbances: 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 swelling 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, cause corneal clouding during treatment due to calcium accumulation.

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 Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorisation holder or the parallel importer.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Dexamytrex

Keep this medicine out of the 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 stated month.
Do not store above 25°C. Store in the outer packaging to 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 required. Such measures help protect the environment.

6. Contents of the package and other information

What Dexamytrex contains

• The active substances in this medicine are: gentamicin (in the form of gentamicin sulfate) and dexamethasone (in the form of dexamethasone sodium phosphate). 1 ml of eye drops contains 5 mg of gentamicin sulfate and 1 mg of dexamethasone sodium phosphate.
• Other ingredients are: cetylpyridinium chloride, disodium phosphate dodecahydrate, potassium dihydrogen phosphate, sodium pyrosulfite, glycerol, povidone, hypromellose, disodium edetate, water for injections.

What Dexamytrex looks like and contents of the pack
Dexamytrex is available as an eye drop solution.
It is supplied in a dropper bottle contained 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, 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:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw
Repackaged in:
CEFEA Sp. z o.o. Sp. Synoptis Industrial Sp. z o.o. Shiraz Productions Sp. z o.o.
spółka komandytowa ul. Forteczna 35-37 ul. Tymiankowa 24/28
ul. Działkowa 56 87-100 Toruń 95-054 Ksawerów
02-234 Warsaw
Marketing Authorisation Number in Greece, country of export: 75842/24-12-2015
Parallel Import Licence Number: 180/25