Dexamitrex

Leaflet attached to the packaging: patient information

WARNING: Keep the leaflet, information on the immediate packaging in a foreign language.

Dexamytrex

(5 mg + 0.3 mg)/g, eye ointment
(Gentamicin sulfate + Dexamethasone)
WARNING!The strength of 3 mg/g of gentamicin on the immediate packaging refers to the equivalent of 5 mg/g, taking into account the content of gentamicin sulfate.

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a 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 or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Dexamytrex eye ointment and what is it used for

Dexamytrex eye ointment contains two active substances: gentamicin sulfate - an antibiotic from the aminoglycoside group and dexamethasone - 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 inflammation with intense inflammatory symptoms, as well as in secondary infected allergic conjunctivitis and blepharitis.

2. Important information before using Dexamytrex eye ointment

When not to use Dexamytrex eye ointment

• 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 an acute, purulent disease of the anterior segment of the eye,
• if the patient has an eye infection caused by viruses (e.g. herpetic keratitis), mycobacteria (e.g. eye tuberculosis) or fungi,
• in the case of corneal ulcers and wounds,
• if the patient has glaucoma with a narrow and open angle of filtration.

Warnings and precautions

Before starting to use Dexamytrex eye ointment, you should discuss it with your doctor or pharmacist:

• 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 while using Dexamytrex eye ointment.
• if the patient has a disease that causes thinning of the cornea or sclera.

You should contact your doctor immediately if, while using Dexamytrex eye ointment, the following occur:

• partial or complete hearing loss or dizziness;
• an increase in purulent discharge, inflammation or pain;
• a sudden, very severe eye and headache with accompanying nausea, vomiting, sudden blurring of vision and decreased visual acuity. These may be symptoms of increased pressure in the eyeball;
• blurred vision or other vision disturbances;
• blurred vision and difficulty seeing in bright light. These may be symptoms of a disease called cataract;
• if any other eye problems occur (pain, redness of the eye, tearing, photophobia). These may be symptoms of eye damage. You should consult a doctor if you experience swelling and weight gain, particularly 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 use of Dexamytrex eye ointment. You should consult a 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 the medicine in children have not been established.

Elderly people

In elderly people, no overall differences in efficacy and safety of the medicine have been observed compared to younger patients.

Dexamytrex eye ointment and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, including those that are available without a prescription.
In particular, you should tell your doctor if you are using: amphotericin B (a medicine used to treat fungal infections), heparin (an anticoagulant), sulfadiazine, cefalotin and cloxacillin (antibiotics used to treat bacterial infections), administered topically to the eye. Concurrent administration of Dexamytrex eye ointment with any of these medicines may lead to the formation of visible precipitates in the conjunctival sac.
You should tell your doctor about taking ritonavir or cobicistat, as these medicines may increase the content of dexamethasone in the blood.
Warning
If Dexamytrex eye ointment is used with other eye drops or ointments, a 15-minute interval should be maintained between the administration of the medicines, and Dexamytrex eye ointment should be used last.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
Dexamytrex eye ointment should not be used during pregnancy and breastfeeding, unless the doctor recommends otherwise after careful evaluation of the benefits and risks.

Driving and using machines

Even when used as recommended, Dexamytrex eye ointment may temporarily disturb vision after application, so you should not drive or operate machinery until the symptoms have completely resolved.

Dexamytrex eye ointment contains lanolin (wool fat), butylhydroxytoluene and propylene glycol (Oxynex 2004 components).

Due to the presence of lanolin, the medicine may cause local skin reactions (e.g. contact dermatitis).
Due to the presence of butylhydroxytoluene, the medicine may cause local skin reactions (e.g. contact dermatitis) or eye and mucous membrane irritation.
Due to the presence of propylene glycol, the medicine may cause skin irritation.

3. How to use Dexamytrex eye ointment

This medicine should be used as recommended by your doctor. If you have any doubts, you should consult your doctor or pharmacist.
Recommended dose
If not otherwise recommended, apply 5 mm of the ointment to the conjunctival sac of the infected eye 2-3 times a day and before bedtime.
Treatment duration
The treatment duration should not exceed 2 weeks.

Warning! Instructions for administering the medicine:

• 1. Wash your hands thoroughly.
• 2. Unscrew the cap.
• 3. Hold the tube with the nozzle down, using your thumb and index finger

pointing.

• 4. Tilt your head back.
• 5. Gently pull down the lower eyelid with your index finger, so that a "pocket" forms between the eyeball and the eyelid, into which the ointment will be inserted.
• 6. Bring the nozzle close to the eye, without touching the nozzle to the eye, eyelid, or surrounding areas.
• 7. Gently squeeze the tube to express the ointment.
• 8. Looking up, insert about 5 mm of ointment into the formed "pocket". If the medicine does not get into the eye, repeat the procedure.
• 9. Gently close your eyelid. Do not squeeze your eyelids tightly, so as not to squeeze the ointment out of the eye.
• 10. Press the inner corner of your eye at the base of your nose with your finger. This will help minimize the risk of the medicine getting into the entire body.
• 11. If the ointment is to be administered to both eyes, repeat the above steps for the second eye.
• 12. Immediately after using the medicine, screw the cap back on the tube.

Having someone else help you or using a mirror can make it easier to administer the medicine.
Dexamytrex eye ointment is a sterile medicine. To avoid contamination, do not touch the nozzle with your fingers or touch it to the eye surface or any other surface.
Using contaminated ointments can lead to serious vision damage, including vision loss.
If you feel that the effect of Dexamytrex eye ointment is too strong or too weak, you should consult your doctor or pharmacist.
Warning: Using Dexamytrex eye ointment with other medicines - see section 2 Medicine

Dexamytrex eye ointment and other medicines.

Using a higher dose of Dexamytrex eye ointment than recommended

Since the medicine is used in the eye, you should not expect symptoms of overdose to occur.

Missing a dose of Dexamytrex eye ointment

You should take the missed dose as soon as possible. Do not take a double dose to make up for the missed dose. If you have missed several doses, you should inform your doctor and follow their recommendations.

Stopping the use of Dexamytrex eye ointment

If you have any further doubts about using this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible side effects:
Rare (may affect up to 1 in 1000 people)

• Mild, transient and short-term vision disturbances.

Frequency not known (cannot be estimated from the available data)

• Hypersensitivity reactions (including eyelid and conjunctival edema, itching, conjunctival hyperemia, contact dermatitis)
• Difficulty in wound healing (if the medicine is used after corneal injury)
• Glaucoma and cataract (after long-term use)
• Pupil dilation
• Eye irritation
• Deposits in the cornea
• Secondary bacterial, viral (including herpes) and fungal eye infections
• Increased intraocular pressure, which may be associated with optic nerve damage, decreased visual acuity and visual field defects
• Perforation (perforation) of the membrane on the surface of the eye
• Hormonal disorders: increased hair growth on the body (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 inhibition in children and adolescents, and swelling and weight gain, particularly on the trunk and face (a disease called Cushing's syndrome) (see section 2 "Warnings and precautions")
• Secondary infections occurring after the use of combinations containing corticosteroids and anti-infective agents
• Blurred vision.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell 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 49 213 09, website: https://smz.ezdrowie.gov.pl. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dexamytrex eye ointment

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.
Store in a temperature below 25°C.
Any remaining ointment should be discarded 6 weeks after first opening the tube.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Dexamytrex eye ointment contains

The active substances of the medicine are gentamicin sulfate and dexamethasone.
1 g of ointment contains 5 mg of gentamicin sulfate and 0.3 mg of dexamethasone.
The other ingredients are: chlorobutanol hemihydrate, myristyl alcohol, lanolin, liquid paraffin, white petrolatum, α-tocopherol, Oxynex 2004.

What Dexamytrex eye ointment looks like and what the packaging contains

Dexamytrex is available in the form of eye ointment.
The medicine is available in a tube containing 3 g of ointment.
To obtain more detailed information, you should contact the marketing authorization holder or parallel importer

Marketing authorization holder in Portugal, the country of export:

Angelini Pharma Portugal, Unipessoal Lda., Rua João Chagas, 53 – Piso 3, 1499-040 Cruz Quebrada-Dafundo, Portugal

Manufacturer:

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

Parallel importer:

PharmaVitae Sp. z o.o. sp. k., ul. E. Orzeszkowej 3/35, 59-820 Leśna

Repackaged by:

CEFEA Sp. z o.o. Sp. komandytowa, ul. Działkowa 56, 02-234 Warsaw
SHIRAZ PRODUCTIONS Sp. z o.o., ul. Tymiankowa 24/28, 95-054 Ksawerów
Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź
Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warszawa
Synoptis Industrial Sp. z o.o., ul. Szosa Bydgoska 58, 87-100 Toruń
Natur Produkt Zdrovit Sp. z o.o., ul. Nocznickiego 31, 01-918 Warszawa
Portuguese marketing authorization number:8707307
Parallel import authorization number:225/17
Date of leaflet approval: 08.06.2022
[Information about the trademark]