DEXAMYTREX (5 mg + 0.3 mg)/g Ointment

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
3. Dexamytrex
   1. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is Dexamytrex and what is it used for
5. Important information before using Dexamytrex
   1. When not to use Dexamytrex
   2. Warnings and precautions
   3. Children and adolescents
   4. Elderly people
   5. Dexamytrex and other medicines
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Dexamytrex contains lanolin (wool fat) and butylhydroxytoluene and propylene glycol (Oxynex 2004 components).
6. How to use Dexamytrex
   1. Warning! Instructions for administering the medicine:
   2. Using a higher dose of Dexamytrex than recommended
   3. Missing a dose of Dexamytrex
   4. Stopping the use of Dexamytrex
7. Possible side effects
   1. Reporting side effects
8. How to store Dexamytrex
9. Contents of the packaging and other information
   1. What Dexamytrex contains
   2. What Dexamytrex looks like and what the packaging contains
   3. Marketing authorization holder in Portugal, the country of export:
   4. Manufacturer:
   5. Parallel importer:
   6. Repackaged by:

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 potency of 3 mg/g stated on the immediate packaging refers to gentamicin and is equivalent to 5 mg/g, taking into account the gentamicin sulfate content.

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 necessary.
• In case of 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 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. Contents of the packaging and other information

1. What is Dexamytrex and what is it used for

Dexamytrex 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 damage with intense inflammatory symptoms, and in secondarily infected allergic conjunctivitis and blepharitis.

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 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, 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 wear contact lenses while using Dexamytrex;
• if the patient has a disease that causes a decrease in the thickness of the cornea or sclera.

You should contact your doctor immediately if, while using Dexamytrex, you experience:

• partial or complete hearing loss or dizziness;
• an increase in the amount of purulent discharge, inflammation, or pain;
• a sudden, very severe eye and head pain 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 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 the patient experiences 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 discontinuing long-term or intensive use of Dexamytrex. You should consult your doctor before the patient decides to discontinue treatment. This risk is particularly important in children and patients treated with ritonavir or cobicistat.
You should 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.

Elderly people

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

Dexamytrex and other medicines

You should tell your doctor about all medicines the patient is currently taking or has recently taken, including those that are available without a prescription.
In particular, you should tell your doctor if the patient is taking: 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 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 dexamethasone content in the blood.
Warning
If Dexamytrex is used with other eye drops or ointments, you should maintain a 15-minute interval between the administration of the medicines, and Dexamytrex should be used last.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Dexamytrex should not be used during pregnancy and breastfeeding, unless the doctor recommends otherwise after a careful assessment of the benefits and risks.

Driving and using machines

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

Dexamytrex contains lanolin (wool fat) and 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 a local skin reaction (e.g., contact dermatitis) or eye and mucous membrane irritation.
The medicine contains 0.275 mg of propylene glycol per 1 g of ointment.

3. How to use Dexamytrex

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.
• 4. Tilt your head back.
• 5. Gently pull down the lower eyelid with your index finger to create a "pocket" 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 "pocket".

If the medicine does not get into the eye, repeat the procedure.

• 9. Gently close your eyelid. Do not squeeze your eyelids tightly, as this may push 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 may make it easier to administer the medicine.
Dexamytrex 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 is too strong or too weak, you should consult your doctor or pharmacist.
Warning:Using Dexamytrex with other medicines - see section 2 "Dexamytrex and other medicines".

Using a higher dose of Dexamytrex than recommended

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

Missing a dose of Dexamytrex

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

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

4. Possible side effects

Like all medicines, Dexamytrex can cause side effects, although not everybody gets them.
Possible side effects:
Rare (may affect up to 1 in 1,000 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 eye surface.
• 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 periods or amenorrhea, changes in protein and calcium levels in the body, growth retardation in children and adolescents, and swelling and weight gain, particularly on the trunk and face (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 the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of 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.
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Dexamytrex

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 stated.
Store in a temperature below 25°C.
You should discard the remaining ointment 6 weeks after first opening the tube.
Medicines should not be disposed of via wastewater or household waste containers. 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 contains

The active substances of Dexamytrex 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, RRR-α-Tocopherol, Oxynex 2004 (butylhydroxytoluene, ascorbyl palmitate, citric acid monohydrate, glycerol monostearate, propylene glycol).

What Dexamytrex 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.
For more detailed information, you should contact the marketing authorization holder or the 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
Brunsbütteler Damm 165-173
13581 Berlin
Germany

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Portuguese marketing authorization number: 8707307
Parallel import authorization number: 240/13
Date of leaflet approval: 16.05.2023
[Information about the trademark]