Dexamytrex

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language!
Dexamytrex
(5 mg + 0.3 mg)/g, ophthalmic ointment
Gentamicini sulfas + Dexamethasonum
WARNING! The strength stated on the immediate packaging as 3 mg/g gentamicin is
equivalent to the expression 5 mg/g taking into account the gentamicin sulfate content.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that 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. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

Dexamytrex ophthalmic ointment contains two active substances: gentamicin sulfate – an antibiotic of the aminoglycoside group, and dexamethasone – a glucocorticosteroid.
This 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 infections showing intense inflammatory signs, as well as in secondarily infected allergic conjunctivitis and eyelid margin inflammation.

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. herpes simplex keratitis), mycobacteria (e.g. ocular tuberculosis), or fungi,
• in cases of corneal wounds or ulcers,
• if the patient has narrow-angle or open-angle glaucoma.

Warnings and precautions
Before starting treatment with Dexamytrex eye ointment, discuss this with a doctor or
pharmacist:

• if the patient is using other medicines applied locally to the eye,
• if the patient wears contact lenses. Use of contact lenses is not recommended during treatment with Dexamytrex.
• if the patient has a disease causing reduced thickness of the cornea or sclera.

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 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 known as 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 deciding to stop treatment. This risk is particularly relevant in children and in patients treated with 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.
Elderly patients
No overall differences in effectiveness and safety have been observed in elderly patients compared to younger patients.
Dexamytrex eye ointment and other medicines
Inform the doctor about all medicines currently used or recently used by the patient, including those obtained without a prescription.
In particular, inform the doctor if the patient is using: amphotericin B (a medicine used to treat fungal infections), heparin (an anticoagulant), sulfadiazine, cephalothin, or cloxacillin (antibiotics used to treat bacterial infections), 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.
Inform the doctor if the patient is taking ritonavir or cobicistat, as these medicines may increase blood levels of dexamethasone.
Note
If Dexamytrex eye ointment is used simultaneously with other eye drops or eye ointments, a 15-minute interval should be maintained between the application of the different products, and Dexamytrex eye ointment should be administered last.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Dexamytrex should not be used during pregnancy or breastfeeding unless, after careful assessment of benefits and risks, the doctor advises otherwise.
Driving and operating machinery
Even when used as directed, Dexamytrex may cause temporary visual disturbances after application. Therefore, patients should refrain from driving or operating machinery until these symptoms have completely subsided.
Dexamytrex contains lanolin (a wool fat), butylated hydroxytoluene, and propylene glycol (components of Oxynex 2004).
Due to the presence of lanolin, this medicine may cause local skin reactions (e.g. contact dermatitis).
Due to the presence of butylated hydroxytoluene, this medicine may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.
Due to the presence of propylene glycol, this medicine may cause skin irritation.

3. How to use Dexamytrex eye ointment

Use this medicine exactly as directed by your doctor. If in doubt, consult your
doctor or pharmacist.
Recommended dose
Unless otherwise prescribed, apply 5 mm of the ointment squeezed into the conjunctival sac of the affected
eye 2–3 times daily and before bedtime.
Duration of treatment
The treatment duration should not exceed 2 weeks.
Important! Instructions for administering the medicine:

1. Wash your hands thoroughly.
2. Unscrew the cap.

3. Hold the tube with the tip pointing downwards, using your thumb and index finger.
4. Tilt your head backwards.
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 tube tip close to the eye, without touching the tip to the eye, eyelid, surrounding areas, or any other surfaces.
7. Gently press the tube to squeeze out the ointment.
8. Look upwards and insert approximately 5 mm of ointment into the formed "pocket". If the medicine did not enter the eye, repeat the procedure.
9. Gently close the eyelid. Do not press firmly on the eyelids, to avoid squeezing the ointment out of the eye.
10. Press gently with your finger on the inner corner of the eye at the bridge of the nose. This helps minimize the risk of the medicine being absorbed into the systemic circulation.
11. If the ointment is to be administered to both eyes, repeat the above steps for the

second eye.

12. Immediately after use, tightly replace the cap on the tube.

Having another person assist or using a mirror may make administration easier.
Dexamytrex eye ointment is a sterile medicine. To avoid contamination, do not touch the tube tip with your fingers or allow it to touch the eye surface or any other surface. Using contaminated ointment may lead to serious eye damage, including vision loss.
If you feel the effect of Dexamytrex medicine is too strong or too weak, consult your doctor or pharmacist.
Note: Using Dexamytrex with other medicines – see section 2 Dexamytrex eye ointment and other
medicines.
Use of a higher than recommended dose of Dexamytrex eye ointment
Since this medicine is applied to the eye, symptoms of overdose are not expected.
Missed dose of Dexamytrex eye ointment
Apply the missed dose as soon as possible. Do not use a double dose to make up for a missed dose. If several doses have been missed, inform your doctor and follow their advice.
Stopping Dexamytrex eye ointment
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Possible adverse effects:
Rare (may affect up to 1 in 1,000 people)

• Mild, transient and short-term visual disturbances.

Frequency not known (cannot be estimated from available data)

• Hypersensitivity reactions (including eyelid and conjunctival swelling, itching, conjunctival hyperaemia, contact dermatitis)
• Delayed wound healing (if the medicine is used following corneal injury)
• Glaucoma and cataract (with prolonged use)
• Pupil dilation
• Eye irritation
• Corneal deposits
• Secondary bacterial, viral (including herpes simplex virus) and fungal eye infections
• Increased intraocular pressure, which may lead to optic nerve damage, worsening of visual acuity, and visual field defects
• Perforation (puncturing) of the surface membrane of the eye
• Hormonal disturbances: excessive body hair growth (particularly 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 and increased body weight, particularly noticeable on the trunk and face (a condition known as Cushing's syndrome) (see section 2 "Warnings and precautions").

• Secondary infections occurring after use of combinations containing corticosteroids and anti-infective agents
• Blurred vision.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can also 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 effects helps to provide more information on the safety of the medicine.

5. How to store Dexamytrex eye ointment

Keep the 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.
Store below 25°C.
Discard any remaining ointment after 6 weeks from first opening of the tube.
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 package and other information

What Dexamytrex eye ointment contains
The active substances are gentamicin sulfate and dexamethasone.
Each 1 g of ointment contains 5 mg gentamicin sulfate and 0.3 mg dexamethasone.
The other components are: chlorobutanol hemihydrate, myristyl alcohol, lanolin, liquid paraffin,
white soft paraffin, RRR-α-Tocopherol, Oxynex 2004.

What Dexamytrex eye ointment looks like and contents of the pack
Dexamytrex is an eye ointment.
The medicine is available in a tube containing 3 g of ointment.
For further information, please contact the Marketing Authorisation Holder or the parallel importer.

Marketing Authorisation Holder in Portugal, 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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Marketing Authorisation number in Portugal, country of export: 8707307
Parallel import licence number: 409/19