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, eye ointment
Gentamicini sulfas + Dexamethasonum
Please read the entire 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, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What Dexamytrex eye ointment is and what it is 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 pack and other information

1. What Dexamytrex eye ointment is and what it is 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 epithelial damage, and eyelid margin disorders exhibiting 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 to use Dexamytrex eye ointment, discuss the following with your doctor or
pharmacist:

• if the patient is using other medicines applied locally to the eye,
• if the patient wears contact lenses. The 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.

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Contact your doctor immediately 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 called cataract;
• any other eye problems occur (pain, 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 on 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 bacteria resistant 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.
Elderly patients
In elderly patients, no general differences in effectiveness and safety of use have been observed compared to younger patients.
Dexamytrex eye ointment and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription.
In particular, inform your doctor if the patient is using: amphotericin B (a medicine used to treat fungal infections), heparin (an anticoagulant), sulfadiazine, cefalotin, or cloxacillin (antibiotics used to treat bacterial infections) applied locally 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.
Inform your doctor if the patient is taking ritonavir or cobicistat, as these medicines may increase the 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 baby, she should consult her doctor or pharmacist before using this medicine.
Dexamytrex should not be used during pregnancy or breastfeeding, unless after careful assessment of benefit and risk, a doctor advises otherwise.
Driving and operating machinery
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Even when used as directed, Dexamytrex may temporarily impair vision after application. Therefore, driving or operating machinery should be avoided until these symptoms have completely resolved.
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.
The medicine contains 0.275 mg of propylene glycol in 1 g of ointment.

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 ointment 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.
Note! 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 tip of the tube close to the eye, without touching the eye, eyelid, surrounding area, or any other surface with the tube tip.
7. Gently squeeze the tube to extrude the ointment.
8. Looking upwards, insert approximately 5 mm of ointment into the formed "pocket". If the medicine does not enter the eye, repeat the procedure.
9. Gently close the eyelid. Do not press firmly 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 assistance from another person or using a mirror may make administration easier.
Dexamytrex eye ointment is a sterile product. To avoid contamination, do not touch the tip of the tube with your fingers or allow it to contact the eye surface or any other surface.
Using contaminated ointment may lead to serious eye damage, including loss of vision.
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If you feel the effect of Dexamytrex 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 more than the recommended dose of Dexamytrex eye ointment
Since the 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Possible side 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 the 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 virus) and fungal eye infections.
• Increased intraocular pressure, which may lead to optic nerve damage, worsening of vision and visual field defects.
• Perforation (puncturing) of the membrane on the surface of the eye.
• Hormonal disorders: increased body hair growth (particularly in women), muscle weakness and loss of muscle mass, purple skin stretch marks, 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").
• Secondary infections occurring after use of combinations containing corticosteroids and anti-infective agents.
• Blurred vision.

Reporting of side effects
If any side effects occur, including any side effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
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02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Dexamytrex eye ointment

Keep this medicine out of the 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.
Store below 25°C. Keep in the original packaging to protect from light.
Discard any remaining ointment 1 month after first opening the tube.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 vaseline, all-rac-α-Tocopherol, Oxynex 2004 (butylated hydroxytoluene, ascorbyl palmitate,
citric acid monohydrate, glycerol monostearate, propylene glycol).

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 Greece, country of export:
Bausch Health Ireland Limited, 3013 Lake Drive, Dublin 24, Ireland

Manufacturer:
Dr. Gerhard Mann Chem. Pharm. Fabrik GmbH, 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: 75841/24.12.2015
Parallel Import Licence Number: 388/21
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