Dexamitrex

Leaflet attached to the packaging: patient information

Dexamytrex

(5 mg + 0.3 mg)/g, eye ointment
(Gentamicin sulfate + Dexamethasone)

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 the symptoms of their illness 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. Package contents 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 damage with intense inflammatory symptoms, 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. 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, the patient should discuss it with their 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 during the use of Dexamytrex eye ointment.
• if the patient has a disease that causes a decrease in the thickness of the cornea or sclera

The patient should immediately contact their doctor if, during the use of Dexamytrex eye ointment:

• partial or complete hearing loss or dizziness occurs;
• the amount of purulent discharge, inflammation or pain increases;
• sudden, very severe eye and head pain occurs, accompanied by 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 occur;
• blurred vision and difficulty seeing in bright light occur. These may be symptoms of a disease called cataract;
• any other eye problems occur (pain, redness of the eye, tearing, photophobia). These may be symptoms of eye damage.

The patient should consult their doctor if they experience swelling and weight gain, particularly on the torso 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 eye ointment. The patient should consult their doctor before deciding to discontinue 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 Dexamytrex eye ointment have not been established in children.

Elderly patients

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

Dexamytrex eye ointment and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, including those available without a prescription.
In particular, the patient should tell their doctor if they 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.
The patient should tell their doctor about the use of ritonavir or cobicistat, as these medicines may increase the dexamethasone content in the blood.
Warning
If Dexamytrex eye ointment is used at the same time as 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 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 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 blur vision after application, so the patient should not drive or operate machines until the symptoms have completely resolved.

Dexamytrex eye ointment 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 local skin reactions (e.g. contact dermatitis) or eye and mucous membrane irritation.
The medicine contains 0.275 mg of propylene glycol in 1 g of ointment.

3. How to use Dexamytrex eye ointment

This medicine should be used as recommended by the doctor. In case of doubts, the patient should consult their 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 created "pocket". If the medicine does not get into the eye, repeat the procedure.
• 9. Gently close the eyelid. Do not squeeze the eyelids tightly, as this may push the ointment out of the eye.
• 10. Press the inner corner of the eye at the base of the 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 or using a mirror may 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 may lead to serious vision damage, including vision loss.
If the patient feels that the effect of Dexamytrex eye ointment is too strong or too weak, they should consult their doctor or pharmacist.
Warning:Using Dexamytrex eye ointment with other medicines - see section 2 Dexamytrex eye ointment and other medicines.

Using a higher dose of Dexamytrex eye ointment than recommended

Since the medicine is used in the eye, it is not expected to cause overdose symptoms.

Missing a dose of Dexamytrex eye ointment

The patient should take the missed dose as soon as possible. They should not take a double dose to make up for the missed dose. If they have missed several doses, they should inform their doctor and follow their recommendations.

Stopping the use of Dexamytrex eye ointment

In case of any further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Dexamytrex eye ointment 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
• Corneal deposits
• Secondary bacterial, viral (including herpes simplex) 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 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 torso 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 the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the 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 specified month.
Store at a temperature below 25°C.
Any remaining ointment should be discarded 6 weeks after the tube is first opened.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What does Dexamytrex eye ointment contain

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, D,L-alpha-tocopherol, Oxynex 2004 (butylhydroxytoluene, ascorbyl palmitate, citric acid monohydrate, glyceryl monostearate, propylene glycol).

What does Dexamytrex eye ointment look like and what does the pack contain

Dexamytrex eye ointment is available in the form of an eye ointment.
The medicine is available in a tube containing 3 g of ointment.

Marketing authorization holder and manufacturer

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

Date of last revision of the leaflet: