Dexamitrex

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Dexamytrex

(5 mg + 0.3 mg)/g, eye ointment
Gentamicin sulfate + Dexamethasone
WARNING!The potency 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 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. 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 damage to the epithelium and damage to the eyelid margins with intense inflammation symptoms, as well as in secondary infected allergic conjunctivitis and eyelid margins.

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.
• 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:

• partial or complete hearing loss or dizziness occurs;
• the amount of purulent discharge, inflammation or pain increases;
• a sudden, very severe eye and head pain occurs 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 occur;
• blurred vision and difficulty seeing in bright light occur. These may be symptoms of a disease called cataracts;
• any other eye problems occur (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 torso and face, as these are usually the first symptoms of a disease called Cushing's syndrome. Suppression of adrenal function may occur as a result of prolonged or intensive use of Dexamytrex. You should consult your doctor before the patient decides 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 have not been established in children.

Elderly people

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

Dexamytrex eye ointment 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 locally to the eye. Concurrent administration of Dexamytrex to the eye 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 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 should be used last.

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, thinks 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 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 may temporarily disturb vision after application, so you should not drive or operate machines until the symptoms have completely disappeared.

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

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

3. How to use Dexamytrex eye ointment

This medicine should be used as recommended by the doctor. In case of doubts, you should consult a doctor or pharmacist.
Recommended dose
If not otherwise recommended, apply 5 mm of the squeezed 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.
• 2.
• 3.
• 4.
• 5.
• 6.
• 7.
• 8. Wash your hands thoroughly. Unscrew the cap. Hold the tube with the nozzle down, using your thumb and index finger. Tilt your head back. With your index finger, gently pull down the lower eyelid to form a "pocket" between the eyeball and the eyelid, into which the ointment will be inserted. Bring the nozzle close to the eye, without touching the nozzle to the eye, eyelid, or surrounding areas.Gently squeeze the tube to express the ointment. 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.
• 10.
• 11. Gently close the eyelid. Do not squeeze the eyelids tightly, as this may push the ointment out of the eye. 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. If the ointment is to be administered to both eyes, repeat the above steps for the second eye.

Immediately after using the medicine, the tube should be carefully screwed back on.
Having someone else's 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 the eye or any other surface with it. 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 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

In case of 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 cataracts (after prolonged 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 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,
• 12.

growth retardation in children and adolescents, as well as swelling and weight gain, particularly on the torso 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 Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products; Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +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 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 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. You should ask your pharmacist how to dispose of medicines that are no longer used. 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, RRR-α-Tocopherol, Oxynex 2004.

What Dexamytrex eye ointment looks like and what the packaging contains

Dexamytrex is available in the form of an 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
Brunsbuetteler Damm 165-173
13581 Berlin
Germany

Parallel importer:

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

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Portugal, the country of export: 8707307
Parallel import authorization number: 409/19

Date of leaflet approval: 14.10.2024

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