Maxitrol

Leaflet accompanying the packaging: patient information

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

Maxitrol

(1 mg + 3500 IU + 6000 IU)/g, eye ointment
Dexamethasone + Neomycin sulfate + Polymyxin B 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 you need to.
In case of any doubts, you should consult a doctor, pharmacist, or nurse.
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 Maxitrol and what is it used for
• 2. Important information before using Maxitrol
• 3. How to use Maxitrol
• 4. Possible side effects
• 5. How to store Maxitrol
• 6. Contents of the packaging and other information

1. What is Maxitrol and what is it used for

Maxitrol is used to treat inflammatory eye diseases that may be accompanied by infection.
Eye inflammation can be caused by infection or other factors entering the eye or eye injuries.
Maxitrol is a combination drug containing antibacterial and corticosteroid components.
Corticosteroids (in this case, dexamethasone) are used to prevent and reduce eye inflammation. The antibacterial drugs contained in the medicine (in this case, neomycin sulfate and polymyxin B sulfate) are active against most pathogenic bacteria that cause eye infections.

2. Important information before using Maxitrol

When not to use Maxitrol

• If the patient is allergicto neomycin sulfate, polymyxin B sulfate, dexamethasone, or any of the other components of this medicine (listed in section 6),
• If the patient has:
• herpetic keratitis, chickenpox, shingles, or any other viral eye infection,
• fungal eye infection,
• untreated parasitic eye infections,
• tuberculous eye infection,
• untreated purulent eye infections.

Warnings and precautions

For use in the eyes only

• In some patients, hypersensitivity to topically applied aminoglycoside antibiotics, such as neomycin, may occur. If symptoms of hypersensitivity occur, the use of the medicine should be discontinued and medical attention should be sought immediately (see section 4). Hypersensitivity reactions may occur in the form of local itching or skin redness, severe allergic reactions (anaphylaxis), or severe skin reactions. Such skin reactions may occur during the use of other topical or systemic antibiotics from the same family (aminoglycosides).
• In addition, topical use of neomycin may lead to redness, irritation, and skin discomfort.
• In patients who have experienced hypersensitivity to topically applied neomycin, hypersensitivity to other antibiotics may also occur.
• If the patient is using other antibiotics during treatment with Maxitrol, they should consult a doctor, as the concurrent use of Maxitrol with other antibiotics may cause serious side effects.
• In patients using corticosteroid eye drops for a long time, the following may occur:
• increased intraocular pressure. Intraocular pressure should be regularly monitored during the use of this medicine. This is especially important in pediatric patients, as corticosteroid-induced increased intraocular pressure may be greater and occur earlier in children than in adults. Patients should consult a doctor, especially in the case of children. The risk of increased intraocular pressure and (or) cataract is also higher in patients with predisposing factors (e.g., diabetes).
• development of Cushing's syndrome caused by the drug entering the bloodstream. Patients should consult a doctor if they experience swelling and weight gain, especially on the trunk and face, as these are usually the first symptoms of Cushing's syndrome. Adrenal insufficiency may occur as a result of discontinuing long-term or intensive use of Maxitrol. Patients should consult a doctor before deciding to discontinue treatment. This risk is especially important in children and patients treated with ritonavir or cobicistat.
• In case of worsening or occurrence of eye infection symptoms, patients should immediately consult a doctor. Patients using Maxitrol may have reduced resistance to eye infections, including bacterial and fungal infections resistant to antibiotic treatment.
• In patients using corticosteroids and non-steroidal anti-inflammatory drugs concurrently, problems with healing of eye surface damage may occur.
• If the patient has diseases leading to thinning of the cornea or sclera, they should inform their doctor.
• It is not recommended to use contact lenses during the treatment of eye inflammation or infection.

If the patient experiences blurred vision or other vision disturbances, they should consult a doctor.
If the patient has glaucoma, the treatment duration should be limited to two weeks, unless the doctor recommends otherwise.
The medicine should be used for as long as the doctor has prescribed. If the symptoms worsen or do not improve, the patient should consult a doctor.

Children

The safety and efficacy of Maxitrol in children have not been established, so its use is not recommended in this age group.

Maxitrol and other medicines

Patient should tell their doctor or pharmacist about all the medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription.
Patient should especially inform their doctor if they are taking:

• topically applied non-steroidal anti-inflammatory drugs. Concurrent topical use of a steroid medicine and a non-steroidal anti-inflammatory drug may cause problems with healing of eye injuries;
• ritonavir or cobicistat, as they may increase the levels of dexamethasone in the blood.

If the patient is using other eye drops or ointments, they should leave an interval of at least 5 minutes between administrations of the different medicines. Eye ointments 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 a doctor or pharmacist before using this medicine.
The medicine is not recommended during pregnancy or breastfeeding.

Driving and using machines

Maxitrol has no or negligible influence on the ability to drive and use machines.
For a while after administration of Maxitrol, vision may be blurred. The patient should not drive or operate machinery until this symptom has resolved.
Maxitrol contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216), which may cause allergic reactions (possible late reactions).
The medicine contains lanolin, which may cause local skin reactions (e.g., contact dermatitis).

3. How to use Maxitrol

Maxitrol should always be used as directed by the doctor. In case of doubts, the patient should consult a doctor or pharmacist.
Maxitrol is intended exclusivelyfor administration to the eyes; only one patient should use the medicine from one package.
If the patient is using other eye drops or ointments, they should leave an interval of at least 5 minutes between administrations of the different medicines. Eye ointments should be used last.

Recommended dose

Usually, a small amount of ointment (a strip about 1.5 cm long) is instilled into the conjunctival sac of the affected eye (or eyes) up to 3 or 4 times a day. The doctor will determine the duration of treatment. The patient should not discontinue treatment prematurely.

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2

• 1. Prepare the Maxitrol tube and a mirror.
• 2. Wash your hands.
• 3. Unscrew the tube.
• 4. Hold the tube between your thumb and index finger.
• 5. Tilt your head back. Pull down the lower eyelid to form a "pocket" between the eyelid and the eye. The ointment strip should be placed in this pocket (Figure 1).
• 6. Bring the tube tip close to the eye, using a mirror to help.
• 7. Do not touch the tube tip to the eye, eyelids, surrounding surfaces, or other surfaces. Failure to follow this instruction may cause infection of the ointment.
• 8. Gently squeeze the tube to expel a strip of ointment (Figure 2).
• 9. After using Maxitrol, release the lower eyelid and blink several times to spread the medicine across the entire eye surface. Gently close the eyelids for a few seconds; this will help prevent the systemic absorption of the medicine.
• 10. If it is necessary to administer the medicine to both eyes, the above steps should be repeated for the second eye.
• 11. The tube should be screwed back on immediately after use.
• 12. Only one tube of medicine should be used at a time.

If the ointment is squeezed out of the eye,the patient should try to apply the ointment correctly to the eye again.

Using more than the recommended dose of Maxitrol

In case of overdose, excess medicine can be rinsed from the eye with lukewarm water. The patient should not use the ointment until the next scheduled dose.

Missing a dose of Maxitrol

If a dose of the medicine is missed, the patient should take the next scheduled dose. However, if it is almost time for the next dose, the missed dose should be skipped and the patient should return to their regular dosing schedule. The patient should nottake a double dose to make up for the missed dose.
In case of any further doubts about the use of this medicine, the patient should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Maxitrol can cause side effects, although not everybody gets them.
If the patient experiences allergic reactions, including rash, swelling of the face, lips, tongue, and (or)
throat, which may cause difficulty breathing or swallowing, or experiences other severe
side effects, they should discontinue the use of Maxitrol and immediately consult a doctor or the Emergency Department of the nearest hospital.
During the use of Maxitrol, the following side effects have been observed:
Uncommon( may occur in less than 1 in 100 patients): keratitis, increased intraocular pressure, eye itching, eye discomfort, eye irritation.
Frequency not known( frequency cannot be estimated from the available data): hypersensitivity, headache, ulcerative keratitis, blurred vision, hypersensitivity to light, dilated pupils, ptosis, eye pain, eye swelling, foreign body sensation in the eye, eye redness, increased lacrimation, severe skin reactions (Stevens-Johnson syndrome), blurred vision; excessive hair growth on the body (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, especially on the trunk and face (Cushing's syndrome) (see section 2 "Warnings and precautions").

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
Reporting side effects will help gather more information on the safety of the medicine.
In case of worsening of any of the symptoms or occurrence of other side effects not listed in this leaflet, the patient should inform their doctor.

5. How to store Maxitrol

To avoid infections, the tube with the remaining medicine should be discarded after four weeks from the first opening.
The date of first opening should be noted below.
Date of first opening:……………………….
The medicine should be stored out of sight and reach of children.
Do not store above 25°C.
Do not store in the refrigerator.
Store the tube tightly closed.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the month.
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. Contents of the packaging and other information

What Maxitrol contains

The active substances of the medicine are:
Dexamethasone 1 mg/g
Neomycin sulfate 3500 IU/g
Polymyxin B sulfate 6000 IU/g
The excipients are:
Methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), lanolin, white petrolatum

What Maxitrol looks like and contents of the pack

Maxitrol is a thick, semi-transparent or non-transparent, white or slightly yellowish, homogeneous, lump-free ointment.
It is available in aluminum tubes coated with epoxy-phenolic resin, with a PE applicator and PE cap, containing 3.5 g, in a cardboard box.
For more detailed information, the patient should consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Croatia, the country of export:

Novartis Hrvatska d.o.o.
Radnička cesta 37b
10 000 Zagreb
Croatia

Manufacturer:

S.A. Alcon-Couvreur N.V.
Rijksweg 14
2870 Puurs
Belgium
Siegfried El Masnou S.A.
Camil Fabra 58, El Masnou
08320 Barcelona
Spain
Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany
Novartis Farmacéutica, S.A.,
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain

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 Croatia, the country of export: HR-H-641598573

Parallel import authorization number: 196/25

Date of leaflet approval: 05.06.2025

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