Maxitrol

Leaflet attached to the packaging: patient information

Maxitrol, (1 mg+3500 IU+6000 IU)/ml, eye drops, suspension
Dexamethasone + Neomycin sulfate + Polymyxin B sulfate

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, 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, pharmacist, or nurse. 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. Package contents 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 medicine containing antibacterial and corticosteroid components.
Corticosteroids (in this case, dexamethasone) are used to prevent and reduce
eye inflammation. The antibacterial agents contained in the drops (in this case, neomycin sulfate and polymyxin B sulfate) are active against most pathogenic bacteria
causing 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,
• tubercular eye infection,
• untreated purulent eye infection.

Warnings and precautions

For eye use only

• In some patients, hypersensitivity to topically applied aminoglycoside antibiotics, such as neomycin, may occur. If symptoms of hypersensitivity occur, the medicine should be discontinued and the doctor should be consulted immediately (see section 4). Hypersensitivity reactions may occur in the form of local itching or skin redness, severe allergic reactions (anaphylactic reaction), or severe skin reactions. Such skin reactions may occur during the use of other topical or systemic antibiotics from the same family (aminoglycosides).
• Additionally, local 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 Maxitrol treatment, they should consult a doctor, as 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 children, as corticosteroid-induced increased intraocular pressure may be greater and occur earlier in children than in adults. Consult a doctor, especially for 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 medicine entering the bloodstream. If the patient experiences swelling and weight gain, particularly in the trunk and face, they should consult a doctor, 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. Consult a doctor before the patient decides to discontinue treatment. This risk is particularly important in children and patients treated with ritonavir or cobicistat.
• If the patient experiences or worsens eye infection symptoms, they should contact their doctor immediately. 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 (NSAIDs) concurrently, problems with healing of eye surface damage may occur.
• If the patient has diseases that lead to thinning of the cornea or sclera, they should inform their doctor.

If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.
If the patient has glaucoma, the treatment time 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 their doctor.

Children

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

Maxitrol and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription.
Particularly, the doctor should be informed if the patient is taking:

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

If the patient is using other eye drops or ointments, they should wait at least 5 minutes between administrations of 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 their 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 some time after administering Maxitrol, vision may be blurred. The patient should not drive or operate machines until this symptom subsides.

Maxitrol eye drops contain benzalkonium chloride

The medicine contains 0.04 mg of benzalkonium chloride per milliliter (0.04 mg/ml).
Benzalkonium chloride may be absorbed by soft contact lenses and change their color. The patient should remove contact lenses before administering the drops and wait at least 15 minutes before putting them back on.
Benzalkonium chloride may also cause eye irritation, especially in people with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If abnormal sensations in the eye, stinging, or eye pain occur after using the medicine, the patient should consult their doctor.

3. How to use Maxitrol

Maxitrol should always be used as directed by the doctor. If in doubt, the patient should consult their doctor or pharmacist.
Maxitrol is intended exclusivelyfor eye use; only one patient should use the medicine from one package.
If the protective cap is loose after removing the cap, it should be removed before using the medicine.
The patient should close their eyelid and gently press the tear duct (nasolacrimal canal) with their finger. This helps reduce the amount of medicine that enters the bloodstream after administration.

Recommended dose

In mild cases, one to two drops are administered to the conjunctival sac (sacs) four to six times a day.
In severe cases, one to two drops are administered every hour. The medicine is gradually administered in smaller doses, and its use is discontinued after the inflammation symptoms subside.
The doctor will determine the treatment duration. The patient should not discontinue treatment prematurely.

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• 1. Prepare the Maxitrol bottle and a mirror.
• 2. Wash your hands.
• 3. Shake the bottle.
• 4. Unscrew the cap.
• 5. Hold the bottle in your hand, with the thumb and middle finger, and direct it upwards (Figure 1).
• 6. Tilt your head back and pull down the lower eyelid with a clean finger to form a "pocket" between the eyelid and the eyeball; the drop should fall into this pocket (Figure 2).
• 7. Bring the bottle tip close to the eye. You can use a mirror to help.
• 8. Do not touch the dropper tip to the eye, eyelid, or surrounding areas.Failing to follow this instruction may cause contamination of the drops.
• 9. Gently squeeze the bottle to release a single drop of Maxitrol (Figure 3).
• 10. After administering the drop, release the lower eyelid and close your eye. Press the tear duct area with your finger (Figure 4). This helps prevent the medicine from entering the entire body.
• 11. If it is necessary to administer drops to both eyes, repeat the above steps for the second eye.
• 12. Immediately after use, screw the bottle cap back on.
• 13. Use only one bottle of medicine at a time.

If the drop does not get into the eye,the patient should try again to administer the drop correctly.

Using more Maxitrol than recommended

In case of local overdose of Maxitrol, the eye (eyes) should be rinsed with lukewarm water.
The patient should not use the drops until the next scheduled dose.

Missing a dose of Maxitrol

If a dose of Maxitrol 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.
If the patient has any further doubts about using this medicine, they should consult their 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, face, lip, tongue, and/or
throat swelling, which may cause difficulty breathing or swallowing, or other severe
side effects, they should discontinue using Maxitrol and contact their doctor or the Emergency Department of the nearest hospital immediately.
During the use of Maxitrol, the following side effects have been observed:
Uncommon( may occur in less than 1 in 1000 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, light sensitivity, pupil dilation, eyelid ptosis, eye pain, eye swelling, foreign body sensation in the eye, eye redness, increased lacrimation, severe skin reactions (Stevens-Johnson syndrome), blurred vision, increased 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, particularly in 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 this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181C
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 helps gather more information on the safety of the medicine.
If any of the symptoms worsen or if other side effects not listed in this leaflet occur, the patient should inform their doctor.

5. How to store Maxitrol

To avoid contamination of the drops, the bottle should be discarded four weeks after first opening. The date of first opening should be written in the space provided 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 bottle upright.
Store the package tightly closed.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month.
The batch number on the packaging is marked as "Lot".
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 Maxitrol contains

The active substances of the medicine are:
Dexamethasone
1 mg/ml
Neomycin sulfate
3500 IU/ml
Polymyxin B sulfate
6000 IU/ml
The excipients are: sodium chloride, polysorbate 20 (E 432), benzalkonium chloride, hydroxypropyl methylcellulose (E 464), purified water.
The medicine may contain minimal amounts of concentrated hydrochloric acid or sodium hydroxide to maintain its pH.

What Maxitrol looks like and what the package contains

Maxitrol is a suspension with a color ranging from white to light yellow, supplied in a plastic bottle containing 5 ml, with a protected cap, in a cardboard box.

Marketing authorization holder

Novartis Poland Sp. z o.o.
Marynarska Street 15
02-674 Warsaw
phone: +48 22 37 54 888

Manufacturer/Importer

Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany
Novartis Manufacturing NV
Rijksweg 14
2870 Puurs-Sint-Amands
Belgium
Siegfried El Masnou, S.A.
Camil Fabra, 58
El Masnou, 08320
Barcelona
Spain
Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Date of last leaflet update:06/2025