Maxitrol

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

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

Maxitrol

(1 mg + 3500 IU + 6000 IU)/ml, eye drops, suspension
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 necessary.
• 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, 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. 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, which may be accompanied by

infection. Eye inflammation can be caused by infection or other factors
penetrating 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

• to neomycin sulfate, polymyxin B sulfate, dexamethasone, or any of the other components of this medicine (listed in section 6),
• 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 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 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 reactions), 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, local use of neomycin may lead to the occurrence of redness, irritation, and skin discomfort.
• In patients who have experienced symptoms of hypersensitivity to topically applied neomycin, hypersensitivity to other antibiotics may also occur.
• If the patient is using other antibiotics at the same time as Maxitrol, they should consult their doctor, as the simultaneous use of Maxitrol with other antibiotics may cause serious side effects.
• In patients using corticosteroids 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. The doctor's advice should be sought, especially in the case of children. The risk of increased intraocular pressure and (or) cataract is also higher in patients with a predisposition (e.g., diabetic patients).
• development of Cushing's syndrome caused by the medicine entering the bloodstream. The doctor should be consulted if the patient experiences swelling and weight gain, especially on the torso and face, as these are usually the first symptoms of the disease called Cushing's syndrome. Adrenal insufficiency may occur as a result of discontinuing long-term or intensive use of Maxitrol. The doctor should be consulted before the patient decides to discontinue treatment. This risk is particularly important in children and patients treated with ritonavir or cobicistat.
• In the event of the occurrence or worsening of eye infection symptoms, the doctor should be contacted immediately. Patients using Maxitrol may have reduced immunity to eye infections, including bacterial and fungal infections resistant to antibiotic treatment.
• In patients using corticosteroids and non-steroidal anti-inflammatory drugs at the same time, 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.

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 of the disease worsen or do not improve, the doctor should be consulted.

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 doctor or pharmacist should be informed about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription.
Particular attention should be drawn to the fact that the patient is taking:

• topically applied non-steroidal anti-inflammatory drugs. The simultaneous 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 dexamethasone content in the blood.

If the patient is using other eye drops or ointments at the same time, a minimum of 5 minutes should be allowed between administrations of the next 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 influence 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 has passed.

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. Contact lenses should be removed before instillation and not put back for at least 15 minutes.
Benzalkonium chloride may also cause eye irritation, especially in people with dry eye syndrome or corneal disorders (the transparent layer on the front of the eye). If abnormal sensations in the eye, stinging, or eye pain occur after using the medicine, the doctor should be consulted.

3. How to use Maxitrol

Maxitrol should always be used as directed by the doctor. In case of doubts, the doctor or pharmacist should be consulted.
Maxitrol is intended exclusivelyfor eye drops; only onepatient should use one package of the medicine.
If the protective cap is loose after removing the cap, it should be removed before using the medicine.
The eyelid should be closed and the nasolacrimal duct (tear duct) gently pressed with a finger at the same time. This can reduce the absorption of the medicine into the bloodstream after administration in the form of eye drops.

Recommended dose

In mild diseases, one to two drops are used in the conjunctival sac (sacs) four to six times a day.
In severe cases, one to two drops are used every hour. The medicine is gradually used in smaller doses, and after the symptoms of inflammation have passed, its use is discontinued. The doctor will determine the duration of treatment. Treatment should not be discontinued 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. Take the bottle in your hand and turn it upside down, holding it with your thumb and middle finger (figure 1).
• 6. Tilt your head back. Pull down the lower eyelid with a clean finger to form a "pocket" between the eyelid and the eyeball; the drop should fall into it (figure 2).
• 7. Bring the tip of the bottle 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 recommendation may cause infection of the drops.

• 9. Gently squeeze the bottom of the bottle to release a single drop of Maxitrol (figure 3).
• 10. After administering Maxitrol, remove the finger that was holding the lower eyelid. Close your eye and press the corner of your eye near your nose with your finger (figure 4). This will help prevent the medicine from entering the entire body.
• 11. If it is necessary to administer drops to both eyes, the above steps should be repeated for the second eye.
• 12. The bottle should be tightened immediately after use.
• 13. Only one bottle of the medicine should be used at a time.

If the drop does not get into the eye, you 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 drops should not be used until the next scheduled dose.

Missing a dose of Maxitrol

If a dose of Maxitrol is missed, the next scheduled dose should be taken. However, if there is not much time left until the next dose, the missed dose should be skipped and the normal administration schedule should be resumed. Do nottake a double dose to make up for the missed dose.
In case of any further doubts about the use of this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, this medicine 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.
The following side effects have been observed during the use of Maxitrol:
Uncommon( may occur less frequently than in 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, corneal ulcers, blurred vision, light hypersensitivity, pupil dilation, eyelid ptosis, eye pain, eye swelling, foreign body sensation in the eye, eye hyperemia, increased lacrimation, severe skin reactions (Stevens-Johnson syndrome), blurred vision, increased body hair growth (especially in women), muscle weakness, and muscle mass loss, purple striae on the skin, increased blood pressure, irregular menstrual cycle 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 torso and face (a disease called Cushing's syndrome) (see section 2 "Warnings and precautions").

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed. 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,
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects can 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 doctor should be informed.

5. How to store Maxitrol

To avoid infection of the drops, the bottle should be discarded 4 weeks after the first opening. The date of opening the bottle 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 at a temperature above 25°C.
Do not store in the refrigerator.
Store the bottle upright.
Store the packaging tightly closed.
The medicine should not be used after the expiry date stated on the packaging.
The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste containers. The pharmacist should be asked 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 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, hypromellose
(E 464), purified water.
The medicine contains minimal amounts of hydrochloric acid and (or) sodium hydroxide to maintain its acidity (pH value).

What Maxitrol looks like and what the packaging contains

Maxitrol eye drops are a non-transparent suspension with a color ranging from white to light yellow.
It is available in plastic bottles with a capacity of 5 ml, with a protective cap.
For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in Bulgaria, the country of export:

Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany

Manufacturer:

Alcon-Couvreur NV
Rijksweg 14
2870 Puurs
Belgium
Siegfried El Masnou, S.A.
Camil Fabra, 58
08320 El Masnou, 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.
Zbąszyńska Street 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
Zbąszyńska Street 3
91-342 Łódź
Marketing authorization number in Bulgaria, the country of export:9600056
Parallel import authorization number:31/24

Date of leaflet approval: 22.01.2024

[Information about the trademark]