Maxitrol

Package leaflet: Information for the patient

Warning! Keep the leaflet – information on the immediate packaging is in a foreign language!
Maxitrol (Maxidrol)
(1 mg + 3500 i.u. + 6000 i.u.)/ml, eye drops
Dexamethasonum + Neomycini sulfas + Polymyxini B sulfas
Maxitrol and Maxidrol are different brand names for the same medicinal product.
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are similar.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet
What Maxitrol is and what it is used for
Important information before using Maxitrol
How to use Maxitrol
Possible side effects
How to store Maxitrol
Contents of the pack and other information

1. What Maxitrol is and what it is used for

Maxitrol is used to treat inflammatory eye diseases, which may be accompanied by infection.
Eye inflammation may result from infection, other agents entering the eye, or eye injury.
Maxitrol is a combination medicine containing antibacterial agents and a corticosteroid.
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 allergic to neomycin sulfate, polymyxin B sulfate, dexamethasone, or to any of the other ingredients of this medicine (listed in section 6),
• if the patient has:
• herpes simplex keratitis, vaccinia, varicella (chickenpox), or any other viral eye infection,
• fungal eye infection,
• untreated parasitic eye infections,
• tuberculous eye infection,
• untreated purulent eye infection.

Warnings and precautions
For ocular use only

• Some patients may develop hypersensitivity to topically applied aminoglycoside antibiotics such as neomycin. If symptoms of hypersensitivity occur, discontinue use of the medicine immediately and contact a doctor without delay (see section 4). Hypersensitivity reactions may manifest as local itching or redness of the skin, severe allergic reactions (anaphylactic reactions), or severe skin reactions. Such skin reactions may also occur during treatment with other topical or systemic antibiotics from the same class (aminoglycosides).
• In addition, topical use of neomycin may cause redness, irritation, and a sensation of discomfort of the skin.
• Patients who have experienced hypersensitivity reactions to topical neomycin may also be hypersensitive to other antibiotics.
• If the patient is using other antibiotics during treatment with Maxitrol, medical advice should be sought, as concomitant use of Maxitrol with other antibiotics may lead to serious adverse effects.
• In patients using corticosteroids in the eye for prolonged periods, the following may occur:
• elevated intraocular pressure. Intraocular pressure should be monitored regularly during treatment with this medicine. This is particularly important in children, as corticosteroid-induced elevation in intraocular pressure may be greater and occur earlier in children than in adults. Consult a doctor, especially in the case of children. The risk of elevated intraocular pressure and/or cataract is also higher in predisposed patients (e.g., diabetic patients).
• development of drug-induced Cushing's syndrome due to systemic absorption of the medicine. Seek medical advice if the patient develops swelling and increased body weight, particularly noticeable in the trunk and face, as these are usually the first signs of a condition called Cushing's syndrome. Adrenal suppression may occur following discontinuation of prolonged or intensive treatment with Maxitrol. Consult a doctor before deciding to stop treatment. This risk is particularly significant in children and in patients treated with ritonavir or cobicistat.
• If signs of eye infection appear or worsen, contact a 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 nonsteroidal anti-inflammatory drugs simultaneously, impaired healing of ocular surface injuries may occur.
• If the patient has diseases causing thinning of the cornea or sclera, this should be reported to the doctor.

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

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

Maxitrol and other medicines
Inform the doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient plans to use, including those available without prescription. It is especially important to inform the doctor if the patient is taking:

• topically acting nonsteroidal anti-inflammatory drugs (NSAIDs). Concurrent topical use of a steroid medicine and a nonsteroidal anti-inflammatory drug may lead to impaired healing of eye injuries;
• ritonavir or cobicistat, as these may increase blood levels of dexamethasone.

If the patient is using other eye drops or ointments simultaneously, at least a 5-minute interval should be maintained between administration of each medicine. Ointments should be applied last.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Maxitrol is not recommended during pregnancy or breastfeeding.

Driving and operating machinery
Maxitrol has no or negligible influence on the ability to drive and operate machinery.
Vision may be blurred for a short time after instillation of Maxitrol. Do not drive or operate machinery until this effect has subsided.

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 may alter their color. Soft contact lenses should be removed before instillation and at least 15 minutes should elapse before reinsertion.
Benzalkonium chloride may also cause eye irritation, particularly in patients with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If abnormal sensations, stinging, or pain in the eye occur after using the medicine, contact a doctor.

3. How to use Maxitrol

Maxitrol should always be used as directed by the physician. If in doubt, consult your doctor or pharmacist.
Maxitrol is intended solely for ophthalmic instillation; each container should be used by only one patient.
If the safety collar is loose after removing the cap, remove it before using the medication.
It is recommended to close the eyelid and gently press the finger against the nasolacrimal duct (lacrimal canal). This helps reduce systemic absorption of the drug after administration as eye drops.

Recommended dose
In mild conditions, one to two drops should be administered into the conjunctival sac (sacs) four to six times daily.
In severe cases, one to two drops should be administered every hour. The dosage should then be gradually reduced, and treatment discontinued after resolution of inflammatory symptoms. The duration of treatment will be determined by the physician. Do not discontinue treatment prematurely.

2 3 4

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 bottom facing upwards, using your thumb and middle finger (Figure 1).
6. Tilt your head backward. Gently pull down the lower eyelid with a clean finger to create a "pocket" between the eyelid and the eyeball; the drop should be instilled into this pocket (Figure 2).
7. Bring the dropper tip close to the eye. A mirror may be used to assist.
8. Do not touch the dropper tip to the eye, eyelid, surrounding areas, or any other surface. Failure to follow this instruction may result in contamination of the drops.
9. Gently press the bottom of the bottle to release a single drop of Maxitrol (Figure 3).
10. After instilling the drop, remove the finger from the lower eyelid. Close the eye and press the inner corner of the eye near the nose with your finger (Figure 4). This helps prevent the medication from draining into the systemic circulation.
11. If drops are required in both eyes, repeat the above steps for the second eye.
12. Immediately after use, replace the cap on the bottle.
13. Only one bottle should be used at a time.

If the drop misses the eye, repeat the procedure to correctly instill the drop.
Overdose of Maxitrol
In case of local overdose of Maxitrol, rinse the eye(s) with lukewarm water. Do not administer further drops until the next scheduled dose.
Missed dose of Maxitrol
If a dose is missed, administer the next scheduled dose. However, if the next dose is due shortly, skip the missed dose and resume the regular dosing schedule. Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences 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 if other serious adverse reactions occur,
treatment with Maxitrol should be discontinued immediately and the doctor or the nearest hospital's
Emergency Department should be contacted without delay.
The following adverse reactions have been observed during treatment with Maxitrol:
Not frequently ( may occur in fewer than 1 in 1,000 patients ): corneal inflammation, increased
intraocular pressure, eye itching, sensation of eye discomfort, eye irritation.
Frequency unknown ( frequency cannot be estimated from available data ): hypersensitivity, headache,
ulcerative keratitis, blurred vision, photophobia, pupil dilation, eyelid drooping, eye pain, eye swelling,
sensation of foreign body in the eye, eye hyperemia, excessive tearing, severe skin reactions
(Stevens-Johnson syndrome), blurred vision, excessive growth of body hair (especially in women),
muscle weakness and loss of muscle mass, purple skin striae, increased blood pressure, irregular
menstruation or absence of menstruation, changes in protein and calcium levels in the body, growth
suppression in children and adolescents, and swelling and weight gain, particularly noticeable in the
trunk and face (a condition known as Cushing's syndrome) (see section 2 "Warnings and precautions").
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist or
nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Faks: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions allows collection of further information on the safety of the medicine.
If any of the symptoms worsen or if any other adverse reactions not mentioned in this leaflet occur,
inform a doctor.

5. How to store Maxitrol medicine

To avoid contamination, the bottle should be discarded 15 days after first opening.
The date of first opening should be recorded in the space indicated below.
Date of first opening: ……………………
Keep the medicine out of the sight and reach of children.
Do not store above 25°C.
Do not store in the refrigerator.
Keep the bottle in an upright position.
Keep the container 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 stated month.
The batch number on the packaging is marked as "Lot".
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Maxitrol contains
The active substances are:
Dexamethasone 1 mg/ml
Neomycin sulfate 3500 i.u./ml
Polymyxin B sulfate 6000 i.u./ml
The excipients are: sodium chloride, polysorbate 20 (E 432), benzalkonium chloride, hypromellose (E 464), purified water.
Minimal amounts of diluted hydrochloric acid and/or sodium hydroxide are added to the medicine to maintain its acidity (pH) within normal range.

What Maxitrol looks like and contents of the pack
Maxitrol eye drops are an opaque solution ranging in colour from white to pale yellow.
It is available in 3 ml polyethylene (PE) bottles.

For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in France, the country of export:

Manufacturer:
Siegfried El Masnou S.A.
Camil Fabra, 58
08320 El Masnou
Barcelona
Spain
Novartis Farmaceutica, S.A.
Gran via de les Corts Catalanes, 764
08013 Barcelona
Spain
Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany
Novartis Manufacturing NV
Rijksweg 14
2870 Puurs-Sint-Amands
Belgium
Parallel importer:
Medezin Sp. z o.o.
Zbąszyńska Street 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska Street 3
91-342 Łódź
Marketing authorization number in France, country of export: 306 525-3
34009 306 525 3 4
Parallel import authorization number: 280/23