Maxitrol

Package leaflet: Information for the patient

Warning! Keep this leaflet. Information on the immediate packaging 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 of the same medicinal product.
Please read carefully all the information in this leaflet before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please 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 other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

1. What Maxitrol is and what it is 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 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 or other agents entering the eye, or from 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,

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• untreated purulent eye infection.

Warnings and precautions
For topical ophthalmic 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 and contact a doctor immediately (see section 4). Hypersensitivity reactions may manifest as local itching or redness of the skin, severe allergic reactions (anaphylactic reaction), 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 in the skin.
• Patients who have experienced hypersensitivity reactions to topical neomycin may also develop hypersensitivity 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 ophthalmic corticosteroids long-term, the following may occur:
  • elevated intraocular pressure. Intraocular pressure should be monitored regularly during treatment with this medicine. This is particularly important in pediatric patients, as corticosteroid-induced increase 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 increased intraocular pressure and/or cataract is also higher in predisposed patients (e.g., diabetic patients).
  • development of drug-induced Cushing's syndrome. Contact a doctor if the patient develops swelling and weight gain, 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 antibiotic-resistant bacterial and fungal infections.
• In patients using corticosteroids and non-steroidal anti-inflammatory drugs simultaneously, problems with healing of corneal or scleral 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 the 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, its use is not recommended in this age group.
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Maxitrol and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use, including over-the-counter medicines.
Especially inform the doctor if the patient is taking:

• topical non-steroidal anti-inflammatory drugs. Concomitant topical use of a steroid medicine and a non-steroidal anti-inflammatory medicine may lead to problems with healing of eye injuries;
• ritonavir or cobicistat, as they 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. Ophthalmic 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 have a child, she should consult a doctor or pharmacist before using this medicine.
This medicine is not recommended during pregnancy or breastfeeding.
Driving and using machines
Maxitrol has no or negligible effect 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 millilitre (0.04 mg/ml).
Benzalkonium chloride may be absorbed by soft contact lenses and may alter their color. 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 in the eye, stinging, or pain occur after using the medicine, contact a doctor.

3. How to use Maxitrol

Maxitrol should always be used exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.

Maxitrol is intended exclusively for instillation into the eye; each container should be used by only one patient.

If the safety collar is loose after removing the cap, remove it before using the medicine.

It is recommended to close the eyelid and gently press the finger against the nasolacrimal duct (tear duct). This helps reduce the amount of medicine absorbed into the bloodstream after instillation into the eye.

Recommended dose
In mild conditions, instill one to two drops into the conjunctival sac(s) four to six times daily.

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In severe cases, instill one to two drops every hour. Gradually reduce the dose as symptoms improve, and discontinue the medicine once inflammation has resolved.

Your doctor will determine the duration of treatment. Do not stop treatment prematurely.

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 form a "pocket" between the eyelid and the eyeball; the drop should be instilled into this pocket (Figure 2).
7. Bring the bottle tip close to the eye. A mirror may help.
8. Do not touch the eye, eyelid, surrounding areas, or any other surface with the dropper tip. Failure to follow this instruction may result in contamination of the drops.
9. Gently squeeze the bottom of the bottle to release a single drop of Maxitrol (Figure 3).
10. After instilling Maxitrol, release the finger holding the lower eyelid. Close the eye and press gently with a finger at the inner corner of the eye near the nose (Figure 4). This helps prevent the medicine from draining into the rest of the body.
11. If drops are needed 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 of medicine should be used at a time.

If the drop misses the eye, repeat the procedure to correctly instill the drop.

Using more than the recommended dose of Maxitrol
In case of local overdose, rinse the eye(s) with lukewarm water.
Do not use further drops until the next scheduled dose.

Missed dose of Maxitrol
If a dose is missed, instill the next scheduled dose as planned. However, if it is almost time for the next dose, skip the missed dose and continue with the regular dosing schedule. Do not use 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 all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
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If the patient experiences allergic reactions, including rash, swelling of the face, lips, tongue and (or) throat,
which may cause difficulty in breathing or swallowing, or other serious adverse reactions occur, use of
Maxitrol must be stopped immediately and the doctor or the nearest hospital Emergency Department
should be contacted without delay.
The following adverse reactions have been observed during treatment with Maxitrol:
Not very common (may occur in up to 1 in 1,000 patients): corneal inflammation, increased
intraocular pressure, eye itching, sensation of eye discomfort, eye irritation.
Frequency not known (frequency cannot be estimated from the available data): hypersensitivity,
headache, corneal ulcerative keratitis, blurred vision, photophobia, pupil dilation, eyelid drooping, eye pain,
eye swelling, sensation of foreign body in the eye, eye hyperaemia, excessive tearing, severe skin reactions
(Stevens-Johnson syndrome), blurred vision, increased body hair growth (especially in women), muscle weakness and loss of muscle mass, purple skin stretch marks, 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 fluid retention with 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 your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Reporting adverse reactions allows further information on the safety of the medicine to be collected.
If any of the symptoms worsen, or if any other adverse reactions not mentioned in this leaflet occur, inform your doctor.

5. How to store Maxitrol medicine

To avoid contamination of the drops, the bottle should be discarded 15 days after first opening.
The date of first opening should be recorded in the space below.
Date of first opening: ……….
Keep the medicine out of sight and reach of children.
Do not store above 25℃. Do not store in the refrigerator.
Store 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.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.
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6. Contents of the pack and other information

What Maxitrol contains
The active substances are:
Dexamethasone 1 mg/ml
Neomycin sulfate 3500 IU/ml
Polymyxin B sulfate 6000 IU/ml

The other components are:
sodium chloride, polysorbate 20, benzalkonium chloride, hypromellose, purified water.
Minimal amounts of diluted hydrochloric acid and (or) sodium hydroxide are added to the preparation to maintain its acidity within normal limits (pH values).

What Maxitrol looks like and contents of the pack
Maxitrol eye drops are an opaque white to light yellow solution.
It is available in a 3 ml polyethylene (PE) bottle, packed in a cardboard box.

For further information, please contact the Marketing Authorisation Holder or the parallel importer.

Marketing Authorisation Holder in France, the country of export:
Novartis Pharma S.A.S., 8-10, rue Henri Sainte-Claire Deville, 92500 Rueil-Malmaison, France

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

Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Marketing Authorisation Number in France, the country of export: 34009 306 525 3 4
Parallel Import Licence Number: 184/22
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