Maxitrol

Package leaflet: information for the patient

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Maxitrol
(1 mg + 3500 i.u. + 6000 i.u.)/ml, eye drops, suspension
Dexamethasonum + Neomycini sulfas + Polymyxini B sulfas
Read the leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet to be able to read it again if necessary.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including those not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

1. What Maxitrol is and what it is used for
2. What you need to know 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 that may be associated with infection.
Eye inflammation may be caused by infection or other agents entering the eye, or by eye injury.
Maxitrol is a combination medicine containing antibacterial components 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 or any other viral eye infection,
  • fungal eye infection,
  • untreated parasitic eye infections,
  • tuberculous eye infection,
  • untreated purulent eye infection.

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Warnings and precautions
For ocular use only.

• Some patients may experience hypersensitivity to topically applied aminoglycoside antibiotics such as neomycin. If symptoms of hypersensitivity occur, treatment should be discontinued and immediate medical advice sought (see section 4). Hypersensitivity reactions may present as local itching or redness of the skin, severe allergic reactions (anaphylactic reactions) or severe skin reactions. Such skin reactions may occur during treatment with other topical or systemic antibiotics of the same class (aminoglycosides).
• In addition, topical use of neomycin may cause redness, irritation and discomfort of 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 corticosteroids in the eye for prolonged periods, the following may occur:
  • increased intraocular pressure. Intraocular pressure should be monitored regularly during treatment with this product. This is particularly important in children, as corticosteroid-induced elevation of intraocular pressure may be greater and occur earlier in children than in adults. Medical advice should be sought, especially for children. The risk of increased intraocular pressure and/or cataract is also higher in predisposed patients (e.g. those with diabetes).
  • development of drug-induced Cushing's syndrome. Medical advice should be sought 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. Medical advice should be sought before the patient decides to discontinue treatment. This risk is particularly relevant in children and in patients treated with ritonavir or cobicistat.
• If signs of eye infection occur or worsen, immediate medical advice should be sought. 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 simultaneously, problems with healing of ocular surface injuries may occur.
• If the patient has diseases leading to thinning of the cornea or sclera, this should be reported to the doctor.

If the patient experiences blurred vision or other visual disturbances, medical advice should be sought.
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, medical advice should be sought.
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
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Inform the doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient plans to use, including over-the-counter medicines.
Particular attention should be paid to inform the doctor if the patient is taking:

• topically acting non-steroidal anti-inflammatory drugs. Concomitant topical use of a steroid medicine and a non-steroidal anti-inflammatory drug 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 5 minutes should be left between applications of each medicine. Eye 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.
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 use machines.
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 change their colour. 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, medical advice should be sought.

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 medicinal product.

It is recommended to close the eyelid and gently press with a finger on the nasolacrimal duct (lacrimal canaliculus). This helps reduce systemic absorption of the medicinal product after ocular instillation.

Recommended dose
For mild conditions, one to two drops should be administered into the conjunctival sac(s) four to six times daily.
For severe conditions, one to two drops should be administered every hour. The dosage should then be gradually reduced, and treatment discontinued after resolution of inflammatory symptoms.

Your doctor will determine the duration of treatment. Do not discontinue 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, inverted, with the bottom facing upwards, held between 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—this is where the drop should be placed (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 squeeze the bottom of the bottle to release a single drop of Maxitrol (Figure 3).
10. After instilling Maxitrol, remove the finger from 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 entering 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 of medication should be used at a time.

If the drop misses the eye, repeat the instillation correctly.

Accidental overdose 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, take the next scheduled dose as planned. 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 effects

Like any medicine, this medicine can cause adverse effects, although they do not occur in everyone.
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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 effects,
stop using Maxitrol and contact a doctor or the nearest hospital Emergency Department immediately.
The following adverse effects have been observed during the use of Maxitrol:
Not common (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, corneal ulceration, blurred vision, photophobia, pupil dilation, drooping eyelid, eye pain,
eye swelling, sensation of foreign body in the eye, eye hyperemia, excessive tearing, severe skin reactions
(Stevens-Johnson syndrome), blurred vision, excessive increase in body hair growth (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 with increased body weight, particularly noticeable in the trunk and face (a condition known as Cushing's syndrome) (see section 2 "Warnings and precautions").
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse effects 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 4921 301, fax: +48 22 4921 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse effects allows further information on the safety of the medicine to be collected.
If any of the symptoms worsen or if any other adverse effects not mentioned in this leaflet occur, inform a doctor about them.

5. How to store Maxitrol medicine

To avoid contamination of the drops, the bottle should be discarded 4 weeks after first opening.
The date of first opening should be recorded in the space provided 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 container tightly closed.
Store the bottle in an upright position.
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 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, benzalkonium chloride, hypromellose, hydrochloric acid and (or) sodium hydroxide
to adjust pH, purified water.

What Maxitrol looks like and contents of the pack
Maxitrol eye drops are a white to pale yellow, slightly opaque suspension.
It is available in a plastic bottle with a dropper and a cap, packed in a cardboard box.

For further information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Belgium, the country of export:
Novartis Pharma NV, Medialaan 40, B-1800 Vilvoorde, Belgium

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

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

Belgian Marketing Authorisation Number (country of export): BE038911
Parallel Import Authorisation Number: 90/24
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