Maxitrol

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Maxitrol, (1 mg + 3500 IU + 6000 IU)/ml, eye drops, suspension
Dexamethasonum + Neomycini sulfas + Polymyxini B sulfas
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, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, 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:

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 for the treatment of inflammatory eye diseases that may be accompanied by
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 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 infection,
• 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 (see section 4). Hypersensitivity reactions may manifest as local itching or redness of the skin, severe allergic reactions (anaphylactic reactions), or serious skin reactions. Such skin reactions may also occur during use of other topical or systemic antibiotics from the same class (aminoglycosides).
• In addition, topical use of neomycin may lead to 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 cause 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 regarding 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 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 nonsteroidal anti-inflammatory drugs simultaneously, problems with healing of ocular surface damage may occur.
• If the patient has diseases leading to thinning of the cornea or sclera, they should inform 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 advised 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
Tell your doctor or pharmacist about all medicines the patient is currently using, has recently used, or plans to use, including those obtained without a prescription.
In particular, inform the doctor if the patient is taking:

• topically acting nonsteroidal anti-inflammatory drugs. 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 at the same time, at least 5 minutes should be left between applications of each medicine. Eye ointments should be used 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 operating machinery
Maxitrol has no effect or a negligible effect on the ability to drive and operate machinery.
For a short period after administration of Maxitrol, vision may be blurred. Do not drive or operate machinery until this symptom has resolved.
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 colour. Contact lenses should be removed before instillation and at least 15 minutes should elapse before reinsertion.
Benzalkonium chloride may also cause eye irritation, especially in individuals 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 must always be used exactly as directed by the physician. If in doubt, consult your doctor or pharmacist.
Maxitrol is intended exclusively for ophthalmic instillation; each container should be used by one patient only.
If the safety collar is loose after removing the cap, it should be removed 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 entering the bloodstream after ocular administration.

Recommended dose
In mild conditions, one to two drops should be administered into the conjunctival sac (or sacs) four to six times daily.
In severe cases, one to two drops should be given every hour. The dosage should then be gradually reduced, and treatment discontinued once inflammatory symptoms have resolved.
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 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—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 let the dropper tip touch the eye, eyelid, surrounding area, or any other surface.
Failure to follow this instruction may result in contamination of the solution.

9. Gently press 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 medicine should be used at a time.

If the drop misses the eye, repeat the instillation procedure correctly.
Use of more than the recommended dose of Maxitrol
In case of local overdose, rinse the eye(s) with lukewarm water.
Do not use the medicine again until the next scheduled dose.
Missed dose of Maxitrol
If a dose is missed, take 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 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 all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
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 severe adverse reactions occur,
Maxitrol treatment must be stopped immediately and the doctor or the nearest hospital Emergency
Department must be contacted without delay.

The following adverse reactions have been observed during treatment with Maxitrol:
Uncommon (may affect fewer than 1 in 1,000 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 ulceration, blurred vision, photophobia, pupil dilation, eyelid drooping, eye pain, eye swelling, foreign body sensation in the eye, eye hyperaemia, 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 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 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, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl .
Reporting adverse reactions helps to provide more information on the safety of this medicine.
If any of the symptoms worsen or if any other adverse reactions not mentioned in this leaflet occur, inform the doctor.

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 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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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, benzalkonium chloride, hypromellose, water
for injections.
Minimal amounts of concentrated hydrochloric acid and/or sodium hydroxide are added to adjust the pH.

What the medicine looks like and contents of the pack
Maxitrol is a white to pale yellow, opaque suspension.
It is available in a 5 ml DROPTAINER bottle with dropper and cap, packed in a cardboard box.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.

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

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

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation Number in Belgium, country of export: BE038911
Parallel Import Licence Number: