Maxitrol

PACKAGE LEAFLET: INFORMATION FOR THE USER

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
Dexamethasone + Neomycin sulfate + Polymyxin B sulfate
Please read carefully the entire leaflet before using this medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can 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. This medicine may harm others, 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.

Leaflet 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 to treat inflammatory eye diseases that may be associated with infection.
Ocular 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 ocular 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 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, treatment should be discontinued and medical advice sought immediately (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 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 be at risk of 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 medicine. This is particularly important in children, as corticosteroid-induced increase in 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. diabetic patients).
  • 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 known as Cushing's syndrome. Adrenal suppression may occur following discontinuation of prolonged or intensive treatment with Maxitrol. Medical advice should be sought before deciding to stop treatment. This risk is particularly relevant in children and in patients treated with ritonavir or cobicistat.
• If signs of eye infection appear or worsen, medical advice should be sought 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 ocular surface damage 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 advised 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
Tell your doctor or pharmacist about all medicines the patient is currently using, has recently used or plans to use, including those available without a prescription.
Particular attention should be given to informing 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 at the same time, at least a 5-minute interval should be maintained between the administration 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 become pregnant, she should consult her 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 passed.

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, particularly in patients with dry eye syndrome or corneal disorders (the transparent front layer 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 medicine.

It is recommended to close the eyelid and gently press with a finger on the nasolacrimal duct (tear duct). This helps reduce the amount of medicine absorbed into the bloodstream after administration as eye drops.

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

For severe conditions, instill one to two drops every hour. The dose should then be gradually reduced, and treatment discontinued after symptoms of inflammation have resolved. Your doctor will determine the duration of treatment. Do not stop 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 area, 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 instillation, remove 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 being absorbed into the rest of the body.
11. If drops are required in both eyes, repeat the above steps for the second eye.
12. Immediately after use, screw the cap back onto the bottle.
13. Only one bottle of medicine should be used at any given 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 further drops until the next scheduled dose.

Missed dose of Maxitrol
If you miss a dose, take the next scheduled dose as planned. However, if it is almost time for the next dose, skip the missed dose and return to your 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 may cause adverse reactions, although not everyone gets 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 if other serious adverse reactions occur,
treatment with Maxitrol should be discontinued immediately and the patient should contact a doctor or
the nearest hospital Emergency Department without delay.
The following adverse reactions have been observed during the use of Maxitrol:
Uncommon ( may occur in fewer than 1 in 1,000 patients ): corneal inflammation, 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, sensation of foreign body in the eye, eye hyperemia, excessive tearing, severe skin reactions (Stevens-Johnson syndrome), blurred vision, excessive 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 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 adverse reactions not listed in this leaflet, patients should inform their doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of 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 the medicine.
If any of the symptoms worsen or if other adverse reactions not mentioned in this leaflet occur, patients should inform their doctor.

5. How to store Maxitrol medicine

To avoid contamination of the drops, discard the bottle 4 weeks after first opening.
The date of first opening should be recorded in the space 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.
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 must 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.

6. Contents of the package 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 excipients are: sodium chloride, polysorbate 20 (E 432), benzalkonium chloride, hypromellose (E 464), purified water.
Minimal amounts of hydrochloric acid and/or sodium hydroxide are added to the preparation to maintain its acidity (pH) within normal limits.

What Maxitrol looks like and contents of the pack
Maxitrol eye drops are a white to pale yellow, opaque suspension.
They are available in 5 ml plastic bottles with a protective cap.

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

Marketing Authorisation Holder in Bulgaria, 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 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Poland

Marketing Authorisation Number in Bulgaria, country of export: 9600056
Parallel Import Licence Number: 31/24