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
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so 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 pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the 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 associated with infection.
Ocular inflammation may be caused by infection or other agents entering the eye, or by eye injuries.
Maxitrol is a combination medicine containing antibacterial components 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. 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 infection of the eye,
  • fungal infection of the eye,
  • untreated parasitic infections of the eye,
  • tuberculous infection of the eye,
  • untreated purulent infection of the eye.

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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 should be sought immediately (see section 4). Hypersensitivity reactions may manifest as local itching or redness of the skin, severe allergic reactions (anaphylactic reaction), or serious 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 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:
  • increased 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. Patients should consult their doctor, especially in the case of children. The risk of elevated intraocular pressure and/or cataract is also higher in predisposed patients (e.g. those with diabetes).
  • development of drug-induced Cushing's syndrome. Patients should consult their doctor if they experience swelling and weight gain, particularly noticeable in the trunk and face, as these are usually the first signs of Cushing's syndrome. Adrenal suppression may occur following discontinuation of prolonged or intensive treatment with Maxitrol. Patients should consult their doctor 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, patients should contact their 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 non-steroidal anti-inflammatory drugs simultaneously, problems with healing of ocular surface injuries may occur.
• Patients with diseases causing thinning of the cornea or sclera should inform their doctor.

If the patient experiences blurred vision or other visual disturbances, they should contact their 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, the patient should consult their 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
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Tell your doctor or pharmacist if the patient is taking, has recently taken, or might take any other medicines, including those obtained without a prescription.
Particularly inform the doctor if the patient is using:

• topical 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 these may increase blood levels of dexamethasone. If the patient is using other eye drops or ointments, at least 5 minutes should be left between the 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 have a baby, 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.
However, vision may be blurred for a short time after instillation of Maxitrol. Patients should not drive or operate machinery until this effect has passed.
Maxitrol contains benzalkonium chloride
This 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 be waited before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially 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, the patient should contact their doctor.

3. How to use Maxitrol

Maxitrol must always be used as directed by the physician. 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, it should be removed 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 entering the bloodstream after ocular administration.

Recommended dose
In mild conditions, instill one to two drops into the conjunctival sac(s) four to six times daily.
In severe cases, one to two drops should be administered every hour. The dose 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 hand, turning it upside down with thumb and middle finger (Figure 1).
6. Tilt head backward. Gently pull the lower eyelid downward 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 tip of the dropper near the eye. A mirror may be used to assist.
8. Do not touch the eye, eyelid, surrounding area, 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 instillation, 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 spreading into the systemic circulation.
11. If drops are required in both eyes, repeat the above steps for the second eye.
12. Immediately recap the bottle after use.
13. Only one bottle should be used at a time.

If a drop misses the eye, repeat the instillation procedure correctly.
Overdose of Maxitrol
In case of local overdose, 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, take the next scheduled dose as planned. However, if it is almost time for the next dose, skip the missed dose and resume the regular dosing schedule. Do not take a double dose to make up for a missed one.
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 may cause adverse reactions, although not everyone experiences 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, the use of Maxitrol must be discontinued and immediate contact must be made with a doctor or the Emergency Department of the nearest hospital.
The following adverse reactions have been observed during treatment with Maxitrol:
Not very common (may occur in fewer than 1 in 1,000 patients): keratitis, 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, pupillary dilation, ptosis (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, increased body hair growth (especially in women), muscle weakness and loss of muscle mass, purple striae on the skin, 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 edema with increased body weight, particularly noticeable on the trunk and face (a condition known as Cushing's syndrome) (see section 2 "Warnings and precautions").
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, 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 reactions allows additional 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 your doctor.

5. How to store the medicine Maxitrol

To avoid contamination, 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℃.
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. This will 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 ingredients are:
sodium chloride, polysorbate 20, benzalkonium chloride, hypromellose, purified water.
Minimal amounts of concentrated hydrochloric acid and/or sodium hydroxide are added to the product 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 bottles made of plastic with a dropper made of low-density polyethylene (LDPE) and a tamper-evident cap made of polypropylene (PP), packed in a cardboard box.

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

Marketing Authorisation Holder in Bulgaria, the country of export:
Novartis Pharma GmbH, Roonstrasse 25, 90429 Nuremberg, Germany

Manufacturer:
Novartis Manufacturing NV
Rijksweg 14, 2870 Puurs-Sint-Amands, Belgium
Siegfried El Masnou, S.A.
Camil Fabra, 58, El Masnou, 08320 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:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Relabelled and/or repackaged by:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Bulgarian, country of export, Marketing Authorisation Number: 9600056
Parallel Import Licence Number: 375/21
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