Maxitrol

Package leaflet: Information for the patient

Warning! Keep this 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 that you can read it again if necessary.
• If you have any doubts, please 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 adverse reactions not listed in this leaflet, inform the 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. Eye inflammation may be caused by infections 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 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 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 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 a sensation of 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:
  ‐ 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 in the case of 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 drug. Seek medical advice if the patient develops swelling and increased body weight, 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. 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 bacterial and fungal infections resistant to antibiotic treatment.
• In patients using corticosteroids and nonsteroidal 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, 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 over-the-counter medicines.
Particularly 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 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 applied last.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, 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 influence on the ability to drive and use machines.
For a short period after administration of Maxitrol, vision may be blurred. 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 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, 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 should always be used 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, remove it before using the medication.

It is recommended to close the eyelid and gently press the finger against the nasolacrimal duct (lacrimal canal). This helps reduce the amount of medication absorbed into the bloodstream after ocular administration.

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

In severe cases, administer one to two drops every hour. Gradually reduce the dosage as symptoms improve, and discontinue the medication once inflammation has 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 with the bottom facing upwards, grasped between the thumb and middle finger (Figure 1).
6. Tilt the head backward. Gently pull the lower eyelid downward with a clean finger to create a "pouch" between the eyelid and the eyeball, into which the drop should be placed (Figure 2).
7. Bring the tip of the dropper close to the eye. A mirror may be used to assist.

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 solution.

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 medication from draining into 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 any given time.

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

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

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 one.

If you have any further questions about the use of this medication, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although not everyone experiences 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 treatment with Maxitrol:
Not frequently (may occur in fewer than 1 in 1,000 patients): keratitis, increased intraocular pressure, eye itching, eye discomfort, eye irritation.
Frequency unknown (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 hyperaemia, excessive tearing, severe skin reactions (Stevens-Johnson syndrome), blurred vision, excessive growth of body hair (particularly 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 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 of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 4921301, Fax: +48 22 4921309, 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 any other adverse reactions not listed in this leaflet occur, inform your 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 or freeze.
Keep the bottle in the original packaging to protect from light.
Keep the bottle 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 in use. This will help protect the environment.

6. Contents of the pack and other information

What Maxitrol contains
The active substances are:
Dexamethasone 1 mg/ml (0.1% w/v)
Neomycin sulphate 3500 i.u./ml (3500 IU/ml)
Polymyxin B sulphate 6000 i.u./ml (6000 IU/ml)

The excipients are: sodium chloride, polysorbate 20, benzalkonium chloride, hypromellose (E 464),
purified water.
Minimal amounts of 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 an opaque, white to pale yellow suspension.
It is available in a low-density polyethylene (LDPE) bottle fitted with an LDPE dropper and a white polypropylene (PP) cap, packed in a cardboard box.

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

Marketing Authorisation Holder in Ireland, the country of export:
Novartis Ireland Limited
Vista Building
Elm Park
Merrion Road, Ballsbridge
Dublin 4, Ireland

Manufacturer:
Novartis Farmacéutica, S.A., Gran Via de les Corts Catalanes, 764, 08013 Barcelona, Spain
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

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

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

Marketing Authorisation Number in Ireland, the country of export: PA0896/019/001
Parallel Import Licence Number: 451/21