Maxitrol

Package leaflet: Information for the patient

Warning! Keep this leaflet, the information on the immediate packaging is in a foreign language.
Maxitrol (Maxidrol), (1 mg + 3500 i.u. + 6000 i.u.)/ml, eye drops
Dexamethasonum + Neomycini sulfas + Polymyxini B sulfas
Maxitrol and Maxidrol are different brand names for the same medicinal product.
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet for possible future reference.
• If you have any questions, 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 other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. 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 to treat inflammatory eye diseases, which may be accompanied by infection. Inflammation of the eye may result from infection, other agents entering the eye, or 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 infection of the eye,
• fungal infection of the eye,
• untreated parasitic infections of the eye,
• tubercular infection of the eye,
• 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 severe skin reactions. Such skin reactions may 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:

• elevated intraocular pressure. Intraocular pressure should be monitored regularly during treatment with this product. This is particularly important in pediatric patients, as corticosteroid-induced elevation in intraocular pressure may be more pronounced 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. Consult a doctor 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 symptoms of eye infection appear or worsen, contact a doctor immediately. Patients using Maxitrol may have reduced resistance to eye infections, including antibiotic- and antifungal-resistant bacterial and fungal infections.

• In patients using corticosteroids and non-steroidal anti-inflammatory drugs simultaneously, impaired healing of ocular surface damage may occur.

• If the patient has diseases causing thinning of the cornea or sclera, this should be reported to 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, its use is not recommended in this age group.

Maxitrol and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines planned for use, including over-the-counter medicines.
Particularly inform the doctor if the patient is taking:

• topically acting non-steroidal anti-inflammatory drugs (NSAIDs). Concurrent topical use of a steroid medicine and a non-steroidal anti-inflammatory drug may cause impaired healing of eye wounds;
• ritonavir or cobicistat, as they may increase blood levels of dexamethasone.

If the patient is using other eye drops or ointments simultaneously, wait at least 5 minutes between applications 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 child, 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 effect or negligible effect on the ability to drive and operate machinery.
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 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 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 medicinal product.
It is recommended to close the eyelid and gently press with a finger on the nasolacrimal duct (lacrimal canal). This helps reduce the amount of medicinal product entering the bloodstream after instillation into the eye.

Recommended dose
In mild conditions, one to two drops should be administered into the conjunctival sac(s) four to six times daily.
In severe cases, 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 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 form a "pocket" between the eyelid and the eyeball, into which 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 instillation, remove the finger that held 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, tightly 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 procedure to correctly instill the drop.
If more than the recommended dose of Maxitrol has been used
In case of local overdose, rinse the eye(s) with lukewarm water. Do not use further drops until the next scheduled dose.
If a dose of Maxitrol is missed
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 may cause adverse reactions, although not everybody 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 other serious adverse reactions occur,
treatment with Maxitrol should be discontinued immediately and the doctor or the nearest hospital's
Emergency Department should be contacted without delay.
The following adverse reactions have been observed during the use of Maxitrol:
Uncommon ( may occur in up to 1 in 1,000 patients ): corneal inflammation, increased intraocular pressure, eye itching, eye discomfort, eye irritation.
Frequency unknown ( frequency cannot be estimated from the available data ): hypersensitivity, headache, corneal ulcerative keratitis, blurred vision, photophobia, pupil dilation, eyelid ptosis, 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 (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 swelling and 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, inform your doctor or pharmacist. 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 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 your doctor.

5. How to store Maxitrol medicine

To avoid contamination of the drops, the bottle should be discarded 15 days after first opening.
The date of first opening should be recorded in the space indicated below.
Date of first opening: ……………………
Keep the medicine out of 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 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.

6. Contents of the pack 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 other components are: sodium chloride, polysorbate 20, benzalkonium chloride, hypromellose (E 464),
purified water.
Minimal amounts of diluted hydrochloric acid and/or sodium hydroxide may be added to the medicine to maintain its acidity (pH) within normal range.

What Maxitrol looks like and contents of the pack
Maxitrol eye drops are an opaque liquid, ranging in colour from white to light yellow.
It is available in 3 ml polyethylene (PE) bottles.

For further information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in France, the country of export:
Novartis Pharma S.A.S.
8-10, rue Henri Sainte-Claire Deville
92500 Rueil-Malmaison
France

Manufacturer
Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany

Parallel Importer:
Polypharm S.A.
ul. Barska 33
02-315 Warsaw
Poland

Repackaged in:
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Poland

Marketing Authorisation Number in France, the country of export: 34009 306 525 3 4
Parallel Import Licence Number: 94/23