Maxitrol

Leaflet attached to the packaging: patient information WARNING: Keep the leaflet,

information on the immediate packaging in a foreign language.
Maxitrol (Maxidrol), (1 mg + 3500 IU + 6000 IU)/ml, eye drops
(Dexamethasone + Neomycin sulfate + Polymyxin B sulfate)
Maxitrol and Maxidrolare different trade names for the same medicine.

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Maxitrol and what is it 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 packaging and other information

1. What is Maxitrol and what is it used for

Maxitrol is used to treat inflammatory eye diseases, which may be accompanied by

infection.
The inflammatory condition of the eye may be caused by infection or other factors entering the eye
or eye injuries.
Maxitrol is a combination medicine containing antibacterial and corticosteroid components.
Corticosteroids (in this case, dexamethasone) are used to prevent and reduce
inflammatory conditions of the eye. 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 allergicto neomycin sulfate, polymyxin B sulfate, dexamethasone, or any of the other components of this medicine (listed in section 6),
• if the patient has:herpetic keratitis, chickenpox, shingles, or any other viral eye infection, fungal eye infection, untreated parasitic eye infections, tubercular eye infection, untreated purulent eye infection.

Warnings and precautions

For use in the eyes only

• In some patients, hypersensitivity to topically applied aminoglycoside antibiotics, such as neomycin, may occur. If symptoms of hypersensitivity occur, the medicine should be discontinued and the doctor should be consulted immediately (see section 4). Hypersensitivity reactions may occur in the form of local itching or skin redness, severe allergic reactions (anaphylactic reactions), or severe skin reactions. Such skin reactions may occur during the use of other topical or systemic antibiotics from the same family (aminoglycosides).
• In addition, topical use of neomycin may lead to redness, irritation, and discomfort of the skin.
• In patients who have experienced hypersensitivity symptoms to topically applied neomycin, hypersensitivity to other antibiotics may also occur.
• If the patient is using other antibiotics during treatment with Maxitrol, they should consult their doctor, as the concurrent use of Maxitrol with other antibiotics may cause serious side effects.
• In patients using corticosteroid eye drops for a long time, the following may occur:
• increased intraocular pressure. Intraocular pressure should be regularly monitored during the use of this product. This is especially important in pediatric patients, as corticosteroid-induced increased intraocular pressure may be greater and occur earlier in children than in adults. The doctor's advice should be sought, especially in the case of children. The risk of increased intraocular pressure and (or) cataract is also higher in patients with a predisposition (e.g., those with diabetes).
• development of Cushing's syndrome caused by the medicine entering the bloodstream. The doctor should be consulted if the patient experiences swelling and weight gain, especially on the trunk and face, as these are usually the first symptoms of the disease called Cushing's syndrome. Adrenal insufficiency may occur as a result of discontinuing long-term or intensive use of Maxitrol. The doctor should be consulted before the patient decides to discontinue treatment. This risk is particularly important in children and patients treated with ritonavir or cobicistat.
• In case of occurrence or worsening of eye infection symptoms, the doctor should be contacted 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 at the same time, problems with healing of eye surface damage may occur.
• If the patient has diseases leading to thinning of the cornea or sclera, they should inform their doctor.

If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.
If the patient has glaucoma, the treatment time should be limited to two weeks, unless the doctor recommends otherwise.
The medicine should be used for as long as the doctor has prescribed. If the symptoms of the disease worsen or do not improve, the doctor should be consulted.

Children

The safety and efficacy of Maxitrol in children have not been documented, so it is not recommended for use in this age group

Maxitrol and other medicines

The doctor or pharmacist should be informed about all medicines the patient is currently using or has recently used, as well as any medicines the patient plans to use, including those available without a prescription.
The doctor should be particularly informed if the patient is taking:

• topically applied non-steroidal anti-inflammatory drugs. Concurrent topical use of a steroid and a non-steroidal anti-inflammatory drug may cause problems with healing of eye injuries;
• ritonavir or cobicistat, as they may increase the dexamethasone content in the blood. If the patient is using other eye drops or ointments, a minimum of 5 minutes should be allowed between administrations of the next medicines. Eye ointments should be used last.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
The medicine is not recommended during pregnancy or breastfeeding.

Driving and using machines

Maxitrol has no influence or negligible influence on the ability to drive and use machines.
For a while after administering Maxitrol, vision may be blurred. The patient should not drive or operate machines until this symptom has resolved.

Maxitrol eye drops contain benzalkonium chloride.

The medicine contains 0.04 mg of benzalkonium chloride per milliliter (0.04 mg/ml).
Benzalkonium chloride may be absorbed by soft contact lenses and change their color. Contact lenses should be removed before administering the drops and not put back for at least 15 minutes.
Benzalkonium chloride may also cause eye irritation, especially in people with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If abnormal sensations in the eye, stinging, or pain in the eye occur after using the medicine, the doctor should be consulted.

3. How to use Maxitrol

Maxitrol should always be used as directed by the doctor. In case of doubts, the doctor or pharmacist should be consulted.
Maxitrol is intended exclusivelyfor eye drops; only onepatient should use the medicine from one package.
If the protective collar is loose after removing the cap, it should be removed before using the medicine.
Closing the eyelid and gently pressing the nasolacrimal duct (tear duct) with a finger is recommended. This can reduce the absorption of the medicine into the bloodstream after administration in the form of eye drops.

Recommended dose

In mild cases, one to two drops are used in the conjunctival sac (sacs) four to six times a day.
In severe cases, one to two drops are used every hour. The medicine is gradually used in smaller doses, and after the inflammation symptoms have resolved, its use is discontinued.
The doctor will determine the duration of treatment. Treatment should not be discontinued 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. Take the bottle in your hand and turn it upside down, holding it with your thumb and middle finger (figure 1).
• 6. Tilt your head back. Pull the lower eyelid down with a clean finger to form a "pocket" between the eyelid and the eyeball; the drop should fall into this pocket (figure 2).
• 7. Bring the tip of the bottle close to the eye. You can use a mirror to help you.
• 8. Do not touch the dropper tip to the eye, eyelid, or surrounding areas.Failure to follow this instruction may cause infection of the drops.
• 9. Gently squeeze the bottom of the bottle to release a single drop of Maxitrol (figure 3).
• 10. After administering the drop, remove the finger that held the lower eyelid. Close your eye and press the corner of your eye near your nose with your finger (figure 4). This will help prevent the medicine from entering the entire body.
• 11. If it is necessary to administer drops to both eyes, the above steps should be repeated for the second eye.
• 12. The bottle should be tightened immediately after use.
• 13. Only one bottle of the medicine should be used at a time.

If the drop does not get into the eye, you should try again to administer the drop correctly.

Using more Maxitrol than recommended

In case of local overdose of the medicine, the eye (eyes) should be rinsed with lukewarm water. The drops should not be used until the next scheduled dose.

Missing a dose of Maxitrol

If a dose of the medicine is missed, the next scheduled dose should be taken. However, if there is not much time left before the next dose is due, the missed dose should be skipped, and the normal dosing schedule should be resumed. Do nottake a double dose to make up for the missed dose.
In case of any further doubts about using this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If the patient experiences allergic reactions, including rash, face, lip, tongue, and
(or) throat swelling, which may cause difficulty breathing or swallowing, or other severe side effects occur, the use of Maxitrol should be discontinued and the doctor or Emergency Department of the nearest hospital should be contacted immediately.
The following side effects have been observed during the use of Maxitrol:
Uncommon( may occur in less than 1 in 100 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, light hypersensitivity, pupil dilation, eyelid ptosis, eye pain, eye swelling, foreign body sensation in the eye, eye hyperemia, increased lacrimation, severe skin reactions (Stevens-Johnson syndrome), blurred vision, increased body hair growth (especially in women), muscle weakness, and muscle mass loss, purple striae on the skin, increased blood pressure, irregular menstrual periods or amenorrhea, changes in protein and calcium levels in the body, growth retardation in children and adolescents, and swelling and weight gain, especially on the trunk and face (a disease called Cushing's syndrome) (see section 2 "Warnings and precautions").

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 side effects can help gather more information on the safety of the medicine.
In case of worsening of any of the symptoms or occurrence of other side effects not listed in this leaflet, the doctor should be informed.

5. How to store Maxitrol

To avoid infection of the drops, the bottle should be discarded 15 days after first opening. The date of first opening of the bottle should be written in the space provided below.
Date of first opening:………………………
The medicine should be kept out of sight and reach of children.
Do not store above 25°C.
Do not store in the refrigerator.
Store the bottle upright.
Store the packaging tightly closed.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the given month.
The batch number on the packaging is marked as "Lot".
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging and other information

What Maxitrol contains

The active substances of the medicine are:
Dexamethasone
1 mg/ml
Neomycin sulfate
3500 IU/ml
Polymyxin B sulfate
6000 IU/ml
Excipients: sodium chloride, polysorbate 20, benzalkonium chloride, hypromellose, hydrochloric acid diluted and (or) sodium hydroxide to adjust the pH, purified water.

What Maxitrol looks like and what the packaging contains

Maxitrol eye drops are a non-transparent suspension, white to light yellow in color.
Available in PE bottles containing 3 ml or 5 ml of drops, in a cardboard box.
For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in France, the country of export:

Novartis Pharma S.A.S., 8-10 Rue Henri Sainte-Claire Deville, 92500 Rueil-Malmaison, France

Manufacturer:

S.A. Alcon-Couvreur N.V., Rijksweg 14, 2870 Puurs, Belgium
SIEGFRIED EL MASNOU S.A., Camil Fabra 58, 08320 El Masnou (Barcelona), Spain
NOVARTIS FARMACEUTICA S.A., Gran Via De Les Corts Catalanes 764, 08013 Barcelona, Spain
NOVARTIS PHARMA GmbH, Roonstrasse 25, 90429 Nuremberg, Germany

Parallel importer:

PharmaVitae Sp. z o.o. sp. k., ul. E. Orzeszkowej 3/35, 59-820 Leśna

Repackaged by:

CEFEA Sp. z o.o. Sp. komandytowa, ul. Działkowa 56, 02-234 Warsaw
Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warsaw
Synoptis Industrial Sp. z o.o., ul. Szosa Bydgoska 58, 87-100 Toruń
Prespack Jacek Karoński, ul. Św. Wawrzyńca 34, 60-541 Poznań

Marketing authorization number in France, the country of export:

34009 306 525 34
306 525-3
331 482-2
34009 331 482 2 5
Parallel import authorization number:167/18
Date of leaflet approval: 03.06.2022
[Information about the trademark]