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 Maxidrol are 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 one person. It should not be given 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 or pharmacist. 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. Eye inflammation can 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 eye inflammation. The antibacterial agents contained in the drops (in this case, neomycin sulfate and polymyxin B sulfate) are active against most pathogenic bacteria that cause eye infections.

2. Important information before using Maxitrol

When not to use Maxitrol

• to neomycin sulfate, polymyxin B sulfate, dexamethasone, or any of the other components of this medicine (listed in section 6),
• 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).

Additionally, topical use of neomycin may lead to redness, irritation, and skin discomfort. Patients who have experienced hypersensitivity symptoms to topically applied neomycin may also be hypersensitive to other antibiotics. If the patient is using other antibiotics while being treated with Maxitrol, they should consult their doctor, as concurrent use of Maxitrol with other antibiotics may cause serious side effects. In patients using eye corticosteroids for a long time, the following may occur: elevated intraocular pressure. Intraocular pressure should be regularly monitored during the use of this product. This is especially important in pediatric patients, as corticosteroid-induced elevated intraocular pressure may be greater and occur earlier in children than in adults. The risk of elevated intraocular pressure and/or cataract is also higher in patients with a predisposition (e.g., diabetic patients). The development of Cushing's syndrome caused by the medicine entering the bloodstream may occur. The patient should consult their doctor if they experience swelling and weight gain, especially on the trunk and face, as these are usually the first symptoms of Cushing's syndrome. Adrenal insufficiency may occur as a result of discontinuing long-term or intensive use of Maxitrol. The patient should consult their doctor before deciding to discontinue treatment. This risk is particularly significant in children and patients treated with ritonavir or cobicistat. If signs of eye infection occur or worsen, the patient should contact their doctor immediately. Patients using Maxitrol may have reduced resistance to eye infections, including bacterial and fungal infections that are resistant to antibiotic treatment. In patients using corticosteroids and non-steroidal anti-inflammatory drugs concurrently, problems with healing of eye surface damage may occur. If the patient has diseases that lead 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 patient should consult their doctor.

Children

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

Maxitrol and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription. The patient should especially inform their doctor if they are taking:

• topically applied non-steroidal anti-inflammatory drugs. Concurrent topical use of a steroid medicine 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, they should leave an interval of at least 5 minutes between administrations of the different 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 or negligible influence on the ability to drive and use machines. For some time 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. The patient should remove their contact lenses before administering the drops and wait at least 15 minutes before putting them back on. 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 the patient experiences any abnormal sensations in the eye, stinging, or eye pain after using the medicine, they should contact their doctor.

3. How to use Maxitrol

Maxitrol should always be used as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist. Maxitrol is exclusivelyintended for administration in the eyes; only onepatient should use the medicine from one package. If the protective cap is loose after removing the screw cap, it should be removed before using the medicinal product. It is recommended to close the eyelid and gently press the tear duct (nasolacrimal canal) with a finger. This can reduce the absorption of the medicinal product into the bloodstream after administration in the form of eye drops.

Recommended dose

In mild cases, one to two drops are administered into the conjunctival sac(s) four to six times a day. In severe cases, one to two drops are administered every hour. The medicine is gradually administered in smaller doses, and its use is discontinued after the inflammation symptoms have resolved. The doctor will determine the duration of treatment. The patient should not discontinue treatment prematurely.

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• 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 thumb and middle finger, and direct it upwards (Figure 1).
• 6. Tilt your head back and 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.

Failing 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 closed 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, the patient should try again to administer the drop correctly.

Using more Maxitrol than recommended

In case of local overdose of Maxitrol, the eye(s) should be rinsed with lukewarm water. The patient should not use the drops until the next scheduled dose.

Missing a dose of Maxitrol

If a dose of Maxitrol is missed, the patient should take the next scheduled dose. However, if it is almost time for the next dose, the missed dose should be skipped, and the patient should return to their regular dosing schedule. The patient should nottake a double dose to make up for the missed dose. If the patient has any further doubts about using this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Maxitrol can cause side effects, 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 breathing or swallowing, or other severe side effects, they should discontinue using Maxitrol and contact their doctor or the Emergency Department of the nearest hospital immediately. During the use of Maxitrol, the following side effects have been observed: Uncommon(may occur in less than 1 in 100 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, ulcerative keratitis, blurred vision, sensitivity to light, pupil dilation, eyelid ptosis, eye pain, eye swelling, foreign body sensation in the eye, eye redness, increased tearing, severe skin reactions (Stevens-Johnson syndrome), blurred vision, increased hair growth on the body (especially in women), muscle weakness, and muscle mass loss, purple stretch marks 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 (Cushing's syndrome) (see section 2 "Warnings and precautions").

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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. By reporting side effects, more information can be collected on the safety of the medicine. If any of the symptoms worsen or if other side effects not listed in this leaflet occur, the patient should inform their doctor.

5. How to store Maxitrol

To avoid infection of the drops, the bottle should be discarded 15 days after first opening. The date of opening the bottle should be written in the space provided below. Date of first opening: …………………. The medicine should be stored 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. The expiry date refers to the last day of the month stated. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. 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. The excipients are: sodium chloride, polysorbate 20, benzalkonium chloride, hypromellose (E 464), purified water. The medicine contains minimal amounts of diluted hydrochloric acid and/or sodium hydroxide to maintain its pH.

What Maxitrol looks like and contents of the packaging

Maxitrol eye drops are opaque drops, white to light yellow in color. They are available in 3 ml PE bottles. For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

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

Novartis Pharma GmbH, Roonstrasse 25, 90429 Nuremberg, Germany

Parallel importer:

Polypharm S.A., ul. Barska 33, 02-315 Warsaw

Repackaged by:

CEFEA Sp. z o.o. Sp. komandytowa, ul. Działkowa 56, 02-234 Warsaw Marketing authorization number in France, the country of export:34009 306 525 3 4

Parallel import authorization number: 94/23

Date of leaflet approval: 01.06.2023

[Information about the trademark]