Maxitrol

Package Leaflet: Information for the Patient

Warning! The leaflet should be kept. 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 drug.

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, 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 their symptoms 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 pack and other information

1. What is Maxitrol and what is it used for

Maxitrol is used to treat inflammatory eye diseases that 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 drug containing antibacterial and corticosteroid components.
Corticosteroids (in this case, dexamethasone) are used to prevent and reduce eye inflammation. The antibacterial agents 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

• if the patient is allergicto neomycin sulfate, polymyxin B sulfate, dexamethasone, or any of the other ingredients 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,

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• 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 (anaphylaxis), 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 skin discomfort.
• Patients who have experienced hypersensitivity 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 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 medicine. 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 should be consulted, 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., diabetic patients).
• development of Cushing's syndrome caused by the drug entering the bloodstream. The doctor should be consulted if the patient experiences swelling and weight gain, especially on the torso 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 especially important in children and patients treated with ritonavir or cobicistat.
• If the patient experiences or worsens symptoms of eye infection, they should contact their doctor immediately. Patients using Maxitrol may have reduced immunity to eye infections, including bacterial and fungal infections resistant to antibiotic treatment.
• In patients using corticosteroids and non-steroidal anti-inflammatory drugs (NSAIDs) at the same time, 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 doctor should be consulted.

Children

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

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

• topical 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 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 influence or negligible influence on the ability to drive and use machines.
For some time after using 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 instillation and not reinserted 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 eye pain 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. If there are any doubts, the doctor or pharmacist should be consulted.
Maxitrol is intended exclusivelyfor use in the eyes; only onepatient should use the medicine from one package.
If the protective cap is loose after removing the cap, it should be removed before using the medicine.
The eyelid should be closed and the nasolacrimal duct (tear duct) gently pressed with a finger. This helps reduce the absorption of the medicine into the bloodstream after administration as eye drops.

Recommended dose

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

• 1. Prepare the Maxitrol bottle and a mirror.
• 2. Wash your hands.
• 3. Shake the bottle.
• 4. Remove the cap.
• 5. Hold 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 eye; 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 instilling the drop, release the lower eyelid. Close your eye and press the corner of your eye near your nose with your finger (figure 4). This helps prevent the medicine from entering the entire body.
• 11. If it is necessary to administer drops to both eyes, repeat the above steps for the second eye.
• 12. Replace the cap on the bottle 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, try again to instill 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 next dose of the medicine should not be used until the scheduled time.

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.
If there are any further doubts about using this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Maxitrol can cause side effects, although not everybody gets them.
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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, they should discontinue using Maxitrol and contact their doctor or the Emergency Department of the nearest hospital 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, photophobia, 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, excessive hair growth on the body (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 torso and face (a condition 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 this leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products, 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 side effects will help gather more information on the safety of the medicine.
If any of the symptoms worsen or if other symptoms occur that are 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 opening the bottle should be written in the space provided below.
Date of first opening:……….
The medicine should be kept out of the sight and reach of children.
Do not store above 25°C. Do not store in the refrigerator.
Store the bottle upright.
Keep the packaging tightly closed.
Do not use the medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the month.
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 needed. This will help protect the environment.
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6. Contents of the pack 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, 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 pack

Maxitrol eye drops are a non-transparent, white to light yellow liquid.
Available in a 3 ml PE bottle, in a cardboard box
For more detailed information, the marketing authorization holder or parallel importer should be consulted.

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:

Siegfried El Masnou, S.A., Camil Fabra, 58, 08320 El Masnou, Barcelona, Spain
S.A. ALCON-COUVREUR N.V., Rijksweg 14, 2870 Puurs, Belgium
Novartis Pharma GmbH, Roonstrasse 25, 90429 Nuremberg, Germany
Novartis Farmaceutica, 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

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
French marketing authorization number: 34009 306 525 3 4

Parallel import authorization number: 184/22 Date of approval of the leaflet: 29.04.2022

[Information about the trademark]
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