Maxitrol

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Maxitrol, (1 mg + 3500 IU + 6000 IU)/g, eye ointment
Dexamethasone + Neomycin sulfate + Polymyxin B sulfate

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 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 packaging 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 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 medicine (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 ingredients of this medicine (listed in section 6.),
• herpetic keratitis, chickenpox, shingles, or any other viral eye infection,
• fungal eye infection,
• untreated parasitic eye infections,
• tuberculous eye infection,
• untreated purulent eye infections.

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 use of the medicine should be discontinued and the doctor should be contacted 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 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 at the same time, they should consult a doctor, as the concurrent use of Maxitrol with other antibiotics may cause serious side effects.
• In patients using corticosteroids 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's advice should be sought, especially in the case of children. The risk of increased intraocular pressure and/or cataracts is also higher in patients with a predisposition (e.g., diabetic patients).
• 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 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.
• 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.
• The use of contact lenses is not recommended during the treatment of eye inflammation or infection.

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 established, therefore its use is not recommended 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 about medicines the patient plans to use, including those available without a prescription.
Particular attention should be paid to informing the doctor if the patient is 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 level of dexamethasone in the blood.

If the patient is using other eye drops or ointments at the same time, a minimum of 5 minutes should be allowed between administrations of successive 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 a certain period after administration of Maxitrol, vision may be blurred. The patient should not drive or operate machines until this symptom has resolved.
Maxitrol contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216), which may cause allergic reactions (possible late reactions).
The medicine contains lanolin, which may cause local skin reactions (e.g., contact dermatitis).

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 administration to the eyes; only one patient should use the medicine from one package.
If the patient is using other eye drops or ointments at the same time, a minimum of 5 minutes should be allowed between administrations of successive medicines. Eye ointments should be used last.

Recommended dose

Usually, a small amount of ointment (a strip about 1.5 cm long) is instilled into the conjunctival sac of the affected eye (eyes) up to 3 or 4 times a day. The doctor will determine the duration of treatment. Treatment should not be discontinued prematurely.

1 2

• 1. Prepare the tube with Maxitrol and a mirror.
• 2. Wash your hands.
• 3. Unscrew the tube.
• 4. Take the tube in your hand, holding it between your thumb and index finger.
• 5. Tilt your head back. Pull down the lower eyelid with a clean finger to create a "pocket" between the eyelid and the eyeball. The ointment strip should be placed in this pocket (Figure 1).
• 6. Bring the tip of the tube close to the eye, using a mirror to help.
• 7.

The tip of the tube should not touch the eye, eyelids, surrounding surfaces, or other surfaces.

Failure to follow this recommendation may cause infection of the ointment.

• 8. Gently squeeze the tube to expel a strip of ointment (Figure 2).
• 9. After using Maxitrol, release the lower eyelid and blink several times to distribute the medicine over the entire surface of the eye. Gently close your eyelids for a few seconds; this will help prevent the systemic absorption of the medicine.
• 10. If it is necessary to administer the medicine to both eyes, the above steps should be repeated for the second eye.

11. The tube should be screwed back on immediately after use.

• 12. Only one tube of medicine should be used at a time.

If the ointment is squeezed out of the eye,an attempt should be made to reapply the ointment correctly to the eye.

Using a higher dose of Maxitrol than recommended

In case of overdose, excess medicine can be rinsed from the eye with lukewarm water. The ointment should not be used until the next scheduled dose.

Missing a dose of Maxitrol

In case of a missed dose, 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 resumed. Do nottake a double dose to make up for a missed dose.
In case of any further doubts about the use of 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.
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 the use of 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 ulcers, blurred vision, light hypersensitivity, pupil dilation, eyelid ptosis, eye pain, eye swelling, foreign body sensation in the eye, eye redness, 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 (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 Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, 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 to gather more information on the safety of the medicine.

5. How to store Maxitrol

To avoid infections, the tube with the remaining medicine should be discarded after 4 weeks from the first opening. The date of opening the tube should be noted 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.
Keep 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 given month.
Medicines should not be disposed of via wastewater or household waste containers. 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/g
Neomycin sulfate 3500 IU/g
Polymyxin B sulfate 6000 IU/g
The excipients are:
methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), liquid lanolin, white petrolatum.

What Maxitrol looks like and contents of the packaging

Maxitrol is a thick, semi-transparent or non-transparent, white or slightly yellowish, homogeneous, lump-free ointment.
It is available in aluminum tubes with a screw cap, containing 3.5 g of ointment, in a cardboard box.
For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in Belgium, the country of export:

Novartis Pharma NV
Medialaan 40, B-1800 Vilvoorde, Belgium

Manufacturer:

Siegfried El Masnou, S.A., Camil Fabra 58, 08320 El Masnou, Barcelona, Spain
SA ALCON-COUVREUR NV, Rijksweg 14, B-2870 Puurs, Belgium
Novartis Farmacéutica, S.A., Gran Via de les Corts Catalanes, 764, 08013 Barcelona, Spain
Novartis Pharma GmbH, Roonstrasse 25, 90429 Nuremberg, Germany

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11, 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249, 04-458 Warsaw
Authorization number in Belgium, the country of export:BE092145
Parallel import authorization number:311/22

Date of leaflet approval: 24.11.2023

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