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)/g, eye ointment
Dexamethasone + Neomycin sulfate + Polymyxin B sulfate
Maxitrol and Maxidrol are different trade names for the same drug.

You should carefully read the contents of the leaflet before using the drug, 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 drug has been prescribed to a specific person. It should not be given to others. The drug may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform 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 drug containing antibacterial and corticosteroid components.
Corticosteroids (in this case, dexamethasone) are used to prevent and reduce eye inflammation. The antibacterial drugs contained in the drug (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 drug (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 ophthalmic use only

• In some patients, hypersensitivity to topically applied aminoglycoside antibiotics, such as neomycin, may occur. If symptoms of hypersensitivity occur, the drug should be discontinued and medical attention should be sought immediately (see section 4). Hypersensitivity reactions may occur in the form of local itching or skin redness, severe allergic reactions (anaphylactic reaction), 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 reactions to topically applied neomycin may also experience hypersensitivity to other antibiotics.
• If the patient is using other antibiotics during treatment 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 treatment with this drug. 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 risk of increased intraocular pressure and/or cataract is also higher in patients with predisposing factors (e.g., diabetes).
• development of Cushing's syndrome caused by the drug entering the bloodstream. If the patient experiences swelling and weight gain, particularly on the trunk and face, they should consult their doctor, 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 important in children and patients treated with ritonavir or cobicistat.
• In case of worsening or occurrence of eye infection symptoms, the patient should immediately consult their doctor. 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 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.
• It is not recommended to use contact lenses during treatment for eye inflammation or infection.

If the patient experiences blurred vision or other vision disturbances, they should consult their doctor.
If the patient has glaucoma, the treatment duration should be limited to two weeks, unless the doctor recommends otherwise.
The drug should be used for as long as the doctor recommends. If the symptoms worsen or do not improve, the patient should consult their doctor.

Children

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

Maxitrol and other drugs

The patient should inform their doctor or pharmacist about all drugs they are currently using or have recently used, as well as any drugs they plan to use, including over-the-counter drugs.
Particularly, the patient should inform their doctor if they are taking:

• topical non-steroidal anti-inflammatory drugs. Concurrent topical use of a steroid drug 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, they should wait at least 5 minutes between administrations of consecutive drugs. 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 drug.
The drug 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 administration of Maxitrol, vision may be blurred. The patient should not drive or operate machines until this symptom subsides.
Maxitrol contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216), which may cause allergic reactions (possible late reactions). The drug contains lanolin, which may cause local skin reactions (e.g., contact dermatitis).

• (216), which may cause allergic reactions (possible late reactions). The drug contains lanolin, which may cause local skin reactions (e.g., contact dermatitis).

3. How to use Maxitrol

Maxitrol should always be used as recommended by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
Maxitrol is intended exclusivelyfor ophthalmic use; only one patient should use the drug from one package.
If the patient is using other eye drops or ointments, they should wait at least 5 minutes between administrations of consecutive drugs. Eye ointments should be used last.

Recommended dose

Usually, a small amount of ointment is instilled into the conjunctival sac of the affected eye(s) up to 3 or 4 times a day. The doctor will determine the treatment duration. The patient should not discontinue treatment prematurely.

1
2

• 1. Prepare the tube with Maxitrol and a mirror.
• 2. Wash your hands.
• 3. Unscrew the tube.
• 4. Hold the tube between your thumb and index finger.
• 5. Tilt your head back. Pull down the lower eyelid with a clean finger to form 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 for assistance.
• 7. Do not touch the tip of the tube to the eye, eyelids, surrounding surfaces, or other surfaces. Failure to comply with this recommendation may cause infection of the ointment.
• 8. Gently squeeze the tube to express a strip of ointment (Figure 2).
• 9. After using Maxitrol, release the lower eyelid and blink several times to allow the drug to spread over the entire surface of the eye. Gently close your eyelids for a few seconds; this will help prevent systemic absorption of the drug.
• 10. If it is necessary to administer the drug 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 the drug should be used at a time.

If the ointment is expressed outside the eye,the patient should retry the correct application of the ointment to the eye.

Using a higher dose of Maxitrol than recommended

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

Missing a dose of Maxitrol

If a dose of the drug is missed, the patient should take the next scheduled dose. However, if there is little time left before the next dose, the missed dose should be skipped, and the patient should return to their normal dosing schedule. The patient should nottake a double dose to make up for the missed dose.
In case of any further doubts about using this drug, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all drugs, 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 immediately consult their doctor or the Emergency Department of the nearest hospital.
During treatment with Maxitrol, the following side effects have been observed:
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, ulcerative keratitis, blurred vision, hypersensitivity to light, 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; 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, particularly 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, pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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
Side effects can also be reported to the marketing authorization holder or parallel importer.
Reporting side effects will help gather more information on the safety of the drug.
In case of worsening of any symptoms or occurrence of other side effects not listed in this leaflet, the patient should inform their doctor.

5. How to store Maxitrol

To avoid infections, the tube with the remaining drug should be discarded after 15 days from the first opening.
The date of opening the tube should be noted below.
Date of first opening:……………………….
The drug 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 drug after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Drugs should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of unused drugs. This will help protect the environment.

6. Contents of the packaging and other information

What Maxitrol contains

The active substances of the drug 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), lanolin, 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 3.5 g, internally coated with epoxy lacquer, with an HDPE applicator or a mixture of HDPE/LDPE and an HDPE cap, in a cardboard box.
For more detailed information, the patient should consult the marketing authorization holder or 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:

Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw

Repackaged by:

CEFEA Sp. z o.o. Sp.
komandytowa
ul. Działkowa 56
02-234 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Forteczna 35-37
87-100 Toruń
Shiraz Productions Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów

Marketing authorization number in France, the country of export:

34009 319 835 6 9
319 835-6

Parallel import authorization number: 7/25

Date of leaflet approval: 13.01.2025

[Information about the trademark]