Maxitrol

Leaflet accompanying the packaging: patient information

Warning! Keep the leaflet, the information on the immediate packaging is 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 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 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 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:

• 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
• 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 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 reaction), 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.
• Patients using corticosteroids for a long time may experience: increased eye pressure. Eye pressure should be regularly checked during the use of this medicine. This is especially important in pediatric patients, as corticosteroid-induced increased eye pressure may be greater and occur earlier in children than in adults. Patients should consult a doctor, especially for children. The risk of increased eye pressure and (or) cataract is also higher in patients with predisposing factors (e.g., diabetes). The development of Cushing's syndrome caused by the drug entering the bloodstream. Patients should consult a 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 stopping long-term or intensive use of Maxitrol. Patients should consult a doctor before deciding to stop treatment. This risk is especially important in children and patients treated with ritonavir or cobicistat.
• In case of worsening or occurrence of eye infection symptoms, patients should contact their doctor immediately. Patients using Maxitrol may have reduced immunity to eye infections, including bacterial and fungal infections resistant to antibiotic treatment
• Patients using corticosteroids and non-steroidal anti-inflammatory drugs at the same time may experience problems with healing of eye surface damage.
• 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 the treatment of 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 medicine should be used for as long as the doctor has prescribed. 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 it is not recommended for use in this age group.

Maxitrol and other medicines

Patient should tell their doctor or pharmacist about all medicines they are currently using or have recently used, as well as any medicines they plan to use, including those available without a prescription.
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 at the same time, 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 a while after administering 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 patient should consult their doctor or pharmacist.
Maxitrol is for ophthalmic use only; only one patient should use the medicine from one package.
If the patient is using other eye drops or ointments at the same time, they should leave an interval of at least 5 minutes between administrations of the different 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 treatment duration. The 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. 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 tube tip close to the eye, using a mirror to help.
• 7.

Do not touch the tube tip to the eye, eyelids, surrounding surfaces, or other surfaces

to avoid contaminating the ointment. Failure to follow this instruction may cause infection of the ointment.

• 8. Gently squeeze the tube to expel the ointment strip (Figure 2).
• 9. After using Maxitrol, release the lower eyelid and blink several times to spread the medicine over the entire eye surface. Gently close your eyelids for a few seconds; this will help prevent 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, the patient should try to apply the ointment correctly to the eye again.

Using a higher dose of Maxitrol than recommended

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

Missing a dose of Maxitrol

If a dose of Maxitrol is missed, the next scheduled dose should be taken. 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. Do nottake a double dose to make up for a missed dose.
In case of any further doubts about using this medicine, the patient 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, face, lip, tongue, and (or) throat swelling, which may cause difficulty breathing or swallowing, or other severe side effects, they should stop 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 affect up to 1 in 100 people): 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, 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 cycle or amenorrhea, changes in protein and calcium levels in the body, growth inhibition 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 this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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. 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 medicine.
In case of worsening of any symptoms or occurrence of other symptoms not listed in this leaflet, the patient should inform their doctor.

5. How to store Maxitrol

To avoid infections, the tube with the remaining medicine should be discarded after 15 days from the first opening of the tube. 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 30°C.
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 month.
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 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, white petrolatum.

What Maxitrol looks like and contents of the pack

Maxitrol is a thick, semi-transparent or non-transparent, white or slightly yellowish, homogeneous, lump-free ointment.
It is available in an aluminum tube with an inner epoxy coating, with an HDPE applicator or a mixture of HDPE/LDPE and an HDPE cap, in a cardboard box, containing 3.5 g of ointment.

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:319 835-6 34009 319 835 6 9

Parallel import authorization number: 284/24

Date of leaflet approval: 10.07.2024

[Information about the trademark]