MAXITROL (1 mg + 3500 IU + 6000 IU)/g Ointment

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
2. What is Maxitrol and what is it used for
3. Important information before using Maxitrol
   1. When not to use Maxitrol
   2. Warnings and precautions
   3. Children
   4. Maxitrol and other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
4. How to use Maxitrol
   1. Recommended dose
   2. Do not touch the tube tip to the eye, eyelids, surrounding surfaces, or other
   3. Using a higher dose of Maxitrol than recommended
   4. Missing a dose of Maxitrol
5. Possible side effects
   1. Reporting side effects
6. How to store Maxitrol
7. Contents of the packaging and other information
   1. What Maxitrol contains
   2. What Maxitrol looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer/Importer

Leaflet attached to the packaging: patient information

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

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

• Keep this leaflet, you may need to read it again.
• In case of 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 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 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,
• tubercular 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 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.
• In patients who have experienced symptoms of hypersensitivity to topically applied neomycin, hypersensitivity to other antibiotics may also occur.
• If the patient is using other antibiotics at the same time, they should consult a doctor, as 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 cataract is also higher in patients with predisposing factors (e.g., diabetes).
• 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 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 worsening or exacerbation of eye infection symptoms, the doctor should be consulted 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.
• 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 a 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 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 taking or has recently taken, as well as about medicines the patient plans to take, including those available without a prescription.
The doctor should be especially informed 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 dexamethasone content 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 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 a 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 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 ophthalmic use; one container of the medicine should be used by only onepatient.
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 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 duration of treatment. The treatment should not be discontinued prematurely.

1
2

• 1. Prepare the Maxitrol tube 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. 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 allow the medicine to spread 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, repeat the above steps for the second eye.
• 11. Replace the tube cap 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

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 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 stop 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 ulcers, blurred vision, light sensitivity, 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; 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 trunk and face (a condition known as 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 inform their doctor or pharmacist. 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
Phone: +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.
Reporting side effects will help to gather more information on the safety of the medicine.
In case of worsening of any of the symptoms or occurrence of other symptoms not listed in this leaflet, the doctor should be informed.

5. How to store Maxitrol

To avoid infections, the tube with the remaining medicine should be discarded after four weeks from the first opening. The date of opening the tube should be noted below.
Date of first opening:……………………….
The medicine should be kept out of sight and reach of children.
Do not store above 25°C.
Do not store in the refrigerator.
Keep the container tightly closed.
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.
The batch number on the packaging is marked as "Lot".
Medicines should not be disposed of via wastewater or household waste containers. The pharmacist should be asked how to dispose of unused medicines. 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 pack

Maxitrol is a thick, semi-transparent or non-transparent, white or slightly yellowish, homogeneous, lump-free ointment.
It is available in tubes of 3.5 g, fitted with a plastic nozzle and cap.

Marketing authorization holder

Novartis Poland Sp. z o.o.
Marynarska 15
02-674 Warsaw
phone: +48 22 37 54 888

Manufacturer/Importer

Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany
Siegfried El Masnou, S.A
Camil Fabra, 58
El Masnou, 08320
Barcelona
Spain
Novartis Manufacturing NV
Rijksweg 14
2870 Puurs-Sint-Amands
Belgium
Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Date of last revision of the leaflet:10/2024