Maxitrol

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. 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

The patient should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be read again if necessary.
• In case of any doubts, the patient should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for this patient. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects 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, which may be accompanied by

infection. Eye inflammation can be caused by infection or other factors
penetrating 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

• If the patient is allergicto neomycin sulfate, polymyxin B sulfate, dexamethasone, or any other component 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 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 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 corticosteroids for a long time, the following may occur:
• increased intraocular pressure. Intraocular pressure should be regularly monitored during treatment with 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 cataracts is also higher in patients with predisposing factors (e.g., diabetes).
• 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 worsening or occurrence 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 concurrently, 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 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 medicine should be used for as long as the doctor recommends. If the symptoms worsen or do not improve, the doctor should be consulted.

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 medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription.
Particularly, the doctor should be 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 levels 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 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 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 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; one container of the medicine should be used by one patient only.
If the patient is using other eye drops or ointments, they should wait at least 5 minutes between administrations of different medicines. Eye ointments should be used last.

Recommended dose

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

• 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 the lower eyelid down with a clean finger to form a "pocket" between the eyelid and the eyeball. The strip of ointment 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.

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

to avoid contaminating 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 spread the medicine over the entire surface of the eye. Gently close the 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 apply the ointment correctly to the eye again.

Using more 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 Maxitrol is missed, the next scheduled dose should be taken. However, if it is almost time for the next dose, the missed dose should be skipped and the regular dosing schedule resumed. A double dose should notbe used 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 an allergic reaction, including rash, swelling of the face, lips, tongue, and/or
throat, which may cause difficulty breathing or swallowing, or experiences other severe
side effects, they should discontinue using Maxitrol and contact their doctor or the Emergency Department of the nearest hospital immediately.
During treatment with 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, 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, 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 inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
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 doctor should be informed.

5. How to store Maxitrol

To avoid infections, the tube with the remaining medicine should be discarded 4 weeks after first opening.
The date of first opening should be noted below.
Date of first opening:
The medicine should be kept out of sight and reach of children.
Store in a temperature below 25°C.
Do not store in the refrigerator.
Keep the tube 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 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.

6. Contents of the packaging and other information

What Maxitrol contains

The active substances of Maxitrol 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 a 3.5 g aluminum tube with a PE applicator and PE cap, in a cardboard box.
For more detailed information, the marketing authorization holder or parallel importer should be consulted.

Marketing authorization holder in Croatia, the country of export:

Novartis Hrvatska d.o.o., Radnička cesta 37b, 10 000 Zagreb, Croatia

Manufacturer:

Novartis Pharma GmbH, Roonstrasse 25, 90429 Nuremberg, Germany
S.A. Alcon-Couvreur N.V., Rijksweg 14, 2870 Puurs, Belgium
Siegfried El Masnou S.A., Camil Fabra 58, El Masnou, 08320 Barcelona, Spain
Novartis Farmacéutica, 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
Croatian marketing authorization number, country of export: HR-H-641598573-01

Parallel import authorization number: 255/23

Date of leaflet approval: 09.11.2023

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