Maxitrol

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

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 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 for a specific person. Do not pass it on to others. The drug may harm another person, even if the symptoms of their disease 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
penetrating 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 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 drug 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 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.
• In patients who have experienced hypersensitivity symptoms to topically applied neomycin, hypersensitivity to other antibiotics may also occur.
• If the patient is using other antibiotics during treatment with Maxitrol, 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 product. 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 predisposed patients (e.g., those with 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, visible mainly on the torso and face, as these are usually the first symptoms of the disease called 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 particularly 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.
• 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 contact their
doctor.
If the patient has glaucoma, the treatment period should be limited to two weeks, unless the doctor
recommends otherwise.
The drug should be used for as long as the doctor has recommended. 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 drugs

The doctor or pharmacist should be informed about all drugs currently or recently used by the patient,
as well as about the drugs the patient plans to use, including those available without a prescription.
Particularly, the doctor should be informed if the patient is taking:

• topically applied 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 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 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 influence 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
vehicles or operate machines until this symptom has resolved.
Maxitrol contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216)
, which may cause allergic 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 doctor or pharmacist
should be consulted.
Maxitrol is intended exclusivelyfor administration to the eyes; only one patient should use
the drug from one packaging.
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 consecutive drugs. 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 (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. 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 ointment strip should be placed in this pocket (Figure 1).
• 6. Bring the tube tip close to the eye, using a mirror for assistance.
• 7.

Do not touch the eye, eyelids, surrounding surfaces, or other

surfaceswith the tube tip. Failure to follow 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 squeezed out of the eye,an attempt should be made to apply the ointment correctly to the eye again.

Using a larger dose of Maxitrol than recommended

In case of overdose, excess drug can be rinsed out of 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 drug is missed, the next scheduled dose should be taken. However, if there is little time left before the next dose is due, the missed dose should be skipped and the normal dosing schedule should be resumed. Do nottake a double dose to make up for a missed dose.
In case of any further doubts about the use of this drug, the doctor or pharmacist should be consulted.

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 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, 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, visible mainly on the torso and face (a disease called 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 or pharmacist should be informed. 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 drug.
In case of worsening of any symptoms or occurrence of other side effects not listed in this leaflet, the doctor should be informed.

5. How to store Maxitrol

To avoid infections, the tube with the remaining drug should be discarded after 15 days from
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 use this drug after the expiry date stated on the packaging.
The expiry date stated on the packaging refers to the last day of the given month.
Drugs should not be disposed of in wastewater or household waste containers. The pharmacist should be asked 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 what the packaging contains

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, with a plastic tip and screw cap.
For more detailed information, the marketing authorization holder or parallel importer should be consulted.

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:

Alcon-Couvreur NV
Rijksweg 14
2870 Puurs
Belgium
Siegfried El Masnou S.A.
Camil Fabra, 58
08320 El Masnou (Barcelona)
Spain
Novartis Farmaceutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in France, the country of export:
319 835-6
34009 319 835 6 9
Parallel import authorization number: 370/19

Date of leaflet approval: 24.09.2024

[Information about the trademark]