Maxitrol

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Maxitrol (Maxidrol)
(1 mg + 3500 IU + 6000 IU)/g, ophthalmic ointment
Dexamethasonum + Neomycini sulfas + Polymyxini B sulfas
Maxitrol and Maxidrol are different trade names for the same medicinal product.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. 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 adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Maxitrol is and what it is 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 pack and other information

1. What Maxitrol is and what it is used for

Maxitrol is used to treat inflammatory eye diseases that may be accompanied by
infection. Eye inflammation may be caused by infection or other factors entering the eye, or by eye injury.
Maxitrol is a combination medicine containing antibacterial agents and a corticosteroid. 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 causing eye infections.

2. Important information before using Maxitrol

When not to use Maxitrol

• if the patient is allergic to neomycin sulfate, polymyxin B sulfate, dexamethasone, or to any of the other ingredients of this medicine (listed in section 6),
• if the patient has:
• herpes simplex keratitis, vaccinia, varicella or any other viral infection of the eye,
• fungal infection of the eye,
• untreated parasitic infections of the eye,
• tuberculous infection of the eye,
• untreated purulent eye infections.

Warnings and precautions
For topical ophthalmic use only.

• Some patients may develop hypersensitivity to locally applied aminoglycoside antibiotics such as neomycin. If symptoms of hypersensitivity occur, treatment with the medicine should be discontinued and medical advice sought immediately (see section 4). Hypersensitivity reactions may manifest as local itching or redness of the skin, severe allergic reactions (anaphylactic reactions), or severe skin reactions. Such skin reactions may also occur during treatment with other local or systemic antibiotics from the same class (aminoglycosides).
• In addition, local use of neomycin may cause redness, irritation, and discomfort of the skin.
• Patients who have experienced hypersensitivity reactions to topical neomycin may also be hypersensitive to other antibiotics.
• If the patient is using other antibiotics during treatment with Maxitrol, medical advice should be sought, as concomitant use of Maxitrol with other antibiotics may lead to serious adverse effects.
• In patients using ophthalmic corticosteroids long-term, the following may occur:
• elevated intraocular pressure. Intraocular pressure should be monitored regularly during treatment with this product. This is particularly important in pediatric patients, as corticosteroid-induced elevation in intraocular pressure may be greater and occur earlier in children than in adults. Medical advice should be sought, especially for children. The risk of elevated intraocular pressure and/or cataract is also higher in predisposed patients (e.g., diabetic patients).
• development of drug-induced Cushing's syndrome due to systemic absorption of the drug. Medical advice should be sought if the patient develops swelling and weight gain, particularly noticeable in the trunk and face, as these are usually the first signs of a condition called Cushing's syndrome. Adrenal suppression may occur following discontinuation of prolonged or intensive treatment with Maxitrol. Medical advice should be sought before deciding to stop treatment. This risk is particularly significant in children and in patients treated with ritonavir or cobicistat.
• If signs of eye infection appear or worsen, medical advice should be sought immediately. Patients using Maxitrol may have reduced resistance to eye infections, including bacterial and fungal infections resistant to antibiotic treatment.
• In patients using both corticosteroids and nonsteroidal anti-inflammatory drugs simultaneously, impaired healing of ocular surface injuries may occur.
• If the patient has diseases causing thinning of the cornea or sclera, this should be reported to the doctor.
• Wearing contact lenses is not recommended during treatment of eye inflammation or infection.

If the patient experiences blurred vision or other visual disturbances, medical advice should be sought.
If the patient has glaucoma, treatment duration should be limited to two weeks unless otherwise directed by the doctor.
The medicine should be used for as long as directed by the doctor. If symptoms worsen or do not improve, medical advice should be sought.
Children
The safety and efficacy of Maxitrol in children have not been established; therefore, use in this age group is not recommended.
Maxitrol and other medicines
Inform the doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient intends to use, including those available without a prescription.
Particular attention should be paid to informing the doctor if the patient is taking:

• topical nonsteroidal anti-inflammatory drugs. Concomitant topical use of steroid and nonsteroidal anti-inflammatory medicines may impair healing of eye injuries;
• ritonavir or cobicistat, as they may increase blood levels of dexamethasone.

If the patient is using other eye drops or ointments simultaneously, at least a 5-minute interval should be maintained between administration of each medicine. Eye ointments should be administered last.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
This medicine is not recommended during pregnancy or breastfeeding.
Driving and operating machinery
Maxitrol has no or negligible effect on the ability to drive or operate machinery.
Vision may be blurred for a short time after instillation of Maxitrol. Driving and operating machinery should be avoided until this effect subsides.
Maxitrol contains methylparaben (E 218) and propylparaben (E 216), which may cause allergic reactions.
The medicine contains lanolin, which may cause local skin reactions (e.g., contact dermatitis).

3. How to use Maxitrol

Maxitrol must always be used exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Maxitrol is intended exclusively for ophthalmic use; each container should be used by only one patient.
If you are using other eye drops or eye ointments at the same time, wait at least 5 minutes between applications of different medications. Eye ointments should be applied last.

Recommended dose
Typically, a small amount of ointment (a strip about 1.5 cm long) should be instilled into the conjunctival sac of the affected eye(s) 3 or 4 times daily. Your doctor will determine the duration of treatment. Do not discontinue treatment prematurely.

1 2

1. Prepare the Maxitrol tube and a mirror.
2. Wash your hands.
3. Unscrew the cap from the tube.
4. Hold the tube between your thumb and index finger.
5. Tilt your head backward. Gently 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 into this pocket (Figure 1).
6. Bring the tip of the tube close to the eye. A mirror may be used to assist.
7. Do not let the tip of the tube touch the eye, eyelids, surrounding areas, or any other surfaces. Failure to follow this instruction may result in contamination of the ointment.
8. Gently squeeze the tube to extrude the ointment strip (Figure 2).
9. After applying Maxitrol ointment, release the lower eyelid and blink several times to help spread the ointment over the entire surface of the eye. Gently close the eyelids for a few seconds; this helps reduce systemic absorption of the medication.
10. If treatment of both eyes is necessary, repeat the above steps for the second eye.
11. Immediately after use, tightly replace the cap on the tube.
12. Only one tube should be used at any given time.

If the ointment is accidentally extruded outside the eye, repeat the procedure to correctly apply the ointment into the eye.

Using more Maxitrol than recommended
In case of overdose: Flush the eye with lukewarm water to remove excess ointment. Do not apply further ointment until the next scheduled dose.

If you forget to use the medicine
If you miss a dose, apply the next dose as scheduled. However, if it is almost time for the next dose, skip the missed dose and return to your regular dosing schedule. Do not use a double dose to make up for a missed dose.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will get them.
If the patient experiences allergic reactions, including rash, swelling of the face, lips, tongue and (or)
throat, which may cause difficulty in breathing or swallowing, or if other serious adverse reactions occur,
treatment with Maxitrol should be stopped immediately and the patient should contact a doctor or
the Emergency Department of the nearest hospital without delay.

The following adverse reactions have been observed during treatment with Maxitrol:

Not common (may occur in up to 1 in 100 patients): corneal inflammation, increased intraocular pressure, eye itching, eye discomfort, eye irritation.

Frequency unknown (frequency cannot be estimated from the available data): hypersensitivity, headache, corneal ulceration, blurred vision, photophobia, pupil dilation, eyelid drooping, eye pain, eye swelling, foreign body sensation in the eye, eye hyperaemia, increased tearing, severe skin reactions (Stevens-Johnson syndrome), blurred vision; excessive body hair growth (particularly in women), muscle weakness and loss of muscle mass, purple striae on the skin, increased blood pressure, irregular menstruation or absence of menstruation, changes in protein and calcium levels in the body, growth suppression in children and adolescents, and fluid retention with weight gain, particularly noticeable in the trunk and face (a condition known as Cushing's syndrome) (see section 2 "Warnings and precautions").

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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 adverse reactions helps to provide more information on the safety of this medicine.

If any of the symptoms worsen or if new adverse reactions not mentioned in this leaflet occur, inform your doctor promptly.

5. How to store Maxitrol medicine

To avoid contamination, discard the tube with any remaining medicine 15 days after the first opening.
Please record the date of first opening below.
Date of first opening:……………………….
Keep the medicine out of sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Maxitrol contains
The active substances in this medicine are:
Dexamethasone 1 mg/g
Neomycin sulfate 3500 i.u./g
Polymyxin B sulfate 6000 i.u./g

The excipients are:
Methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), lanolin, vaseline.

What the medicine looks like and contents of the pack
Maxitrol is a greasy, translucent or opaque, white or slightly yellowish, homogeneous ointment free from lumps.
It is available in tubes containing 3.5 g, equipped with a plastic tip and cap.

For more detailed information, please contact the Marketing Authorisation Holder or the parallel importer.

Marketing Authorisation 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.
Zbąszyńska Street 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska Street 3
91-342 Łódź
Poland

Marketing Authorisation number in France, the country of export:
319 835-6
34009 319 835 6 9

Parallel import licence number: 370/19