Maxitrol

Package leaflet: Information for the patient

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

• Keep this leaflet, so that you may read it again if necessary.
• If you have any questions, please 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 you experience 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, which may be accompanied by infection.
Eye inflammation may result from infection, other agents entering the eye, or eye injury.
Maxitrol is a combination medicine containing antibacterial components and a corticosteroid.
Corticosteroids (in this case dexamethasone) are used to prevent and reduce inflammatory conditions of the eye. 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 (chickenpox), or any other viral eye infection,
• fungal eye infection,
• untreated parasitic eye infections,
• tuberculous eye infection,
• untreated purulent eye infections.

Warnings and precautions
For ophthalmic use only

• Some patients may develop hypersensitivity to topically applied aminoglycoside antibiotics such as neomycin. If symptoms of hypersensitivity occur, discontinue use of the medicine and contact a doctor immediately (see section 4). Hypersensitivity reactions may manifest as local itching or redness of the skin, severe allergic reactions (anaphylactic reactions), or serious skin reactions. Such skin reactions may also occur during treatment with other topical or systemic antibiotics from the same class (aminoglycosides).
• In addition, topical use of neomycin may cause redness, irritation, and a sensation of skin discomfort.
• 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 corticosteroids in the eye for prolonged periods, the following may occur:
• elevated intraocular pressure. Intraocular pressure should be monitored regularly during treatment with this medicine. 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. Consult a doctor, especially in the case of children. The risk of elevated intraocular pressure and/or cataract is also higher in predisposed patients (e.g., patients with diabetes).
• development of drug-induced Cushing's syndrome due to systemic absorption of the medicine. Seek medical advice 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. Consult a doctor 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, contact a doctor 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 (NSAIDs) simultaneously, impaired healing of ocular surface damage may occur.
• If the patient has conditions leading to thinning of the cornea or sclera, inform the doctor.
• It is not recommended to wear contact lenses during treatment of eye inflammation or eye infection.

If the patient experiences blurred vision or other visual disturbances, contact a doctor.
If the patient has glaucoma, treatment duration should be limited to two weeks unless otherwise directed by a doctor.
The medicine should be used for as long as the doctor has instructed. If symptoms worsen or do not improve, consult a doctor.

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
Tell your doctor or pharmacist about all medicines the patient is currently using or has recently used, including over-the-counter medicines, and any medicines the patient plans to use.
Particularly inform the doctor if the patient is taking:

• topical non-steroidal anti-inflammatory drugs (NSAIDs). Concurrent topical use of a steroid medicine and a non-steroidal anti-inflammatory drug may lead to impaired 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, wait at least 5 minutes between administration of each medicine. Ophthalmic ointments should be applied 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 using machines
Maxitrol has no or negligible effect on the ability to drive and operate machinery.
However, vision may be blurred for a short time after instillation of Maxitrol. Do not drive or operate machinery until this effect has subsided.

Maxitrol contains methylparahydroxybenzoate (E 218) and propylparahydroxybenzoate (E 216), which may cause allergic reactions (including delayed-type 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 physician. If in doubt, consult your doctor or pharmacist.
Maxitrol is intended exclusively for ophthalmic use; each package should be used by only one patient.
If the patient is using other eye drops or eye ointments simultaneously, at least a 5-minute interval should be maintained between the administration of each medication. Eye ointments should be applied last.

Recommended dosage
Typically, a small amount of ointment 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 therapy 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 and 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 here (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 surface. Failure to follow this instruction may result in contamination of the ointment.
8. Gently squeeze the tube to extrude a strip of ointment (Figure 2).
9. After applying Maxitrol ointment, release the lower eyelid and blink several times to help spread the ointment over the entire eye surface. Gently close the eyelids for a few seconds; this helps reduce systemic absorption of the drug.
10. If treatment of both eyes is required, repeat the above steps for the second eye.
11. Immediately recap the tube after use.
12. Only one tube should be used at a time.

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

Use of more Maxitrol than recommended
In case of overdose: Excess ointment can be rinsed from the eye with lukewarm water. Do not apply further ointment until the next scheduled dose.

Missed dose
If a dose is missed, apply the next scheduled dose as planned. However, if it is almost time for the next dose, skip the missed dose and continue with the 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 may cause adverse reactions, although not everyone will experience 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,
discontinue use of Maxitrol immediately and contact a doctor or the nearest hospital Emergency Department
immediately.

The following adverse reactions have been observed during treatment with Maxitrol:
Not common (may occur in no more than 1 in 100 patients): corneal inflammation, increased intraocular pressure, eye itching, sensation of eye discomfort, eye irritation.
Frequency unknown (frequency cannot be estimated from available data): hypersensitivity, headache, corneal ulcerative keratitis, blurred vision, photophobia, pupil dilation, eyelid drooping, eye pain, eye swelling, sensation of foreign body in the eye, eye hyperemia, excessive tearing, severe skin reactions (Stevens-Johnson syndrome), blurred vision; excessive increase in body hair growth (especially in women), muscle weakness and loss of muscle mass, purple skin striae, 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 swelling and 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, pharmacist, or nurse. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions at 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
Adverse reactions can also be reported to the Marketing Authorisation Holder or parallel importer.
Reporting adverse reactions helps to provide more information on the safety of this medicine.
If any of the symptoms worsen or if any other adverse reactions not mentioned in this leaflet occur, inform your doctor.

5. How to store Maxitrol

To avoid contamination, discard the tube with any remaining medicine 15 days after first opening.
Please record the date of first opening below.
Date of first opening:……………………….
Keep the medicine out of the 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. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Maxitrol contains
The active substances 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 Maxitrol 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 epoxy lacquered aluminum tubes with an internal coating, containing 3.5 g, equipped with an applicator made of HDPE or a mixture of HDPE/LDPE and an HDPE cap, packed in a cardboard box.

For further information, please contact the marketing authorization holder or the parallel importer.

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:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw
Poland

Repackaged in:
CEFEA Sp. z o.o. Sp. Synoptis Industrial Sp. z o.o. Shiraz Productions Sp. z o.o.
spółka komandytowa ul. Forteczna 35-37 ul. Tymiankowa 24/28
ul. Działkowa 56 87-100 Toruń 95-054 Ksawerów
02-234 Warsaw
Poland

Marketing Authorization Number in France, the country of export: 34009 319 835 6 9
319 835-6

Parallel Import License Number: 7/25