Maxitrol

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Maxitrol, (1 mg + 3500 i.u. + 6000 i.u.)/g, ophthalmic ointment
Dexamethasonum + Neomycini sulfas + Polymyxini B sulfas
Please read the following information 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 give it 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 the 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 package and other information

1. What Maxitrol is and what it is used for

Maxitrol is used to treat inflammatory eye diseases, which may be associated with infection.
Eye inflammation may be caused by infection or by other agents 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 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 topical use in the eyes only.

• Some patients may experience hypersensitivity to topically applied aminoglycoside antibiotics such as neomycin. If symptoms of hypersensitivity occur, treatment should be discontinued and medical advice should be 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 topical or systemic antibiotics from the same class (aminoglycosides).
• In addition, topical use of neomycin may cause redness, irritation, and a sensation of 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 ocular corticosteroids 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 paediatric 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. those with diabetes).
• development of drug-induced Cushing's syndrome due to systemic absorption of the medicine. 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 known as Cushing's syndrome. Adrenal suppression may occur following discontinuation of prolonged or intensive treatment with Maxitrol. Medical advice should be sought before stopping 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 antibiotic-resistant bacterial and fungal infections.
• In patients using corticosteroids and non-steroidal anti-inflammatory drugs (NSAIDs) simultaneously, impaired healing of ocular surface injuries may occur.
• If the patient has diseases leading to thinning of the cornea or sclera, this should be reported to the doctor.
• Wearing contact lenses is not recommended during treatment for 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 advised by a physician.
The medicine should be used for as long as prescribed 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 your doctor or pharmacist about all medicines the patient is currently using or has recently used, as well as any medicines the patient plans to use, including those available without a prescription.
Particular attention should be paid if the patient is using:

• topical non-steroidal anti-inflammatory drugs (NSAIDs). Concurrent topical use of a steroid and a non-steroidal anti-inflammatory drug may impair healing of eye injuries;
• ritonavir or cobicistat, as these may increase systemic levels of dexamethasone.

If the patient is using other eye drops or ointments simultaneously, at least a 5-minute interval should be maintained between the administration of each medicine. Eye 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 become pregnant, she should consult her 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 influence on the ability to drive and operate machinery.
However, vision may be blurred for a short time after instillation of Maxitrol. Driving and operating machinery should be avoided until this symptom resolves.

Maxitrol contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (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 exactly as directed by the physician. If in doubt, consult a doctor or pharmacist.
Maxitrol is intended exclusively for ophthalmic use; each container should be used by only one patient.
If the patient is using other eye drops or ointments simultaneously, at least a 5-minute interval should be maintained between the administration of each product. Ointments should be applied last.

Recommended dose
Typically, a small amount of ointment (a strip approximately 1.5 cm long) should be instilled into the conjunctival sac of the affected eye(s) up to 3 or 4 times daily. The duration of treatment will be determined by the physician. 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, adjacent surfaces, 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 surface of the eye. Gently close the eyelids for a few seconds; this may help reduce systemic absorption of the drug.

10. If treatment of both eyes is necessary, 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 properly administer the ointment into the eye.
Use of more than the recommended dose of Maxitrol ointment
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 of Maxitrol
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 return to 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 effects

Like all medicines, this medicine can cause adverse effects, 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 other serious adverse effects occur,
discontinue use of Maxitrol immediately and contact a doctor or the nearest hospital Emergency Department
without delay.
The following adverse effects have been observed during use of Maxitrol:
Not common ( may occur in up to 1 in 100 patients ): keratitis, increased intraocular pressure, eye itching,
sensation of discomfort in the eye, eye irritation.
Frequency not known ( frequency cannot be estimated from available data ): hypersensitivity, headache,
corneal ulceration, blurred vision, photophobia, pupil dilation, eyelid drooping, eye pain, eye swelling,
sensation of foreign body in the eye, eye hyperaemia, excessive tearing, severe skin reactions (Stevens-Johnson syndrome),
blurred vision; increased body hair growth (especially 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 oedema 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 effects
If any adverse effects occur, including any not listed in this leaflet, inform a doctor, pharmacist or nurse.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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 adverse effects helps to provide more information on the safety of this medicine.
If any of the symptoms worsen or if other adverse effects not mentioned in this leaflet occur, inform a doctor promptly.

5. How to store Maxitrol medicine

To avoid contamination, discard the tube with any remaining medicine 4 weeks after first opening.
Please record the date of first opening below.
Date of first opening:
Keep the medicine out of sight and reach of children.
Store below 25°C.
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 in use. This will help protect the environment.

6. Contents of the package and other information

What the medicinal product 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, white
vaseline.

What the medicinal product looks like and contents of the pack
Maxitrol is a greasy, semi-transparent or opaque, white or slightly yellowish, homogeneous,
lump-free ointment.
It is available in an aluminum tube of 3.5 g with a polyethylene cap, packed in a cardboard box.
For more detailed information, please contact the responsible entity or the parallel importer.

Marketing Authorisation Holder in the Czech Republic, country of export:
Novartis s.r.o.
Na Pankráci 1724/129
140 00 Prague 4
Czech Republic

Manufacturer:
Novartis Pharma GmbH, Roonstrasse 25 and Obere Turnstrasse 8-10, 90429 Nuremberg, Germany
Siegfried El Masnou, S.A., Camil Fabra, 58, 08320 El Masnou, Barcelona, Spain
Novartis Farmacéutica, S.A., Gran Via de les Corts Catalanes 764, 08013 Barcelona, Spain

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged in:
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw

Marketing Authorisation Number in the Czech Republic, country of export: 64/630/70-C
Parallel Import Licence Number: 213/19