Maxitrol

Package leaflet: Information for the patient

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Maxitrol
(1 mg + 3500 i.u. + 6000 i.u.)/g, ophthalmic ointment
Dexamethasonum + Neomycini sulfas + Polymyxini B sulfas
Read the following information carefully before using the medicine, as it contains important information for the patient.
Keep this leaflet, as you may need to read it again.
If you have any doubts, 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 those not listed in this leaflet, inform a doctor or pharmacist. See section 4.
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 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 infections of the eye.

Warnings and precautions
For ocular use only

• Some patients may develop hypersensitivity to topically applied aminoglycoside antibiotics such as neomycin. If symptoms of hypersensitivity occur, treatment 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 reaction) or severe skin reactions. Such skin reactions may also occur during the use of other topical or systemic antibiotics from the same class (aminoglycosides).
• In addition, topical use of neomycin may lead to redness, irritation and 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 cause 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 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. diabetic patients).
• development of drug-induced Cushing's syndrome due to systemic absorption. 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. Medical advice should be sought before the patient decides 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 antibiotic-resistant bacterial and fungal infections.
• In patients using corticosteroids and non-steroidal anti-inflammatory drugs simultaneously, problems with healing of ocular surface damage may occur.
• If the patient has diseases causing thinning of the cornea or sclera, they should inform 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, 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 directed by the doctor. If symptoms worsen or do not improve, consult a doctor.
Children
The safety and efficacy of Maxitrol in children have not been established; therefore, its use is not recommended in this age group.
Other medicines and Maxitrol
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken or might take, including those obtained 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 lead to problems with 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 at the same time, at least 5 minutes should be left between the administration of each medicine. 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 effect or negligible effect on the ability to drive and use machines.
Vision may be blurred for a short time after instillation of Maxitrol. Do not drive or operate machinery until this effect subsides.
Maxitrol contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216), which may cause allergic reactions (delayed-type reactions possible).
The medicine contains lanolin, which may cause local skin reactions (e.g. contact dermatitis).

3. How to use Maxitrol

Maxitrol must always be used as directed by the physician. 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 the patient is using other eye drops or ointments simultaneously, a minimum interval of 5 minutes should be maintained between the administration of each product. Eye 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) 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 in hand, between thumb and index finger.
5. Tilt the head backward. Gently pull down the lower eyelid with a clean finger to form a "pocket" between the eyelid and the eyeball, into which the ointment strip should be placed (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 surfaces. 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, 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 drug.
10. If treatment of both eyes is necessary, repeat the above steps for the other 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 than the recommended dose of Maxitrol
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, take the next scheduled dose as planned. However, if it is almost time for the next dose, skip the missed dose and resume 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 any medicine, this medicine can 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
without delay.

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

Not very 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 ulceration, blurred vision, photophobia, pupil dilation, eyelid drooping, eye pain, eye swelling,
sensation of a foreign body in the eye, eye hyperemia, 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 skin striae, increased blood pressure, irregular menstruation or amenorrhea, 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 a 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 provide more information on the safety of the medicine.
If any of the symptoms worsen or if any other adverse reactions not mentioned in this leaflet occur, inform a doctor.

5. How to store Maxitrol

To avoid contamination, the tube with any remaining medicine should be discarded four weeks after first opening.
The date of first opening should be recorded 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 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 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 package 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 other components are:
Methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), lanolin, white soft paraffin.

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 3.5 g aluminium tubes with an epoxy-phenolic resin coating, equipped with a PE applicator and a PE cap, packed in a cardboard box.

For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in Croatia, the country of export:
Novartis Hrvatska d.o.o.
Radnička cesta 37b
10 000 Zagreb
Croatia

Manufacturer:
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 Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany
Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain

Parallel Importer:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Poland

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

Marketing Authorisation number in Croatia, the country of export: HR-H-641598573
Parallel Import Licence number: 196/25