Maxitrol

Package leaflet: Information for the patient

Warning! Please keep the leaflet. Information on the immediate packaging in a foreign language.
Maxitrol
(1 mg + 3500 IU + 6000 IU)/g, ophthalmic ointment
Dexamethasonum + Neomycini sulfas + Polymyxini B sulfas
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Please keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, 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 someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

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.
Inflammation of the eye may be caused by infection or by other agents entering the eye, or by eye injury.
Maxitrol is a combination medicine containing antibacterial components 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, 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 ocular use only.

• Some patients may develop hypersensitivity to topically applied aminoglycoside antibiotics such as neomycin. If symptoms of hypersensitivity occur, discontinue use 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 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 long-term, 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. 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. diabetic patients).
  • development of drug-induced Cushing's syndrome due to systemic absorption. Seek medical advice if the patient develops swelling and increased body weight, 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 relevant 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 (NSAIDs) simultaneously, impaired healing of ocular surface damage 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, 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.

Maxitrol with other medicines
Inform the doctor or pharmacist about all medicines currently used, recently taken, or planned for use, including over-the-counter medicines.
Particularly inform the doctor if the patient is taking:

• topically acting 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 these 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. 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 operating machinery
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 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 as directed by the physician. If in doubt, consult a 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 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. Prepare the Maxitrol tube and a mirror.
2. Wash your hands.
3. Unscrew the cap of the tube.
4. Hold the tube in your hand, between the 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 touch the eye, eyelids, adjacent areas, or any other surfaces with the tip of the tube. Failure to follow this instruction may result in contamination and infection 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. Close the eyelids gently 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 of medication should be used at a time.

If the ointment is extruded outside the eye, repeat the application attempt correctly into the eye.
Use of more than the recommended dose of Maxitrol
In case of overdose, excess medication can be rinsed from the eye with lukewarm water. Do not use the ointment again 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 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,
treatment with Maxitrol should be discontinued immediately and the patient should contact a doctor or
the nearest hospital Emergency Department without delay.
The following adverse reactions have been observed during treatment with Maxitrol:
Not common (may affect up to 1 in 100 patients): keratitis, increased intraocular pressure, eye itching,
sensation of eye discomfort, eye irritation.
Frequency unknown (cannot be estimated from available data): hypersensitivity, headache, ulcerative
keratitis, blurred vision, photophobia, pupil dilation, eyelid drooping, eye pain, eye swelling, sensation of
a foreign body in the eye, eye hyperaemia, excessive tearing, severe skin reactions (Stevens-Johnson
syndrome), blurred vision; increased 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 oedema with increased body weight, 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, patients should inform their doctor,
pharmacist or nurse. Adverse reactions can also 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 the medicine.
If any of the symptoms worsen, or if any other adverse reactions not mentioned in this leaflet occur,
patients should inform their doctor.

5. How to store Maxitrol medicine

To avoid infections, the tube containing the remaining medicine should be discarded 4 weeks after first opening.
The date of first opening should be recorded below.
Date of first opening:
Keep the medicine out of sight and reach of children.
Store below 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 must not be disposed of via sewage systems or household waste bins. 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 excipients 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 particles.
It is available in a 3.5 g aluminium tube lined with epoxy-phenolic resin, with a PE applicator and 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, country of export:
Novartis Hrvatska d.o.o., Radnička cesta 37b, 10 000 Zagreb, Croatia

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

Parallel Importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Marketing Authorisation Number in Croatia, country of export: HR-H-641598573-01
Parallel Import Licence Number: 255/23