Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging is 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 medicine.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet so that you can 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 share it with others. This medicine may harm another person, even if their symptoms are the same.
If you experience any adverse effects, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

What Maxitrol is and what it is used for
Important information before using Maxitrol
How to use Maxitrol
Possible side effects
How to store Maxitrol
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 associated with
infection.
Eye inflammation may be caused by infection, other agents entering the eye, or 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 (chickenpox), 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 ocular 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 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 corticosteroids in the eye for prolonged periods, the following may occur:
increased 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 increased 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. Contact a doctor 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 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 bacterial and fungal infections resistant to antibiotic treatment.
In patients using corticosteroids together with non-steroidal anti-inflammatory drugs (NSAIDs), problems with healing of ocular surface damage 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 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, use in this age group is not recommended.

Other medicines and Maxitrol
Inform the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription.
Particular attention should be given if the patient is using:

topically acting 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 these may increase blood levels of dexamethasone. If the patient is using other eye drops or ointments, at least a 5-minute interval should be maintained between 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 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 influence on the ability to drive and operate machinery.
Vision may be blurred for a short time after instillation of Maxitrol. Do not drive or operate machinery until this effect has passed.

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 must always be used 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 eye ointments simultaneously, at least a 5-minute interval 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.

Hand holding a small bottle with an applicator, dispensing drops of medication directly into the patient's eye, just above the lower eyelid

1 2

Prepare the Maxitrol tube and a mirror.
Wash your hands.
Unscrew the cap of the tube.
Hold the tube in hand, gripping it between the thumb and index finger.
Tilt the head backward. Gently pull down the lower eyelid with a clean finger to create a "pocket" between the eyelid and the eyeball. The ointment strip should be placed into this pocket (Figure 1).
Bring the tip of the tube close to the eye; a mirror may be used to assist.
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.
Gently squeeze the tube to extrude the ointment strip (Figure 2).
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 minimize systemic absorption of the drug.
If treatment of both eyes is required, repeat the above steps for the second eye.
Immediately recap the tube after use.
Only one tube of medication 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
In case of overdose, excess ointment can be rinsed from the eye with lukewarm water. Do not use the ointment again until the next scheduled dose.

Missed dose of Maxitrol
If a dose is missed, apply the next scheduled dose as planned. However, if the next dose is due shortly, 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody 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 side effects occur,
discontinue use of Maxitrol and contact a doctor or the nearest hospital Emergency Department immediately.
The following side effects have been observed during use of Maxitrol:
Not common ( may occur in up to 1 in 100 patients ): corneal inflammation, increased intraocular pressure, eye itching, sensation of eye discomfort, eye irritation.
Frequency not known ( frequency cannot be estimated from the 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 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 swelling and 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 side effects
If any side effects occur, including any side effects not listed in this leaflet, inform a doctor, pharmacist or nurse. Side effects can also 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 side effects helps to provide more information on the safety of this medicine.

5. How to store Maxitrol medicine

To avoid contamination, discard the tube with any remaining medicine 15 days 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.
Keep the packaging 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 other components 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 aluminium tubes of 3.5 g with an applicator, packed in a cardboard box.
For further 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:
Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany
Novartis Manufacturing NV
Rijksweg 14
2870 Puurs-Sint-Amands
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

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

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation Number in France, the country of export: 319 835-6
Parallel Import Licence Number: 838/15