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
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 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 any adverse reactions 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 that may be associated with infection.
Ocular inflammation may be caused by infection or 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 ocular 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 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 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:
  • increased 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 higher 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. Consult a doctor if the patient develops swelling and weight gain, particularly 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 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, 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 injuries may occur.
• If the patient has diseases causing thinning of the cornea or sclera, 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 advised 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.

Maxitrol with other medicines
Inform the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription, as well as any medicines the patient plans to use.
Particularly inform the doctor if the patient is taking:

• topically acting non-steroidal anti-inflammatory drugs (NSAIDs). Concurrent topical use of a steroid 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 administering each medicine. Eye ointments should be used 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. The medicine is not recommended during pregnancy or breastfeeding.

Driving and operating machinery
Maxitrol has no effect or has a negligible effect on the ability to drive and operate machinery.
However, vision may be blurred for a short time after administration of Maxitrol. Do not drive or operate machinery 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 your doctor. If in doubt, consult your doctor or pharmacist.
Maxitrol is intended exclusively for ophthalmic use; each tube should be used by only one patient.
If you are using other eye drops or ointments at the same time, wait at least 5 minutes between applications. 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) up to 3 or 4 times daily. Your doctor will determine the duration of treatment. 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 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 should be placed into this pocket (Figure 1).
6. Bring the tip of the tube close to the eye; you may use a mirror 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 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 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 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 you miss a dose, apply the next dose as scheduled. However, if it is almost time for the next dose, skip the missed dose and return to your 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 if other serious adverse effects 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 effects have been observed during treatment with 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 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 hyperaemia, 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 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 effects

If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can also be reported directly to the Department of Monitoring 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 effects helps to provide more information on the safety of this medicine.

If any of the symptoms worsen or if any other adverse effects not mentioned in this leaflet occur, inform your doctor.

5. How to store Maxitrol

To avoid infections, 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 the sight and reach of children.
Do not store above 25°C. Do not store in the refrigerator.
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 packaging 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), anhydrous 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 a 3.5 g tube with a screw cap, packed in a cardboard box.
For further information, please contact the responsible entity or the parallel importer.

Marketing Authorisation Holder in Belgium, the country of export:
Novartis Pharma NV, Medialaan 40, B-1800 Vilvoorde, Belgium

Manufacturers:
Siegfried El Masnou, Camil Fabra 58, 08320 El Masnou, Barcelona, Spain
SA Alcon-Couvreur NV, Rijksweg 14, B-2870 Puurs, Belgium
Novartis Pharma GmbH, Roonstrasse 25, 90429 Nuremberg, Germany
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

Belgium, country of export, Marketing Authorisation Number: BE092145
Parallel Import Authorisation Number: 2/23