Maxitrol

Package leaflet: Information for the patient

Caution! Keep the leaflet. Information on the immediate packaging in a foreign language.
Maxitrol
(1 mg + 3500 i.u. + 6000 i.u.)/ml, eye drops, suspension
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 for future reference.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including those 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 for the treatment of inflammatory eye diseases, which 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 drops (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 components 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 infection.

Warnings and precautions
For ocular use only.

• Some patients may experience 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 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 discomfort of the skin.
• Patients who have experienced hypersensitivity reactions to topical neomycin may also develop hypersensitivity 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 of intraocular pressure may be more pronounced and occur earlier in children than in adults. Consult a doctor, especially for children. The risk of increased 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. 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 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 nonsteroidal anti-inflammatory drugs simultaneously, 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.

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 prescribed 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 and other medicines
Inform the doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient plans to use, including those available without prescription.
Particularly inform the doctor if the patient is taking:

• topically acting nonsteroidal anti-inflammatory drugs. Concurrent topical use of steroid and nonsteroidal anti-inflammatory medicines 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 simultaneously, at least a 5-minute interval should be maintained between administrations 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.
For a short time after administration of Maxitrol, vision may be blurred. Do not drive or operate machinery until this symptom resolves.

Maxitrol eye drops contain benzalkonium chloride
The medicine contains 0.04 mg of benzalkonium chloride per millilitre (0.04 mg/ml).
Benzalkonium chloride may be absorbed by soft contact lenses and may alter their colour. Contact lenses should be removed before instillation and at least 15 minutes should elapse before reinsertion.
Benzalkonium chloride may also cause eye irritation, especially in individuals with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If abnormal sensations, stinging, or pain in the eye occur after using the medicine, contact a doctor.

3. How to use Maxitrol

Maxitrol must always be used exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Maxitrol is intended only for instillation into the eye; each container should be used by one patient only.
If the safety collar is loose after removing the cap, it should be removed before using the medicine.
It is recommended to close the eyelid and gently press with a finger on the nasolacrimal duct (tear duct). This helps reduce the amount of medicine absorbed into the bloodstream after instillation into the eye.

Recommended dose
For mild conditions, instill one to two drops into the conjunctival sac(s) four to six times daily.
For severe conditions, instill one to two drops every hour. The dose should then be gradually reduced, and treatment discontinued after symptoms of inflammation have resolved.
Your doctor will determine the duration of treatment. Do not stop treatment prematurely.

1. Prepare the Maxitrol bottle and a mirror.
2. Wash your hands.
3. Shake the bottle.
4. Unscrew the cap.
5. Hold the bottle in your hand with the bottom facing upwards, grasping it between your thumb and middle finger (Figure 1).
6. Tilt your head backward. Pull the lower eyelid downward gently with a clean finger to form a "pocket" between the eyelid and the eyeball, into which the drop should be instilled (Figure 2).
7. Bring the tip of the dropper close to the eye. A mirror may be used to assist.
8. Do not touch the dropper tip to the eye, eyelid, surrounding area, or any other surface. Failure to follow this instruction may result in contamination of the drops.
9. Gently squeeze the bottom of the bottle to release a single drop of Maxitrol (Figure 3).
10. After instilling Maxitrol, remove the finger holding the lower eyelid. Close the eye and press gently with a finger at the inner corner of the eye near the nose (Figure 4). This helps prevent the medicine from being absorbed into the rest of the body.
11. If drops are required in both eyes, repeat the above steps for the other eye.
12. Immediately after use, replace the cap on the bottle.
13. Only one bottle of medicine should be used at a time.

If the drop misses the eye, repeat the procedure to correctly instill the drop.

Accidental overdose of Maxitrol eye drops
In case of local overdose, rinse the eye(s) with lukewarm water.
Do not use further drops until the next scheduled dose.

Missed dose of Maxitrol
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 continue with the regular dosing schedule. Do not take 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 all medicines, this product may cause adverse reactions, although not everyone experiences them.
If the patient develops allergic reactions, including rash, swelling of the face, lips, tongue and
(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:
Uncommon ( may occur in not more than 1 in 1,000 patients ): keratitis, increased intraocular pressure, eye itching, eye discomfort, eye irritation.
Frequency not known ( frequency cannot be estimated from the available data ): hypersensitivity, headache, corneal ulceration, blurred vision, photophobia, pupillary dilation, ptosis, eye pain, eye swelling, sensation of foreign body in the eye, eye hyperaemia, excessive tearing, severe skin reactions (Stevens-Johnson syndrome), blurred vision, marked increase in 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 fluid retention 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 reactions
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department for Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 effects not mentioned in this leaflet occur, inform your doctor.

5. How to store Maxitrol medicine

To avoid contamination of the drops, the bottle should be discarded 4 weeks after first opening.
The date of first opening of the bottle should be recorded in the space indicated below.
Date of first opening: ……….
Keep the medicine out of the sight and reach of children.
Store below 25°C. Do not store in the refrigerator and do not freeze.
Store the bottle in an upright position. Keep the bottle 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 pack and other information

What Maxitrol contains
The active substances are:
Dexamethasone 1 mg/ml
Neomycin sulfate 3500 IU/ml
Polymyxin B sulfate 6000 IU/ml

The other components (excipients) are:
sodium chloride, polysorbate 20, benzalkonium chloride solution, hypromellose (E 464), purified water.
Minimal amounts of concentrated hydrochloric acid and/or sodium hydroxide may be added to adjust and maintain the pH within normal range.

What Maxitrol looks like and contents of the pack
Maxitrol eye drops are an opaque suspension, white to pale yellow in colour.
It is available in a 5 ml LDPE bottle with an LDPE dropper and a PP cap, packed in a cardboard box.

For further information, please contact the responsible party or the parallel importer.

Responsible party 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
Novartis Pharma GmbH
Roonstrasse 25, D-90429 Nuremberg, Germany
Siegfried El Masnou S.A.
Camil Fabra, 58, El Masnou, 08320 Barcelona, Spain
Novartis Farmacéutica S.A.
Gran Vía 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 by:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Marketing Authorization number in Croatia, the country of export: HR-H-013807789-01
Parallel import authorization number: 344/22