Maxitrol

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Maxitrol
(1 mg + 3500 IU + 6000 IU)/ml, eye drops, suspension
Dexamethasone + Neomycin sulfate + Polymyxin B sulfate
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. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any 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 associated with infection.
Eye 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 eye inflammation. The antibacterial agents 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 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 infection,
• tuberculous eye infection,
• untreated purulent eye infection.

Warnings and precautions
For topical ophthalmic 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 immediately and contact a doctor (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 ophthalmic 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 children, 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. 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. Consult a doctor before deciding 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 bacterial and fungal infections resistant to antibiotic treatment.
• 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 leading to thinning of the cornea or sclera, they should inform 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, use in this age group is not recommended.

Maxitrol and other medicines
Inform the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including over-the-counter medicines.

Specifically inform the doctor if the patient is taking:

• topically acting non-steroidal anti-inflammatory drugs. Concurrent topical use of a steroid medicine 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 simultaneously, at least a 5-minute interval should be maintained between administrations of the different medicines. Eye ointments should be administered last.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, 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 effect or negligible effect 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 subsides.

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 change 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 patients with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If abnormal sensations in the eye, stinging, or eye pain occur after using the medicine, contact a doctor.

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 instillation into the eye; each container should be used by only one patient.
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
In mild conditions, one to two drops should be administered into the conjunctival sac (or sacs) four to six times daily.
In severe cases, one to two drops should be administered every hour. The dose should then be gradually reduced, and treatment discontinued once inflammatory symptoms have resolved.
Your doctor will determine the duration of treatment. Do not discontinue 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. Gently pull the lower eyelid downward with a clean finger to form a "pocket" between the eyelid and the eyeball, into which the drop should be placed (Figure 2).
7. Bring the dropper tip close to the eye. A mirror may be used to assist.

8. Do not touch the dropper tip to the eye, eyelid, surrounding areas, 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 instillation, remove the finger used to hold 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 draining into the rest of the body.
11. If drops are required in both eyes, repeat the above steps for the second 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 of Maxitrol, rinse the eye(s) with lukewarm water.
Do not use the medicine again until the next scheduled dose is due.

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 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,
treatment with Maxitrol should be stopped immediately and medical advice should be sought
immediately from a doctor or the nearest hospital Emergency Department.
The following side effects have been reported during treatment with Maxitrol:
Uncommon (may affect fewer than 1 in 1,000 patients): keratitis, increased intraocular pressure, eye itching,
feeling of eye discomfort, eye irritation.
Frequency not known (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 hyperaemia, excessive tearing, severe skin reactions (Stevens-Johnson syndrome), blurred vision, excessive 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 swelling 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 side effects
If any side effects occur, including any not listed in this leaflet, patients should inform their doctor, pharmacist or nurse. Side 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 4921 301, Fax: +48 22 4921 309, website: https://smz.ezdrowie.gov.pl.
Reporting side effects helps to provide more information on the safety of the medicine.
If any of the symptoms worsen or if new side effects not mentioned in this leaflet occur, patients should inform their doctor.

5. How to store Maxitrol

To avoid contamination of the drops, the bottle should be discarded 28 days after first opening.
The date of first opening should be recorded in the space provided below.
Date of first opening: …………………
Keep the medicine out of sight and reach of children.
Store below 25°C, in the original packaging.
Do not store in the refrigerator.
Keep the bottle in an upright position.
Keep the container 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/ml
Neomycin sulfate 3500 IU/ml
Polymyxin B sulfate 6000 IU/ml

The other components are:
Sodium chloride, polysorbate 20, benzalkonium chloride, hypromellose, 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 is a suspension ranging from white to pale yellow, supplied in a plastic bottle containing 5 ml, with a tamper-evident cap, packed in a cardboard box.

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

Responsible party in Romania, the country of export:
Novartis Europharm Limited
Vista Building Elm Park
Merrion Road Dublin 4
Ireland

Manufacturer:
Alcon-Couvreur NV
Rijksweg 14, 2870 Puurs, Belgium
Novartis Farmacéutica, S.A.
Gran Vía de les Corts Catalanes 764, 08013 Barcelona, Spain
Novartis Pharma GmbH
Roonstrasse 25, 90429 Nuremberg, Germany

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

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

Authorization number in Romania, the country of export: 11751/2019/01
Parallel import authorization number: 837/15