Maxitrol

Patient leaflet: information for the patient ATTENTION: Keep this leaflet

Information on the outer packaging in a foreign language.
Maxitrol (Maxidrol), (1 mg + 3500 i.u. + 6000 i.u.)/ml, eye drops
(Dexamethasone + Neomycin sulfate + Polymyxin B sulfate)
Maxitrol and Maxidrol are different trade names for the same medicinal product.
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, 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 others, 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 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.
Eye inflammation may be caused by infection, other agents entering the eye, or eye injuries.
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 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, chickenpox, or any other viral eye infection, fungal eye infection, untreated parasitic eye infection, tuberculous eye infection, or untreated purulent eye infection.

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 reaction), or severe skin reactions. Such skin reactions may occur during use of 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 product. This is particularly important in pediatric 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. 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 known as 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 develop 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 causing 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 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.

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 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 administration of each medicine. 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 eye drops have no 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 milliliter (0.04 mg/ml).
Benzalkonium chloride may be absorbed by soft contact lenses and may alter their color. Contact lenses should be removed before instillation and at least 15 minutes should elapse before reinsertion.
Benzalkonium chloride may also cause eye irritation, particularly 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 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 discarded before using the medicinal product.
It is recommended to close the eyelid and gently press with a finger on the nasolacrimal duct (tear duct). This helps reduce absorption of the medicinal product 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 given every hour. The dosage 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 2 3 4

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, gripping it between your thumb and middle finger (Figure 1).
6. Tilt your head backward. Gently pull down the lower eyelid with a clean finger to form a "pocket" between the eyelid and the eyeball—this is where 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 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 on the inner corner of the eye near the nose (Figure 4). This helps prevent the medication from entering 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, tightly replace the cap on the bottle.
13. Only one bottle of medication should be used at a time.

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

Accidental overdose of Maxitrol
In case of local overdose of Maxitrol, 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 dose as scheduled. However, if it is almost time for the next dose, skip the missed dose and resume the regular dosing schedule. Do not take a double dose to make up for a missed one.

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 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 must 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): 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, dilated pupils, drooping eyelid, eye pain, eye swelling, sensation of foreign body in the eye, eye hyperaemia, excessive tearing, severe skin reactions (Stevens-Johnson syndrome), blurred vision, excessive growth of body hair (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 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 adverse effects not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions 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 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, inform a doctor immediately.

5. How to store Maxitrol

To avoid contamination of the drops, discard the bottle 15 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.
Do not store above 25°C.
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 after EXP.
The expiry date refers to the last day of the stated month.
The batch number on the packaging is marked as "Lot".
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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 i.u./ml
Polymyxin B sulfate 6000 i.u./ml

The other components are: sodium chloride, polysorbate 20, benzalkonium chloride, hypromellose, diluted hydrochloric acid and/or sodium hydroxide to adjust pH, purified water.

What Maxitrol looks like and contents of the pack
Maxitrol eye drops are a white to slightly yellow, opaque suspension.
It is available in PE bottles containing 3 ml or 5 ml of eye drops, packed in a cardboard carton.

For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in France, country of export:
Novartis Pharma S.A.S., 8-10 Rue Henri Sainte-Claire Deville, 92500 Rueil-Malmaison, France

Manufacturer:
S.A. Alcon-Couvreur N.V., Rijksweg 14, 2870 Puurs, 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
NOVARTIS PHARMA GmbH, Roonstrasse 25, 90429 Nuremberg, Germany

Parallel Importer:
PharmaVitae Sp. z o.o. sp. k., ul. E. Orzeszkowej 3/35, 59-820 Leśna

Repackaged in:
CEFEA Sp. z o.o. Sp. komandytowa, ul. Działkowa 56, 02-234 Warsaw
Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warsaw
Synoptis Industrial Sp. z o.o., ul. Szosa Bydgoska 58, 87-100 Toruń
Prespack Jacek Karoński, ul. Św. Wawrzyńca 34, 60-541 Poznań

Marketing Authorisation Number in France, country of export:
34009 306 525 34
306 525-3
331 482-2
34009 331 482 2 5

Parallel Import Licence Number: 167/18