Maxitrol

Package Leaflet: Information for the Patient

Warning! Keep the 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

You Should Carefully Read the Contents of the Leaflet Before Using the Medication, as it Contains Important Information for the Patient.

• You Should Keep This Leaflet, so That You Can Read it Again if Necessary.
• In Case of Any Doubts, You Should Consult a Doctor, Pharmacist, or Nurse.
• This Medication Has Been Prescribed to a Specific Person. Do Not Pass it on to Others. The Medication May Harm Another Person, Even if the Symptoms of Their Disease are the Same.
• If the Patient Experiences Any Adverse Reactions, Including Any Adverse Reactions Not Listed in This Leaflet, They Should Inform Their Doctor, Pharmacist, or Nurse. See Section 4.

Table of Contents of the Leaflet:

• 1. What is Maxitrol and What is it Used for
• 2. Important Information Before Using Maxitrol
• 3. How to Use Maxitrol
• 4. Possible Side Effects
• 5. How to Store Maxitrol
• 6. Package Contents and Other Information

1. What is Maxitrol and What is it Used for

Maxitrol is Used to Treat Inflammatory Eye Diseases, Which May be Accompanied by

Infection.Eye Inflammation can be Caused by Infection or Other Factors
Penetrating the Eye or Eye Injuries.

Maxitrol is a Combination Medication Containing Antibacterial and Corticosteroid Components.

Corticosteroids (in this Case, Dexamethasone) are Used to Prevent and Reduce
Eye Inflammation. The Antibacterial Medications 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 Allergicto Neomycin Sulfate, Polymyxin B Sulfate, Dexamethasone, or Any of the Other Components of this Medication (Listed in Section 6),
• If the Patient Has:
• Herpetic Keratitis, Chickenpox, Shingles, or Any Other Viral Eye Infection,
• Fungal Eye Infection,
• Untreated Parasitic Eye Infection,
• Tubercular Eye Infection,
• Untreated Purulent Eye Infection.

Warnings and Precautions

For Ophthalmic Use Only.

• In Some Patients, Hypersensitivity to Topically Applied Aminoglycoside Antibiotics, such as Neomycin, May Occur. If Symptoms of Hypersensitivity Occur, the Medication Should be Discontinued and the Doctor Consulted Immediately (See Section 4). Hypersensitivity Reactions May Occur in the Form of Local Itching or Skin Redness,
  Severe Allergic Reactions (Anaphylactic Reaction) or Severe Skin Reactions. Such Skin Reactions May Occur During the Use of Other Topical or Systemic Antibiotics from the Same Family (Aminoglycosides).

Additionally, Local Use of Neomycin May Lead to Redness, Irritation, and Discomfort of the Skin.

• Furthermore, Patients Who Have Experienced Hypersensitivity to Topically Applied Neomycin May Also be Hypersensitive to Other Antibiotics.
• If the Patient is Using Other Antibiotics During Treatment with Maxitrol, They Should Consult Their Doctor, as Concurrent Use of Maxitrol with Other Antibiotics May Cause Serious Side Effects.
• In Patients Using Corticosteroid Eye Drops for a Long Time, the Following May Occur: - Increased Intraocular Pressure. Intraocular Pressure Should be Regularly Monitored During Treatment with this Medication. This is Especially Important in Children, as Corticosteroid-Induced Increased Intraocular Pressure May be Greater and Occur Earlier in Children than in Adults. The Patient Should Consult Their Doctor, Especially if They Have Children. The Risk of Increased Intraocular Pressure and (or) Cataract is Also Higher in Patients with a History of Diabetes.

If the Patient Experiences Blurred Vision or Other Vision Disturbances, They Should Consult Their Doctor.
If the Patient Has Glaucoma, the Treatment Duration Should be Limited to Two Weeks, Unless the Doctor Recommends Otherwise.
The Medication Should be Used for as Long as the Doctor Recommends.If the Symptoms Worsen or Do Not Improve, the Patient Should Consult Their Doctor.

Children

The Safety and Efficacy of Maxitrol in Children Have Not Been Documented, Therefore, its Use is Not Recommended in this Age Group.

Maxitrol and Other Medications

The Patient Should Inform Their Doctor or Pharmacist About All Medications They are Currently Taking or Have Recently Taken, as Well as Any Medications They Plan to Take, Including Those Available Without a Prescription.
Particularly, the Patient Should Inform Their Doctor if They are Taking:

• Topical Non-Steroidal Anti-Inflammatory Drugs. Concurrent Topical Use of Steroid and Non-Steroid Anti-Inflammatory Drugs May Cause Problems with Wound Healing in the Eye;
• Ritonavir or Cobicistat, as They May Increase the Blood Levels of Dexamethasone.

If the Patient is Using Other Eye Drops or Ointments, They Should Wait at Least 5 Minutes Between Administrations of Different Medications. Eye Ointments Should be Used Last.

Pregnancy, Breastfeeding, and Fertility

If the Patient is Pregnant or Breastfeeding, Thinks They May be Pregnant, or Plans to Have a Child, They Should Consult Their Doctor or Pharmacist Before Using this Medication.
This Medication is Not Recommended During Pregnancy or Breastfeeding.

Driving and Using Machines

Maxitrol Has No or Negligible Influence on the Ability to Drive and Use Machines.
For a While After Administering Maxitrol, Vision May be Blurred. The Patient Should Not Drive or Use Machines Until this Symptom Resolves.

Maxitrol Eye Drops Contain Benzalkonium Chloride

The Medication Contains 0.04 mg of Benzalkonium Chloride per Milliliter (0.04 mg/ml).
Benzalkonium Chloride May be Absorbed by Soft Contact Lenses and Change Their Color. The Patient Should Remove Their Contact Lenses Before Administering the Drops and Wait at Least 15 Minutes Before Reinserting Them.
Benzalkonium Chloride May Also Cause Eye Irritation, Especially in Patients with Dry Eye Syndrome or Corneal Disorders (the Transparent Layer on the Front of the Eye). If the Patient Experiences Any Abnormal Sensations in the Eye, Stinging, or Eye Pain After Using the Medication, They Should Consult Their Doctor.

3. How to Use Maxitrol

Maxitrol Should Always be Used as Directed by the Doctor. If the Patient Has Any Doubts, They Should Consult Their Doctor or Pharmacist.
Maxitrol is Intended Exclusivelyfor Ophthalmic Use; One Package of the Medication Should be Used by OnlyOne Patient.
If the Protective Cap is Loose After Removing the Seal, it Should be Removed Before Using the Medication.
The Patient Should Close Their Eyelid and Gently Press the Nasolacrimal Duct (Tear Duct) with Their Finger. This Helps Reduce the Absorption of the Medication into the Bloodstream After Ophthalmic Administration.

Recommended Dose

In Mild Cases, One to Two Drops are Administered into the Conjunctival Sac (Sacs) Four to Six Times a Day.
In Severe Cases, One to Two Drops are Administered Every Hour. The Medication is Gradually Administered in Decreasing Doses, and its Use is Discontinued After the Inflammatory Symptoms Resolve.
The Doctor Will Determine the Duration of Treatment. The Patient Should Not Discontinue Treatment Prematurely.

• 1. Prepare the Maxitrol Bottle and a Mirror.
• 2. Wash Your Hands.
• 3. Shake the Bottle.
• 4. Remove the Cap.
• 5. Hold the Bottle in Your Hand, with the Thumb and Middle Finger, and Point it Upwards (Figure 1).
• 6. Tilt Your Head Backwards. Pull the Lower Eyelid Down with a Clean Finger to Create a "Pocket" Between the Eyelid and the Eye. The Drop Should Fall into this Pocket (Figure 2).
• 7. Bring the Tip of the Bottle Close to the Eye. You Can Use a Mirror to Help.

8. Do Not Touch the Dropper Tip to the Eye, Eyelid, or Surrounding Areas.

Failing to Follow this Instruction May Cause Infection of the Drops.

• 9. Gently Squeeze the Bottom of the Bottle to Release a Single Drop of Maxitrol (Figure 3).
• 10. After Administering the Drop, Release the Lower Eyelid and Close Your Eye. Press the Corner of Your Eye Near the Nose with Your Finger (Figure 4). This Helps Prevent the Medication from Entering the Entire Body.
• 11. If You Need to Administer Drops to Both Eyes, Repeat the Above Steps for the Second Eye.
• 12. Immediately After Using the Medication, Replace the Cap on the Bottle.
• 13. Use Only One Bottle of the Medication at a Time.

If the Drop Does Not Enter the Eye,You Should Repeat the Attempt to Administer the Drop Correctly.

Using More Maxitrol Than Recommended

In Case of Local Overdose of Maxitrol, the Eye (Eyes) Should be Rinsed with Lukewarm Water.
The Medication Should Not be Used Until the Next Scheduled Dose.

Missing a Dose of Maxitrol

If a Dose is Missed, the Next Scheduled Dose Should be Taken. However, if There is Not Much Time Left Before the Next Dose, the Missed Dose Should be Omitted and the Normal Administration Schedule Resumed. Do NotTake a Double Dose to Make Up for the Missed Dose.
If You Have Any Further Questions About Using this Medication, Consult Your Doctor or Pharmacist.

4. Possible Side Effects

Like All Medications, Maxitrol Can Cause Side Effects, Although Not Everybody Gets Them.
If the Patient Experiences Allergic Reactions, Including Rash, Face, Lip, Tongue, and (or)
Throat Swelling, Which May Cause Difficulty Breathing or Swallowing, or Other Severe
Side Effects, They Should Discontinue Using Maxitrol and Immediately Consult Their Doctor or the Emergency Department of the Nearest Hospital.
During Treatment with Maxitrol, the Following Side Effects Have Been Observed:
Uncommon(May Occur in Less Than 1 in 1000 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, Light Sensitivity, Pupil Dilation, Ptosis, Eye Pain, Eye Swelling, Foreign Body Sensation in the Eye, Eye Redness, Increased Lacrimation, Severe Skin Reactions (Stevens-Johnson Syndrome), Blurred Vision, Excessive Hair Growth on the Body (Especially in Women), Muscle Weakness, and Muscle Mass Loss, Purple Streaks on the Skin, Increased Blood Pressure, Irregular Menstruation or Amenorrhea, Changes in Protein and Calcium Levels in the Body, Growth Inhibition in Children and Adolescents, and Edema and Weight Gain, Especially on the Trunk and Face (Cushing's Syndrome) (See Section 2 "Warnings and Precautions").

Reporting Side Effects

If the Patient Experiences Any Side Effects, Including Any Side Effects Not Listed in the Leaflet, They Should Inform Their Doctor, Pharmacist, or Nurse. Side Effects Can be Reported Directly to the Department of Adverse Reaction Monitoring 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 Collect More Information on the Safety of the Medication.
If Any of the Symptoms Worsen or if Other Symptoms Not Listed in this Leaflet Occur, the Patient Should Inform Their Doctor.

5. How to Store Maxitrol

To Avoid Infection of the Drops, the Bottle Should be Discarded 4 Weeks After First Opening. The Date of First Opening Should be Written in the Space Provided Below.
Date of First Opening: ...............
The Medication Should be Stored Out of Sight and Reach of Children.
Do Not Store Above 25°C.
Do Not Store in the Refrigerator.
Store the Bottle Upright.
Store the Package Tightly Closed.
Do Not Use the Medication After the Expiration Date Stated on the Package. The Expiration Date Refers to the Last Day of the Specified Month.
Medications Should Not be Disposed of in Wastewater or Household Waste. The Patient Should Ask Their Pharmacist How to Dispose of Unused Medications. This Will Help Protect the Environment.

6. Package Contents and Other Information

What Maxitrol Contains

The Active Substances of the Medication are:
Dexamethasone 1 mg/ml
Neomycin Sulfate 3500 IU/ml
Polymyxin B Sulfate 6000 IU/ml
The Excipients are: Sodium Chloride, Polysorbate 20, Benzalkonium Chloride, Hypromellose, Purified Water.
The Medication May Contain Minimal Amounts of Hydrochloric Acid and (or) Sodium Hydroxide to Adjust the pH.

What Maxitrol Looks Like and What the Package Contains

Maxitrol Eye Drops are a Non-Clear Suspension with a Color Ranging from White to Light Yellow.
It is Available in a 5 ml Low-Density Polyethylene (LDPE) Bottle with a Dropper, in a Cardboard Box.
For More Detailed Information, the Patient Should Consult the Marketing Authorization Holder or the Parallel Importer.

Marketing Authorization Holder in the Czech Republic, the Country of Export:

Novartis s.r.o., Na Pankráci 1724/129, 140 00 Prague 4, Czech Republic

Manufacturer:

Novartis Pharma GmbH, Roonstrasse 25 und Obere Turnstrasse 8-10, 90429 Nuremberg, Germany
Siegfried El Masnou, S.A., Camil Fabra, 58, 08320 El Masnou, Barcelona, Spain
Novartis Farmacéutica, 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

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorization Number in the Czech Republic, the Country of Export:64/631/70-C

Parallel Import Authorization Number: 83/24

Date of Leaflet Approval: 28.02.2024

[Information About the Trademark]