Maxitrol

Package Leaflet: Information for the Patient

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Maxitrol

(1 mg + 3500 IU + 6000 IU)/g, eye ointment
Dexamethasone + Neomycin sulfate + Polymyxin B sulfate
Before using the medicine, carefully read the contents of the leaflet, as it contains important information for the patient.

• The leaflet should be kept so that it can be read again if necessary.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for this person. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, tell the 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. Contents of the pack 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 entering the eye or eye injuries.
Maxitrol is a combination medicine containing antibacterial and corticosteroid components.
Corticosteroids (in this case, dexamethasone) are used to prevent and reduce eye inflammation.
Antibacterial agents contained in the medicine (in this case, neomycin sulfate and polymyxin B sulfate) are active against most pathogenic bacteria that cause 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 ingredients of this medicine (listed in section 6),
• if the patient has:
• herpetic keratitis, chickenpox, shingles, or any other viral eye infection,
• fungal eye infection,
• untreated parasitic eye infections,
• tubercular eye infection,
• untreated purulent eye infections.

Warnings and precautions

For use in the eyes only.

• In some patients, hypersensitivity to topically applied aminoglycoside antibiotics, such as neomycin, may occur. If symptoms of hypersensitivity occur, discontinue use of the medicine and contact a doctor 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).
• In addition, topical use of neomycin may lead to redness, irritation, and skin discomfort.
• Patients who have experienced hypersensitivity symptoms to topically applied neomycin may also be hypersensitive to other antibiotics.
• If the patient is using other antibiotics at the same time, they should consult a doctor, as concurrent use of Maxitrol with other antibiotics may cause serious side effects.
• In patients using corticosteroids for a long time, the following may occur:
• increased intraocular pressure. Intraocular pressure should be regularly monitored during treatment with this medicine. This is especially important in pediatric patients, as corticosteroid-induced increased intraocular pressure may be greater 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 patients with predisposition (e.g., diabetes).
• development of Cushing's syndrome caused by the medicine entering the bloodstream. If the patient experiences swelling and weight gain, especially on the trunk and face, they should consult a doctor, as these are usually the first symptoms of Cushing's syndrome. Adrenal insufficiency may occur as a result of discontinuing long-term or intensive use of Maxitrol. Consult a doctor before the patient decides to discontinue treatment. This risk is especially important in children and patients treated with ritonavir or cobicistat.
• If the patient experiences or worsens symptoms of eye infection, they should contact a doctor immediately. Patients using Maxitrol may have reduced immunity to eye infections, including bacterial and fungal infections resistant to antibiotic treatment.
• In patients using corticosteroids and non-steroidal anti-inflammatory drugs at the same time, problems with healing of eye surface damage may occur.
• If the patient has diseases that lead to thinning of the cornea or sclera, they should inform their doctor.
• It is not recommended to use contact lenses during treatment for eye inflammation or infection.

If the patient experiences blurred vision or other vision disturbances, they should contact a doctor.
If the patient has glaucoma, the treatment duration should be limited to two weeks, unless the doctor recommends otherwise.
The medicine should be used for as long as the doctor has prescribed. If the symptoms worsen or do not improve, consult a doctor.

Children

The safety and efficacy of Maxitrol in children have not been established, so it is not recommended for use in this age group.

Maxitrol and other medicines

Tell 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 those available without a prescription.
Especially inform the doctor if the patient is taking:

• topically applied non-steroidal anti-inflammatory drugs. Concurrent topical use of a steroid medicine and a non-steroidal anti-inflammatory drug may cause problems with healing of eye injuries;
• ritonavir or cobicistat, as they may increase the level of dexamethasone in the blood.

If the patient is using other eye drops or ointments at the same time, keep a gap of at least 5 minutes between administrations of the different medicines. 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 a doctor or pharmacist before using this medicine. The medicine 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 using Maxitrol, vision may be blurred. Do not drive or operate machinery until this symptom has resolved.
Maxitrol contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216), which may cause allergic reactions (possible late 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 as directed by the doctor. In case of doubts, consult a doctor or pharmacist.
Maxitrol is intended exclusivelyfor administration to the eyes; only one patient should use the medicine from one package.
If the patient is using other eye drops or ointments at the same time, keep a gap of at least 5 minutes between administrations of the different medicines. Eye ointments should be used last.

Recommended dose

Usually, a small amount of ointment (a strip about 1.5 cm long) is instilled into the conjunctival sac of the affected eye (eyes) up to 3 or 4 times a day. The doctor will determine the treatment duration. Do not discontinue treatment prematurely.

• 1. Prepare the tube with Maxitrol and a mirror.
• 2. Wash your hands.
• 3. Unscrew the tube.
• 4. Hold the tube between your thumb and index finger.

• 5. Tilt your head back. Pull the lower eyelid down with a clean finger to form a "pocket" between the eyelid and the eyeball. The ointment strip should be placed in this pocket (Figure 1).
• 6. Bring the tube tip close to the eye, using a mirror to help.
• 7.

Do not touch the tube tip to the eye, eyelids, surrounding surfaces, or other

surfaces. Failure to follow this instruction may cause infection of the ointment.

• 8. Gently squeeze the tube to expel a strip of ointment (Figure 2).
• 9. After using Maxitrol, release the lower eyelid and blink several times to spread the medicine over the entire eye surface. Gently close the eyelids for a few seconds; this will help prevent systemic absorption of the medicine.
• 10. If it is necessary to administer the medicine to both eyes, repeat the above steps for the second eye.
• 11. Replace the tube cap immediately after use.
• 12. Use only one tube of medicine at a time.

If the ointment is squeezed out of the eye, try to apply the ointment correctly again.

Using a higher dose of Maxitrol than recommended

In case of overdose, excess medicine can be rinsed out of the eye with lukewarm water. Do not use the ointment until the next scheduled dose.

Missing a dose of Maxitrol

If a dose of the medicine is missed, take the next scheduled dose. However, if it is almost time for the next dose, skip the missed dose and return to the normal dosing schedule. Do nottake a double dose to make up for the missed dose.
In case of any further doubts about using this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, 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 experiences other severe
side effects, discontinue use of Maxitrol and contact a doctor or the Emergency Department of the nearest hospital immediately.
During treatment with Maxitrol, the following side effects have been observed:
Uncommon(may affect up to 1 in 100 people): keratitis, increased intraocular pressure, eye itching, eye discomfort, eye irritation.
Frequency not known(frequency cannot be estimated from the available data): hypersensitivity, headache, ulcerative keratitis, blurred vision, light sensitivity, pupil dilation, eyelid ptosis, eye pain, eye swelling, foreign body sensation in the eye, eye redness, increased tearing, severe skin reactions (Stevens-Johnson syndrome), blurred vision; excessive hair growth on the body (especially in women), muscle weakness, and muscle mass loss, purple striae on the skin, increased blood pressure, irregular menstrual periods or amenorrhea, changes in protein and calcium levels in the body, growth retardation in children and adolescents, and swelling and weight gain, especially on the trunk and face (Cushing's syndrome) (see section 2 "Warnings and precautions").

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, tell the doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of 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 side effects will help gather more information on the safety of the medicine.
In case of worsening of any of the symptoms or occurrence of other symptoms not listed in this leaflet, inform the doctor.

5. How to store Maxitrol

To avoid infections, the tube with the remaining medicine should be discarded after 4 weeks from the first opening.
Record the date of opening the tube 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 month.
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Maxitrol contains

The active substances of the medicine are:
Dexamethasone
1 mg/g
Neomycin sulfate
3500 IU/g
Polymyxin B sulfate
6000 IU/g
The excipients are: methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), anhydrous liquid lanolin, white petrolatum.

What Maxitrol looks like and contents of the pack

Maxitrol is a thick, translucent or non-translucent, white or slightly yellowish, homogeneous, lump-free ointment.
It is available in a 3.5 g tube with a screw cap, in a cardboard box.
For more detailed information, contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Belgium, the country of export:

Novartis Pharma NV, Medialaan 40, B-1800 Vilvoorde, Belgium

Manufacturer:

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

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Belgian marketing authorization number: BE092145

Parallel import authorization number: 2/23

Date of leaflet approval: 10.01.2024

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