Maxitrol

Leaflet attached to the packaging: patient information

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

The leaflet should be carefully read before using the medicine, as it contains important information for the patient.

• The leaflet should be kept, so that it can be re-read if necessary.
• In case of any doubts, the doctor, pharmacist, or nurse should be consulted.
• This medicine has been prescribed for a specific person. It should not be given 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, they should inform 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 packaging 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 medicine containing antibacterial and corticosteroid components.
Corticosteroids (in this case, dexamethasone) are used to prevent and reduce
eye inflammation. The antibacterial agents contained in the medicine (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 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, the medicine should be discontinued and the doctor should be 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, topical use of neomycin may lead to redness, irritation, and skin discomfort.
• Patients who have experienced symptoms of 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 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. The doctor's advice should be sought, especially in the case of children. The risk of increased intraocular pressure and (or) cataract is also higher in patients with predisposition (e.g., diabetic patients).
• development of Cushing's syndrome caused by the medicine entering the bloodstream. The doctor should be consulted if the patient experiences swelling and weight gain, especially on the trunk and face, as these are usually the first symptoms of the disease called Cushing's syndrome. Adrenal insufficiency may occur as a result of discontinuing long-term or intensive use of Maxitrol. The doctor should be consulted before the patient decides to discontinue treatment. This risk is especially important in children and patients treated with ritonavir or cobicistat.
• In case of occurrence or worsening of eye infection symptoms, the doctor should be contacted 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 concurrently, problems with healing of eye surface damage may occur.
• If the patient has diseases leading to thinning of the cornea or sclera, they should inform the 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 consult 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 of the disease worsen or do not improve, the doctor should be consulted.

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

The doctor or pharmacist should be informed about all medicines the patient is currently using or has recently used, as well as about medicines the patient plans to use, including those available without a prescription.
The doctor should be especially informed 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 dexamethasone content in the blood.

If the patient is using other eye drops or ointments, a minimum of 5 minutes should be allowed between administrations of consecutive 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 influence or negligible influence on the ability to drive and use machines.
For some time after administration of Maxitrol, vision may be blurred. The patient should not drive or operate machines until this symptom subsides.
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, the doctor or pharmacist should be consulted.
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, a minimum of 5 minutes should be allowed between administrations of consecutive 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. The treatment should not be discontinued 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 down the lower eyelid 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 for assistance.
• 7.

The tube tip should not touch the eye, eyelids, surrounding surfaces, or other

surfaces. Failure to follow this recommendation 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 distribute the medicine over the entire eye surface. Gently close your 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, the above steps should be repeated for the second eye.
• 11. The tube should be screwed back on immediately after use.
• 12. Only one tube of medicine should be used at a time.

If the ointment is squeezed out of the eye, an attempt should be made to reapply the ointment correctly to the eye.

Using a higher dose of Maxitrol than recommended

In case of overdose, excess medicine can be rinsed from the eye with lukewarm water. The ointment should not be used until the next scheduled dose.

Missing a dose of Maxitrol

If a dose of the medicine is missed, the next scheduled dose should be taken. However, if there is little time left before the next dose is due, the missed dose should be skipped and the normal dosing schedule resumed. A double dose should notbe administered to make up for a missed dose.
In case of any further doubts about the use of this medicine, the doctor or pharmacist should be consulted.

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 other severe
side effects, they should discontinue using Maxitrol and contact the doctor or the Emergency Department of the nearest hospital immediately.
During treatment with Maxitrol, the following side effects have been observed:
Uncommon( may occur in less than 1 in 100 patients): 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, hypersensitivity to light, pupil dilation, eyelid ptosis, eye pain, eye swelling, foreign body sensation in the eye, eye hyperemia, 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 striae on the skin, increased blood pressure, irregular menstrual cycle 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 (a disease called Cushing's syndrome) (see section 2 "Warnings and precautions").

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the doctor, pharmacist, or nurse should be informed. 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.

5. How to store Maxitrol

To avoid infections, the tube with the remaining medicine should be discarded after four
weeks from the first opening. The date of opening the tube should be noted below.
The medicine should be stored out of sight and reach of children.
It should not be stored at a temperature above 25°C.
The medicine should not be used after the expiry date stated on the packaging.
The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste containers. The pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. Contents of the packaging 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), lanolin, white petrolatum.

What Maxitrol looks like and what the pack contains

Maxitrol is a thick, semi-transparent or non-transparent, white or slightly yellowish, homogeneous, lump-free ointment.
It is available in 3.5 g tubes with a PE cap in a cardboard box.
For more detailed information, the marketing authorization holder or parallel importer should be contacted.

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:

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
Marketing authorization number in the Czech Republic, the country of export: 64/630/70-C

Parallel import authorization number: 226/09

Date of leaflet approval: 08.11.2024

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