Maxitrol

Package leaflet: Information for the patient

Warning! Please keep the leaflet. Information on the immediate packaging is in a foreign language.
Maxitrol (Maxidrol)
(1 mg + 3500 i.u. + 6000 i.u.)/g, eye ointment
Dexamethasonum + Neomycini sulfas + Polymyxini B sulfas
Maxitrol and Maxidrol are different brand names for the same medicinal product.
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if necessary.
• If you have any questions, 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 other people, 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 packaging and other information

1. What Maxitrol is and what it is used for

Maxitrol is used for the treatment of inflammatory eye diseases that may be accompanied by infection.
Eye inflammation may be caused by infection or other factors 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 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 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, smallpox, chickenpox, or any other viral eye infection,
  • fungal eye infection,
  • untreated parasitic eye infections,
  • tuberculous eye infection,
  • untreated purulent eye infections.

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, treatment should be discontinued and medical advice sought immediately (see section 4). Hypersensitivity reactions may manifest as local itching or redness of the skin, severe allergic reactions (anaphylactic reactions), or serious skin reactions. Such skin reactions may 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 a sensation of 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 corticosteroids in the eye over a long period, the following may occur:
  • increased intraocular pressure. Intraocular pressure should be monitored regularly during treatment with this medicine. This is particularly important in pediatric patients, as corticosteroid-induced elevation in intraocular pressure may be higher and occur earlier in children than in adults. Medical advice should be sought, especially for children. The risk of increased intraocular pressure and/or cataract is also higher in predisposed patients (e.g., diabetic patients).
  • development of drug-induced Cushing's syndrome due to systemic absorption. Medical advice should be sought if the patient develops swelling and weight gain, particularly noticeable in the trunk and face, as these are usually the first signs of Cushing's syndrome. Adrenal suppression may occur following discontinuation of prolonged or intensive treatment with Maxitrol. Medical advice should be sought before stopping treatment. This risk is particularly significant in children and in patients treated with ritonavir or cobicistat.
• If symptoms of eye infection appear or worsen, medical advice should be sought immediately. Patients using Maxitrol may have reduced resistance to eye infections, including antibiotic-resistant bacterial and fungal infections.
• In patients using corticosteroids and nonsteroidal anti-inflammatory drugs (NSAIDs) simultaneously, impaired healing of ocular surface injuries may occur.
• If the patient has diseases causing thinning of the cornea or sclera, this should be reported to the physician.
• Wearing contact lenses is not recommended during treatment of eye inflammation or infection.

If the patient experiences blurred vision or other visual disturbances, medical advice should be sought.
If the patient has glaucoma, treatment duration should be limited to two weeks unless otherwise directed by a physician.
The medicine should be used for as long as directed by the physician. If symptoms worsen or do not improve, medical advice should be sought.

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 using or has recently used, as well as any medicines the patient plans to use, including those obtained without a prescription.
Particular attention should be given if the patient is using:

• topically acting nonsteroidal anti-inflammatory drugs (NSAIDs). Concurrent topical use of a steroid and a nonsteroidal anti-inflammatory drug may lead to impaired 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 5 minutes should be left between the administration of each product. Eye 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 become pregnant, she 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 effect on the ability to drive and operate machinery.
However, vision may be blurred for a short time after instillation of Maxitrol. Driving and operating machinery should be avoided until this effect subsides.

Maxitrol contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216), which may cause allergic reactions (including delayed-type reactions).
The medicine contains lanolin, which may cause local skin reactions (e.g., contact dermatitis).

3. How to use Maxitrol

Maxitrol must always be used exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Maxitrol is intended exclusively for ophthalmic use; each tube should be used by only one patient.
If you are using other eye drops or eye ointments at the same time, wait at least 5 minutes between applying each medication. Eye ointments should be applied last.

Recommended dose
Typically, a small amount of ointment (a strip about 1.5 cm long) should be applied into the conjunctival sac of the affected eye(s) 3 or 4 times daily. Your doctor will determine the duration of treatment. Do not stop treatment prematurely.

1. Prepare the Maxitrol tube and a mirror.
2. Wash your hands.
3. Unscrew the cap from the tube.
4. Hold the tube between your thumb and index finger.
5. 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 ointment strip should be placed (Figure 1).
6. Bring the tip of the tube close to the eye; you may use a mirror to assist.
7. Do not let the tip of the tube touch the eye, eyelids, surrounding areas, or any other surface. Failure to follow this instruction may result in contamination of the ointment.
8. Gently squeeze the tube to express the ointment (Figure 2).
9. After applying Maxitrol ointment, release the lower eyelid and blink several times to help spread the ointment over the entire eye surface. Gently close the eyelids for a few seconds; this helps reduce systemic absorption of the drug.
10. If treatment of both eyes is necessary, repeat the above steps for the second eye.
11. Immediately recap the tube after use.
12. Only one tube of the medication should be used at any given time.

If the ointment is accidentally expressed outside the eye, repeat the procedure to correctly apply the ointment into the eye.

Use of more than the recommended dose of Maxitrol
In case of overdose, flush the eye with lukewarm water. Do not apply the ointment again until the next scheduled dose.

Missed dose
If you miss a dose, apply the next scheduled dose as planned. However, if it is almost time for the next dose, skip the missed dose and continue with your regular dosing schedule. Do not use 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 get 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,
discontinue use of Maxitrol immediately and contact a doctor or the nearest hospital Emergency Department
without delay.

The following side effects have been observed during treatment with Maxitrol:
Not common (may affect up to 1 in 100 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, ulcerative keratitis, blurred vision, photophobia, pupil dilation, ptosis (drooping eyelid), eye pain, eye swelling, sensation of foreign body in the eye, eye hyperemia, excessive tearing, severe skin reactions (Stevens-Johnson syndrome), blurred vision; increased 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 and 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 adverse effects occur, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of 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 side effects helps provide more information on the safety of this medicine.
If any of the symptoms worsen, or if any other adverse effects not mentioned in this leaflet occur, inform a doctor immediately.

5. How to store Maxitrol medicine

To avoid contamination, the tube with any remaining medicine must be discarded 15 days after the first opening.
Please record the date of first opening below.
Date of first opening:
Keep the medicine out of the sight and reach of children.
Store below 25°C.
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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Maxitrol contains
The active substances are:
Dexamethasone 1 mg/g
Neomycin sulfate 3500 i.u./g
Polymyxin B sulfate 6000 i.u./g
The excipients are: methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), lanolin, vaseline.

What the medicine looks like and contents of the pack
Maxitrol is a greasy, translucent or opaque, white or slightly yellowish, homogeneous ointment free from lumps.
It is available in tubes of 3.5 g packed in a cardboard box.
For further information, please contact the marketing authorisation holder or the parallel importer.

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

Manufacturer:
Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany
Alcon-Couvreur NV
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

Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Marketing authorisation number in France, the country of export: 3400931983569
Parallel import authorisation number: 218/15