Maxitrol
Poland
Table of Contents
Package leaflet: Information for the patient
Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Maxitrol
(1 mg + 3500 i.u. + 6000 i.u.)/ml, eye drops, suspension
Dexamethasonum + Neomycini sulfas + Polymyxini B sulfas
Please read the following leaflet carefully before using the medicine, as it contains
important information for the patient.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, please consult your doctor, pharmacist, or nurse.
- This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
- If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
Table of contents:
- What Maxitrol is and what it is used for
- Important information before using Maxitrol
- How to use Maxitrol
- Possible side effects
- How to store Maxitrol
- Contents of the pack and other information
1. What Maxitrol is and what it is used for
Maxitrol is used to treat inflammatory eye conditions that may be associated with infection.
Eye inflammation may result from infection, other agents entering the eye, or eye injuries.
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 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, varicella (chickenpox), or any other viral eye infection,
- fungal eye infection,
- untreated parasitic eye infections,
- tuberculous eye infection,
- untreated purulent eye infection.
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Warnings and precautions
For ocular use only.
- Some patients may develop hypersensitivity to locally applied aminoglycoside antibiotics such as neomycin. If symptoms of hypersensitivity occur, discontinue use of the medicine immediately and contact a doctor without delay (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 also occur during treatment with other topical or systemic antibiotics from the same class (aminoglycosides).
- In addition, topical use of neomycin may lead to redness, irritation, and a sensation of discomfort in 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 over a long period, the following may occur:
- elevated intraocular pressure. Intraocular pressure should be monitored regularly during treatment with this medicine. This is particularly important in children, 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. patients with diabetes).
- development of drug-induced Cushing's syndrome. Seek medical advice if the patient develops swelling and increased body weight, 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 appear or worsen, contact a doctor immediately. Patients using Maxitrol may have reduced resistance to eye infections, including antibiotic-resistant bacterial and fungal infections.
- In patients using corticosteroids and non-steroidal anti-inflammatory drugs simultaneously, problems with healing of ocular surface injuries may occur.
- If the patient has diseases leading to 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 advised by the 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, its use is not recommended in this age group.
Maxitrol and other medicines
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Inform your 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 a prescription.
It is especially important to 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 these 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 used last.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, 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 use machinery.
Vision may be blurred for a short time after instillation of Maxitrol. Do not drive or operate machinery until this effect has subsided.
Maxitrol eye drops contain benzalkonium chloride.
The medicine contains 0.04 mg of benzalkonium chloride per millilitre (0.04 mg/ml).
Benzalkonium chloride may be absorbed by soft contact lenses and may alter their colour. Contact lenses should be removed before instillation and at least 15 minutes should elapse before reinsertion.
Benzalkonium chloride may also cause eye irritation, especially 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 medicine.
It is recommended to close the eyelid and gently press with a finger on the nasolacrimal duct (tear duct). This helps reduce systemic absorption of the medicine after instillation into the eye.
Recommended dose
For mild conditions, one to two drops should be administered into the conjunctival sac(s) four to six times daily.
For severe conditions, one to two drops should be administered every hour. The dose should then be gradually reduced, and treatment discontinued once signs of inflammation have resolved.
Your doctor will determine the duration of treatment. Do not discontinue treatment prematurely.
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- Prepare the Maxitrol bottle and a mirror.
- Wash your hands.
- Shake the bottle.
- Unscrew the cap.
- Hold the bottle in your hand with the bottom facing upwards, using your thumb and middle finger (Figure 1).
- Tilt your head backward. Gently pull down the lower eyelid with a clean finger to form a "pocket" between the eyelid and the eyeball, into which the drop should be placed (Figure 2).
- Bring the dropper tip close to the eye. A mirror may be used to assist.
- 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.
- Gently squeeze the bottom of the bottle to release a single drop of Maxitrol (Figure 3).
- After instilling the drop, remove the finger from the lower eyelid. Close the eye and gently press with a finger on the inner corner of the eye near the nose (Figure 4). This helps prevent the medicine from entering the systemic circulation.
- If drops are required in both eyes, repeat the above steps for the other eye.
- Immediately after use, replace the cap on the bottle.
- Only one bottle should be used at a time.
If the drop misses the eye, repeat the instillation correctly.
Accidental overdose of Maxitrol
In case of local overdose, rinse the eye(s) with lukewarm water.
Do not administer additional drops until the next scheduled dose.
Missed dose of Maxitrol
If a dose is missed, take the next scheduled dose as planned. However, if the next dose is due shortly, skip the missed dose and resume the regular dosing schedule. Do not take 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 adverse reactions
Like any medicine, 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
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adverse reactions occur, stop using Maxitrol and contact a doctor or the nearest hospital Emergency Department immediately.
The following adverse reactions have been observed during the use of Maxitrol:
Not common ( may occur in fewer than 1 in 1,000 patients ): corneal inflammation, increased
intraocular pressure, eye itching, sensation of eye discomfort, eye irritation.
Frequency unknown ( frequency cannot be determined from available data ): hypersensitivity,
headache, ulcerative keratitis, blurred vision, photophobia, pupil dilation, drooping eyelid, eye pain, eye swelling, sensation of a foreign body in the eye, eye hyperaemia, excessive tearing, severe skin reactions (Stevens-Johnson syndrome), blurred vision, marked increase in body hair growth (especially in women), muscle weakness and loss of muscle mass, purple skin striae, 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 increased body weight, 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 be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting adverse reactions, more information on the safety of this medicine can be collected.
If any of the symptoms worsen or if any other adverse effects not mentioned in this leaflet occur, inform a doctor.
5. How to store Maxitrol medicine
To avoid contamination of the drops, the bottle should be discarded 28 days after first opening.
The date of first opening should be recorded in the space provided below.
Date of first opening: ……….
Keep this medicine out of sight and reach of children.
Store below 25°C in the original packaging.
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.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via sewage systems or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.
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6. Contents of the pack and other information
What the medicinal product Maxitrol contains
The active substances 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.
Minimal amounts of concentrated hydrochloric acid and/or sodium hydroxide may be added to the product to maintain its acidity (pH) within normal limits.
What the medicinal product looks like and contents of the pack
Maxitrol eye drops are a white to slightly yellowish, opaque suspension.
They are supplied in a low-density polyethylene (LDPE) bottle fitted with a polypropylene (PP) screw cap, packed in a cardboard box.
For more detailed information, please contact the Marketing Authorisation Holder or Parallel Importer.
Marketing Authorisation Holder in Romania, country of export:
NOVARTIS PHARMA GmbH, Roonstrasse 25, D-90429, Nuremberg, Germany
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, El Masnou, 08320 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, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Romanian (country of export) Marketing Authorisation Number: 11751/2019/01
Parallel Import Licence Number: 246/21
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