Maxitrol
Poland
Table of Contents
Package leaflet: Information for the patient
Warning! Keep this leaflet! Information on the immediate packaging 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 information 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, ask your doctor, pharmacist, or nurse.
- This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
- If you experience any adverse reactions, including any 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 diseases that may be associated with
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 components 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 infection,
- tuberculous eye infection,
- untreated purulent eye infection.
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, 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 severe skin reactions. Such skin reactions may also occur during treatment with other topical or systemic antibiotics from the same family (aminoglycosides).
- In addition, topical use of neomycin may lead to redness, irritation, and 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 for prolonged periods, 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., diabetic patients).
‐ development of drug-induced Cushing's syndrome. Seek medical advice if the patient develops swelling and weight gain, particularly noticeable in the trunk and face, as these are usually the first signs of a condition called 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 nonsteroidal anti-inflammatory drugs simultaneously, problems with healing of ocular surface damage 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 directed by a 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, use in this age group is not recommended.
Maxitrol and other medicines
Inform your doctor or pharmacist about any other medicines the patient is currently using, has recently used, or plans to use, including those obtained without a prescription.
Particularly inform the doctor if the patient is taking:
- topically acting nonsteroidal anti-inflammatory drugs. Concurrent topical use of steroid and nonsteroidal anti-inflammatory medicines may cause problems with 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 a 5-minute interval should be maintained between administration of each medicine. Eye ointments should be applied last.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
This medicine is not recommended during pregnancy or breastfeeding.
Driving and operating machinery
Maxitrol has no or negligible influence on the ability to drive and operate machinery.
However, 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 milliliter (0.04 mg/ml).
Benzalkonium chloride may be absorbed by soft contact lenses and may alter their color. Contact lenses must be removed before instillation and at least 15 minutes should elapse before reinsertion.
Benzalkonium chloride may also cause eye irritation, particularly in patients 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 must 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, remove it 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 absorption of the medicine into the bloodstream after instillation into the eye.
Recommended dose
In mild conditions, one to two drops should be administered into the conjunctival sac (sacs) four to six times daily.
In severe cases, one to two drops should be given every hour. The dose should then be gradually reduced, and treatment should be discontinued once inflammatory symptoms have resolved.
Your doctor will determine the duration of treatment. Do not discontinue treatment prematurely.
- 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, grasping it between the thumb and middle finger (Figure 1).
- Tilt your head backward. Gently pull the lower eyelid downward with a clean finger to form a "pocket" between the eyelid and the eyeball, into which the drop should be instilled (Figure 2).
- Bring the tip of the dropper 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 Maxitrol, remove the finger holding the lower eyelid. Close the eye and press gently with a finger at 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 second eye.
- Immediately after use, replace the cap on the bottle.
- Only one bottle of medicine should be used at a time.
If the drop misses the eye, repeat the procedure to correctly instill the drop.
Accidental overdose of Maxitrol
In case of local overdose of Maxitrol, rinse the eye(s) thoroughly with lukewarm water.
Do not use the medicine again until the next scheduled dose.
Missed dose of Maxitrol
If a dose is missed, take the next scheduled dose as planned. However, if it is almost time for the next dose, skip the missed dose and return to the regular dosing schedule. Do not take a double dose to make up for a missed one.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, 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 adverse reactions occur,
Maxitrol treatment must be discontinued immediately and the doctor or the nearest hospital’s Emergency Department
should be contacted without delay.
The following adverse reactions have been observed during treatment with Maxitrol:
Not very common (may occur in fewer than 1 in 1,000 patients): corneal inflammation, increased intraocular pressure, eye itching, eye discomfort, eye irritation.
Frequency unknown (frequency cannot be estimated from available data): hypersensitivity, headache, corneal ulceration, blurred vision, photophobia, pupil dilation, eyelid drooping, eye pain, eye swelling, sensation of foreign body in the eye, eye hyperemia, excessive tearing, severe skin reactions (Stevens-Johnson syndrome), blurred vision, excessive increase in body hair (particularly in women), muscle weakness and loss of muscle mass, purple stretch marks 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 adverse reactions
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of 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.
Reporting adverse reactions helps to provide more information on the safety of the medicine.
If any of the symptoms worsen or if any other adverse effects not mentioned in this leaflet occur, inform your doctor.
5. How to store Maxitrol
To avoid contamination of the drops, the bottle should be discarded 4 weeks after first opening.
The date of first opening should be recorded in the space provided below.
Date of first opening: ...............
Keep the medicine out of sight and reach of children.
Do not store above 25°C.
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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.
6. Contents of the package and other information
What Maxitrol contains
The active substances are:
Dexamethasone 1 mg/ml
Neomycin sulfate 3500 IU/ml
Polymyxin B sulfate 6000 IU/ml
The other components are: sodium chloride, polysorbate 20, benzalkonium chloride, hypromellose, water for injections.
Minimal amounts of hydrochloric acid and/or sodium hydroxide are added to adjust the pH.
What Maxitrol looks like and contents of the pack
Maxitrol is a white to light yellow, opaque suspension supplied in a 5 ml low-density polyethylene (LDPE) dropper bottle with a cap, contained in a cardboard box.
For more detailed information, please contact the Marketing Authorisation Holder or the parallel importer.
Marketing Authorisation Holder in the Czech Republic, 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, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing Authorisation Number in the Czech Republic, country of export: 64/631/70-C
Parallel Import Licence Number: 83/24