Lotemax 0,5%

Leaflet attached to the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Lotemax 0.5% (Lotemax)

0.5%, eye drops, suspension
Loteprednol etabonate
Lotemax 0.5% and Lotemax are different trade names for the same medicine.

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to 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 tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Lotemax 0.5% and what is it used for
• 2. Important information before using Lotemax 0.5%
• 3. How to use Lotemax 0.5%
• 4. Possible side effects
• 5. How to store Lotemax 0.5%
• 6. Contents of the packaging and other information

1. What is Lotemax 0.5% and what is it used for

Lotemax 0.5% is an eye drop suspension.
Lotemax 0.5% is used to treat inflammatory conditions of the eye after surgical procedures.
Sometimes, an inflammatory condition (redness and pain) may occur in the eye. Loteprednol etabonate is
one of the medicines belonging to a group called corticosteroids. It reduces inflammation and alleviates its
symptoms. Since it is used in small doses, directly where it is needed, its action occurs only in that place.

2. Important information before using Lotemax 0.5%

When not to use Lotemax 0.5%:

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• if the patient has been diagnosed with hypersensitivity (allergy) to other corticosteroids.
• if the patient has been diagnosed with eye diseases caused by viruses such as: herpes simplex, chickenpox, and shingles.
• if the patient has been diagnosed with tuberculosis or fungal eye diseases.
• if the patient is breastfeeding.

Warnings and precautions

• The doctor should be informed if the patient has cataracts.
• If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.
• The doctor should be informed if the pain increases or if redness, itching, or inflammation worsens.
• The doctor should be contacted if there is no improvement within 2 days. The doctor may want to re-evaluate the patient's condition.
• The medicine Lotemax 0.5% should not be used for more than 10 days without checking the eye pressure by a doctor.
• Long-term use of Lotemax 0.5% or other eye drops containing corticosteroids may lead to the development of glaucoma or increased eye pressure, which can lead to damage to the optic nerve, vision disturbances, and cataracts.
• Long-term use of Lotemax 0.5% or other eye drops containing corticosteroids may lead to a decrease in the ability to fight infections and may increase the risk of developing an infection in the eye, including a herpes simplex virus infection.
• The use of corticosteroid eye drops, such as Lotemax 0.5%, may exacerbate viral eye inflammation and prolong its duration.

Contact lenses

It is not recommended to wear contact lenses after cataract surgery. If the patient usually wears
contact lenses, the doctor will recommend wearing glasses after cataract surgery. This will allow for
recovery after the procedure. The doctor will inform when it is possible to start using contact lenses again (see also "Lotemax 0.5% contains benzalkonium chloride, solution").

Lotemax 0.5% and other medicines

The doctor should be told about all medicines the patient is currently taking or has recently taken, including
those that are available without a prescription. In particular, the doctor should be informed if the patient is taking:

• medicines known as anticholinergic medicines (used to treat many different conditions, such as stomach and intestinal cramps, muscle cramps, urinary incontinence when there is a sudden urge, or asthma)
• eye drops used to reduce intraocular pressure. Some medicines may enhance the effect of Lotemax 0.5% and the doctor may want to closely monitor the patient's condition when taking such medicines (including some HIV medicines: ritonavir, cobicistat).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should
consult their doctor or pharmacist before using this medicine.
It is possible that Lotemax 0.5% will still be used, but it is also possible that a different treatment will be used.
Lotemax 0.5% should not be used during breastfeeding.

Driving and using machines

Using eye drops may cause vision disturbances. These disturbances usually pass quickly. The patient should not
drive or operate machines until their vision returns to normal.

Lotemax 0.5% contains benzalkonium chloride, solution

This medicine contains 0.0152 mg of benzalkonium chloride, solution in each dose (2 drops), which corresponds
to 0.20 mg/ml.
Benzalkonium chloride, solution may be absorbed by soft contact lenses and change their color. Contact lenses should be removed before instillation and waited at least 15 minutes before reinserting.
Benzalkonium chloride, solution may also cause eye irritation, especially in people with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye).
If abnormal sensations in the eye, stinging, or eye pain occur after using the medicine, the doctor should be contacted.

3. How to use Lotemax 0.5%

This medicine should always be used as directed by the doctor or pharmacist. In case of doubts, the doctor or
pharmacist should be consulted.
The recommended dose for adults and the elderly is one to two drops four times a day.
Usually, treatment with Lotemax 0.5% starts 24 hours after surgery and continues for 2 weeks.
Use in adults:

• Lotemax 0.5% should be shaken before use.
• Looking up, gently pull down the lower eyelid of the affected eye.
• Instill 1 or 2 drops of Lotemax 0.5% into the space between the eyeball and the eyelid, 4 times a day or as directed by the doctor.
• Do not allow the tip of the dropper to come into contact with any surface, as this may contaminate the suspension.
• The container should be closed immediately after use.
• The doctor will inform how long to continue treatment with Lotemax 0.5%.
• Treatment should not be stopped without consulting a doctor.

Use in children and adolescents

Lotemax 0.5% should not be used in children and adolescents until further data are available.

Using a higher dose of Lotemax 0.5% than recommended

The doctor or pharmacist should be contacted.

Missing a dose of Lotemax 0.5%

A double dose should not be used to make up for a missed dose.
Wait until the next dose is due and continue treatment as before.

Stopping treatment with Lotemax 0.5%

This medicine should always be used as directed by the doctor. Treatment with Lotemax 0.5% should not be
stopped without first talking to a doctor.
In case of any further doubts about using this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If the patient experiences the following symptoms: redness, itching, swelling of the membrane covering the white part of the eye and/or eyelids or general symptoms such as: difficulty breathing, difficulty swallowing, flushing or redness of the face, swelling of the face, tongue should stop
using this medicine and seek immediate medical attention.These may be symptoms of severe allergic reactions.
In case of the following side effects, the doctor should be contacted immediately, as urgent medical attention may be necessary:

• Increased eye pain, especially when exposed to bright light, and eye redness during use of this medicine. This may be due to inflammation of the colored part of the eye, the iris - an uncommon side effect (may occur in less than 1 in 100 patients).
• A lump or thickening in the breast, change in size, shape, or texture of the breast, swelling or a lump under the arm, or change in the shape of the nipple. These may be symptoms of breast cancer, which is a rare side effect (may occur in less than 1 in 1000 patients).
• Involuntary muscle contractions (muscle twitching) - a rare side effect (may occur in less than 1 in 1000 patients).
• Nervousness - a rare side effect (may occur in less than 1 in 1000 patients).
• Noise (ringing in the ears), ear noises - a rare side effect (may occur in less than 1 in 1000 patients).
• Chest pain - a rare side effect (may occur in less than 1 in 1000 patients).

The following side effects may also occur during treatment with this medicine:

Common side effects (may occur in up to 1 in 10 people):

• Eye disorders:corneal damage, eye discharge, eye discomfort, dry eye, tearing, feeling of a foreign body in the eye, eye redness, eye itching, burning sensation at the site of instillation, and increased intraocular pressure.
• General disorders:headache.

Uncommon side effects (may occur in up to 1 in 100 people):

• Eye disorders:vision disturbances, eyelid itching, conjunctivitis, eye irritation, eye pain, papillae on the conjunctiva, sensitivity to light, eye inflammation, corneal and conjunctival inflammation, eye infections, and cataract.
• General disorders: fatigue, nasal discharge, and sore throat.

Rare side effects (may occur in up to 1 in 1000 people):

• General disorders:migraine, taste disturbances, dizziness, numbness, chills, fever, and pain, cough, urinary tract infection or inflammation, hives, rash, dry skin, eczema, diarrhea, nausea, and vomiting, weight gain.

Frequency not known (frequency cannot be estimated from the available data):

• Eye disorders:blurred vision.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be
told. 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.
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Lotemax 0.5%

The medicine should be stored out of sight and reach of children.
The bottle should be stored upright.
Do not store above 25°C. Do not freeze.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
Any unused contents should be discarded 28 days after first opening the bottle.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

DO NOT USE IF THE SEAL IS DAMAGED

6. Contents of the packaging and other information

What Lotemax 0.5% contains

• The active substance of the medicine is loteprednol etabonate. Each ml of suspension contains 5 mg (0.5%) of loteprednol etabonate.
• The other ingredients are: disodium edetate, glycerol, povidone, purified water, tyloxapol, benzalkonium chloride, solution (0.01%) added as a preservative.
• Hydrochloric acid and/or sodium hydroxide are added to adjust the pH.

What Lotemax 0.5% looks like and contents of the pack

Lotemax 0.5% is a milky-white eye drop suspension.
Lotemax 0.5% is available in bottles containing 5 ml.
For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in Lithuania, the country of export:

Dr. Gerhard Mann, Chem.-Pharm. Fabrik GmbH
Brunsbütteler Damm 165/173
13581 Berlin
Germany

Manufacturer:

Bausch + Lomb Ireland Limited
3013 Lake Drive, Citywest Business Campus
Dublin 24, D24 PPT3, Ireland
Bausch Health Poland sp. z o.o.
ul. Kosztowska 21
41-409 Mysłowice, Poland
Bausch Health Poland sp. z o.o.
ul. Przemysłowa 2
35-959 Rzeszów, Poland
Dr. Gerhard Mann, Chem.-Pharm. Fabrik GmbH
Brunsbütteler Damm 165/173
13581 Berlin, Germany

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Lithuanian, the country of export, marketing authorization number:LT/1/05/0388/002
Parallel import authorization number:95/25

Date of leaflet approval: 13.03.2025

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