Lotemax 0.5%

Patient Information Leaflet

Keep this leaflet! The information on the immediate packaging is 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.
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other individuals, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of Contents

1. What Lotemax 0.5% is and what it is 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 pack and other information

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

Lotemax 0.5% is an eye drop suspension.
Lotemax 0.5% is used to treat inflammatory conditions of the eye following surgical procedures.
Sometimes, inflammation (redness and pain) may occur in the eye. Loteprednol etabonate is one of a group of medicines called corticosteroids. It reduces inflammation and relieves its symptoms. Because it is administered in small doses directly to the site where it is needed, its action is localized to that area.

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 to any of the other ingredients of this medicine (listed in section 6).
• if the patient has hypersensitivity (allergy) to other corticosteroids.
• if the patient has been diagnosed with viral eye diseases such as herpes simplex, varicella (chickenpox), or zoster (shingles).
• if the patient has been diagnosed with tuberculosis or fungal infections of the eye.
• if the patient is breastfeeding.

Warnings and precautions

• Inform the doctor if the patient has cataracts.
• If the patient experiences blurred vision or other visual disturbances, contact the doctor.
• Inform the doctor if pain increases or if redness, itching, or inflammation worsens.
• Contact the doctor if there is no improvement within 2 days. The doctor may wish to reassess the patient's condition.
• Do not use Lotemax 0.5% for longer than 10 days without having intraocular pressure examined by a doctor.
• Prolonged use of Lotemax 0.5% or other eye drops containing corticosteroids may lead to the development of glaucoma or increased intraocular pressure, which may damage the optic nerve, impair vision, and cause cataracts.
• Prolonged use of Lotemax 0.5% or other eye drops containing corticosteroids may reduce the ability to fight infections and may increase the risk of eye infections, including herpes simplex virus infection.
• The use of corticosteroid-containing eye drops, such as Lotemax 0.5%, may worsen viral eye infections and prolong their duration.

Contact lenses
The use of contact lenses is not recommended after cataract surgery. If the patient usually wears
contact lenses, the doctor will advise using glasses after cataract surgery. This approach allows for
proper recovery after the procedure. The doctor will inform the patient when it is safe to resume
wearing contact lenses (see also “Lotemax 0.5% contains benzalkonium chloride, solution”).
Lotemax 0.5% and other medicines
Inform the doctor about all medicines the patient is currently taking or has recently taken, including
those available without a prescription. Especially inform the doctor if the patient is using:

• medicines known as anticholinergics (used in the treatment of various conditions such as stomach and intestinal spasms, muscle spasms, urge incontinence, or asthma)
• eye drops used to reduce intraocular pressure. Some medicines may enhance the effect of Lotemax 0.5%, and the doctor may wish to monitor the patient closely (including certain HIV medications: ritonavir, cobicistat).

Pregnancy and breastfeeding
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.
Lotemax 0.5% may still be used, but alternative treatment may also be considered.
Lotemax 0.5% should not be used during breastfeeding.
Driving and operating machinery
Using eye drops may cause visual disturbances. These effects usually resolve quickly. Do not drive or
operate machinery until vision returns to normal.
Lotemax 0.5% contains benzalkonium chloride, solution
This medicine contains 0.0152 mg of benzalkonium chloride, solution per dose (2 drops), equivalent to 0.20 mg/ml.
Benzalkonium chloride, solution may be absorbed by soft contact lenses and may change their color. Contact lenses must be removed before instillation and at least 15 minutes should be waited before reinserting them.
Benzalkonium chloride, solution 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 in the eye, stinging, or eye pain occur after using the medicine, contact the doctor.

3. How to use Lotemax 0.5%

This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
The recommended dose for adult and elderly patients is one to two drops four times
daily.
Treatment with Lotemax 0.5% usually begins 24 hours after surgery and continues
for 2 weeks.

Instructions for use in adults:

• Shake the Lotemax 0.5% bottle well before use.
• Look upwards and 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 lower eyelid, four times daily or as directed by your doctor.
• Avoid contact between the dropper tip and any surface, as this may contaminate the suspension.
• Close the container immediately after use.
• Your doctor will inform you how long treatment with Lotemax 0.5% should continue.
• Do not stop treatment without consulting your doctor.

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

If you use more than the recommended dose of Lotemax 0.5%
Contact your doctor or pharmacist.

If you forget to use Lotemax 0.5%
Do not use a double dose to make up for the missed dose.
Wait until the next scheduled dose and continue treatment as before.

Stopping treatment with Lotemax 0.5%
This medicine should always be used as directed by your doctor. Do not stop using Lotemax 0.5% without first discussing it with your doctor.

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 experiences them.
If the patient experiences any of 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, they should stop using this medicine
and seek immediate medical help. These may be symptoms of severe allergic reactions.
If any of the following adverse reactions occur, immediately contact a doctor, as urgent medical care may be required:

• Worsening of eye pain, especially when exposed to bright light, and eye redness during treatment with this medicine. This may result from inflammation of the coloured part of the eye, the iris – an uncommon adverse reaction (may occur in up to 1 in 100 patients).
• Lump or thickening in the breast, change in size, shape or texture of the breast, swelling or lump under the arm, or change in the shape of the nipple. These may be symptoms of breast cancer, a rare adverse reaction (may occur in up to 1 in 1000 patients).
• Involuntary muscle twitching (muscle tremor) – a rare adverse reaction (may occur in up to 1 in 1000 patients).
• Nervousness – a rare adverse reaction (may occur in up to 1 in 1000 patients).
• Noise (ringing in the ears), tinnitus – a rare adverse reaction (may occur in up to 1 in 1000 patients).
• Chest pain – a rare adverse reaction (may occur in up to 1 in 1000 patients).

The following adverse reactions may also occur during treatment with this medicine:
Common adverse reactions (may affect up to 1 in 10 people):

• Eye disorders: corneal damage, eye discharge, eye discomfort, dry eye, watery eyes, sensation of a foreign body in the eye, eye redness, itchy eyes, burning sensation at the site of instillation, and increased intraocular pressure.
• General adverse reactions: headache.

Uncommon adverse reactions (may affect up to 1 in 100 people):

• Eye disorders: visual disturbance, itchy conjunctiva, conjunctivitis, eye irritation, eye pain, conjunctival papillae, photophobia, eye inflammation, keratoconjunctivitis, eye infections, and lens opacity.
• General adverse reactions: fatigue, nasal discharge, and sore throat.

Rare adverse reactions (may affect up to 1 in 1000 people):

• General adverse reactions: migraine, taste disturbances, dizziness, numbness, chills, fever and pain, cough, urinary tract infection or inflammation, urticaria, rash, dry skin, skin eruption, diarrhoea, nausea and vomiting, weight gain.

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

• Eye disorders: blurred vision.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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.

5. How to store Lotemax 0.5% medication

Keep the medicine out of the sight and reach of children.
Store the bottle in an upright position.
Do not store at temperatures 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 specified month.
Discard any unused contents 28 days after first opening the bottle.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This helps protect the environment.
DO NOT USE IF THE SEAL IS DAMAGED

6. Contents of the package and other information

What Lotemax 0.5% contains

• The active substance 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, please contact the responsible entity or parallel importer.

Marketing Authorisation Holder in Lithuania, 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, Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland

Marketing Authorisation Number in Lithuania, country of export: LT/1/05/0388/002
Parallel Import Authorisation Number: 95/25