Lotemax 0,5%

Package Leaflet: Information for the User

Lotemax 0.5%

5 mg/ml, eye drops, suspension
Loteprednol etabonate

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Package Leaflet Contents

• 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. Package contents 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, inflammation (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 relieves its
symptoms. Since it is used in small doses, directly where it is needed, its action occurs only at that site.

2. Important information before using Lotemax 0.5%

When not to use Lotemax 0.5%:

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

Warnings and precautions

• Tell your doctor if you have cataracts.
• If you experience blurred vision or other vision disturbances, contact your doctor.
• Tell your doctor if the pain increases or if redness, itching, or inflammation worsens.
• Contact your doctor if there is no improvement within 2 days. Your doctor may want to re-evaluate your condition.
• Do not use Lotemax 0.5% for more than 10 days without having your eye pressure checked by your doctor.
• Long-term use of Lotemax 0.5% or other corticosteroid eye drops 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 corticosteroid eye drops may lead to a decrease in the ability to fight infections and may increase the risk of developing an eye infection, including herpes simplex virus infection.
• Using corticosteroid eye drops, such as Lotemax 0.5%, may exacerbate viral eye infections and prolong their duration.

Contact lenses

It is not recommended to wear contact lenses after cataract surgery. If you normally wear contact lenses, your doctor will advise you to wear glasses after cataract surgery. This will allow for recovery after the procedure. Your doctor will inform you when you can start wearing contact lenses again (see also "Lotemax 0.5% contains benzalkonium chloride").

Lotemax 0.5% and other medicines

Tell your doctor about all medicines you are taking, or have recently taken, including those obtained without a prescription. In particular, tell your doctor if you are taking:

• medicines known as anticholinergic agents (used to treat various conditions, such as stomach and intestinal cramps, muscle cramps, urinary incontinence, or asthma)
• eye drops used to reduce intraocular pressure. Some medicines may enhance the effect of Lotemax and your doctor may want to monitor your condition closely while taking such medicines (including some HIV medicines: ritonavir, cobicistat).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
It is possible that Lotemax 0.5% will still be used, but it is also possible that alternative treatment will be used.
Do not use Lotemax 0.5% during breastfeeding.

Driving and using machines

Using eye drops may cause vision disturbances. These disturbances usually disappear quickly. Do not drive or operate machinery until your vision has returned to normal.

Lotemax 0.5% contains benzalkonium chloride

This medicine contains 0.0152 mg of benzalkonium chloride per dose (2 drops), which is equivalent to

• 0.20 mg/ml. Benzalkonium chloride may be absorbed by soft contact lenses and change their color. Remove contact lenses before instilling and wait at least 15 minutes before reinserting. Benzalkonium chloride 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 you experience any abnormal sensations in the eye, stinging, or eye pain after using the medicine, contact your doctor.

3. How to use Lotemax 0.5%

Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose for adults and the elderly is one to two drops four times a day.
Treatment with Lotemax 0.5% usually starts 24 hours after surgery and continues for 2 weeks.
Use in adults:

• Shake the bottle before use.
• Look up 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 eyelid, 4 times a day or as directed by your doctor.
• Do not allow the tip of the dropper to touch any surface, as this may contaminate the suspension.
• Close the container immediately after use.
• Your doctor will tell you how long to continue using Lotemax 0.5%.
• Do not stop using this medicine 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.

Using more than the recommended dose of Lotemax 0.5%

Contact your doctor or pharmacist.

Missing a dose of Lotemax 0.5%

Do not use a double dose to make up for a missed dose.
Wait until the next dose is due and continue treatment as before.

Stopping use of Lotemax 0.5%

Always use this medicine exactly as your doctor has told you. Do not stop using Lotemax 0.5% without first talking to your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience 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 stop using
this medicine and seek immediate medical attention.These may be symptoms of a severe allergic reaction.
If you experience any of the following side effects, contact your doctor immediately, as you may need urgent medical attention:

• 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 affect up to 1 in 100 people).
• A lump or thickening in the breast, change in breast size or shape, swelling or a lump under the arm or change in the shape of the nipple. These may be symptoms of breast cancer, a rare side effect (may affect up to 1 in 1,000 people).
• Involuntary muscle contractions (muscle twitching) - a rare side effect (may affect up to 1 in 1,000 people).
• Nervousness - a rare side effect (may affect up to 1 in 1,000 people).
• Ringing in the ears (tinnitus) - a rare side effect (may affect up to 1 in 1,000 people).
• Chest pain - a rare side effect (may affect up to 1 in 1,000 people).

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

Common side effects (may affect 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 affect up to 1 in 100 people):

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

Rare side effects (may affect up to 1 in 1,000 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 you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring
Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lotemax 0.5%

Keep the medicine out of the sight and reach of children.
Store the container in an upright position.
Do not store above 25°C. Do not freeze.
Do not use this medicine after the expiry date stated on the carton and bottle after:
“EXP”. The expiry date refers to the last day of the month.
Discard any unused contents 28 days after first opening the bottle.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

DO NOT USE IF THE SEAL IS BROKEN

6. Package contents 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 (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 2.5 ml, 5 ml, or 10 ml.
Not all pack sizes are marketed.

Marketing authorization holder

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
Dr. Gerhard Mann
Chem.-Pharm. Fabrik GmbH
Brunsbütteler Damm 165/173
13581 Berlin, Germany
Date of last revision of the leaflet:11/2024
Lotemax is a registered trademark of Bausch & Lomb Incorporated or its affiliates.
©Bausch & Lomb Incorporated