Lotemax 0,5%

Package Leaflet: Information for the User

Warning! The leaflet must be kept. Information on the immediate packaging in a foreign language.

Lotemax 0.5% (Lotemax)

0.5% (5 mg/ml), eye drops, suspension
Loteprednol etabonate
Lotemax 0.5% and Lotemax are different trade names for the same medicine.

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

• The leaflet should be kept so that it can be read again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. 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, 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 alleviates 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 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.
• Lotemax 0.5% should not be used for more than 10 days without the doctor checking the eye pressure.
• 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 eye drops containing corticosteroids, 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").

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 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

This medicine contains 0.0152 mg of benzalkonium chloride in each dose (2 drops), which corresponds to

• 0.20 mg/ml. Benzalkonium chloride 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 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. If there are any 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.
Treatment with Lotemax 0.5% usually 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.
• Avoid touching the tip of the dropper bottle to 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 the 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%

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 the doctor.
If there are 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, facial swelling, tongue should stop
using this medicine and seek immediate medical attention.These may be symptoms of a severe allergic reaction.
If the following side effects occur, the doctor should be contacted immediately, as urgent medical attention may be necessary:

• Increased eye pain, especially when exposed to light, and eye redness during treatment with 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, 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, eyelid papillae, sensitivity to light, eye inflammation, keratitis, and 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 any side effects occur, including any side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be told. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +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 container 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 carton and bottle. The expiry date refers to the last day of the stated month.
Any unused suspension 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 needed. This will help protect the environment.

DO NOT USE IF THE SEAL IS BROKEN

6. Contents of the packaging and other information

What does Lotemax 0.5% contain?

• 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 (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:

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

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Lithuanian, in the country of export, license number: LT/1/05/0388/002

Parallel import license number: 185/19

Date of leaflet approval: 17.04.2024

[Information about the trademark]