LOTEMAX 0.5% EYE DROPS SUSPENSION

Active substance: LOTEPREDNOL ETABONATE

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Eye Drops, Suspension
loteprednol etabonate
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start using this medicine.
Keep this leaflet. You may need to read it again.
If you have any questions, please ask your doctor or your pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their
symptoms are the same as yours.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
In this leaflet:
1. What Lotemax is and what it is used for
2. Before you use Lotemax
3. How to use Lotemax
4. Possible side effects
5. How to store Lotemax
6. Further information
1. What Lotemax is and what it is used for
Lotemax is an eye drop suspension.
Lotemax is used to treat inflammation of the eye, after surgery.
Sometimes the eye may become inflamed (red and painful). Loteprednol etabonate is one of a group of
medicines called corticosteroids. It acts by reducing inflammation and eases the symptoms. Because it is
used in low doses directly where it is needed, its action is only at this place.
2. Before you use Lotemax
Do not use Lotemax:
• if you are allergic (hypersensitive) to the active substance (loteprednol) or any of the other ingredients
(refer to the end of this leaflet).
• if you have been allergic to any other corticosteroid.
• if you have eye diseases caused by viruses such as herpes simplex, vaccinia, and varicella.
• if you have eye diseases caused by mycobacterium and fungi.
• If you are breast-feeding.
Take special care with Lotemax:
• Tell your doctor if you already have glaucoma.
• Tell your doctor if pain develops, or if redness, itching, or inflammation gets worse.
• See your doctor if your symptoms do not get better within 2 days. He/she may want to re-evaluate
your condition.
• You should not use Lotemax longer than 10 days without having the pressure in your eye checked by
your doctor.
• Long-term use of Lotemax or other eye drops that contain steroids, may result in glaucoma or raised
pressure in the eye, which can cause damage to the optic nerve, problems with vision, and cataracts.
• Long-term use of Lotemax or other eye drops that contain steroids, may lower your ability to fight
infections and may increase your chance of getting an eye infection including herpes simplex.
• Using steroid eye drops like Lotemax may make viral diseases of the eye worse and last longer.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken:
• any other medicines, including medicines obtained without a prescription
• other treatments such as anticholinergics
• other ocular therapies used to decrease the pressure inside the eye
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine in case of known or suspected
pregnancy. It is possible that you may still receive Lotemax, but it is also possible that an alternative may
be used.
Lotemax should not be used when breast-feeding.
Driving and using machines
Eye drops can cause your vision to be blurred. This usually passes quickly. Do not drive or use machines until
your vision is clear.
Important information about some of the ingredients of Lotemax
The preservative Benzalkonium chloride may cause eye irritation.
Contact lenses
Avoid contact with soft contact lenses. Remove contact lenses prior to application and wait at least 15
minutes before reinsertion. Benzalkonium chloride is known to discolour soft contact lenses.
3. How to use Lotemax
Always use Lotemax exactly as your doctor has told you. Treatment with Lotemax normally begins 24 hours
after surgery and continues for two weeks.
For Adults:
• Shake Lotemax well before using.
• Look upwards and gently pull down the lower eyelid of the affected eye(s).
• Apply one to two drops of Lotemax into the gap between your eyeball and eyelid, four times a day or as
directed by your doctor.
• Do not allow the tip of the dropper to touch any surface because this may contaminate the medicine.
• The bottle should be closed immediately after use.
• Your doctor will tell you how long your treatment with Lotemax will last.
• Do not stop treatment without talking with your doctor.
Lotemax should not be used in children until further data becomes available.
If you use more Lotemax than you should
Tell your doctor or a pharmacist.
If you forget to use Lotemax
Do not take a double dose to make up for a forgotten dose.
Wait until the next dose and then continue as before.

4. Possible side effects
Like all medicines, Lotemax can cause side effects, although not everybody gets them.
Signs of a severe ocular allergic reaction include: redness, itching, swelling of the membrane covering the
white part of the eye and/or eyelid(s).
However general signs such as difficulty breathing, difficulty swallowing, flushing or redness of the face and
swelling of the face, eyes, or tongue, may be reported in the case of severe allergic reaction.
Eye Disorders
Common: Corneal defect, eye discharge, ocular discomfort, dry eye, tearing, foreign body sensation
in eyes, eye redness, ocular itching, burning sensation at the site of instillation and rise in
intra-ocular pressure.
Uncommon: Abnormal vision, blurring of vision, conjunctiva swelling, conjunctivitis, iris inflammation,
eye irritation, eye pain, fine elevations on the conjunctiva, light sensitivity, ocular
inflammation, inflammation of the cornea and conjunctiva, ocular infection and lens
opacification.
Non-ocular events possibly related to treatment:
Common: Headache
Uncommon: Fatigue, running nose and sore throat
Rare:
Migraine, taste change, sensation of vertigo, numbness, chest pain, chills, fever and pain,
cough, urinary tract infection or inflammation, face swelling, urticaria, rash, dry skin,
eczema, diarrhoea, nausea and vomiting, weight gain, noise in the ears, breast cancer,
involuntary muscular contractions and nervousness.
If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
5. How to store Lotemax
Keep out of the reach and sight of children.
Store the container in an upright position.
Do not store above 25ºC. Do not freeze.
Do not use Lotemax after the expiry date which is stated on the carton and bottle after expiry. The expiry
date refers to the last day of the month.
Throw away any solution 28 days after opening.
DO NOT USE IF PROTECTIVE SEAL IS BROKEN
6. Further information
What Lotemax contains
• The active ingredient is Loteprednol Etabonate. Each ml contains 5 mg (0.5%) Loteprednol Etabonate.
• The other ingredients are Disodium Edetate, Glycerol, Povidone, Purified Water and Tyloxapol.
• Benzalkonium Chloride (0.01%) is added as a preservative.
• Sodium Hydroxide and/or Hydrochloric Acid are added to adjust the pH.
Contents of the pack
Lotemax is available in 5ml bottles.
Marketing Authorisation Holder
UK: Bausch & Lomb GmbH
IE: Dr. Gerhard Mann chem.-pharm. Fabrik GmbH
Brunsbütteler Damm 165-173 Brunsbütteler Damm 165-173
13581 Berlin 13581 Berlin
Germany Germany


PL 17947/0001 PA 1245/001/001

Manufacturer
Dr. Gerhard Mann chem.-pharm. Fabrik GmbH
Brunsbütteler Damm 165-173
13581 Berlin
Germany
DATE OF LEAFLET: October 2012
For any information about this medicine, please contact Bausch & Lomb, 106 London Road, Kingston-UponThames, Surrey, KT2 6TN, UK.
Lotemax is a registered trademark of Bausch & Lomb Incorporated.
© Bausch & Lomb Incorporated.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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