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BAUSCH+LOMB

Lotemax® 0.5% w/v

Eye Drops, Suspension loteprednol etabonate

PACKAGE LEAFLET: INFORMATION FOR THE USER

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 25°C. 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.

IE: Dr. Gerhard Mann chem.-pharm. Fabrik GmbH Brunsbutteler Damm 165-173 13581 Berlin Germany

PA 1245/001/001

Manufacturer

Dr. Gerhard Mann chem.-pharm. Fabrik GmbH Brunsbutteler 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-Upon-Thames, Surrey, KT2 6TN, UK.

Lotemax is a registered trademark of Bausch & Lomb Incorporated.

© Bausch & Lomb Incorporated.

9218701 (Flat) 9218801 (Folded)