Lotemax 0.5% w/v Eye Drops, Suspension

• Keep this 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Lotemax is and what it is used for
2. What you need to know before you use (Invented name)
3. How to use Lotemax)
4. Possible side effects
5. How to store Lotemax
6. Contents of the pack and other information

• if you are allergic to the active substance (loteprednol) or any of the other ingredients of this medicine (listed in section 6).
• 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.

Tell your doctor if you already have glaucoma.

Contact your doctor if you experience blurred vision or other visual disturbances.

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.

Contact lenses

Wearing contact lenses is not recommended after cataract surgery. If you normally wear contact lenses, your doctor will recommend you use glasses for a time following cataract surgery. This is to allow your eyes to recover from the procedure. Your doctor will advise you when you can use contact lenses again (see also “(Lotemax contains benzalkonium chloride”).

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially, tell you doctor if you use:

• medicines known as anticholinergics (used to treat a variety of conditions, e.g. gastrointestinal cramps, muscular spasms, urge incontinence or asthma)
• eye drops for the treatment of high pressure in the eye.

Some medicines may increase the effects of Lotemax and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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.

Eye drops can cause your vision to be blurred. This usually passes quickly. Do not drive or use machines until your vision is clear.

This medicine contains 0.0152 mg benzalkonium chloride in each dosage unit (2 drops) which is equivalent to 0.20 mg/1 ml.

Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using this medicine and put them back 15 minutes afterwards.

Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.

• 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 and adolescents until further data becomes available.

Tell your doctor or a pharmacist.

Do not take a double dose to make up for a forgotten dose.

Wait until the next dose and then continue as before.

Always use this medicine exactly as your doctor has told you. Do not stop using Lotemax without speaking to your doctor first.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:

United Kingdom

or search for MHRA Yellow Card in the Google Play or Apple App Store.

Ireland

By reporting side effects you can help provide more information on the safety of this medicine.

• 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.

Lotemax is a milky-white eye-drops suspension.

Lotemax is available in bottles containing 2.5 mL, 5 mL or 10 mL.

Not all pack sizes may be marketed.

IE:

UK: