Lotemax 0.5% w/v eye drops, suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Loteprednol etabonate

Available from:

Dr. Gerhard Mann, chem.-pharm. Fabrik GmbH

ATC code:

S01BA; S01BA14

INN (International Name):

Loteprednol etabonate

Dosage:

0.5 percent weight/volume

Pharmaceutical form:

Eye drops, suspension

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Corticosteroids, plain; loteprednol

Authorization status:

Not marketed

Authorization date:

2006-11-10

Patient Information leaflet

Eye Drops, Suspension
Loteprednol Etabonate
PACKAGE LEAFLET: INFORMATION FOR THE USER
WHAT IS IN THIS LEAFLET
1. What Lotemax is and what it is used for
2. What you need to know before you use Lotemax
3. How to use Lotemax
4. Possible side effects
5. How to store Lotemax
6. Contents of the pack and other 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. WHAT YOU NEED TO KNOW BEFORE YOU USE LOTEMAX
DO NOT USE LOTEMAX:
•
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.
WARNINGS AND PRECAUTIONS
•
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 e

Summary of Product characteristics

Health Products Regulatory Authority
11 January 2021
CRN009Z8J
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lotemax 0.5% w/v eye drops, suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The suspension contains 0.5%w/v loteprednol etabonate (5 mg/ml).
Each drop contains 0.19 mg loteprednol etabonate.
Excipient with known effect: Benzalkonium Chloride (0.01%)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye-drops, suspension.
Milky-white.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of post-operative inflammation following ocular surgery.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and elderly_
One to two drops four times daily beginning 24 hours after surgery and
continuing throughout the post-operative period.
The duration of treatment should not exceed 2 weeks.
_Paediatric Population_
Lotemax should not be used in the paediatric age group until further
data become available.
Method of administration
Ocular use
Shake the bottle vigorously before using the eye drops.
This product is sterile when packaged. Patients should be advised not
to allow the dropper tip to touch any surface, as this
may contaminate the suspension. The bottle should be closed
immediately after use.
4.3 CONTRAINDICATIONS
Lotemax is contraindicated in most viral diseases of the cornea and
conjunctiva including epithelial herpes simplex keratitis
(dendritic keratitis), vaccinia, varicella, and also in mycobacterial
infection of the eye and fungal diseases of ocular structures;
untreated purulent acute infections which, similar to other infectious
diseases, can be masked and worsened by corticoids, ‘red
eye’ with unknown diagnosis and infection caused by amoeba.
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1 or to other corticosteroids.
Health Products Regulatory Authority
11 January 2021
CRN009Z8J
Page 2 of 7
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Prolonged use of corticosteroids may result in ocu