LOTEMAX Eye-drops, suspension Ref.[9454] Active ingredients: Loteprednol

Prolonged use of corticosteroids may result in ocular hypertension or glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. Steroids should be used with caution in the presence of glaucoma.

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

Prolonged use of corticosteroids may suppress the host response and may increase the possibility of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection.

Long term treating with corticosteroids can cause fungal disease. Fungal disease should be considered in the differential diagnosis when a corneal ulcer persists.

Lotemax contains benzalkonium chloride which may cause eye irritation.

In general patients should not wear contact lenses after cataract surgery, unless contact lens wearing is medically indicated.

Contact with soft contact lenses should be avoided. Patients should be advised to remove contact lenses prior to application and wait at least 15 minutes before reinsertion. Known to discolour soft contact lenses.

If signs and symptoms fail to improve after two days, the patient should be re-evaluated. If this product is used for 10 days or longer, intraocular pressure should be monitored.

Since loteprednol etabonate is not detected in plasma following the topical administration of Lotemax, it is not expected to affect the pharmacokinetics of systemically administered medicinal products. However, the low potential of ocular loteprednol etabonate eye drops to increase the intraocular pressure may be adversely affected by systemically administered medicinal products with anticholinergic activity. In patients receiving concomitant ocular hypotensive therapy, the addition of loteprednol etabonate may increase intraocular pressure and decrease the apparent ocular hypotensive effect of these medicinal products.

Concurrent administration of cycloplegics may increase the risk of raised intraocular pressure.

Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweights the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.

Pregnancy

For Lotemax no clinical data on exposed pregnancies are available. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown and Lotemax should not be used in pregnancy unless clearly necessary.

Breastfeeding

It is not known whether loteprednol etabonate is excreted in human milk. Excretion of loteprednol etabonate in breast milk has not been investigated in animal studies. Therefore, the use of loteprednol etabonate is contraindicated in lactating women.

No studies on the effects on the ability to drive and use machines have been performed.

If there are any transient effects on vision, the patient should be advised to wait until these subside before driving or operating machinery.

Reactions associated with ophthalmic steroids include elevated intraocular pressure in steroid responsive patients, which may be associated with optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera.

Ocular adverse reactions occurring in patients treated with loteprednol etabonate ophthalmic suspension in clinical studies included the following:

All undesirable effects have been classified as follows very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000, <1/100), rare (>1/10,000, <1/1000), or very rare (<1/10,000), not known (cannot be estimated from the available data).

Eye disorders

Common: Corneal defect, eye discharge, ocular discomfort, dry eye, epiphora, foreign body sensation in eyes, conjunctival hyperaemia and ocular itching.

Uncommon: Abnormal vision, chemosis, keratoconjunctivitis, conjunctivitis, iritis, eye irritation, eye pain, conjunctival papillae, photophobia and uveitis.

Not known: Vision blurred (see also section 4.4).

Some of these events were similar to the underlying ocular disease being studied

Non-ocular events possibly related to treatment occurring in patients included:

Infections and infestations

Uncommon: Pharyngitis

Rare: Urinary tract infection and urethritis

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Rare: Breast neoplasm

Psychiatric disorders

Rare: Nervousness

Nervous system disorders

Common: Headache

Rare: Migraine, taste perversion, dizziness, paresthesia

Ear and labyrinth disorders

Rare: Tinnitus

Respiratory, thoracic and mediastinal disorders

Uncommon: Rhinitis

Rare: Cough

Gastrointestinal disorders

Rare: Diarrhoea, nausea and vomiting

Skin and subcutaneous tissue disorders

Rare: Face oedema, urticaria, rash, dry skin and eczema

Musculoskeletal and connective tissue disorders

Rare: Twitching

General disorders and administration site conditions

Common: Instillation site burning

Uncommon: Asthenia

Rare: Chest pain, chills, fever and pain

Investigations

Rare: Weight gain

In a summation of controlled, randomised studies of individuals treated for 28 days or longer with loteprednol etabonate, the incidence of significant elevation of intraocular pressure (≥10 mmHg) was 2% (15/901) among patients receiving loteprednol etabonate, 7% (11/164) among patients receiving 1% prednisolone acetate and 0.5% (3/583) among patients receiving placebo.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via: United Kingdom: Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard.

In the absence of incompatibility studies, this medicinal product must not be mixed with other medicinal products.