Alcon Laboratories (U.K) Limited

MAXIDEX 0.1% w/w Eye Ointment

1 g of ointment contains 1 mg dexamethasone

Excipients: Also contains Methyl parahydroxybenzoate (E218) 0.05% w/w

Propyl parahydroxybenzoate (E216) 0.01% w/w

For a full list of excipients, see section 6.1.

Eye ointment

A colourless to pale straw coloured slightly transparent ointment.

Indicated for the treatment of allergic and inflammatory conditions of the eye

Apply a small amount into the conjunctival sac 3-4 times daily for 3-4 days or until a satisfactory response occurs.

• Ocular viral infections such as vaccinia, varicella (except herpes zoster keratitis)

• Patients with a history of acute epithelial herpes simplex keratitis.

• Fungal disease of ocular structures and mycobacterial ocular infections.

• Acute, untreated purulent bacterial infections.

• Hypersensitivity to dexamethasone or to any of the excipients.

• For ocular use only.

• Prolonged use of topical ophthalmic corticosteroids may result in ocular hypertension and/or glaucoma, with damage to the optic nerve, reduced visual acuity and visual field defects, and posterior subcapsular cataract formation. In patients receiving prolonged ophthalmic corticosteroid therapy, intraocular pressure and the lens should be checked routinely and frequently, particularly in patients with a history or presence of glaucoma.

• Corticosteroid usage may reduce resistance to and aid in the establishment of bacterial, viral and fungal infections and mask the clinical signs of infections, preventing recognition of ineffectiveness of the antibiotic. Fungal infection should be suspected in patients with persistent corneal ulceration who have been or are receiving these drugs, and corticosteroids therapy should be discontinued if fungal infection occurs.

• Topical corticosteroids should not be used for longer than one week except under ophthalmic supervision, with regular checks of intraocular pressure.

• Topical ophthalmic corticosteroids may slow corneal wound healing.

• Topical steroids may induce corneal perforation. Topical steroids may lead to perforation if used in the presence of the diseases causing thinning of the cornea or sclera.

• Use with great caution, and only in conjunction with antiviral therapy, in the treatment of stromal keratitis or uveitis caused by herpes simplex; periodic slit-lamp microscopy is essential.

• There is no evidence of safety in use in children under two years of age.

• Contact lens wear is not recommended during treatment of an ocular inflammation.

No interaction studies have been performed.

If more than one topical ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart. Eye ointments should be administered last.

Pregnancy

There are no or limited amount of data from the use of Maxidex in pregnant woman. Studies in animals have shown reproductive toxicity (see section 5.3).

Maxidex is not recommended during pregnancy.

Lactation

Systemically administered corticosteroids appear in human milk in quantities that could affect the child being breastfed. However, when instilled topically, systemic exposure is low. It is unknown whether Maxidex is excreted in human milk. A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Maxidex therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Maxidex has no or negligible influence on the ability to drive and use machines. As with any topical ophthalmic medicinal product, temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs upon instillation, the patient must wait until the vision clears before driving or using machinery.

Summary of the safety profile

In clinical trials, the most common adverse reaction was ocular discomfort.

Tabulated list of adverse reactions

The following adverse reactions are classified according to the following convention:

very common ( 1/10), common ( 1/100 to <1/10), uncommon (1/1,000 to <1/100), rare (1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the available data). Within each frequency-grouping, adverse reactions are presented in order of decreasing seriousness. The adverse reactions have been observed during clinical trials and post-marketing experience with Maxidex.

Description of selected adverse reactions

Prolonged topical ophthalmic corticosteroids may result in increased intraocular pressure with damage to the optic nerve, reduced visual acuity and visual field defects, and to posterior subcapsular cataract formation (see section 4.4).

Due to the corticosteroid component, in diseases causing thinning of the cornea or sclera there is a higher risk for perforation especially after long treatments (see section 4.4).

Corticosteroids may reduce resistance to and aid in the establishment of infections (see section 4.4).

Long-term intensive topical use may lead to systemic effects. Oral ingestion of the contents of one tube is unlikely to lead to any serious adverse effects.

An ocular overdose of Maxidex can be flushed from the eye(s) with lukewarm water.

Pharmacotherapeutic Group - Ophthalmologicals: Anti-inflammatory Agents

ATC Code SO1B A01.

Dexamethasone is a synthetic glucocorticoid with a potent anti-inflammatory activity. The relative anti-inflammatory potency of dexamethasone is 25 times that of cortisone, but its effects on sodium and water retention, potassium loss and abnormal sugar metabolism are minimal.

Dexamethasone, like other corticosteroids, is absorbed rapidly after oral administration and has a biological half-life of about 190 minutes. Sufficient absorption may occur after topical application to the skin and eye to produce systemic effects. Intraocular penetration of dexamethasone occurs in significant amounts and contributes to the effectiveness of dexamethasone in anterior segment inflammatory disease.

Repeat dose topical ocular safety studies with dexamethasone in rabbits have shown systemic corticosteroid effects. Such effects are considered to be unlikely when Maxidex is used as recommended.

Dexamethasone was clastogenic in the in vitro human lymphocyte assay and in vivo in the mouse micronucleus assay at doses in excess of those obtained following topical application. Conventional carcinogenicity studies with Maxidex have not been performed.

Dexamethasone has been found to be teratogenic in animal models. Dexamethasone induced abnormalities of foetal development including cleft palate, intra-uterine growth retardation and affects on brain growth and development.

There are no other preclinical data of relevance to the prescriber which are additional to that included in other sections of the SPC.

Anhydrous liquid lanolin

Methyl parahydroxybenzoate (E218)

Propyl parahydroxybenzoate (E216)

White Soft Paraffin

Not applicable.

4 years (unopened).

Discard 4 weeks after first opening.

Do not store above 25°C. Do not refrigerate or freeze. Discard 4 weeks after first opening.

3.5g collapsible tin tube with an ophthalmic dispensing nozzle and HDPE screw cap.

No special requirements

Alcon Laboratories (UK) Ltd.

Pentagon Park

Boundary Way

Hemel Hempstead

Herts., HP2 7UD, U.K.

PA 290/56/2

Date of first authorisation: 05 January 1984

Date of last renewal: 05 January 2009

March 2011