LACRI-LUBE^® Eye ointment

REFRESH NIGHT TIME^® Eye ointment

No pharmacologically active ingredient is present.

For full list of excipients, see section 6.1.

Eye ointment.

Smooth, homogeneous, off-white, preservative-free ointment.

As adjunctive therapy to lubricate and protect the eye in conditions such as exposure keratitis, decreased corneal sensitivity, recurrent corneal erosions, keratitis sicca, ophthalmic and non-ophthalmic surgery.

For topical ocular administration.

Pull lower eye lid down to form a pocket and apply small amount as required.

There is no variation in dosage for age.

Hypersensitivity to wool alcohols or to any of the excipients.

To avoid contamination during use, do not touch the tube tip to any surface.

Wash hands before administration of product.

If irritation, pain, redness and changes in vision occur or worsen, treatment discontinuation should be considered and a re-evaluation of the patient's condition should be made.

Contact lenses should not be worn during instillation of the drug. After instillation there should be an interval of at least 30 minutes before reinsertion.

In circumstances where concomitant topical ocular medication is necessary, there should be an interval of at least 5 minutes between the two medications. LACRI-LUBE^® / REFRESH NIGHT TIME^® should always be the last medication instilled.

To avoid injury to the eye do not allow the tube tip to come into contact with the eye during application of the product.

No interactions have been observed with LACRI-LUBE^® / REFRESH NIGHT TIME^®. Since the constituents have a well-established medicinal use, no interactions are anticipated.

Pregnancy:

No effects during pregnancy are anticipated since there is no systemic exposure of the pregnant woman to a pharmacologically active substance.

Breastfeeding:

No effects on the breastfed infant are anticipated since there is no systemic exposure of the breast-feeding woman to a pharmacologically active substance.

Fertility:

There are no known fertility implications with the use of LACRI-LUBE.

May cause transient blurring of vision. Do not drive or use machinery unless vision is clear.

No adverse events have been reported in clinical trials. All adverse events recorded below were identified in post-marketing reports.

The frequency of adverse reactions documented from spontaneous post-marketing reporting is given below and is defined as follows: Not Known (cannot be estimated from available data).

Within each frequency grouping, the undesirable effects are presented in order of decreasing seriousness:

Eye Disorders:

Not known:      Eye pain (including stinging), eye irritation (including burning sensation), eye allergy, vision blurred, eye swelling, eye inflammation, eyelid oedema, eye pruritus, eye discharge, foreign body sensation, ocular/conjunctival hyperaemia, eyelid erythema, lacrimation increased.

Immune System disorders:

Not known:      Hypersensitivity

Accidental topical ocular overdosage will present no hazard, apart from a potential transient effect on vision (see section 4.7).

Pharmacotherapeutic group (ATC code) = S01X A 20.

The ingredients of LACRI-LUBE^® / REFRESH NIGHT TIME^® are pharmacologically inert, bland oleaginous substances for lubrication and to maintain hydration of the ocular surfaces by occlusion.

Not applicable.

No information.

White soft paraffin (white petroleum jelly)

Liquid paraffin

Wool alcohols

Not applicable

Shelf life of the medicinal product as packaged for sale = 36 months.

Shelf life after first opening of container = 1 month.

Do not store above 25°C.

Epoxy-phenolic lined collapsible aluminium tube with a black polyethylene screw cap. The tube contains 3.5 g or 5.0g of eye ointment.

Not all pack sizes may be marketed.

Dispensing under medical prescription or sale from registered pharmacies.

Discard any unused product 1 month after first opening.

Allergan Ltd

Marlow International

The Parkway

Marlow

Bucks

SL7 1YL

United Kingdom

PL 00426/0041

Date of first authorisation: 5 November 1981

Date of latest renewal: 23 July 2003

24^th January 2012