LACRI-LUBE EYE OINTMENT

LACRI-LUBE Eye Ointment

There is no specific active ingredient.

Excipients: 1g of LACRI-LUBE contains 2mg wool alcohols

For a full list ofexcipients, see section 6.1.

Eye ointment

Smooth, homogenous, off white, sterile ophthalmic ointment.

As a lubricant and for protection in dry eye.

A small amount of ointment as needed or directed by the physician into the topical instillation into the conjunctival sac.

Use in patients hypersensitive to lanolin alcohols or to any of the excipients.

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.

Wool alcohols may cause local skin reactions (e.g. Contact dermatitis)

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 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. 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

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:

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

Pharmacotherapeutic group (ATC code) = S01X A20.

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

Not applicable.

Not applicable.

White soft paraffin (white petroleum jelly)

Liquid paraffin

Wool alcohols

Not applicable

Unopened: 3 years.

Opened: 1 month (28 days).

Do not store above 25°C.

An aluminium tube with an ophthalmic delivery tip, an inner coating of protective lacquer and a polyethylene cap, containing 3.5g or 5g of sterile ophthalmic ointment.

Not all pack sizes may be marketed.

No special requirements.

Allergan Pharmaceuticals Ireland

Castlebar Road

Westport

Co. Mayo

PA 148/38/1

Date of first authorisation: 25 January 1984

Date of last renewal: 25 January 2009

December 2014