SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

LACRI-LUBE® Eye ointment REFRESH NIGHT TIME® Eye ointment

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

No pharmacologically active ingredient is present.

For full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Eye ointment.

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

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

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.

4.2 Posology and method of administration

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.

Contraindications

Hypersensitivity to wool alcohols or to any of the excipients.

4.4. Special warnings and precautions for use

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.

4.5 Interaction with other medicinal products and other forms of interaction

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

4.6. Pregnancy and lactation

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.

4.7 Effects on ability to drive and use machines

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

Undesirable effects

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 postmarketing 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:

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

4.9. Overdose

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

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

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.

5.2 Pharmacokinetic properties

Not applicable.

5.3 Preclinical safety data

No information.

6    PHARMACEUTICAL PARTICULARS

6.1 List of excipients

White soft paraffin (white petroleum jelly)

Liquid paraffin Wool alcohols

6.2. Incompatibilities

Not applicable

6.3    Shelf life

Shelf life of the medicinal product as packaged for sale = 36 months. Shelf life after first opening of container = 1 month.

6.4 Special precautions for storage

Do not store above 25°C.

Nature and contents of container