Lubri-Tears

1. Name Of The Medicinal Product

LUBRI-TEARS eye ointment

2. Qualitative And Quantitative Composition

White soft paraffin 60% w/w

Liquid paraffin 30% w/w

Wool fat 10% w/w

3. Pharmaceutical Form

Eye ointment.

A soft yellowish ointment.

4. Clinical Particulars

4.1 Therapeutic Indications

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

4.2 Posology And Method Of Administration

Adults (including the elderly) and Children

Pull down the lower eyelid and place a small quantity in the conjunctival sac. Use as required.

4.3 Contraindications

Hypersensitivity to the active ingredients.

4.4 Special Warnings And Precautions For Use

To avoid contamination during use, do not allow the tube tip to touch any surface. Close the tube after each application.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Suitable for use in pregnancy and lactation.

4.7 Effects On Ability To Drive And Use Machines

Application of the ointment may cause blurring of vision. Patients should be advised not to drive or operate machinery if affected.

4.8 Undesirable Effects

None known.

4.9 Overdose

Not applicable.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

White soft paraffin, liquid paraffin and wool fat provide a bland preparation of a consistency suitable for application as an ophthalmic ointment. The preparation reduces ocular dryness and provides corneal protection where prolonged contact time is appropriate. These materials are commonly used in ophthalmic preparations.

5.2 Pharmacokinetic Properties

None.

5.3 Preclinical Safety Data

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

6. Pharmaceutical Particulars

6.1 List Of Excipients

None.

6.2 Incompatibilities

None known.

6.3 Shelf Life

5 years (unopened), 1 month (after first opening).

6.4 Special Precautions For Storage

Do not store above 30°C. Discard 1 month after opening.

6.5 Nature And Contents Of Container

Aluminium tube with nozzle and screw on sealed polypropylene cap. The tube contains 5g of ointment.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Alcon Laboratories (UK) Limited

Pentagon Park,

Boundary Way,

Hemel Hempstead,

Hertfordshire, HP2 7UD,

England

8. Marketing Authorisation Number(S)

PL 00649/0143

9. Date Of First Authorisation/Renewal Of The Authorisation

22 December 1995

10. Date Of Revision Of The Text

July 2004