OPTI-FREE® Enzymatic Cleaner Effervescent Tablets

INDICATIONS CONTRA-INDICATIONS DOSAGE SIDE-EFFECTS PREGNANCY OVERDOSE IDENTIFICATION PATIENT INFORMATION

OPTI-FREE® Enzymatic Cleaner Effervescent Tablets

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

OPTI-FREE^® Enzymatic Cleaner Effervescent Tablets

COMPOSITION:
OPTI-FREE^® Enzymatic Cleaner contains 1,25 mg purified pancreatin per tablet.

PHARMACOLOGICAL CLASSIFICATION:
A.34 Contact lens preparations

PHARMACOLOGICAL ACTION:
OPTI-FREE Enzymatic Cleaner breaks up protein and other tear deposits (e.g. lipids, mucins) on the lens surface to facilitate their removal, and when dissolved in OPTI-FREE Rinsing, Disinfecting and Storage Solution, disinfects the lens.

INDICATIONS:
OPTI-FREE Enzymatic Cleaner is dissolved in OPTI-FREE Rinsing, Disinfecting and Storage Solution or a similar product for the combined weekly enzymatic cleaning and disinfection of soft (hydrophilic) contact lenses in one step.

For use as recommended by an eye care practitioner.

CONTRA-INDICATIONS:
Persons who are allergic to pork should not use this product.

WARNINGS:
PROBLEMS WITH CONTACT LENSES AND LENS CARE PRODUCTS COULD RESULT IN SERIOUS INJURY TO THE EYE. It is essential to follow an eye care practitioner's directions and all labelling instructions for proper use of lenses and lens care products. EYE PROBLEMS, INCLUDING CORNEAL ULCERS, CAN DEVELOP RAPIDLY AND LEAD TO LOSS OF VISION: THEREFORE, IF EYE DISCOMFORT, EXCESSIVE TEARING, VISION CHANGES, REDNESS OF THE EYE, SHOULD BE EXPERIENCED, IMMEDIATELY REMOVE LENSES AND PROMPTLY CONTACT AN EYE CARE PRACTITIONER.

•	All contact lens wearers must see an eye care practitioner as directed. If lenses are for extended wear more frequent visits may be prescribed.
•	OPTI-FREE Enzymatic Cleaner is NOT for use directly in the eye or for internal use.
•	DO NOT USE DISTILLED WATER OR TAP WATER TO DISSOLVE THE TABLETS.

DOSAGE AND DIRECTIONS FOR USE:

•	Always wash and rinse the hands before handling contact lenses.
•	Always handle one lens, the right or left, first to avoid mix-ups.

Step I

•	Fill the lens case up to the fill line (10 mL) with OPTI-FREE Rinsing, Disinfecting and Storage Solution or a similar product. DO NOT USE DISTILLED OR TAP WATER.

Step II

•	Clean lenses with a daily cleaner and then place lenses in the appropriate baskets (R for right, L for left).
•	Drop one OPTI-FREE Enzymatic Cleaner tablet into the lens case. The tablet will rapidly dissolve.

Step III

•	Soak the lenses in the enzyme solution overnight (for a minimum of 8 hours)

Step IV

•	Remove lenses from the cleaning and disinfecting solution.
•	Rinse thoroughly with OPTI-FREE Rinsing, Disinfecting and Storage Solution or a similar product to remove all traces of loosened deposits and enzyme solution.
•	Discard any remaining solution, rinse the lens case thoroughly with tap water and allow to air dry. Do not use soap or detergent.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The following problems may occur:

•	Eyes stinging, burning or itching (irritation)
•	Excessive watering (tearing) of the eyes
•	Unusual eye secretions
•	Redness of the eyes
•	Reduced sharpness of vision (visual acuity)
•	Blurred vision
•	Sensitivity to light (photophobia)
•	Dry eyes

If any of the above problems should be noticed immediately remove and examine the lenses. If the problem stops and the lenses appear to be undamaged, thoroughly clean, rinse and disinfect the lenses and reinsert them. If the problem continues or a lens appears to be damaged, immediately remove the lenses and immediately consult an eye care practitioner.

If any of the above symptoms occur, a serious condition such as infection, corneal ulcer, neovascularization or iritis may be present. Seek immediate professional identification of the problem and treatment to avoid serious eye damage.

No finality has been reached on the long-term safety of soft contact lens preparations.

PRECAUTIONS:
ONLY FOR USE WITH OPTI-FREE RINSING, DISINFECTING AND STORAGE SOLUTION.

•	Use only freshly prepared enzyme cleaning solution and discard immediately after use.
•	Use only the lens case designed for use with OPTI-FREE Enzymatic Cleaner for soaking lenses. Do not use any other container.
•	Do not use tablet if it is brown in colour.
•	Lenses should never be placed directly on the eyes from the cleaning solution. Lenses must always be rinsed after each cleaning/disinfecting procedure.

NOTE: Failure to rinse lenses may cause discomfort due to debris remaining on the lens.

•	The cleaning solution is not intended for storage of lenses.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Please see Side-effects above.

IDENTIFICATION:
White, round, biconvex, effervescent tablet with a diameter of 4,6 mm.

PRESENTATION:
Carton containing strip packs of 12 or 24 tablets.

STORAGE INSTRUCTIONS:
Store at room temperature, below 25°C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
28/34/0225

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Alcon Laboratories (SA) (Pty) Ltd
Surrey Avenue
RANDBURG 2194

DATE OF PUBLICATION OF THIS PACKAGE INSERT:

1 November 1993

35639-A