POLYZYM®

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

POLYZYM®

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

POLYZYM^®Effervescent Enzymatic Cleaning Tablets

COMPOSITION:
Each tablet contains 2,5 mg highly purified pancreatin.

PHARMACOLOGICAL CLASSIFICATION:
A.34 Contact lens preparations

PHARMACOLOGICAL ACTION:
Pancreatin is a preparation of mammalian pancreas containing enzymes with protease lipase and amylase activity. It hydrolyses fats, changes protein into proteoses and derived substances and converts starches into dextrins and sugars. POLYZYM^® enzymatic cleaning tablets loosen organic deposits on the lens surface to facilitate their removal.

INDICATIONS:
POLYZYM^® enzymatic cleaning tablets are indicated for weekly use in thermal or chemical lens care systems of daily and extended wear soft (hydrophilic) and rigid gas permeable (silicone/acrylate) contact lenses. For weekly use with soft (hydrophilic) and rigid gas permeable (silicone/acrylate) contact lenses dissolved in sterile preserved or unpreserved saline solutions to clean lenses or for weekly use with soft (hydrophilic) contact lenses dissolved in sterile hydrogen peroxide solutions to clean and disinfect in one step. For use as recommended by an eye care practitioner.
NOTE: Enzymatic cleaning is not a substitute for regular cleaning of contact lenses. Contact lenses must be cleaned and disinfected each time they are removed.

CONTRA-INDICATIONS:
Persons who are allergic to pancreatin 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 their eye care practitioner as directed. If lenses are for extended wear an eye care practitioner may prescribe more frequent visits.
•	POLYZYM enzymatic cleaning tablets are NOT for use directly in the eye or for internal use.

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.

DIRECTIONS FOR USE DISSOLVED IN SALINE SOLUTIONS TO CLEAN SOFT (HYDROPHILIC) AND RIGID GAS PERMEABLE (SILICONE/ACRYLATE) LENSES:
Fill the glass vials up to the fill line (5 mL) with sterile preserved or unpreserved saline solution. Because POLYZYM^® enzymatic cleaning tablets contain no preservatives, if sensitive to thiomersal use a thiomersal-free sterile preserved or an unpreserved saline solution. DO NOT USE DISTILLED OR ORDINARY TAP WATER. Drop one POLYZYM^® enzymatic cleaning tablet into each vial. The tablets will rapidly dissolve. After removing lenses clean each lens surface then rinse thoroughly with sterile preserved or unpreserved saline solution. Place each lens in the appropriate vial (R for right, L for left). Fasten caps on vials.
Soak the lenses in the enzyme solution for a minimum of 15 minutes.
If lenses are very dirty, have not been cleaned regularly or become uncomfortable, extending the soaking time for one hour or more is recommended.
NOTE: The solution is not a disinfecting solution; therefore, do NOT soak lenses in solution for more than 12 hours.
Remove lenses from the enzyme solution. Rinse thoroughly with sterile preserved or unpreserved saline solutions to remove all traces of loosened deposits and enzyme solution.
Gently rub lenses between thumb and forefinger or place lens in palm of hand and rub each side with forefinger. Rinse again with sterile preserved or unpreserved saline solution. Discard any remaining cleaning solution. Rinse the vials thoroughly with tap water and allow to air dry. Do not use soap or detergent. Disinfect the lenses in the usual manner with a suitable thermal or chemical disinfecting solution. After disinfection, rinse lenses thoroughly with a sterile preserved orunpreserved saline solution and insert.

DIRECTIONS FOR USE DISSOLVED IN HYDROGEN PEROXIDE TO CLEAN AND DISINFECT SOFT LENSES IN ONE STEP:
POLYZYM^® enzymatic cleaning tablets may be dissolved in sterile hydrogen peroxide as part of a chemical disinfection regimen for soft (hydrophilic) lenses. After removing lenses clean each lens surface, then rinse the lenses thoroughly by holding the lenses in a steady stream of sterile preserved orunpreserved saline solution or sterile hydrogen peroxide for about 10 seconds. When using hydrogen peroxide lenses should be cleaned and disinfected in the lens case provided as part of the hydrogen peroxide disinfection system. Add 1 or 2 POLYZYM^® tablets to the hydrogen peroxide disinfection lens case. If lenses stay clean and deposit free, one tablet may be sufficient. Follow the directions provided by the hydrogen peroxide manufacturer concerning filling of the lens case with hydrogen peroxide disinfection solution, disinfecting, neutralizing and rinsing. Keep lenses in disinfecting/cleaning solution for the disinfecting time recommended by the hydrogen peroxide manufacturer. Discard any remaining cleaning and disinfecting solution. Neutralise lenses as directed before wearing. Rinse the lens case 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 FOR USE DISSOLVED IN SALINE SOLUTIONS:

•	Use only freshly prepared enzyme cleaning solution and discard immediately after use.
•	Use only the special mixing vials provided with the POLYZYM^® package for soaking lenses. Do not use any other container.
•	Do not use the 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 and disinfected after each cleaning procedure.

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

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

PRECAUTIONS FOR USE DISSOLVED IN HYDROGEN PEROXIDE SOLUTIONS:

•	Use only freshly prepared enzyme cleaning and disinfecting solution and discard immediately after use.
•	Use only the lens case provided with the hydrogen peroxide system for cleaning and disinfecting the lenses.
•	Do not use the tablet if it is brown in colour.
•	Lenses should never be placed directly on the eyes from the cleaning and disinfecting solution. Follow the instructions for disinfection and neutralization in the hydrogen peroxide system.
•	Disinfect and neutralize for the length of time directed in the hydrogen peroxide system.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See side-effects above.

IDENTIFICATION:
White, round, biconvex, effervescent tablet with a diameter of 6,125 mm.

PRESENTATION:
Cartons containing strip packs of 8 or 24 tablets.

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

REGISTRATION NUMBER:
R/34/175

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

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
17 August 1989

0393

34411-5