BAUSCH & LOMB FizziClean® Cleaning Tablets

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

BAUSCH & LOMB FizziClean® Cleaning Tablets

SCHEDULING STATUS:
Not Scheduled.

PROPRIETARY NAME
(and dosage form)

BAUSCH & LOMB FizziClean^® Cleaning Tablets

COMPOSITION:
Each tablet contains:

	Proteolytic Enzyme Powder II	25,0 mg
	Sodium Carbonate	12, 0 mg
	Sodium Chloride	87,0 mg
	Tartaric Acid	10,0 mg
	Polyethylene Glycol 3350	6,0 mg

PHARMACOLOGICAL CLASSIFICATION:
A 34 (Other) Contact Lens Preparation.

PHARMACOLOGICAL ACTION:
BAUSCH & LOMB FIZZICLEAN CLEANING TABLETS loosen surface deposits which adhere to contact lenses, and thereby facilitate their removal.

INDICATIONS:
Removal of surface deposits from contact lenses.

CONTRA-INDICATIONS:
Sensitivity to any of the ingredients.

WARNINGS:
Tablets must not be ingested.

DOSAGE AND DIRECTIONS FOR USE:
The cleaning process with BAUSCH & LOMB FIZZICLEAN CLEANING TABLETS should be carried out once-a-week, unless otherwise directed by an eye care practitioner, using one tablet per contact lens.

DIRECTIONS:
Rinse the lens case and fill each compartment with Preserved Saline Solution or Bausch & Lomb Multi-Purpose Solution. Dissolve one Bausch & Lomb FizziClean Cleaning Tablet in each compartment. Place contact lens in this cleaning solution for 15 minutes to 12 hours. Contact lenses should not be soaked for less than 15 minutes. It is recommended that lenses should not remain in the cleaning solution for longer than 12 hours. After the required soaking period, remove the lenses from the lens case, rub and rinse the lenses with Daily Cleaner and Preserved Saline Solution, or Multi-Purpose Solution and proceed with disinfecting regimen, (either chemical or thermal disinfection). Lens case must be rinsed thoroughly after protein cleaning procedure.

Note: Lenses must be rinsed and disinfected before wearing, after the protein cleaning process.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:

1.	Lenses should never be placed directly on the eye from the protein cleaning solution –rinse and disinfect before resuming wear.
2.	Always wash hands thoroughly before handling lenses.
3.	Use only freshly prepared solution, and discard immediately after use. Do not re-use the cleaning solution.
4.	If eye irritation occurs and persists, discontinue use of Bausch & Lomb FizziClean Cleaning Tablets and consult an eye care practitioner.
5	Concurrent eye medication should not be used unless under professional supervision.
6.	Stinging, burning, itching, excessive watering, unusual secretions and redness of the eye. If any of the above problems occur, 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 the lens appears to be damaged, immediately consult an eye care practitioner.
7.	No finality has been reached on the long-term safety of contact lens solutions.

IDENTIFICATION:
Flat, off-while, mottled, bevelled edge circular tablet.

PRESENTATION:
Carton of 12 tablets (a six week supply) and 24 tablets (a twelve week supply) when used as recommended.

STORAGE INSTRUCTIONS:
Store below 25°C.
Protect from light.
KEEP OUT OF REACH OF CHILDREN
Not to be taken

REGISTRATION NUMBER:
X/34/93

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Soflens (Pty) Ltd
Corner Hammer Avenue and Standard Close
Strijdom Park
Randburg
2194.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
November 1993.

Bausch & Lomb and FizziClean are trademarks of Bausch & Lomb Incorporated, Rochester, New York.

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	Futura Offset	08/94