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Logo OPTI-FREE® Multi-Action solution.

SCHEDULING STATUS:
S0

PROPRIETARY NAME
(and dosage form):

OPTI-FREE® Multi-Action solution.

COMPOSITION:
OPTI-FREE Multi-Action solution is part of the OPTI-FREE disinfection system. OPTI-FREE Multi-Action solution is a sterile buffered, isotonic aqueous solution containing a citrate buffer and
sodium chloride, with edetate disodium 0.05% (w/v) and polyquaternium-1 0.001% (w/v) as preservatives.

PHARMACOLOGICAL CLASSIFICATION:
A.34 Contact Lens Preparations

PHARMACOLOGICAL ACTION:
OPTI-FREEMulti-Action solution when used in a chemical disinfection system, destroys harmful micro-organisms on the surfaces of lenses.
OPTI-FREE Multi-Action solution also cleans soft (hydrophilic) lenses by removing deposits and debris from the lenses.

INDICATIONS:
CHEMICAL LENS CARE SYSTEM - For the cleaning, disinfection, rinsing and storage of daily and extended wear soft (hydrophilic) contact lenses including all types of disposable lenses. For use as recommended by an eye care practitioner.

CONTRA-INDICATIONS:
Hypersensitivity to any ingredient in OPTI-FREE Multi-Action solution.

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 direction 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 OR REDNESS OF THE EYE SHOULD BE EXPERIENCED, IMMEDIATELY REMOVE LENSES AND PROMPTLY CONTACT AN EYE CARE PRACTITIONER.

DOSAGE AND DIRECTIONS FOR USE:
General Precautions:
Always wash and rinse the hands before handling contact lenses.
Always handle the same lens, the right or left, first in order to avoid mixups.
Always use fresh OPTI-FREE Multi-Action solution in the lens storage case.
NOTE: After inserting the lenses, always empty the lens storage case, rinse and allow to air dry. Never re-use the solution in the lens storage case.
Use before the expiration date marked on the containers and cartons.
Clean the lenses weekly with an enzymatic cleaner.
Never touch the dropper tip of the container to any surface, since this may contaminate the solution.
Keep the containers tightly closed when not in use.
All contact lens wearers must see their eye care practitioner as directed. If the lenses are for extended wear an eye care practitioner may prescribe more frequent visits.
Directions for Use:
OPTI-FREEMulti-Action solution is used alone to clean, rinse, disinfect and store lenses in. (Alternatively if preferred, a separate daily cleaner may be used)
No saline solution is required with the OPTI-FREE disinfection system.
The lenses must firstly be cleaned by using OPTI-FREE Multi-Action solution (or by using a separate daily cleaner) and then secondly stored in OPTI-FREEMulti-Action solution each time they are removed. Both steps (cleaning and storage) are necessary to provide disinfection. One step does not replace the other. Always follow these three steps:
STEP 1: CLEAN
Wash hands and rinse thoroughly before handling lenses.
Depending on whether OPTI-FREE Multi-Action solution or a separate daily cleaner is used to clean lenses, follow the procedure given below:
i) If using OPTI-FREE Multi-Action solution to clean the lenses:
        Remove each lens in turn and place lens on palm of hand. Apply 2 drops of OPTI-FREE Multi-Action solution to each lens surface. Gently rub the lens for about 20 seconds in the palm of the hand using the forefinger of the other hand. Be sure to clean each side of the lens.
ii) If using a separate daily cleaner to clean lenses:
        Remove each lens in turn and clean by applying 1 or 2 drops of a daily cleaner to each lens surface. Rub the lens for about 20 seconds in the palm of the hand using the forefinger of the other hand. Be sure to clean each side of the lens.
STEP 2: RINSE
Thoroughly rinse both surfaces of the lens with OPTI-FREE Multi-Action solution for at least 10 seconds to remove all traces of debris from the lenses.
STEP 3: STORE
As the final step in disinfection fill the storage case with enough fresh OPTI-FREE Multi-Action solution to cover the lenses. Place the lenses in the storage case and check to see that the lenses are completely submerged. Close the storage case tightly. Leave lenses in the unopened storage case overnight or for at least 4 hours.
Before wearing:
Rinsing of lenses with fresh OPTI-FREE Multi-Action solution prior to insertion in the eyes is recommended to remove any particulate material on the lens surfaces.
After removing the lenses from the lens case, empty and rinse the lens storage case and allow it to air dry. Refill the case with fresh OPTI-FREEMulti-Action solution immediately before the next use of the case.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
The following problems may occur while wearing contact lenses:
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 clears up and the lenses appear to be undamaged, thoroughly clean, rinse and disinfect the lenses and re-insert them. If the problem continues or a lens appears to be damaged, IMMEDIATELY remove the lenses and IMMEDIATELY consult an eye care practitioner. Do not reinsert a damaged lens.
No finality has been reached on the long-term safety of soft contact lens preparations.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See Side-Effects above.

IDENTIFICATION:
A clear, colourless solution.

PRESENTATION:
OPTI-FREE Multi-Action solution is supplied in sterile plastic bottles containing 120 mL, 240 mL and 360 mL.

STORAGE INSTRUCTIONS:
Store at room temperature below 25ºC.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
X/34/342

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Alcon Laboratories (SA) (Pty) Ltd
65 Peter Place
Bryanston Extension 13
2191

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
1 October 2004

Rev: 0704

Updated on this site: January 2008
Source: Pharmaceutical Industry

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