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Logo OPTI-FREE® EXPRESS® MPDS

SCHEDULING STATUS:
S0

PROPRIETARY NAME
(and dosage form):

OPTI-FREE® EXPRESS® MPDS

COMPOSITION:
OPTI-FREE EXPRESS solution is a sterile buffered, isotonic aqueous solution containing sodium citrate, sodium chloride, boric acid, sorbitol, aminomethylpropanol, poloxamine and edetate disodium with polyquaternium-1 0.001% (w/v) and myristamidopropyl dimethylamine 0.0005% (w/v) as preservatives.

PHARMACOLOGICAL CLASSIFICATION:
A.34
Contact Lens Preparations.

PHARMACOLOGICAL ACTION:
OPTI-FREE EXPRESS solution cleans soft (hydrophilic) lenses by loosening and removing accumulations of deposits and debris from the lenses.
OPTI-FREE EXPRESS solution exhibits antimicrobial activity against Gram-positive bacteria, Gram-negative bacteria, fungi and Acanthamoeba.
OPTI-FREE EXPRESS solution is formulated for use in disinfection and storage of lenses for up to 30 days after disinfection.

INDICATIONS:
OPTI-FREE EXPRESS solution is indicated for the daily cleaning, rinsing, disinfection, rewetting and storage of all soft contact lenses.

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

WARNINGS:
It is essential to follow an eye care practitioner's directions and all labelling instructions for proper use and care of lenses and lens care products, including the lens case.
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 as the problem could become more serious.

DOSAGE AND DIRECTIONS FOR USE:
General Precautions:
Always wash and rinse the hands before handling contact lenses.
When using a new lens case, rinse the case with fresh OPTI-FREE EXPRESS solution before use to remove any debris.
Always handle the same lens, the right or left, first in order to avoid mixups.
Always use fresh OPTI-FREE EXPRESS solution in the lens storage case. Never re-use the solution in your lens storage case.
To avoid contamination, do not touch the tip of the container to any surface.
Replace the cap after using.
Not for use with heat (thermal) disinfection.
Keep the container tightly closed when not in use.
For clean and disinfected lenses, always do the following:
Cleaning
Rinse each side of the lens thoroughly with OPTI-FREE EXPRESS solution. Fill your lens case with enough fresh OPTI-FREE EXPRESS solution to cover the lenses. Leave lenses in the closed lens case overnight or at least 6 hours. Before wear, rinse each side of the lens thoroughly to remove any debris on the lens.
Alternative Directions for Cleaning
Always follow the eye care practitioner’s instructions.
If an eye care practitioner recommends an additional rubbing step, apply 2 drops of OPTI-FREE EXPRESS solution to each lens surface. Clean each side of the lens by rubbing gently in the palm of your hand. Thoroughly rinse both surfaces of the lens. Fill the lens case with enough fresh OPTI-FREE EXPRESS solution to cover the lenses. Leave lenses in the closed lens case overnight or at least 6 hours. Lenses are ready to wear. Lenses may be rinsed before reinsertion.
Both of the cleaning procedures may be applied to all contact lenses.
Rinse
Thoroughly rinse both surfaces of the lens with OPTI-FREE EXPRESS solution. You may use this product to rinse debris or daily cleaners from the surface of the lens or to use as a diluent for enzymatic lens cleaning products and to rinse lenses before wearing.
Disinfect and Store
Fill your storage case with fresh OPTI-FREE EXPRESS solution, using enough solution to cover the lenses. Place the lenses in your storage case. Leave lenses in your closed storage case overnight or for at least 6 hours. Lenses are ready to wear. Rinsing of lenses with fresh OPTI-FREE EXPRESS solution before wearing is recommended. Wash and dry your hands before handling and inserting your lenses. You may store your lenses in the unopened case until ready to wear up to a maximum of thirty days. If your lenses are stored for longer periods of time, they must be cleaned and disinfected with fresh solution every thirty days and prior to wear.
After removing the lenses from the lens case, always discard old solution and rinse the lens case with fresh OPTI-FREE EXPRESS solution and allow it to air dry. Refill the case with fresh OPTI-FREE EXPRESS solution immediately before the next use of the case. Never re-use the solution. Alcon recommends that you replace your lens case on a frequent basis.
Rewetting
If minor irritation, discomfort or blurring occurs while you are wearing your contact lenses, place one or two drops of OPTI-FREE EXPRESS solution directly on the eye and blink two or three times. OPTI-FREE EXPRESS solution may be used for rewetting as needed throughout the day.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
The following problems may occur while wearing contact lenses:
Eyes stinging, burning or itching (irritation).
Feeling of something in the eye (foreign body, scratched area).
Excessive watering (tearing) of the eyes.
Unusual eye secretions.
Redness of the eye.
Reduced sharpness of vision (visual acuity).
Blurred vision, rainbows or halos around objects.
Sensitivity to light (photophobia).
Dry eyes.
If any of the above problems should be noticed:
Immediately remove the lenses.
If the discomfort or problem stops, then look closely at the lens.
If the lens is in any way damaged, DO NOT put the lens back on the eye. Place the lens in the storage case and contact an eye care practitioner.
If the lens has dirt, an eyelash, or other foreign body on it or the problem stops and the lens appears undamaged, thoroughly clean, rinse and disinfect the lens and re-insert it.
If the problem continues, IMMEDIATELY remove the lens and consult an eye care practitioner.

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

IDENTIFICATION:
A clear, colourless solution.

PRESENTATION:
OPTI-FREE EXPRESS solution is supplied in white, plastic bottles containing 120 ml, 240 ml or 355 ml.

STORAGE INSTRUCTIONS:
Store at room temperature below 25°C. Avoid excessive heat.
KEEP OUT OF REACH OF CHILDREN.
Discard any remaining solution six months after first opening.
Use before the expiration date marked on the product.
The product is sterile until opened.

REGISTRATION NUMBER:
34/34/0432

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

South African Patent No. 82/6966

Rev. 0704

New addition to this site: January 2008
Source: Pharmaceutical Industry

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