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Logo OPTI-TEARS® Contact lens comfort drops

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

OPTI-TEARS® Contact lens comfort drops

COMPOSITION:
OPTI-TEARS is a sterile, isotonic, aqueous solution.
Each mL contains 1 mg
Dextran as wetting agent and 0,001% (m/v) POLYQUAD™ (polyquaternium-1 ) as preservative.

PHARMACOLOGICAL CLASSIFICATION:
A.34 Contact lens preparations

PHARMACOLOGICAL ACTION:
OPTI-TEARS comfort drops moistens contact lenses and helps to remove particulate material that may cause irritation and/or discomfort.

INDICATIONS:
OPTI-TEARS comfort drops may be used with all contact lenses for the following:
Moistening of daily wear, soft and hard gas permeable lenses while on the eyes during the day.
Moistening of extended wear lenses upon awakening and as needed during the day.
Placing 1 or 2 drops of OPTI-TEARS comfort drops on the eyes followed by blinking 2 or 3 times will relieve minor irritation, discomfort or blurring which may occur while wearing lenses.

CONTRA-INDICATIONS:
Hypersensitivity to any ingredient in OPTI-TEARS comfort drops.

WARNINGS:
Serious damage to the eye and the loss of vision may result from wearing contaminated or damaged contact lenses. Immediately consult an eye care practitioner to identify the cause of any unexplained eye discomfort, watering, vision change, or redness of the eye and to begin any necessary treatment.

DOSAGE AND DIRECTIONS FOR USE:
OPTI-TEARS comfort drops may be used as needed throughout the day. If minor irritation, discomfort, or blurring occurs while wearing lenses, place 1 or 2 drops on the eye and blink 2 or 3 times. If discomfort persists, immediately remove lenses and immediately see an eye care practitioner.
Precautions:
Always wash and rinse hands before handling the lenses.
Never touch the dropper tip of the container to any surface since this may contaminate the solution.
Keep container tightly closed when not in use.
TAMPER RESISTANT: DO NOT USE IF BOTTLE CAP BAND MARKED Alcon IS DAMAGED OR MISSING.
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 you notice any of the above problems, remove and examine the lenses. Do not reinsert a damaged lens. 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 IMMEDIATELY remove lenses and consult an eye care practitioner for proper 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.

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

IDENTIFICATION:
Clear, colourless solution

PRESENTATION:
OPTI-TEARS comfort drops are supplied in sterile plastic bottles containing 15 mL.

STORAGE INSTRUCTIONS:
Store at room temperature (8° to 30°C). KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
X/34/67

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

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
9 February 1990

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