Systane Complete 10 ml, preservative-free, lubricating eye drops
INSTRUCTIONS FOR USE
The following instructions for use contain important product use and safety information. Please read it carefully and keep it for future reference.
Product name:
SYSTANE COMPLETE Lubricating Eye Drops
DESCRIPTION:
SYSTANE COMPLETE Lubricating Eye Drops are a sterile, preservative-free, white emulsion containing propylene glycol, hydroxypropylglyar, mineral oil, dimyristoyl phosphatidyl glycerol, polyoxyl-40 stearate, sorbitan tristearate, boric acid, sorbitol and purified water. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.
SYSTANE COMPLETE Lubricating Eye Drops are inherently white in colour prior to application.
CLINICAL BENEFITS:
When used as prescribed, SYSTANE COMPLETE is a lubricating eye drop:
- Protects the surface of the eye.
- Provides protection of the eye area.
- Helps to restore the health of the ocular surface.
- Provides relief from the symptoms of dry eye.
APPLICATIONS (Indications):
SYSTANE COMPLETE Lubricating Eye Drops are used to temporarily relieve the burning sensation and irritation caused by dry eyes.
INTENDED PURPOSE/INTENDED USE AND TARGET USER GROUP:
SYSTANE COMPLETE lubricating eye drops are recommended for those who need temporary relief of dry eye. It can also be used to relieve the symptoms of dry eye during contact lens wear: before contact lenses are fitted and after lenses have been removed.
PERFORMANCE CHARACTERISTICS:
Based on all the evidence from clinical studies, published clinical literature and market experience (post-marketing surveillance), SYSTANE COMPLETE Lubricating Eye Drops are intended to provide temporary relief of burning sensation and irritation caused by dry eye.
Instructions:
- Shake the bottle thoroughly before the first opening.
- To open, grasp the bottle directly under the cap and twist the cap.
- BEFORE FIRST USE, hold the bottle at an angle of approximately 90 degrees and drop one drop of product. Shake the bottle to remove any remaining product.
SYSTANE COMPLETE Lubricating Eye Drops can be used as needed throughout the day to relieve symptoms of dry eye. It can also be used to relieve the symptoms of dry eye during contact lens wear: before contact lenses are fitted and after lenses are removed.
- Shake well before use.
- If necessary, drop 1 or 2 drops into the affected eye and blink a few times.
- After use, before closing the bottle cap, shake the bottle downwards to remove any residual product left on the dropper.
Contraindications (When not to use):
In case of allergy to any of the ingredients of SYSTANETM COMPLETE Lubricating Eye Drops, the use of this product is contraindicated.
WARNINGS:
It is important to follow the instructions of your eye care professional and the instructions in the accompanying leaflet for proper use of the product. If you experience persistent discomfort in your eyes or severe watering, blurred vision or redness of the eyes, stop using SYSTANETM COMPLETE Lubricating Eye Drops and consult your eye care professional as the problem may worsen.
Temporary blurred vision or other visual disturbances may affect your ability to drive or operate machinery. If you develop blurred vision after use, wait for your vision to clear before driving or operating machinery.
Precautionary principles:
- For ophthalmic use only.
- Caution: Do not use if the cap with the tamper-evident cap is damaged or missing.
- Do not use if the packaging or the bottle (sterile packaging) is damaged.
- To avoid contamination, never touch the dropper of the bottle to any surface.
- In case of ingestion, seek medical advice.
- If the emulsion changes colour, do not use.
- Screw the cap back on after use.
- Keep the bottle tightly closed when not in use!
- When used as directed, the product is safe for boric acid concentration.
- Use the product within the expiry date indicated on the packaging.
- After opening the bottle, pour out the remaining emulsion according to the instructions below:
- For 3 ml containers, pour out the remaining emulsion after 30 days
- For the 10 ml container, pour out the remaining emulsion after three months
- Store at a temperature between 2 °C and 30 °C
- Keep out of the reach of children.
CE 0123
Manufacturer:
Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, Texas 76134-2099, US
