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

Logo SYSTANE® Gel Drops, Lubricant eye gel

PROPRIETARY NAME
(and dosage form):

SYSTANE® Gel Drops, Lubricant eye gel

COMPOSITION:
SYSTANE
®Gel Drops is a sterile solution containing polyethylene glycol 400, propylene glycol, hydroxypropyl guar, sorbitol, aminomethyl propanol, boric acid, potassium chloride, sodium chloride, disodium edetate and POLYQUAD® (polyquaternium-1) 0.001% as preservative.

PHARMACOLOGICAL ACTION:
SYSTANE
®Gel Drops provides relief from moderate to severe symptoms of dry eye. Its formulation is specifically designed to lubricate and aid in restoring the ocular surface, protecting it from further damage.

INDICATIONS:
SYSTANE
®Gel Drops is suitable for day time and night time application as a dry eye therapy for the temporary relief of ocular symptoms due to dryness of the eye, such as discomfort, burning and irritation.
May be used to treat dry eye associated with contact lens usage.

CONTRA-INDICATIONS:
Hypersensitivity to any of the ingredients.

WARNINGS:
For external use only. It is essential to follow the eye care practitioners’ directions and all labelling instructions for proper use of the product. If eye discomfort, excessive tearing, vision changes or redness of the eye persist, consult a doctor as the problem could become more serious.

INTERACTIONS
Interactions of
SYSTANE®Gel Dropswith other medications have not been specifically evaluated.

PREGNANCY AND LACTATION:
The safety of use in pregnancy and lactation has not been established.

DOSAGE AND DIRECTIONS FOR USE:
SYSTANE
®Gel Drops may be used as needed throughout the day and also at night time. For treatment of dry eye associated with contact lens usage, instil drops 10 minutes prior to inserting contact lenses and after the removal of contact lenses. Shake well before use. Place drops on the eye and blink.
To avoid contamination, never touch the dropper tip of the container to any surface.
Replace cap after use.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The most frequently reported reactions are ocular irritation and ineffectiveness, which are typical of artificial tear and lubricant eye drop products.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
None known.

IDENTIFICATION:
Colourless, sterile solution.

PRESENTATION:
Natural plastic 10 mL Drop-Tainer® bottle with a natural dispensing plug and closure.
Samples are available in identical packaging in 3 mL sizes.

STORAGE INSTRUCTIONS:
Store at room temperature below 25ºC, in a cool place.
Keep container tightly closed when not in use.
Use before expiry date on the bottle.
Do not use longer than 30 days after opening.
KEEP OUT OF REACH OF CHILDREN.

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

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
6 November 2012

New addition to this site: September 2014
Source: Pharmaceutical Industry

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