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

Logo SYSTANE® BALANCE, Lubricant Eye Drops

PROPRIETARY NAME
(and dosage form)

SYSTANE® BALANCE, Lubricant Eye Drops

COMPOSITION:
SYSTANE®
BALANCE is a sterile eye drop containing
propylene glycol, hydroxypropyl guar, mineral oil, dimiristoyl phosphatidyl glycerol, polyoxyl 40 stearate, sorbitan tristearate, boric acid, sorbitol, disodium edetate, and POLYQUAD® (polyquaternium-1) 0.001% as preservative.

PHARMACOLOGICAL ACTION:
SYSTANE®
BALANCE lubricates the ocular surface, supplements and stabilizes the lipid layer of the tear film and reduces excessive tear evaporation.

INDICATIONS:
SYSTANE®
BALANCE is a dry eye therapy for the temporary relief of burning and irritation due to dryness of the eye.
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® BALANCE with 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®
BALANCE
may be used as needed throughout the day. 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. Place drops on the eye and blink.
Shake well before use. Replace cap after use.
To avoid contamination, never touch the dropper tip of the container to any surface.

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.

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 container.
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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