INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
REFRESH LIQUIGEL® (Lubricant Eye Drops)

SCHEDULING STATUS:
Schedule 0

PROPRIETARY NAME
(and dosage form):

REFRESH LIQUIGEL^® (Lubricant Eye Drops)

COMPOSITION
REFRESH LIQUIGEL^®lubricant eye drops contain carboxymethylcellulose sodium 10 mg/mL.
Preservative
PURITE™ (stabilized oxychloro complex): 0,0075% m/v

PHARMACOLOGICAL CLASSIFICATION
A.15.4 Ophthalmic preparations. Other.

PHARMACOLOGICAL ACTION
The mode of action of REFRESH LIQUIGEL^®as a lubricant is entirely mechanical. It has no pharmacological activity. Due to its high molecular weight, REFRESH LIQUIGEL^®is unlikely to penetrate the cornea.

INDICATIONS
REFRESH LIQUIGEL^®is indicated for use as a lubricant in dry eye (keratoconjunctivitis sicca [KCS]).
This indication includes the temporary relief of burning, irritation, and/or discomfort due to dryness of the eye.
REFRESH LIQUIGEL^®is indicated for lubricating and rewetting of soft and rigid gas permeable contact lenses. It is also indicated to relieve the dryness, irritation, and discomfort that may be associated with lens wear.

CONTRA-INDICATIONS
REFRESH LIQUIGEL^®is contra-indicated in patients with previously demonstrated hypersensitivity to any of the ingredients

WARNINGS
For external use only. Do not use if solution changes colour or becomes cloudy.
Discontinue use and consult a medical practitioner if eye pain, changes in vision, continued redness or irritation of the eye is experienced, or if the condition worsens or persists for more than 72 hours.
Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Centre right away.
If irritation develops, discontinue lens wear and consult the eye practitioner. Use before the expiration date marked on the container.
To prevent infection, NEVER wet contact lenses with saliva or place lenses in mouth.

For use with rewetting indication:
Not for use in lens case.

INTERACTIONS
Concomitant ocular medications should be administered at least 5 minutes apart from the instillation of REFRESH LIQUIGEL^®to avoid washout effects.

PREGNANCY AND LACTATION
There are no data on the use of REFRESH LIQUIGEL^®during pregnancy and lactation in humans. Animal studies did not show harmful effects with the active ingredient carboxymethylcellulose.
Because REFRESH LIQUIGEL^®is not absorbed systemically, there is no known potential for excretion in human breast milk.

DOSAGE AND DIRECTIONS FOR USE
REFRESH LIQUIGEL^®may be used in conjunction with rigid gas-permeable and soft contact lenses.
Dry eye indication
Instil 1 or 2 drops in the affected eye(s) as needed.
Rewetting indication
To lubricate and rewet soft and rigid gas-permeable lenses during the day: With the lenses on the eye, apply 1 to 2 drops to each eye as needed, or as directed by the eye care practitioner. Blink several times.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Side-effects
The following adverse drug reactions were reported with REFRESH LIQUIGEL^®:
Eye disorders
Very common (>1/10): Visual disturbances and eye discharge
Common (>1/100, <1/10): Ocular discharge and eye pruritus
Less frequent (>1/1000, <1/100): Conjunctival hyperaemia and eyelid edema
Special precautions
Should patients experience transient blurred vision, they should be advised not to drive or operate machinery until vision has cleared.
To avoid contamination, do not touch tip of container to any surface. Replace cap after using.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
No toxic side effects from systemic overdose are expected. See “Side-effects and special precautions”. Treatment is symptomatic and supportive.

IDENTIFICATION
Clear to slightly hazy, colourless to slightly yellow, viscous solution.

PRESENTATION
15 mL multiple dose, low-density polyethylene container and tip with a polystyrene cap.
STORAGE INSTRUCTIONS
Stored below 25°C. Do not use more than 30 days after first opening.
Do not touch tip of container to any surface. Replace cap after using.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER
A38/15.4/0592

NAME AND BUSINESS ADDRESS OF THE APPLICANT
Allergan Pharmaceuticals (Pty) Ltd
Mount Royal Industrial Park
James Crescent
Halfway House
SOUTH AFRICA

DATE OF PUBLICATION OF THIS PACKAGE INSERT
24 November 2005

New addition to this site: November 2006
Source: Pharmaceutical Industry
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