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

Logo REFRESH TEARS Lubricating Eye Drops

SCHEDULING STATUS:
Schedule 0

PROPRIETARY NAME
(and dosage form):

REFRESH TEARS Lubricating Eye Drops

COMPOSITION:
REFRESH TEARS Lubricating Eye Drops contain:
Carboxymethylcellulose sodium 5 mg/mL
Other ingredients:
Sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, boric acid and sodium borate decahydrate (as buffering agents) and purified water.
Stabilised oxychloro complex (Purite™) equivalent to 0,005% m/v stabilised chlorine dioxide, a mild, non-sensitising preservative that, when used, ultimately changes into components of natural tears.

PHARMACOLOGICAL CLASSIFICATION
Conventional medicine: A 32.5 Artificial tear and contact lens solutions

PHARMACOLOGICAL ACTION
REFRESH TEARS is a lubricating formulation similar to normal tears, containing a mild non-sensitising preservative that, when used, ultimately changes into components of natural tears.

PHARMACODYNAMIC PROPERTIES
The pharmacological effect of the active substance, carboxymethylcellulose sodium is not receptor-mediated, but is due to its property as viscosity enhancer resulting in increasing the retention time of REFRESH TEARS.

PHARMACOKINETIC PROPERTIES
Due to its high molecular weight carboxymethylcellulose sodium is unlikely to penetrate the cornea.

INDICATIONS
REFRESH TEARS is used as a lubricant to relieve irritation and discomfort due to dryness of the eye or due to exposure to wind or sun.

CONTRA-INDICATIONS
Hypersensitivity to any of the ingredients.
REFRESH TEARS should not be used in infants and small children under 3 years.

WARNINGS
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 discontinue use and consult a medical doctor.

INTERACTIONS
None known.

PREGNANCY AND LACTATION
Safe use during pregnancy and lactation has not been established.

DOSAGE AND DIRECTIONS FOR USE
Unless otherwise prescribed, instil 1 drop in the affected eye(s) 4 times a day or as needed.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
The following adverse drug reactions were reported with REFRESH TEARS; the most frequently reported treatment-related undesirable effect was burning (approximately 2%):
Eye Disorders
Common (>1/100, <1/10): burning, dry eye, eye irritation/pruritus
Uncommon (>1/1000, <1/100): eyelid oedema, epiphora, eyelid erythema, conjunctival hyperaemia, eye pain, eye discharge.
Special Precautions
To avoid contamination, do not touch the tip of the container to any surface and avoid direct contact with the eye.
Concomitant ocular medication should be administered 15 minutes prior to the installation of REFRESH TEARS.

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

IDENTIFICATION
A clear, colourless to slightly straw-coloured solution, practically free from particulate matter.

PRESENTATION
REFRESH TEARS is a sterile solution supplied in teal green opaque plastic dropper bottles with a cap, containing 15 mL of solution.

STORAGE INSTRUCTIONS
Store below 25ºC. Do not refrigerate. To avoid contamination of the solution keep container tightly closed. Do not touch dropper tip to any surface. Do not use more than 30 days after first opening. Contents are sterile if seal is intact. KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER
37/32.5/0092

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION
Allergan Pharmaceuticals (Pty) Ltd
30 New Road (entrance off Bavaria Road)
Randjespark Ext 11, Midrand, 1682
Johannesburg, Gauteng
SOUTH AFRICA

DATE OF PUBLICATION OF THIS PACKAGE INSERT
November 2004

Updated on this site: July 2008
Current: August 2014
Source: Pharmaceutical Industry

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