REFRESH TEARS® Lubricating Eye Drops
(and dosage form)
REFRESH TEARS® Lubricating Eye Drops
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.
Conventional medicine: A 32.5 Artificial tear and contact lens solutions
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.
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®.
Due to its high molecular weight carboxymethylcellulose sodium is unlikely to penetrate the cornea.
REFRESH TEARS® is used as a lubricant irritation and discomfort due to dryness of the eye or due to exposure to wind or sun.
Hypersensitivity to any of the ingredients.
REFRESH TEARS® should not be used in infants and small children under 3 years.
WARNINGS AND SPECIAL PRECAUTIONS
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.
To avoid contamination, do not touch the tip of the container to any surface and avoid direct contact with the eye.
To avoid washout effects, concomitant ocular medication should be administered 15 minutes prior to the installation of REFRESH TEARS® (see INTERACTIONS).
Recap after use. Do not use if solution changes colour of becomes cloudy.
Effects on ability to drive and use machines
Should patients experience transient blurred vision, they should be advised not to drive or operate machinery until their vision has cleared.
Concomitant ocular medication should be administered 15 minutes prior to the installation of REFRESH TEARS® (see WARNINGS AND SPECIAL PRECAUTIONS).
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.
The following adverse drug reactions were reported with REFRESH TEARS®, the most frequently reported treatment-related undesirable effect was burning (approximately 2%):
Common (>1/100, <1/10): burning, dry eye, eye irritation/pruritus, eye discomfort, visual disturbance
Uncommon (>1/1000, <1/100): epiphora, conjunctival hyperaemia, eye pain, eye discharge.
The following additional adverse reactions have been identified during postmarketing use of REFRESH TEARS® in clinical practice. Because postmarketing reporting of these reactions is voluntary and from a population of uncertain size, it is not always possible to reliably estimate the frequency of these reactions.
Eye disorders: Foreign body sensation in eyes, ocular hyperaemia
Immune system disorders: Hypersensitivity including eye allergy with symptoms of eye swelling, eyelid oedema or erythema of eyelid
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
No toxic side effects from systemic overdose are expected. Refer to SIDE EFFECTS and WARNINGS AND SPECIAL PRECAUTIONS. Treatment is symptomatic and supportive.
A clear, colourless to slightly straw-coloured solution, practically free from particulate matter.
REFRESH TEARS® is a sterile solution supplied in teal green opaque plastic dropper bottles with a cap, containing 15 mL of solution.
Store at or below 25°C. 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.
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
DATE OF PUBLICATION OF THE PACKAGE INSERT
Date of registration: 12 November 2004
Date of most recent package insert as approved by Council: 12 November 2004
Updated on this site: November 2016
Source: Pharmaceutical Industry [Ref: mcc-74.2016; Approved: 23 Sep 2016]
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