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GENTEAL
and GENTEAL
Gel
hypromellose and hypromellose/carbomer 980
NAME OF THE DRUG
Eye drops
GenTeal drops, 0.3%, eye drops, solution.
Eye gel
GenTeal Gel, 0.3%, eye gel.
DESCRIPTION
Eye drops
1 g of GenTeal drops contains 3 mg hypromellose.
Excipients: Sodium perborate, sodium chloride, boric acid, potassium chloride,
diethylenetriamine pentamethylene phosphonic acid, hydrochloric acid, water for injections.
Eye gel
1 g of GenTeal Gel contains 3 mg hypromellose and 2 mg carbomer 980.
Excipients: Sodium perborate, sorbitol, sodium hydroxide, diethylenetriamine
pentamethylene phosphonic acid, water for injections.
PHARMACOLOGY
Pharmacodynamics
Eye drops
GenTeal lubricant eye drops are suitable for use with all types of contact lenses to increase
comfort of the lens during wear or to aid in the insertion of the contact lens. The product has
a buffered pH close to that of tears and contains a unique disappearing preservative, sodium
perborate. Sodium perborate degrades in water to yield trace amounts of hydrogen peroxide
(50-500 ppm), providing an antimicrobial action. Instilled in the eye, hydrogen peroxide is
rapidly degraded by catalases to yield water and oxygen. The antimicrobial buffer system
results in a solution which is free of the usual preservatives which may cause hypersensitivity
or allergic reactions and yet prevents the opened bottle from becoming contaminated.
Eye gel
GenTeal Gel is a long acting eye gel for lubricating the surface of the eye for all patients with
ocular discomfort. The slight hypotonicity of the gel is rapidly neutralised by the slightly
hypertonic tear fluid caused by dry eyes. GenTeal Gel contains the same unique preservative
system as GenTeal eye drops.
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Pharmacokinetics
No studies were performed.
INDICATIONS
Eye drops, solution
Lubricant eye drops for wetting the surface of the eye and for wearers of all types of contact
lenses.
Eye gel
GenTeal Gel soothes the sensation of dryness induced for example, by contact lenses, smoke,
wind, extended computer screen use or other irritations by wetting and lubricating the surface
of the eye.
CONTRAINDICATIONS
Hypersensitivity to any of the ingredients.
PRECAUTIONS
If eye pain, changes in vision, continued redness or irritation of the eye are noticed, GenTeal
must be discontinued and a doctor should be consulted.
If GenTeal Gel changes colour or becomes cloudy, the product should not be used.
Eye drops/gels are not for injection. They should never be injected subconjunctivally, nor
should they be directly introduced into the anterior chamber of the eye.
GenTeal Gel is not intended to be used during surgery.
Use in Pregnancy and Lactation
There is no experience regarding the safety of GenTeal in human pregnancy or lactation.
Interactions with Other Drugs
Eye drops
The compatibility of GenTeal eye drops has been demonstrated with lotrafilcon, tefilcon and
vifilcon soft contact lenses. Optical, physical and surface properties were unchanged after
soaking in GenTeal for up to 7 days.
Eye gel
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GenTeal Gel can be used in combination with contact lenses. No compatibility study with
lens material is available, however the results obtained with GenTeal eye drops can also be
applied for GenTeal Gel.
Effects on ability to drive and use machines
Any patient who experiences blurred vision should not drive or operate machines.
ADVERSE REACTIONS
Eye drops and eye gel
GenTeal is very well tolerated by users. However, some cases of burning, stinging, allergic
reactions or red eyes after instillation have been reported. Transient blurring of vision after
administration has also been reported.
DOSAGE AND ADMINISTRATION
Eye drops
Adults: Instill 1 or 2 drops in each eye(s) and blink several times or apply a few drops to each
lens before insertion.
Eye gel
Adults: Instil 1 or 2 drops in the conjunctival sac of the affected eye(s), as needed. The
frequency of administration depends on the severity of the condition. On average, one drop is
administered 1-3 times daily. If needed, GenTeal Gel may be administered more frequently.
The tube must be held vertically above the eye.
Eye drops and Eye gel
Elderly: There is no indication that dosage needs to be modified for the elderly.
Paediatric use: Studies in the paediatric population have not been performed.
The dispenser remains sterile until the original closure is broken. Patients must be instructed
to avoid allowing the tip of the dispensing container to contact the eyes, surrounding
structures or anything else as this may contaminate the solution/gel.
If more than one medication needs to be instilled in the eye, an interval of at least 5 minutes
between application of the different products must be allowed. GenTeal should be applied
last.
Instructions for Use and Handling
Check bottle seal is intact before first use. If already broken do not use. Remove tamper
evident ring before use.
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Incompatibilities
No information available.
OVERDOSAGE
No case of overdose has been reported. As GenTeal contains no pharmacologically active
ingredients, no adverse effects are likely to occur in case of overdose.
PRESENTATION
Eye drops
Eye drops, solution. Pack size: 15mL bottle.
Eye gel
Eye gel. Pack size: 10g tube.
Storage:
Eye drops
Store below 25C. Close bottle after use. Discard remaining contents four weeks after
opening.
Eye Gel
Store below 25C. Close tube after use. Discard remaining contents four weeks after opening.
Poison schedule: Unscheduled.
SPONSOR
Novartis Pharmaceuticals Australia Pty Limited
ABN 18 004 244 160
54 Waterloo Road
North Ryde NSW 2113
=Registered Trademark
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ged111102i_geg111102i.doc based on the BPI of 11/11/02
