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Logo EYE-GENE EYE DROPS
SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

EYE-GENE EYE DROPS

COMPOSITION:
Each 100 mL contains:
Phenylephrine Hydrochloride (Lexatol)        0,043 g
Preserved with:
Benzalkonium Chloride 50% Solution        0,02% m/v
Disodium Edetate        0,02% m/v

PHARMACOLOGICAL CLASSIFICATION:
A 15.4 - Ophthalmic Preparations

PHARMACOLOGICAL ACTION:
EYE-GENE EYE DROPS is an isotonic solution with peripheral vasoconstriction and decongestant properties.
Phenylephrine acts on alpha-adrenergic receptors in the arterioles of the conjunctiva producing vasoconstriction.
The vasoconstriction results in blanching of the conjunctiva which at the same time reduces the absorption from the conjunctival sac into the blood stream and so limits undesirable systemic action.
It also has a mild antiseptic and slight anaesthetic reaction.

INDICATIONS:
EYE-GENE EYE DROPS is indicated as a topical ocular vasoconstrictor for the symptomatic relief of tired, red and itching eyes. EYE-GENE EYE DROPS relieves eyestrain and prevents bacterial infection.

CONTRA-INDICATIONS:
Hypersensitivity to any of the ingredients; narrow-angle glaucoma.

WARNINGS:
If symptoms persist, consult a doctor.
As the possibility of adverse effects on the corneal permeability and the danger of disruption of the corneal epithelium with prolonged or repeated usage of benzalkonium chloride preserved ophthalmological preparations cannot be excluded, regular ophthalmological examination is required. Caution should be exercised in the use of benzalkonium chloride preserved topical medication over an extended period in patients with extensive ocular surface disease.

DOSAGE AND DIRECTIONS FOR USE:
Wipe eyelids clean. Tip head well back and closing eyes squeeze one to two drops of EYE-GENE EYE DROPS into corners closest to the nose. Now open and close eyelids several times.
Instill 1 to 2 drops every 3 to 4 hours.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Ophthalmic Phenylephrine may be systemically absorbed. Effects in pregnancy and breast-feeding have not been established.
EYE-GENE EYE DROPS should be used with caution in the presence of hypertension, cardiac irregularities, hyperglycemia or hyperthyroidism
Transient irritation may occur.
Nausea and headache may occur.
Pupillary dilation, increase in intraocular pressure, systemic effects due to absorption (i.e. hypertension, cardiac irregularities and hyperglycemia).
Drowsiness may be experienced.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Accidental ingestion (especially in children) may cause depression of the central nervous system with reduction in body temperature and symptoms of bradycardia, sweating, drowsiness and coma.
Hypertension may be followed by rebound hypotension. Treatment is symptomatic and supportive.

IDENTIFICATION:
Clear, colourless solution.

PRESENTATION:
EYE-GENE EYE DROPS is available in 5 mL, 10 mL and 15 mL sizes.

STORAGE INSTRUCTIONS:
Keep out of reach of children.
Do not use more than 30 days after opening.
Store in a dark place below 25ºC.

REGISTRATION NUMBER:
H1246 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Group Laboratories S A (Pty) Limited
39 Hawkins Avenue
Epping Industria 1
Cape Town
7460

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
January 2001

Copyright © 2008, DXS Ltd.
All Rights Reserved

New addition to this site: December 2008
Source: Pharmaceutical Industry

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