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

Logo OCULERGE EYE DROPS
SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

OCULERGE EYE DROPS

COMPOSITION:
Each 1 ml contains: )
AntazolineHCl         0,5 mg
TetrahydrozolineHCl        0,4 mg
Preservatives:
Benzalkonium chloride        0,01% m/v

PHARMACOLOGICAL CLASSIFICATION:
A - 15.4 : Ophthalmic preparations, other

PHARMACOLOGICAL ACTION:
Antazoline a synthetic antihistamine is combined with tetrahydrozoline, a vasoconstrictor. Tetrahydrozoline causes conjunctival decongestion.

INDICATIONS:
Hay-fever conjunctivitis
Allergic conjunctivitis

CONTRA-INDICATIONS:
Patients who experience hypersensitivity to any of the ingredients. Patients receiving monoamine oxidase inhibitors, or within 14 days of its termination.
Closed-angle glaucoma.
Safety in pregnancy and lactation has not been established.
Not recommended for children under 6 years of age.

WARNINGS:
For external use only.
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:
1 drop, 3 or 4 times daily, or more, into the lower eyelid.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Transient irritation may occur.
Systemic reactions may occur.
Hypersensitivity reactions, nausea and headache have been reported. Drowsiness may be experienced by some patients.
OCULERGE EYE DROPS should be used with caution in the presence of hypertension, cardiac irregularities, hyperglycaemia (diabetes mellitus) or hyperthyroidism.

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 odourless liquid.

PRESENTATION:
Plastic bottles of 15 mL.

STORAGE INSTRUCTIONS:
Store below 25°C in well-closed containers.
Protect from light.
Discard 30 days after opening.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
31/15.4/0144

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pharmacare Limited
Healthcare Park
Woodlands Drive
Woodmead
Sandton
2148

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
8 April 1997

New addition to this site: Aug 2006
Source: Pharmaceutical Indutry

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