OCULERGE EYE DROPS
(and dosage form):
OCULERGE EYE DROPS
Each 1 ml contains: )
AntazolineHCl 0,5 mg
TetrahydrozolineHCl 0,4 mg
Benzalkonium chloride 0,01% m/v
A - 15.4 : Ophthalmic preparations, other
Antazoline a synthetic antihistamine is combined with tetrahydrozoline, a vasoconstrictor. Tetrahydrozoline causes conjunctival decongestion.
Patients who experience hypersensitivity to any of the ingredients. Patients receiving monoamine oxidase inhibitors, or within 14 days of its termination.
Safety in pregnancy and lactation has not been established.
Not recommended for children under 6 years of age.
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.
Clear, colourless odourless liquid.
Plastic bottles of 15 mL.
Store below 25°C in well-closed containers.
Protect from light.
Discard 30 days after opening.
KEEP OUT OF REACH OF CHILDREN.
NAME AND BUSINESS ADDRESS OF APPLICANT:
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
8 April 1997
New addition to this site: Aug 2006
Source: Pharmaceutical Indutry
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