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

Logo SPERSATEAR EYE DROPS

SCHEDULING STATUS:
Not Scheduled

PROPRIETARY NAME
(and dosage form):

SPERSATEAR EYE DROPS

COMPOSITION:
Each 1 mL contains:
Hydroxypropylmethylcellulose         3 mg
Benzalkonium Chloride 0,01% m/v
(as preservative)

PHARMACOLOGICAL CLASSIFICATION:
A 15.4 Ophthalmic preparations - others.

PHARMACOLOGICAL ACTION:
Spersatear is a corneal wetting agent.

INDICATIONS:
An artificial tear. For mucin and aqueous deficient dry eye con.

CONTRA-INDICATIONS:
Known sensitivity to the active ingredient or the preser.

WARNINGS:
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:
Two drops three times a day into each eye or as required.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The solution is not intended as a vehicle for other medications.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
None known.

IDENTIFICATION:
Clear aqueous solution.

PRESENTATION:
20 mL dropper bottle.

STORAGE INSTRUCTIONS:
Store in cool place, below 30°C. Protect from light. Keep out of reach of children.

REGISTRATION NUMBER:
N/15.4/22

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
The Premier Pharmaceutical Company Limited
Adcock Ingram Park
17 Harrison Avenue, Bryanston, Ext. 77
Private Bag X69, Bryanston, 2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
4/4/84

New addition to this site: April 2004
Source: Pharmaceutical Industry

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