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

Logo PREFRIN Liquifilm Sterile Eye Drops

SCHEDULING STATUS:
Schedule 0

PROPRIETARY NAME
(and dosage form):

PREFRIN Liquifilm Sterile Eye Drops

COMPOSITION:
PREFRIN Liquifilm Sterile Eye Drops contain:
Phenylephrine hydrochloride         1,2 mg/mL
Liquifilm (polyvinyl alcohol)         14 mg/mL
Preservative: 
Benzalkonium chloride 0,005% m/v.

PHARMACOLOGICAL CLASSIFICATION
A. 15.4 Ophthalmic preparations. Other.

PHARMACOLOGICAL ACTION
PREFRIN Liquifilm is a lubricating decongestant that whitens the eyes and has been found to be beneficial in the relief of minor eye irritation caused by colds, hayfever, dust, smog, hard contact lenses, sun, swimming and wind, in the absence of infection.

INDICATIONS
Relief of minor eye irritations.

CONTRA-INDICATIONS
Contra-indicated in narrow angle glaucoma. Not intended for use with soft contact lenses.

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
One or two drops instilled into each eye. May be repeated at intervals of 3 to 4 hours as required.

SIDE EFFECTS AND SPECIAL PRECAUTIONS
Pupillary dilation may occur in some individuals. Should not be used in the presence of narrow angle glaucoma, and in persons with a known history of hypersensitivity towards any of the ingredients.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT.
Ocular overdosage may rarely cause systemic sympathomimetic effects (e.g. palpitation, tachycardia, premature ventricular contractions, occipital headache, pallor, trembling, increased perspiration and hypertension). These effects may be treated with an alpha-adrenoreceptor blocking agent followed, if necessary, by a beta-adrenoreceptor blocking agent.

IDENTIFICATION
A clear colourless solution.

PRESENTATION
PREFRIN Liquifilm Sterile Eye Drops are supplied in sterile dropper bottles containing 15 mL solution.

STORAGE INSTRUCTIONS
Store below 25ºC. Keep bottle tightly closed when not in use. Do not use for more than 30 days after opening. KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER
J/15.4/84

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION
Allergan Pharmaceuticals (Pty) Ltd.
30 New Road (entrance off Bavaria Road)
Randjespark Ext 11, Midrand, 1682
Johannesburg, Gauteng
South Africa

DATE OF PUBLICATION OF THIS PACKAGE INSERT
23 December 1976

Updated on this site: August 2014
Source: Pharmaceutical Industry

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