Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Allergan
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 0,004% 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 and 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 Read the complete document