COMPOSITION: (gram per 7,5 mL)
Eppy contains L-adrenaline base 1% in a buffered ophthalmic solution, preserved with benzalkonium chloride 0,01% m/v.
PHARMACOLOGICAL CLASSIFICATION: A 15.4 Ophthalmic preparations: Other
PHARMACOLOGICAL ACTION: Ocular instillation of Eppy reduces intra-ocular pressure by decreasing the rate of aqueous production. Eppy can be used in combination with miotics, beta-adrenergic blocking agents or carbonic anhydrase inhibitors where indicated. Eppy has no miotic action and is particularly valuable in the older patient in whom central lens opacities are reducing vision, and in younger patients who may develop ciliary muscle spasm with the parasympathomimetic group of drugs.
INDICATIONS: Eppy is indicated for the treatment of elevated intraocular pressure in open-angle (chronic simple) glaucoma.
CONTRA-INDICATIONS: Eppy should not be used where the diagnosis of open-angle glaucoma has not been verified. It is contra-indicated in narrow angle glaucoma because pupillary dilation may precipitate angle-closure glaucoma.
Topical adrenaline has occasionally been shown to cause macular oedema in aphakic eyes, and thus the use of adrenaline-containing eye drops in aphakic patients is not recommended.
Hypersensitivity to adrenaline or any other component of the preparation. This product contains benzalkonium chloride and should not be used when soft contact lenses are worn.
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. Safety for use in pregnancy and lactation has not been established. Do not use if the solution has become dark amber.
Discard one month after opening.
DOSAGE AND DIRECTIONS FOR USE:
one or two drops instilled into the eye once or twice daily. Determine the frequency of instillation by tonometry.
at the discretion of the ophthalmologist. Safety and efficacy of use in children has not been established.
When used in conjunction with miotics, Eppy should be instilled five or ten minutes after the miotic.
Eppy should not be diluted, nor should it be dispensed from any container other than the original bottle. This preparation should only be used under medical supervision.
SIDE EFFECTS AND SPECIAL PRECAUTIONS: Severe smarting on instillation, blurred vision, photophobia, eye pain, conjunctival hyperaemia, (resulting in red eye as a frequent response).
Conjunctival sensitisation, and allergy and local skin reactions occur occasionally. Pigmentary deposits in the conjunctiva cornea, or eyelids may occur after prolonged use. Headache or browache are also common but usually diminish as treatment is continued.
Systemic effects are rare but include palpitations, tachycardia, extrasystoles and elevation of blood pressure, cardiac arrhythmias, faintness, sweating, pallor, trembling, and perspiration.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: See side effects and special precautions. Treatment is symptomatic and supportive.
IDENTIFICATION: A clear colourless to almost colourless liquid.
PRESENTATION: Eppy is supplied in 7,5 mL bottles, each provided with a stand and separate sterile dropper.
STORAGE INSTRUCTIONS: Store the bottle upright in the closed box with the dropper tightly sealed. Store in the refrigerator away from strong light.
DO NOT FREEZE. Keep out of reach of children.
REFERENCE NUMBER: H1162 (Act 101/1965)
NAME AND BUSINESS ADDRESS OF APPLICANT: S & N Pharmaceuticals (Pty) Ltd
30 Gillitts Road
DATE OF PUBLICATION OF THIS PACKAGE INSERT: December 1974
* Trade Mark
9/76 SNP 6/2