COMPOSITION: (grams per 7,5 mL)
Simplene contains adrenaline B.P. 0,075 g in a buffered isotonic solution, preserved with benzalkonium chloride solution 0,02% v/v.
PHARMACOLOGICAL CLASSIFICATION: A 15.4 Ophthalmic preparations: other
PHARMACOLOGICAL ACTION: Simplene reduces intra-ocular pressure and is used in the treatment of primary open-angle or secondary glaucoma. It may be used in conjunction with miotics or carbonic anhydrase inhibitors.
Simplene has no miotic action and is particularly valuable in the older patient in whom central lens opacities are reducing vision, and in younger patients where the use of parasympathomimetic drugs may produce ciliary muscle spasm.
INDICATIONS: For the treatment of primary open-angle or secondary glaucoma.
CONTRA-INDICATIONS: Simplene should not be used when 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 eyedrops in aphakic patients is not recommended.
DOSAGE AND DIRECTIONS FOR USE:
one drop to be instilled into the eye, once or twice daily, or at the discretion of the ophthalmologist.
at the discretion of the ophthalmologist.
Simplene should not be diluted nor should it be dispensed from any container other than the original bottle. Simplene should not be used if the solution has become dark amber. Simplene should be discarded one month after opening.
This preparation should only be used under medical supervision.
SIDE EFFECTS AND SPECIAL PRECAUTIONS: The occasional patient may complain of orbital discomfort or red eye. Rarely headache, irritation and local skin reactions occur. As with other adrenaline preparations, melanosis may occasionally occur, but this has no pathological significance.
Systemic effects are rare, but include tachycardia, extrasystoles and elevation of blood pressure. When used in conjunction with miotics, Simplene should follow the miotic after an interval of 5-10 minutes.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: Not applicable.
CONDITIONS OF REGISTRATION: Advertising to the professions only.
IDENTIFICATION: Simplene is a clear, viscous, colourless to almost colourless liquid.
PRESENTATION: Simplene is supplied in a plastic dropper bottle packed in a nitrogen-filled pouch, inside a carton.
STORAGE INSTRUCTIONS: Simplene must be dispensed and stored in the foil pouch provided.
Store below 15°C away from strong light refrigeration may become necessary in hot climates.
Simplene is fully potent for two years unopened, and remains stable for at least 30 days after opening.
REGISTRATION NUMBER: J/15.4/1
NAME AND BUSINESS ADDRESS OF APPLICANT: S & N Pharmaceuticals (Pty) Limited
30 Gillitts Road
DATE OF PUBLICATION OF THIS PACKAGE INSERT: September 26, 1984.