Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2022 Publisher: Esteve Pharmaceuticals Ltd, The Courtyard Barns, Choke Lane, Cookham Dean, Maidenhead, Berks SL6 6PT, United Kingdom
One drop of 0.5% solution instilled into the eye, repeated after 15 minutes if necessary, approximately 40 minutes before examination.
Deeply pigmented eyes may require the use of a 1% solution.
NB: Maximum effect is reached after 30-60 minutes.
One drop of 1% solution instilled into the eye, repeated after 15 minutes if necessary, approximately 40 minutes before examination.
One or two drops of 1% solution instilled into the eye, repeated after 15 minutes if necessary, approximately 40 minutes before examination.
One or two drops of 0.5% solution instilled into the eye, up to 4 times daily or as required.
Deeply pigmented eyes may require the use of a 1% solution.
At the discretion of the physician.
Do not use during the first three months of life due to possible association between the cycloplegia produced and the development of amblyopia and also the increased risks of systemic toxicity in neonates.
Cycloplegia following administration is quick in onset and short-lived. Maximal cycloplegia is achieved within 15-45 minutes of instillation and lasts on average about 20 minutes. Recovery normally takes place in about 4 hours, but very occasionally some effect persists for up to 24 hours.
Mydriasis is produced very rapidly and an average pupil diameter of 7 mm is usually reached 15-30 minutes after instillation of one drop of 0.5% solution. Complete recovery from the mydriatic effect generally occurs spontaneously in not more than 20 hours.
No specific information on the use of this product in the elderly is available. Clinical trials have included patients over 65 years and no adverse reactions specific to this age group have been reported.
Systemic toxicity may occur following topical use, particularly in children. It is manifested by flushing and dryness of the skin (a rash may be present in children), blurred vision, a rapid and irregular pulse, fever, abdominal distension in infants, convulsions and hallucinations and the loss of neuromuscular co-ordination.
Treatment is supportive (there is no evidence that physostigmine is superior to supportive management). In infants and small children the body surface must be kept moist. If accidentally ingested, induce emesis or perform gastric lavage.
Unopened: 2 years.
After first opening: 28 days.
Do not freeze. Keep the bottle in the outer carton in order to protect from light.
Before first opening: store at 2°C-8°C in a refrigerator.
Prior to first opening: remove from refrigerator and store at room temperature for 30 minutes.
After first opening: do not store above 25°C, do not refrigerate.
Discard 28 days after first opening.
Do not dilute or dispense from any container other than the original bottle
5 ml dropper bottle of 1.0% solution.
Bottle: LDPE, natural colour.
Cap: White plastic.
When using the product for the first time, screw down the cap firmly on the bottle to pierce the seal at the tip of the plastic nozzle and unscrew the cap for use.
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