Source: Health Products Regulatory Authority (IE) Revision Year: 2022 Publisher: AbbVie Limited, Citywest Business Campus, Co Dublin 24, Ireland
Treatment of the symptoms of seasonal allergic conjunctivitis.
The recommended dose for adults is one drop instilled in each affected eye twice daily, during the symptomatic period.
There is no experience in clinical studies with the use of Relestat for more than 8 weeks.
Relestat has not been studied in older people. Post-marketing safety data from the tablet formulation of epinastine hydrochloride (up to 20 mg once daily) indicates that there are no particular safety issues for older people compared with adult patients. As such, no dosage adjustment is considered to be necessary.
The safety and efficacy in children ≥12 years has been established in clinical trials. Relestat may be used in adolescents (12 years of age and older) at the same dosage as in adults.
The safety and efficacy of Relestat in children aged less than 3 years have not been established. No data are available. There are limited data on the safety in children aged 3-12 years, described in section 5.1.
Relestat has not been studied in patients with hepatic impairment. Post‑marketing safety data from the tablet formulation of epinastine hydrochloride (up to 20 mg once daily) indicates that the incidence of adverse reactions was higher in this group compared with adult patients without hepatic impairment. The daily dose of a 10 mg epinastine hydrochloride tablet is more than 100-fold higher than the daily dose following Relestat. In addition, the metabolism of epinastine in humans is minimal (<10%). Therefore, no dosage adjustment is considered to be necessary.
Relestat has not been studied in patients with renal impairment. Post‑marketing safety data from the tablet formulation of epinastine hydrochloride (up to 20 mg once daily) indicate that there are no particular safety issues for patients with renal impairment. As such, no dosage adjustment is considered to be necessary.
Relestat is for topical ophthalmic use only.
To avoid contamination of the eye or eye drops do not allow the dropper tip to come into contact with any surface.
If more than one topical ophthalmic medicinal product is being used, the different medicinal products should be administered at least 10 minutes apart.
fter instillation of 0.3% epinastine hydrochloride eye drops 3 times daily (corresponds to 9 times the recommended daily dose) reversible miosis, without influence on visual acuity or other ocular parameters, was observed.
The 5 ml bottle of Relestat contains 2.5 mg of epinastine hydrochloride. A tablet formulation is marketed at a once daily dose of up to 20 mg epinastine hydrochloride, as such, intoxication after oral ingestion of the ophthalmic formulation is not expected even if the whole content of the bottle is swallowed.
No case of overdose has been reported.
2 years.
After first opening: 4 weeks.
Keep the bottle in the outer carton in order to protect from light.
Do not store above 25°C.
10 ml polyethylene bottle with a white polystyrene screw cap.
The fill volume is 5 ml.
No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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