Relestat 0.5mg Eye Drops

RELESTAT is indicated for the short-term 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, and use RELESTAT beyond that time span is therefore not recommended (see WARNINGS AND SPECIAL PRECAUTIONS). 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 medicinal products should be administered at least 10 minutes apart.

Elderly patients: RELESTAT has not been studied in elderly patients.

Children: 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 less than 12 years of age have not been established.

Hepatic impairment: RELESTAT has not been studied in patients with hepatic impairment.

Renal impairment: RELESTAT has not been studied in patients with renal impairment.

Hypersensitivity to epinastine, benzalkonium chloride, or to any of the excipients in RELESTAT.

RELESTAT is for topical ophthalmic use only and not for injection or oral use. RELESTAT contains benzalkonium chloride as a preservative which has been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy. Benzalkonium chloride may be absorbed by and discolour soft contact lenses. Patients should be instructed to wait until 15 minutes after instillation of RELESTAT before inserting contact lenses. RELESTAT should not be administered while wearing contact lenses. 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 (see DOSAGE AND DIRECTIONS FOR USE).

No interaction studies have been performed. No interactions are anticipated in humans since systemic concentrations of epinastine are extremely low following ocular dosing. In addition, epinastine is mainly excreted unchanged in humans, indicating a low level of metabolism.

Pregnancy: Safe use of RELESTAT in pregnancy has not been established. RELESTAT should not be used during pregnancy.

Lactation: Safe use of RELESTAT during lactation has not been established. RELESTAT should not be used by woman breastfeeding their infants. Alternatively, mothers on RELESTAT should not breastfeed their infants.

Transient blurring of vision may occur upon instillation of eye drops. Patients should be cautioned to not drive or operate hazardous machinery unless their vision is clear.

The most common adverse reaction was burning sensation in eye (mostly mild); all other adverse reactions were uncommon. Within each frequency grouping, adverse reactions are presented according to System Organ Class in order of decreasing seriousness. The following terminologies have been used in order to classify the occurrence of undesirable effects: Very common (u2265 1/10); common (u2265 1/100 to < 1/10); uncommon (u2265 1/1 000 to < 1/100); rare (u2265 1/10 000 to < 1/1 000); very rare (< 1/10 000); not known (cannot be estimated from the available data). The following adverse medicine reactions were reported during clinical trials with RELESTAT.

Eye disorders: Common: Burning sensation/eye irritation. Uncommon: Conjunctival/ocular hyperaemia, eye dryness, eye pruritus, visual disturbance, eye discharge, increased lacrimation*, eye pain*.

Nervous system disorders: Uncommon: Headache.

Respiratory, thoracic and mediastinal disorders: Uncommon: Asthma, nasal irritation, rhinitis, sinusitis.

Gastrointestinal disorders: Uncommon: Dysgeusia.

Post-marketing experience: The following adverse reactions have been identified during post-marketing use of RELESTAT. Eye disorders: Ocular hyperemia, lacrimation increased, eye pain, eye swelling, eyelid edema. Immune system disorders: Hypersensitivity reaction including symptoms or signs of eye allergy and skin allergic reaction. Paediatric population: Frequency, type and severity of adverse reaction in adolescents u2265 12 years of age are expected to be the same as in adults.

See u2018SIDE EFFECTSu2019. Treatment is symptomatic and supportive. No case of overdose has been reported.