RELESTAT

Posology 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. Elderly Relestat has not been studied in elderly 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 elderly compared with adult patients. As such, no dosage adjustment is considered to be necessary.

Paediatric population 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. 1. Patients with hepatic impairment 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.

Patients with renal impairment 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. Method of administration 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.

Summary of the safety profile In clinical studies, the overall incidence of adverse reactions following Relestat was less than 10%. No serious adverse reactions occurred. Most were ocular and mild. The most common adverse reaction was burning sensation in eye (mostly mild); all other adverse reactions were uncommon.

Tabulated list of adverse reactions Within each frequency grouping, adverse reactions are presented according to System Organ Class in order of decreased seriousness. The following terminologies have been used in order to classify the occurrence of undesirable effects: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1 000 to <1/100); rare (≥1/10 000 to <1/1 000); very rare (<1/10 000); not known (cannot be estimated from the available data).

The following adverse reactions have been reported with epinastine:

System Organ Class Frequency Adverse reaction Immune system disorders Not known Hypersensitivity reaction including symptoms or signs of eye allergy and extra-ocular allergic reactions, including angioedema, skin rash and redness Nervous system disorders Uncommon Headache Common Burning sensation, eye irritation Uncommon Conjunctival/ocular hyperaemia, eye discharge, eye dryness, eye pruritus, visual disturbance Eye disorders Not known Increased lacrimation, eye pain, eye swelling, eyelid oedema Respiratory, thoracic and mediastinal disorders Uncommon Asthma, nasal irritation, rhinitis Gastrointestinal disorders Uncommon Dysgeusia Paediatric population Frequency, type and severity of adverse reaction in adolescents ≥ 12 years of age are expected to be the same as in adults.

There is limited experience in children aged 3-12 years regarding frequency, type and severity of adverse reactions. 4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

Relestat is for topical ophthalmic use only and not for injection or oral use. Excipients with known effect Benzalkonium chloride Benzalkonium chloride is commonly used as a preservative in ophthalmic products and has been reported rarely to cause punctate keratopathy and/or toxic ulcerative keratopathy.

Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. Patients should be instructed to remove contact lenses before using this medicine and put them back 15 minutes afterwards.

Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface. Should be used with caution in dry eye patients and in patients where the cornea may be compromised.

Patients should be monitored in case of prolonged use. Phosphates Relestat also contains phosphates. 8)

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