Relestat 0.5 mg / ml

Eye drops

Composition :

1 ml of eye drops, solution, contains 0.5 mg of epinastine hydrochloride. (equivalent to 0.436 mg epinastine) Excipient: benzalkonium chloride 0.1 mg / ml For the full list of excipients, see section 6.1.

Excipients

Benzalkonium chloride, disodium edetate, sodium chloride, monobasic sodium phosphate dihydrate, sodium hydroxide / hydrochloric acid (for pH adjustment), purified water.

Therapeutic indications

Symptomatic treatment of seasonal allergic conjunctivitis.

Contraindications

Hypersensitivity to epinastine or to any of the excipients.

Dosage

In adults, the recommended dose is one drop instilled into each affected eye twice a day, during the symptomatic phase. There are no clinical trial data available on the use of Relestat for longer than 8 weeks. To avoid contaminating the eye or eye drops, the dropper tip must not come into contact with any surface. In the case of joint use of several topical ophthalmic products, administer the different drugs at least 10 minutes apart from each other. Use in the elderly Relestat has not been studied in elderly patients. Post-marketing data on the safety of epinastine hydrochloride tablets (administered once daily up to a dose of 20 mg) indicated that there are no particular safety concerns in elderly patients compared to adult patients. For this reason, no dosage adjustment is considered necessary. Use in the pediatric population The safety and efficacy in patients ≥ 12 years of age have been established in clinical studies. Relestat can be used in adolescents (12 years and older) at the same dosage as for adults. The safety and efficacy of Relestat has not been established in children aged less than 3 years. There are limited safety data in children 3 to 12 years of age, see section 5.1. Use in patients with hepatic impairment The use of Relestat has not been studied in patients with hepatic impairment. Post-marketing data on the safety of epinastine hydrochloride tablets (administered once daily up to a dose of 20 mg) indicated a higher incidence of adverse reactions in this patient group than in adult patients with no hepatic impairment. The daily dose of one 10 mg epinastine hydrochloride tablet is more than 100 times the recommended daily dose of Relestat. Furthermore, the metabolism of epinastine is minimal in humans (<10%). For this reason, no dosage adjustment is considered necessary. Use in patients with renal impairment The use of Relestat has not been studied in patients with renal impairment. Post-marketing data on the safety of epinastine hydrochloride tablets (administered once daily up to a dose of 20 mg) did not indicate any particular safety concerns in patients with renal impairment. For this reason, no dosage adjustment is considered necessary.

Warnings and Precautions

Relestat is for topical ophthalmic use only and not for injectable or oral use. Benzalkonium chloride is commonly used in ophthalmic products as a preservative; Cases of punctate keratitis and / or toxic ulcerative keratopathy have been reported rarely. Benzalkonium chloride can be absorbed by soft contact lenses and cause discoloration: patients should therefore be advised to wait at least 10-15 minutes after administration of Relestat before applying contact lenses. Relestat should not be given while wearing contact lenses.

Interactions

No interaction studies have been performed. Given the very low systemic concentrations of epinastine relative to ocular dosage, no interactions between Relestat and other drugs are expected in humans. Furthermore, epinastine is eliminated predominantly in unmodified form in humans indicating a low level of metabolism.

Side effects

In clinical trials, the overall incidence of side effects related to the use of Relestat was less than 10%. No cases of serious side effects have been reported. Most of the cases were minor eye disorders. The most common side effect reported was a burning sensation in the eye (mostly mild); all other side effects were uncommon. Within each frequency class, the undesirable effects are reported according to the System Organ Class in decreasing order of severity. The following terminologies have been used for the purpose of classifying the occurrence of undesirable effects: very common (≥ 1/10); common (≥1 / 100 to <1/10); uncommon (≥1 / 1000 to <1/100); rare (≥1 / 10,000 to <1/1000); very rare (<1/10000), not known (cannot be estimated from the available data). The following side effects have been reported in clinical trials with Relestat: Nervous system disorders Uncommon: headache Eye disorders Common: burning sensation / eye irritation Uncommon: conjunctival / ocular hyperaemia, ocular discharge , dry eye, itchy eye, visual disturbances, increased lacrimation *, eye pain *. Respiratory, thoracic and mediastinal disorders Uncommon: asthma, nasal irritation, rhinitis Gastrointestinal disorders Uncommon: dysgeusia. * Increased lacrimation and eye pain have been reported during post-marketing use of Relestat in clinical practice. Pediatric population The frequency, type and severity of adverse reactions in adolescents aged ≥ 12 years are the same as expected in adults. There is limited experience in children between 3 and 12 years of age with regard to the frequency, type and severity of adverse reactions.

Pregnancy and breastfeeding

Pregnancy Data on a limited number (11) of pregnant women indicate that there are no adverse effects related to the use of epinastine in pregnancy or on the health of the fetus / newborn. To date, no other relevant epidemiological data are available. Animal studies have not indicated direct or indirect harmful effects with respect to pregnancy, embryonal / fetal development, parturition or postnatal development (see section 5.3). Prescribing the drug to pregnant women should be done with caution. Lactation Epinastine is excreted in the milk of rats but it is not known whether it is excreted in human milk. Given the lack of experience, the prescription of the drug to breastfeeding women should be done with caution. Fertility There are no adequate human fertility data from the use of epinastine.