Relestat eye drops bottle 5 ml 0.5 mg/ml

RELESTAT * COLL FL 5ML 0,5MG / ML

Therapeutic indications

Symptomatic treatment of seasonal allergic conjunctivitis.

Dosage and method of use

DosageIn 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. People elderly Relestat has not been studied in older people. 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 older people compared to adult patients. For this reason, no dosage adjustment is considered necessary. Pediatric population The safety and efficacy in children aged ≥ 12 years 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 in children aged less than 3 years have not been established. No data are available. There are limited safety data in children 3 to 12 years of age described in section 5.1. 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 (Patients with kidney damageThe 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.Method of administration Relestat is for topical ophthalmic use only. To avoid contaminating the eye or eye drops, the dropper tip must not come into contact with any surface. In the case of use of several topical ophthalmic products, the different drugs must be administered at least 10 minutes apart from each other.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Side effects

Summary of the safety profileIn 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.Table of adverse reactionsWithin each frequency class, undesirable effects are reported according to the System Organ Class in descending 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 y

The following adverse reactions have been reported in clinical practice during post-marketing use of epinastine:

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 aged 3 to 12 years with regard to the frequency, type and severity of adverse reactions.Adverse reactions reported with phosphate-containing eye dropsCases of corneal calcification associated with the use of phosphate-containing eye drops have been reported very rarely in patients with severe corneal impairment (see section 4.4).Reporting of suspected adverse reactionsReporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

Relestat is for topical ophthalmic use only and not for injectable or oral use. Excipients 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 15 minutes after administration of Relestat before applying contact lenses. Relestat should not be given while wearing contact lenses. Relestat also contains phosphates. Cases of corneal calcification associated with the use of phosphate-containing eye drops have been reported very rarely in patients with significantly damaged cornea (see section 4.8).

Pregnancy and breastfeeding

PregnancyData 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.Feeding timeEpinastine is excreted in rat milk 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.FertilityThere are no adequate data from the use of epinastine on human fertility.

Expiration and retention

Keep the bottle inside the box to protect the product from light. Store at a temperature not exceeding 25 ° C.

Interactions with other drugs

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.

Overdose

Following instillation of 0.3% epinastine hydrochloride eye drops, three times a day (corresponding to a dosage 9 times the recommended daily dosage) cases of reversible miosis have been observed, with no influence on visual acuity or on other ocular parameters. The 5 ml bottle of Relestat contains 2.5 mg of epinastine hydrochloride. Tablets containing up to 20 mg of epinastine hydrochloride to be taken once a day are marketed and, consequently, the possibility of intoxication due to oral ingestion, even after ingesting the entire vial, is not anticipated. No cases of overdose have been reported.

Active principles

1 ml of eye drops, solution, contains 0.5 mg of epinastine hydrochloride. (equivalent to 0.436 mg of epinastine) Excipient (s) with known effect: benzalkonium chloride 0.1 mg / ml and phosphates 4.75 mg / ml. For the full list of excipients, see section 6.1.

Excipients

Benzalkonium chloride, Disodium edetate, Sodium chloride, Sodium dihydrogen phosphate dihydrate, Sodium hydroxide / hydrochloric acid (to adjust the pH), Purified water.