RELESTAT COLL FL 5ML 0.5MG/ML

RELESTAT, 0.5 MG/ML, COLLIRIO, SOLUTION

active ingredients

1 ml of eye drops, solution, contains 0.5 mg of epinastine hydrochloride. (equivalent to 0.436 mg of epinastine) Excipient(s) with known effects: benzalconium chloride 0.1 mg/ml and phosphates 4,75 mg/ml. For the full list of excipients, see paragraph 6.1.

Excellent

Benzalconio chloride, Detoxed disode, Sodium chloride, Sodium phosphate monobasic dihydrate, Sodium hydroxide/chloric acid (to adjust the pH), Purified water.

Therapeutic indications

Syntomatic treatment of seasonal allergic conjunctivitis.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1.

Population

Population In adults the recommended dose is a drop instilled in each eye twice a day, during the symptomatic phase. Data are not available from clinical studies on the use of Relestat for periods greater than 8 weeks. Persons elderly Relestat was not studied in older people. Post-marketing data on the safety of epinastine hydrochloride in tablets ( administered once a day until a dosage of 20 mg) have indicated that there are no particular security problems in older people compared to adult patients. For this reason, no posological adjustment is required. Pediatric population Safety and effectiveness in children aged ≥ 12 years has been established in clinical trials. Relestat can be used in teenagers (from 12 years on) to the same posology used for adults. Relestat’s safety and effectiveness in children under 3 years of age has not been established. There are no available data. There are limited data on child safety from 3 to 12 years of age, described in paragraph 5.1. Patients with liver impairment The use of Relestat was not studied in patients with liver impairment. Post-marketing data on the safety of epinastine hydrochloride in tablets ( administered once a day until a dosage of 20 mg) have indicated a greater incidence of adverse reactions in this group of patients than adult patients without liver impairment. The daily dose of an epinastine 10 mg hydrochloride tablet is more than 100 times higher than the recommended daily dose of Relestat. Moreover, the metabolism of epinastine is minimal in man ( Patients with kidney damage The use of Relestat was not studied in patients with kidney damage. Post-marketing data on the safety of epinastine hydrochloride in tablets ( administered once a day until a dosage of 20 mg) have not indicated the presence of particular safety problems in patients with kidney impairment. For this reason, no posological adjustment is required. Method of administration Relestat is for exclusive topical ophthalmic use. To avoid contaminating the eye or the eye, the tip of the dropper should not come into contact with any surface. In case of use of multiple ophthalmic topical products, the various drugs must be administered at least 10 minutes away from each other.

Conservation

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

Warnings

Relestat is exclusively for topical ophthalmic use and not for injectable or oral use. Benzalconio chloride is commonly used in ophthalmic products as preservative; seldom reported cases of episode keratin and/or toxic ulcerative keratopathy. Benzalconio chloride can be absorbed by soft contact lenses and cause discoloration: patients should therefore be informed to wait at least 15 minutes after administration of Relestat before applying contact lenses. Relestat should not be administered while bringing contact lenses. Relestat also contains phosphates. Very rarely have been reported cases of cornea calcification associated with the use of phosphates in patients with significantly damaged cornea (see paragraph 4.8).

Interactions

No interaction studies have been carried out. Given the very low systemic concentrations of epinastine related to the ocular dose, human interactions between Relestat and other drugs are not foreseen. In addition, epinastine is mainly eliminated in unmodified form, indicating a low level of metabolism.

Effects

Summary of security profile During clinical trials, the overall incidence of side effects linked to the use of Relestat was less than 10%. No serious side effects reported. In most cases it was a mild eye disorder. The most common side effect reported was the feeling of burning to the eye (predominantly mild); all other side effects were uncommon. Table of adverse reactions Within each frequency class, the unwanted effects are reported in accordance with the Classification for systems and organs in descending order of gravity. The following terminologies were used to classify the appearance of unwanted effects: Very common (≥ 1/10); common (≥1/100 a Classification for systems and organs Frequency Action against Diseases of the nervous system Not common Headache Pathologies of the eye Town Feeling of burning, eye irritation Not commonConjunctive/ocular hyperemia, eye secretion, eye dryness, eye itching, visual disorders. Respiratory, chest and mediastinic pathologies Not common Asthma, nasal irritation, rhinitis Gastrointestinal diseases Not common Disgeusia. During post-marketing use of epinastine, the following adverse reactions were reported in clinical practice:

Classification for systems and organs	Frequency	Action against
Immune system disorders	Notable	Reaction from hypersensitivity including symptoms or signs of eye allergy and extraocular allergic reactions, including angioedema, rash and redness.
Pathologies of the eye	Notable	Increased tearing, eye pain, swelling of eyes, eyelid edema

Pediatric population The frequency, type and severity of adverse reactions in adolescents aged ≥ 12 years are the same in adults. There is a limited experience in children between 3 and 12 years of age relative to the frequency, type and severity of adverse reactions. Adverse reactions reported with phosphates Very rarely, in patients with severe impairment of cornea, cases of corneal calcification were reported associated with the use of phosphate-containing colliders (see paragraph 4.4) Reporting of suspected adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Following the instillation of epinastine hydrochloride based colliery 0.3%, three times a day (corresponding to a dosage 9 times higher than the recommended daily dosage) cases of reversible myosis were observed, without any influence on visual acuity or other eye 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, it is not foreseen the possibility of an intoxication due to oral ingestion, also following the ingestion of the whole bottle. No overdose cases have been reported.

Pregnancy

Data on a limited number (11) of pregnant women indicate that there are no adverse effects on the use of pregnant epinastine or on the health of fetus/neonate. Until now, there are no other relevant epidemiological data available. Animal studies have shown no harmful, direct or indirect effects in relation to pregnancy, embryo/fetal development, childbirth or postnatal development (see paragraph 5.3). Prescription of the drug to pregnant women should be done with caution.

Food

Epinastine is excreted in rat milk but it is not known if it is excreted in human milk. Given the poor experience, the prescription of the medicine to nursing women must be carried out with caution.

Fertility

There is no adequate data from the use of epinastine on fertility in man.

Source: Farmadati