OPATANOL * COLL 1FL 5ML 1MG / ML

OPATANOL * COLL 1FL 5ML 1MG / ML

Therapeutic indications

Treatment of ocular signs and symptoms of seasonal allergic conjunctivitis.

Dosage and method of use

DosageThe dose is one drop of Opatanol in the conjunctival sac of the affected eye (s) twice daily (every 8 hours). Treatment can be extended up to four months if considered necessary. Use in the elderly No dose adjustment is required in elderly patients. Pediatric population Opatanol can be used in pediatric patients (3 years and older) at the same dose as for adults. The safety and efficacy of Opatanol in children under the age of 3 have not yet been established. No data are available. Use in patients with hepatic and renal insufficiency Olopatadine, in the form of eye drops (Opatanol), has not been studied in patients with liver or kidney disease. However, in case of hepatic or renal insufficiency, no dosage adjustment is considered necessary (see section 5.2).Method of administrationFor ophthalmic use only. After the cap has been removed, if the safety ring has come loose, remove it before using the product. In order to prevent contamination of the dropper tip and solution, take special care not to touch the eyelids, surrounding areas or other surfaces with the dropper tip of the bottle. Keep the bottle tightly closed when not in use. In case of concomitant therapy with other topical ocular medicinal products, an interval of five minutes should be left between one administration and the next. Eye ointments should be given last.

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 studies involving 1,680 patients, Opatanol was administered one to four times daily in both eyes for up to four months, as monotherapy or add-on therapy to 10 mg loratadine. Approximately 4.5% of patients may experience adverse reactions associated with the use of Opatanol, however, only 1.6% of patients discontinued the clinical trial due to these adverse reactions. Clinical studies did not report any serious ophthalmic or systemic adverse reactions related to Opatanol. The most frequent treatment-related adverse reaction is eye pain, reported with an overall incidence of 0.7%.Tabular list of adverse reactionsThe following adverse reactions have been reported during clinical trials and post-marketing data and are classified according to the following convention: very common (≥1 / 10), common (≥1 / 100 to

Cases of corneal calcification associated with the use of phosphate-containing eye drops have been reported very rarely in patients with significantly damaged cornea.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 Italian Medicines Agency website:http://www.aifa.gov.it/content/segnalazioni-reazioniavverse.

Special warnings

Opatanol is an antiallergic / antihistamine which, although administered topically, is absorbed systemically. In case of severe reactions or hypersensitivity, discontinue treatment. Opatanol contains benzalkonium chloride, which can cause eye irritation. Benzalkonium chloride has been reported to cause punctate keratopathy and / or toxic ulcerative keratopathy. Patients with dry eyes or other conditions in which the cornea is compromised should be carefully monitored for frequent or prolonged use.Contact lensesBenzalkonium is known for the discoloring action of soft contact lenses. Avoid contact with soft contact lenses. Patients should be advised to remove contact lenses prior to administering eye drops and to wait at least 15 minutes after instillation before reinserting contact lenses.

Pregnancy and breastfeeding

PregnancyThere are no or limited data from the use of olopatadine by the ophthalmic route in pregnant women. Animal studies have shown reproductive toxicity following systemic administration (see section 5.3). Olopatadine is not recommended during pregnancy and in women of childbearing potential who are not using contraceptive measures.Feeding timeAvailable data in animals have shown excretion of olopatadine in milk following oral administration (for details see section 5.3). A risk to the newborns / infants cannot be excluded. Opatanol should not be used during breastfeeding.FertilityNo studies have been performed to evaluate the effect of topical ophthalmic administration of olopatadine on human fertility.

Expiry and retention

This medicine does not require any special storage conditions.

Interactions with other drugs

No interaction studies with other medicinal products have been performed. Educationin vitrodemonstrated that olopatadine does not inhibit metabolic reactions involving cytochrome P-450 isoenzymes 1A2, 2C8, 2C9, 2C19, 2D6, 2E1 and 3A4. These results indicate that olopatadine is unlikely to induce metabolic interactions with other concomitantly administered active substances.

Overdose

There are no data on overdose in humans following accidental or deliberate ingestion. Olopatadine is characterized by a low order of acute toxicity in animals. Accidental ingestion of the entire contents of one bottle of Opatanol would result in a maximum systemic exposure of 5 mg olopatadine. This exposure would be equivalent to a final dose of 0.5 mg / kg in a 10 kg child assuming 100% absorption. QTc interval prolongation was observed in dogs only at exposures considered sufficiently in excess of the maximum human exposure indicating minimal relevance for clinical purposes. An oral dose of 5 mg was administered twice daily, for 2.5 days, to 102 young and elderly healthy male and female volunteers, with no significant prolongation of the QTc interval compared to placebo. The steady state peak olopatadine plasma concentration range (35 to 127 ng / mL) observed in this study represents a safety margin of at least 70-fold for topical olopatadine with respect to effects on cardiac repolarization. In the event of an overdose, appropriate monitoring and treatment of the patient should be undertaken.

Active principles

One mL of solution contains 1 mg of olopatadine (as hydrochloride).Excipient (s) with known effect: Benzalkonium chloride 0.1 mg / ml. Dibasic sodium phosphate dodecahydrate (E339) 12.61 mg / ml (equivalent to 3.34 mg / ml of phosphates). For the full list of excipients, see section 6.1.

Excipients

Benzalkonium chloride Sodium chloride Disodium phosphate dodecahydrate (E339) Hydrochloric acid (E507) (for pH adjustment) Sodium hydroxide (E524) (for pH adjustment) Purified water