OPATANOL COLL 1FL 5ML 1MG/ML

OPATANOL 1 MG/ML COLLECTION

active ingredients

One mL solution contains 1 mg of olopatadine (such as hydrochloride). Excipient(s) with known effects: Benzalconio chloride 0.1 mg/ml. Sodium phosphate bibasic dodecaidrate (E339) 12,61 mg/ml (equivalent to 3,34 mg/ml of phosphates). For the full list of excipients, see paragraph 6.1.

Excellent

Benzalconio chloride Sodium chloride Sodium phosphate dibasic dodecaidrate (E339) Hydrochloric acid (E507) (to adjust the pH) Hydroxide sodium (E524) (to adjust the pH) Purified water

Therapeutic indications

Treatment of signs and eye symptoms of seasonal allergic conjunctivitis.

Contraindications

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

Population

Population The dose is a drop of Opatanol in the conjunctive sack of the eye/i affection/i twice a day (every 8 hours). Treatment can be extended up to four months, if considered necessary. Use in the elderly In elderly patients it is not necessary to change the dose. Pediatric population Opatanol can be used in pediatric patients (from 3 years on) at the same dose used for adults. Opatanol’s safety and effectiveness in children under 3 years have not yet been established. There are no available data. Use in patients with liver and kidney failure Olopatadine, in the form of colliary (Opatanol), has not been studied in patients with liver or kidney diseases. However, in case of hepatic or renal failure, the dosage should not be changed (see paragraph 5.2). Method of administration Only for ophthalmic use. After the cap has been removed, if the safety ring has loosened, remove it before using the product. In order to prevent contamination of the dropper tip and solution, pay particular attention not to touch the eyelids, surrounding areas or other surfaces with the dropper tip of the bottle. Keep the bottle closed when not used. In case of treatment with other topical eye medicines, a five-minute interval between administration and the next one should be left. Eye ointments should be administered last.

Conservation

This medicine does not require any special condition of conservation.

Warnings

Opatanol is an anti-allergic/anti-histamine that, although administered by topical means, is absorbed on a systemic level. In case of severe reactions or hypersensitivity suspend treatment. Opatanol contains benzalconio chloride, which can cause eye irritation. It has been reported that benzalconio chloride can cause bent keratopathy and/or ulcerative toxic keratopathy. Patients with eye dryness or other conditions in which cornea is compromised must be monitored in case of frequent or prolonged use.Contact lenses The benzalconio is known for the action of discoloration of soft contact lenses. Avoid contact with soft contact lenses. Patients should be informed to remove contact lenses before taking colliery and wait at least 15 minutes after instillation before reinserting contact lenses.

Interactions

No interaction studies have been carried out with other medicines. Studies in vitro have shown that olopatadine does not inhibit metabolic reactions involving isoenzymes 1A2, 2C8, 2C9, 2C19, 2D6, 2E1 and 3A4 of cytochrome P-450. These results indicate that olopatadine is unlikely to induce metabolic interactions with other active substances administered at the same time.

Effects

Summary of security profile In clinical studies carried out on 1680 patients, Opatanol was administered from one to four times a day in both eyes up to four months, such as monotherapy or additional loratadine therapy 10 mg. In about 4.5% of patients may experience adverse reactions associated with the use of Opatanol, however, only 1.6% of patients have interrupted clinical study due to these adverse reactions. Clinical studies have not reported any serious ophthalmic or systemic adverse reaction related to Opatanol. The most frequent adverse reaction related to treatment is eye pain, reported with a total incidence of 0.7%. Table list of adverse reactions The following adverse reactions were reported during clinical studies and post-marketing data and are classified according to the following convention: very common (≥1/10), common (from ≥1/100 to Classification for systems and organs Frequency References Infections and infestations Not common Rehabilitation Immune system disorders Notable Hypersensitivity, swelling of the face Diseases of the nervous system Town Cephalea, disgeusia Not common Capogiro, hypoesthesia Notable Sleep Pathologies of the eye Town Eye pain, eye irritation, dry eye, anomaly in the eyes Not common Corneal erosion, corneal epithelium defect, corneal epithelium disorder, pointed keratite, keratin, corneal coloring, eye secretion, photophobia, blurred vision, reduced visual acuity, blepharospasm, eye discomfort, ocular itching, conjunctive follicles, conjunctiviral disorder, conjunctiviral body feeling Notable Corneal edema, eye edema, eye swelling, conjunctivitis, midriasis, vision disorder, formation of crusts on the eyelid Respiratory, chest and mediastinic pathologies Town Nasal dryness Notable Dispnea, sinusite Gastrointestinal diseases Notable Nausea, vomiting Pathologies of skin and subcutaneous tissue Not common Contact dermatitis, skin burning sensation, skin dryness Notable Dermatitis, erythema Systemic pathologies and conditions for administration Town Fatigue Notable Astenia, malaise Very rarely have been reported cases of cornea calcification associated with the use of phosphates in patients with significantly damaged cornea. Reporting of suspicious 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 professionals are required to report any adverse reaction suspected through the Italian Pharmaco Agency, website: http://www.aifa.gov.it/content/segnalazioni-reazioniavverse.

Overdosing

Data relating to overdose in man are not available as a result of accidental or voluntary ingestion. Olopatadine is characterized by a low order of acute toxicity in animals. The accidental ingestion of the entire content of an Opatanol bottle would result in a systemic exposure of up to 5 mg of olopatadine. This exposure would be equivalent to a final dose of 0.5 mg/kg in a child of 10 kg, assuming a 100% absorption. In dogs, the extension of the QTc range was observed only at exposures considered sufficiently excessive compared to the maximum exposure in man, since it indicates a minimal relevance to clinical purposes. An oral dose of 5 mg has been given twice a day, for 2.5 days, to 102 healthy volunteers young and elderly, males and females, without highlighting any significant extension of the QTc range compared to the placebo. The peak of plasma concentrations of stationary olopatadine (from 35 to 127 ng/ml) observed in this study represents a safety margin of at least 70 times for topical holopatadine compared to effects on cardiac repolarization. In case of overdose, you will have to carry out a special monitoring and treatment of the patient.

Pregnancy

Data relating to the use of olopatadine by ophthalmic means in pregnant women do not exist or are in limited number. Animal studies showed reproductive toxicity following systemic administration (see paragraph 5.3). Holopatadine is not recommended during pregnancy and in women of fertile age who do not use contraceptive measures.

Food

The data available in animals showed the excretion of olopatadine in milk following oral administration (see paragraph 5.3). The risk for infants/ infants cannot be escluso.Opatanol should not be used during lactation.

Fertility

Studies have not been carried out to assess the effect on human fertility of the topical ophthalmic administration of olopatadine.

Source: Farmadati