LEVOREACT OFTA*COLL 4ML 0,5MG/

Allergic conjunctivitis

Therapeutic indications

Allergic conjunctivitis.

Dosage and method of use

Posology Adults and children : the usual dose is 1 drop of LEVOREACT OPTHALMIC per eye, 2 times a day. The dose can be increased to 1 drop up to 3 or 4 times a day. Treatment should be continued for as long as symptoms disappear. Method of administration Ophthalmic use. For instructions on the use and handling of the medicinal product before administration, see section 6.6.

Contraindications

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

Side effects

Adverse drug reactions identified during clinical and epidemiological studies and from postmarketing experience following the use of LEVOREACT OPTHALMIC are listed in Table 1 ; frequencies are reported according to the following conventional classification: Very common ≥1/10 Common ≥1/100 and <1/10 Uncommon ≥1/1000 and <1/100 Rare ≥1/10,000 and <1/1000 Very rare < 1/10,000 Not known Frequency cannot be estimated from the available data Table 1: Adverse drug reactions identified during clinical trials and postmarketing experience with LEVOREACT OPHTHALMIC.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.

Special warnings

As with all ophthalmic preparations containing benzalkonium chloride, propylene glycol and esters, patients should be advised not to use soft (hydrophilic) contact lenses during treatment with LEVOREACT OPHTHALMIC eye drops suspension as they may cause eye irritation. Remove contact lenses before applying the medicine and wait at least 15 minutes before putting them back on. The medicine discolours soft contact lenses.

Pregnancy and breastfeeding

Pregnancy Studies in animals have not shown embryotoxic or teratogenic effects (see section 5.3). There is limited postmarketing data from the use of levocabastine eye drops, suspension in pregnant women; the risk for humans is not known, therefore LEVOREACT OPTHALMIC should not be used during pregnancy, unless the potential benefit to the woman justifies the potential risk to the foetus. Breast-feeding Based on concentration determinations of levocabastine in saliva and breast milk from a nursing woman given a single oral dose of 0.5 mg levocabastine, approximately 0.3% of the dose would be expected to amount of levocabastine administered ophthalmologically, can be transmitted to the infant. However, due to the limited availability of clinical and experimental data, caution is recommended when administering LEVOREACT OPTHALMIC to breastfeeding women. Fertility Animal data have shown no effect on male or female fertility (see section 5.3).

Expiration and conservation

Do not store above 25°C.

Interactions with other drugs

No interaction studies have been performed.

Overdose

Symptoms No cases of overdose with LEVOREACT OPTHALMIC have been reported. However, the occurrence of sedation after accidental ingestion of the vial contents cannot be excluded. Treatment In case of accidental ingestion, advise the patient to drink plenty of non-alcoholic liquids in order to accelerate the renal elimination of levocabastine.

Active principles

One ml of eye drops, suspension contains: levocabastine hydrochloride 0.54 mg (equivalent to 0.5 mg of levocabastine). Excipients with known effect: propylene glycol, benzalkonium chloride. For the full list of excipients, see section 6.1.

Excipients

Propylene glycol, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate anhydrous, hydroxypropyl methylcellulose 2910, polysorbate 80, benzalkonium chloride, disodium edetate, water for injections.