LEVOREACT OFTA COLL 4ML 0.5MG/

LEVOREACT OFTALMIC 0.05% COLLIRIUM, SOSPENSION

active ingredients

A ml of colliery, suspension contains: levocabastina hydrochloride 0.54 mg (equal to 0.5 mg of levocabastina). Excipients with known effects: glycol propylene, benzalconio chloride. For the full list of excipients, see paragraph 6.1.

Excellent

Propylene glycol, sodium hydrogen phosphate monohydrate, disodium hydrogen phosphate anidro, hydroxypropylmethylcellulose 2910, polysorbate 80, benzalconio chloride, disodium edetate, water for injectable preparations.

Therapeutic indications

Allergies.

Contraindications

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

Population

Population Adults and children: the usual dose is 1 drop LEVOREACT OFTALMIC by eye, twice a day. The dose can be increased to 1 drop up to 3 or 4 times a day. Treatment must be continued for the period necessary for the disappearance of symptoms. Method of administration Ophthalmic use. For instructions on the use and manipulation of the medicinal product before administration, see paragraph 6.6.

Conservation

Do not store at temperature above 25° C.

Warnings

As for all ophthalmic preparations containing benzalconio chloride, glycol propylene and esters, patients must be informed not to use soft contact lenses (idrofile) during treatment with LEVOREACT OFTALMICO pendant lamp because they can cause eye irritation. Remove contact lenses before applying the medicine and wait at least 15 minutes before returning them. The medicine decolors soft contact lenses.

Interactions

Interaction studies have not been carried out.

Effects

Drug adverse reactions detected during clinical and epidemiological studies and postmarketing experience following the use of LEVOREACT OFTALMIC are reported in Table 1; the frequencies are given according to the following conventional classification: Very common ≥1/10 Municipality ≥1/100 and Table 1: Drug adverse reactions detected during clinical studies and postmarketing experience with LEVOREACT OFTALMICO.

Heart disease
Notable	Palpitations
Pathologies of the eye
Town	Eye pain, blurred vision;
Not common	Edema of the eyelids;
Notable	Conjunctivitis, swelling of the eyes, blepharite, eye hyperemia.
Systemic pathologies and conditions for administration
Town	Reaction in the application, including burning/irritating sensation in the eyes, eye irritation.
Very rare	Reaction in application, such as redness of the eyes, itching eye.
Notable	Reaction in application, such as tearing.
Immune system disorders
Notable	Angioedema, hypersensitivity, anaphylactic reaction.
Pathologies of skin and subcutaneous tissue
Notable	Contact dermatitis, hives.
Diseases of the nervous system
Town	Cephalea.

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 workers are required to report any suspected adverse reaction via the national reporting system at the address www.agenziafarmaco.gov.it/it/responsabili.

Overdosing

Synonyms No overdose cases were reported with LEVOREACT OFTALMICO. However, it cannot be excluded the occurrence of sedation after accidental ingestion of the content of the bottle. Treatment In case of accidental ingestion, advise the patient to drink many non-alcoholic liquids in order to accelerate the renal elimination of levocabastine.

Pregnancy Studies in animals showed no embryotoxic or teratogenic effects (see paragraph 5.3). Postmarketing data on the use of colliary levocabastine, suspension in pregnant women are limited; the risk for man is not known, therefore LEVOREACT OFTALMICO should not be used during pregnancy, unless the potential benefit for women, warrants the potential fetal risk. In accordance with the determinations of the concentration of levocabasin in saliva and breast milk, of a woman who has been given a single oral dose of 0.5 mg of levocabasin, it is expected that approximately 0.3% of the total dose of levocabasin administered ophthalmologically, can be transmitted to the lactating person. However, due to poor availability of clinical and experimental data, caution is recommended in administering LEVOREACT OFTALMICO to nursing women. Fertility Animal data has not shown effects on male or female fertility (see paragraph 5.3).

Source: Farmadati