Levoreact Ofta Eye Drops 4 ml 0.5 mg/ml

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219

INDICATIONS

Allergic conjunctivitis.

CONTRAINDICATIONS

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

WARNINGS AND PRECAUTIONS FOR USE

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 OFTHALMIC eye drops suspension because they can cause eye irritation. Remove contact lenses before applying the medicine and wait at least 15 minutes before putting them back. The medicine discolors soft contact lenses.

INTERACTIONS

No interaction studies have been carried out.

SIDE EFFECTS

Adverse drug reactions identified during clinical and epidemiological studies and with postmarketing experience following the use of OPHTHALMIC LEVOREACT are reported 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 The frequency cannot be estimated from the available data Table 1: Adverse drug reactions identified during clinical trials and postmarketing experience with LEVOREACT OFTHALMIC.

Cardiac diseases

Not known | Palpitations

Eye pathologies

Municipality | Eye pain, blurred vision;

Uncommon | Edema of the eyelids;

Not known | Conjunctivitis, eye swelling, blepharitis, ocular hyperemia.

Systemic pathologies and conditions relating to the administration site

Municipality | Application site reaction, including burning/eye irritation, eye irritation.

Very rare | Application site reaction, such as redness of the eyes, ocular itching.

Not known | Application site reaction, such as tearing.

Immune system disorders

Not known | Angioedema, hypersensitivity, anaphylactic reaction.

Pathologies of the skin and subcutaneous tissue

Not known | Contact dermatitis, urticaria.

Nervous system disorders

Municipality | Headache.

Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.