Imidazyl Eye Drops 10 Single Dose Vials 1 mg/ml

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

INDICATIONS

In allergic and inflammatory states of the conjunctiva characterized by a burning sensation, even from external agents, associated with excessive tearing, photophobia, hyperemia.

CONTRAINDICATIONS

Hypersensitivity to the active ingredient or to any of the excipients listed in paragraph 6.1 or to other closely related substances from a chemical point of view; in particular towards xylometazoline, oxymetazoline, tetrizoline. Narrow-angle glaucoma or other serious eye diseases. Children under 12 years old. Simultaneous treatment with monoamine oxidase inhibitor drugs (see section 4.5).

WARNINGS AND PRECAUTIONS FOR USE

The product, although presenting very little systemic absorption, must be used with caution in subjects suffering from hypertension, hyperthyroidism, cardiac disorders, bronchial asthma and hyperglycemia (diabetes). The product should be kept out of the reach of children as accidental ingestion can cause CNS depression. (marked sedation and hypotonia), coma. In these cases, immediate medical assistance is always necessary. The product is not suitable for the treatment of infections, mechanical (trauma), chemical or heat damage or for eliminating foreign bodies in the eye. These situations require medical attention. Imidazyl 10 ml bottle contains benzalkonium chloride. May cause eye irritation during treatment, soft contact lenses should not be worn. Since benzalkonium chloride is not present in the single-dose package, this can be used by contact lens wearers, or by those who show hypersensitivity to benzalkonium chloride.

INTERACTIONS

Imidazyl must not be used if you are taking monoamine oxidase inhibitor drugs or if less than two weeks have passed since the last administration of these medicines as serious hypertensive crises may occur.

SIDE EFFECTS

The use of the product can sometimes cause pupillary dilation, systemic effects from absorption (hypertension, cardiac disorders, hyperglycemia), increased intraocular pressure, nausea, headache. Rarely, hypersensitivity phenomena may occur. In this case it is necessary to interrupt the treatment and institute suitable therapy. 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.