“Composition
Active ingredients:1 ml of solution contains 1 mg of naphazoline nitrate (equivalent to 770 mcg of naphazoline). Excipient with a known effect: 10 ml bottle: 1 ml of solution contains 0.10 mg of benzalkonium chloride.
Excipients:Imidazyl 10 ml bottle Benzalkonium chloride Sodium chloride Disodium salt of edetic acid Sodium phosphate monobasic dihydrate Sodium phosphate dibasic dihydrate Purified water.
Therapeutic indications
For allergic and inflammatory diseases of the conjunctiva, characterized by a burning sensation, even from external factors, accompanied by increased lacrimation, photophobia, hyperemia.
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, or to other chemically related substances; in particular to xylometazoline, oxymetazoline, tetryzoline. Closed-angle glaucoma or other serious eye diseases. Children under 12 years of age. Concomitant treatment with monoamine oxidase inhibitors (see section 4.5).
Dosage
Instill 1-2 drops into the affected eye 1-2 times a day. Do not exceed the recommended doses. If symptoms persist or worsen after a short period of treatment, consult a doctor. In any case, the product should not be used for more than 4 consecutive days, unless otherwise prescribed by a doctor, given the possibility of side effects. Strictly adhere to the recommended doses. A higher dosage of the product, even when applied locally and for a short period of time, may cause serious systemic effects.
Warnings and precautions
Despite the fact that the drug has very low systemic absorption, it should be used with caution in people suffering from hypertension, hyperthyroidism, heart disease, bronchial asthma and hyperglycemia (diabetes). The product should be kept out of the reach of children, as accidental ingestion may cause central nervous system depression (pronounced sedation and hypotension), coma. In these cases, immediate medical attention is always necessary. The product is not intended for the treatment of infections, mechanical (traumatic), chemical or thermal damage, or for the removal of foreign bodies from the eye. In such situations, medical attention is required. A 10 ml bottle of Imidazil contains benzalkonium chloride. Eye irritation may occur during treatment, do not wear soft contact lenses. Since the single-use package does not contain benzalkonium chloride, it can be used by contact lens wearers or individuals with hypersensitivity to benzalkonium chloride.
Interactions
Imidazyl should not be used if you are taking monoamine oxidase inhibitors or if less than two weeks have passed since the last use of these drugs, as serious hypertensive crises may occur.
Side effects
Use of the drug can sometimes cause dilation of the pupils, systemic effects from absorption (hypertension, cardiac arrhythmia, hyperglycemia), increased intraocular pressure, nausea, headache. Rarely, hypersensitivity phenomena may occur. In this case, treatment should be discontinued and appropriate therapy should be prescribed. Reporting suspected adverse reactions It is important to report suspected adverse reactions that occur after registration of the medicinal product. Allows for continuous monitoring of the benefit/risk ratio 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.
Pregnancy and breastfeeding
It is not known whether the component of the drug has a teratogenic or embryotoxic effect when applied topically. However, the drug should be used in pregnant women and during breastfeeding only if really necessary and under the direct supervision of a physician.”
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