Recordati
10 Single-dose vials 0.5 ml
Active ingredients
1 ml of solution contains 1 mg of naphazoline nitrate (equivalent to 770 mcg of naphazoline).
Excipients
Imidazyl single-dose container Sodium phosphate monobasic Sodium chloride Water for injections.
Therapeutic indications
In allergic and inflammatory conditions of the conjunctiva characterised by a burning sensation, even from external agents, associated with excessive lacrimation, photophobia, hyperaemia.
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to other closely related substances from a chemical point of view; in particular to xylometazoline, oxymetazoline, tetryzoline. Narrow-angle glaucoma or other serious eye diseases. Children under 12 years. Concomitant treatment with monoamine oxidase inhibitor drugs (see section 4.5).
Dosage
Instill 1–2 drops in the affected eye, 1–2 times a day. Do not exceed the recommended dose. If symptoms persist or worsen after a short period of treatment, consult your doctor. In any case, the product should not be used for more than 4 consecutive days unless otherwise prescribed by your doctor, given the possibility that adverse effects may otherwise occur. Strictly adhere to the recommended doses. A higher dosage of the product, even if taken topically and for a short period of time, can cause serious systemic effects.
Warnings and precautions
Although the product has very low systemic absorption, it should 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) and coma. In these cases, immediate medical attention is always required. The product is not suitable for treating 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. It may cause eye irritation during treatment; soft contact lenses should not be worn. Since benzalkonium chloride is not present in the single-dose pack, it can be used by contact lens wearers or by those who are hypersensitive to benzalkonium chloride.
Interactions
Imidazyl should 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
Use of the product may cause eye irritation. Sometimes cause pupillary dilation, systemic effects from absorption (hypertension, cardiac disorders, hyperglycemia), increased intraocular pressure, nausea, headache. Hypersensitivity phenomena may rarely occur. In this case, treatment should be discontinued and appropriate therapy instituted. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous 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.
Pregnancy and breastfeeding
There are no known teratogenic or embryotoxic effects of the component of the specialty when used topically. However, in pregnant and breastfeeding women, the product should be used only if clearly needed and under the direct supervision of a doctor.
Product Code:FRCM046653
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