IMIDAZYL * COLL 10FL 1D 1MG / ML
In allergic and inflammatory states of the conjunctiva characterized by a sense of burning, also by external agents, associated with excessive lacrimation, photophobia, hyperemia.
Dosage and method of use
Instill 1–2 drops into 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, given the possibility that unwanted 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 give rise to serious systemic effects.
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 towards xylometazoline, oximetazoline, tetrizoline. Narrow-angle glaucoma or other serious eye disease. Children under 12 years old. Concurrent treatment with monoamine oxidase inhibitors (see section 4.5).
The use of the product can sometimes cause pupillary dilation, systemic effects of absorption (hypertension, cardiac disorders, hyperglycaemia), increased intraocular pressure, nausea, headache. Hypersensitivity phenomena may rarely occur. In this case, treatment must be interrupted and appropriate therapy instituted. Reporting of suspected adverse reactions Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system www.agenziafarmaco.gov.it/it/responsabili.
The product, although presenting a very poor systemic absorption, must be used with caution in subjects suffering from hypertension, hyperthyroidism, heart 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 attention is always required. The product is not suitable for the treatment of infections, mechanical (trauma), chemical or heat damage or to eliminate foreign bodies in the eye. These situations require the attention of the doctor. Imidazyl 10ml 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.
Pregnancy and breastfeeding
There are no known teratogenic and embryotoxic effects of the component of the specialty, in topical use. However, in pregnant and lactating women, the product should be used only in case of real need and under direct medical supervision.
Expiry and retention
Store in the original packaging.
Interactions with other drugs
Imidazyl should not be used if you are taking monoamine oxidase inhibitors or if it has been less than two weeks since the last administration of these medicines as severe hypertensive crises can occur.
Strictly adhere to the recommended doses. The product, if accidentally ingested or if used for a long period in excessive doses, can cause toxic phenomena. Accidental ingestion of the drug, especially in children, can cause central nervous system depression: marked sedation (severe drowsiness), hypotonia and coma. If this happens: gastric lavage, sedation with diazepam and general supportive measures.
1 ml of solution contains 1 mg of naphazoline nitrate (equal to 770 mcg of naphazoline). Excipient with known effect: 10 ml bottle: 1 ml of solution contains 0.10 mg of benzalkonium chloride. For the full list of excipients, see section 6.1.
Imidazyl bottle of 10 ml Benzalkonium chloride Sodium chloride Disodium edetate Sodium dihydrogen phosphate dihydrate Disodium phosphate dihydrate Purified water. Imidazyl single-dose container Sodium monobasic phosphate Sodium chloride Water for injections.