IMIDAZYL*COLL FL 10ML 0.1%

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

Therapeutic indications

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

Dosage and method of use

Instill in the affected eye 1-2 drops, 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 a doctor given the possibility that undesirable effects may occur otherwise. Scrupulously follow 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.

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 towards xylometazoline, oxymetazoline, tetryzoline. Narrow-angle glaucoma or other serious eye diseases. Children under 12 years old. Simultaneous treatment with monoamine oxidase inhibitor drugs (see section 4.5).

Side effects

The use of the product can sometimes cause pupillary dilatation, systemic effects from absorption (hypertension, cardiac disorders, hyperglycemia), increase in intraocular pressure, nausea, headache. Hypersensitivity phenomena may rarely occur. In this case it is necessary to interrupt the treatment and institute a suitable therapy. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued 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.

Special warnings

Although the product has very little systemic absorption, it must be used with caution in subjects 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 can cause CNS depression (marked sedation and hypotonia), coma. Immediate medical assistance is always required in these cases. 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.

Pregnancy and breastfeeding

There are no known teratogenic and embryotoxic effects of the specialty component, in topical use. However, the product should only be used in pregnant and lactating women if clearly needed and under the direct supervision of a doctor.

Expiration and conservation

Store in the original packaging.

Interactions with other drugs

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

Overdose

Scrupulously follow 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 occurs: gastric lavage, sedation with diazepam and general supportive measures.

Active principles

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.

Excipients

Imidazyl 10 ml bottle Benzalkonium chloride Sodium chloride Disodium edetate Sodium dihydrogen phosphate dihydrate Disodium phosphate dihydrate Purified water. Imidazyl single-dose container Sodium dihydrogen phosphate Sodium chloride Water for injections.