IRIREACT 3 MG/ML + 0.5 MG/ML EYE DROPS, SOLUTION IN SINGLE-DOSE CONTAINER

Active ingredients

100 ml of solution contain : Active ingredients: Pheniramine maleate 0.30 g; Tetryzoline hydrochloride 0.05 g. For the full list of excipients, see section 6.1.

Excipients

Boric acid; Borax; Water for injections.

Therapeutic indications

IRIREACT is indicated in the treatment of allergic and inflammatory conditions of the conjunctiva accompanied by photophobia, tearing, foreign body sensation, pain.

Contraindications

Hypersensitivity to the components of the product or other closely related substances from a chemical point of view; in particular to xylometazoline, oxymetazoline, naphazoline. Narrow-angle/closure glaucoma or other serious eye diseases. Contraindicated in children under 12 years. Generally contraindicated during pregnancy and breastfeeding (see paragraph 4.6). Contraindicated in concomitant treatment with monoamine oxidase inhibitor drugs (tranylcypromine, phenelzine, pargyline) (see paragraph 4.5).

Dosage

Dosage 1-2 drops to be instilled in the affected eye 2-3 times a day. Do not exceed the recommended doses. 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. IRIREACT is contraindicated in children under 12 years of age. (see paragraph 4.3).

Warnings and precautions

The product, although having very low systemic absorption, must be used with caution in subjects suffering from hypertension, hyperthyroidism, cardiac disorders, and hyperglycemia (diabetes). In case of persistence or worsening of symptoms after a short period of treatment, invite the patient to consult a doctor. In any case, the product must not be used for more than 4 consecutive days, unless otherwise prescribed by a doctor, given the possibility that otherwise, undesirable effects may occur. The product, if accidentally ingested or if used for long periods at excessive doses, can cause toxic phenomena. Infections, pus, foreign bodies in the eye, mechanical, chemical, heat damage, require medical intervention. The use, especially if prolonged, of topical products can give rise to sensitization phenomena. In this case it is necessary to interrupt the treatment and institute appropriate therapy.

Interactions

IRIREACT should not be used concomitantly with monoamine oxidase inhibitor drugs, as this may lead to the onset of serious hypertensive crises.

Side effects

The use of the product may sometimes cause pupillary dilation, systemic effects from absorption (hypertension, cardiac disorders, hyperglycemia), increased intraocular pressure, nausea, headache. In children, if accidentally ingested, the preparation may cause even deep drowsiness and hypotonia. Hypersensitivity phenomena may rarely occur. In this case, treatment should be stopped and appropriate therapy instituted. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation 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.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Pregnancy and breastfeeding

There are no or limited amount of data on the use of pheniramine maleate and tetrizoline hydrochloride in pregnant women. As a precaution, it is preferable during pregnancy and breastfeeding to use IRIREACT only in case of real need, under the direct supervision of a doctor.