Irireact 3 + 0.5 mg/ml 10 ml eye drops solution

In ottemperanza all'articolo 118 “autorizzazione della pubblicità presso il pubblico” del decreto legislativo 24 aprile 2006, numero 219

INDICATIONS

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

ACTIVE INGREDIENTS

100 ml of solution contain: Active ingredients: Pheniramine maleate 0.30 g; Tetrizoline hydrochloride 0.05 g. Excipient with known effects: benzalkonium chloride. For the full list of excipients, see section 6.1.

EXCIPIENTS

Boric acid; Borax; Benzalkonium Chloride; Water for injections.

CONTRAINDICATIONS AND SIDE EFFECTS

Hypersensitivity towards the components of the product or other substances closely related from a chemical point of view; in particular towards xylometazoline, oxymetazoline, naphazoline. Narrow/closed-angle glaucoma or other serious eye diseases. Contraindicated in children under 12 years. Generally contraindicated during pregnancy and breastfeeding (see section 4.6). Contraindicated in simultaneous treatment with monoamine oxidase inhibitor drugs (tranylcypromine, phenelzine, pargyline) (see section 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. Carefully 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. IRIREACT is contraindicated in children under 12 years of age. (see paragraph 4.3).

CONSERVATION

Store at a temperature not exceeding 30° C.

WARNINGS

The product, although presenting very little systemic absorption, must be used with caution in subjects suffering from hypertension, hyperthyroidism, cardiac disorders, and hyperglycemia (diabetes). If symptoms persist or worsen 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 unwanted effects may otherwise 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 and heat damage require medical intervention. The use of topical products, especially if prolonged, can give rise to sensitization phenomena. In this case it is necessary to interrupt treatment and institute suitable therapy. The product contains 0.012 mg of benzalkonium chloride as a preservative for the maximum recommended daily dose of 6 drops (0.24 ml) equivalent to 0.05 mg/ml. Benzalkonium chloride can give rise to hypersensitivity reactions and must not be applied while wearing contact lenses (in the case of contact lens wearers, wear them only 15 minutes after using the product). In these cases it is possible to use the single-dose container which does not contain preservatives. Benzalkonium chloride can also cause eye irritation especially if you have dry eye or corneal disorders.

INTERACTIONS

IRIREACT must not be used in conjunction with taking monoamine oxidase inhibitor drugs, as this can lead to the onset of serious hypertensive crises.

SIDE EFFECTS

The use of the product can sometimes cause pupillary dilation, systemic effects from absorption (hypertension, cardiac disorders, hyperglycemia), increased intraocular pressure, nausea, headache. In children, if accidentally ingested, the preparation can cause even profound drowsiness and hypotonia. Rarely, hypersensitivity phenomena may occur. In this case it is necessary to interrupt the treatment and institute suitable therapy. 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.aifa.gov.it/content/segnalazioni-reazioni-avverse.

OVERDOSE

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), coma. If this occurs, use gastric lavage and general supportive measures.

PREGNANCY AND BREASTFEEDING

There are no or limited 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 actual need, under the direct supervision of a doctor.

EFFECTS ON DRIVING ABILITY

Based on the available data Irireact does not or negligibly alter the ability to drive vehicles or use machinery.