Fexactiv single-dose eye drops 10fl 0.5ml 043904010

FEXACTIV * COLL 10FL 0,5ML

Therapeutic indications

Fexactiv is indicated in adults and adolescents over 12 years of age for the symptomatic treatment of allergic and inflammatory states of the conjunctiva accompanied by photophobia, lacrimation, foreign body sensation, pain.

Dosage and method of use

Instill 1-2 drops in the affected eye 2-3 times a day. Do not exceed the recommended dose. 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.

Contraindications

Hypersensitivity towards the components of the product or other strictly correlated substances from a chemical point of view; in particular towards xylometazoline, oximetazoline, tetrizoline. Narrow / closed angle glaucoma or other serious eye disease. Contraindicated in children under the age of twelve. Generally contraindicated during pregnancy and lactation (see section 4.6). Contraindicated in the simultaneous treatment with monoamine oxidase inhibitors (tranylcypromine, phenelzine, pargiline) (see par. 4.5).

Side effects

The use of the product can sometimes cause pupillary dilation, systemic effects of absorption (hypertension, cardiac disorders, hyperglycaemia), increased intraocular pressure, nausea, headache. In children, if accidentally ingested, the preparation can cause deep sleep and hypotonia. Hypersensitivity phenomena may rarely occur. In this case, treatment must be interrupted and appropriate therapy instituted.Reporting of suspected adverse reactionsReporting 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 at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

Special warnings

The product, although presenting a very low systemic absorption, must be used with caution in subjects suffering from hypertension, hyperthyroidism, heart disorders, and hyperglycemia (diabetes). In case of persistence or worsening of symptoms after a short period of treatment, invite the patient to consult the 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. The product, if accidentally ingested or if used for long periods in excessive doses, can cause toxic phenomena. Infections, pus, foreign bodies in the eye, mechanical, chemical, heat damage require medical attention. 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 a suitable therapy. Since the product, in the 10 ml bottle package, contains benzalkonium chloride as a preservative which can give rise to sensitization reactions, it should not be applied while wearing contact lenses (in the case of contact lens wearers, wear the same only 15 minutes after using the product). In these cases it is possible to use the single-dose container that does not contain preservatives.

Pregnancy and breastfeeding

There are no or limited data from the use of pheniramine maleate and tetrizoline hydrochloride in pregnant women. As a precaution, it is preferable during pregnancy and breastfeeding to use Fexactiv only if clearly needed, under the direct supervision of your doctor.

Expiration and retention

Do not store above 25 ° C.

Interactions with other drugs

FEXACTIV should not be used concomitantly with monoamine oxidase inhibitor medications, as this can lead to severe hypertensive crisis.

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 happens, use gastric lavage and general supportive measures.

Active principles

100 ml of solution contain: Active ingredients: Pheniramine maleate 0.30 g Tetrizoline hydrochloride 0.05 g For excipients see. par. 6.1

Excipients

Multidose bottle Boric acid; Borax; Benzalkonium Chloride; Water for injections. Single-dose container Boric acid; Borax; Water for injections.