OCTILIA ALL INF * COLL10FL 0.5ML
Therapeutic indications
In 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 from absorption (hypertension, cardiac disorders, hyperglycemia), 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 reactions. Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows for continuous monitoring of the benefit / risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the Italian Medicines Agency, Website: (https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse).
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.Important information about some of the ingredients:This medicine, in the 10 ml bottle pack, contains 0.012 mg of benzalkonium chloride for the maximum recommended daily dose of 6 drops (0.24 ml) equivalent to 0.05 mg / ml. Benzalkonium chloride as a preservative can be absorbed by soft contact lenses and can lead to a change in their color, can give rise to sensitization reactions and 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). Benzalkonium chloride can also cause eye irritation especially if you have dry eye or corneal disease (the topmost transparent layer of the eye). 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 lactation to use OCTILIA ALLERGY AND INFLAMMATION only in case of real need, under the direct supervision of the doctor.
Expiry and retention
Do not store above 25 ° C.
Interactions with other drugs
OCTILIA ALLERGY AND INFLAMMATION should not be used concomitantly with the intake of monoamine oxidase inhibitor drugs, as this can lead to the onset of 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. Excipient with known effect (10 ml bottle): benzalkonium chloride. par. 6.1
Excipients
Multidose bottle : Boric acid; Borax; Benzalkonium Chloride; Water for injections. Single-dose container : Boric acid; Borax; Water for injections.