Indications
Fexactiv eye drops are indicated in allergic and inflammatory conditions of the conjunctiva accompanied by photophobia, tearing, foreign body sensation, pain.
Composition
Active ingredients 100 ml of solution contain:
- Active ingredients: Pheniramine maleate 0.30 g Tetryzoline hydrochloride 0.05 g
- Excipients Boric acid; Borax; Benzalkonium chloride; Water for injections.
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 result in serious systemic effects.
Contraindications
Hypersensitivity to the components of the product or other closely related substances from a chemical point of view; in particular to xylometazoline, oxymetazoline, tetryzoline. Narrow-angle glaucoma or other serious eye diseases. Contraindicated in children under twelve years of age. Generally contraindicated during pregnancy and breastfeeding. Contraindicated in concomitant treatment with monoamine oxidase inhibitor drugs (tranylcypromine, phenelzine, pargyline).
Storage
Do not store above 25°C. C.
Warnings
Although the product has very low systemic absorption, it should be used with caution in subjects suffering from hypertension, hyperthyroidism, heart disease, and hyperglycemia (diabetes). If symptoms persist or worsen after a short period of treatment, advise the patient to consult a 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 adverse 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, or heat damage require medical intervention. Use, especially if prolonged, of topical products can give rise to sensitization phenomena. In this case, it is necessary to discontinue treatment and institute appropriate therapy.
Since the product is not absorbed, it may cause sensitization. The product, in the 10 ml bottle, contains benzalkonium chloride as a preservative which may cause sensitization reactions and should not be applied while wearing contact lenses (in the case of contact lens wearers, put them in only 15 minutes after using the product). In these cases, it is possible to use the single-dose container which does not contain preservatives.
Interactions
Fexactiv should not be used in conjunction 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. If accidentally ingested in children, the preparation may cause drowsiness, even profound, and hypotonia. Hypersensitivity phenomena may rarely occur. In this case, treatment should be discontinued and appropriate therapy instituted. 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.
Overdose
The product, if accidentally ingested or if used for a long period at excessive doses, can cause toxic phenomena. Accidental ingestion of the drug, especially in children, can cause depression of the central nervous system: marked sedation (severe drowsiness), coma. If this occurs, consult a doctor immediately. 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 tetryzoline hydrochloride in pregnant women. As a precaution, during pregnancy and breastfeeding, it is preferable to use Fexactiv only if clearly needed, under the direct supervision of a doctor.
Format
10 single-dose vials of 0.5 ml.
Product Code:FRCM084841
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