Antihistamine drug useful in case of eye discomfort caused by allergies.
Indications
Imidazyl Antihistamine is indicated in allergic and inflammatory conditions of the conjunctiva accompanied by photophobia, tearing, foreign body sensation, and pain.
Composition
Active ingredients
1 ml of solution contains 1 mg of naphazoline nitrate (equivalent to 770 mcg of naphazoline) and 1 mg of thonzylamine hydrochloride (equivalent to 890 mcg of thonzylamine). Excipient with known effects: 10 ml bottle: 1 ml of solution contains 0.10 mg of benzalkonium chloride. For a full list of excipients, see section 6.1 of the package leaflet.
Excipients
Imidazyl Antihistamine 10 ml bottle Benzalkonium chloride Sodium chloride Disodium edetate Sodium phosphate monobasic dihydrate Sodium phosphate dibasic dihydrate Purified water.
Directions for use and Dosage
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 cause serious systemic effects. 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 1 month. of 4 consecutive days, unless otherwise prescribed by your doctor, given the possibility that adverse effects may otherwise occur.
Warnings
The product, although having very low systemic absorption, must be used with caution in subjects suffering from hypertension, hyperthyroidism, heart disease and hyperglycemia (diabetes).
Accidental ingestion can cause central nervous system depression: marked sedation (severe drowsiness), coma. In these cases, immediate medical assistance is always required. The product is not suitable for the treatment of infections, mechanical (trauma), chemical or heat damage or for eliminating foreign bodies in the eye. These situations require medical attention.
The 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. Imidazyl Antihistamine 10 ml bottle contains benzalkonium chloride. May cause eye irritation during treatment; soft contact lenses should not be worn.
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to other closely related substances from a chemical point of view; in particular to xylometazoline, oxymetazoline, tetryzoline. Narrow-angle glaucoma or other serious eye diseases. Children under 12 years. Pregnancy and breastfeeding (see section 4.6). Concomitant treatment with monoamine oxidase inhibitor drugs (see section 4.5)
Undesirable effects
The use of the product may cause eye irritation during treatment. Sometimes, this may cause pupil dilation, systemic effects from absorption (hypertension, cardiac disorders, hyperglycemia), increased intraocular pressure, nausea, and headache. 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
If accidentally ingested or if used for a long time at excessive doses, the product 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: gastric lavage, sedation with diazepam, and general supportive measures.
Pregnancy and breastfeeding
There are no known teratogenic or embryotoxic effects of the two components of the specialty when used topically. However, the use of Imidazyl Antihistamine in pregnant and breastfeeding women requires the approval of a physician.
Format
10 ml vial
Product Code:FRCM046128
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