OCTILIA COLL 10ML 0.5MG/ML

OCTILIA 0.5 MG/ML COLLIRIUM, DEVELOPMENT

active ingredients

100 ml contain Active ingredient: Tetrizolina Hydrochloride: 0.05 g. Excipient with known effects (10 ml bottle): benzalconio chloride. For the full list of excipients, see paragraph 6.1.

Excellent

Flacons: Sodium chloride, Boric acid, Borace, Benzalconio chloride sol., Denoted disode, Sodium hydroxide and Hydrochloric acid (for pH regulation), Water for injectable preparations. Single-dose containers: Chloride Sodium, Boric Acid, Borace, Sodium Hydroxide and Hydrochloric Acid (for pH regulation), Water for injectable preparations.

Therapeutic indications

OCTILIA it is indicated in the symptomatic treatment of eye irritations due to smoke, wind, salt water, prolonged exposure to light, allergic conjunctivitis and other irritative agents.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. OCTILIA should not be administered: - in patients with narrow-angle glaucoma and patients with severe eye diseases; - in patients with severe cardiovascular diseases (disorders of coronary arteries, hypertension); - patients with feochromocytoma; - in patients with disorders of metabolism and nutrition (e.g. hyperthyroidism, diabetes mellitus); -in patients in treatment with monoaminooxidase inhibitors (see paragraph 4.5) or other drugs that can potentially increase pressure - in patients with rhinitis and keratin joints; - children under three years.

Population

Ocular use. Instill one or two drops of OCTILIA in every eye twice or three times a day. Do not exceed the recommended doses. Open by turning and pulling the cap, exert a slight pressure on the body of the container, which will be enough to drop the drop in the eye. To avoid contamination of the product avoid contact of the end of the dropper with any surface. After instillation it is convenient to beat the eyelids gently for a few seconds to facilitate the uniform distribution of the drops. Contact lenses must be removed before use (See paragraph 4.4). The product must be used exclusively for minor eye irritations. If you do not get relief within 48 hours or if irritation or redness persist or increase, suspend use and consult your doctor. Stop the treatment as soon as the symptoms disappear and never continue over a week.

Conservation

Flacons: do not store the medicinal product above 25°C. Single-dose containers: do not store the medicinal product above 30°C.

Warnings

OCTILIA should not be used in children under three years of age. Precaution is recommended in patients over 65 years old. As in other ophthalmic products there is the possibility of systemic absorption. If eye pains, headaches, sudden changes in the field of vision, appearance of visual spots, intense redness of the eye, intolerance to light or diplopia, stop treatment and consult the doctor promptly. Use only for ophthalmic use. If you do not get an improvement in 48 hours or if irritation or roasting persist or increase, suspend use and consult your doctor. Infections, pus, foreign bodies in the eye, mechanical, chemical damage, from heat require the attention of the doctor. The product must be used with caution in patients suffering from hypertension, hyperthyroidism, severe cardiovascular disease and hyperglycemia (diabete mellitus). The product, if ingested or used for a long period at excessive doses, may determine toxic phenomena (see paragraph 4.8). Long-term use and product abuse can produce an increase in hyperemia or rebound hyperemia. The use of the product can cause a temporary midriasis. Important information about some excipients: This medicine, concerning the formulation in the 10 ml bottle, contains 0.03 mg of benzalconio chloride for the recommended daily maximum dose of 6 drops (0.3 ml) equivalent to 0.1 mg/ml. As for all ophthalmic preparations containing benzalconio chloride, the use of the product may cause irritation to the eyes. Avoid contact with soft contact lenses. Benzalconio chloride can be absorbed by soft contact lenses and can lead to change of their color, so it is necessary to remove contact lenses before application and wait at least 15 minutes before reapplying them. Benzalconio chloride can also cause eye irritation especially if it has dry eye or cornea disorders (the most superficial transparent layer of the eye).

Interactions

OCTILIA should not be used in patients in treatment with monoamminoosidase inhibitors for the possible occurrence of severe hypertensive crisis (see paragraph 4.3). If you use another product by ophthalmic means, it is recommended to wait at least 5 minutes between the two administrations.

Effects

Accidental ingestion or use of OCTILIA for a long period at excessive doses can determine toxic phenomena. Not common (>1/1.000, 1/10.000, https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Excessive use or ingestion can lead to depression of the central nervous system. This risk is especially present in infants and children by product ingestion. The main symptoms are nervous system alterations, increased blood pressure, arrhythmia, tachycardia, reactive bradycardia. Tetrizoline has a toxicity when taken at the dose of 0.01 mg/kg body weight. Symptoms associated with overdose are midriasis, nausea, cyanosis, fever, cramps, tachycardia, heart arrhythmia, cardiac arrest, hypertension, pulmonary edema, respiratory and mental alterations. Moreover, in certain circumstances, the inhibition of the activity of the central nervous system can cause letargy, decrease in body temperature, bradycardia, hypotension, apnea and coma. In case of overdose it is recommended to use activated carbon, to empty gastric and to subject the subject to oxygentherapy. To reduce blood pressure slowly, intravenously administer 5 mg of phenolamine in saline solution or 100 mg by mouth. Vasopressor drugs are contraindicated in patients with hypotension. If anticholinergic symptoms occur, antidotes such as physostigmine can be administered.

No adequate and well-controlled studies have been conducted to determine the effect of Tetrizolina Hydrochloride on the fetus. It is not known whether the product is excreted in breast milk. In pregnant women or during breastfeeding, the product should be administered in cases of actual need, under the direct control of the doctor. Preclinical studies have not been identified for the evaluation of mutagenic, carcinogenic or teratogenic potential of the product or its potential impact on fertility or development.

Source: Farmadati