IMIDAZYL COLL FL 10ML 0.1%

IMIDAZYL 1 MG/ML COLLIRIUM, DEVELOPMENT

active ingredients

1 ml of solution contains 1 mg of nitrate nafazoline (equal to 770 mcg of nafazoline). Excipient with known effects: 10 ml bottle: 1 ml solution contains 0.10 mg of benzalconio chloride. For the full list of excipients, see paragraph 6.1.

Excellent

Imidazyl 10 ml bottle Benzalconio Chloride Sodium Chloride Detoxed Sodium Phosphate Monobasic Dihydrate Sodium Phosphate Dibasic Dihydrate Purified Water. Imidazyl monodose container Sodium phosphate monobasic Sodium chloride Water for injectable preparations.

Therapeutic indications

In the allergic and inflammatory states of the conjunctiva characterized by sense of burning, also by external agents, associated with excessive tearing, photophobia, hyperemia.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1 or to other substances closely related to the chemical; in particular towards xilometazolina, oximetazolina, tetrizolina. Glaucoma at a narrow angle or other serious eye diseases. Children under 12. Contemporaneous treatment with inhibiting drugs of monoaminoxydasis (see paragraph 4.5).

Population

Instill in the affected eye 1–2 drops, 1–2 times a day. Do not exceed the recommended doses. In case of persisting or aggravating symptoms after a short period of treatment consult your doctor. In any case, the product should not be used for more than 4 consecutive days unless otherwise prescribed by a prescription, as the possibility of undesirable effects may occur. Strictly stick to the recommended doses. A higher dose of the product even if taken in a topical way and for a short period of time can give rise to serious systemic effects.

Conservation

Store in the original packaging.

Warnings

The product, while presenting a very low systemic absorption, must be used with caution in subjects suffering from hypertension, hyperthyroidism, heart disorders, bronchial asthma and hyperglycemia (diabetes). The product should be kept away from the reach of children since accidental ingestion can cause depression of S.N.C. (sighted sitting and hypotonia), coma. In these cases immediate medical care is always necessary. The product is not suitable for treating infections, mechanical damage (traumas), chemical or heat or for eliminating foreign bodies in the eye. These situations require the attention of the doctor. Imidazyl 10 ml bottle contains benzalconio chloride. It can cause eye irritation during treatment, soft contact lenses should not be worn. Since benzalconio chloride is not present in the monodose packaging, this can be used by contact lens holders, or by those who manifest hypersensitivity to benzalconio chloride.

Interactions

Imidazyl should not be used if you are taking inhibitor drugs of monoaminoxydase or if it has been less than two weeks since the last administration of these medicines as severe hypertensive crises may arise.

Effects

The use of the product can sometimes determine pupilal dilation, systemic effects from absorption (hypertension, heart disorders, hyperglycemia), increased blood pressure, nausea, headache. Rarely, phenomena of hypersensitivity can occur. In this case it is necessary to stop the treatment and establish suitable therapy. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address www.agenziafarmaco.gov.it/it/responsabili.

Overdosing

Strictly stick to the recommended doses. The product, if accidentally ingested or used for a long period at excessive doses, can determine toxic phenomena. Accidental ingestion of the drug, especially in children, can cause depression of the central nervous system: strong drowsiness, hypotonia and coma. If this happens: gastric lavender, sedation with diazepam and general support measures.

There are no known teratogenic and embryotoxic effects of the component the specialty, in topical use. However, in pregnant women and during breastfeeding, the product should only be used in case of actual need and under the direct control of the doctor.

Source: Farmadati