IMIDAZYL ANTIST COLL 1FL 10ML

IMIDAZYL ANTISTAMINIC 1 MG/ML + 1 MG/ML COLLIRIUM, SOLUTION

active ingredients

1 ml of solution contains 1 mg of nitrate nafazoline (equal to 770 mcg of nafazoline) and 1 mg of tonzilamine hydrochloride (equal to 890 mcg of tonzilamine). 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 Antihistamine 10 ml bottle Benzalconio Chloride Sodium Chloride Detoxed Sodium Phosphate Monobasic Dihydrate Sodium Phosphate Dibasic Dihydrate Purified Water. Imidazyl Antihistamine monodose container Sodium phosphate monobasic monohydrate Sodium chloride Sodium hydroxide Water for injectable preparations.

Therapeutic indications

In the allergic and inflammatory states of the conjunctiva accompanied by photophobia, tearing, feeling of foreign body, pain.

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. Pregnancy and nursing (see paragraph 4.6). Contemporary treatment with inhibiting drugs of monoaminoxydase (see paragraph 4.5)

Population

Instill in the affected eye 1–2 drops, 2–3 times a day. Do not exceed the recommended doses. 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. In case of persisting or aggravating 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, as the possibility of undesirable effects may occur.

Conservation

Store at temperature below 30° C 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 and hyperglycemia (diabetes). Accidental ingestion can cause depression of the central nervous system: severe sedation (strong drowsiness), 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. The use, especially if prolonged, of topical products can give rise to awareness-raising phenomena. In this case it is necessary to stop treatment and establish suitable therapy. Imidazyl Antihistamine 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 Antihistamine should not be used if you are taking inhibitor drugs of monoaminoxydasis or if you have passed less than two weeks since the last administration of these medicines as they can arise severe hypertensive crises.

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

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: sedation marked (strong drowsiness), coma. If this happens: gastric lavender, sedation with diazepam and general support measures.

There are no known teratogenic and embryotoxic effects of the two components the specialty, in topical use. However, in pregnant women and during breastfeeding the use of Imidazyl Antihistamine requires medical approval.

Source: Farmadati