Ophthalmil 0.020% + 0.016%

Eye drops

Active principles

100 ml of eye drops contain: Active ingredients: Zinc sulfophenate g 0.020; Naphazoline hydrochloride 0.016 g. Excipients with known effect :, para-hydroxy benzoic esters (methyl-p-hydroxybenzoate and propyl-p-hydroxybenzoate) For a full list of excipients, see section 6.1.

Excipients

Methyl – p – oxybenzoate; Propyl – p – oxybenzoate; Menthol; Sodium chloride; Distilled water of Hamamelis virginiana; Distilled water of Rosa gallica; Distilled water of Malva silvestris.

Therapeutic indications

In all cases of redness of the eyes, sensation of a foreign body, a sense of heaviness in the eyelids.

Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Closed-angle glaucoma. It must not be used by people with severe infectious diseases of the eye. Contraindicated in children under the age of six.

Dosage

Instill one or two drops of the preparation, several times a day, in the inferior conjunctival fornix. Oftalmil can be used, due to its dual astringent and antiseptic action, by contact lens wearers. Strictly adhere to the recommended doses. A higher dosage of the product even if taken topically and for a short period of time can give rise to serious systemic effects.

Warnings and Precautions

Do not exceed the dosage recommended by the doctor. If symptoms persist or worsen after a short period of treatment, consult your doctor; in any case, the product must not be used for more than four consecutive days, given the possibility that, otherwise, undesirable effects may occur. In case of: infections, pus, foreign bodies in the eye, mechanical damage, chemical damage from heat, consult your doctor. The product, although having poor systemic absorption, should be used with caution in patients suffering from hypertension, hyperthyroidism, cardiac disorders and hyperglycemia (diabetes) and in subjects undergoing treatment with antidepressant drugs. The product, if accidentally ingested or if used for a long period in excessive doses, can cause toxic phenomena. It should be kept out of the reach of children as accidental ingestion can cause marked sedation. Oftalmil contains para-hydroxy benzoic esters (methyl – p – hydroxybenzoate and propyl – p– hydroxybenzoate) which can cause hypersensitivity phenomena, even if delayed.

Interactions

No particular interactions are known, nor incompatibility with other ophthalmic preparations. Use with caution in subjects undergoing treatment with antidepressant drugs.

Side effects

The use of the product can sometimes lead to pupillary dilation, systemic effects from absorption (hypertension, cardiac disorders, hyperglycemia), increased intraocular pressure in predisposed subjects, nausea, headache. Hypersensitivity phenomena may rarely occur, in this case it is necessary to interrupt the treatment and consult the doctor so that, where necessary, appropriate therapy can be instituted. In very irritated eyes, a momentary burning sensation may be felt, especially during the first applications. 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 ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system www.agenziafarmaco.gov.it/it/responsabili.

Pregnancy and breastfeeding

There are no known contraindications.