Alfa decongestant eye drops 0.8mg/ml eye drops solution 10ml

INDICATIONS

Redness, tearing, burning and itching of the eyes caused by irritative phenomena (excessive exposure to dust, smoke, etc.).

ACTIVE INGREDIENTS

Alfa decongestant eye drops 0.8 mg/ml eye drops, solution 1 ml of solution contains: Active ingredient: Naphazoline nitrate: 0.8 mg. For excipients see point 6.1

EXCIPIENTS

Eye drops (10 ml bottle): Sodium chloride, Potassium monobasic phosphate, Sodium phosphate dodecahydrate, Benzalkonium chloride, Hamamelis Virginiana concentrated distilled water, Ethyl alcohol, Camphor, Water for injections. Eye drops (single-dose container) Sodium chloride, Potassium monobasic phosphate, Sodium phosphate dodecahydrate, Hamamelis Virginiana concentrated distilled water, Ethyl alcohol, Camphor, Water for injections.

CONTRAINDICATIONS AND SIDE EFFECTS

It should not be used by people with closed-angle glaucoma or other serious eye diseases. Hypersensitivity towards the components or towards other substances closely related from a chemical point of view. It should not be used in children under twelve years of age. Simultaneous treatment with monoamine oxidase inhibitor drugs (see point 4.5).

DOSAGE

Eye drops: 1-2 drops in the conjunctival sac once or twice a day. Carefully follow the recommended doses. 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 4 consecutive days, unless otherwise prescribed by a doctor, as unwanted effects may occur. A higher dosage of the product, even if taken topically and for a short period of time, can give rise to serious systemic effects.

CONSERVATION

Eye drops (10 ml bottle) Store in the original packaging. Validity after first opening: 30 days. Eye drops (single-dose container) Store in the original packaging. Store at a temperature not exceeding 30°C. Contains no preservatives; for this reason each single-dose container, once opened, must be thrown away after use, even if only partially used.

WARNINGS

The product, although presenting poor systemic absorption, must be used with caution in patients suffering from hypertension, hyperthyroidism, cardiac disorders, bronchial asthma and hyperglycemia (diabetes). Infections, pus, foreign bodies in the eye, mechanical, chemical, heat damage require medical attention. The product should be kept out of the reach of children as accidental ingestion can cause CNS depression (marked sedation or hypotonia). Since the product, in the 10 ml bottle, contains benzalkonium chloride, soft contact lenses should not be worn during treatment. Since benzalkonium chloride is not present in the single-dose package, this can be used by contact lens wearers, or by those who show hypersensitivity to benzalkonium chloride.

INTERACTIONS

Alfa decongestant eye drops should not be used in subjects undergoing treatment with antidepressant drugs (MAOI) and in the two weeks following such treatment as serious hypertensive crises may arise.

SIDE EFFECTS

The use of the product can sometimes cause pupillary dilation, systemic effects from absorption (hypertension, cardiac disorders, hyperglycemia), increased intraocular pressure, nausea, headache. Rarely, hypersensitivity phenomena may occur. In this case it is necessary to interrupt the treatment and consult the doctor so that, where necessary, suitable therapy can be instituted. The patient is invited to report any undesirable effects not described to the doctor or pharmacist.

OVERDOSE

Carefully follow the recommended doses. The product, if accidentally ingested or if used for a long period in excessive doses, can cause toxic phenomena, especially in children. If this occurs: gastric lavage, sedation with diazepam and general supportive measures.

PREGNANCY AND BREASTFEEDING

During pregnancy and breastfeeding, use only if clearly necessary, under the direct supervision of a doctor.

EFFECTS ON DRIVING ABILITY

Nothing to report.