Naphalon

• This ophthalmic solution is indicated in-
• Acute and chronic non-infectious conjunctivitis,
• nonspecific conjunctival irritation;

also after successful treatment of bacterial and viral conjunctivitis.

Irrigation of the tear ducts.

Adults

: One drop in the conjunctival sac, three to four times per day.

Children

: This eye drop has not been studied in children. Generally, in children the dosage of vasoconstrictors should be low and selected with caution.

Zinc ions, the active compound of zinc sulphate, have an astringent, i.e. tissue-sealing and slightly anti-septic effect. Naphazoline constricts the blood vessels and reduces the inflammation and swelling of the conjunctiva. This effect of naphazoline, a substance of the benzylimidazoline group, is due to direct binding to a-adrenergic receptor sites on unstriated muscle cells in the blood vessels.

Mydriasis and a slight increase of intraocular pressure in isolated cases. A slight and transient burning sensation may occur after instillation, which does not affect the success of the treatment. Long term use may result in reactive redness of the eye (rebound effect).

Systemic effects: In very rare cases systemic cardiovascular effects, such as hypertension and arrhythmia, may occur. Nonspecific fatigue has been observed in some patients.

Hypersensitivity to zinc sulphate, Naphazoline and other ingredients. Naphazoline & Zinc is contraindicated in patients suffering from narrow-angle glaucoma, dry eye and especially keratoconjunctivits sicca Sjogren's syndrome. Naphazoline & Zinc must not be used in infants.

Uncontrolled use of Naphazoline & Zinc over extended periods of time should be avoided. If no improvement is seen after 2 days, treatment should be discontinued and other therapeutic measures should be considered. If ocular discomfort or visual disturbance occurs during Naphazoline & Zinc treatment, the therapy must be discontinued. Caution is indicated in patients with predisposition to glaucoma and in patients suffering from hypertension, cardiovascular diseases, pheochromocytoma, aneurysm, hyperglycemia, and hyperthyroidism.

Pregnancy category C. There are neither controlled animal studies nor studies in pregnant women available.Therefore,during pregnancy the product should only be used if the benefit out-weighs the risk to the fetus. The effects of Naphazoline & Zinc Sulphate treatment during lactation has not been investigated.

Naphazoline containing products should not be administered during treatment with MAO-blockers nor during 10 days after discontinuation of such treatment. The effects of Naphazoline may be increased by concomitant use of tricyclic antidepressants.

Store in a cool,dry place and away from light. Do not use longer than 30 days after first opening. Keep out of the reach of children.