Spersallerg

Spersallerg is available as a clear, colourless ophthalmic solution, free from visible particles, packaged in a bottle fitted with a dropper for topical administration. 

Each ml of solution contains 0.5 mg of antazoline and 0.4 mg of tetrizoline, together with excipients such as benzalkonium chloride (preservative), methylhydroxypropylcellulose, dilute hydrochloric acid, sodium chloride and distilled water for injections.

Spersallerg is indicated for:

• seasonal allergic conjunctivitis, where it rapidly reduces inflammation and redness;
• non-specific or catarrhal allergic conjunctivitis;
• minor eye irritations caused by dust, smoke, pollen or other environmental factors.

Through the local vasoconstriction induced by tetrizoline and the blocking of histamine H1 receptors by antazoline, the medicine alleviates burning, stinging, the sensation of a foreign body, itching and conjunctival congestion.

The usual recommended dose for adults and children over 2 years of age is 1 drop instilled into the conjunctival sac, 2–3 times a day.

To prevent contamination of the bottle, the patient must avoid touching the dropper with their eyelids or other surfaces. The bottle must be kept closed between uses.

Although no detailed clinical studies are available on children under 12 years of age, medical experience shows that the product can be administered to children over 2 years of age, following the doctor’s instructions.

The use of Spersallerg is contraindicated in the following situations:

• hypersensitivity to antazoline, tetrizoline or the excipients (in particular benzalkonium chloride);
• atrophic rhinitis;
• angle-closure glaucoma;
• severe organic cardiovascular disease (e.g. severe ischaemic heart disease, severe arrhythmias);
• children under 2 years of age.

The use of Spersallerg requires additional precautions in certain situations:

• Soft contact lenses: these must be removed before administration and may be reinserted after at least 15 minutes, as benzalkonium chloride may damage the lens material.
• Persistent symptoms require medical re-evaluation to rule out infectious conjunctivitis.
• Frequent use may lead to tolerance or a rebound effect, which manifests as worsening conjunctival congestion.
• Caution is advised in patients with: hypertension, diabetes mellitus, coronary artery disease, advanced atherosclerosis, hyperthyroidism, pheochromocytoma, or in the elderly, due to the possibility of systemic absorption.

Spersallerg is generally well tolerated. However, the following may occur:

• temporary blurred vision, eye burning, foreign body sensation, conjunctival hyperaemia, subconjunctival haemorrhage, photophobia, corneal erosions;
• hypersensitivity reactions (erythema, eczema, urticaria), dry mouth, headache, drowsiness.

Avoid concomitant use with:

• monoamine oxidase inhibitors (MAOIs),
• bromocriptine,
• tricyclic antidepressants.

Concomitant administration with other ophthalmic solutions should be carried out at intervals of at least 5 minutes.

No cases of overdose with Spersallerg have been reported. If an excessive amount is suspected to have been taken, symptomatic treatment and medical monitoring are recommended.

Massive systemic absorption of alpha-sympathomimetics may lead to central nervous system depression, particularly in children.

Store below 25 °C, in the original packaging, protected from light and moisture. The product is valid for 3 years prior to opening, but once the bottle has been opened, the solution must be used within a maximum of 1 month. Between doses, the bottle must be kept tightly closed to prevent contamination. The medicine must not be frozen, as low temperatures may affect the stability of the solution.

• MDPI, Allergic conjunctivitis: a review of types, treatments and current trends
• PubMed, Antazoline/tetrizoline eye drops versus levocabastine eye drops in acute allergic conjunctivitis
• PubMed, Clinical evaluation of Spersallerg for non-infectious conjunctivitis and infectious conjunctivitis with a hyperergic component
• British Journal of General Practice, Topical treatments for seasonal allergic conjunctivitis: systematic review and meta-analysis of efficacy and efficiency