Spersallergâ 0.5 mg /1 ml. Sterile eye drops

• Hay-fever conjunctivitis.
• Allergic conjunctivitis as consequence of drug sensitivity.
• Conjunctivitis vernalis.
• Conjunctivitis ecchymotosa.

Adult
Instill 1 drop, 3 or 4 times daily, into the lower eyelid.
Children 2 u2013 12 years
Instill 1 drop daily or twice daily. Not recommended for children under the age of 2 years. If redness or irritation continues, gets worse or lasts for more than 3 days consult your doctor.

• Hypersensitivity to antazoline HCl, tetryzoline HCl or to any of the excipients of SPERSALLERG u00ae (see section 6.1).
• Patients with dry eyes, especially keratoconjunctivitis sicca
• Patients at a risk of narrow angle glaucoma.
• Patients receiving monoamine oxidase inhibitors or within 14 days of its treatment.
• Not recommended for children under two years of age, due to the greater incidence of systemic absorption and effects.

Soft contact lenses should not be worn during instillation of SPERSALLERG u00ae. They can be reinserted after an interval of at least 5 minutes. Tetryzoline should be given with care in cases of high hypertension or hyperglycaemia (diabetes), also in children under 2 years. Use with caution in patients with increased intra-ocular pressure, hypertension, cardiac irregularities including heart failure, in patients with poorly controlled hypertension and diabetes mellitus, hyperthyroidism or pheochromocytoma and eye infections.

No synergic effect can occur due to the low dose. In cases where another ophthalmic treatment is used, allow an interval of 5 minutes between each administration so as not to wash away the active ingredient. Preparations containing tetryzoline may not be used in patients receiving MAO inhibitors until ten days after the last treatment with such active ingredients (increase in blood pressure resulting from the concomitant use of MAO inhibitors and tricyclic antidepressants).

Safety in pregnancy and lactation has not been established. No controlled studies are available either in animals, pregnant or nursing women. It is not known whether either active substance of SPERSALLERG u00ae passes into breast milk.

Patients with visual disturbances such as blurred vision after application of the SPERSALLERG u00ae should not drive vehicles or use machines until their vision is restored.

Tabulated list of adverse reactions
MedDRA System Organ Class Frequency Frequency unknown
Immune system disorders Unknown frequency Hypersensitivity reactions may occur
Nervous system disorders Rare Headaches, drowsiness, tremor, agitation
Eye disorders Rare Transient irritation may occur immediately after instillation, blurred vision (after systemic absorption), mydriasis, elevation of intraocular pressure, systemic undesirable effects due to absorption, reactive hyperaemia (after discontinuation of the treatment)
Cardiac disorders Rare Tachycardia (particularly in small children), pectanginous symptoms
Vascular disorders Rare Hypertension
Skin and subcutaneous tissue disorders Rare Perspiration

Symptoms
After accidental ingestion, especially in children, overdosage is associated with antimuscarinic, extrapyramidal and CNS stimulation and depression. CNS stimulation causes ataxia, excitement, tremors, psychoses, hallucinations, convulsions, hyperexia may also occur. Deepening coma and cardiorespiratory collapse may follow. CNS depression causes drowsiness, coma, convulsions, progressing to respiratory failure or possible cardiovascular collapse.
Treatment
Treatment is symptomatic and supportive, including artificial respiration if necessary. If patient is conscious and has not lost the gag reflex and not having seizures, emesis should be induced. If emesis cannot be induced, gastric lavage is indicated.