COMPOSITION AND PHARMACEUTICAL FORM
1 mL of Spersallerg contains:
Antazoline hydrochloride 0.5 mg
Tetryzoline hydrochloride 0.4 mg.
For a full list of excipients, see section EXCIPIENTS.
Temporary relief of the signs and symptoms of allergic conjunctivitis
including conjunctival hyperaemia, chemosis and itching in adults and
children above 2 years of age.
DOSAGE AND ADMINISTRATION
Adults and adolescents: 1 drop 2 to 3 times daily for up to 14 days.
Children (older than 2 years of age): No specific studies are
available in this patient group. Due to possible systemic effects, the
dosage should not exceed 1 to 2 drops per day. Not to be used in children
below 2 years of age. Spersallerg should not be used for longer periods than
14 days as this may cause rebound hyperaemia and toxic follicular
Following instillation of the eye drops, nasolacrimal occlusion or
closing the eyes for 3 minutes may reduce systemic absorption. This may
result in a decrease in systemic side effects and an increase in local
If more than one medication needs to be instilled in the eye, an interval
of at least 5 minutes should be allowed between application of the different
The dispenser remains sterile until the original closure is broken. Patients
must be instructed to avoid allowing the tip of the dispensing container to
come into contact with the eye or surrounding structures as this may
contaminate the solution.
The contents remain sterile until the original closure is broken. To avoid
contamination patients must be instructed not to touch any surface with the
tip of the container. Patients must discard residual contents after each
• Known hypersensitivity to antazoline and/or tetryzoline or to any of the
• Concomitant use with Monoamine Oxidase Inhibitors (MAOI) (see section
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Spersallerg should be used with caution in elderly patients with severe
cardiovascular disease, including arrhythmia, poorly controlled hypertension
Sympathomimetic drugs should be used with caution in patients with
diabetes, hypertension, hyperthyroidism and elevated thyroid hormone
concentrations, arrhythmias or tachycardia and phaeochromocytomas. Care
should be taken in patients at risk of or with angle closure glaucoma,
unless iridectomy (or iridotomy) has been performed. Patients should be
informed that overuse of vasoconstrictors may produce rebound hyperaemia.
Spersallerg is not suitable for patients suffering from dry eyes without
first seeking medical advice. Patients experiencing symptoms of dry eyes
should discontinue the use of this product and seek the advice of their
medical practitioner. Eye infections may be masked by the use of Spersallerg.
Patients with rhinitis sicca should take special care to perform
nasolacrimal occlusion correctly to prevent Spersallerg from reaching the
Patients should consult their doctor if symptoms persist for more than 3
to 4 days, if the symptoms become more severe, or if they experience ocular
pain and blurred vision while using Spersallerg.
If the patient wears contact lenses, these should be removed before
instillation and not reinserted for at least 15 minutes.
Furthermore, Spersallerg in multidose containers contains the
preservative benzalkonium chloride, which may cause eye irritation and is
known to discolour soft contact lenses.
Sympathomimetic agents may cause a hypertensive crisis if used during
treatment with MAOls. Concomitant use with MAOIs is therefore
contraindicated (see section CONTRAINDICATIONS).
Sedating anti-histamines can enhance the sedating effects of CNS
depressants including alcohol, hypnotics, opioid analgesics, anxiolytic
sedatives and anti-psychotics. They also have an additive anti-muscarinic
action with other antimuscarinic drugs, such as atropine and some
antidepressants (both tricyclics and MAOIs). As systemic absorption of
antazoline is possible, caution should be exercised when using Spersallerg
concomitantly with these medicinal products.
PREGNANCY AND LACTATION
No clinical data on exposed pregnancies are available. Spersallerg should
only be used if the potential benefits outweigh the risks to the foetus or
It is not known whether either of the active substances of Spersallerg
passes into breast milk. Caution should be exercised when using the product
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Spersallerg may cause drowsiness, dizziness, somnolence or blurred vision.
Patients who experience any of these side effects should not drive or
operate machines until they have resolved.
Patients may experience any of the adverse effects noted for each of the
individual active substances. The most common adverse effect is
burning/stinging upon instillation, which is mild and transient in nature.
Burning/stinging upon instillation and signs and symptoms indicative of a
local allergic reaction have been reported with Spersallerg. The following
may also occur: iris pigment dispersion, mydriasis, blurred vision, acute
conjunctivitis, chronic conjunctivitis, toxic follicular conjunctivitis, dry
eye, rebound congestion, reactive hyperaemia, angle closure glaucoma.
Nervous system disorders
These may include headache, somnolence, drowsiness, dizziness, tremor and
These may include angina pectoris, hypertension and tachycardia.
General disorders and administration site conditions
Burning sensation in the eye has been reported. Sweating may also occur.
Immune system disorder
Hypersensitivity reactions may occur very rarely.
Inadvertent oral ingestion of one 10 mL bottle of Spersallerg, corresponding
to 5 mg antazoline hydrochloride and 4 mg tetryzoline hydrochloride is not
likely to have any serious consequences in an adult. In children, especially
in those under 2 years of age, nausea, somnolence, arrhythmia/tachycardia
and possibly shock may occur. CNS depression, shock like hypotension and
coma have occurred following overdose of tetryzoline.
In the event of accidental overdosage following oral ingestion, induce
vomiting if the patient is still conscious. Otherwise, gastric lavage and/or
activated charcoal should be considered. Give artificial respiration if
necessary. General intensive supportive measures may be required in severe
Antazoline is an anti-histamine of the ethylenediamine class, which are
selective H1-antagonists. When used systemically, this group of anti
-histamines can cause. moderate sedation (despite having weak CNS effects),
gastric disturbances, and skin sensitisation. Antazoline competitively
blocks H1 receptors. Effects mediated by HI receptors include the
contraction of smooth muscle and the dilatation and increased permeability
of the capillaries. Tetryzoline is a sympathomimetic with alpha adrenergic
activity. Its vasoconstrictive effect reduces redness and oedema in allergic
Antihistamines, which act by blocking the H1 histamine receptor, are
highly effective in providing relief of itching but are not very active in
relieving the associated redness. The use of products combining an
anti-histamine and a vasoconstrictor is well established in the symptomatic
relief of allergic eye disease.
In a double masked, multicentre, randomised study, Spersallerg was found
to be statistically superior to levocabastine at air early time point (30
minutes) post instillation. No difference at later time points (days 4 and
15) were observed, indicating a faster onset of action for Spersallerg
especially with respect to hyperaemia (p=0.0004) and chemosis (p=0.0029).
In an open-label study in 1,156 patients, the effect of tetryzoline was
found to last between I and 4 hours with an onset of action within 1 to 5
minutes following instillation. Tetryzoline has a rapid onset of action and
its effect can last for 4 to 8 hours.
No specific human pharmacokinetic studies have been conducted with
Spersallerg. However, systemic effects have been reported following topical
administration of naphazoline (which is very similar to tetryzoline).
PRECLINICAL SAFETY DATA
No standard studies for mutagenicity, carcinogenicity, teratogenicity nor
reproduction toxicity and reproductive performance have been performed with
Preclinical effects were only observed at exposures considered
sufficiently in excess of the maximum human exposure indicating little
relevance to clinical use.
Benzalkonium chloride as preservative; hypromellose/
methylhydroxypropylcellulose; sodium chloride; dilute hydrochloric acid and
water for injections.
Hypromellose/methylhydroxypropylcellulose; sodium chloride; dilute
hydrochloric acid and water for injections. Pharmaceutical formulations may
vary between countries.
Do not use for longer than 1 month after opening.
Opened blister: 1 month. After opening, the contents of a single-dose
container should be used immediately. See also folding box.
Information might differ in some countries.
Spersallerg should not be used after the date marked <EXP> on the pack.