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Spersallerg
Tetryzoline, combinations.

COMPOSITION AND PHARMACEUTICAL FORM
1 mL of Spersallerg contains:
Antazoline hydrochloride 0.5 mg
Tetryzoline hydrochloride 0.4 mg.
Eye drops.
For a full list of excipients, see section EXCIPIENTS.

INDICATIONS
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 conjunctivitis.

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 activity.

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 products.

Spersallerg
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.

Spersallerg SDU
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 use.

CONTRAINDICATIONS
Known hypersensitivity to antazoline and/or tetryzoline or to any of the excipients.
Concomitant use with Monoamine Oxidase Inhibitors (MAOI) (see section INTERACTIONS).

SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Spersallerg should be used with caution in elderly patients with severe cardiovascular disease, including arrhythmia, poorly controlled hypertension or diabetes.

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 nasal mucosa.

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.

INTERACTIONS
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
Pregnancy
No clinical data on exposed pregnancies are available. Spersallerg should only be used if the potential benefits outweigh the risks to the foetus or infant.

Lactation
It is not known whether either of the active substances of Spersallerg passes into breast milk. Caution should be exercised when using the product during breast-feeding.

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.

UNDESIRABLE EFFECTS
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.

Eye disorders
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 central excitation.

Cardiac disorders
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.

OVERDOSE
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 cases.

PHARMACODYNAMICS
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 conjunctivitis.

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.

PHARMACOKINETICS
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 Spersallerg.

Preclinical effects were only observed at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.

EXCIPIENTS

Spersallerg
Benzalkonium chloride as preservative; hypromellose/ methylhydroxypropylcellulose; sodium chloride; dilute hydrochloric acid and water for injections.

Spersallerg SDU
Hypromellose/methylhydroxypropylcellulose; sodium chloride; dilute hydrochloric acid and water for injections. Pharmaceutical formulations may vary between countries.

INCOMPATIBILITIES
None known.

STORAGE
Spersallerg
Do not use for longer than 1 month after opening.

Spersallerg SDU
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.

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