OTRIVINE ANTISTIN Contains TWO active ingredients:
• Xylometazoline Hydrochloride - a long acting vasoconstrictor, reducing redness
• Antazoline Sulphate - A H1 receptor antagonist, to reduce histamine - induced symptoms
Otrivine Antistin® Eye Drops (Xylometazoline hydrochloride 0.05% Antazoline sulphate 0.5%).
Product licence number: PL 20162/0016. Product licence holder: Laboratoires Thea 12, rue Louis-Blériot, 63017 Clermont-Ferrand Cedex 2, France.
Supply classification: P. Please see Summary of Product Characteristics before recommending. Indications - Temporary relief of redness and itching of the eye due to allergies such as hay fever or house dust.
Contraindications: Hypersensitivity to any of the ingredients, narrow angle glaucoma, contact lenses, monoamine oxidase inhibitors or within 14 days of stopping such treatment.
Possible Side effects: Slight transient local stinging on instillation, blurred vision, mydriasis, headache, drowsiness and reactive hyperaemia. Local allergic reactions (rash, oedema, pruritus) and eye irritation have been reported. Systemic side effects may occur in sensitive patients : tachycardia (especially in small children), palpitations, arrhythmia, hypertension, occipital headache, nausea, paleness and sweating.
Precautions for use: Otrivine-Antistin may occasionally cause systemic effects such as hypertension, nervousness, nausea, dizziness, headache, insomnia, palpitations, tachycardia, and arrhythmia. Use with caution in elderly patients with severe cardiovascular disease, arrhythmia, poorly controlled hypertension, or diabetes. Use with caution with hypertension, cardiac irregularities, hyperthyroidism, diabetes mellitus or phaeochromocytomas or in patients with urinary retention or those currently receiving other sympathomimetic drugs. Not suitable for patients with dry eyes without medical advice. Rebound hyperaemia may follow prolonged frequent use. Do not use without supervision
over a long period of time. If the symptoms do not improve after 2 days, the possibility of a bacterial infection should be medically ruled out. Inflammation arising from infection requires appropriate anti-bacterial therapy.
Eye drops are not for injectioninto the eye. Sedating anti-histamines can enhance the sedating effects of CNS depressants including alcohol, hypnotics, opioid analgesics, anxiolytic sedatives and antipsychotics. They also have additive anti-muscarinic action with other antimuscarinic drugs, such as atropine, and some antidepressants. Use with caution in patients receiving digitalis, beta- adrenergic blockers, guanetidine, reserpine, methyldopa or anti-hypertensive agents. Concurrent use with halogenated anaesthetic agents such as chloroform, cyclopropane, halothane, enflurane or isoflurane may provoke or worsen ventricular arrhythmias Do not drive or operate machines if vision is blurred.
Pregnancy and lactation: Do not use medication during pregnancy unless considered essential. Do not give to nursing mothers or interrupt breast feeding for 48 hours after administration.
Overdose: Excessive dosage in children may cause profound CNS depression possibly necessitating intensive supportive care. CNS depression, shock-like hypotension, and coma are possible with xylometazoline.
Dosage and method of use: Local administration to the eye. Adults: 1 or 2 drops, 2 - 3 times a day. Children: Do not use in children younger than 12. Elderly: One drop, 2 to 3 times a day. Do not use for more than seven consecutive days. Sterile until the closure is first broken. Instruct patients to avoid touching the tip of the container on or around the eye as this may contaminate the solution. Leave at least 5 minutes between applications of different medicines.
Cost: RRP £5.48 Date of preparation: 16th March 2018
*Benzalkonium chloride is contained as a preservative. It can sometimes cause mild irritation of the eyes. Adverse events should be reported. Reporting forms can be found at
www.mhra.gov.uk/yellowcard. Adverse events
should be reported to Thea Pharmaceuticals Ltd. Thea Pharmaceuticals Limited
IC5 Building • Keele University Science & Business Park • Keele Newcastle Under Lyme • ST5 5NT
Head Office: 0845 521 1290 • Medical Information: 0870 192 3283
E-Mail:
thea.support@
theapharma.co.uk www.thea-pharmaceuticals.co.uk
®
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