OTRIVINE ANTISTIN

Posology Adults 1 or 2 drops instilled 2 - 3 times a day. Paediatric population Children aged 12 years and over: 1 drop instilled 2 to 3 times a day. No specific studies are available in this patient group. 4). Elderly 1 drop instilled 2 to 3 times a day.

Otrivine-Antistin Eye Drops should not be used for more than seven consecutive days. Method of administration For local administration to the eye. The dispenser remains sterile until the original closure is broken. Patients must be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures as this may contaminate the solution.

If more than one medication needs to be instilled in the eye, an interval of at least 5 minutes between application of the different medicinal products must be allowed.

Otrivine-Antistin is generally well tolerated, but the following effects have been reported. Adverse events are categorised by frequency as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000), not known (frequency cannot be estimated from the available data).

g. rash, oedema, pruritus) have been reported post- marketing. Although administered via the topical route, systematic side effects may occur in sensitive patients: - tachycardia (especially in small children), palpitations, arrhythmia, hypertension, - occipital headache, - nausea, paleness and sweating Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

Like other topically applied ophthalmic drugs, Otrivine-Antistin may be absorbed systemically and occasionally cause systemic sympathomimetic effects such as hypertension, nervousness, nausea, dizziness, headache, insomnia, palpitations, tachycardia, and arrhythmia.

Otrivine-Antistin should be used with caution in elderly patients with severe cardiovascular disease, including arrhythmia, poorly controlled hypertension or diabetes. Use with caution in the presence of hypertension, cardiac irregularities, hyperthyroidism, diabetes mellitus or phaeochromocytomas.

Patients with long QT syndrome treated with xylometazoline may be at increased risk of serious ventricular arrhythmias. Otrivine-Antistin should also be used with caution in patients with conditions causing urinary retention such as prostatic hypertrophy and should also be used in caution in patients who are currently receiving other sympathomimetic drugs.

Not suitable for patients suffering from dry eyes without first seeking medical advice. Rebound hyperaemia may follow prolonged frequent use. Otrivine- Antistin should not be used without supervision over a long period of time. If the symptoms do not improve after 2 days, medical advice should be sought to rule out the possibility of a bacterial infection.

Inflammation arising from infection should receive appropriate anti-bacterial therapy. Eye drops are not for injection. They should never be injected subconjunctivally, nor should they be directly introduced into the anterior chamber of the eye.

1 mg/ml. Benzalkonium chloride may cause eye irritation, especially with dry eyes or disorders of the cornea. Patients should be instructed to talk to a doctor if they feel abnormal eye sensation, stinging or pain in the eye after using this medicine.

This medicine contains boric acid. This medicine should not be given to a child younger than 2 years without medical advice, as it contains boron and may impair fertility in the future.

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