OTRIVINE ADULT NASAL

Adults and elderly (all indications): 2 or 3 drops in each nostril up to 3 times daily. Do not exceed 3 applications daily into each nostril. The drops are suitable for children over 12 years of age. The recommended dose should not be exceeded, especially in children and the elderly.

Route of administration:

Nasal use.

The adverse effects listed below are classified by system organ class and frequency according to the following convention: 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) or very rare (<1/10,000).

MeDRA SOC Adverse reaction Frequency Immune System Disorders Hypersensitivity reaction (angioedema, rash, pruritus) Very rare Nervous System Disorders Headache Common Eye Disorders Transient visual impairment Very rare Cardiac Disorders Heart rate irregular Heart rate increased Very rare Very rare Respiratory, thoracic and mediastinal disorders Nasal Dryness Nasal Discomfort Epistaxis Common Common Uncommon Gastrointestinal disorders Nausea Common General disorders and administration site Application site burning Common Other side effects include: • A burning sensation in the nose and throat Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

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Patients are advised not to take decongestants for more than seven consecutive days. Prolonged or excessive use may cause rebound congestion and/or atrophy of the nasal mucosa. Otrivine, like other preparations belonging to the same class of active substances, should be used only with caution in patients showing a strong reaction to sympathomimetic agents as evidenced by signs of insomnia, dizziness, tremor, cardiac arrhythmias or elevated blood pressure.

Caution is recommended in patients with hypertension, cardiovascular disease, hyperthyroidism, diabetes mellitus or tri and tetra-cyclic antidepressant treatment (see Interactions). Patients with long QT syndrome treated with xylometazoline may be at increased risk of serious ventricular arrhythmias.

Keep medicines out of the sight and reach of children Information concerning excipients Otrivine contains benzalkonium chloride. This may cause irritation of the nasal mucosa.

Known hypersensitivity to Otrivine Patients with trans-sphenoidal hypophysectomy or surgery exposing the dura mater Narrow-angle glaucoma Rhinitis sicca or atrophic rhinitis. 1% is contraindicated in children aged less than 12 years People with phaeochromocytoma or prostatic hypertrophy or receiving monoamine oxidase inhibitors (MAOI) treatment or who have received them in the last two weeks.