OTRIVINE CONGESTION RELIEF

1% Nasal Spray should not be used in children aged less than 12 years old.

Adults and children over 12 years:

One application in each nostril up to 3 times daily as needed. Do not exceed 3 applications daily into each nostril.

Route of administration:

Nasal use Laterally actuated pump (Khone): The laterally actuated metered-dose spray ensures that the solution is well distributed over the surface of the nasal mucosa by spraying a fine mist. Before using for the first time, prime the pump by actuating 5 times.

Once primed, the pump will normally remain charged throughout regular daily treatment periods. If the spray is not ejected during the full actuation stroke, or if the product has not been used for longer than 7 days, the pump will need to be re-primed with 2 actuations.

Vertically actuated pump (Freepod):

Before the first application, prime the pump by actuating 4 times. Once primed, the pump will normally remain charged throughout regular daily treatment periods. If the spray is not ejected during the full actuation stroke, or if the product has not been used for longer than 7 days, the pump will need to be reprimed with 4 actuations.

If the full spray is not administered, the dose should not be repeated. The recommended dose should not be exceeded, especially in children and the elderly.

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 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store.

1% Nasal Spray should not be used for more than seven consecutive days, prolonged or excessive use may cause rebound congestion and/or atrophy of the nasal mucosa. 1% Nasal Spray, like other sympathomimetic agents, should be used with caution in patients showing a strong reaction to adrenergic substances, as manifested by signs of insomnia, dizziness, tremor, cardiac arrhythmias or elevated blood pressure.

Caution is recommended in patients with hypertension, cardiovascular disease, hyperthyroidism or diabetes mellitus or tri and tetra-cyclic antidepressants (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. 750 mg/ml) which may cause skin reactions.

1. 1% Nasal Spray should not be used in patients with trans-sphenoidal hypophysectomy or surgery exposing the dura mater, Narrow-angle glaucoma, rhinitis sicca or atrophic rhinitis. Use in people with phaeochromocytoma, prostatic hypertrophy or those receiving monoamine oxidase inhibitors (MAOI) treatment or who have used them in the last two weeks.

1% is contraindicated in children aged less than 12 years.