XYLOMETAZOLINE DECONGESTANT NASAL

i) Posology Adults, the elderly and children over 12 years of age One application in each nostril up to 3 times daily. Do not exceed 3 applications daily into each nostril. Children under 12 years Not suitable. (ii) Method of administration Application to the nasal passages.

The spray pump guarantees a good distribution of the solution on the surface of the mucosa. The dosing mechanism enables an accurate dosage and prevents an unintended overdose. Remove the protective cap. Before first use, press the pump 5 times until an even spray is formed.

The nasal spray is ready for use now. With repeated administration, the nasal spray will be ready for immediate use. If the spray has not been used for a maximum of 14 days (after first use), press the pump once to activate the nasal spray.

Avoid contact with eyes and mouth. 1. Blow your nose. 2. Hold the bottle upright and place your thumb at the bottom of the bottle and hold the nozzle between 2 fingers. 3. Tilt your head forward slightly and put the nozzle in a nostril. 4.

Breath in slowly and gently through your nose whilst pressing down the pump. 5. Clean and dry the nozzle before placing the protective cap. 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).

MedDRA 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 rare irregular Heart rate increased Very Rare Respiratory, thoracic and mediastinal disorders Nasal Dryness Common Nasal Discomfort Epistaxis Uncommon Gastrointestinal disorders Nausea Common General disorders and administration site conditions 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.

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.

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. 1%w/v, 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 or diabetes mellitus. Patients with long QT syndrome treated with xylometazoline may be at increased risk of serious ventricular arrhythmias.

1%w/v contains benzalkonium chloride. This may cause irritation of the nasal mucosa. This medicine contains less than 1mmol sodium (23mg) per dose, that is to say essentially ‘sodium-free’.

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