SUDAFED MUCUS RELIEF

Posology Adults and children 12 years and over:

One spray to be expressed into each nostril 2-3 times daily, as necessary. Maximum daily dose: 3 sprays in 24 hours. 4].

Children under 12 years:

Do not give to children under 12 years of age. 2]. 2]. Method of administration Nasal

Adverse Drug Reactions (ADRs) identified during clinical trials and post- marketing experience with xylometazoline are listed below by System Organ Class (SOC).

The frequencies are defined in accordance with current guidance, as:

Very common ≥1/10 Common ≥1/100 and < 1/10 Uncommon ≥1/1,000 and <1/100 Rare ≥1/10,000 and <1/1,000 Very rare <1/10,000 Not known (cannot be estimated from the available data) ADRs are presented by frequency category based on 1) incidence in adequately designed clinical trials or epidemiology studies, if available or 2) when incidence is unavailable, frequency category is listed as Not known.

System Organ Class (SOC) Frequency Adverse Drug Reaction (Preferred Term) Nervous System Disorders Rare Not known Headache Burning sensation mucosal Uncommon EpistaxisRespiratory, Thoracic and Mediastinal Disorders Not known Nasal discomfort Nasal dryness Nasal pruritus Rhinalgia Sneezing Gastrointestinal Disorders Rare Nausea General Disorders and Administration Site Conditions Not known Rebound effect 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.

There is minimal systemic absorption with topically applied imidazoline sympathomimetics such as xylometazoline, however, this product should be used with caution in patients suffering coronary artery disease, hypertension, hyperthyroidism or diabetes mellitus.

Patients with long QT syndrome treated with xylometazoline may be at increased risk of serious ventricular arrhythmias. This medicine is intended for short term use only. Prolonged treatment may lead to reactive hyperemia of the nasal mucosa.

8). 196 mg/ml of product. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time. Long-term use may cause oedema of the nasal mucosa.

1. Children under 12 years of age. This product is contraindicated in individuals who are taking or have taken monoamine oxidase inhibitors within the preceding two weeks. This product is contraindicated in individuals with hypophysectomy or surgery exposing dura mater.