SUDAFED PLUS BLOCKED NOSE

Posology Adults and children 12 years and over:

One spray into each nostril up to 3 times a day, as necessary. Maximum daily dose: 3 sprays in 24 hours. The dosage depends on individual sensitivity and clinical efficacy. 4). Do not exceed the recommended dose.

Children under 12 years:

Do not give to children under 12 years of age. For hygienic reasons and to avoid infections, each spray bottle should only be used by the same person.

Method of administration:

Nasal First the protective cap should be removed from the sprayer. Before the first use the spray head should be pressed five times away from the face until a fine spray appears. If the spray has not been used for a long period of time the head should be pressed two times away from the face before use.

The sprayer tip should be inserted as upright as possible into one nostril and the spray head should be pressed once. Patient should gently inhale through the nose while spraying. If necessary, the procedure should be repeated for the other nostril.

After each use, the sprayer tip should be wiped with a paper tissue and the cap placed back on the sprayer.

The following definitions apply to the incidence of the undesirable effects: - 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) - Very rare (< 1/10,000) - Not known (cannot be estimated from the available data) Tabulated list of adverse reactions Uncommon Rare Very rare Not known Immune system Disorders hypersensitivity reaction (angioedema, skin rash, pruritus)Psychiatric disorders, especially with prolonged and/or heavy use.

restlessness, insomnia, hallucinations and paranoid delusions. irritability, anxiety, excitability Nervous system Disorders fatigue (drowsiness, sedation), headache, convulsions Cardiac disorders, especially with prolonged and/or heavy use palpitations, tachycardia, hypertension arrhythmias Respiratory, thoracic and mediastinal disorders rebound congestion (rhinitis medicamentosa) - especially with prolonged and/or heavy use, nosebleed Sneezing, burning, irritation and dryness of the nasal mucosa.

) Reporting of suspected adverse reactions Reporting of 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.

4 Special warnings and pre cautions for us e There is minimal systemic absorption with topically applied imidazoline sympathomimetics such as xylometazoline. This medicinal product may be used only after a careful assessment of the risks and benefits in cases of: - increased intraocular pressure - porphyria - prostate hyperplasia.

Use during chronic rhinitis may only be carried out under medical supervision owing to the danger of the atrophy of the nasal mucosa. Use with caution in occlusive vascular disease. 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 hyperaemia of the nasal mucosa. 8). Keep away from the eyes. 9). If any of the following occur, use of Sudafed Plus Blocked Nose Spray should be stopped: - Hallucinations - Restlessness - Sleep disturbances

1. Contraindicated in children under 12 years of age. Concomitant use of other sympathomimetic decongestants. Cardiovascular disease including hypertension. Phaeochromocytoma. Diabetes Mellitus Hyperthyroidism Closed angle glaucoma. 5). Inflammation of the skin and/or mucosa of the nasal vestibule.

Contraindicated in individuals with dry inflammation of the nasal mucosa (rhinitis sicca). 5). Contraindicated in individuals with a history of transsphenoidal hypophysectomy or other surgical interventions which expose the dura mater.