Sudafed blocked nose spray 15ml.This product is indicated for the symptomatic relief of nasal congestion associated with the common cold, influenza, sinusitis, allergic and non-allergic rhinitis, and other upper respiratory tract allergies.
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.
Use for more than seven consecutive days is not recommended, [See Undesirable effects].
Children under 12 years:
This product is not recommended for children under 12 years of age.
The Elderly
Experience has indicated that normal adult dosage is appropriate, [See Pharmacokinetics in the elderly].
Hepatic/renal dysfunction
Normal adult dosage is appropriate, [See Pharmacokinetic properties].
Method of administration
Nasal
This product is an aqueous solution of Xylometazoline Hydrochloride 0.1% w/v presented in a metered-dose pack, delivering 0.14 ml per actuation.Benzalkonium chloride solution
Disodium edetate
Sodium dihydrogen phosphate dihydrate
Sodium monohydrogen phosphate dihydrate
Sodium chloride
Sorbitol solution, 70% (Non crystalline)
Purified water
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
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.
4.4 Special warnings and precautions for use
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.
Prolonged treatment may lead to reactive hyperemia of the nasal mucosa.
This rebound effect may lead to nasal congestion or nasal obstruction during continued use or after discontinuation, resulting in repeated or even continuous use of the medicine by the patient
Xylometazoline nasal preparations are generally well tolerated following short-term use and local side effects are mild and infrequent. Localised burning, stinging, itching, soreness, dryness or irritation and sneezing may occur occasionally. Rarely, nausea and headache may occur.
Rebound congestion has been reported occasionally, particularly following longer-term use of xylometazoline.
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