Narhimed Blocked Nose 1 mg/ml 10 ml nasal drops solution

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219

INDICATIONS

Decongestant of the nasal mucosa (in case of colds, hay fever or other allergic rhinitis, sinusitis)

CONTRAINDICATIONS

- Hypersensitivity to xylometazoline or to any of the excipients listed in section 6.1. - Closed-angle glaucoma. - Chronic rhinitis. - Patients with dry or atrophic rhinitis. - Pregnancy (see section 4.6). - Children under the age of 12. Like other vasoconstrictors, do not use Narhimed stuffy nose in patients undergoing transsphenoidal hypophysectomy or surgery with exposure of the dura mater.

WARNINGS AND PRECAUTIONS FOR USE

Narhimed stuffy nose, like other sympathomimetic agents, should be used with caution in patients who show a strong reaction to adrenergic substances manifested by signs of insomnia, dizziness, tremor, cardiac arrhythmia, or elevated blood pressure. Like other vasoconstrictors for local use, Narhimed stuffy nose should not be used for more than 7 consecutive days: prolonged or excessive use may cause rebound congestion and/or atrophy of the nasal mucosa. Do not exceed the indicated doses, especially in the elderly. Caution is recommended in patients with hypertension, cardiovascular disease, hyperthyroidism or diabetes mellitus, pheochromocytoma as well as in patients with prostatic hypertrophy and in patients treated with monoamine oxidase inhibitors (MAOIs) or who have taken them in the last two weeks (see section 4.5). Patients with long QT syndrome treated with xylometazoline may be at increased risk of serious ventricular arrhythmias. Important information about some excipients Narhimed stuffy nose contains benzalkonium chloride (BAC) as a preservative which, especially when used for long periods, may cause swelling of the nasal mucosa. If such a reaction (persistent nasal congestion) is suspected, a medicinal product for nasal use without benzalkonium chloride should be used, if possible. If such medicinal products for nasal use without benzalkonium chloride are not available, another pharmaceutical form should be considered. May cause bronchospasm.

INTERACTIONS

Monoamine oxidase inhibitors (MAOIs): xylometazoline can potentiate the action of monoamine oxidase inhibitors and can cause hypertensive crises. Xylometazoline is not recommended in patients who are taking or have taken MAOIs in the last two weeks (see section 4.4). Tricyclic and tetracyclic antidepressants: Concomitant use of tricyclic and tetracyclic antidepressants and sympathomimetics may reinforce the sympathomimetic effect of xylometazoline and is therefore not recommended.

SIDE EFFECTS

Adverse reactions are listed by system organ class and frequency. Frequencies are defined as: 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). Within each frequency class, undesirable effects are presented in order of decreasing seriousness.

Immune system disorders

Very rare: | Hypersensitivity reactions (angioedema, rash, pruritus)

Nervous system disorders

Municipality: | Headache

Eye pathologies

Very rare: | Transient visual disturbances

Cardiac diseases

Very rare: | Irregular heart rate and increased heart rate

Respiratory, thoracic and mediastinal disorders

Municipality: | Nasal dryness or discomfort

Uncommon: | Epistaxis

Gastrointestinal disorders

Municipality: | Nausea

Systemic pathologies and conditions relating to the administration site

Municipality: | Burning at the application site

Other side effects noted: arterial hypertension, reflex bradycardia, urination disorders, insomnia and restlessness. Reporting of suspected adverse reactions. Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse