OTRIVIN ADULT Menthol Nasal spray, solution Ref.[50845] Active ingredients: Xylometazoline

Otrivine, like other sympathomimetic agents, should be used only with caution in patients showing a strong reaction to adrenergic substances as manifested by signs of insomnia, dizziness, tremor, cardiac arrhythmias or elevated blood pressure.

Patients with long QT syndrome treated with xylometazoline may be at increased risk of serious ventricular arrhythmias.

Like other topical vasoconstrictors, Otrivine should not be used for more than seven consecutive days: prolonged or excessive use may cause rebound congestion and/or atrophy of the nasal mucosa.

Do not exceed the recommended dose, especially in children and in the elderly.

Otrivine should be used with caution in patients with:

• hypertension, cardiovascular disease
• diabetes mellitus, phaeochromocytoma,
• prostatic hypertrophy

Keep out of the sight and reach of children.

For prevention of cross infection, it is recommended that each product package is used by one person only.

Paediatric population:

Otrivine Adult Menthol Nasal Spray should not be used in children aged less than 12 years old.

Information concerning excipients

Otrivine Adult Menthol Nasal Spray contains benzalkonium chloride which may cause irritation or swelling inside the nose, especially if used for a long time. It also contains polyoxyl hydrogenated castor oil, which may cause skin reactions.

This product may alter the effects of some anti-hypertensives, such as beta-blockers, and of some anti-depressants, such as monoamine oxidase inhibitors (MAOIs), tricyclic and tetracyclic anti-depressants.

The concomitant use of xylometazoline with monoamine oxidase inhibitors (MAO) or tri-and tetra-cyclic antidepressants, may cause an increase in blood pressure due to the cardiovascular effects of these substances.

Monoamine oxidase inhibitors (MAO inhibitors): xylometazoline may potentiate the action of monoamine oxidase inhibitors and may induce hypertensive crisis. Xylometazoline is not recommended in patients who are taking or have taken MAOIs within the past two weeks (see section 4.3).

Tri- and tetra-cyclic antidepressants: concomitant use of tri- or tetra cyclic antidepressants and sympathomimetic preparations may result in an increased sympathomimetic effect of xylometazoline and is therefore not recommended.

Pregnancy

No foetal toxicity or fertility studies have been carried out in animals. In view of its potential systemic vasoconstrictor effect, it is advisable to take the precaution of not using Otrivine Adult Menthol Nasal Spray during pregnancy.

Breastfeeding

There is no evidence of any adverse effect on the breast-fed infant. However, it is not known if xylometazoline is excreted in breast milk, therefore caution should be exercised and Otrivine Adult Menthol Nasal Spray should only be used under medical advice, whilst breastfeeding.

Fertility

There are no adequate data for the effects of Otrivine Adult Menthol Nasal Spray on fertility and no animal studies are available. As the systemic exposure to xylometazoline hydrochloride is very low, effects on fertility are therefore very unlikely.

Otrivine Adult Menthol Nasal Spray has no or negligible influence on the ability to drive and use machines.

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).

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. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, website: www.hpra.ie.

Not applicable.