Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom
Known hypersensitivity to xylometazoline or any of the excipients listed in section 6.1
Patients with trans-sphenoidal hypophysectomy or surgery exposing the dura mater.
Narrow-angle glaucoma
Rhinitis sicca or atrophic rhinitis.
Otrivine 0.1% is contraindicated in children aged less than 12 years.
People with phaeochromocytoma or prostatic hypertrophy or receiving monoamine oxidase inhibitors (MAOI) treatment or who have received them in the last two weeks.
Patients are advised not to take decongestants for more than seven consecutive days. Prolonged or excessive use may cause rebound congestion and/or atrophy of the nasal mucosa.
Otrivine, like other preparations belonging to the same class of active substances, should be used only with caution in patients showing a strong reaction to sympathomimetic agents as evidenced by signs of insomnia, dizziness, tremor, cardiac arrhythmias or elevated blood pressure.
Caution is recommended in patients with hypertension, cardiovascular disease, hyperthyroidism or diabetes mellitus.
Patients with long QT syndrome treated with xylometazoline may be at increased risk of serious ventricular arrhythmias.
Keep medicines out of the sight and reach of children.
Otrivine contains benzalkonium chloride. This may cause irritation of the nasal mucosa.
The concomitant use of xylometazoline with monoamine oxidase (MAO) inhibitors or tri- and tetra-cyclic antidepressants, may cause an increase in blood pressure due to the cardiovascular effects of these substances (see Contraindications).
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 during pregnancy.
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 should be used only on the advice of a doctor whilst breastfeeding.
Otrivine 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).
| MeDRA SOC | Adverse reaction | Frequency |
|---|---|---|
| Immune System Disorders | Hypersensitivity reaction (angioedema, rash, pruritus) | Very rare |
| Nervous System Disorders | Headache | Common |
| Eye Disorders | Transient visual impairment | Very rare |
| Cardiac Disorders | Heart rate irregular Heart rate increased | Very rare Very rare |
| Respiratory, thoracic and mediastinal disorders | Nasal Dryness Nasal Discomfort Epistaxis Apnoea in young infants and newborns | Common Common Uncommon Very rare |
| Gastrointestinal disorders | Nausea | Common |
| General disorders and administration site | Application site burning | Common |
Other side effects include:
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 the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store.
None.
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