GlaxoSmithKline Consumer Healthcare (Ireland) Ltd
Summary of Product Characteristics last updated on medicines.ie: 3/10/2016
Otrivine Adult 0.1% w/v Nasal Spray, Solution
Otrivine Adult 0.1% w/v Nasal Spray, Solution
Xylometazoline Hydrochloride 0.1% w/v
Excipients: Benzalkonium chloride 0.01%w/v.
For a full list of excipients, see section 6.1.
Nasal spray, solution (nasal spray)
A clear, colourless solution
4.1 Therapeutic indications
As a nasal decongestant for relief of the symptoms of acute rhinitis in allergic or upper respiratory tract infections, including the common cold or influenza. Relief of sinusitis.
4.2 Posology and method of administration
Otrivine should not be used for more than seven consecutive days (see section 4.4).
The recommended dose should not be exceeded.
Adults (including the elderly) and adolescents over 12 years of age:
1 to 2 sprays into each nostril, up to 3 times daily as needed. Do not exceed 3 applications daily into each nostril. It is recommended to make the last application shortly before retiring to bed.
Otrivine Adult Nasal Spray should not be used in children aged less than 12 years old.
Route of administration: Nasal use.
1. To produce a fine spray, the nebuliser should be held upright with the nozzle pointing upwards. Be careful not to spray in the eyes.
2. Blow your nose gently.
3. Remove protective cap.
4. Lean forward slightly and insert the nozzle into a nostril.
5. Squeeze the bottle once and breathe in gently at the same time.
6. Remove the nozzle before releasing the pressure on the bottle.
7. Repeat with the other nostril.
8. Clean and dry the nozzle before replacing back the cap right after use.
Hypersensitivity to xylometazoline or to any of the excipients (see list in section 6.1).
Otrivine should not be used in patients with trans-sphenoidal hypophysectomy or surgery exposing the dura mater.
Patients with acute coronary disease, hyperthyroidism or narrow angle glaucoma.
Use in patients who are receiving monoamine oxidase inhibitors, or within 14 days of stopping such treatments.
Rhinitis sicca and Atrophic rhinitis.
4.4 Special warnings and precautions for use
Otrivine should be used with caution in patients with:
• hypertension, cardiovascular disease
• diabetes mellitus, phaeochromocytoma, prostatic hypertrophy
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 .
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.
Otrivine Adult Nasal Spray contains benzalkonium chloride which may cause nasal irritation and bronchospasm.
Do not exceed the recommended dose. The adult spray should not be used for infants or children under 12 years.
For prevention of cross infection, it is recommended that each product package is used by one person only.
Otrivine Adult Nasal Spray contains benzalkonium chloride which can cause nasal irritation or bronchospasm.
4.5 Interaction with other medicinal products and other forms of interaction
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.
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.
4.6 Pregnancy and lactation
No foetal toxicity or fertility studies have been carried out in animals. In view of its potential systemic vasoconstrictor effect, Otrivine Adult Nasal Spray should not be used during pregnancy.
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 Nasal Spray should only be used under medical advice, whilst breastfeeding.
There are no adequate data for the effects of Otrivine Adult 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.
4.7 Effects on ability to drive and use machines
Otrivine Adult Nasal Spray has no or negligible influence on the ability to drive and use machinery.
4.8 Undesirable effects
Systemic cardiovascular effects have occurred, and this should be kept in mind when giving Otrivine Adult Nasal Spray to people with cardiovascular disease.
Adverse reactions are listed below, 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 grouping, undesirable effects are presented in order of decreasing seriousness.
Immune system disorders (very rare): Hypersensitivity reaction (angioedema, rash, pruritus)
Nervous System Disorders (Common): Headache
Eye Disorders (Very rare): Transient visual impairment
Cardiac Disorders (Very rare): Heart rate irregular and heart rate increased
Respiratory, thoracic and mediastinal Disorders (Common): Nasal dryness and nasal discomfort
Gastro-intestinal disorders (Common): Nausea
General disorders and administration site conditions (Common): Application site burning
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, Earlsfort Terrace, IRL - Dublin 2;
Tel: +353 1 6764971;
Fax: +353 1 6762517.
Overdose of oral or excessive administration of topical xylometazoline hydrochloride may cause severe dizziness, perspiration, severely lowered body temperature, headache, bradycardia, hypertension, respiratory depression, coma and convulsions. Hypertension may be followed by hypotension. Small children are more sensitive to toxicity than adults.
Appropriate supportive measures should be initiated in all individuals suspected of an overdose, and urgent symptomatic treatment under medical supervision is indicated when warranted. This may include observation of the individual for at least several hours.
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: decongestants for topical use.
ATC Code: R01A A07
Mechanism of action and pharmacodynamic effects:
Otrivine Adult Nasal Spray is a sympathomimetic agent with marked alpha-adrenergic activity and is intended for use in the nose. It constricts the nasal blood vessels, thereby decongesting the mucosa of the nose and neighbouring regions of the pharynx. It also reduces associated symptoms of mucus hypersecretion and facilitates drainage of blocked secretions. This enables patients with a blocked nose to breathe more easily through the nose.
The effect of Otrivine Adult Nasal Spray begins within a few minutes and lasts for up to 10 hours. Otrivine Adult Nasal Spray is generally well tolerated and does not impair the function of ciliated epithelium.
5.2 Pharmacokinetic properties
Plasma concentrations of xylometazoline in man after local nasal application of the product are very low and close to the limit of detection.
Systemic absorption may occur following nasal application of xylometazoline hydrochloride solutions. It is not used systemically.
5.3 Preclinical safety data
Xylometazoline has no mutagenic effect. No teratogenic effects were shown in a study where xylometazoline was given subcutaneously in mice and rats.
6.1 List of excipients
Disodium phosphate dodecahydrate (Sodium phosphate)
Sodium dihydrogen phophate dihydrate (Sodium acid phosphate)
6.3 Shelf life
6.4 Special precautions for storage
Do not store above 25°C. Keep the bottle in the outer carton.
6.5 Nature and contents of container
Spray plug and capillary:
Low density polyethylene
High density polyethylene
Low density polyethylene
Pack size: 10 ml
6.6 Special precautions for disposal and other handling
No special requirements.
GlaxoSmithKline Consumer Healthcare (Ireland) Limited
12 Riverwalk, CityWest Business Campus,
24th May 1984 / 24th May 2009
29th July 2016