It is recommended that you also refer to http://www.medicines.ie as the Summary of Product Characteristics may have been updated since this copy was printed.

GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

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

1. NAME OF THE MEDICINAL PRODUCT

Otrivine Adult 0.1% w/v Nasal Spray, Solution

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Xylometazoline Hydrochloride 0.1% w/v

Excipients: Benzalkonium chloride 0.01%w/v.

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Nasal spray, solution (nasal spray)

A clear, colourless solution

4. CLINICAL PARTICULARS

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.

Paediatric population:

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.

4.3 Contraindications

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

Pregnancy

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.

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 Nasal Spray should only be used under medical advice, whilst breastfeeding.

Fertility

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.

Website: www.hpra.ie;

E-mail: medsafety@hpra.ie.

4.9 Overdose

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. PHARMACOLOGICAL PROPERTIES

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. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Benzalkonium chloride

Disodium phosphate dodecahydrate (Sodium phosphate)

Disodium edetate

Sodium dihydrogen phophate dihydrate (Sodium acid phosphate)

Sodium chloride

Purified water

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

Unopened:

Opened:

3 years.

28 days

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

Bottle:

Cap:

Spray plug and capillary:

Carton:

Low density polyethylene

High density polyethylene

Low density polyethylene

Cardboard

Pack size: 10 ml

6.6 Special precautions for disposal and other handling

No special requirements.

7. MARKETING AUTHORISATION HOLDER

GlaxoSmithKline Consumer Healthcare (Ireland) Limited

12 Riverwalk, CityWest Business Campus,

Dublin 24,

Ireland

8. MARKETING AUTHORISATION NUMBER(S)

PA 0678/120/002

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

24th May 1984 / 24th May 2009

10. DATE OF REVISION OF THE TEXT

29th July 2016

It is recommended that you also refer to http://www.medicines.ie as the Summary of Product Characteristics may have been updated since this copy was printed.