Otrivine Allergy Relief 0.1% Nasal Spray

Summary of Product Characteristics Updated 08-Dec-2020 | GlaxoSmithKline Consumer Healthcare

1. Name of the medicinal product

Otrivine Adult Measured Dose Sinusitis Spray

Otrivine Adult Metered Dose, 0.1% Nasal Spray

Otrivine Allergy Relief, 0.1% Nasal Spray

2. Qualitative and quantitative composition

Active ingredient: 0.1% wlv Xylometazoline Hydrochloride

For excipients see 6.1

3. Pharmaceutical form

Nasal spray, solution (Nasal Spray)

A clear, colourless solution

4. Clinical particulars
4.1 Therapeutic indications

For the symptomatic relief of nasal congestion, perennial and allergic rhinitis (including hay fever), sinusitis.

4.2 Posology and method of administration

Adults and elderly: One application in each nostril up to 3 times daily. Do not exceed 3 applications daily into each nostril.

Not suitable for children under 12 years.

Route of administration: Application to the nasal passages.

Before the first application, prime the pump by actuating 4 times. Once primed, the pump will normally remain charged throughout regular daily treatment periods. If the spray is not ejected during the full actuation stroke, or if the product has not been used for longer than 7 days, the pump will need to be reprimed with 4 actuations.

The recommended dose should not be exceeded, especially in children and the elderly.

4.3 Contraindications

Known hypersensitivity to xylometazoline.

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.

Use in people with phaeochromocytoma, prostatic hypertrophy or those receiving monoamine oxidase inhibitors (MAOI) treatment or who have received them in the last two weeks.

4.4 Special warnings and precautions for use

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.

Information concerning excipients

Otrivine contains benzalkonium chloride. This may cause irritation of the nasal mucosa.

4.5 Interaction with other medicinal products and other forms of interaction

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).

4.6 Fertility, pregnancy and lactation

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.

4.7 Effects on ability to drive and use machines

Otrivine has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable effects

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

Common

Common

Gastrointestinal disorders

Nausea

Common

General disorders and administration site

Application site burning

Common

Other side effects include:

• A burning sensation in the nose and throat

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 the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store.

4.9 Overdose

Symptoms and Signs

Excessive administration of topical xylometazoline hydrochloride or accidental ingestion 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.

Treatment

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 would include observation of the individual for several hours.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Otrivine Adult Measured Dose Sinusitis 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. This enables patients suffering from colds to breathe more easily through the nose. The effect of Otrivine Adult Measured Dose Sinusitis Spray begins within a few minutes and lasts for up to 10 hours. Otrivine Adult Measured Dose Sinusitis Spray is generally well tolerated and does not impair the function of ciliated epithelium.

In a double-blind, saline solution (Otrisal) controlled study in patients with common cold, the decongestant effect of Otrivine was significantly superior (p<0.0001) to Otrisal saline solution based on rhinomanometry measurement at 1 hour after administration of the study drugs.

5.2 Pharmacokinetic properties

Systemic absorption may occur following nasal application of xylometazoline hydrochloride solutions. It is not used systemically.

5.3 Preclinical safety data

Not applicable.

6. Pharmaceutical particulars
6.1 List of excipients

Benzalkonium chloride

Disodium phosphate dodecahydrate (Sodium phosphate)

Disodium edetate

Sodium dihydrogen phosphate dihydrate (Sodium acid phosphate)

Sodium chloride

Sorbitol

Hypromellose

Purified water

6.2 Incompatibilities

None

6.3 Shelf life

36 months

After first opening, the nasal spray can be used until the end of the shelf-life.

6.4 Special precautions for storage

No special precautions.

6.5 Nature and contents of container

High density polyethylene bottle with a polypropylene/polyethylene metered dose pump (materials in contact with the solution: low density polyethylene, high density polyethylene, polyethylene/butyl, stainless steel) and a polypropylene nozzle with a protective cap in a cardboard carton.

Pack size 10 ml.

6.6 Special precautions for disposal and other handling

Medicines should be kept out of the reach of children.

7. Marketing authorisation holder

GlaxoSmithKline Consumer Healthcare (UK) Trading Limited,

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

8. Marketing authorisation number(s)

PL 44673/0184

9. Date of first authorisation/renewal of the authorisation

1st October 1997/19TH August 2010

10. Date of revision of the text

1st December 2020

Company Contact Details
GlaxoSmithKline Consumer Healthcare
Address

980 Great West Road, Brentford, Middlesex, TW8 9GS

Medical Information e-mail
Medical Information Direct Line

0800 783 8881

Customer Care direct line

0800 783 8881