OTRIVINE ADULT NASAL SPRAY - summary of medicine characteristics

Summary of medicine characteristics - OTRIVINE ADULT NASAL SPRAY

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Otrivine Adult Nasal Spray

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Xylometazoline Hydrochloride 0.1% w/v

For excipients, see section 6.1

PHARMACEUTICAL FORM

Nasal spray, solution

The spray is a clear, colourless solution.

CLINICAL PARTICULARS

4.1 Therapeutic indications

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

4.2 Posology and method of administration

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

Adults, children over 12 years One application in each nostril up to 3 times daily. Do not exceed 3 applications daily into each nostril.

Route of administration: Nasal use.

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

4.3 Contraindications

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.

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 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:

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 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. This enables patients suffering from colds 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.

In a double-blind, saline solution (Otrisal) controlled study in patients with common cold, the

decongestant effect of Otrivin 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

There are no findings in the preclinical testing which are of relevance to the prescriber.

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

Purified water

6.2 Incompatibilities

None.

6.3 Shelf life

Unopened: 24 months

After the container is opened for the first time: 28 days

6.4 Special precautions for storage

Do not store above 25°C

6.5 Nature and contents of container

Bottle: Low density polyethylene

Cap: High density polyethylene

Spray valve and capillary: Low density polyethylene

Carton: Cardboard

Pack size: 10 ml

6.6 Special precautions for disposal

Keep all medicines out of the reach of children