Otrivine Congestion Relief 0.1% Nasal Spray with Khone Spray

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

By intranasal administration using nasal spray.

Adults and children 12 years and above: 1 spray into each nostril 1-3 times a day as required, for a maximum of 5 days. Maximum daily use: no more than 3 doses should be given in any 24 hours.

Otrivine Congestion Relief 0.1% Nasal Spray should not be used in children aged less than 12 years old.

Laterally actuated pump (Khone): The laterally actuated metered-dose spray ensures that the solution is well distributed over the surface of the nasal mucosa by spraying a fine mist.

Before using for the first time, prime the pump by actuating 5 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 re-primed with 2 actuations.

Vertically actuated pump (Freepod): 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.

If the full spray is not administered, the dose should not be repeated.

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

Leave at least 8 hours between doses, unless otherwise advised by your doctor or healthcare professional.

Do not exceed the recommended dose. Do not use for more than 5 consecutive days.

Continuous use of the product for more than 5 days can lead to an increased risk of side effects (see section 4.4).

Medical advice should be sought if symptoms of nasal congestion persist or worsen or do not improve after 5 days as alternative treatment may be required.

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Do not take with other sympathomimetic decongestants.

Like other vasoconstrictors, Otrivine Congestion Relief 0.1% Nasal Spray should not be used in patients with trans-sphenoidal hypophysectomy or surgery exposing the dura mater, Narrow-angle glaucoma, rhinitis sicca or atrophic rhinitis.

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

Otrivine 0.1% is contraindicated in children aged less than 12 years.

This medicine is intended for short-term use only. Repeated and/or prolonged administration can cause appreciable systemic exposure to the active substances and increase the risk of side effects.

Tachyphylaxis – a rapidly diminishing response to the drug after a few doses. Using more of this product and/or using it for longer than recommended may also lead to reduced effect of a dose (due to repetitive drug exposure) and rebound congestion (see 4.8).

Prolonged or excessive use may result in reactive hyperaemia, chronic swelling of the nasal mucosa known as rhinitis medicamentosa, and atrophy of the nasal mucosa. Increasing the dose and/or frequency of xylometazoline nasal spray at onset of rebound congestion and/or rhinitis medicamentosa, will worsen the nasal congestion. Patients must stop treatment rather than increasing the dose or prolonging treatment. It is necessary to ensure that the treatment period does not exceed 5 days of continuous use. Alternative treatment may be required if nasal congestion persists beyond the recommended treatment period (see 4.8).

Otrivine Congestion Relief 0.1% Nasal Spray, like other sympathomimetic agents, should be used 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.

Caution is recommended in patients with hypertension, cardiovascular disease, hyperthyroidism or diabetes mellitus or tri and tetra-cyclic antidepressants (see Interactions).

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

This medicine contains polyoxyl hydrogenated castor oil (2.750 mg/ml) which may cause skin reactions.

Labelling (outer pack):

The label will state (to be displayed prominently on the front of the outer pack):

For 5 days use only.

The label will also state:

Leave at least 8 hours between doses.

For short-term use only.

Do not use for more than 5 days in a row. Do not use more medicine than the label tells you to. If your symptoms worsen or you do not feel better after 5 days, stop treatment and seek medical advice.

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 Congestion Relief 0.1% Nasal Spray 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).

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.

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.

Pharmacotherapeutic group: decongestants for topical use, sympathomimetics, plain.

ATC Code: R01A A07

Mechanism of action and pharmacodynamic effects

Xylometazoline is a sympathomimetic agent acting on alpha-adrenergic receptors in the nasal mucosa. Administered in the nose, it constricts the nasal blood vessels, thereby decongesting the mucosa of the nose and neighbouring regions of the pharynx. This decongests nasal passages and enables patients suffering from blocked nose to breathe more easily through the nose. The effect of Otrivine begins within a few minutes and lasts for up to 10 hours.

In a double-blind, saline solution controlled study in patients with common cold, the decongestant effect of Otrivine 0.1% nasal solution was significantly superior (p<0.0001) to saline solution based on rhinomanometry measurement. Relief of blocked nose developed twice as fast in the Otrivine group compared to saline solution as of 5 minutes post treatment (p= 0.047).

Otrivine is well tolerated, even by patients with a sensitive mucosa, and does not impair the mucociliary function.

Plasma concentrations of xylometazoline in man after local nasal application of the product are very low and close to the limit of detection.

Xylometazoline has no mutagenic effect. No teratogenic effects were shown in a study where xylometazoline was given subcutaneously in mice and rats.

Not applicable.

30 months

Do not use the bottle for more than 28 days after opening.

Do not store above 25°C.

Store in the original package.

High density polyethylene bottle with a metered dose pump (materials in contact with product: low density polyethylene, stainless steel, compound PE/butyl) polypropylene nozzle with cap.

or

High density polyethylene bottle with a laterally actuated metered dose pump (materials in contact with product: low density polyethylene/polyethylene compound, lubricant, stainless steel, polydimethyl-siloxane, PTFE/PET layer) with a polypropylene nozzle with protective cap.

Content: 10 ml.

No special requirements.

Any unused product or waste material should be disposed of in accordance with local requirements.