Document: Otrivin Menthol nasal spray, solution ENG SmPC change

• Otrivin Menthol nasal spray, solution SmPC
• Otrivin Menthol nasal spray, solution ENG SmPC

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Summary of product characteristics

Otrivin Menthol (without preservative) 1.0 mg/ml nasal spray, solution

1 ml contains 1.0 mg xylometazoline hydrochloride.

For the full list of excipients, see 6.1.

Nasal spray, solution.

Rhinitis. For decongestion in sinusitis and for facilitating rhinoscopy.

Adults and children above twelve years of age: One application in each nostril as required 2-3 times daily for a maximum of ten days.

Before the first application, prime the pump by actuating 4 times. Once primed the pump will normally remain charged throughout regular daily treatment periods. Should the spray not be ejected during the full actuation stroke or if the product has not been used for longer than 6 days, the pump will need to be reprimed with 4 actuations as initially performed.

Each metered-dose spray delivers 0.14 ml per actuation (0.14 mg of xylometazoline hydrochloride).

Otrivin Menthol is not recommended for use in children below 12 years of age due to insufficient data on safety (see section 4.4). It is recommended to make the last application shortly before retiring to bed.

Hypersensitivity to xylometazoline hydrochloride or to menthol or any of the other excipients. Narrow angle glaucoma.After transsphenoidal hypophysectomy or surgery exposing the dura mater.Patients with rhinitis sicca or atrophic rhinitis.

Otrivin Menthol is to be used with care in patients who are sensitive to adrenergic substances which can cause symptoms such as sleep disturbances, dizziness, tremor, cardiac arrhythmias or elevated blood pressure.

Otrivin should be used with caution in:

• patients with hypertension, cardiovascular disease

• patients with hyperthyroidism, diabetes mellitus, phaeochromocytoma

• patients with prostatic hypertrophy

• patients treated with monoamine oxidase inhibitors (MAOI) or who have received them in the last two weeks (see section 4.5)

Otrivin Menthol should be used for a maximum of ten successive days in order to avoid a rebound effect in form of nasal congestion and drug-induced rhinitis, which may lead to physical drug dependence and/or atrophy of the nasal mucosa.

Instillation of decongestant preparations containing menthol directly into the nostrils of infants and young children must be avoided, as it has resulted in acute respiratory distress with cyanosis and respiration arrest.Do not exceed the recommended dose, especially in children and in the elderly.

Otrivin Menthol should not be used in children aged less than 12 years.

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 4.4).

Tricyclic or tetracyclic 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.

Pregnancy

In view of its potential systemic vasoconstrictor effect it is advisable to take the precaution of not using Otrivn Menthol during pregnancy.

Lactation

It is not known if xylometazoline is excreted in breast milk, therefore caution should be exercised and Otrivin Menthol should be used only under medical advice while breast-feeding.

Fertility

There are no adequate data for the effects of Otrivin 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.

Not applicable.

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), very rare (<1/10,000) or not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Immune system disorders:

Not known:Hypersensitivity reaction (angioedema, rash, pruritus)

Nervous system disorders

Common: Headache

Eye disorders

Not known: Visual impairment

Cardiac Disorders

Not known: Heart rate irregular and heart rate increased

Respiratory, thoracic and mediastinal disorders

Common: Nasal dryness or nasal discomfort, burning sensation

Very rare: Rebound congestion

Gastrointestinal disorders

Common: Nausea

Investigations

Not known: Increased blood pressure

Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorization 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 national reporting system.

Toxicity: 2.5 mg per os in two- to three-year-olds caused mild intoxication. Eight drops 0.1% solution nasally in a nine-month-old infant caused mild intoxication. Three times the adult dose nasally in a one-month-old infant caused moderate to severe intoxication.

Symptoms:Excessive administration of topical xylometazoline hydrochloride or accidental ingestion may cause severe dizziness, perspiration, headache, respiratory depression, coma, seizures, hypothermia, hypertension, peripheral vasoconstriction, cold extremities, bradycardia, mydriasis, bronchospasm and convulsions. Hypertension may be followed by hypotension. Small children are more sensitive to toxicity than adults.

Treatment:Appropriate supportive measures should be initiated under medical supervision in all individuals suspected of an overdose. This would include observation of the individual for several hours. Where necessary, gastric lavage at an early stage, activated charcoal. Monitor respiration and circulation. Oxygen, respirator where necessary. In case of seizure appropriate anticonvulsant therapy such as diazepam.

In the event of a severe overdose with cardiac arrest, resuscitation should be continued for at least 1 hour.

Pharmacotherapeutic group: Decongestant nasal spray. ATC code: R01AA07.

Xylometazoline is a sympathomimetic which acts on the α-adrenergic receptors. It has a vasoconstrictive effect and thus acts as decongestant and facilitates drainage of secretions. Xylometazoline constricts the blood vessels in the nose and so decongests the nasal mucosa and neighboring regions of the pharynx. The effect of Otrivin Menthol begins within a few minutes and lasts for 6-8 hours.

In vitro assays have shown that xylometazoline reduces the infectious activity of three serotypes of human rhinoviruses associated with the common cold. Clinical relevance of this effect is so far unknown.

Maximum plasma concentration of xylometazoline in man after local nasal application of the product are very low (in the range of 0.1 ng/ml).

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

Menthol, cineole, disodium edetate, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, sodium chloride, sorbitol, macrogol glycerol hydroxystearate, purified water.

The contents are free from preservatives.

Not applicable.

30 months.

Do not store above 25° C.

10 ml HDPE bottle mounted with a metered-dose spray pump (materials in contact withthe solution:LDPE, HDPE, PE / butyl, stainless steel) and a PP nozzle with a protective cap.

No special instructions.

Novartis Sverige AB

Box 1150

SE-183 11 Täby

13979

20 March 1998/ 20 March 2008

2015-01-15