Name of the medical product
Otrivin Menthol (without preservative) 1.0 mg/ml nasal spray, solution
Qualitative and quantitative composition
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.
Posology and method of administration
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 . 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 duramater. Patients with rhinitis sicca or atrophic rhinitis.
Special warnings and precautions for use
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 long QT syndrome treated with xylometazoline may be at increased risk of serious ventricular arrhythmias
- 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
Otrivin 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.
Pregnancy and lactation
In view of its potential systemic vasoconstrictor effect it is advisable to take the precaution of not using Otrivn Menthol during pregnancy.
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.
There are no adequate data for the effects of Otrivin on fertility and no animal studies areavailable. As the systemic exposure to xylometazoline hydrochloride is very low, effects on fertility are therefore very unlikely.
Effects on ability to drive and use machines
Adverse reactions are listed below, by system organ class and frequency. Frequencies aredefined 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 estimatedfrom 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
Not known: Visual impairment
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
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.
2.5 mg per os in two- to three-year-old 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.
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.
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, activated charcoal. Monitor respiration and circulation. Oxygen, respirator where necessary. In case of seizure appropriate anticonvulsant therapy such as diazepam.
List of excipients
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.
Special precautions for storage
Do not store above 25° C.