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Otrepin-Arpi, nasal spray

Drug form: Liquid (for external use)

ATC category: Decongestants and other nasal preparations for topical use, sympathomimetics, plain

					
1.1. TRADE NAME – Otrepin-Arpi 1.2. INTERNATIONAL NON-PROPERTY NAME - Xylometazoline 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml of Otrepin-Arpi, spray nasal, metered-dose 0.1% contains: Active ingredient:Xylometazoline hydrochloride – 1 mg; For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Spray nasal, metered-dose. Clear solution, with menthol and eucalyptol (cineole) odour. 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 Posology Paediatric population Otrepin-Arpi should not be used in children aged less than 12 years old. Method of administration

Strength

Age Posology

0.1%

Adults and adolescents over 2 years of age

1 spray into each nostril, 1 to 3 times daily as needed. Do not exceed 3 applications daily into each nostril.

The metered-dose spray permits accuracy of dosage and ensures that the solution is well distributed over the surface of the nasal mucosa. It precludes the possibility of unintentional overdose. 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, the pump will need to be reprimed with the same number of actuations as initially performed. Be careful not to spray in the eyes. 1. Blow the nose gently. 2. Remove protective cap. 3. Do not cut the nozzle. The metered-dose spray is ready to prime before use. 4. Hold the bottle upright with thumb under base and nozzle between two fingers. 5. Lean forward slightly and insert the nozzle into a nostril. 6. Spray and breathe in gently through the nose at the same time. 7. Repeat in the other nostril. 8. Clean and dry the nozzle before replacing back the cap right after use. To avoid possible spread of infection, the spray should only be used by one person. 4.3. Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Like other vasoconstrictors, xylometazoline should not be used in patients with trans-sphenoidal hypophysectomy or surgery exposing the dura mater. 4.4. Special warnings and precautions for use Xylometazoline, 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. Otrepin-Arpi should not be used for more than seven consecutive days. Caution is recommended in patients with hypertension, cardiovascular disease, hyperthyroidism, narrow angle glaucoma or diabetes mellitus. Precautions Additional leaflet warnings and precautions • Do not use if you are sensitive to any of the ingredients of Otrepin-Arpi • Do not use if you have had recent neurosurgery • Consult your doctor before using Otrepin-Arpi if you have heart or circulatory disease • Other side effects such as palpitations, nausea and headache are very rare Information concerning excipients This medicine macrogol glycerol hydroxystearate (2.50 mg/ml) which may cause skin reactions. This medicine contains benzalkonium chloride (0.05 mg/ml) which irritant and may cause skin reactions. 4.5. Interaction with other medicinal products and other forms of interaction Like for all sympathomimetics, a reinforcement of the systemic effects of xylometazoline by concomitant use of monoamine oxidase inhibitors, tricyclic or tetracyclic antidepressants, cannot be excluded, especially in case of overdose. 4.6. Fertility, pregnancy and lactation Pregnancy 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 Otrepin-Arpi during pregnancy. Breastfeeding 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 Otrepin-Arpi should be used only on the advice of a doctor whilst breastfeeding. 4.7. Effects on ability to drive and use machines Xylometazoline has no or negligible influence on the ability to drive and use machines. 4.8. Undesirable effects Systemic cardiovascular effects have occurred, and this should be kept in mind when giving this product to people with cardiovascular disease. 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) or very rare (<1/10,000). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Adverse reactions
System Organ Class Frequency Undesirable Effect
Immune system disorders Very rare Hypersensitivity reaction (angioedema, rash, pruritus)
Nervous system disorders Common Headache
Eye disorders Very rare Transient visual impairment
Cardiac Disorders Very rare Heart rate irregular and heart rate increased
Respiratory, thoracic and mediastinal disorders Common Nasal dryness or discomfort, burning sensation
Gastrointestinal disorders Common Nausea
General disorders and administration site conditions Common Application site burning
4.9. Overdose In rare instances of accidental poisoning in children, the clinical picture has been marked chiefly by signs such as acceleration and irregularity of the pulse, elevated blood pressure and sometimes clouding of consciousness. There is no specific treatment. Appropriate supportive measures should be initiated and symptomatic treatment under medical supervision is indicated.
  1. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties 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 Otrepin-Arpi 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 xylometazoline was significantly superior (p<0.0001) to saline solution based on rhinomanometry measurement. Relief of blocked nose developed twice as fast in the xylometazoline group compared to saline solution as of 5 minutes post treatment (p= 0.047). Xylometazoline is well tolerated, even by patients with a sensitive mucosa, and does not impair the mucociliary function. 5.2 Pharmacokinetic properties Plasma concentrations of xylometazoline in man after local nasal application of the product are very low and close to the limit of detection. 5.3 Preclinical safety data Xylometazoline has no mutagenic effect. No teratogenic effects were shown in a study where xylometazoline was given subcutaneously in mice and rats. 6. PHARMACEUTICAL PARTICULARS 6.1. List of excipients Sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dodecahydrate, benzalkonium chloride as 50% water solution, macrogol glycerol hydroxystearate, sodium chloride, disodium edetate, cineol (eucalyptol), levomenthol, sorbitol, purified water. 6.2. Incompatibilities Not applicable. 6.3. Shelf life 2.5 years. Do not use the medicine for more than 28 days after opening. 6.4 Special precautions for storage Store at a temperature not higher than 250C, in the original package, out of the reach of children. 6.5 Nature and contents of container 15 ml solution in plastic bottle with a metered-dose pump, plastic nozzle with cap. 1 bottle with insert-leaflet in cardboard box. 6.6 Special precautions for disposal and other handling No special requirements.