Multingrip nasal
Ukraine
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INSTRUCTION for medical use of the medicinal product MULTIGRIP NASAL ( MULTIGRIP® NASAL) Composition: active ingredient: xylometazoline hydrochloride; 1 ml of solution contains xylometazoline hydrochloride 0.5 mg or 1 mg; excipients: benzalkonium chloride; potassium dihydrogen phosphate; sodium hydrogen phosphate, dodecahydrate; sorbitol (E 420); disodium edetate; sodium chloride; purified water. Pharmaceutical form. Nasal drops, solution. Main physicochemical properties: clear, colourless, odourless liquid. Pharmacotherapeutic group. Preparations used in nasal disorders. Simple sympathomimetics. ATC code: R01A A07. Pharmacological properties. Pharmacodynamics. Xylometazoline is a sympathomimetic agent (an imidazole derivative) acting on α-adrenergic receptors of the nasal mucosa. After nasal administration, xylometazoline causes vasoconstriction, thereby reducing swelling of the nasal and nasopharyngeal mucosa. The effect of the drug begins within 2 minutes after application and lasts up to 12 hours. The drug is well tolerated, including by patients with sensitive mucosa. The drug does not impair mucociliary function. Laboratory test results have shown that xylometazoline reduces the infective activity of human rhinovirus associated with the common cold. Pharmacokinetics. After nasal administration, the amount of absorbed substance may sometimes be sufficient to produce systemic effects, for example, on the central nervous and cardiovascular systems. No metabolites or excretion pathways have been identified. Clinical characteristics. Indications.
Contraindications.
Multigrip Nasal , nasal drops, 0.05% solution :
Multigrip Nasal , nasal drops, 0.1% solution :
Special precautions . As with other sympathomimetics, xylometazoline should be used with caution in patients who experience strong reactions such as insomnia, dizziness, tremor, cardiac arrhythmias, or high blood pressure when using adrenergic agents. Repeated use of xylometazoline may lead to tachyphylaxis and drug-induced rhinitis. Repeated and/or prolonged instillations may lead to systemic absorption of xylometazoline in amounts sufficient to cause systemic adverse reactions. Xylometazoline should be used with caution in patients with cardiovascular disorders, arterial hypertension, phaeochromocytoma, metabolic disorders (e.g. hyperthyroidism, diabetes mellitus), prostate hyperplasia, history of stroke or presence of risk factors for stroke (use of vasoconstrictive agents, history of seizures, urinary retention due to urethral or prostatic disorders caused by direct action of sympathomimetic agents). Decongestant sympathomimetics may cause reactive hyperaemia of the nasal mucosa, especially after prolonged treatment or use of high doses. Repeated or chronic use of this drug may lead to rebound congestion and narrowing of the upper airways. This may manifest as chronic hyperaemia of the nasal mucosa (which may later lead to atrophic rhinitis). In moderate cases, administration of the drug into one nostril may be paused or, alternatively, not administered into both nostrils until symptoms subside, in order to partially preserve nasal patency. Prolonged treatment with xylometazoline may cause drug-induced rhinitis and swelling of the nasal mucosa with symptoms similar to those of a cold. The medicinal product contains benzalkonium chloride, which is an irritant and may cause undesirable skin reactions. The medicinal product contains sorbitol. Patients with rare hereditary fructose intolerance should not use this product. Patients with QT interval prolongation syndrome who receive xylometazoline may be at increased risk of serious ventricular arrhythmias. Interaction with other medicinal products and other forms of interaction. Monoamine oxidase inhibitors (MAOIs). Xylometazoline may potentiate the effect of monoamine oxidase inhibitors and induce a hypertensive crisis. Xylometazoline is not recommended for patients taking or who have taken MAOIs within the last two weeks. Tricyclic and tetracyclic antidepressants. Concomitant use of tricyclic or tetracyclic antidepressants and sympathomimetic agents may enhance the sympathomimetic effect of xylometazoline; therefore, concomitant use is not recommended. Xylometazoline may affect the action of certain antihypertensive agents, such as β-blockers. Special instructions for use. The bottle should be used by only one person to avoid spreading pathogenic microorganisms via the dropper. Use during pregnancy or breastfeeding. The medicinal product should not be used during pregnancy due to its potential vasoconstrictive effect. Evidence of adverse effects on the infant is lacking. It is unknown whether xylometazoline is excreted in breast milk; therefore, caution is required, and Multigrip Nasal should be used during breastfeeding only on medical advice. Fertility. Adequate data on the effect of Multigrip Nasal on fertility are lacking. Since systemic exposure to xylometazoline hydrochloride is very low, the likelihood of an effect on fertility is extremely small. Ability to influence reaction rate when driving or operating machinery. Xylometazoline has a minor influence on the ability to drive or operate machinery, as there is a risk of adverse effects that may affect psychomotor reaction speed. Method of administration and dosage. Multigrip Nasal , nasal drops, 0.05% solution. Children aged 2 to 12 years. The recommended dose is 1-2 drops 1-2 times daily into each nostril. Multigrip Nasal , nasal drops, 0.1% solution. Adults and children aged 12 years and older. The recommended dose is 2-3 drops 2-3 times daily into each nostril. Do not use in doses exceeding the recommended doses. Duration of use. The product should not be used for longer than 5 consecutive days unless otherwise advised by a physician. Children. Use in children aged 2 to 12 years should be supervised by an adult. Multigrip Nasal , nasal drops, 0.05% solution. For treatment of children aged 2 to 12 years. Contraindicated in children under 2 years of age. Multigrip Nasal , nasal drops, 0.1% solution. For treatment of children aged 12 years and older. Contraindicated in children under 12 years of age. Overdose. Excessive local use of xylometazoline hydrochloride or accidental ingestion may lead to sympatholytic effects, including central nervous system depression (e.g. drowsiness, coma), pronounced dizziness, excessive sweating, significant decrease in body temperature, pallor, headache, tachycardia, bradycardia, arterial hypertension, respiratory depression, miosis, seizures, ataxia, restlessness. Elevated blood pressure may be followed by hypotension. Gastrointestinal symptoms such as nausea and vomiting may also occur. Younger children are more sensitive to toxicity than adults. Severe symptoms after accidental use have not been observed, but in newborns (2 weeks old), administration of 1 drop of 0.1% solution into each nostril may lead to coma. All patients suspected of overdose should receive appropriate supportive measures and, if necessary, immediate symptomatic treatment under medical supervision. Medical care should include monitoring of the patient for several hours. There is no specific antidote; atropine may be used in case of bradycardia. In cases of severe overdose with cardiac arrest, resuscitation measures should continue for at least 1 hour. Adverse reactions. Immune system disorders: very rare (<1/10,000): hypersensitivity reactions, including angioedema, rash, pruritus. Nervous system disorders: frequently (≥1/100 - <1/10): headache. Eye disorders: very rare (<1/10,000): transient visual disturbances. Cardiac disorders: very rare (<1/10,000): irregular or rapid heartbeat, hypertension, arrhythmia. Respiratory, thoracic and mediastinal disorders: frequently (≥1/100 - <1/10): dryness or discomfort of the nasal mucosa, burning sensation, drug-induced rhinitis. uncommon (≥1/1,000 - <1/100): epistaxis. Gastrointestinal disorders: frequently (≥1/100 - <1/10): nausea. General disorders and administration site conditions: frequently (≥1/100 - <1/10): burning sensation at site of application. Reporting suspected adverse reactions Reporting of suspected adverse reactions after marketing authorization is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are obliged to report any suspected adverse reactions through the national reporting system. Shelf life. 3 years. Use within 30 days after first opening of the bottle. Storage conditions. Store in the original packaging, protected from light, at a temperature not exceeding 25 °C. Keep out of reach of children. Packaging. 10 ml of solution in 15 ml white polyethylene bottles with nasal applicator, closed with a polypropylene cap, №1 in a cardboard box. Prescription status. Over-the-counter. Manufacturer. Biofarma S.A., Romania Manufacturer's address and location of its operations . Str. Logofătul Teutu no. 99, sector 3, postal code 031212, Bucharest, Romania |