Rinol for children nasal spray 0.5mg/ml 10ml №1

NAME Rinol. PHARMACOTHERAPEUTIC GROUP Decongestants and other topical agents. Sympathomimetics. ATX code: R01AA07. RELEASE FORM Nasal spray 0.5 mg/ml. DESCRIPTION A clear, colorless to yellowish solution, odorless. COMPOSITION 1 ml contains: Active ingredient: xylometazoline hydrochloride 0.5 mg. Excipients: benzalkonium chloride, sodium dihydrophosphate dihydrate, disodium phosphate dodecahydrate, disodium edetate, sodium chloride, purified water, concentrated hydrochloric acid. PHARMACOLOGICAL PROPERTIESPharmacodynamics. Xylometazoline is a sympathomimetic agent that acts on alpha-adrenergic receptors in the nasal mucosa. When applied to the nose, it causes constriction of the blood vessels of the nasal mucosa, thus eliminating swelling of the nasal mucosa and nasopharynx. Facilitates nasal breathing. The action comes in a few minutes and lasts for 10 hours. The drug Rinol for children does not violate the function of the ciliated epithelium. Pharmacokinetics. When applied topically, plasma concentrations of xylometazoline are low and close to the detection limit. INDICATIONS FOR USE Rhinitis of various origins. To facilitate the outflow of secretion in case of inflammation of the paranasal sinuses. As an adjuvant therapy for otitis media (to reduce swelling of the nasopharyngeal mucosa). To facilitate rhinoscopy. CONTRAINDICATIONS Hypersensitivity to xylometazoline and other components of the drug, angle-closure glaucoma, dry rhinitis, atrophic rhinitis, transsphenoidal removal of the pituitary gland (or transnasal or transoral surgical interventions with exposure of the dura mater). Children under 2 years of age. METHOD OF APPLICATION AND DOSES Children aged 2 to 11 years: use under adult supervision. 1 injection in each nasal passage 1-2 times a day. Do not use more than 3 times a day. Children under 1 year of age: The medicinal product should not be used. It is recommended that the last application be carried out immediately before bedtime. Rinol for children should not be used for more than 1 week, as long-term use can lead to drug-induced rhinitis. Before use, clean the nasal passages. Recommendations for the use of nasal spray. Before use, thoroughly clean the nasal passages. Remove the protective cap. Before the first use, press the sprayer several times until the spray begins to spray. With subsequent use, the spray will already be ready for use. If, after repeatedly pressing the sprayer, the spray does not come out completely, for example, after a temporary cessation of the use of the spray, press the sprayer again 4 times. Place the tip in the nasal passage, sharply press the sprayer 1 time, and at the same time inhale shallowly – this will ensure optimal distribution of the spray in the nasal cavity. After use, the protective cap must be put back on. To avoid transmission of infection, the spray should only be used by one patient. PRECAUTIONS AND SPECIAL INSTRUCTIONS Rinol for children should be used with caution in patients with: high blood pressure, cardiovascular disease; with hyperthyroidism, diabetes mellitus, pheochromocytoma; with prostatic hypertrophy; receiving or receiving treatment with monoamine oxidase inhibitors within the last 14 days (see section “Interaction with other medicinal products and other forms of interaction”); with hypersensitivity to sympathomimetics, which is manifested by symptoms such as insomnia, dizziness, etc. It is not recommended to use Rinol for children continuously for more than 1 week, as well as other topical vasoconstrictors, since it is possible to develop drug-induced rhinitis with swelling of the nasal mucosa, the symptoms of which are similar to a runny nose. Patients with long QT syndrome receiving xylometazoline may be at an increased risk of developing serious ventricular arrhythmias. Benzalkonium chloride, which is part of the drug, can cause irritation and swelling of the nasal mucosa, especially with prolonged use. Do not exceed recommended doses. Rinol for children should not be used in children under 1 year of age. INTERACTION WITH OTHER DRUGS AND OTHER INTERACTIONS Monoamine oxidase inhibitors. Xylometazoline can enhance the effect of monoamine oxidase inhibitors and cause a hypertensive crisis. Xylometazoline is not recommended for patients receiving or receiving treatment with monoamine oxidase inhibitors in the past 14 days (see “Precautions and special instructions”). Tri- or tetracyclic antidepressants. Simultaneous use of tri- or tetracyclic antidepressants with sympathomimetic agents is not recommended, as it may increase the sympathomimetic effect of xylometazoline. PREGNANCY AND LACTATION Pregnancy. Due to the vasoconstrictive properties of Rinol for children, it should not be used during pregnancy. Breast-feeding. It is not known whether xylometazoline passes into breast milk. The use of the drug Rinol for children during breastfeeding is possible only on prescription. Fertility. Relevant data on the effect of the drug Rinol for children on fertility are not available. There are no controlled animal studies. Since the systemic exposure of xylometazoline is very low, the likelihood of an effect on fertility is extremely small. SIDE EFFECTS Undesirable reactions are listed below by systems and organs, frequency of occurrence. The frequency of occurrence is defined as: very often (≥ 1/10), often (≥ 1/100 and <1/10), infrequently (≥ 1/1000 and <1/100), rare (≥ 1/10,000 and <1 / 1000), very rarely (<1/10 000), the frequency is unknown (cannot be estimated from the available data). Within each group, adverse events are presented in decreasing order of severity. From the immune system: very rarely - hypersensitivity reactions (rash, itching, angioedema). From the nervous system: often - headache. On the part of the organs of vision: very rarely - temporary visual impairment. From the side of the cardiovascular system: very rarely - irregular or increased heart rate, hypertension, arrhythmia. On the part of the respiratory system Often - dryness, discomfort, burning of the nasal mucosa, drug-induced rhinitis. From the gastrointestinal tract: often - nausea General disorders: often - burning at the site of application. Reporting Suspected Adverse Reactions If you experience any adverse reactions, it is recommended that you consult your doctor. This recommendation applies to any possible adverse reactions, including those not listed in the instructions for use of the drug. You can also report adverse reactions to the adverse drug reactions (actions) information database, including reports of drug failures. By reporting adverse reactions, you help to get more information about the safety of the drug. OVERDOSE Excessive topical use of xylometazoline or accidental ingestion may cause sympatholytic effects, including CNS depression (eg, drowsiness, coma), hypertension or hypotension, tachycardia, and bradycardia. Gastrointestinal symptoms such as nausea and vomiting may also occur. Other symptoms are pallor, excessive sweating, hypothermia, pupillary constriction, respiratory depression, ataxia, and anxiety. No severe symptoms have been observed following accidental overuse. In one newborn (age 2 weeks), the use of 1 drop of a 0.1% solution in each nasal passage resulted in coma. In young children, the use of the drug up to 0.5 mg / kg of body weight did not cause clinically relevant symptoms. Due to the lack of data on the use of more than 0.5 mg / kg body weight, severe symptoms cannot be excluded. In such cases, medical supervision after consultation with an experienced clinician or poison information center and administration of a single dose of activated charcoal are indicated. There is no specific antidote. Bradycardia can be treated with atropine. STORAGE CONDITIONS At a temperature not higher than 25 ˚С. Keep out of the reach of children. EXPIRY DATE 2 years. Do not use the medicinal product after the expiration date. HOLIDAY CONDITIONSWithout a doctor's prescription. PACKAGING 10 ml or 15 ml of the drug in a bottle with a sprayer and a protective cap. One bottle, together with instructions for medical use, is placed in a cardboard box. MANUFACTURERBelarusian-Dutch joint venture limited liability company "Pharmland", Republic of Belarus, Minsk region, Nesvizh, st. Leninskaya, 124, building 3, tel. 8(017) 373-31-90. Buy Rinol for children nasal spray 0.5mg/ml 10ml №1 Price for Rinol for children nasal spray 0.5mg/ml 10ml /ml 10ml №1