Product Description Rinol. Release formSpray. Pharmacotherapeutic group Decongestants and other topical agents. Sympathomimetics. ATX code: R01AA07. DescriptionClear, colorless to yellowish solution, odorless. Composition 1 ml contains: Active ingredient: xylometazoline hydrochloride 1 mg. Excipients: benzalkonium chloride, sodium dihydrophosphate dihydrate, disodium phosphate dodecahydrate, disodium edetate, sodium chloride, purified water, concentrated hydrochloric acid. Pharmacological properties Pharmacodynamics Xylometazoline belongs to the group of local vasoconstrictors (decongestants) with α-adrenomimetic action: it causes constriction of the blood vessels of the nasal mucosa, eliminating swelling and hyperemia of the nasal mucosa and nasopharynx. Facilitates nasal breathing in rhinitis. Rinol is well tolerated by patients even with sensitive mucous membranes. Rinol has a balanced pH characteristic of the nasal cavity. In therapeutic concentrations, Rinol does not irritate the mucous membrane, does not cause hyperemia. The action comes in a few minutes and lasts for 12 hours. Pharmacokinetics When applied topically, xylometazoline is practically not absorbed, its plasma concentrations are so low that they cannot be determined by modern analytical methods. Indications for use Acute respiratory diseases with symptoms of rhinitis (runny nose), allergic rhinitis, hay fever, sinusitis, otitis media (to reduce swelling of the nasopharyngeal mucosa). Preparation of the patient for diagnostic manipulations in the nasal passages. Contraindications Hypersensitivity to xylometazoline and other components of the drug, angle-closure glaucoma, dry rhinitis or atrophic rhinitis, condition after transsphenoidal hypophysectomy, surgical interventions on the meninges (in history). Dosage and administrationFor adults and children over 12 years of age. 1 spray in each nasal passage 3 times a day. The interval between doses should be 8-10 hours. Should not be used more than 3 times a day. Before use, clean the nasal passages. Precautions and special instructions Avoid contact with eyes! Do not use continuously for more than 7 days; prolonged or excessive use may cause increased secretion of mucus and swelling of the mucous membrane (drug rhinitis). Do not exceed recommended doses, especially in children and elderly patients. It should be used with caution in patients with hypersensitivity to sympathomimetics, which is manifested by symptoms such as insomnia, dizziness, tremor, cardiac arrhythmia and high blood pressure. It should be used with caution in patients with hypertension, cardiovascular disease, hyperthyroidism, diabetes mellitus, pheochromocytoma, prostatic hyperplasia, angle-closure glaucoma, and those taking monoamine oxidase inhibitors or who have taken them within 14 days prior to the start of Rinol’s use. Interaction with other medicinal products and other forms of interaction The systemic effect of xylometazoline may be enhanced when used simultaneously with monoamine oxidase inhibitors and tri- or tetracyclic antidepressants, especially in case of an overdose of xylometazoline. It is not recommended to use the drug in patients receiving monoamine oxidase inhibitors or receiving them within 2 weeks prior to the start of the use of Rinol. Pregnancy and lactationIn connection with the possible manifestation of a systemic vasoconstrictor effect, it is not recommended to take Rinol during pregnancy. Since it is not known whether xylometazoline passes into breast milk, it is not recommended to take Rinol during breastfeeding. Influence on the ability to drive vehicles and control mechanisms Xylometazoline in doses exceeding the recommended ones may affect the ability to drive a vehicle or equipment, since systemic vasoconstriction may develop. Side effect 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). From the respiratory system: often - slight short-term irritation at the site of application, burning or dryness of the nasal mucosa, drug-induced rhinitis. From the nervous system: often - headache. On the part of the gastrointestinal tract: often - nausea On the part of the organs of vision: very rarely - temporary visual impairment On the part of the cardiovascular system: very rarely - cardiac arrhythmia, increased heart rate, hypertension. From the immune system: very rarely - allergic reactions (rash, itching, angioedema). General disorders and disorders at the injection site: often - a burning sensation at the application site. Reporting Suspected Adverse Reactions It is important to report suspected adverse reactions after registration of a medicinal product in order to ensure continuous monitoring of the risk-benefit ratio of the medicinal product. Healthcare professionals are encouraged to report any suspected adverse reactions through national adverse drug reaction and drug failure reporting systems. OverdoseSymptoms: Excessive use of xylometazoline or accidental ingestion may cause the following symptoms: severe dizziness, perspiration, severe decrease in body temperature, headache, bradycardia, hypertension, respiratory depression, coma and convulsions. Hypotension may be followed by hypertension accompanied by nausea and vomiting. Young children are more sensitive to toxic effects than adults. Treatment: symptomatic treatment under medical supervision is required. This will require observation of the patient for several hours. In case of severe overdose with cardiac arrest, resuscitation should be continued for at least an hour. Storage conditions At a temperature not higher than 25 °C. Keep out of the reach of children. Shelf life 2 years. Do not use the medicinal product after the expiration date. Holiday conditions Without a doctor's prescription. Upakovka10 ml or 15 ml of the drug in a bottle with a sprayer. One bottle, together with instructions for medical use, is placed in a cardboard box. ProducerBelarusian-Dutch joint venture limited liability company "Pharmland", Republic of Belarus, Minsk region, Nesvizh, st. Leninskaya, 124-3, tel. 8(017) 293-31-90. Buy Rinol nasal spray 1mg/ml 10ml №1 Price for Rinol nasal spray 1mg/ml 10ml №1Instruction for use for Rinol nasal spray 1mg/ml 10ml №1
INN | XYLOMETAZOLINE |
---|---|
The code | 139 082 |
Barcode | 4 810 368 013 354 |
Dosage | 1mg/ml 10ml |
Active substance | Xylometazoline |
Manufacturer | Pharmland SP LLC, Belarus |
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