Galazolin gel nasal gel 1mg/g №1

Name:
Galazolin Gel gel naz. 1mg/g per vial p/e with pump., dosing and applic. with protective nozzle
Description:
Colorless or almost colorless, transparent or slightly opalescent viscous liquid. The main active substance Xylometazoline Form of release Gel nasal Dosage 1 mg / g Pharmacological action The drug Galazolin Gel contains xylometazoline hydrochloride as an active substance, which is an imidazoline derivative with a sympathomimetic effect. The drug applied to the nasal mucosa causes constriction of blood vessels, reduces swelling and hyperemia of the mucous membrane of the nasal cavity and nasopharynx, reduces the amount of secretions, thereby facilitating nasal breathing. The dosage form in the form of a gel promotes a soft and uniform distribution of the drug on the mucous membrane and prevents it from flowing to the bottom of the nasal cavity and into the pharynx. Due to this, the vasoconstrictive effect is retained for a long time and on a limited surface. The drug in the form of a gel does not actually affect the function of the ciliary apparatus of the mucous membranes of the respiratory tract, due to the absence of a sharp anemization of the epithelium. The sensation of dryness occurs less frequently compared to drops. Xylometazoline in the form of a nasal gel has a positive effect in the combined therapy of inflammatory diseases of the nasal cavities and sinuses. It promotes good penetration of the locally applied antibiotic and does not impair the function of the regional NALT immune system in the mucosa. The action of xylometazoline begins 5-10 minutes after application and lasts for 10 hours. Indications for use Symptomatic treatment: acute rhinitis of viral or bacterial origin; acute or chronic, recurrent inflammation of the paranasal sinuses; allergic rhinitis; acute inflammation of the middle ear – in order to restore the patency of the Eustachian tube; the drug can be used in preparing the patient for diagnostic procedures in the nasal passages. Route of administration and doses The drug should be used in accordance with the leaflet or in accordance with the recommendations of a doctor or pharmacist. In case of any doubt, you should consult your doctor or pharmacist. The drug Galazolin Gel is intended only for intranasal use (also for inflammation of the middle ear). The drug Galazolin Gel should not be used for more than 7 days in a row. Do not use doses higher than recommended. Galazolin Gel, 1 mg/g Galazolin Gel, 1 mg/g is intended for use in adults and adolescents over the age of 12 years. 1 dose contains 0.1 mg xylometazoline hydrochloride. Adults and adolescents over 12 years of age: One dose of gel in each nasal passage, every 8-10 hours. How to use Before each use of the drug, remove the protective cap. Before using a new bottle for the first time, after removing the nozzle, press the dispenser 3-5 times until the gel appears. The dispenser tip should be inserted into the nostril. While holding the vial in a vertical position, the dispenser should be pressed, which causes the dose of the drug to be sprayed into the nasal cavity. For hygienic reasons, only one patient should use this package of the drug. If during treatment it seems to the patient that the effect of the drug is too strong or weak, he should consult a doctor. Overdose Use during pregnancy and lactation If the patient is pregnant, breastfeeding, suspects that she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using the drug. Given the presence of xylometazoline vasoconstrictor properties, for reasons of precaution, it is recommended not to use Galazolin Gel during pregnancy. There are no data on the penetration of xylometazoline into breast milk. Caution should be exercised if Galazolin Gel is used during breastfeeding. The ability to influence the reaction rate when driving vehicles or operating other mechanisms Galazolin Gel does not affect the ability to drive vehicles and maintain mechanisms if it is used at recommended doses and for a short time. With prolonged use or use in high doses, undesirable effects on the cardiovascular system and the central nervous system may appear, you should not drive vehicles and service mechanisms until the symptoms stop. Precautions Before you start using the drug Galazolin Gel, you should consult your doctor or pharmacist. The drug Galazolin Gel, 0.5 mg / g should not be used in children under 3 years of age. The drug Galazolin Gel, 1 mg / g should not be used in children under 12 years of age. Galazolin Gel should only be administered into the nose (also for inflammation of the middle ear). Galazolin Gel, like other sympathomimetics, should be used with extreme caution in patients with hypersensitivity to adrenomimetic drugs. If during the use of the drug Galazolin Gel symptoms such as insomnia, dizziness, tremors, irregular heartbeat, high blood pressure appear, the patient should stop using the drug. Do not use the drug Galazolin Gel in patients with chronic or vasomotor rhinitis, as they have a tendency to use the drug for longer than 7 days. The use of the drug for longer than the recommended time may lead to secondary dilation of blood vessels and subsequently to secondary drug-induced rhinitis (rhinitis medicamentosa). The cause of this disease, most likely, is the inhibition of the release of norepinephrine from nerve endings through the excitation of presynaptic ?-2 receptors. Use with caution in patients with arterial hypertension, angina pectoris and other diseases of the circulatory system, diabetes mellitus, angle-closure glaucoma, prostatic hyperplasia, hyperthyroidism. Do not use doses higher than recommended, especially in children and elderly patients. Galazolin Gel should not be used during treatment with monoamine oxidase inhibitors and tricyclic antidepressants. Galazolin Gel contains benzalkonium chloride, which can cause irritation of the nasal mucosa. Interactions with other drugs The doctor or pharmacist should be informed about all drugs currently or recently used, as well as the drugs that the patient plans to use. There have been cases of interaction of xylometazoline with tricyclic antidepressants and MAO inhibitors. Do not use the drug during treatment with these drugs. The simultaneous use of the drug with other sympathomimetics (eg, ephedrine, pseudoephedrine) should be avoided due to the summation of the action. Contraindications Hypersensitivity to the active substance or any of the excipients of the drug. It is not used in patients after removal of the pituitary gland or after other surgical interventions that open the dura mater. atrophic rhinitis. Composition 1 g of gel contains: active substance: xylometazoline hydrochloride 1 mg; excipients: sodium dihydrogen phosphate monohydrate; disodium phosphate dodecahydrate; sodium chloride; sorbitol; disodium edetate; benzalkonium chloride, solution 50%; hydroxyethylcellulose; glycerol; purified water. Overdose No cases of drug overdose in adults have been reported. Overdose in children has been confirmed in rare cases. Overdose or accidental ingestion of the drug, especially by children, may cause the following symptoms: rapid and irregular heartbeat, high blood pressure, drowsiness, respiratory depression or irregular breathing, impaired consciousness. Children may become overly sedated. If the above symptoms appear, you should immediately consult a doctor. Treatment is symptomatic – according to the doctor’s instructions. Skipping a dose of the drug Do not use a double dose to compensate for the missed dose of the drug. Side effects Like all medicines, Galazolin Gel can cause side effects, although not everybody gets them. If the patient develops allergic reactions, such as swelling of the face, lips, tongue, throat, causing problems with breathing or swallowing, stop using the drug and consult a doctor immediately. Such reactions are very rare. The following are the side effects associated with the use of xylometazoline. Very rare (may affect less than 1 in 10,000 patients): Immune system disorders: allergic reaction (suffocation, angioedema). Nervous system disorders: headache, drowsiness. On the part of the organ of vision: visual impairment. Cardiac disorders: palpitations, tachycardia. Vascular disorders: increased blood pressure (especially in patients with diseases of the circulatory system). Respiratory, chest and mediastinal disorders: sneezing. The use of the drug for longer than recommended and (or) at doses higher than recommended may lead to the development of secondary drug-induced rhinitis. Gastrointestinal disorders: nausea. General disorders and reactions at the injection site: weakness, fatigue. There may be dryness of the nasal mucosa, irritation of the nasal mucosa, a burning sensation in the nose and throat. Reporting adverse reactions If you experience any of the above adverse reactions or other undesirable effects not listed in this package leaflet, you should report them to your doctor or pharmacist. Through such reports of adverse reactions, it will be possible to collect extensive information on the safety of the drug. Storage conditionsStore at a temperature not exceeding 25°C. Keep out of reach of children. 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