Galazolin Combi nasal spray (0.5+50) mg/ml №1

Name:
Galazolin Combi nas. spray (0.5+50) mg/ml №1
Description:
Transparent colorless solution. The main active ingredient Xylometazoline + dexpanthenol Release form Nasal spray Dosage (0.5 + 50) mg / ml Pharmacological actionGalazolin Combi is a combined drug, which includes alpha-sympathomimetic (xylometazoline) and provitamin B5 (dexpanthenol), intended for topical application to the mucous membrane nose. Xylometazoline has a vasoconstrictive effect, as a result of which it eliminates the swelling of the mucous membrane. Dexpanthenol is a derivative of pantothenic acid (vitamin B5), promotes wound healing and protects mucous membranes. Galazolin Combi reduces swelling and redness of the nasal mucosa, reduces the amount of discharge and improves its outflow from the sinuses. Galazolin Combi accelerates wound healing and is involved in the process of regeneration of the nasal mucosa. Galazolin Combi restores the patency of the nasal passages and promotes the regeneration of the nasal mucosa. Indications for use Galazolin Combi is used to reduce swelling of the nasal mucosa in acute respiratory diseases with symptoms of rhinitis, vasomotor rhinitis, as maintenance therapy for the healing of the mucous membrane and restoration of nasal breathing after surgery in the nasal cavity. Route of administration and doses The drug should be used in accordance with the leaflet or as recommended by a doctor or pharmacist. In case of any doubt, you should consult your doctor or pharmacist. The drug is intended for intranasal use only. The drug Galazolin Combi should not be used for longer than 7 days. If after 7 days there is no improvement or the patient feels worse, you should consult a doctor. Doses of the drug depend on the individual tolerability of the drug and therapeutic efficacy. Do not use doses higher than recommended. Galazolin Combi, (0.5 mg + 50.0 mg) / ml 1 spray dose contains 0.1 ml of solution. Children aged 2 to 6 years: One dose of spray in each nasal passage 1 or 2 times a day (every 8-10 hours). Do not use more than 3 doses of the drug in each nasal passage per day (maximum 6 doses per day). For a child, Galazolin Combi 0.05% should only be administered by an adult. 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 a spray cloud appears. Before subsequent use, it is not necessary to press the dispenser several times. The tip of the dispenser should be inserted into the nasal passage. While holding the vial in an upright position, press the dispenser. which leads to spraying the dose of the drug in the nasal cavity. Repeat the procedure when introducing the drug into the other nasal passage. 6. After use, put on the protective cap. 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. 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. Studies regarding the effect of the drug on fetal development are insufficient, so Galazolin Combi should not be used during pregnancy. There are no data on the penetration of xylometazoline into breast milk, so women who are breastfeeding should not use Galazolin Combi. The ability to influence the reaction rate when driving vehicles or operating other mechanisms If the drug Galazolin Combi is used in accordance with the information contained in this leaflet, it usually does not affect the ability to drive vehicles and operate mechanisms. With prolonged use or use in doses greater than recommended, the effect of the drug on the functions of the cardiovascular and nervous system cannot be excluded. In such cases, psychophysical activity, the ability to drive vehicles and maintain mechanisms may be impaired. In the event of the symptoms described in the section “Side effects” (for example, insomnia), you can not drive vehicles and service moving mechanisms until the symptoms stop. Precautions Before you start using the drug Galazolin Combi, you should consult your doctor or pharmacist. The drug Galazolin Combi should be used taking into account the assessment of the benefit / risk ratio in the following cases: in patients who are taking MAO inhibitors or other pressor drugs; with increased intraocular pressure, especially with angle-closure glaucoma; in severe diseases of the cardiovascular system (for example, coronary heart disease, arterial hypertension); in patients with pheochromocytoma; with metabolic disorders (for example, hyperthyroidism, diabetes mellitus); with porphyria; with prostatic hyperplasia. Due to the risk of atrophy of the nasal mucosa, the use of the drug in chronic rhinitis is recommended only under medical supervision. Galazolin Combi contains benzalkonium chloride, which can cause irritation of the nasal mucosa. Decongestants sympathomimetics can, especially with prolonged use or as a result of an overdose, lead to the development of reactive hyperemia of the nasal mucosa. This “rebound effect” leads to narrowing of the nasal passages, which forces the patient to reapply this drug and switch to permanent use. Subsequently, chronic edema develops (drug-induced rhinitis) and even atrophy of the nasal mucosa. In milder cases, it may be sufficient to stop the use of the sympathomimetic agent first in one nostril and then, as soon as the symptoms disappear, repeat it in the other, to maintain, at least partially, nasal breathing in an upright position. Use in children Galazolin Combi, (0.5 mg + 50.0 mg) / ml should not be used in children under 2 years of age. Galazolin Combi (1.0 mg + 50.0 mg)/ml should not be used in children under 6 years of age. If during the use of the drug in children there is excitement or difficulty falling asleep, the use of the drug should be discontinued. Interaction with other drugs If the drug Galazolin Combi is used in accordance with the information contained in this leaflet, it usually does not affect the ability to drive vehicles and operate machinery. With prolonged use or use in doses greater than recommended, the effect of the drug on the functions of the cardiovascular and nervous system cannot be excluded. In such cases, psychophysical activity, the ability to drive vehicles and maintain mechanisms may be impaired. In the event of the symptoms described in the section “Side effects” (for example, insomnia), you can not drive vehicles and service moving mechanisms until the symptoms stop. Contraindications Hypersensitivity to xylometazoline hydrochloride, dexpanthenol or any of the excipients of the drug. Dry rhinitis (rhinitis sicca). Conditions following transsphenoidal hypophysectomy or other surgical procedures that expose the dura mater. For Galazolin Combi, nasal spray (0.5 mg + 50.0 mg)/ml: age up to 2 years. For Galazolin Combi, nasal spray (1.0 mg + 50.0 mg)/ml: age up to 6 years; period of pregnancy and lactation. The composition of the spray includes benzalkonium chloride, so patients with hypersensitivity to this substance should refrain from using this drug. Composition 1 ml of solution contains: Active ingredients: 0.5 mg xylometazoline hydrochloride and 50.0 mg dexpanthenol. Excipients: disodium phosphate dodecahydrate; potassium dihydrogen phosphate, benzalkonium chloride solution 50%; purified water. 1 dose of nasal spray (0.1 ml solution) contains 0.05 mg xylometazoline hydrochloride and 5.0 mg dexpanthenol. Overdose In case of overdose or in case of accidental ingestion, you should immediately consult a doctor. The clinical picture of intoxication with imidazole derivatives may be unclear, since periods of stimulation may alternate with periods of depression of the central nervous system and the cardiovascular system. Overdose, especially in children, can lead to significant CNS effects, including convulsions, coma, bradycardia, apnea, and hypertension that may progress to hypotension. Symptoms of CNS stimulation include anxiety, agitation, hallucinations, and seizures. Symptoms of CNS depression are manifested in the form of a decrease in body temperature, lethargy, drowsiness and coma. Additional symptoms may also occur: miosis, mydriasis, sweating, fever, cyanosis, pallor of the skin, nausea, tachycardia, bradycardia, arrhythmia, cardiac arrest, hypertension, shock-like hypotension, pulmonary edema, respiratory depression and apnea. Treatment. In case of severe overdose, inpatient treatment is required. Since xylometazoline hydrochloride is rapidly absorbed, you should immediately take activated charcoal (absorbent), sodium sulfate (laxative) or resort to gastric lavage (at high doses). You can lower blood pressure with non-selective a-adrenergic blockers. Vasoconstrictor drugs are contraindicated. If necessary, antipyretic and anticonvulsant drugs and oxygen therapy are indicated. Skipping a dose Do not use a double dose to make up for a missed dose. Also, do not use more than 3 doses of the drug in each nasal passage during the day. Side effects Like all medicines, Galazolin Combi can have side effects, although not everybody gets them. The frequency of occurrence of possible side effects is indicated as: very often (? 1/10); often (from? 1/100 to <1/10); infrequently (from ? 1/1,000 to < 1/100); rarely (from? 1/10,000 to <1/1,000); very rarely (< 1/10,000); the frequency is unknown (it is impossible to determine the frequency from the available data). From the nervous system: very rarely - anxiety, insomnia, fatigue (drowsiness, sedation), headache, hallucinations (mainly in children). From the side of the cardiovascular system: rarely - palpitations, tachycardia, arterial hypertension; very rarely - arrhythmias. From the respiratory system: very rarely - increased mucosal edema with a decrease in the effect of the drug, epistaxis; frequency unknown - burning and dryness of the nasal mucosa, sneezing. From the musculoskeletal system: very rarely - convulsions (especially in children). From the immune system: infrequently - hypersensitivity reactions (angioedema, urticaria, itching). Reporting adverse reactions If you experience any of the above adverse reactions or other undesirable effects not listed in this package leaflet, please inform 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 the reach of children. Buy Galazolin Combi nasal spray (0.5+50) mg/ml No. 1 0.5+50)mg/ml №1