Septolete Total oral mucosal spray (1.5mg+5mg)/ml 30ml (250 doses) №1

Name:
Septolete Total spray for mucus.rot.pol., doses. (1.5mg + 5mg) ml in vial. 30ml (250 doses) per pack. No. 1
Description:
Transparent solution from colorless to yellowish. The main active ingredient benzidamine + cetylpyridinium chloride Release form Dosed spray for local use, 0.15 mg + 0.5 mg / dose. 30 ml (250 doses) of the drug in a high-density polyethylene vial, equipped with a dosing device (pump), with a spray head with an applicator tube made of combined material and a colored protective cap made of polypropylene. 1 bottle together with instructions for use is placed in a cardboard box. Dosage To obtain a single dose, press the spray head 1-2 times. Special instructions Hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, bronchial asthma (including history), liver disease, alcoholism, traumatic brain injury, brain disease. Pharmacodynamics Benzydamine is a non-steroidal anti-inflammatory drug with anti-inflammatory, analgesic and local anesthetic effects. Cetylpyridinium chloride is an antiseptic from the group of quaternary ammonium compounds, has an antimicrobial, antifungal, virucidal effect. Pharmacokinetics Absorption Of the two active ingredients – cetylpyridinium chloride and benzydamine – only benzydamine is absorbed through the mucous membranes. Therefore, cetylpyridinium chloride does not enter into pharmacokinetic interaction with benzydamine at the system level. The absorption of benzydamine through the mucous membranes of the oral cavity and pharynx was shown by detecting the active substance in the blood serum, the amount of which, however, was not enough to provide a systemic effect. When using benzydamine in the dosage form of a topical spray at recommended doses, absorption is negligible. Distribution The volume of distribution of all dosage forms is the same. Excretion Excretion occurs mainly by the kidneys, mostly in the form of inactive metabolites. The half-life and total clearance are similar for all dosage forms. Indications for use Symptomatic therapy of pain syndrome of inflammatory diseases of the oral cavity and ENT organs (of various etiologies), including tonsillitis, pharyngitis, as part of complex therapy. Dosage and administration Locally. Adults and children over 12 years of age To obtain a single dose, press the spray head 1-2 times. It is recommended to apply every 2 hours, 3-5 times a day for 4 days. Children aged 6 to 12 years For a single dose, press the spray head 1 time. It is recommended to apply every 2 hours, 3-5 times a day for 4 days. In children aged 6 to 12 years, the drug should be used only after consulting a doctor. Do not exceed the indicated dose. To achieve the optimal effect, it is not recommended to use Septolete Total immediately before or after brushing your teeth. If after treatment there is no improvement or new symptoms appear, you should consult your doctor. Use the drug only according to the method of application and in the doses indicated in the instructions. If necessary, please consult your doctor before taking the medicine. You should contact your doctor if symptoms worsen or do not improve after 4 days of treatment. Before the first use of the drug Septolete® total, press the spray head of the dosing device several times until a uniform spray is obtained. If the drug Septolete® total has not been used for a long time (for at least 1 week), you should press the spray head of the dosing device 1 time until a uniform spray is obtained. Remove the colored protective cap before use. Use during pregnancy and lactation The use of the drug Septolete® total is contraindicated during pregnancy and during breastfeeding. If necessary, the use of the drug during lactation, breastfeeding should be discontinued. Precautions Read the instructions carefully before you start using the drug. Save the instructions, you may need them again. If you have any questions, please contact your doctor. The medicine you are taking is for you personally and should not be passed on to others as it may harm them even if they have the same symptoms as you. When using the drug Septolete® total, hypersensitivity reactions to the drug may develop. In this case, it is recommended to stop treatment and consult a doctor to prescribe appropriate therapy. In the presence of an ulcerative lesion of the oropharyngeal mucosa, the patient should consult a doctor if symptoms persist for more than three days. The use of the drug Septolete® total is not recommended in patients with hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs. The drug Septolete® total should not be used simultaneously with anionic compounds (for example, present in toothpaste). Therefore, it is not recommended to use the drug immediately before or after brushing your teeth. Contact of the drug Septolete® total with the mucous membrane of the eyes should be avoided. The spray must not be inhaled. A single dose of Septolete® total contains 0.0264 g of absolute ethyl alcohol, the maximum daily dose of Septolete® total for children 6-12 years old contains 0.132 g of absolute ethyl alcohol, for children 12 years and older and adults – 0.264 g. After opening the vial the drug should be used within 6 months. Interaction with other drugs Not described. Simultaneous use with other drugs from the group of antiseptics should be avoided. ContraindicationsHypersensitivity to the active substances, or to any auxiliary components of the drug. Children’s age up to 6 years. Pregnancy, breastfeeding period. Composition 1 spray dose / 1 ml spray Active ingredients: Benzydamine hydrochloride 0.150 mg / 1.50 mg Cetylpyridinium chloride monohydrate 0.526 mg / 5.26 mg, equivalent to cetylpyridinium chloride 0.500 mg / 5.00 mg Excipients: ethanol, glycerol, macrogol glyceryl hydroxystearate, sodium saccharinate, peppermint leaves oil, purified water 1 dose of the drug – about 0.1 ml of solution. 30 ml of the drug in the primary package contains 250 doses. OverdoseSymptoms Intoxication is possible only if significant amounts of benzydamine (> 300 mg) are accidentally swallowed. With an overdose of benzydamine, symptoms are observed, mainly from the gastrointestinal tract (GIT) and the central nervous system (CNS). The most common gastrointestinal symptoms are nausea, vomiting, abdominal pain, and irritation of the esophageal mucosa. CNS symptoms include dizziness, hallucinations, agitation, restlessness, and irritability. Signs and symptoms of intoxication when ingesting significant amounts of cetylpyridinium chloride: nausea, vomiting, edema, cyanosis, dyspnea, asphyxia followed by paralysis of the respiratory muscles, depression of the central nervous system, arterial hypotension and coma. The lethal dose for humans is about 1-3 g. Treatment In acute overdose of benzydamine, treatment is symptomatic. It is necessary to provide medical supervision, supportive therapy and necessary hydration. Treatment of an overdose of cetylpyridinium chloride is also symptomatic. In case of overdose, you should consult a doctor. Side effects Classification of the frequency of side effects recommended by the World Health Organization (WHO): very often? 1/10 often from ? 1/100 to < 1/10 infrequently from ? 1/1000 to <1/100 rare from ? 1/10000 to < 1/1000 very rare < 1/10000 frequency unknown cannot be estimated from the available data. Immune system disorders: frequency unknown: hypersensitivity reactions, anaphylactic reactions. Nervous system disorders: frequency unknown: numbness of the oral mucosa. Respiratory, thoracic and mediastinal disorders: Rare: Bronchospasm. Gastrointestinal disorders: very rare: irritation of the oral mucosa, burning sensation in the mouth. Skin and subcutaneous tissue disorders: rarely: urticaria, photosensitivity; frequency unknown: angioedema, pruritus. If any of the side effects listed in the instructions get worse, or if you notice any other side effects not listed in the instructions, tell your doctor. Storage conditions Tablets should be stored in their original packaging to protect from light, out of the reach of children. The drug in the form of tablets does not require special temperature storage conditions. Shelf life - 2 years. Spray should be stored out of the reach of children at a temperature not exceeding 25 ° C. 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