NAMESeptangin. DESCRIPTION Clear, colorless or yellowish liquid. MAIN ACTIVE SUBSTANCE FORM OF RELEASESpray. PHARMACOTHERAPEUTIC GROUP Means for the treatment of diseases of the larynx and pharynx. Antiseptics. ATC code: R02AA20 COMPOSITION 1 ml of spray contains: active ingredients: 1.5 mg of benzydamine hydrochloride and 5.0 mg of cetylpyridinium chloride. excipients: ethyl alcohol 96%, glycerin, macrogolglycerol hydroxystearate, sodium saccharin, flavor “Novamint fresh peppermint 506041 TP0504” (corn maltodextrin, modified corn starch, glyceryl triacetate, mentofuran, pulegone, estragol), purified water. A single press corresponds to 0.1 ml of spray and contains 0.15 mg of benzydamine hydrochloride and 0.5 mg of cetylpyridinium chloride. PHARMACOLOGICAL PROPERTIES Benzydamine hydrochloride is a non-steroidal anti-inflammatory drug that has anti-inflammatory and local analgesic effects. The mechanism of action is associated with inhibition of prostaglandin synthesis. Cetylpyridinium chloride is an antiseptic from the group of quaternary ammonium compounds that act as a cationic detergent. It is active against Gram-positive and, to a lesser extent, Gram-negative bacteria. Cetylpyridinium chloride also has antifungal properties. Septangin spray for the oral mucosa has anti-inflammatory, analgesic and antiseptic effects. The drug is designed to disinfect the oral cavity and reduce signs of the inflammatory process. INDICATIONS FOR USE Local treatment as part of the complex therapy of infectious and inflammatory diseases of the oral cavity and pharynx (tonsillitis, pharyngitis, stomatitis, gingivitis). METHOD OF APPLICATION AND DOSAGE Dosage Children aged 6 to 12 years: to receive a single dose, press the dispenser once, irrigate the inflamed area. If necessary, the procedure is repeated every 2 hours 3-5 times a day. In children aged 6 to 12 years, the drug should be used only after consulting a doctor. The drug is contraindicated in children under 6 years of age. Children aged 12 years and older: for a single dose, press the dispenser once or twice, irrigate the inflamed area. If necessary, the procedure is repeated every 2 hours 3-5 times a day. Adults: to receive a single dose, press the dispenser once or twice, irrigate the inflamed area. If necessary, the procedure is repeated every 2 hours 3-5 times a day. To achieve the optimal effect, do not use the drug immediately before or immediately after brushing your teeth. Recommended doses should not be exceeded. Duration of taking the drug – up to 7 days. Elderly patients Recommendations for use correspond to those for adults. METHOD OF APPLICATION Before the first use of the spray, press the dispenser several times until a jet appears. If the drug has not been used for a long time (at least for one week), then press the dispenser once until a jet appears. Inhalation of the drug should be avoided. CONTRAINDICATIONS Hypersensitivity to the active substances or other components of the drug. This dosage form is not intended for use in children under 6 years of age. PRECAUTIONS The drug should not be used for more than 7 days. If there are no noticeable signs of improvement after 3 days of treatment, you should consult your doctor. Dosage forms for topical use can cause hypersensitivity reactions, especially with long-term therapy. In this case, it is recommended to stop treatment and consult a doctor to prescribe appropriate therapy. The drug should not be used simultaneously with anionic compounds (for example, present in toothpaste). Accordingly, it is not recommended to use the drug immediately before or after brushing your teeth. Avoid getting Septangin in the eyes. It is necessary to avoid inhalation or ingestion of the drug during its use. In children aged 6 to 12 years, the drug should be used only after consulting a doctor. The medicinal product contains a small amount of ethyl alcohol: 26 mg / single dose PREGNANCY AND LACTATION Pregnancy There are limited data on the use of benzydamine hydrochloride and cetylpyridinium chloride in pregnant women. The use of the drug during pregnancy is not recommended. Breastfeeding There are no data on the presence of benzydamine hydrochloride or its metabolites in breast milk. A risk to newborns and infants cannot be excluded. When prescribing a drug to a woman who is breastfeeding, a decision should be made to stop breastfeeding, taking into account its benefits for the child and the expected benefit of therapy for the mother. EFFECT ON THE ABILITY TO DRIVE A CAR OR OTHER MECHANISMS The drug has no or little effect on the ability to drive vehicles or work with mechanisms. SIDE EFFECTS Like all medicines, Septangin oral mucosal spray can cause side effects in some cases. In rare cases (1 in 1,000), hypersensitivity reactions, urticaria, increased skin sensitivity to sunlight, bronchospasm are possible. In very rare cases (1 in 10,000) are possible: local irritation of the oral mucosa, slight burning sensation in the oral cavity. In cases for which the frequency is not known (cannot be established on the basis of available data), there may be: a burning sensation or numbness (loss of sensation) of the oral mucosa. In the event of adverse reactions, including those not listed in this leaflet, stop using the drug and consult a doctor. By following the directions for use in this leaflet, you will reduce the risk of adverse reactions. 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 Symptoms of benzydamine overdose: agitation, convulsions, increased sweating, ataxia, tremor, vomiting. Signs and symptoms of intoxication as a result of ingestion of significant amounts of cetylpyridinium chloride: nausea, vomiting, respiratory disorders, cyanosis, asphyxia due to paralysis of the respiratory muscles, depression of the central nervous system, arterial hypotension, coma. The lethal dose for humans is about 1 – 3 g (corresponding to 2000 – 6000 single doses of a spray). There is no specific antidote. Treatment is symptomatic. Interaction with other drugs: Simultaneous use with drugs from the group of antiseptics should be avoided. STORAGE CONDITIONS Store at a temperature not exceeding 25°C. Keep out of the reach of children. EXPIRY DATE 2 years. After opening the vial, the drug should be used within 6 months. HOLIDAY CONDITIONS without a doctor’s prescription. PACKAGING 30 ml in a polymer bottle with a spray nozzle and a plastic cap, with a leaflet in a secondary packaging made of cardboard box. MANUFACTURER “Belarusian-Dutch Joint Venture Limited Liability Company “Pharmland” (JV LLC “Pharmland”), Republic of Belarus, Nesvizh, st. Leninskaya, 124-3, tel/fax 373-31-90. Buy Septangin spray 1.5mg/ml+5.0mg/ml 30ml №1 Price for Septangin spray 1.5mg/ml+5.0mg/ml 30ml №1 ml 30ml №1
INN | Benzydamine+Citylpyridinium |
---|---|
The code | 139 092 |
Barcode | 4 810 368 012 821 |
Dosage | 1.5mg/ml+5.0mg/ml 30 |
Active substance | Benzydamine, cetylpyridinium |
Manufacturer | Pharmland SP LLC, Belarus |
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