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Tanflex 0.15% 30 ml spray

Instructions for medical use of the drug TANFLEX Trade name Tanflex International nonproprietary name Benzidamine Dosage form Oral spray 0.15% Composition 30 ml of spray contain the active substance - benzydamine hydrochloride 0.045 g, excipients: glycerin, sodium saccharin, sodium bicarbonate, ethyl alcohol 96% , methylparaben, mint essence, polysorbate 20, purified water. Description Transparent, colorless liquid with the smell of mint Pharmacotherapeutic group Other drugs for the treatment of diseases of the oral cavity Code ATC A01AD02 Pharmacological properties Pharmacokinetics When applied topically, the drug is easily absorbed into the oral mucosa and quickly penetrates into inflammatory tissues Benzidamine hydrochloride is metabolized in the body in the form of metabolites and excreted kidneys through the intestines. Pharmacodynamics Non-steroidal anti-inflammatory drug. It has anti-inflammatory, anti-edematous and analgesic effects. The mechanism of action is associated with the stabilization of cell membranes and inhibition of prostaglandin synthesis. Indications for use Inflammatory diseases of the oral cavity: - gingivitis, glossitis, stomatitis (including after radiation chemotherapy) periodontal disease, periodontosis - condition after tooth extraction Inflammatory diseases of the ENT organs: - pharyngitis, laryngitis, tonsillitis, tonsillectomy - jaw fractures - calculous inflammation salivary glands. Method of administration and dosage Spray for irrigation of the mouth and throat. Adults and elderly people 4 or 8 times a day with intervals between doses of 1.5-3 hours. Children (aged 6 to 12 years) no more than 4 times a day with intervals of 1.5-3 hours between doses. The treatment period is 4-5 days. If a positive result is not achieved, consult your doctor. Side effects - allergic reactions, drowsiness Local reactions (numbness of tissues or burning sensation in the mouth, dryness of the oral mucosa). Contraindications - hypersensitivity to the active substance or to one of the ingredients - children under 6 years of age Drug interactions Not established Special instructions For infectious and inflammatory diseases, use as part of complex therapy is possible. Avoid contact of the drug with the eyes. Pregnancy and lactation Use with caution during pregnancy and lactation. Features of the effect of the drug on the ability to drive vehicles and work with potentially dangerous mechanisms Not identified Overdose No cases of overdose were noted. Release form and packaging 30 ml of the drug is poured into dark glass bottles equipped with a mechanical sprayer. 1 bottle, along with instructions for medical use in the state and Russian languages, is placed in a cardboard box. Storage conditions Store in a dry place, protected from light, at a temperature not exceeding 30° C. Keep out of the reach of children! Shelf life: 3 years Do not use after the expiration date indicated on the package! Dispensing conditions Without a prescription, Turkey Owner of the registration certificate "ABDI IBRAHIM", Turkey Address of the organization that accepts claims from consumers on the quality of products in the territory of the Republic of Kazakhstan "Abdi Ibrahim Global Pharm" LLP Republic of Kazakhstan, Almaty, st. Dzhandosova 184 “g”, tel., fax +7 (727) 309-74-14 e-mail

Tanflex Plus 0.15% spray for topical use 30ml

Trade name Tanflex Plus International nonproprietary name No Dosage form Spray for topical use Composition 1 bottle (30 ml) contains active substance: benzydamine hydrochloride - 45 mg, chlorhexidine digluconate solution * - 180 mg excipients: glycerin, sodium saccharin, ethanol 96%, peppermint oil, polysorbate 20, sodium bicarbonate or hydrochloric acid, purified water. *- 0.036 g of chlorhexidine gluconate is equivalent to 180.00 mg of chlorhexidine digluconate solution. Description Colorless, transparent liquid with a mint odor. Pharmacological group Digestive tract and metabolism. Dental preparations. Other drugs for the treatment of diseases of the oral cavity Code ATC A01AD Pharmacological properties Pharmacokinetics Absorption After topical application of benzydamine hydrochloride, benzydamine is absorbed from the inflamed mucosa and has an anti-inflammatory and local anesthetic effect at the treatment site. Distribution Tanflex Plus is a topical medicine. Therefore, it should not be swallowed when used as described. Therefore, systemic absorption and distribution are not expected. In addition, the absorption of both components from the gastrointestinal mucosa is low. Approximately 30% of the administered chlorhexidine gluconate remains in the mouth and is excreted in saliva within 24 hours. Biotransformation Due to the minimal absorption of chlorhexidine, it cannot be measured in plasma. In general, benzydamine is metabolized by oxidation and conjugation in the liver. Elimination Chlorhexidine does not accumulate in the body and only a small amount is metabolized. Approximately 10% of ingested chlorhexidine is excreted by the kidneys after absorption and the remaining unabsorbed 90% of the drug is excreted in the feces. Benzidamine and metabolites that enter the systemic circulation are mainly excreted in the urine. Pharmacodynamics Benzydamine is an anti-inflammatory analgesic agent that is not structurally related to steroids. Benzidamine differs from other non-steroidal anti-inflammatory agents due to its basic structure. At concentrations used for topical treatment, benzydamine has a local anesthetic effect. The analgesic effect of benzydamine was more often recorded in experimental models of inflammation compared to non-inflammatory pain. The anti-inflammatory mechanism of action of benzydamine is not associated with the adrenal secretion channels. Like other nonsteroidal anti-inflammatory agents, benzydamine inhibits prostaglandin biosynthesis under certain conditions. This property, however, has not been precisely studied. It may depend on a stabilizing mechanism of action on cell membranes. Chlorhexidine is a biguanide antiseptic that helps reduce the development of plaque and gingivitis while interrupting general oral hygiene. It has an affinity for hydroxyapatite enamel, tooth surfaces, and oral tissues containing bacteria and salivary proteins. Chlorhexidine reduces plaque deposition and associated gum inflammation, which is characterized by redness, swelling and bleeding from the gums. It reduces the incidence of aphthous ulcer formation and increases the rate of healing after periodontal surgery. After routine topical use of the drug, chlorhexidine has a bactericidal effect after a long-term bacteriostatic effect. Chlorhexidine is effective against most microorganisms, such as gram (+) and gram (-) bacteria, mold and some fungi and viruses. Due to its delayed effect on the surface, chlorhexidine slows down the growth of bacteria. It is absorbed from the microbial cell wall and causes the membrane to leak. Indications for use - treatment of gingivitis, stomatitis, pharyngitis, tonsillitis and aphthous wounds - inflammation and pain of the mucous membranes of the mouth and throat - disinfection of the oral cavity and throat, to make it easier for the patient to swallow and symptoms of gum disease - before and after periodontal interventions - treatment of mucositis caused by radiotherapy, chemotherapy or other origin - prevention of dental plaque Method of administration and dosage Tanflex Plus is used without dilution. Tanflex Plus should not be swallowed or spat out after use. Adults The usual dose of Tanflex Plus spray for direct treatment of the throat/inflamed area is 4-8 applications every 1.5 - 3 hours during the day. Chlorhexidine in Tanflex Plus promotes the formation of plaque in the treatment of gingivitis. Before use, you should first brush your teeth with a toothbrush. If Tanflex Plus spray is used as an alternative to oral hygiene procedures, the mouth should be rinsed for at least 1 minute. In order to reduce the formation of stains caused by chlorhexidine in Tanflex Plus spray, you should first brush your teeth with a toothbrush. Children Not recommended for use by children under 12 years of age. The usual dose of Tanflex Plus spray for children over 12 years of age for direct treatment of the throat/inflamed area is 4 applications every 1.5 - 3 hours during the day. Elderly patients. For elderly patients, the same doses are used as for adults. Patients with renal and hepatic impairment Use with caution in patients with severe renal dysfunction or severe hepatic dysfunction. If your sore throat is caused by or associated with a bacterial infection, additional treatment may be considered besides Tanflex Plus. Side Effects Reported side effects are listed below according to the following frequency of occurrence. Very common (≥1/10); often (>1/100, <1/10); uncommon (>1/1,000, <1/100); rare (>1/10,000, <1/1,000); very rare (<1/10,000), unknown (cannot be determined from available data). Immune system disorders Very rare: Allergic reactions, hypersensitivity and anaphylaxis Endocrine system disorders Very rare: Temporary swelling of the parotid gland Nervous system disorders Very common: Temporary loss of taste Common: Tingling and burning in the mouth Not known: Dizziness, headache, drowsiness Respiratory diseases tract, chest and mediastinum: Very rare: Laryngospasm, bronchospasm Not known: Cough, pharyngeal irritation Gastrointestinal disorders Common: Nausea, vomiting, retching, gastrointestinal disorders Skin and subcutaneous tissue disorders Very rare: Skin reactions due to irritation, itching, rash, urticaria, photodermatosis, oral desquamation General disorders and conditions at the site of application: Common: Changes in taste and discoloration of teeth, increased formation of tartar Rare: Burning and tingling sensations Very rare: Local dryness, dryness, tingling, coolness in the mouth Contraindications - hypersensitivity to benzydamine, chlorhexidine or any other ingredients of the composition - children under 12 years of age - during pregnancy and breastfeeding Drug interactions Chlorhexidine is incompatible with anionic additives in conventional toothpastes. Therefore, you should use Tanflex Plus before brushing your teeth with toothpaste. Chlorhexidine salts are incompatible with soap and other anionic compounds. Although chlorhexidine salts are compatible with cationic and nonionic surfactants, when used in high concentrations, the activity of chlorhexidine may be reduced due to micelle binding. The solubility of chlorhexidine salts can be increased by surfactants such as cetrimide and lissapol NX. Chlorhexidine salts are incompatible with anionic polyelectrolytes such as gum arabic, sodium alginate, sodium carboxymethylcellulose, starch and tragacanth; their effectiveness decreases when used simultaneously. They are also incompatible with brilliant green, chloramphenicol, copper sulfate, sodium fluorescein, formaldehyde, silver nitrate and zinc sulfate. When diluting the drug with hard water, it may precipitate in the form of invisible salts because it interacts with Ca2 + and Mg2 + cations. If the concentration of solutions of chlorhexidine salts with benzoate, bicarbonate, carbonate, borate, nitrate, phosphate and sulfates exceeds 0.05%, precipitation may occur due to the formation of less soluble salts. Chlorhexidine gluconate is compatible with cetrimide and benzalkonium chloride. They increase the bactericidal effect of chlorhexidine synergistically. Cetrimide prevents chlorhexidine from settling in hard water. Compared to chlorhexidine gluconate, chlorhexidine and other salts are more soluble in alcohol than in water. The presence of 7% alcohol in the composition makes the solution more effective against gram-negative microorganisms. They can be absorbed when filtered through cellulose filters. No interaction of the drug with benzydamine has been recorded. Special instructions Avoid getting the spray in your eyes. Women of reproductive potential / Contraception Tanflex Plus should be used with caution by women of reproductive potential due to the fact that it contains alcohol. Pregnancy and lactation The use of Tanflex Plus during pregnancy and nursing mothers is contraindicated. Features of the effect of the drug on the ability to drive vehicles and work with potentially dangerous mechanisms The drug does not affect the ability to drive vehicles and other activities that require increased attention. Overdose In case of alcohol consumption, symptomatic and supportive therapy must be carried out. There is no specific antidote. Release form and packaging 30 ml of the drug is poured into dark glass bottles equipped with a spray bottle. A self-adhesive label is placed on the bottle. 1 bottle, along with instructions for medical use in the state and Russian languages, is placed in a cardboard box. Storage conditions Store in a place protected from light, at a temperature not exceeding 25° C. life: 2 years Do not use after the expiration date indicated on the package!