Attributes
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- Description en
- STREPSILS® INTENSIVE Trade name: STREPSILS® INTENSIVE International Nonproprietary Name: Flurbiprofen Chemical Name: (RS)-2-(2-fluorobiphenyl-4-yl)propanoic acid. Dosage form: Lozenges [Honey-Lemon]. Composition One lozenge contains: Active substance: Flurbiprofen 8.75 mg, Excipients: Macrogol 300 5.47 mg, Potassium hydroxide 2.19 mg, Liquid sucrose 1407 mg, Levomenthol 2 mg, Dextrose 1069 mg, Honey 50.4 mg, Lemon flavouring (502904A) 3.6 mg. Description Round, semi-transparent, caramel-mass lozenges, from light yellow to light brown, with the letter S imprinted on both sides of the lozenge. The presence of air bubbles in the caramel mass and slight unevenness of the edges are permissible. White plaque may form. Pharmacotherapeutic group: Non-steroidal anti-inflammatory drug (NSAID). Other drugs for throat diseases. See blog: Strepsils - A drug for the treatment of infectious-inflammatory diseases of the oral cavity and throat ATC code: R02AX01 Pharmacological properties Pharmacodynamics Flurbiprofen is a propionic acid derivative from the group of non-steroidal anti-inflammatory drugs (NSAIDs) and has a strong analgesic, anti-inflammatory, and antipyretic effect by inhibiting cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2), with some selectivity towards COX-1, resulting in reduced production of prostaglandins, which are mediators of pain, inflammation, and hyperthermic reactions. Ex vivo studies of the 8.75 mg lozenge dosage form have shown that flurbiprofen penetrates the pharyngeal tissue, including deeper layers. The drug has a local analgesic and anti-inflammatory effect on the oral mucosa and throat: it reduces swelling, difficulty swallowing, and the sensation of pain and irritation in the throat. The lozenge completely dissolves in the oral cavity within 5-12 minutes. The soothing effect begins from 2 minutes. Significant reduction of throat pain begins from 22 minutes, with maximum effect achieved in 70 minutes and lasting up to 4 hours. Two hours after the first use of the lozenge, a significant reduction in some accompanying symptoms observed at the beginning of therapy, such as cough, loss of appetite, and feverish condition, is noted. Pharmacokinetics The lozenge completely dissolves in the oral cavity within 5-12 minutes. It is characterized by high absorption; flurbiprofen is rapidly and almost completely absorbed, distributed throughout the body, and significantly binds to plasma proteins. Flurbiprofen is detected in the blood within 5 minutes, and the maximum plasma concentration (Cmax) of flurbiprofen is reached 40-45 minutes after sucking. Flurbiprofen absorption through the oral mucosa via passive diffusion is possible. The rate of absorption depends on the dosage form; maximum flurbiprofen concentration is achieved faster when sucked than when an equivalent dose of flurbiprofen is taken orally. The half-life (T1/2) is 3-6 hours. It undergoes metabolism in the liver through hydroxylation and is excreted by the kidneys and to a lesser extent by bile. Flurbiprofen is excreted in breast milk in negligible amounts (<0.05 mcg/ml). Approximately 20-25% of the oral dose of flurbiprofen is excreted unchanged. Indications for use As a symptomatic treatment for the relief of sore throat in infectious-inflammatory diseases of the oral cavity and pharynx. Contraindications Hypersensitivity to flurbiprofen or any of the other components of the preparation. History of hypersensitivity reactions (bronchial asthma, bronchospasm, rhinitis, angioedema, urticaria, recurrent nasal and sinus polyposis) resulting from the use of acetylsalicylic acid or other NSAIDs. Erosive-ulcerative diseases of the gastrointestinal tract (including gastric and duodenal ulcer disease, Crohn's disease, ulcerative colitis) or ulcer bleeding in the exacerbation phase or in history (two or more confirmed episodes of ulcer disease or ulcer bleeding). Gastrointestinal bleeding or perforation of an ulcer in history, caused by the use of NSAIDs. Glucose-6-phosphate dehydrogenase deficiency, hemophilia, and other blood clotting disorders (including hypocoagulation), hemorrhagic diathesis. Severe hepatic insufficiency or active liver disease. Severe renal insufficiency (creatinine clearance <30 ml/min), confirmed hyperkalemia. Decompensated heart failure; period after coronary artery bypass grafting. Sucrose/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption. Pregnancy (III trimester). Age under 12 years. Use with caution If the following conditions are present, consult your doctor before using the preparation. Concomitant use of other NSAIDs; a single episode of gastric ulcer disease or gastrointestinal ulcer bleeding in history. Gastrointestinal diseases in history (ulcerative colitis, Crohn's disease), gastritis, enteritis, colitis, presence of Helicobacter pylori infection; bronchial asthma or allergic diseases in the exacerbation stage or in history – bronchospasm is likely to develop; systemic lupus erythematosus or mixed connective tissue disease (Sharpe's syndrome) – increased risk of aseptic meningitis (risk is negligible with short-term use of flurbiprofen); renal insufficiency, including dehydration (creatinine clearance <30-60 ml/min), nephrotic syndrome; hepatic insufficiency, liver cirrhosis with portal hypertension, hyperbilirubinemia, arterial hypertension and/or heart failure, edema; concomitant administration of other drugs that may increase the risk of ulcers or bleeding, particularly oral glucocorticosteroids (including prednisolone), anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline); pregnancy (I-II trimester), lactation period; elderly age; alcohol consumption. Use during pregnancy and lactation The use of the preparation is contraindicated in the III trimester of pregnancy. Flurbiprofen use should be avoided in the I-II trimester of pregnancy; if the preparation needs to be used, consult your doctor. There are reports that flurbiprofen may be present in breast milk in negligible amounts without any negative impact on the health of the nursing infant, however, due to potential side effects, the use of NSAIDs during lactation is not recommended. Dosage and administration Read the instructions for use carefully before using the preparation. For local use. For short-term use only. Adults and children over 12 years of age: Slowly suck 1 lozenge every 3-6 hours. Maximum daily dose: 5 lozenges in 24 hours. Duration of treatment: Not more than 3 days. If symptoms persist or worsen within 3 days of taking the preparation, discontinue treatment immediately and consult a doctor. Side effects The use of some NSAIDs, especially at high doses and for prolonged periods, may lead to a slightly increased risk of arterial thrombotic events (e.g., myocardial infarction or stroke). Existing data are insufficient to exclude a similar risk factor when using flurbiprofen 8.75 mg lozenges. Hypersensitivity reactions to NSAIDs have been reported, which may manifest as: non-specific allergic and anaphylactic reactions; respiratory tract hyperreactivity, including asthma, asthma exacerbation, bronchospasm, dyspnea. Various skin reactions, such as itching, urticaria, angioneurotic edema, and rarely, exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme). Cases of edema, arterial hypertension, and heart failure have been reported in patients taking NSAIDs. The risk of side effects can be minimized by using the preparation for a short course at the minimum effective dose necessary to control symptoms. The side effects listed below were observed with short-term use of the preparation. Other side effects are expected with chronic conditions and long-term use. The frequency of side effects was assessed according to the following criteria: very common (>1/10), common (>1/10 to <1/10), uncommon (>1/1000 to <1/100), rare (>1/10,000 to <1/1000), very rare (<1/10,000), frequency unknown (frequency cannot be estimated from available data). Disorders of the blood and lymphatic system Frequency unknown: Blood formation disorders (anemia, thrombocytopenia). Nervous system disorders Common: Dizziness, headache, paresthesia. Uncommon: Drowsiness. Immune system disorders Rare: Anaphylactic reactions. Cardiac disorders Frequency unknown: Heart failure, edema. Vascular disorders Frequency unknown: Increased blood pressure. Respiratory, thoracic and mediastinal disorders Common: Sensation of irritation in the throat. Uncommon: Exacerbation of asthma and bronchospasm, dyspnea, wheezing, blisters in the mouth and throat, pharyngeal hypesthesia (reduced sensation in the mouth and throat). Gastrointestinal disorders Common: Diarrhea, oral ulceration, vomiting, oral pain, oral paresthesia, oral and pharyngeal pain, oral discomfort (sensation of heat, burning, and tingling in the mouth). Uncommon: Abdominal bloating, abdominal pain, constipation, dry mouth, dyspepsia, flatulence, glossalgia (burning mouth syndrome), dysgeusia (altered taste sensation), oral dysesthesia, vomiting. Skin and subcutaneous tissue disorders Uncommon: Rash, itching. Frequency unknown: Severe skin reactions, such as bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome). Hepatic and biliary system disorders Frequency unknown: Hepatitis. Psychiatric disorders Uncommon: Insomnia. Other Uncommon: Fever, pain. Overdose Symptoms: Vomiting, nausea, epigastric pain or, rarely, diarrhea, tinnitus, headache, and gastrointestinal bleeding. In more severe cases, central nervous system events have been observed: drowsiness, rarely – agitation, convulsions, visual disturbances, disorientation, coma. In severe poisoning, metabolic acidosis and increased prothrombin time, acute renal failure, liver tissue damage, decreased blood pressure, respiratory depression, and cyanosis may develop. In patients with bronchial asthma, exacerbation of this disease is expected. Treatment: Symptomatic, with essential provision of airway patency, monitoring of ECG and vital signs until the patient's condition normalizes. Oral administration of activated charcoal or gastric lavage within one hour of ingesting a potentially toxic dose of flurbiprofen is recommended. Frequent or prolonged seizures should be managed by intravenous administration of diazepam or lorazepam. Bronchodilators are recommended for exacerbation of bronchial asthma. There is no specific antidote for flurbiprofen. Interactions with other drugs Avoid concomitant use of flurbiprofen with the following drugs: Acetylsalicylic acid: Except for low-dose acetylsalicylic acid (not exceeding 75 mg per day) prescribed by a doctor, as concomitant use may increase the risk of side effects. Other NSAIDs, including ibuprofen and cyclooxygenase-2 selective inhibitors: Avoid concomitant use of two or more drugs from the NSAID group due to the increased risk of side effects. Use with caution with the following drugs: Anticoagulants: NSAIDs may enhance the effect of anticoagulants, particularly warfarin. Antiplatelet agents and selective serotonin reuptake inhibitors: High risk of gastrointestinal bleeding. Hypotensive agents (ACE inhibitors and angiotensin II antagonists) and diuretics: NSAIDs may reduce the efficacy of these drugs and increase nephrotoxicity due to cyclooxygenase inhibition, especially in patients with impaired renal function (adequate fluid intake should be ensured in these patients). Alcohol: Increased risk of side effects, especially gastrointestinal bleeding, is expected. Cardiac glycosides: Concomitant use of NSAIDs and cardiac glycosides may complicate heart failure, reduce glomerular filtration rate, and increase plasma concentrations of cardiac glycosides. Cyclosporine: Increased risk of nephrotoxicity with concomitant use of NSAIDs and cyclosporine. Glucocorticosteroids: Increased risk of gastrointestinal ulceration and gastrointestinal bleeding. Lithium preparations: There is evidence of an increased probability of increased lithium concentrations in plasma with NSAID use. Methotrexate: There is evidence of an increased probability of increased methotrexate concentrations in plasma with NSAID use. NSAIDs should be taken with a 24-hour interval before or after methotrexate. Mifepristone: NSAID use should begin at least 8-12 days after completion of mifepristone use, as NSAIDs may reduce the effectiveness of mifepristone. Quinolone antibiotics: Patients taking NSAIDs and quinolone antibiotics concurrently may have an increased risk of seizures. Tacrolimus: Concomitant use of NSAIDs and tacrolimus increases the risk of nephrotoxicity. Zidovudine: Concomitant use of NSAIDs and zidovudine may increase hematotoxicity. Oral hypoglycemic agents: Changes in blood glucose levels are expected (frequent monitoring of blood glucose levels is recommended). Phenytoin: Increased serum levels of phenytoin are expected (serum phenytoin monitoring and dose adjustment if necessary are recommended). Potassium-sparing diuretics: Concomitant use of potassium-sparing diuretics and flurbiprofen may cause hyperkalemia. Probenecid and sulfinpyrazone: Drugs containing probenecid or sulfinpyrazone may inhibit the excretion of flurbiprofen. Tolbutamide and antacids: Studies to date have not revealed interactions between flurbiprofen and tolbutamide or antacids. Special instructions It is recommended to take the preparation for a maximum short course of treatment at the minimum effective dose necessary to eliminate symptoms. Diabetic patients should consider that each honey-lemon lozenge contains approximately 2.5 g of sugar (0.21 bread units). In case of gastropathy symptoms, strict monitoring is indicated, including esophagogastroduodenoscopy, complete blood count (hemoglobin determination), and fecal occult blood test. If 17-ketosteroids need to be determined, the preparation should be discontinued 48 hours before the examination. Ethanol intake is not recommended during treatment. Patients with renal or hepatic insufficiency, as well as the elderly and patients taking diuretics, should consult a doctor before using the preparation, as there is a risk of worsening renal function. The risk is negligible with short-term use of the preparation. Patients with arterial hypertension, including those with a history and/or chronic heart failure, should consult a doctor before using the preparation, as the preparation may cause fluid retention, increased blood pressure, and edema. Information for women planning pregnancy: The preparation inhibits cyclooxygenase and prostaglandin synthesis and may affect ovulation, leading to impaired female reproductive function (reversible after discontinuation of treatment). If irritation of the oral mucosa, rash, damage to mucous membranes, or other allergic reactions occur, discontinue use of the preparation and consult a doctor. If symptoms worsen or new ones appear, including signs of bacterial infection, consult a doctor immediately to review the therapy. Effect on ability to drive and operate machinery Patients experiencing dizziness, drowsiness, blurred vision, or visual disturbances while using flurbiprofen should not drive vehicles or operate machinery. Dosage form Lozenges, 8.75 mg. 4, 6, 8, 10 or 12 lozenges are placed in a blister (PVC/PVDC/Aluminum). 1, 2, 3, 4, or 5 blisters are placed in a cardboard box together with the instructions for use. Storage conditions Store at a temperature not exceeding 25°C. Keep out of reach of children. Shelf life 3 years. Do not use after the expiry date. Dispensing conditions Pharmaceutical product group III, available without a prescription.
- Active
- flurbiprofen
What is it?
STREPSILS® INTENSIVE Trade name: STREPSILS® INTENSIVE International Nonproprietary Name: Flurbiprofen Chemical Name: (RS)-2-(2-fluorobiphenyl-4-yl)propanoic acid. Dosage form: Lozenges [Honey-Lemon]. Composition One lozenge contains: Active substance: Flurbiprofen 8.75 mg, Excipients: Macrogol 300 5.47 mg, Potassium hydroxide 2.19 mg, Liquid sucrose 1407 mg, Levomenthol 2 mg, Dextrose 1069 mg, Honey 50.4 mg, Lemon flavouring (502904A) 3.6 mg. Description Round, semi-transparent, caramel-mass lozenges, from light yellow to light brown, with the letter S imprinted on both sides of the lozenge. The presence of air bubbles in the caramel mass and slight unevenness of the edges are permissible. White plaque may form. Pharmacotherapeutic group: Non-steroidal anti-inflammatory drug (NSAID). Other drugs for throat diseases. See blog: Strepsils - A drug for the treatment of infectious-inflammatory diseases of the oral cavity and throat ATC code: R02AX01 Pharmacological properties Pharmacodynamics Flurbiprofen is a propionic acid derivative from the group of non-steroidal anti-inflammatory drugs (NSAIDs) and has a strong analgesic, anti-inflammatory, and antipyretic effect by inhibiting cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2), with some selectivity towards COX-1, resulting in reduced production of prostaglandins, which are mediators of pain, inflammation, and hyperthermic reactions. Ex vivo studies of the 8.75 mg lozenge dosage form have shown that flurbiprofen penetrates the pharyngeal tissue, including deeper layers. The drug has a local analgesic and anti-inflammatory effect on the oral mucosa and throat: it reduces swelling, difficulty swallowing, and the sensation of pain and irritation in the throat. The lozenge completely dissolves in the oral cavity within 5-12 minutes. The soothing effect begins from 2 minutes. Significant reduction of throat pain begins from 22 minutes, with maximum effect achieved in 70 minutes and lasting up to 4 hours. Two hours after the first use of the lozenge, a significant reduction in some accompanying symptoms observed at the beginning of therapy, such as cough, loss of appetite, and feverish condition, is noted. Pharmacokinetics The lozenge completely dissolves in the oral cavity within 5-12 minutes. It is characterized by high absorption; flurbiprofen is rapidly and almost completely absorbed, distributed throughout the body, and significantly binds to plasma proteins. Flurbiprofen is detected in the blood within 5 minutes, and the maximum plasma concentration (Cmax) of flurbiprofen is reached 40-45 minutes after sucking. Flurbiprofen absorption through the oral mucosa via passive diffusion is possible. The rate of absorption depends on the dosage form; maximum flurbiprofen concentration is achieved faster when sucked than when an equivalent dose of flurbiprofen is taken orally. The half-life (T1/2) is 3-6 hours. It undergoes metabolism in the liver through hydroxylation and is excreted by the kidneys and to a lesser extent by bile. Flurbiprofen is excreted in breast milk in negligible amounts (<0.05 mcg/ml). Approximately 20-25% of the oral dose of flurbiprofen is excreted unchanged. Indications for use As a symptomatic treatment for the relief of sore throat in infectious-inflammatory diseases of the oral cavity and pharynx. Contraindications Hypersensitivity to flurbiprofen or any of the other components of the preparation. History of hypersensitivity reactions (bronchial asthma, bronchospasm, rhinitis, angioedema, urticaria, recurrent nasal and sinus polyposis) resulting from the use of acetylsalicylic acid or other NSAIDs. Erosive-ulcerative diseases of the gastrointestinal tract (including gastric and duodenal ulcer disease, Crohn's disease, ulcerative colitis) or ulcer bleeding in the exacerbation phase or in history (two or more confirmed episodes of ulcer disease or ulcer bleeding). Gastrointestinal bleeding or perforation of an ulcer in history, caused by the use of NSAIDs. Glucose-6-phosphate dehydrogenase deficiency, hemophilia, and other blood clotting disorders (including hypocoagulation), hemorrhagic diathesis. Severe hepatic insufficiency or active liver disease. Severe renal insufficiency (creatinine clearance <30 ml/min), confirmed hyperkalemia. Decompensated heart failure; period after coronary artery bypass grafting. Sucrose/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption. Pregnancy (III trimester). Age under 12 years. Use with caution If the following conditions are present, consult your doctor before using the preparation. Concomitant use of other NSAIDs; a single episode of gastric ulcer disease or gastrointestinal ulcer bleeding in history. Gastrointestinal diseases in history (ulcerative colitis, Crohn's disease), gastritis, enteritis, colitis, presence of Helicobacter pylori infection; bronchial asthma or allergic diseases in the exacerbation stage or in history – bronchospasm is likely to develop; systemic lupus erythematosus or mixed connective tissue disease (Sharpe's syndrome) – increased risk of aseptic meningitis (risk is negligible with short-term use of flurbiprofen); renal insufficiency, including dehydration (creatinine clearance <30-60 ml/min), nephrotic syndrome; hepatic insufficiency, liver cirrhosis with portal hypertension, hyperbilirubinemia, arterial hypertension and/or heart failure, edema; concomitant administration of other drugs that may increase the risk of ulcers or bleeding, particularly oral glucocorticosteroids (including prednisolone), anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline); pregnancy (I-II trimester), lactation period; elderly age; alcohol consumption. Use during pregnancy and lactation The use of the preparation is contraindicated in the III trimester of pregnancy. Flurbiprofen use should be avoided in the I-II trimester of pregnancy; if the preparation needs to be used, consult your doctor. There are reports that flurbiprofen may be present in breast milk in negligible amounts without any negative impact on the health of the nursing infant, however, due to potential side effects, the use of NSAIDs during lactation is not recommended. Dosage and administration Read the instructions for use carefully before using the preparation. For local use. For short-term use only. Adults and children over 12 years of age: Slowly suck 1 lozenge every 3-6 hours. Maximum daily dose: 5 lozenges in 24 hours. Duration of treatment: Not more than 3 days. If symptoms persist or worsen within 3 days of taking the preparation, discontinue treatment immediately and consult a doctor. Side effects The use of some NSAIDs, especially at high doses and for prolonged periods, may lead to a slightly increased risk of arterial thrombotic events (e.g., myocardial infarction or stroke). Existing data are insufficient to exclude a similar risk factor when using flurbiprofen 8.75 mg lozenges. Hypersensitivity reactions to NSAIDs have been reported, which may manifest as: non-specific allergic and anaphylactic reactions; respiratory tract hyperreactivity, including asthma, asthma exacerbation, bronchospasm, dyspnea. Various skin reactions, such as itching, urticaria, angioneurotic edema, and rarely, exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme). Cases of edema, arterial hypertension, and heart failure have been reported in patients taking NSAIDs. The risk of side effects can be minimized by using the preparation for a short course at the minimum effective dose necessary to control symptoms. The side effects listed below were observed with short-term use of the preparation. Other side effects are expected with chronic conditions and long-term use. The frequency of side effects was assessed according to the following criteria: very common (>1/10), common (>1/10 to <1/10), uncommon (>1/1000 to <1/100), rare (>1/10,000 to <1/1000), very rare (<1/10,000), frequency unknown (frequency cannot be estimated from available data). Disorders of the blood and lymphatic system Frequency unknown: Blood formation disorders (anemia, thrombocytopenia). Nervous system disorders Common: Dizziness, headache, paresthesia. Uncommon: Drowsiness. Immune system disorders Rare: Anaphylactic reactions. Cardiac disorders Frequency unknown: Heart failure, edema. Vascular disorders Frequency unknown: Increased blood pressure. Respiratory, thoracic and mediastinal disorders Common: Sensation of irritation in the throat. Uncommon: Exacerbation of asthma and bronchospasm, dyspnea, wheezing, blisters in the mouth and throat, pharyngeal hypesthesia (reduced sensation in the mouth and throat). Gastrointestinal disorders Common: Diarrhea, oral ulceration, vomiting, oral pain, oral paresthesia, oral and pharyngeal pain, oral discomfort (sensation of heat, burning, and tingling in the mouth). Uncommon: Abdominal bloating, abdominal pain, constipation, dry mouth, dyspepsia, flatulence, glossalgia (burning mouth syndrome), dysgeusia (altered taste sensation), oral dysesthesia, vomiting. Skin and subcutaneous tissue disorders Uncommon: Rash, itching. Frequency unknown: Severe skin reactions, such as bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome). Hepatic and biliary system disorders Frequency unknown: Hepatitis. Psychiatric disorders Uncommon: Insomnia. Other Uncommon: Fever, pain. Overdose Symptoms: Vomiting, nausea, epigastric pain or, rarely, diarrhea, tinnitus, headache, and gastrointestinal bleeding. In more severe cases, central nervous system events have been observed: drowsiness, rarely – agitation, convulsions, visual disturbances, disorientation, coma. In severe poisoning, metabolic acidosis and increased prothrombin time, acute renal failure, liver tissue damage, decreased blood pressure, respiratory depression, and cyanosis may develop. In patients with bronchial asthma, exacerbation of this disease is expected. Treatment: Symptomatic, with essential provision of airway patency, monitoring of ECG and vital signs until the patient's condition normalizes. Oral administration of activated charcoal or gastric lavage within one hour of ingesting a potentially toxic dose of flurbiprofen is recommended. Frequent or prolonged seizures should be managed by intravenous administration of diazepam or lorazepam. Bronchodilators are recommended for exacerbation of bronchial asthma. There is no specific antidote for flurbiprofen. Interactions with other drugs Avoid concomitant use of flurbiprofen with the following drugs: Acetylsalicylic acid: Except for low-dose acetylsalicylic acid (not exceeding 75 mg per day) prescribed by a doctor, as concomitant use may increase the risk of side effects. Other NSAIDs, including ibuprofen and cyclooxygenase-2 selective inhibitors: Avoid concomitant use of two or more drugs from the NSAID group due to the increased risk of side effects. Use with caution with the following drugs: Anticoagulants: NSAIDs may enhance the effect of anticoagulants, particularly warfarin. Antiplatelet agents and selective serotonin reuptake inhibitors: High risk of gastrointestinal bleeding. Hypotensive agents (ACE inhibitors and angiotensin II antagonists) and diuretics: NSAIDs may reduce the efficacy of these drugs and increase nephrotoxicity due to cyclooxygenase inhibition, especially in patients with impaired renal function (adequate fluid intake should be ensured in these patients). Alcohol: Increased risk of side effects, especially gastrointestinal bleeding, is expected. Cardiac glycosides: Concomitant use of NSAIDs and cardiac glycosides may complicate heart failure, reduce glomerular filtration rate, and increase plasma concentrations of cardiac glycosides. Cyclosporine: Increased risk of nephrotoxicity with concomitant use of NSAIDs and cyclosporine. Glucocorticosteroids: Increased risk of gastrointestinal ulceration and gastrointestinal bleeding. Lithium preparations: There is evidence of an increased probability of increased lithium concentrations in plasma with NSAID use. Methotrexate: There is evidence of an increased probability of increased methotrexate concentrations in plasma with NSAID use. NSAIDs should be taken with a 24-hour interval before or after methotrexate. Mifepristone: NSAID use should begin at least 8-12 days after completion of mifepristone use, as NSAIDs may reduce the effectiveness of mifepristone. Quinolone antibiotics: Patients taking NSAIDs and quinolone antibiotics concurrently may have an increased risk of seizures. Tacrolimus: Concomitant use of NSAIDs and tacrolimus increases the risk of nephrotoxicity. Zidovudine: Concomitant use of NSAIDs and zidovudine may increase hematotoxicity. Oral hypoglycemic agents: Changes in blood glucose levels are expected (frequent monitoring of blood glucose levels is recommended). Phenytoin: Increased serum levels of phenytoin are expected (serum phenytoin monitoring and dose adjustment if necessary are recommended). Potassium-sparing diuretics: Concomitant use of potassium-sparing diuretics and flurbiprofen may cause hyperkalemia. Probenecid and sulfinpyrazone: Drugs containing probenecid or sulfinpyrazone may inhibit the excretion of flurbiprofen. Tolbutamide and antacids: Studies to date have not revealed interactions between flurbiprofen and tolbutamide or antacids. Special instructions It is recommended to take the preparation for a maximum short course of treatment at the minimum effective dose necessary to eliminate symptoms. Diabetic patients should consider that each honey-lemon lozenge contains approximately 2.5 g of sugar (0.21 bread units). In case of gastropathy symptoms, strict monitoring is indicated, including esophagogastroduodenoscopy, complete blood count (hemoglobin determination), and fecal occult blood test. If 17-ketosteroids need to be determined, the preparation should be discontinued 48 hours before the examination. Ethanol intake is not recommended during treatment. Patients with renal or hepatic insufficiency, as well as the elderly and patients taking diuretics, should consult a doctor before using the preparation, as there is a risk of worsening renal function. The risk is negligible with short-term use of the preparation. Patients with arterial hypertension, including those with a history and/or chronic heart failure, should consult a doctor before using the preparation, as the preparation may cause fluid retention, increased blood pressure, and edema. Information for women planning pregnancy: The preparation inhibits cyclooxygenase and prostaglandin synthesis and may affect ovulation, leading to impaired female reproductive function (reversible after discontinuation of treatment). If irritation of the oral mucosa, rash, damage to mucous membranes, or other allergic reactions occur, discontinue use of the preparation and consult a doctor. If symptoms worsen or new ones appear, including signs of bacterial infection, consult a doctor immediately to review the therapy. Effect on ability to drive and operate machinery Patients experiencing dizziness, drowsiness, blurred vision, or visual disturbances while using flurbiprofen should not drive vehicles or operate machinery. Dosage form Lozenges, 8.75 mg. 4, 6, 8, 10 or 12 lozenges are placed in a blister (PVC/PVDC/Aluminum). 1, 2, 3, 4, or 5 blisters are placed in a cardboard box together with the instructions for use. Storage conditions Store at a temperature not exceeding 25°C. Keep out of reach of children. Shelf life 3 years. Do not use after the expiry date. Dispensing conditions Pharmaceutical product group III, available without a prescription.