Strepsils Intensive tablets honey-lemon, No. 24

To relieve sore throat with infectious and inflammatory diseases of the oral cavity and pharynx (as a symptomatic agent).

Read the instructions carefully before using the drug.

For topical use.

For short term use only.

Adults and children over 12 years of age: Slowly dissolve 1 tablet every 3-6 hours.

Maximum daily dose: 5 tablets in 24 hours. Duration of the course of therapy: no more than 3 days. If, after taking the drug for 3 days, the symptoms persist or worsen, it is necessary to stop treatment and consult a doctor.

One lozenge contains the active ingredient: flurbiprofen 8.75 mg,

excipients: lozenges [honey-lemon]: 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 flavor (502904 A ) 3.6 mg.

Х Hypersensitivity to flurbiprofen or any of the components that make up the drug.

Х A history of hypersensitivity reactions (bronchial asthma, bronchospasm, rhinitis, Quincke's edema, urticaria, recurrent polyposis of the nose or paranasal sinuses) in response to the use of acetylsalicylic acid or other NSAIDs.

Х Erosive and ulcerative diseases of the gastrointestinal tract (including peptic ulcer and duodenal ulcer, Crohn's disease, ulcerative colitis) or ulcerative bleeding in the acute phase or in history (two or more confirmed episodes of peptic ulcer or ulcerative bleeding).

Х Bleeding or perforation of gastrointestinal ulcers in history, provoked by the use of NSAIDs.

Х Deficiency of glucose-6-phosphate dehydrogenase, hemophilia and other blood clotting disorders (including hypocoagulation), hemorrhagic diathesis.

Х Severe liver failure or active liver disease.

Х Renal failure of severe severity (creatinine clearance <30 ml / min), confirmed hyperkalemia.

Х Decompensated heart failure; period after coronary artery bypass grafting.

Х Deficiency of sucrase / isomaltase, fructose intolerance, glucose-galactose malabsorption.

Х Pregnancy (III trimester).

Х Children under 12 years of age.

Precautions: If you have the conditions listed in this section, you should consult your doctor before using the drug. Concomitant use of other NSAIDs; a history of a single episode of gastric ulcer or gastrointestinal ulcer bleeding; history of gastrointestinal tract diseases (ulcerative colitis, Crohn's disease), gastritis, enteritis, colitis, Helicobacter pylori infection; bronchial asthma or allergic diseases in the stage of exacerbation or in history - the development of bronchospasm is possible; systemic lupus erythematosus or mixed connective tissue disease (Sharp's syndrome) - the risk of aseptic meningitis is increased (with short-term use of flurbiprofen, the risk is negligible); renal failure, including dehydration (creatinine clearance less than 30-60 ml / min), nephrotic syndrome;liver failure, liver cirrhosis with portal hypertension, hyperbilirubinemia; arterial hypertension and / or heart failure, edema; concomitant use of drugs that can increase the risk of ulcers or bleeding, in particular 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, breastfeeding period; elderly age; alcohol consumption.which can increase the risk of ulceration or bleeding, in particular 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, breastfeeding period; elderly age; alcohol consumption.which can increase the risk of ulcers or bleeding, in particular 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, breastfeeding period; elderly age; alcohol consumption.breastfeeding period; elderly age; alcohol consumption.breastfeeding period; elderly age; alcohol consumption.

Application during pregnancy and breastfeeding:

The use of the drug in the third trimester of pregnancy is contraindicated.

Avoid the use of flurbiprofen in the I-II trimesters of pregnancy, if necessary, consult a doctor. There is evidence that small amounts of flurbiprofen can pass into breast milk without any negative consequences for the health of an infant, however, due to the possible side effects of NSAIDs, the use of the drug during breastfeeding is not recommended.

Pharmacology.

Flurbiprofen is a propionic acid derivative from the group of non-steroidal anti-inflammatory drugs (NSAIDs) and has a significant analgesic, anti-inflammatory and antipyretic effect by suppressing cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2), with some COX selectivity -1, as a result of which the production of prostaglandins - mediators of pain, inflammation and hyperthermic reaction - decreases. The drug has a local analgesic and anti-inflammatory effect on the mucous membrane of the mouth and throat: reduces swelling, difficulty in swallowing, pain and irritation in the throat. The tablet dissolves completely in the mouth within 5-12 minutes. The calming effect starts from the 2nd minute.A significant reduction in the intensity of sore throat begins at 22 minutes with a maximum effect after 70 minutes and lasts up to 4 hours.

Pharmacokinetics:

The tablet dissolves completely in the mouth within 5-12 minutes. Absorption - high, flurbiprofen is rapidly and almost completely absorbed, distributed throughout the body and largely binds to plasma proteins. Flurbiprofen is detected in the blood after 5 minutes, the maximum concentration of flurbiprofen in the blood plasma (Cmax) is reached 40Ц45 minutes after resorption. Flurbiprofen can be absorbed in the oral cavity by passive diffusion. The absorption rate depends on the dosage form, with resorption, the maximum concentration of flurbiprofen is reached faster than when an equivalent dose of flurbiprofen is taken orally. The half-life (T1 / 2) is 3-6 hours. It is metabolized in the liver by hydroxylation and excreted by the kidneys and, to a lesser extent, with bile.Flurbiprofen is excreted in breast milk in small amounts (<0.05 ?g / ml). Approximately 20-25% of an oral dose of flurbiprofen is excreted unchanged.

Special instructions:

It is recommended to take the drug in the shortest possible course and in the minimum effective dose necessary to eliminate symptoms. Patients with diabetes should take into account that each honey-lemon lozenge contains about 2.5 g of sugar (0.21 XE) (orange lozenges do not contain sugar). Orange lozenges in the composition contain liquid maltitol and isomalt (the maximum daily dose of which exceeds 2 g), therefore, they can have a laxative effect. When symptoms of gastropathy appear, careful monitoring is shown, including esophagogastroduodenoscopy, general blood count (hemoglobin determination), and fecal occult blood test. If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study.During the period of treatment, it is not recommended to take ethanol. Patients with renal or hepatic impairment, as well as elderly patients and patients taking diuretics, should consult a doctor before using the drug, as there is a risk of deterioration in the functional state of the kidneys. With short-term use of the drug, the risk is negligible. Patients with arterial hypertension, including a history of and / or chronic heart failure, should consult a doctor before using the drug, as the drug can cause fluid retention, increased blood pressure and edema. Information for women planning pregnancy: the drug inhibits cyclooxygenase and prostaglandin synthesis and can affect ovulation,disrupting female reproductive function (reversible after discontinuation of treatment). If irritation occurs in the oral cavity, skin rash, mucosal lesions and other manifestations of an allergic reaction, you should stop using the drug and consult a doctor. If existing symptoms worsen or new ones appear, including when signs of a bacterial infection appear, you should immediately consult a doctor to review therapy. Patients who report dizziness, drowsiness, lethargy or visual impairment while taking flurbiprofen should avoid driving or operating machinery.If existing symptoms worsen or new ones appear, including when signs of a bacterial infection appear, you should immediately consult a doctor to review therapy. Patients who report dizziness, drowsiness, lethargy or visual impairment while taking flurbiprofen should avoid driving or operating machinery.If existing symptoms worsen or new ones appear, including when signs of a bacterial infection appear, you should immediately consult a doctor to review therapy. Patients who report dizziness, drowsiness, lethargy or visual impairment while taking flurbiprofen should avoid driving or operating machinery.

Side effect:

Blood and lymphatic system disorders

Х Frequency unknown: hematopoietic disorders (anemia, thrombocytopenia).

Nervous system disorders

Х Often: dizziness, headache, paresthesia.

Х Uncommon: drowsiness.

Immune system disorders

Х Rarely: anaphylactic reactions.

Heart disorders

Х Frequency unknown: heart failure, edema.

Vascular disorders

Х Frequency unknown: increased blood pressure.

Respiratory, Chest and Mediastinal Disorders

Х Often: Sore throat feeling.

Х Uncommon: exacerbation of asthma and bronchospasm, shortness of breath, wheezing, blisters in the mouth and pharynx, pharyngeal hypoesthesia (decreased sensitivity in the mouth and pharynx).

Gastrointestinal disorders

Х Often: diarrhea, oral ulceration, nausea, pain in the mouth, oral paresthesia, pain in the mouth and pharynx, discomfort in the mouth (warmth, burning or tingling sensation in the mouth).

Х Uncommon: bloating, abdominal pain, constipation, dry mouth, dyspepsia, flatulence, glossalgia (burning mouth syndrome), dysgeusia (change in taste perception), oral dysesthesia, vomiting.

Skin and subcutaneous tissue disorders

Х Uncommon: skin rash, itching.

Х Frequency not known: Severe skin reactions such as bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome).

Liver and biliary tract disorders

Х Frequency not known: hepatitis.

Mental disorders

Х Uncommon: insomnia.

Other

Х Uncommon: fever, pain.

Overdose:

Symptoms include nausea, vomiting, epigastric pain or, less commonly, diarrhea, tinnitus, headache, and gastrointestinal bleeding. In more severe cases, manifestations from the central nervous system are observed: drowsiness, rarely - agitation, convulsions, disorientation, coma. In cases of severe poisoning, metabolic acidosis and an increase in prothrombin time, acute renal failure, liver tissue damage, decreased blood pressure, respiratory depression and cyanosis may develop. In patients with bronchial asthma, an exacerbation of this disease is possible.

Treatment: symptomatic, with mandatory provision of airway patency, ECG monitoring and vital signs until the patient's condition is normalized. Oral administration of activated charcoal or gastric lavage is recommended within one hour of taking a potentially toxic dose of flurbiprofen. Frequent or prolonged seizures should be treated with intravenous diazepam or lorazepam. When bronchial asthma worsens, the use of bronchodilators is recommended. There is no specific antidote for flurbiprofen.

Interaction with other medicinal products:

The simultaneous use of flurbiprofen with the following drugs should be avoided:

Х Acetylsalicylic acid: with the exception of low doses of acetylsalicylic acid (no more than 75 mg per day) prescribed by your doctor, since combined use may increase the risk of side effects.

Х Other NSAIDs, including ibuprofen and selective cyclooxygenase-2 inhibitors: the simultaneous use of two or more drugs from the NSAID group should be avoided due to the possible increased risk of side effects. Use with caution simultaneously with the following drugs:

Х Anticoagulants: NSAIDs can enhance the effect of anticoagulants, in particular warfarin.

Х Antiplatelet agents and selective serotonin reuptake inhibitors: increased risk of gastrointestinal bleeding.

Х Antihypertensives (ACE inhibitors and angiotensin II antagonists) and diuretics: NSAIDs can reduce the effectiveness of these groups of drugs and can increase nephrotoxicity due to inhibition of cyclooxygenase, especially in patients with impaired renal function (it is necessary to ensure adequate fluid replacement in such patients).

Х Alcohol: there may be an increased risk of adverse reactions, especially bleeding in the gastrointestinal tract.

Х Cardiac glycosides: the simultaneous use of NSAIDs and cardiac glycosides can lead to worsening heart failure, decreased glomerular filtration rate and increased plasma concentration of cardiac glycosides.

Х Cyclosporine: increased risk of nephrotoxicity with concomitant use of NSAIDs and cyclosporine.

Х Glucocorticosteroids: increased risk of gastrointestinal ulcers and gastrointestinal bleeding.

Х Lithium preparations: there is evidence of the likelihood of an increase in the concentration of lithium in the blood plasma with the use of NSAIDs.

Х Methotrexate: there is evidence of the likelihood of an increase in the concentration of methotrexate in blood plasma with the use of NSAIDs. You must take NSAIDs 24 hours before or after you take methotrexate.

Х Mifepristone: NSAIDs should be started no earlier than 8-12 days after the end of mifepristone, as NSAIDs can reduce the effectiveness of mifepristone.

Х Quinolone antibiotics: in patients receiving concomitant treatment with NSAIDs and quinolone antibiotics, there may be an increased risk of seizures.

Х Tacrolimus: with the simultaneous use of NSAIDs and tacrolimus may increase the risk of nephrotoxicity.

Х Zidovudine: Concomitant use of NSAIDs and zidovudine may increase hematotoxicity.

Х Oral hypoglycemic drugs: changes in blood glucose levels are possible (it is recommended to increase the frequency of blood glucose monitoring).

Х Phenytoin: an increase in serum phenytoin levels is possible (monitoring of serum phenytoin levels and, if necessary, dose adjustments is recommended).

Х Potassium-sparing diuretics: Concomitant use of potassium-sparing diuretics and flurbiprofen can lead to hyperkalemia.

Х Probenecid and sulfinpyrazone: Medicines containing probenecid or sulfinpyrazone may delay the elimination of flurbiprofen.

Х Tolbutamide and antacids: To date, no interactions have been identified between flurbiprofen and tolbutamide or antacids.