Strepsils Intensive spray 8.75mg / dose, 15ml
Expiration Date: 05/2027
Russian Pharmacy name:
Стрепсилс Интенсив спрей 8,75мг/доза, 15мл
Read the instructions carefully before using the drug. For topical use. For short term use only.
Adults and children over 12 years old: spray 1 dose of the drug (3 presses on the dispenser) along the back wall of the oropharynx every 3-6 hours, no more than 5 doses within 24 hours.
Duration of the course of therapy: no more than 3 days. Do not inhale when spraying.
Before the first use of the drug, it is necessary to make at least four clicks on the dispenser in the opposite direction from you until a uniform spray appears.
Before each subsequent use, it is necessary to make at least one press on the dispenser in the opposite direction from you until a uniform spray appears.
1 spray dose (3 pressings on the dispenser) contains:
active substance: flurbiprofen 8.75 mg;
excipients: betadex 22.83 mg, sodium hydrogen phosphate dodecahydrate 17.19 mg, citric acid monohydrate 0.63 mg, methyl parahydroxybenzoate 1.18 mg, propyl parahydroxybenzoate 0.24 mg, sodium hydroxide 1.30 mg, mint flavor (PHL 175628) 1.08 mg, cherry flavor (PHL 175629) 1.35 mg, N-2,3-trimethyl-2-isopropyl butanamide 0.54 mg, sodium saccharinate 0.27 mg, hydroxypropylbetadex 12.09 mg, water 492.55 mg ...
Х Hypersensitivity to flurbiprofen or any of the components of 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), ulcerative bleeding in the active phase or history (two or more confirmed episodes of peptic ulcer or bleeding ulcer).
Х Bleeding or perforation of gastrointestinal ulcers, ulcerative colitis, history of hemorrhagic and hematopoietic disorders, provoked by the use of NSAIDs.
Х Pregnancy (III trimester).
Х Breastfeeding period.
Х Children under 12 years of age.
Х Severe liver failure or active liver disease.
Х Renal failure of severe severity (creatinine clearance <30 ml / min).
Х Decompensated heart failure.
Х The period after coronary artery bypass grafting.
Х Confirmed hyperkalemia.
Х Deficiency of glucose-6-phosphate dehydrogenase.
Х Hemophilia and other blood clotting disorders (including hypocoagulation), hemorrhagic diathesis.
Carefully:
In the presence of diseases and / or conditions specified in this section, you should consult a 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 and other systemic autoimmune diseases of the connective tissue (increased risk of aseptic meningitis) - with short-term use of flurbiprofen, the risk is insignificant; arterial hypertension and / or heart failure, edema;renal failure, including dehydration (creatinine clearance less than 60 ml / min), nephrotic syndrome, hepatic failure, liver cirrhosis with portal hypertension, hyperbilirubinemia (with short-term use of flurbiprofen, the risk is insignificant); 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); alcoholism; I-II trimester of pregnancy; elderly age.hyperbilirubinemia (with short-term use of flurbiprofen, the risk is insignificant); 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); alcoholism; I-II trimester of pregnancy; elderly age.hyperbilirubinemia (with short-term use of flurbiprofen, the risk is insignificant); 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); alcoholism; I-II trimester of pregnancy; elderly age.anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline); alcoholism; I-II trimester of pregnancy; elderly age.anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline); alcoholism; I-II trimester of pregnancy; elderly age.
Pharmacology.
Flurbiprofen is a non-steroidal anti-inflammatory drug (NSAID) derived from propionic acid. Flurbiprofen has analgesic, anti-inflammatory and antipyretic effects due to the suppression of cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2), with some selectivity in relation to COX-1, as a result of which the production of prostaglandins - mediators of pain and inflammation and hyperthermic reaction. When using the drug in a single dose (3 presses on the dispenser), a decrease in pain and difficulty in swallowing is noted after 5 minutes, a significant decrease in pain intensity - after 20 minutes, a decrease in edema 30 minutes after application. The analgesic and decongestant effect of the drug lasts up to 6 hours.
Pharmacokinetics:
When a single dose of the drug is applied (3 presses on the dispenser) on the mucous membrane of the oropharynx, flurbiprofen is rapidly absorbed and determined in blood plasma after 2-5 minutes. The maximum concentration of flurbiprofen in blood plasma is reached 30 minutes after application and is 1.6 ?g / ml, which is 4 times lower than when 50 mg of flurbiprofen is taken orally. Flurbiprofen quickly binds to blood plasma proteins and is distributed throughout the body. Flurbiprofen is metabolized mainly by hydroxylation and excreted by the kidneys, the half-life (T1 / 2) is 3-6 hours. Approximately 20-25% of an oral dose of flurbiprofen is excreted unchanged by the kidneys
Special instructions:
It is recommended to take the drug in the shortest possible course and in the minimum effective dose necessary to eliminate symptoms. 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. 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, you should consult your 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). During the treatment period, alcohol intake is not recommended. 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 must 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: Frequency unknown: anemia, thrombocytopenia.
Nervous system disorders: Often: 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, chest and mediastinal disorders: Often: irritation in the throat. Uncommon: exacerbation of bronchial asthma and bronchospasm, shortness of breath, wheezing, blisters in the mouth and pharynx, pharyngeal hypoesthesia (decreased sensitivity in the mouth and pharynx).
Gastrointestinal tract disorders: Often: diarrhea, oral ulceration, nausea, oral pain, oral paresthesia, pain in the oral cavity and pharynx, oral discomfort (feeling of warmth, burning or tingling sensation in the mouth). 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: Uncommon: skin rash, itching. 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: Frequency unknown: hepatitis.
Mental Disorders: Uncommon: insomnia.
Others: Uncommon: fever, pain. If any of the side effects indicated in the instructions are aggravated or you notice any other side effects not listed in the instructions, inform your doctor.
Overdose:
Symptoms: nausea, vomiting, epigastric pain, less often diarrhea. Tinnitus, headache, gastrointestinal bleeding are also possible. In more severe cases, the following manifestations from the central nervous system are observed: drowsiness, rarely - agitation, blurred vision, disorientation or coma. In rare cases, patients have convulsions. In cases of severe NSAID poisoning, metabolic acidosis, an increase in prothrombin time, may develop, which is probably associated with the effect on the action of blood coagulation factors. Acute renal failure and liver damage, low 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 1 hour after taking a potentially toxic dose of flurbiprofen. Frequent or prolonged seizures should be treated with intravenous diazepam or lorazepam. In case of exacerbation of bronchial asthma, the use of bronchodilators is recommended. There is no specific antidote for flurbiprofen.
Interaction with other medicinal products:
Avoid the simultaneous use of the drug with the following drugs:
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 effects of anticoagulants, including 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 Ethanol: may increase the risk of adverse reactions, especially gastrointestinal bleeding.
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.
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: when used together with NSAIDs, the risk of nephrotoxicity may be increased.
Х Zidovudine: when used together with NSAIDs, the risk of hematotoxicity may be increased.
Х Oral hypoglycemic drugs: may change the concentration of glucose in the blood (it is recommended to increase the frequency of monitoring the concentration of glucose in the blood).
Х Phenytoin: it is possible to increase the concentration of phenytoin in the blood serum (it is recommended to control the concentration of phenytoin in the blood serum and, if necessary, adjust the dose).
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.