Ibuklin tablets p/o 400mg/325mg №10×2

Name:
Ibuklin tablets. Derivatives of propionic acid. ATC code: M01AE51 Composition Each tablet contains active ingredients: ibuprofen – 400 mg, paracetamol – 325 mg. Excipients: microcrystalline cellulose, corn starch, glycerin, sodium starch glycolate, anhydrous colloidal silicon dioxide, purified talc, magnesium stearate, hypromellose (6 cps), macrogol (polyethylene glycol 6000), orange yellow FCF varnish (E 110), titanium dioxide (E171) ), sorbic acid, polysorbate 80, dimethicone.
Description:
Film-coated tablets, orange or pale orange in color, spotty or marble heterogeneity of color is possible, capsule-shaped, with bevelled edges, one side is smooth, on the other there is a risk. Pharmacological propertiesPharmacodynamics Ibuprofen is a non-steroidal anti-inflammatory drug, a derivative of phenylpropionic acid, has anti-inflammatory, antipyretic and analgesic effects, by inhibiting the activity of COX, the main enzyme responsible for the metabolism of arachidonic acid, which is a precursor of prostaglandins, which play a major role in the pathogenesis of inflammation, pain and fever. The analgesic effect is due to both peripheral (directly, through a decrease in prostaglandin synthesis) and the central mechanism (inhibition of prostaglandin synthesis in the central and peripheral nervous system). Suppresses platelet aggregation. Paracetamol is a non-narcotic analgesic that has an analgesic, antipyretic and weak anti-inflammatory effect by suppressing the activity of COX and reducing the production of prostaglandins; It has a predominant effect on the thermoregulatory center in the hypothalamus. Pharmacokinetics Ibuprofen after oral administration is rapidly and almost completely absorbed from the gastrointestinal tract. The maximum concentration in the blood after taking the film-coated tablets is determined after 1-2 hours. In the synovial fluid, the maximum concentration is reached 3 hours after ingestion. Ibuprofen is metabolized in the liver (90%). It is excreted by the kidneys (80% of the administered dose) both unchanged (10%) and as metabolites (70%). 20% is excreted as metabolites through the intestines. The half-life is about 2-3 hours. Paracetamol is rapidly absorbed from the gastrointestinal tract, mainly in the small intestine, after a single dose, the maximum concentration in the blood is reached after 10-60 minutes, then gradually decreases. Paracetamol is well distributed in tissues and fluids, with the exception of adipose tissue and cerebrospinal fluid. Protein binding is less than 10%. It is metabolized mainly in the liver by binding to glucuronide, sulfate and oxidation with the participation of liver oxidases and cytochrome P450. In adults, most paracetamol binds to glucuronic acid, in children – to sulfuric acid. These conjugated metabolites have no metabolic activity and do not bind to plasma proteins. Also, in case of an overdose, an accumulation of a hydroxylated metabolite with a toxic effect, N-acetyl-p-benzoquinoneimine, can occur, which is formed in the liver and kidneys under the influence of mixed oxidases and, under normal conditions, is detoxified by binding to glutathione. The half-life is 1-3 hours and may increase with cirrhosis of the liver. Renal clearance of paracetamol is 5%. It is excreted unchanged (about 5%) and in the form of glucuronide and sulfate conjugates. Indications for useTemporary relief of mild to moderate pain caused by migraine, headache, back pain, toothache, menstrual pain, rheumatic and muscle pain, pain in uncomplicated and / or non-severe forms of arthritis, sore throat, pain syndromes in inflammatory diseases ENT organs. This drug is recommended for use in cases where the analgesic effect of monotherapy with ibuprofen or paracetamol is not enough. Method of application and dosage regimen For adults, Ibuklin is usually prescribed 1 tablet 2-3 times a day after meals. The maximum daily dose is 3 tablets, the interval between doses should not be less than 8 hours. The drug should not be taken for more than 5 days as an anesthetic. If symptoms persist for more than 3 days or worsen, a doctor should be consulted. In order to minimize the risk of developing adverse reactions, ibuprofen should be taken at the lowest effective dose and for the shortest period necessary to achieve a clinical effect. Side effects The results of clinical trials suggest a possible relationship between taking ibuprofen, especially when taken at high doses (? 2400 mg / day), and a slight increased risk of developing arterial thrombotic events (for example, myocardial infarction and stroke). The following adverse reactions are classified by organs, systems and frequency of occurrence, with the most common listed first. Classification of the frequency of occurrence of adverse reactions: very often (? 1/10), often (> 1/100 and ? 1/10), infrequently (> 1/1000 and ? 1/100), rarely (> 1/10000 and ? 1 /1000), very rare (? 1/10000, including single messages). For each frequency in the group, adverse reactions are arranged in order of increasing severity. Blood system and lymphatic system: very rarely – violation of hematopoiesis (agranulocytosis, anemia, aplastic anemia, hemolytic anemia, leukopenia, neutropenia, pancytopenia, thrombocytopenia). Immune system: very rarely – hypersensitivity reactions (nonspecific allergic reactions and anaphylaxis). Mental disorders: very rarely – confusion, depression, hallucinations. Nervous system: infrequently – headache and dizziness; very rarely – paresthesia, optic neuritis, drowsiness, aseptic meningitis. Organ of vision: very rarely – visual impairment. Organ of hearing and vestibular apparatus: very rarely – tinnitus and dizziness. Cardiovascular system: very rarely – edema, hypertension, heart failure. Respiratory system and chest organs: very rarely – asthma, worsening of asthma, bronchospasm, dyspnea. Digestive system: often – abdominal pain, diarrhea, dyspepsia, nausea, stomach discomfort, vomiting; infrequently – flatulence, constipation, gastric ulcer, perforation or gastrointestinal bleeding with symptoms of melena, hematemesis, sometimes fatal, more often in the elderly, ulcerative stomatitis, exacerbation of ulcerative colitis and Crohn’s disease, gastritis, pancreatitis. Hepatobiliary system: very rarely – abnormal liver function, hepatitis, jaundice, acute liver failure, liver necrosis, liver damage (with an overdose of paracetamol). Skin and subcutaneous fat: infrequently – a rash of various types, including itching and urticaria, Quincke’s edema and swelling of the face; very rarely – hyperhidrosis, purpura, photosensitivity, exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis. Kidneys and urinary system: very rarely – nephrotoxicity in various forms, including interstitial nephritis, nephrotic syndrome, acute and chronic renal failure. General disorders: very rarely – fatigue and malaise. Research: often – increased ALT and gamma-glutamyl transferase, impaired liver function tests, increased creatinine and urea; infrequently – an increase in AST, alkaline phosphatase and CPK, a decrease in hemoglobin, an increase in the number of platelets. The first signs of impaired hematopoiesis are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, emaciation, unexplained bleeding and bruising, epistaxis. Hypersensitivity reactions were manifested by swelling of the face, tongue and larynx, dyspnea, tachycardia, hypotension, Quincke’s edema, anaphylactic shock. Isolated cases of aseptic meningitis have been reported in patients with autoimmune disorders (such as systemic lupus erythematosus and systemic connective tissue diseases) treated with ibuprofen, accompanied by symptoms of neck stiffness, headache, nausea, vomiting, fever, or confusion. ContraindicationsIncreased individual sensitivity to the components of the drug; a history of hypersensitivity reactions (bronchospasm, urticaria, asthma, rhinitis, rash and other allergic symptoms) when using acetylsalicylic acid or other NSAIDs; acute ulcer of the stomach or intestines; gastrointestinal bleeding or perforation, as well as patients with a history of these diseases, including those associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs); diseases of the blood system, defects in coagulation hemostasis; damage to the optic nerve; impaired renal function with a decrease in glomerular filtration rate less than 30 ml / min; liver or kidney disease; severe heart failure (NYHA IV); combined use with other NSAIDs, including COX-2 inhibitors and acetylsalicylic acid more than 75 mg / day – increases the risk of adverse reactions; combined use with paracetamol-containing drugs – increased risk of adverse reactions; genetically determined lack of glucose-6-phosphate dehydrogenase; pregnancy; lactation; age up to 18 years. Ingestion of 5 g of paracetamol or more can lead to liver damage if the patient has one or more risk factors: long-term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. John’s wort, or other drugs that induce liver enzymes; regular alcohol consumption above safe doses; glutathione deficiency, which can be observed in eating disorders; cystic fibrosis, HIV infection, starvation, cachexia. Symptoms: symptoms of an overdose of paracetamol in the first 24 hours include pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent between 12 and 48 hours after ingestion, when liver function changes. Dysfunction of glucose metabolism and metabolic acidosis may develop. In severe poisoning, liver failure can progress to encephalopathy, bleeding, hypoglycemia, cerebral edema, and death. Acute renal failure with acute tubular necrosis, manifested by low back pain, hematuria, and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and the development of pancreatitis were also registered. Treatment: An overdose of paracetamol requires immediate medical attention, even in the absence of symptoms in the early period. An overdose may present only with nausea or vomiting and may not be consistent with the severity of poisoning or the risk of organ damage. Treatment should be guided by locally established principles of therapy. Reception of activated charcoal is required within 1 hour after taking paracetamol inside. Plasma concentrations of paracetamol should be assessed 4 hours or later after taking the drug (earlier determination of the concentration is unreliable). Treatment with N-acetylcysteine can be used within 24 hours after taking paracetamol, however, the maximum protective effect develops when taking acetylcysteine within 8 hours after taking paracetamol. The effectiveness of the antidote action after this time is sharply reduced. In the absence of vomiting, oral methionine may be used as an alternative if acetylcysteine cannot be given. Management of patients with severe liver damage beyond 24 hours after taking paracetamol should be carried out in accordance with local practice. Ibuprofen symptoms. Most patients who have taken a clinically significant amount of NSAIDs develop nausea, vomiting, epigastric pain, and less often diarrhea. There may also be tinnitus, headache, and gastrointestinal bleeding. In more severe cases, central nervous system toxicity may develop, manifested by drowsiness, sometimes agitation and confusion, or coma. Sometimes seizures develop. In severe cases, it is possible to develop metabolic acidosis, prolongation of prothrombin time / INR, probably associated with an effect on circulating blood coagulation factors. Acute renal failure and liver damage may occur, especially in the presence of dehydration. Patients suffering from bronchial asthma may develop an exacerbation. Treatment. Treatment should be symptomatic and supportive and include maintaining an airway and monitoring cardiac and vital functions until the condition stabilizes. Oral administration of activated charcoal is recommended within 1 hour of a potentially toxic dose. Precautions Elderly patients: the risk of adverse reactions, especially from the gastrointestinal tract (bleeding, perforation) in this category of patients is higher, and therefore caution is recommended when using the drug. Respiratory diseases: NSAIDs can cause bronchospasm in patients suffering from bronchial asthma or allergic diseases. Cardiovascular system: NSAIDs can cause fluid retention and edema, and therefore may worsen the condition of patients suffering from arterial hypertension and / or heart failure. The results of clinical trials suggest a possible relationship between taking ibuprofen, especially at high doses (? 2400 mg / day), with a slight increased risk of developing arterial, thrombotic events (for example, myocardial infarction and stroke). Epidemiological studies do not suggest a relationship between low-dose ibuprofen (≥ 1200 mg/day) and an increased risk of arterial thrombotic events. In patients with uncontrolled hypertension, NYHA class II-III congestive heart failure, established coronary artery disease, peripheral arterial disease, and/or cerebrovascular disease, ibuprofen should only be used after a careful benefit-risk assessment, and high doses of ibuprofen should be avoided. (2400 mg/day). Prior to the initiation of long-term ibuprofen therapy, especially at high doses (≥ 2400 mg / day), in patients with risk factors for the development of cardiovascular complications (for example, hypertension, hyperlipidemia, diabetes mellitus, smoking), a careful assessment of the benefit-risk ratio is necessary. Gastrointestinal tract: NSAIDs can cause bleeding, ulcers and perforation of the gastrointestinal tract, including in patients with no previous history of gastrointestinal disease. The risk of these complications is higher in patients with a burdened history, when using high doses of NSAIDs, in elderly patients, and therefore in this group it is recommended to start therapy with the minimum recommended dose. You should also consider the use of drugs such as misoprostol or proton pump inhibitors in this category of patients, as well as those requiring concomitant use of low doses of salicylic acid or other drugs that can increase the risk of side effects from the gastrointestinal tract (corticosteroids, anticoagulants, inhibitors of the reverse serotonin uptake, etc.). Patients with a history of episodes of gastrointestinal bleeding should be informed of the need to inform the attending physician about the occurrence of any unusual symptoms from the gastrointestinal tract, especially at the initial stage of therapy. If symptoms of a gastrointestinal ulcer or bleeding occur, the drug should be discontinued immediately. NSAIDs should be used with caution in patients with a history of gastrointestinal disease (ulcerative colitis, Crohn’s disease) due to the risk of deterioration. Systemic diseases: In patients with systemic lupus erythematosus and other connective tissue diseases, NSAIDs may increase the risk of developing aseptic meningitis. Dermatological disorders: very rarely, when using NSAIDs, severe reactions from the skin were observed, including those with a fatal outcome (exfoliative dermatitis, Steven-Johnson syndrome, toxic epidermal necrolysis). The risk of these disorders is higher during the first month of taking NSAIDs. In this regard, you should stop taking the drug in case of any rashes on the skin and mucous membranes, as well as any other signs of hypersensitivity. Renal dysfunction: the risk of complications is higher in patients in whom the production of prostaglandins plays a compensatory role in maintaining renal blood flow (dehydration, impaired liver and kidney function, heart failure, severe atherosclerosis, taking diuretics, ACE inhibitors, elderly patients). In this regard, when prescribing the drug to patients at risk, the following precautions are recommended: monitoring of liver and kidney functions when prescribing the drug to elderly patients, patients with arterial hypertension and diabetes mellitus during the first week of administration when prescribing the drug for more than 1 week. Serum creatinine control blood 48-72 hours after the start of taking the drug in patients with chronic heart failure and chronic renal failure with a glomerular filtration rate of less than 60 ml / min. Also, the drug should be used with caution in patients with impaired liver or kidney function, immediately after surgical interventions, with a history of allergic reactions associated with the use of NSAIDs, polyps of the nasal mucosa. With prolonged (more than 5 days) taking the drug, monitoring of peripheral blood and the functional state of the liver and kidneys is necessary. If there are signs of impaired renal function (back pain, decrease in daily urine volume, edema) or liver (pain in the hypochondrium, jaundice, discoloration of urine), the drug should be stopped immediately and consult your doctor. In order to avoid a possible hepatotoxic effect of the drug, it is recommended to refrain from drinking alcohol during treatment. Pregnancy and lactation During pregnancy and lactation, the use of the drug is not recommended. If it is necessary to take during lactation, it is necessary to resolve the issue of transferring to artificial feeding. The drug can affect female fertility, and therefore its use is not recommended for patients who are about to become pregnant. In women who have problems conceiving, the drug should be discontinued. Influence on the ability to drive vehicles and other mechanisms When using the drug, the patient is recommended to refrain from engaging in potentially hazardous activities that require increased attention and speed of psychomotor reactions. Drug Interactions This drug (as with any paracetamol-containing drugs) is contraindicated in combination with other paracetamol-containing drugs due to an increased risk of serious side effects (see section “Side Effects”). This drug (like any other drugs containing ibuprofen and NSAIDs) is contraindicated in combination with: acetylsalicylic acid: the simultaneous use of ibuprofen and acetylsalicylic acid is not recommended due to a possible increase in the development of adverse events. Based on the results of laboratory studies, it is assumed that ibuprofen, when used simultaneously with low doses of acetylsalicylic acid, can competitively inhibit platelet aggregation. Although the admissibility of extrapolating these data to clinical practice remains uncertain, the possible effect of regular long-term ibuprofen use on reducing the cardioprotective effect of low doses of acetylsalicylic acid cannot be ruled out. The effect of episodic use of ibuprofen on the cardioprotective properties of acetylsalicylic acid seems unlikely. possible increased risk of side effects (see section “Side effects”). This drug (as well as any other drugs containing paracetamol) should be used with caution in combination with: chloramphenicol: increased plasma concentration of chloramphenicol. cholestyramine: decreased rate of absorption of paracetamol . If maximum pain relief is required, cholestyramine should be taken no earlier than one hour after taking Ibuklin. Metoclopramide and domperidone: the absorption of paracetamol increases. It is necessary to avoid co-administration of these drugs with warfarin: the effect of warfarin and other coumarins may be enhanced by long-term regular use of paracetamol with an increased risk of bleeding. Single use does not have a significant effect. This drug (like any other drugs containing ibuprofen and NSAIDs) should be used with caution in combination with: anticoagulants: NSAIDs may increase the effect of anticoagulants, such as warfarin. antihypertensives: NSAIDs may reduce the effects of these drugs. and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding. However, limited data and uncertainties in extrapolating study results to clinical practice make it impossible to draw a conclusion for the regular use of ibuprofen. The clinical significance of this effect for a single use of the drug is considered unlikely. Cardiac glycosides: NSAIDs can cause decompensation of heart failure, a decrease in GFR and an increase in plasma levels of cardiac glycosides. Cyclosporine: increased risk of nephrotoxicity. Corticosteroids: increased risk of gastrointestinal bleeding or ulcers. Diuretics: the diuretic effect decreases. Diuretics may increase the risk of NSAID nephrotoxicity. Lithium: Decreased elimination of lithium. Methotrexate: Decreased elimination of methotrexate. Mifepristone: NSAIDs should not be used within 8-12 days after taking mifepristone, as NSAIDs may reduce the effect of mifepristone. Quinolone antibiotics: Animal studies showed that NSAIDs may increase the risk of seizures associated with the use of quinolone antibiotics. In patients taking NSAIDs and quinolones, the risk of developing seizures may increase. Tacrolimus: possible increased risk of nephrotoxicity. Zidovudine: increased risk of hematological toxicity. There have been cases of an increased risk of hemarthrosis and hematoma in HIV (+) patients with hemophilia receiving concurrent treatment with zidovudine and ibuprofen. The risk of developing adverse reactions from the kidneys increases when ibuprofen is co-administered with drugs that affect the renin-angiotensin-aldosterone system away from moisture and light place at temperatures up to 25 °C. Keep out of the reach of children. Shelf life 5 years. Do not use after the expiry date stated on the package. Release from pharmacies Released by prescription. Release form 10 tablets in PVC / aluminum blister. 2 blisters in a cardboard box with instructions for use. Buy Ibuklin tablets p/o 400mg/325mg No. 10×2