Ibuklin for children flavored dispersible tablets 100mg/125mg №10×2

Name:
Ibuklin for children No. 20
Description:
Pills of pink color with white patches, round, without a shell with a risk on one side and a smooth surface on the other Main active ingredient Ibuprofen, paracetamol Release form 10 tablets in PVC / aluminum blister. 2 blisters in a cardboard box with instructions for use. Dosage 20 tablets Pharmacodynamics 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 soluble tablets is determined after 15-45 minutes. 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 widely 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 use Temporary relief of mild to moderate pain associated with migraine, headache, back pain, toothache, menstrual pain, rheumatic and muscle pain, pain in uncomplicated and / or non-severe forms of arthritis, pain syndrome in inflammatory diseases of the ENT organs. Fever in infectious and inflammatory diseases. The drug can be used only in case of ineffectiveness of the use of single-component drugs Paracetamol or Ibuprofen in children older than 3 years and in a short course. Dosage and administration Ibuklin for children should be dissolved in 5 ml (1 teaspoon) of water before use. Children: A single dose depends on the age and weight of the child: children aged 3-14 years (body weight 15-30 kg) – 1 tablet per dose, children over 14 years old – 2 tablets. Take the drug 3-4 times a day. Adults: The drug can be used in adults, 2 tablets 3-4 times a day. A single dose of the drug cannot exceed 2 tablets, the interval between doses of the drug should be at least 6 hours, in case of impaired renal or liver function – at least 8 hours. If symptoms persist for more than 3 days or if the condition worsens, you should consult a doctor. 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. Precautions The risk of adverse effects can be reduced by prescribing the drug at the minimum effective dose for the shortest duration necessary to control symptoms, as well as by taking the drug with food. 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 be used only after a careful benefit-risk assessment and should be avoided. the use of high doses of ibuprofen (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. Renal dysfunction: the risk of complications is higher in patients in whom the production of prostaglandins has a compensatory role to maintain renal blood flow (dehydration, impaired renal and hepatic function, heart failure, severe atherosclerosis, diuretics, angiotensin-converting enzyme inhibitors, elderly patients) . In this regard, when prescribing the drug to patients at risk, the following precautions are recommended: ensuring monitoring of renal function when administered to elderly patients, patients with arterial hypertension and diabetes mellitus during the first week of administration if administered for more than one week; ensuring monitoring of serum creatinine after 48-72 hours from the start of administration in patients with chronic heart failure and chronic renal failure with a glomerular filtration rate of less than 60 ml / min. 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, the use of high doses of NSAIDs, elderly patients, and therefore in this group it is recommended to start therapy with the minimum recommended dose. Consideration should also be given to the use of drugs such as misoprostol or proton pump inhibitors in this category of patients, as well as in those requiring the 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 serotonin reuptake, 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. 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 taking 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. Fertility in women: The use of the drug may lead to impaired fertility in women and is not recommended for women who are planning a pregnancy. In women who have problems conceiving or are under observation for infertility, it is necessary to stop using the drug. Information about excipients: The medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp-lactase deficiency or glucose-galactose malabsorption should not take this medicine. The medicinal product contains aspartame. Patients with phenylketonuria should not take this drug. Interaction with other drugs This drug (as well as any other drugs containing paracetamol) is contraindicated in combination with other drugs containing paracetamol 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; other NSAIDs, including selective cyclooxygenase type 2 inhibitors, tk. may increase the risk of side effects (see section “Side effect”). This drug (like any other drug containing paracetamol) should be used with caution in combination with: chloramphenicol: increased plasma concentrations of chloramphenicol; cholestyramine: the rate of absorption of paracetamol decreases. If maximum pain relief is required, cholestyramine should be taken no earlier than one hour after taking Ibuklin; metoclopramide and domperidone: increased absorption of paracetamol. Avoid co-administration of these drugs; warfarin: the effect of warfarin and other coumarins may be enhanced by long-term regular use of paracetamol with an increased risk of bleeding. A single application does not have a significant effect. This drug (as well as 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; antihypertensive: NSAIDs may reduce the effects of these drugs; antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding; acetylsalicylic acid: experimental data suggest that ibuprofen can inhibit the effect of low doses of acetylsalicylic acid on platelet aggregation when used simultaneously. 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 is reduced. Diuretics may increase the risk of NSAID nephrotoxicity; lithium: lithium elimination decreases; methotrexate: reduced 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 have shown that NSAIDs may increase the risk of seizures associated with the use of quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of seizures; 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 concomitant treatment with zidovudine and ibuprofen. Contraindications? increased 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 – the risk of adverse reactions increases; ? combined use with paracetamol-containing drugs – the risk of adverse reactions increases; ? genetically determined absence of glucose-6-phosphate dehydrogenase; ? pregnancy; ? lactation; ? age up to 3 years. Composition Each tablet contains active ingredients: ibuprofen – 100 mg, paracetamol – 125 mg. Excipients: corn starch, microcrystalline cellulose, talc, sodium starch glycolate, lactose, colloidal anhydrous silicon dioxide, magnesium stearate, crimson dye 4R (E 124), glycerin, DC100 PH orange flavor, DC 106 PH pineapple flavor, aspartame, mint oil . Overdose Paracetamol Taking 10 g of paracetamol (equivalent to 80 tablets) or more in adults can lead to liver damage. Ingestion of 5 g paracetamol (equivalent to 40 tablets) or more may cause liver damage if the patient has one or more of the following risk factors: long-term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. John’s wort, or other drugs that induce hepatic enzymes; regular alcohol consumption in excess of safe doses; glutathione deficiency, which can be observed in eating disorders; cystic fibrosis, HIV infection, starvation, cachexia. Symptoms: Symptoms of paracetamol overdose 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 be manifested only by nausea or vomiting and may not correspond to 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 (an 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, including 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. Side effects The results of clinical trials suggest a possible relationship between taking ibuprofen, especially when taken at high doses (? 2400 mg per 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 rarely (? 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. Storage conditionsKeep in a place protected from moisture and light at temperatures up to 25°C. Keep out of the reach of children. Buy Ibuklin for children flavored dispersible tablets 100mg / 125mg No. 10×2