Taffa® for children
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Taffa® for Kids |
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Composition:Active ingredient: ibuprofen; 5 ml of oral suspension contain 100 mg of ibuprofen; Excipients: glycerin, sorbitol solution 70 %, non-crystallizing (E 420); xanthan gum; microcrystalline cellulose and sodium carmellose; polysorbates; disodium edetate; sodium saccharin; citric acid, monohydrate; sodium citrate, dihydrate; sodium benzoate (E 211); simethicone emulsion 30 %; sodium chloride; purified water; apricot flavor contains: propylene glycol; flavoring substances; natural flavoring substances; orange oil; lemon oil; flavoring and aromatic components: potato maltodextrin; flavoring substances; aspartame (E 951); acesulfame-K (E 950). Pharmaceutical form. Oral suspension. Main physicochemical properties: homogeneous suspension ranging from almost white to brownish color with apricot odor. Pharmacotherapeutic group. Non-steroidal anti-inflammatory and antirheumatic agents. Propionic acid derivatives. Ibuprofen. ATC code M01A E01. Pharmacological properties.Pharmacodynamics. Ibuprofen is a propionic acid derivative, a non-steroidal anti-inflammatory drug (NSAID) that exerts analgesic, anti-inflammatory and antipyretic effects. In addition, ibuprofen reversibly inhibits platelet aggregation. The therapeutic effect of the drug is believed to result from inhibition of the cyclooxygenase enzyme, leading to a significant reduction in prostaglandin synthesis. These properties provide relief from symptoms of inflammation, pain and fever. Experimental data indicate that ibuprofen may competitively inhibit the effect of low-dose acetylsalicylic acid/aspirin on platelet aggregation when administered concomitantly. Some pharmacodynamic studies show that administration of single doses of 400 mg ibuprofen within 8 hours before or within 30 minutes after immediate-release aspirin (81 mg) was associated with reduced effect of acetylsalicylic acid on thromboxane production or platelet aggregation. Although there is uncertainty regarding extrapolation of these data to the clinical situation, it cannot be excluded that regular long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid. With occasional use of ibuprofen, such a clinically significant effect is considered unlikely. Pharmacokinetics. Ibuprofen is rapidly absorbed after oral administration. After administration on an empty stomach, maximum plasma concentration is reached approximately within 45 minutes. Administration of the same dose after food intake showed slower absorption, with Cmax in plasma achieved within 1.5–3 hours. The elimination half-life from plasma is 2 hours. Ibuprofen is metabolized in the liver to form two inactive metabolites, which, together with unchanged ibuprofen, are excreted by the kidneys either unchanged or as conjugates. Excretion is rapid, and plasma concentrations do not show any signs of accumulation. 44 % of the ibuprofen dose is excreted in urine as two pharmacologically inactive metabolites and 20 % unchanged. Clinical characteristics.Indications. Short-term treatment of fever and pain in children. Contraindications. Known hypersensitivity to the active substance or to any other component of the drug. History of hypersensitivity reactions (such as bronchial asthma, rhinitis, angioneurotic edema or urticaria) in response to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs). Increased tendency to bleeding or active bleeding. Active or recurrent peptic ulcer or gastrointestinal bleeding in history (two or more episodes of confirmed ulceration or bleeding). History of gastrointestinal bleeding or perforation associated with NSAID use. Severe heart failure (NYHA functional class IV). Severe hepatic insufficiency. Severe renal insufficiency (glomerular filtration rate ˂ 30 ml/min). Severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake). Third trimester of pregnancy. Cerebrovascular or other bleeding. Disorders of hematopoiesis or blood coagulation. Hereditary fructose intolerance. Interaction with other medicinal products and other types of interactions. The following medicinal products should be used with caution, as interactions have been reported in some patients: Diuretics, ACE inhibitors, beta-blockers and angiotensin II receptor antagonists. NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. Diuretics may increase the risk of nephrotoxicity associated with NSAID use. In some patients with impaired renal function (e.g., dehydrated patients or elderly patients with impaired renal function), concomitant use of ACE inhibitors, beta-blockers or angiotensin II receptor antagonists with cyclooxygenase inhibitors may lead to further deterioration of renal function, including the possibility of acute renal failure, which is usually reversible. Therefore, such combinations should be prescribed with caution, especially in elderly patients. Patients should consume sufficient amounts of water; renal function should also be monitored at the beginning of concomitant therapy and periodically thereafter. Cardiac glycosides. NSAIDs may cause exacerbation of heart failure, decreased glomerular filtration rate (GFR), and increased plasma levels of cardiac glycosides (e.g., digoxin). Monitoring of serum glycoside levels is recommended. Lithium. Concomitant use of ibuprofen and lithium preparations leads to increased lithium levels in plasma. Methotrexate. NSAIDs may inhibit tubular secretion of methotrexate and reduce methotrexate clearance, increasing the risk of toxicity. Moclobemide increases the effect of ibuprofen. Cyclosporine increases the risk of NSAID-induced kidney damage. This effect cannot be excluded for the combination of cyclosporine and ibuprofen. Mifepristone. Reduced efficacy of the drug may theoretically occur due to anti-prostaglandin properties of NSAIDs, including acetylsalicylic acid. Limited data suggest that concomitant use of NSAIDs on the day of prostaglandin administration does not alter the effect of mifepristone or prostaglandin on cervical ripening or uterine contractility and does not reduce the clinical efficacy of medical abortion. Corticosteroids. Ibuprofen should be used with caution in combination with corticosteroids due to possible increased risk of adverse reactions, especially gastrointestinal (gastrointestinal ulcers or bleeding, see sections "Contraindications" and "Special precautions for use"). Anticoagulants. NSAIDs may potentiate the effects of anticoagulants such as warfarin (see section "Special precautions for use"). Acetylsalicylic acid. It is not recommended to use ibuprofen concomitantly with acetylsalicylic acid/aspirin or other medicinal products containing NSAIDs, including selective cyclooxygenase-2 (COX-2) inhibitors, due to increased likelihood of adverse reactions. Experimental data indicate that ibuprofen may competitively inhibit the effect of low-dose acetylsalicylic acid/aspirin on platelet aggregation when administered concomitantly. However, despite uncertainties regarding the possibility of extrapolating these data to the clinical situation, it cannot be excluded that regular long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid/aspirin. No clinically significant effects are observed with irregular use of ibuprofen (see section "Pharmacodynamics"). Sulfonylureas. NSAIDs may potentiate the effects of sulfonylurea drugs. Rare cases of hypoglycemia have been reported in patients taking sulfonylureas when ibuprofen was prescribed. Monitoring of blood glucose levels is recommended when used concomitantly. Zidovudine. Increased risk of hematological toxicity with concomitant use of NSAIDs and zidovudine. Evidence suggests increased risk of hemarthrosis and hematomas in HIV-positive patients with hemophilia when the drug is used during zidovudine therapy. Hematological examination is recommended 1–2 weeks after initiation of treatment. Other NSAIDs, including salicylates and selective COX-2 inhibitors. Concomitant use of multiple NSAIDs may increase the risk of gastrointestinal ulcers and bleeding due to synergistic effects. Therefore, concomitant use of ibuprofen with other NSAIDs should be avoided (see section "Special precautions for use"). Aminoglycosides. NSAIDs may reduce excretion of aminoglycosides. Cholestyramine. Concomitant use of ibuprofen and cholestyramine may reduce ibuprofen absorption in the gastrointestinal tract. However, the clinical significance of this interaction is unknown. Tacrolimus. Increased risk of nephrotoxicity with concomitant use of both drugs. Antiplatelet agents and selective serotonin reuptake inhibitors increase the risk of gastrointestinal bleeding (see section "Special precautions for use"). Herbal extracts. Ginkgo biloba may potentiate the risk of bleeding associated with NSAIDs. Quinolone antibiotics. Animal experimental data indicate that NSAIDs may increase the risk of seizures associated with quinolone antibiotics. Patients taking NSAIDs and quinolones concomitantly have an increased risk of developing seizures. CYP2C9 inhibitors. Concomitant administration of ibuprofen with CYP2C9 inhibitors may increase ibuprofen exposure (CYP2C9 substrate). In one study, voriconazole and fluconazole (CYP2C9 inhibitors) increased S(+) ibuprofen exposure by approximately 80–100 %. A reduction in ibuprofen dose should be anticipated when co-administered with CYP2C9 inhibitors, especially when high doses of ibuprofen are prescribed to patients taking voriconazole or fluconazole. Special precautions for use.General warnings Adverse reactions can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see section "Method of administration and dosage" and effects on the gastrointestinal tract and cardiovascular system described below). Concomitant use of ibuprofen with other NSAIDs, including selective COX-2 inhibitors, should be avoided due to the potential for additive effects (see section "Interaction with other medicinal products and other types of interactions"). Ibuprofen may temporarily inhibit platelet function (platelet aggregation). With prolonged use of any analgesic drugs, headache may develop, which should not be treated with increased doses of this medicinal product. The risk of adverse reactions caused by the active substance, especially gastrointestinal or central nervous system (CNS), may increase when alcohol is consumed concomitantly with NSAIDs. Elderly patients In elderly patients, the frequency of adverse reactions with NSAID use is higher, especially gastrointestinal bleeding and perforation, which can be fatal. Cardiovascular and cerebrovascular system disorders Caution (consultation with a physician or pharmacist) is advised before initiating treatment in patients with a history of hypertension and/or heart failure, as fluid retention and edema have been reported with NSAID use. NSAIDs may reduce the effects of diuretics and other antihypertensive drugs (see section "Interaction with other medicinal products and other types of interactions"). Clinical trial data indicate that use of ibuprofen, especially at high doses (2400 mg per day), may slightly increase the risk of arterial thrombotic complications (e.g., myocardial infarction or stroke). Overall, epidemiological data suggest that low-dose ibuprofen (e.g., ≤1200 mg per day) does not increase the risk of arterial thrombotic complications. Ibuprofen should be prescribed with particular caution to patients with uncontrolled hypertension, congestive heart failure (NYHA functional class II–III), established ischemic heart disease, peripheral arterial disease and/or cerebrovascular diseases, avoiding high doses of ibuprofen (2400 mg per day). Great caution is required for long-term treatment of patients with risk factors for cardiovascular disorders (such as arterial hypertension, hyperlipidemia, diabetes, smoking), especially if high doses (2400 mg per day) of ibuprofen are required. Cases of Kounis syndrome have been reported in patients using ibuprofen. Kounis syndrome is defined as cardiovascular symptoms caused by an allergic or hypersensitivity reaction associated with coronary artery constriction, potentially leading to myocardial infarction. Gastrointestinal bleeding, ulceration and perforation Cases of gastrointestinal bleeding, perforation or ulceration, which may be fatal, have been reported with use of all NSAIDs at any stage of treatment. These events may occur without warning symptoms or history of serious gastrointestinal disorders. In patients with a history of ulcers, especially complicated by bleeding or perforation (see section "Contraindications"), and in elderly patients, increasing NSAID doses increases the risk of gastrointestinal bleeding, ulceration or perforation. Treatment of these patients should start with the lowest available dose. For such patients, as well as for patients requiring concomitant therapy with low-dose acetylsalicylic acid or other drugs capable of increasing the risk of gastrointestinal complications, consideration should be given to the appropriateness of combination therapy with protective agents (e.g., misoprostol or proton pump inhibitors) (see section "Interaction with other medicinal products and other types of interactions"). Patients with a history of gastrointestinal toxicity, especially elderly patients, should be informed about the need to report any unusual abdominal symptoms (particularly gastrointestinal bleeding), especially at the beginning of treatment. Ibuprofen should be prescribed with caution to patients taking concomitant drugs that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants (e.g., warfarin), selective serotonin reuptake inhibitors (SSRIs), or antiplatelet agents such as acetylsalicylic acid (see section "Interaction with other medicinal products and other types of interactions"). Treatment with ibuprofen should be discontinued in patients with gastrointestinal bleeding or ulceration. NSAIDs should be used with caution in patients with a history of peptic ulcers and other gastrointestinal disorders, such as ulcerative colitis and Crohn's disease, due to possible exacerbation of these conditions (see section "Adverse reactions"). Use with caution in patients with coagulation disorders. Renal effects Caution should be exercised when prescribing the drug to dehydrated patients, especially children, adolescents and elderly patients, due to the risk of renal failure. Chronic use of analgesic drugs, particularly concomitant therapy with multiple pain-relieving substances, may lead to irreversible kidney damage with risk of renal failure (analgesic nephropathy). This risk may increase under conditions of physical exertion accompanied by salt loss and dehydration. Therefore, this should be avoided. Caution should be exercised when prescribing the drug to patients with hypertension and/or cardiac disorders due to possible worsening of renal function (see sections "Contraindications" and "Adverse reactions"). Development of renal tubular acidosis and hypokalemia may occur after acute overdose and in patients taking high doses of ibuprofen for prolonged periods (usually longer than 4 weeks), including doses exceeding the recommended daily dose. Long-term use of ibuprofen, as with other NSAIDs, has been associated with renal papillary necrosis and other pathological disturbances of renal function. The highest risk of such reactions exists in patients with impaired renal function, cardiac decompensation, hepatic dysfunction, elderly patients, and those taking diuretics and ACE inhibitors. Discontinuation of NSAID therapy is usually followed by recovery to the pre-treatment state. Respiratory tract effects Ibuprofen should be prescribed with caution to patients with bronchial asthma, chronic rhinitis, allergic diseases, including history, as cases of bronchospasm, urticaria or Quincke's edema induced by NSAIDs have been observed in such patients. Dermatological effects Severe skin adverse reactions, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis, which may be life-threatening or fatal, have been reported with ibuprofen use (see section "Adverse reactions"). Most such reactions occurred within the first month. If signs and symptoms indicating these reactions appear, ibuprofen should be discontinued immediately and alternative treatment considered (if necessary). In rare cases, serious infectious complications of the skin and soft tissues may be caused by varicella. At present, the influence of NSAIDs on exacerbation of these infections cannot be excluded. Therefore, it is recommended to avoid use of ibuprofen in patients with varicella. Systemic lupus erythematosus (SLE) and mixed connective tissue disorders Caution should be exercised when prescribing the drug to patients with SLE and mixed connective tissue disorders. There is an increased risk of developing aseptic meningitis (see section "Adverse reactions"). Cardiac, renal and hepatic function disorders Particular caution should be exercised in treating patients with cardiac, hepatic or renal dysfunction, as NSAID use may lead to impaired renal function. Regular concomitant use of analgesics may increase this risk. Patients with cardiac, hepatic or renal dysfunction should receive treatment at the lowest effective dose for the shortest possible duration, and clinical and laboratory parameters should be monitored periodically, especially during long-term treatment (see section "Contraindications"). Hematological effects Like other NSAIDs, ibuprofen may inhibit platelet aggregation and has demonstrated evidence of prolonged bleeding time in healthy volunteers. Therefore, patients with coagulation disorders or patients receiving anticoagulant therapy should be under close supervision. Aseptic meningitis In rare cases, symptoms of aseptic meningitis have been observed in patients using ibuprofen. Although this is more likely in patients with SLE and associated connective tissue disorders, it has also been observed in patients without manifestations of chronic diseases (see section "Adverse reactions"). Ibuprofen may mask symptoms of infection (fever, pain and swelling). Female fertility disorders Use of ibuprofen, like any inhibitor of prostaglandin and cyclooxygenase synthesis, is contraindicated in women intending to become pregnant (see section "Use during pregnancy or breastfeeding"). Ibuprofen use should be discontinued in women experiencing fertility problems or undergoing fertility testing. Hypersensitivity reactions Severe acute hypersensitivity reactions (e.g., anaphylactic shock) are very rare. At the first signs of hypersensitivity reaction after ibuprofen intake, therapy must be discontinued and qualified personnel should be involved in providing medical measures according to symptoms. Caution should be exercised when prescribing ibuprofen to patients who have experienced hypersensitivity or allergic reactions to other substances, such as other analgesics, antipyretics, NSAIDs, as they are at increased risk of hypersensitivity reactions with ibuprofen use. Caution should be exercised when prescribing ibuprofen to patients with bronchial asthma, hay fever, nasal polyps or chronic obstructive respiratory diseases or previous episodes of angioedema, due to increased risk of allergic reactions in such patients. These may manifest as asthma attacks (so-called analgesic asthma), Quincke's edema or urticaria. Masking symptoms of concomitant infections The medicinal product Taffa® for Kids may mask symptoms of infection, which may lead to delayed initiation of appropriate treatment and thus worsen infection outcomes. This has been observed in bacterial community-acquired pneumonia and bacterial complications of varicella. During use of the medicinal product Taffa® for Kids for treatment of elevated temperature and relief of infection-related pain, infection should be monitored. If the patient is not hospitalized but symptoms persist or worsen, he/she should consult a physician. Information on excipients The medicinal product Taffa® for Kids contains 1.5 g of sorbitol in 5 ml. If intolerance to certain sugars is established, consultation with a physician is required before taking this medicinal product. Taffa® for Kids contains 0.19 mg of aspartame in 5 ml. Aspartame is hydrolyzed in the gastrointestinal tract upon oral intake. It is a derivative of phenylalanine, which poses a risk for patients with phenylketonuria. Taffa® for Kids contains 0.442 mmol (or 10.17 mg) of sodium in 5 ml. This should be considered when treating patients on a sodium-controlled diet. Taffa® for Kids contains propylene glycol. May cause symptoms similar to those arising from alcohol consumption. Use during pregnancy or breastfeeding. Effect on fertility Data exist that drugs inhibiting cyclooxygenase/prostaglandin synthesis impair female fertility by affecting ovulation. This process is reversible upon discontinuation of treatment. Pregnancy Inhibition of prostaglandin synthesis may adversely affect pregnancy course and/or embryonic/fetal development. Epidemiological data indicate increased risk of miscarriage, congenital heart defects and gastroschisis after use of prostaglandin synthesis inhibitors in early pregnancy. The risk increases with increasing dose and duration of therapy. In animals, use of prostaglandin synthesis inhibitors caused increased pre- and post-implantation losses and embryonic/fetal mortality. Additionally, increased frequency of various developmental abnormalities, including cardiovascular system, was observed in animals receiving prostaglandin synthesis inhibitor during organogenesis. From the 20th week of pregnancy, use of ibuprofen may cause oligohydramnios due to fetal renal dysfunction. This condition may occur soon after initiation of treatment and is usually reversible after discontinuation of treatment. Additionally, reports exist of arterial duct constriction after treatment in the second trimester of pregnancy, which in most cases resolved after discontinuation of treatment. Therefore, ibuprofen should not be prescribed in the first and second trimesters of pregnancy without strong necessity. If ibuprofen is prescribed to women planning pregnancy or during the first and second trimesters of pregnancy, the lowest possible dose should be used for the shortest possible duration. Prenatal monitoring for oligohydramnios and arterial duct constriction after ibuprofen exposure for several days starting from the 20th gestational week may be appropriate. Use of the medicinal product containing ibuprofen should be discontinued if oligohydramnios or arterial duct constriction is detected. Use of any prostaglandin inhibitors in the third trimester of pregnancy may affect the fetus, causing:
Towards the end of pregnancy, prostaglandin synthesis inhibitors may affect the condition of the mother and child:
Thus, use of ibuprofen in the third trimester of pregnancy is contraindicated (see section "Contraindications"). Delivery Use of ibuprofen during delivery is not recommended. Possible delayed and prolonged labor, as well as prolonged bleeding time in mother and child, may occur. Breastfeeding period In a limited number of studies, ibuprofen was detected in breast milk at very low concentrations. Ibuprofen is not recommended for women who are breastfeeding. Ability to influence reaction rate when driving or operating machinery. Ibuprofen intake may affect patients' reaction speed, as cephalgia, somnolence, dizziness, fatigue and visual disturbances may occur. This should be considered when engaging in activities requiring increased attention, such as driving or operating machinery. This is particularly relevant with concomitant use of ibuprofen and alcohol. Method of administration and dosage.Dosage For oral use only and short-term use. Unwanted effects can be minimized by using the lowest effective dose for the shortest duration necessary to eliminate symptoms (see section "Special precautions for use"). The dose of ibuprofen depends on the patient's age and body weight. The maximum single dose for adolescents should not exceed 400 mg of ibuprofen. A single dose exceeding 400 mg does not provide better analgesic effect. The interval between doses should be at least 4 hours. The total dose for adolescents should not exceed 1200 mg of ibuprofen within 24 hours. Adolescents (from 12 years of age) 200–400 mg (10–20 ml) as a single dose or 3–4 times daily. For children, the daily dose is 20 mg/kg/day, divided into 3–4 doses, as described in the table below (data in the table are given as an example for children with body weight from 7 kg to 30 kg, but are not limited to them). For correct calculation of the daily dose, it is assumed that 1 ml of suspension corresponds to 1 kg of body weight, equivalent to 20 mg of ibuprofen (e.g., for a child weighing 9 kg, administer 9 ml of suspension per day, equivalent to 180 mg of ibuprofen). To calculate the single dose, divide the daily dose by 3–4 administrations. The medicinal product Taffa® for Kids, 20 mg/ml suspension, is not recommended for use in children with body weight less than 7 kg. The suspension can be administered using the measuring syringe provided in the package with the product.
The drug can be taken on an empty stomach to achieve its effect more quickly. Patients suffering from gastrointestinal disorders should take the drug during meals. There are no specific recommendations regarding whether the drug should be taken with water. The drug may be used without medical consultation for no more than 3 days. Children under 6 months of age: if symptoms worsen or persist for more than 24 hours from the start of treatment, immediate medical advice should be sought. If symptoms in children aged 6 months and adolescents persist for more than 3 days from the start of treatment or worsen, medical advice should be sought. Instructions for using the graduated oral syringe for dosing:
Patients with renal impairment Patients with mild or moderate renal impairment should use the lowest possible dose for the shortest duration necessary to control symptoms, and renal function should be monitored (for patients with severe renal impairment, see section "Contraindications"). Patients with hepatic impairment (see section "Pharmacological properties") In patients with mild or moderate hepatic impairment, the lowest possible dose should be used for the shortest duration necessary to control symptoms, and liver function should be monitored. Ibuprofen is contraindicated in patients with severe hepatic impairment (for patients with severe hepatic dysfunction, see section "Contraindications"). Children. To be administered to children with body weight of 7 kg and above. Overdose. Toxicity Signs of toxicity in children or adults were generally not observed at doses below 100 mg/kg. However, supportive measures may be required in some cases. Signs of toxicity in children were observed after ingestion of 400 mg/kg or more. In adults, the dose-dependent effect is less pronounced. The half-life in overdose is 1.5–3 hours. Symptoms In most patients, symptoms of ibuprofen overdose appear within 4–6 hours after ingestion. The most common symptoms of overdose include nausea, vomiting, abdominal pain, lethargy, and drowsiness. CNS manifestations include headache, tinnitus, dizziness, seizures, and loss of consciousness. Rarely reported are nystagmus, metabolic acidosis, hypothermia, renal symptoms, gastrointestinal bleeding, coma, apnea, CNS depression, and respiratory depression. Cardiovascular toxicity has been reported, including development of arterial hypotension, bradycardia, and tachycardia. In cases of significant overdose, kidney and liver damage may occur. Significant overdose is usually well tolerated if no other drugs are involved. In severe poisoning, metabolic acidosis and prolonged prothrombin time/international normalized ratio (INR) may occur, likely due to interaction with circulating coagulation factors. Prolonged use at doses higher than recommended may lead to severe hypokalemia and renal tubular acidosis. Symptoms may include decreased level of consciousness and general weakness (see sections "Special precautions for use" and "Adverse reactions"). Treatment There is no specific antidote for ibuprofen overdose. Symptomatic treatment is required. Activated charcoal should be considered within one hour after ingestion of a potentially toxic amount. If necessary, serum electrolyte balance should be corrected. If the amount ingested exceeds 400 mg/kg, gastric lavage/emptying should be performed within one hour after ingestion, followed by symptomatic treatment. Treatment should include ensuring airway patency and monitoring cardiac function and vital signs until the patient's condition normalizes. For the most up-to-date information, contact the local poison control center. Adverse reactions.The most common adverse reactions are gastrointestinal disorders. There is a risk of peptic ulcers, perforation, or gastrointestinal bleeding, sometimes fatal, particularly in elderly patients (see section "Special precautions for use"). After taking the drug, nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, hematemesis, ulcerative stomatitis, and exacerbation of colitis and Crohn's disease have been reported (see section "Special precautions for use"). Gastritis development has been reported less frequently. Burning sensation in the mouth or throat may occur temporarily after taking the drug.
Hypersensitivity reactions have been observed during treatment with NSAIDs. These include non-specific allergic reactions and anaphylactic phenomena, respiratory reactivity including bronchial asthma, exacerbation of bronchial asthma, bronchospasm or dyspnea, or mixed skin disorders including various types of rash, pruritus, urticaria, purpura, angioedema, and very rarely, erythema multiforme and bullous dermatoses (including Stevens-Johnson syndrome, toxic epidermal necrolysis).
Cases of skin inflammation exacerbated by infection (e.g., development of necrotizing fasciitis) have been described during NSAID use. If signs of infection develop or worsen during ibuprofen use, the patient should seek immediate medical advice.
In exceptional cases, severe skin infections and soft tissue complications may occur during chickenpox (see also "Infections and infestations" and section "Special precautions for use").
Clinical trial data indicate that the use of ibuprofen, especially at high doses (2400 mg per day), may slightly increase the risk of arterial thrombotic events, such as myocardial infarction or stroke (see section "Special precautions for use"). The adverse reactions listed below may be associated with ibuprofen and are classified by frequency and organ systems according to MedRA. Frequency groups are defined as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10000 to <1/1000), very rare (<1/10000), and frequency not known (frequency cannot be estimated from available data). The stated frequency refers to short-term use of the drug at a daily dose of no more than 1200 mg ibuprofen in oral dosage forms. Infections and infestations Uncommon: rhinitis. Very rare: aseptic meningitis. Blood and lymphatic system disorders Very rare: leukopenia, thrombocytopenia, neutropenia, agranulocytosis, aplastic and hemolytic anemia. Initial signs include fever, sore throat, oral mucosal ulcers, influenza-like symptoms, severe fatigue, bleeding, and unexplained bruising. Immune system disorders Uncommon: hypersensitivity. Very rare: severe hypersensitivity reactions. Symptoms may include facial, tongue, and laryngeal swelling, dyspnea, tachycardia, and arterial hypotension (anaphylaxis, angioedema, or severe shock). Psychiatric disorders Uncommon: insomnia, restlessness. Rare: depression, confusion, hallucinations. Nervous system disorders Common: dizziness. Uncommon: headache, paresthesia, somnolence. Rare: optic neuritis. Eye disorders Uncommon: visual disturbances. Rare: toxic optic neuropathy. Ear and labyrinth disorders Uncommon: hearing disturbances. Rare: tinnitus, dizziness. Respiratory, thoracic and mediastinal disorders Uncommon: bronchial asthma, bronchospasm, dyspnea. Gastrointestinal disorders Common: dyspepsia, diarrhea, nausea, vomiting, abdominal pain, flatulence, constipation, melena, hematemesis, gastrointestinal bleeding. Uncommon: gastritis, duodenal ulcer, gastric ulcer, ulcerative stomatitis, gastrointestinal perforation. Very rare: pancreatitis. Frequency not known: colitis and Crohn's disease. Hepatobiliary disorders Uncommon: hepatitis, jaundice, abnormal liver function tests. Rare: liver injury. Very rare: liver failure. Skin and subcutaneous tissue disorders Uncommon: rash, urticaria, pruritus, purpura. Very rare: bullous dermatosis, severe skin adverse reactions (including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme). Frequency not known: drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), acute generalized exanthematous pustulosis, photosensitivity reactions. Metabolism and nutrition disorders Frequency not known: decreased appetite, hypokalemia*. Renal and urinary disorders Very rare: tubulointerstitial nephritis, nephrotic syndrome, and renal failure. Acute renal failure, papillary necrosis (especially with prolonged use), associated with increased plasma urea levels. Frequency not known: ureteric colic, dysuria, renal tubular acidosis*. General disorders and administration site conditions Common: fatigue. Rare: edema. Cardiovascular system disorders Very rare: heart failure, myocardial infarction (see section "Special precautions for use"), arterial hypertension. Frequency not known: Kounis syndrome. *Renal tubular acidosis and hypokalemia have been reported during the post-marketing period, usually after prolonged use of ibuprofen at doses higher than recommended. Reporting suspected adverse reactions Reporting of adverse reactions after drug registration is highly important. It allows continuous monitoring of the benefit-risk balance of the drug. Healthcare professionals, pharmacists, patients, and their legal representatives should report all suspected adverse reactions and lack of efficacy through the automated pharmacovigilance information system at the following link: https://aisf.dec.gov.ua. Shelf life. 3 years. Do not use after the expiry date stated on the packaging. After opening the bottle, the suspension remains stable for 3 months. Storage conditions. This drug does not require special storage temperature conditions. Keep out of reach of children. Packaging. 100 mL of suspension in a bottle; 1 bottle with a dosing syringe in a cardboard box. Prescription status. Over-the-counter. Manufacturer. ALKALOID AD Skopje. ALKALOID AD Skopje. Manufacturer's address and place of business. Boulevard Aleksandar Makedonski 12, Skopje, 1000, Republic of North Macedonia. Boulevard Aleksandar Makedonski 12, Skopje, 1000, Republic of North Macedonia. |
Marketing Authorization Holder. JSC "Farmak".
Address of the Marketing Authorization Holder. 63 Kyrylivska St., Kyiv, 04080, Ukraine.