Nurofen for children fotre oral suspension 200 mg/5 ml bottle with strawberry flavor 100 ml

Instructions Nurofen for children fotre oral suspension 200 mg/5 ml bottle with strawberry flavor 100 ml

Composition

active ingredient: ibuprofen;

5 ml of suspension contain 200 mg of ibuprofen;

Excipients: liquid maltitol; citric acid, monohydrate; sodium citrate; sodium chloride; sodium saccharin; domiphene bromide; polysorbate 80; xanthan gum; strawberry flavoring; glycerin; purified water.

Dosage form

Oral suspension with strawberry flavor.

Main physicochemical properties: almost white syrupy suspension with a characteristic strawberry odor.

Pharmacotherapeutic group

Nonsteroidal anti-inflammatory and antirheumatic drugs. Propionic acid derivatives. ATC code M01A E01.

Pharmacological properties

Pharmacodynamics. Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID), a propionic acid derivative, which has demonstrated its effectiveness by inhibiting the synthesis of prostaglandins - mediators of pain and inflammation. Ibuprofen has analgesic, antipyretic and anti-inflammatory effects. In addition, ibuprofen reversibly inhibits platelet aggregation.

The clinical efficacy of ibuprofen has been demonstrated in the symptomatic treatment of mild to moderate pain, such as toothache, headache, and in the symptomatic treatment of fever.

The analgesic dose for children is 7 to 10 mg/kg body weight with a maximum use of 30 mg/kg/day. Nurofen® for children forte contains ibuprofen, which has been shown in an open study to have an antipyretic effect as early as 15 minutes after administration and to reduce fever in children for up to 8 hours.

Experimental data suggest that ibuprofen may inhibit the effect of low-dose aspirin (acetylsalicylic acid) on platelet aggregation when these drugs are used concomitantly. In one study, when a single dose of ibuprofen 400 mg was taken within 8 hours before or 30 minutes after immediate-release aspirin (81 mg), there was a reduction in the effect of acetylsalicylic acid on thromboxane formation or platelet aggregation. Although there is uncertainty regarding the extrapolation of the data to the clinical picture, it cannot be excluded that systematic long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid. With non-systematic use of ibuprofen, a clinically significant effect is considered unlikely.

Pharmacokinetics.

No specific pharmacokinetic studies have been conducted in children. Published data suggest that the absorption, metabolism and elimination of ibuprofen in children are similar to those in adults.

After oral administration, ibuprofen is partially absorbed in the stomach, then completely in the small intestine. After metabolism in the liver (hydroxylation, carboxylation, conjugation), pharmacologically inactive metabolites are excreted completely, mainly by the kidneys (90%), as well as with bile. The half-life in healthy volunteers, as well as in patients with kidney or liver diseases, is from 1.8 to 3.5 hours. Binding to plasma proteins is about 99%.

Kidney failure.

Since ibuprofen and its metabolites are excreted primarily by the kidneys, the pharmacokinetics of the drug may be altered in patients with varying degrees of renal impairment. In patients with impaired renal function, lower plasma protein binding, increased plasma levels of total ibuprofen and unbound (S)-ibuprofen, higher AUC values for (S)-ibuprofen and increased enantiomeric AUC (S/R) ratios were observed compared with healthy control volunteers. In patients with end-stage renal disease undergoing dialysis, the mean fraction of ibuprofen was approximately 3% compared with 1% in healthy volunteers. Severe renal impairment may lead to accumulation of ibuprofen metabolites. The significance of this effect is unknown. Metabolites can be removed by haemodialysis.

Liver dysfunction.

Alcoholic liver disease with mild to moderate hepatic impairment did not significantly alter pharmacokinetic parameters. Liver disease may alter the disposition kinetics of ibuprofen. Cirrhotic patients with moderate hepatic impairment (Child-Pugh score 6-10) had an average 2-fold increase in half-life and a significantly lower enantiomeric AUC (S/R) ratio compared to healthy control subjects, indicating impaired metabolic inversion of (R)-ibuprofen to the active (S)-enantiomer.

Indication

Symptomatic treatment of fever and pain of various origins in children aged 6 months to 12 years with a body weight of at least 7 kg (including fever after immunization, acute respiratory viral infections, influenza, teething pain, pain after tooth extraction, toothache, headache, sore throat, pain from sprains and other types of pain, including inflammatory genesis).

Contraindication

History of hypersensitivity reactions (such as bronchospasm, asthma, rhinitis, angioedema or urticaria) after taking ibuprofen, acetylsalicylic acid (aspirin) or other NSAIDs.

History of active or recurrent gastric or duodenal ulcer/bleeding (two or more severe episodes of confirmed ulceration or bleeding).

History of gastrointestinal bleeding or perforation associated with NSAID use.

Inflammatory bowel disease in active form.

Cerebrovascular or other bleeding.

Hemorrhagic diathesis or other blood clotting disorders.

Severe heart failure (NYHA class IV), severe hepatic failure or severe renal failure.

Hereditary fructose intolerance.

The last trimester of pregnancy.

Severe dehydration (due to vomiting, diarrhea, or insufficient fluid intake).

Interaction with other medicinal products and other types of interactions

Ibuprofen, like other NSAIDs, should not be used in combination with:

acetylsalicylic acid (aspirin), as this may increase the risk of adverse reactions, unless aspirin (dose not exceeding 75 mg per day) has been prescribed by a doctor. Experimental data suggest that ibuprofen may inhibit the antiplatelet effect of low-dose aspirin when used concomitantly. However, the limitations of these data and the uncertainty regarding the extrapolation of ex vivo data to the clinical picture do not allow for firm conclusions regarding the systematic use of ibuprofen. Therefore, such clinically significant effects are considered unlikely with non-systematic use of ibuprofen;

with other NSAIDs, including selective cyclooxygenase-2 inhibitors, as this may increase the risk of side effects.

Ibuprofen (like other NSAIDs) should be used with caution in combination with the following drugs:

Anticoagulants: NSAIDs may enhance the effect of anticoagulants such as warfarin;

Antihypertensives (ACE inhibitors, beta-blockers and angiotensin II antagonists): NSAIDs may reduce the effect of these drugs. In some patients with impaired renal function (e.g. dehydrated patients or elderly patients with impaired renal function), the concomitant use of ACE inhibitors, beta-blockers or angiotensin II antagonists and cyclooxygenase inhibitors may lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible. Therefore, such a combination should be used with caution, especially in elderly patients. Patients should be adequately hydrated and renal function should be monitored after initiation of concomitant therapy and periodically thereafter;

corticosteroids: increased risk of ulcers and bleeding in the gastrointestinal tract;

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

Cardiac glycosides, such as digoxin: NSAIDs may exacerbate cardiac dysfunction, reduce glomerular filtration rate and increase plasma glycoside levels. NSAIDs may increase plasma digoxin levels and therefore increase the risk of digoxin toxicity; when used correctly (maximum 3 days), monitoring of serum digoxin levels is usually not necessary.

Pentoxifylline: Patients receiving ibuprofen therapy in combination with pentoxifylline may have an increased risk of hemorrhage, so bleeding time should be monitored.

Lithium: NSAIDs may increase plasma lithium levels, possibly due to decreased renal clearance. Concomitant use of these drugs should be avoided if lithium levels are not controlled. A reduction in the lithium dose should be considered; with appropriate use (maximum 3 days), monitoring of serum lithium levels is usually not necessary.

Methotrexate at a dose of 15 mg/week or higher: the use of NSAIDs within 24 hours before or after methotrexate administration may lead to an increase in the plasma concentration of methotrexate (it is likely that the renal clearance of methotrexate may be reduced by the effect of NSAIDs) and a further increase in its toxic effect. Therefore, the use of ibuprofen should be avoided in patients receiving high doses of methotrexate;

Methotrexate at doses below 15 mg/week: ibuprofen increases methotrexate levels. When ibuprofen is used in combination with low doses of methotrexate, the patient's blood picture should be carefully monitored, especially during the first weeks of concomitant use. Monitoring should be intensified in cases of even minimal deterioration of renal function and in elderly patients, and renal function should be monitored to prevent a possible decrease in methotrexate clearance;

Cyclosporine and tacrolimus: possible increased risk of nephrotoxicity with concomitant use of NSAIDs due to decreased renal prostaglandin synthesis. Renal function should be closely monitored when these drugs are used concomitantly with NSAIDs;

Sulfonylurea drugs: NSAIDs have been observed to interact with hypoglycemic agents (sulfonylureas). NSAIDs may enhance the hypoglycemic effect of sulfonylureas by displacing them from plasma protein binding; it is recommended to monitor blood glucose levels when sulfonylureas are used concomitantly with ibuprofen.

Probenecid and sulfinpyrazone: possible increase in ibuprofen plasma concentration and delay in ibuprofen elimination; which may be due to an inhibitory mechanism at the site of renal tubular secretion and glucuronidation; therefore, ibuprofen dose adjustment may be required;

Baclofen: increases the risk of developing baclofen toxicity after starting use

ibuprofen;

Ritonavir: possible increase in plasma concentrations of NSAIDs;

Aminoglycosides: NSAIDs may reduce the excretion of aminoglycosides;

Captopril: experimental studies have shown that ibuprofen inhibits the effect of captopril on sodium excretion;

Voriconazole and fluconazole (CYP2C9 inhibitors): Concomitant use of ibuprofen with CYP2C9 inhibitors may increase the exposure of ibuprofen (CYP2C9 substrate). A study with voriconazole and fluconazole (CYP2C9 inhibitors) demonstrated an increase in exposure of S(+)-ibuprofen by approximately 80-100%. When ibuprofen is co-administered with strong CYP2C9 inhibitors, a reduction in ibuprofen doses is recommended, especially when high doses of ibuprofen are co-administered with voriconazole or fluconazole;

Cholestyramine: Ibuprofen and cholestyramine should be taken several hours apart due to the slowing and reduction (25%) of ibuprofen absorption when used simultaneously;

Zidovudine: Increased risk of hematological toxicity with concomitant use of zidovudine and NSAIDs. There is evidence of an increased risk of hemarthrosis and hematoma in HIV-infected patients with hemophilia when treated concomitantly with zidovudine and ibuprofen.

herbal extracts: when used together with NSAIDs, ginkgo biloba may potentiate the risk of bleeding;

Quinolone antibiotics: Animal data suggest that NSAIDs may increase the risk of seizures associated with the use of quinolone antibiotics. Patients taking NSAIDs and quinolones may be at increased risk of developing seizures.

Hydantoins and sulfonamides: possible increase in the toxic effect of these drugs. Phenytoin plasma levels may increase with concomitant treatment with ibuprofen; with proper use (maximum 3 days), monitoring of phenytoin serum levels is usually not necessary.

Thiazides, thiazide-like substances, loop diuretics and potassium-sparing diuretics: NSAIDs may antagonize the diuretic effect of these medicinal products. Concomitant use of NSAIDs and diuretics may increase the risk of NSAID-induced nephrotoxicity (e.g. in dehydrated patients or in elderly patients with compromised renal function) due to decreased renal blood flow. Therefore, this combination should be used with caution, especially in elderly patients. Patients should be adequately hydrated and renal function should be monitored after initiation of concomitant therapy and periodically thereafter. As with other NSAIDs, concomitant therapy with potassium-sparing diuretics may be associated with increases in potassium levels, therefore plasma potassium levels should be monitored;

Taking ibuprofen with food slows down absorption, although it does not affect the extent of absorption (see section "Pharmacokinetics").

Application features

Side effects of ibuprofen therapy can be minimized by using the lowest effective dose necessary to treat symptoms for the shortest period of time.

Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal. Elderly patients are at increased risk of adverse reactions. Long-term use of NSAIDs in elderly patients is not recommended. In case of long-term therapy, patients should be regularly monitored.

Caution should be exercised in patients with the following conditions:

systemic lupus erythematosus, as well as mixed connective tissue disease – due to an increased risk of aseptic meningitis;

congenital disorder of porphyrin metabolism, such as acute concomitant porphyria;

gastrointestinal disorders and chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);

history of hypertension and/or heart failure, as fluid retention and edema have been reported in association with NSAID therapy;

renal failure – due to the possibility of worsening kidney function;

liver dysfunction;

immediately after extensive surgical interventions;

hay fever, nasal polyps or chronic obstructive airway diseases – due to an increased risk of allergic reactions, which include asthma attacks (so-called analgesic asthma), angioedema or urticaria;

history of allergic reactions to other substances – due to an increased risk of hypersensitivity reactions to ibuprofen.

Bronchospasm may occur in patients with bronchial asthma or allergic diseases or with a history of such diseases.

Other NSAIDs.

The concomitant use of ibuprofen with other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided as this increases the risk of adverse reactions.

Like other NSAIDs, ibuprofen can cause allergic reactions, such as anaphylactic/anaphylactoid reactions, even when the drug is used for the first time.

Systemic lupus erythematosus and mixed connective tissue disease.

Ibuprofen should be used with caution in systemic lupus erythematosus and mixed connective tissue disease due to an increased risk of aseptic meningitis.

Effects on the cardiovascular and cerebrovascular systems.

Patients with a history of hypertension and/or heart failure should start treatment with caution (consultation with a doctor is necessary), since cases of fluid retention, hypertension and edema have been reported with ibuprofen therapy, as with other NSAIDs.

Clinical trials and epidemiological data suggest that the use of ibuprofen, especially at high doses (2400 mg per day) and in long-term treatment, may be associated with a small increased risk of arterial thrombotic events (such as myocardial infarction or stroke). Overall, epidemiological studies do not show that low doses of ibuprofen (e.g. ≤1200 mg per day) are associated with an increased risk of myocardial infarction.

Patients with uncontrolled hypertension, congestive heart failure (NYHA class II-III), established coronary heart disease, peripheral arterial disease and/or cerebrovascular disease should only take ibuprofen after careful clinical assessment. High doses (2400 mg/day) should be avoided.

The clinical picture should also be carefully assessed before starting long-term treatment in patients with risk factors for cardiovascular complications (such as hypertension, hyperlipidemia, diabetes mellitus, smoking), especially if high doses of ibuprofen (2400 mg per day) are required.

Cases of Kounis syndrome have been reported in patients treated with ibuprofen. Kounis syndrome is defined as cardiovascular symptoms caused by an allergic or hypersensitivity reaction associated with narrowing of the coronary arteries, potentially leading to myocardial infarction.

Effects on kidneys and liver.

Caution should be exercised in patients with renal insufficiency due to the possibility of worsening of renal function. Ibuprofen should be used with caution in patients with renal or hepatic disease and especially during concomitant therapy with diuretics, since inhibition of prostaglandins may lead to fluid retention and further deterioration of renal function. In such patients, the lowest possible dose of ibuprofen should be used and renal function should be monitored regularly. In case of dehydration, adequate fluid intake should be ensured. There is a risk of renal failure in children and adolescents with dehydration.

In general, the habitual use of analgesics, especially combinations of different analgesics, can lead to long-term kidney damage with the risk of renal failure (analgesic nephropathy). The risk of this reaction is highest in elderly patients, patients with renal failure, heart failure and liver failure, and those receiving diuretics or ACE inhibitors. After discontinuation of NSAID therapy, renal function usually returns to the state observed before treatment.

Liver function may be impaired. Like other NSAIDs, ibuprofen may cause transient increases in certain liver function tests, including significant increases in AST and ALT. If these values are significantly elevated, treatment should be discontinued.

Effect on the gastrointestinal tract.

NSAIDs should be used with caution in patients with a history of gastrointestinal diseases (ulcerative colitis, Crohn's disease) as their condition may be exacerbated. Such patients should seek medical advice.

There are reports of cases of gastrointestinal bleeding, perforation, ulcers, potentially fatal, which occurred at any stage of treatment with NSAIDs, regardless of the presence of warning symptoms or the presence of severe gastrointestinal disorders in history.

The risk of gastrointestinal bleeding, perforation or ulceration increases with increasing doses of NSAIDs, with a history of peptic ulcer disease, especially complicated by bleeding or perforation, and in elderly patients. These patients should start treatment with the lowest dose. In such patients, as well as in patients who require concomitant use of low-dose acetylsalicylic acid or other drugs that may increase the risk from the gastrointestinal tract, combination therapy with protective drugs (e.g. misoprostol or proton pump inhibitors) is recommended.

Caution should be exercised when treating patients who are taking concomitant medications that may increase the risk of ulceration or bleeding, including oral corticosteroids, anticoagulants (e.g. warfarin), selective serotonin reuptake inhibitors or antiplatelet agents (e.g. acetylsalicylic acid).

In the event of gastrointestinal bleeding or ulceration in patients receiving ibuprofen, treatment should be discontinued immediately.

Impaired fertility in women.

There is limited evidence that cyclooxygenase/prostaglandin synthesis inhibitors may impair female fertility by affecting ovulation. This is reversible upon discontinuation of therapy.

Severe skin adverse reactions

Severe cutaneous adverse reactions (SCARs), including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug-induced eosinophilia with systemic symptoms (DRESS) and acute generalised exanthematous pustulosis (AGEP), which can be life-threatening or fatal, have been reported with ibuprofen (see section 4.8). Most of these reactions occurred within the first month of treatment.

If signs and symptoms suggestive of these reactions occur, ibuprofen should be discontinued immediately and alternative treatment considered (if necessary).

In exceptional cases, chickenpox can cause severe skin and soft tissue infections. At present, it cannot be ruled out that NSAIDs may worsen these infections, and it is therefore recommended that ibuprofen be avoided in the presence of chickenpox.

Severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been observed very rarely. At the first signs of a hypersensitivity reaction after taking ibuprofen, therapy should be discontinued and a doctor should be consulted immediately.

Masking the symptoms of underlying infections.

This medicine may mask the symptoms of an infectious disease, which may delay the initiation of appropriate treatment and thereby complicate the course of the disease. This has been observed in bacterial community-acquired pneumonia and bacterial complications of varicella. When this medicine is used for fever or for pain relief in an infection, monitoring for the infectious disease is recommended. In the context of treatment outside a medical institution, the patient should consult a doctor if symptoms persist or worsen.

Ibuprofen may temporarily inhibit platelet aggregation. Therefore, it is recommended to carefully monitor the condition of patients with blood clotting disorders.

With prolonged use of ibuprofen, liver function, kidney function, and hematological function/blood count should be regularly monitored.

Prolonged use of any painkiller for headache may worsen this condition. In such cases, a doctor should be consulted and treatment should be discontinued. The possibility of drug overuse headache should be considered in patients who suffer from frequent or daily headaches despite regular use of headache medication.

The concomitant use of alcohol and NSAIDs may increase adverse reactions associated with the active substance, especially those affecting the gastrointestinal tract or central nervous system.

NSAIDs can mask symptoms of infection and fever.

This medicinal product contains liquid maltitol. It should not be administered to patients with rare hereditary problems of fructose intolerance. Due to the presence of liquid maltitol, this medicinal product may have a mild laxative effect.

This medicinal product contains sodium, which should be taken into consideration by patients on a controlled sodium diet. 15 ml of suspension contains 28.09 mg sodium (=1.87 mg sodium per 1 ml of suspension). Caution should be exercised when used in patients on a controlled sodium diet.

For use by adults, you should consult a doctor before taking this medicine in the following cases: You are pregnant, you are trying to become pregnant, you are elderly, you smoke.

Impact on laboratory test results:

Bleeding time may increase up to one day after stopping treatment;

Blood glucose concentration may decrease;

creatinine clearance may decrease;

hematocrit or hemoglobin may decrease;

Blood urea nitrogen concentration and serum creatinine and potassium concentrations may increase;

Liver function tests: increased transaminase levels.

Use during pregnancy or breastfeeding

The drug is used in children under 12 years of age.

Pregnancy.

From the 20th week of pregnancy onwards, ibuprofen may cause oligohydramnios due to fetal renal dysfunction. This may occur shortly after initiation of treatment and is usually reversible after discontinuation of treatment. In addition, there have been reports of narrowing of the ductus arteriosus following treatment in the second trimester of pregnancy, most of which resolved after discontinuation of treatment. Therefore, ibuprofen should not be given during the first and second trimesters of pregnancy unless clearly necessary. If ibuprofen is used by a woman attempting to conceive or during the first and second trimesters of pregnancy, the dose should be kept as low and the duration of treatment as short as possible. Antenatal monitoring for oligohydramnios and narrowing of the ductus arteriosus should be considered after exposure to ibuprofen for several days from the 20th week of gestation onwards. Ibuprofen should be discontinued if oligohydramnios or narrowing of the ductus arteriosus is detected.

During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may pose risks:

Risks to the fetus:

cardiopulmonary toxicity (premature narrowing/closure of the ductus arteriosus and pulmonary hypertension);

renal dysfunction (see above);

Risks for the mother at the end of pregnancy and for the newborn:

possible prolongation of bleeding time, anti-aggregation effect, which can occur even at very low doses;

suppression of uterine contractions, leading to delayed or prolonged labor.

Therefore, ibuprofen is contraindicated during the third trimester of pregnancy (see Contraindications section).

Breastfeeding. Ibuprofen and its metabolites are excreted in breast milk in low concentrations. There are currently no known adverse effects on the infant, so for short-term treatment of pain and fever at recommended doses, it is usually not necessary to discontinue breastfeeding.

Fertility.

There is some evidence that drugs that inhibit cyclooxygenase/prostaglandin synthesis may impair female fertility by affecting ovulation. This effect is reversible upon discontinuation of treatment.

The use of ibuprofen is not recommended in women attempting to conceive. In women who have difficulty conceiving or who are undergoing investigation of infertility, discontinuation of the drug should be considered.

Ability to influence reaction speed when driving vehicles or other mechanisms

Patients who experience dizziness, vertigo, visual disturbances or other central nervous system disorders when taking ibuprofen should avoid driving or operating other machinery during therapy with this drug.

No special precautions are required when using a single dose of ibuprofen or for a short period of time.

Method of administration and doses

The lowest effective dose should be used for the shortest time necessary to relieve symptoms (see section "Special instructions").

Side effects can be minimized by using the lowest effective dose necessary to control symptoms for the shortest period of time.

For oral use. The drug can be used diluted with water or undiluted. The recommended daily dose of the drug is 20–30 mg per 1 kg of body weight, divided into equal doses, the intervals between doses are 6–8 hours. To ensure accurate dosing, use the syringe-doser included in the package.

Do not exceed recommended dose. For short-term use only. Shake well before use.

If your child's symptoms persist for more than 3 days after starting treatment or worsen, you should consult a doctor.

Patients with sensitive stomachs should take the drug with meals.

Special categories of patients:

NSAIDs should be used with caution in patients with renal impairment, as ibuprofen is excreted primarily by the kidneys. Lower doses should be used in patients with mild to moderate renal impairment.

Although no differences in the pharmacokinetic profile of ibuprofen have been observed in patients with hepatic impairment, NSAIDs should be used with caution in such patients. Patients with mild to moderate hepatic impairment should be started on low doses and closely monitored. Ibuprofen should not be used in patients with severe hepatic impairment (see section 4.3).

Patients should consult a doctor if symptoms persist or worsen during treatment.

If you use a dose that exceeds the recommended dose, you should immediately consult a doctor.

Children

The drug is used in children aged 6 months, weighing at least 7 kg, up to 12 years.

Overdose

In children, symptoms of overdose may occur when taking ibuprofen doses exceeding 400 mg/kg. In adults, dose-related reactions are less pronounced. The half-life in overdose is 1.5–3 hours.

Symptoms. In most patients, the use of clinically significant amounts of NSAIDs caused only nausea, vomiting, epigastric pain or, less commonly, diarrhea. Tinnitus, headache and gastrointestinal bleeding are also possible. In more severe poisoning, toxic lesions of the central nervous system are possible in the form of vertigo, dizziness, drowsiness, sometimes - an excited state and disorientation or coma. Sometimes patients develop convulsions. In severe poisoning, hyperkalemia, metabolic acidosis, hypothermia and an increase in prothrombin time/INR (probably due to interaction with blood clotting factors circulating in the bloodstream) may occur. Acute renal failure, liver damage, hypotension, respiratory depression and cyanosis may occur. In patients with bronchial asthma, exacerbation of the course of asthma is possible. Nystagmus, blurred vision, and loss of consciousness are possible.

Treatment. There is no specific antidote. Treatment is symptomatic and supportive, including maintaining a patent airway and monitoring cardiac function and vital signs until the patient's condition is normal. Consider oral administration of activated charcoal or gastric lavage if it is less than 1 hour after the patient has taken a potentially toxic dose. If ibuprofen has already been absorbed, alkaline agents may be used to help eliminate acidic ibuprofen in the urine. Frequent or prolonged seizures should be treated with intravenous diazepam or lorazepam. Bronchodilators should be used in the case of bronchial asthma. Medical advice should be sought.

Side effects

The following list of adverse reactions includes all adverse reactions known to occur with ibuprofen, including those observed with high doses, in long-term treatment of patients with rheumatism. The frequency reported, which is beyond the very rare reports, refers to short-term use (maximum 1200 mg ibuprofen per day) of oral formulations.

Adverse reactions that have occurred with ibuprofen are listed below by system organ class and frequency. The frequency of adverse reactions is defined as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

The most frequently observed adverse reactions were gastrointestinal. The majority of adverse reactions are