ALGIDRIN * OS 120ML 20MG / ML + SIR

ALGIDRIN * OS 120ML 20MG / ML + SIR

Therapeutic indications

ALGIDRIN is indicated for children over 3 months of age and adolescents: • for the symptomatic treatment of fever • for the symptomatic treatment of mild to moderate pain

Dosage and method of use

Dosage: The lowest effective dose should be taken, as soon as possible, needed to control symptoms (see section 4.4)Pediatric population:The dose of ibuprofen to be given depends on the age and weight of the child. For children aged 3 months to 12 years, the recommended daily dose of ibuprofen is 20 to 30 mg / kg of body weight, divided into three or four individual doses (see table below). The use of this medicine is not recommended in children under 3 months of age or weighing less than 5 kg. The interval between doses depends on the course of symptoms, but should never be less than 4 hours. The following dosing schedule is recommended as a guideline. The doses can be repeated every 6-8 hours, without exceeding the daily quantities indicated in the last column:

The recommended dose is 10-20 ml (equivalent to 200-400 mg of ibuprofen) every 4-6 hours, if necessary, without exceeding the daily dose of 1200 mg of ibuprofen in 24 hours. Given the amount of ibuprofen in this medicinal product, the use of other packs with more suitable doses is recommended for the treatment of adults and adolescents over 12 years of age.Kidney failure:Certain precautions should be taken when using non-steroidal anti-inflammatory drugs (NSAIDs) in patients with renal insufficiency, as ibuprofen is usually eliminated by the kidney. Lower doses are used for patients with mild to moderate renal dysfunction. Ibuprofen must not be used in patients with severe renal insufficiency (see section 4.3).Liver failure:Although no differences in the pharmacokinetic profile of ibuprofen have been observed in patients with hepatic insufficiency, it is advisable to take precautions in the use of NSAIDs in this type of patient. Patients with mild to moderate hepatic impairment should start treatment at lower doses and be closely monitored. Ibuprofen must not be used in patients with severe hepatic impairment (see section 4.3).Method of administration: This medicine is administered orally. It can be administered directly or diluted with water. Shake the bottle before use. The packs contain a 5 ml graduated oral syringe for accurate dosing. The syringe should be unhooked from the bottle, disassembled, washed and dried well after each use. Patients with gastric problems should take the medicine with meals.

Contraindications

- Hypersensitivity to ibuprofen, to any other NSAID or to any of the excipients listed in section 6.1. - Patients who have developed allergic reactions, asthma attacks, acute rhinitis, urticaria or angioneurotic edema after taking substances with similar actions (for example acetylsalicylic acid or other anti-inflammatory drugs). - A history of gastrointestinal bleeding or perforation related to previous treatment with non-steroidal anti-inflammatory drugs (NSAIDs). - Peptic ulcer, active or recurrent gastrointestinal bleeding (two or more separate episodes of ulceration or bleeding occurring). - Patients with diseases that tend to increase bleeding. - Severe heart failure (NYHA: class IV). - Severe renal insufficiency (glomerular filtration rate below 30 ml / min). - Severe hepatic insufficiency. - Patients with severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake). - During the third trimester of pregnancy (see section 4.6).

Side effects

The most frequently observed undesirable effects are gastrointestinal in nature. Peptide ulcers, gastrointestinal perforation or haemorrhage, in some cases fatal, may occur, especially in the elderly (see section 4.4). Cases of nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis and exacerbation of colitis and Crohn's disease have also been reported (see section 4.4). The occurrence of gastritis was observed less frequently. Undesirable effects are reported by organ or system and by frequency according to the following classification: very common (≥ 1/10); Common (≥1 / 100, Gastrointestinal disorders. Common: dyspepsia, diarrhea, nausea, vomiting, abdominal pain, flatulence, constipation, melaena, haematemesis, gastrointestinal haemorrhage; Uncommon: gastritis, duodenal ulcer, gastric ulcer, mouth ulcer, perforation gastrointestinal; Very rare: pancreatitis; Frequency not known: exacerbation of colitis, Crohn's disease.Skin disorders and hypersensitivity reactions.Uncommon: rash, urticaria, pruritus, purpura (including allergic purpura), photosensitivity reaction; Very rare: Bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis, erythema multiforme. Serious skin infections and soft tissue complications may exceptionally occur during chickenpox (see also “Infections and infestations” and section 4.4). Frequency not known: drug reaction with eosinophilic and systemic symptoms (Dress's syndrome). Acute generalized exanthematous pustulosis (AGEP).Infections and infestations¹.Uncommon: rhinitis; Rare: aseptic meningitis (see section 4.4).Disorders of the immune system.Uncommon: hypersensitivity²; Rare: anaphylactic reaction: symptoms may include swelling of the face, tongue and larynx, dyspnoea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock).pathologies of the central nervous system.Common: headache, dizziness; Uncommon: paraesthesia, somnolence; Rare: optic neuritis.Psychiatric disorders.Uncommon: insomnia, anxiety; Rare: depression, confusion, disorientation.Ear and labyrinth disorders.Uncommon: hearing disorders; Rare: vertigo, tinnitus.Eye disorders.Uncommon: visual changes; Rare: reversible toxic amblyopia.Respiratory, thoracic and mediastinal disorders.Uncommon: asthma, bronchospasm, dyspnoea.Disorders of the blood and lymphatic system.Rare: thrombocytopenia, leukopenia, neutropenia, agranulocytosis, aplastic anemia and haemolytic anemia. Initial symptoms are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, excessive fatigue, and nose and skin bleeding from unknown causes.Cardiac pathologies.Very rare: heart failure myocardial infarction (see section 4.4).Vascular pathologies⁴.Very rare: hypertension.Hepatobiliary disorders.Uncommon: hepatitis, jaundice, hepatic dysfunction; Rare: hepatic failure; Very rare: hepatic failure.Renal and urinary disorders.Uncommon: interstitial nephritis, nephrotic syndrome, renal failure, acute renal failure, papillary necrosis (especially after prolonged use), associated with increased urea.Systemic pathologies.Common: fatigue; Rare: edema. ¹Infections and infestations:An exacerbation of infection-related inflammations (e.g. necrotizing fasciitis) has been reported in conjunction with the use of NSAIDs. You should see a doctor as soon as possible if there are any signs or worsening of the infection while using ibuprofen. ²Hypersensitivity: hypersensitivity reactions have been observed after treatment with NSAIDs. These may consist of: (a) non-specific respiratory tract allergy and anaphylaxia; (b) respiratory tract reactivity such as asthma, aggravated asthma, bronchospasm or dyspnoea; or (c) various skin changes, including various types of rash, pruritus, purpura, angioedema and, in very rare cases, erythema multiforme and dermatosis (including Stevens-Johnson syndrome, toxic epidermal necrosis).^3.4 Cardiac and vascular diseases: Clinical studies suggest that the use of ibuprofen, especially at high doses (2,400 mg per day) may be associated with a small increased risk of arterial thrombotic events (such as myocardial infarction or stroke, see section 4.4).Reporting of suspected adverse reactions. Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at:https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

Masking of symptoms of underlying infections: ALGIDRIN can mask the symptoms of infection, which can lead to delayed initiation of appropriate treatment and thus worsen the outcome of the infection. This has been observed in community-acquired bacterial pneumonia and bacterial complications of chickenpox. When ALGIDRIN i is given to relieve fever or pain related to infection, monitoring of the infection is advised. In non-hospital settings, the patient should consult a physician if symptoms persist or worsen. Adverse reactions caused by the combination of the active substance and concomitant alcohol consumption, in particular reactions related to the gastrointestinal tract or the central nervous system, may be increased by the use of NSAIDs.Gastrointestinal Risks: Gastrointestinal bleeding, ulcers and perforations: During treatment with NSAIDs, including ibuprofen, reports of gastrointestinal bleeding, ulcers and perforations (which can be fatal) have been received at any time, with or without prior warning symptoms and with or without a previous history of serious gastrointestinal events. The risk of gastrointestinal bleeding, ulcer or perforation is higher with increasing doses of NSAIDs, in patients with a history of ulcer, particularly if ulcers are complicated by haemorrhage or perforation (see section 4.3) and in elderly patients. These patients should start treatment with the lowest possible dose and be prescribed concomitant treatment with protective agents (eg, misoprostol or proton pump inhibitors); the combination treatment should also be considered for patients requiring low doses of acetylsalicylic acid or other medicinal products that may increase gastrointestinal risk factors (see section 4.5). Patients with a history of gastrointestinal toxicity, and particularly elderly patients, should be advised to seek immediate medical attention in the event of infrequent abdominal symptoms (especially gastrointestinal bleeding) during treatment and especially during the initial stages. Special caution is recommended for patients receiving concomitant treatments that may increase the risk of gastrointestinal ulcer or bleeding such as dicumarin-based oral anticoagulants or antiplatelet agents such as acetylsalicylic acid (see section 4.5). In addition, certain precautions must be taken in case of concomitant administration of oral corticosteroids and selective serotonin reuptake inhibitor antidepressants (SSRIs). Treatment should be stopped immediately in the event of gastrointestinal bleeding or ulceration in patients under treatment with this medicinal product (see section 4.3). NSAIDs should be administered with caution to patients with a history of ulcerative colitis or Crohn's disease, as they may aggravate these conditions (see section 4.8).Cardiovascular and cerebrovascular risks: Special care should be taken in patients with a history of hypertension and / or heart failure as fluid retention and edema have been associated with NSAID treatments. Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg per day), may be associated with a small increased risk of arterial thrombotic events (eg, myocardial infarction or stroke). In general, epidemiological studies do not suggest that low-dose ibuprofen (e.g. 1,200 mg / day) is associated with an increased risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), established ischemic heart disease, peripheral artery disease and / or cerebrovascular disease, should only be treated with ibuprofen after careful consideration and avoiding high doses (2400 mg / die). Careful consideration should also be made before initiating long-term treatment in patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, smokers), especially if they require high doses of ibuprofen (2400 mg / day ).Risk of severe skin reactionsVery rare reports have been received of serious skin reactions, some fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis in association with use of NSAIDs (see section 4.8). Patients appear to be at increased risk of these reactions at the start of treatment: in most cases these side effects appear during the first month of treatment Acute generalized exanthematous pustulosis (acute exanthematous pustulosis) has been reported (Acute Generalized Exanthematous Pustulosis- AGEP) in relation to products containing ibuprofen. Administration of the medicinal product should be stopped immediately at the first symptoms of skin rash, mucosal lesions or other signs of hypersensitivity. On exceptional occasions, chickenpox can cause infectious skin and soft tissue complications. To date, the role of NSAIDs in exacerbating these infections cannot be ruled out. Therefore ibuprofen should be avoided in case of chickenpox.Allergic reactions: On very rare occasions, severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been observed. Treatment should be stopped when the first signs of a hypersensitivity reaction appear after taking / administering ibuprofen. Based on the symptoms, the necessary medical measures must be initiated by specialized personnel. Caution is required in patients who have suffered from hypersensitivity or allergic reactions to other substances, as this may increase the risk of hypersensitivity reactions to ibuprofen. Caution is required in patients suffering from seasonal allergies, nasal polyps or chronic obstructive respiratory disorders, as there is a high risk of allergic reactions. These reactions can present as asthma attacks, Quincke's edema or hives.Renal and / or hepatic insufficiency: Ibuprofen should be used with caution in patients with liver or kidney disease, particularly during simultaneous treatment with diuretics, as inhibition of prostaglandins can produce fluid retention and impair renal function. When administered to these patients, the ibuprofen dose should be as low as possible and renal function should be monitored regularly. There is a risk of renal impairment in dehydrated children, adolescents and elderly patients. In case of dehydration, ensure adequate fluid intake. Special precautions should be taken in children with severe dehydration, for example due to diarrhea, as dehydration could act as a trigger for the development of kidney failure. In general, the habitual use of analgesics, in particular the combination of different analgesic substances, can cause lasting kidney damage, with a risk of kidney failure (analgesic nephropathy). Like other NSAIDs, long-term ibuprofen treatments can cause renal papillary necrosis and other kidney diseases. Renal toxicity has also been observed in patients whose renal prostaglandins play a compensatory role in renal perfusion. Elderly patients, patients with renal insufficiency, heart failure, hepatic dysfunction and those treated with diuretics or antihypertensives (ACE inhibitors) have a high risk of experiencing this reaction. Stopping NSAID therapy normally restores the state before treatment. Like other NSAIDs, ibuprofen can produce transient mild increases in some liver parameters and significant increases in AST and ALT levels. Treatment should be discontinued in the event of a significant increase in these parameters (see sections 4.2 and 4.3).Use in the elderly population: Elderly patients suffer from an increased incidence of adverse reactions to NSAIDs, particularly gastrointestinal bleeding and perforation, which can be fatal (see section 4.2).Other: As with other NSAIDs, anaphylactic / anaphylactoid reactions can occur without prior drug exposure. It should also be used with caution in patients with a history of bronchial asthma, chronic rhinitis and allergic disease, as bronchospasm, urticaria and angioedema have been reported in these types of patients (see section 4.3). On rare occasions, cases of aseptic meningitis have been reported with the use of ibuprofen. In the majority of cases, patients suffered from some form of autoimmune disease (such as systemic lupus erythematosus or other connective tissue diseases), which was a risk factor, although cases have also been reported in patients without chronic disease (see section 4.8. ). The observed symptoms of aseptic meningitis were stiff neck, headache, nausea, vomiting, fever and disorientation. Special medical supervision is required when administering to patients immediately after undergoing major surgery. Like other NSAIDs, it should only be used after a rigorous risk / benefit assessment in patients with acute intermittent porphyria. Renal and hepatic function, haematological function and red blood cell count should be monitored as a precautionary measure in patients on long-term treatment, as ibuprofen, like other NSAIDs, can inhibit platelet aggregation and prolong bleeding time. Undesirable effects can be minimized by using the lowest effective dose for as short a period as possible.Warnings on excipients: This medicine may produce allergic reactions because it contains Allura AC red dye (E-129). It can cause asthma, especially in patients allergic to acetylsalicylic acid. This medicine contains maltitol (E-965) and each ml of suspension contains 25 mg of sorbitol (E-420). Patients with hereditary fructose intolerance should not take this medicine. This medicinal product contains methyl para-hydroxybenzoate (E-218), ethyl para-hydroxybenzoate (E-214) and propyl para-hydroxybenzoate (E-216) and may produce allergic reactions (possibly delayed).Interference with analytical tests: Bleeding time (can be prolonged for 1 day after stopping treatment). Blood sugar levels (can be reduced). Creatinine clearance (can be reduced). Hematocrit or hemoglobin levels (can be reduced). Blood urea nitrogen concentrations and serum creatinine and potassium concentrations (may be increased). Liver function tests: transaminase values increased.

Pregnancy and breastfeeding

Pregnancy. 1) First and second trimester of pregnancy: Inhibition of prostaglandin synthesis negatively affects pregnancy and / or the development of the embryo / fetus. Data from epidemiological studies suggest an increased risk of spontaneous abortion and cardiac malformations and gastroschisis after the use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk appears to increase with dose and duration of treatment. In animals, administration of a prostaglandin synthesis inhibitor has been shown to produce increased pre- and post-implantation losses and embryo / fetal mortality. There have also been reports of increased incidence of various malformations, including cardiovascular malformations, in animals given a prostaglandin synthesis inhibitor during the organogenic period. Ibuprofen should not be given during the first and second trimester of pregnancy unless considered strictly necessary. If ibuprofen is to be used in a woman trying to get pregnant, or during the first and second trimester of pregnancy, the dose and duration of treatment should be reduced as much as possible. 2) Third trimester of pregnancy: During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose: - The fetus to: - cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension); - renal dysfunction, which can progress to renal failure with oligohydramnios. - The mother, at the end of pregnancy, to: - possible prolongation of the bleeding time and of the antiplatelet effect, which can occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged delivery (with a tendency towards more bleeding in the mother and baby). Therefore, this medicinal product is contraindicated during the third trimester of pregnancy (see section 4.3).Breastfeeding: Ibuprofen and its metabolites enter breast milk in low concentrations. To date, no harmful effects have been found for infants, so in general breastfeeding should not be discontinued during short-term treatment at the recommended dose for pain and fever.Fertility: The use of ibuprofen can impair female fertility and is not recommended in women trying to get pregnant. Women who have difficulty conceiving or who are undergoing fertility tests should consider stopping this medicine.

Expiry and retention

Do not store above 30 ° C.

Interactions with other drugs

In general, NSAIDs should be taken with caution when used in conjunction with other drugs that may increase the risk of gastrointestinal ulcer, gastrointestinal bleeding, and renal dysfunction. Interactions have been reported with the following medicines: - Diuretics : they can increase the nephrotoxicity of NSAIDs, as a consequence of the reduction of renal blood flow. As with other NSAIDs, concomitant treatment with potassium-sparing diuretics may be associated with an increase in potassium levels, requiring monitoring of plasma levels of this ion. - Anticoagulants:NSAIDs may enhance the effects of dicumarin anticoagulants such as warfarin (see section 4.4). - Antiplatelet agents : increase the risk of gastrointestinal bleeding (see section 4.4). NSAIDs should not be combined with ticlopidine, due to the risk of an additional effect in inhibiting platelet function. - Corticosteroids:they may also increase the risk of gastrointestinal ulcer or bleeding (see section 4.4). - Selective Serotonin Reuptake Inhibitors (SSRIs) : may also increase the risk of gastrointestinal bleeding (see section 4.4). - Antihypertensive agents (including ACE inhibitors, beta blockers and angiotensin II receptor antagonists) : NSAIDs may reduce the efficacy of antihypertensive agents, including ACE inhibitors or beta-blocking agents and angiotensin II antagonists. Simultaneous treatment with NSAIDs, ACE inhibitors, beta-blockers or angiotensin receptor blockers may be associated with the risk of acute kidney disease, including acute kidney failure, which is usually reversible. Therefore, the combination should be administered with caution, especially in elderly patients. Patients should be well hydrated and regular monitoring of renal function should be considered after initiation of concomitant treatment. - Acetyl salicylic acid and other NSAIDs, which include selective inhibitors of cyclooxygenase-2 (COX-2): Simultaneous use should be avoided as administration of several NSAIDs may increase the risk of gastrointestinal ulceration and bleeding. - Acetylsalicylic acid : in general, concomitant administration of ibuprofen and acetylsalicylic acid is not recommended due to the potential to increase side effects. Experimental data suggest that ibuprofen may competitively inhibit the effect of low doses of acetylsalicylic acid on platelet aggregation when administered concomitantly. Although there are uncertainties regarding the extrapolation of these data to clinical situations, the possibility that regular long-term use of ibuprofen may reduce the cardioprotective effect of low doses of acetylsalicylic acid cannot be excluded. There is likely to be no clinically relevant effect with the occasional use of ibuprofen (see section 5.1.). - Lithium : NSAIDs may increase plasma lithium levels, possibly due to a decrease in its renal clearance. Co-administration should be avoided unless lithium levels are monitored. A reduction of the lithium dose should be considered. - Methotrexate administered at doses of 15 mg / week or greater : If NSAIDs and methotrexate are administered over a 24 hour interval, an increase in plasma levels of methotrexate may occur (NSAIDs appear to reduce tubular secretion and renal clearance of methotrexate), with an increased risk of methotrexate toxicity. Therefore, the use of ibuprofen in patients receiving high dose methotrexate treatment should be avoided. - Methotrexate given in low doses, below 15 mg / week : ibuprofen increases methotrexate levels. When used in combination with low dose methotrexate, the patient's blood chemistry should be closely monitored, especially during the first few weeks of simultaneous administration. Vigilance should also be increased in even minimal impaired renal function and in elderly patients. Renal function should be monitored to prevent any possible decrease in methotrexate clearance. - Sulfonylureas:NSAIDs can enhance the effect of sulfonylureas. Rare cases of hypoglycaemia have been reported in patients treated with sulfonylureas and ibuprofen. - Mifepristone:theoretically, the effectiveness of this drug may be reduced due to the antiprostaglandin properties of NSAIDs. Limited evidence suggests that concomitant same-day NSAID administration of prostaglandin does not negatively impact the effects of mifepristone or prostaglandin in cervical ripening or uterine contractility and does not reduce clinical efficacy in inducing abortion. - Cardiac glycosides (digoxin):NSAIDs can exacerbate heart failure, reduce glomerular filtration rate and increase cardiac glycoside levels, thereby increasing the risk of digoxin toxicity. - Pentoxifylline:the risk of bleeding may be increased in patients receiving ibuprofen in combination with pentoxifylline. Therefore, monitoring of bleeding time is recommended. - Probenecid and sulfinpyrazones : can cause an increase in plasma concentrations of ibuprofen; this interaction may be due to an inhibitory mechanism at the level of renal tubule secretion and glucuronidation, and the ibuprofen dose may need to be adjusted. - Quinolone antibiotics:data from animal studies indicate that NSAIDs may increase the risk of seizures associated with the use of quinolone antibiotics. Patients who have taken NSAIDs and quinolones may have a higher risk of experiencing seizures. - Idantoins (phenytoin) and sulfonamides:the toxic effects of these substances can be increased. During simultaneous treatment with ibuprofen, the plasma levels of phenytoin may increase. - Cholestyramine:concomitant administration of ibuprofen and cholestyramine may reduce the absorption of ibuprofen from the gastrointestinal tract, although the clinical relevance is unknown. - Tacrine:administration of ibuprofen together with tacrine increases the toxicity of tacrine, with episodes of delirium, due to the possible inhibition of its binding to plasma proteins. - Ciclosporine, tacrolimus:simultaneous administration of NSAIDs may increase the risk of nephrotoxicity due to a reduction in the renal synthesis of prostaglandins. If administered concomitantly, renal function should be closely monitored. - Thrombolytics:the risk of bleeding may increase. - Zidovudine:the risk of haematological toxicity may increase when NSAIDs are co-administered with zidovudine. There is an increased risk of joint bleeding and hematoma in HIV (+) patients with haemophilia who receive concomitant treatment with zidovudine and ibuprofen. - Aminoglycosides:NSAIDs can reduce the excretion of aminoglycosides. - Herbal extracts:Ginkgo biloba may increase the risk of bleeding with NSAIDs - Alcohol:concomitant use of alcohol may increase NSAID-related adverse effects, especially those involving the gastrointestinal tract and central nervous system (see sections 4.4 and 4.8). - Food:Administration of ibuprofen with food reduces the rate of absorption, although this has no effect on the extent of absorption (see section 5.2). - CYP2C9 inhibitors:administration of ibuprofen with CYP2C9 inhibitors may increase exposure to ibuprofen (CYP2C9 substrate). A study with voriconazole and fluconazole (CYP2C9 inhibitors) showed an approximately 80% to 100% increase in exposure to ibuprofen S (+). A lower dose of ibuprofen should be considered when administered concomitantly with a potent CYP2C9 inhibitor, especially when ibuprofen is administered in high doses with voriconazole or fluconazole.

Overdose

Most cases of overdose are asymptomatic. Generally no signs of toxicity have been observed at doses below 100 mg / kg in children and adults. However, in some cases additional assistance may be required. Children have been observed to show signs and symptoms of toxicity after ingesting quantities of 400 mg / kg or more.SymptomsMost patients who took significant amounts of ibuprofen showed symptoms within the next 4-6 hours. The most frequently reported symptoms of overdose include abdominal pain, nausea, vomiting, lethargy, somnolence. Effects on the central nervous system (CNS) include headache, tinnitus, dizziness, seizures, loss of consciousness and ataxia. Rare cases of nystagmus, metabolic acidosis, hypothermia, impaired renal function, gastrointestinal haemorrhage, coma, apnea and depression of the central nervous and respiratory systems have also been reported. Cases of cardiovascular disease, including hypotension, bradycardia and tachycardia, have been reported. In case of severe poisoning, metabolic acidosis can occur. In the event of a severe overdose, kidney and liver damage may occur.Therapeutic measures for overdose:Treatment is symptomatic and no specific antidote is available. For amounts where symptoms are unlikely to occur (less than 50 mg / kg ibuprofen) water can be given to reduce gastrointestinal discomfort as much as possible. If large quantities have been ingested, activated charcoal should be given. Vomiting stomach emptying should only be considered within 60 minutes of ingestion. Therefore, gastric lavage should not be considered unless the patient has ingested a life-threatening amount of the drug and less than 60 minutes have elapsed since ingestion. The benefit of measures such as forced diuresis, hemodialysis or hemoperfusion is questionable, as ibuprofen binds strongly to plasma proteins.

Active principles

Each ml of oral suspension contains: 20 mg of ibuprofen (provided by 34.17 mg of ibuprofen lysine). Excipients with known effects: Sorbitol (E-420) 25 mg, maltitol (E-965) 100 mg, Allura AC red dye (E129) 0.0786 mg, methyl para-hydroxybenzoate (E-218) 1.45 mg, ethyl para-hydroxybenzoate (E-214) 0.32 mg, propyl para-hydroxybenzoate (E-216) 0.22 mg. For the full list of excipients, see section 6.1.

Excipients

Purified water, Microcrystalline cellulose, Sodium carboxymethylcellulose, Sorbitol (E-420), Maltitol (E-965), Beta-cyclodextrin, Sodium saccharin, Sucralose (E-955), Berry flavor, Allura-AC red coloring (E -129), methyl para-hydroxybenzoate (E-218), ethyl para-hydroxybenzoate (E-214), propyl para-hydroxybenzoate (E-216).