Pediatric Ibudol (40 Mg/Ml Oral Suspension 1 Bottle 150 Ml + Oral Syringe)

ACTION AND MECHANISM

- Analgesic, anti-inflammatory, antipyretic. Ibuprofen is a propionic acid derivative, with anti-inflammatory, analgesic and antipyretic activity. Its mechanisms of action could be due to the inhibition of peripheral synthesis of prostaglandins due to its competitive and reversible binding to the enzyme cyclooxygenase, an enzyme that transforms arachidonic acid into said prostaglandins.

PHARMACOKINETICS

Ibuprofen acid is a racemic compound, of which the S(+)-enantiomer possesses almost all the pharmacological activity. In vivo, almost 70% of the R(-)-enantiomer of acidic ibuprofen is converted to the pharmacologically active S(+)-enantiomer.

Linear pharmacokinetics in the dosage range of 200-800 mg

- Absorption:

* Oral administration: good and rapid oral absorption, with a bioavailability of 80% and a tmax of 1-3 h, depending on the pharmaceutical form (47 min in suspension, 120 min in tablets). Arginine and lysine salts promote the solubilization of ibuprofen, so it is absorbed even more quickly, with a tmax of 20-30 min. After administration of a 200 mg dose, the cmax is 15-20 mcg/ml.

The antipyretic effects begin after one hour, are maximum at 2-4 hours, and can last for periods of 6-8 hours.

For its part, up to 2 weeks of treatment may be required to achieve anti-inflammatory effects.

Effect of food : they delay absorption by around 30-60 min and cmax by 30-50%, although they do not affect the total amount absorbed.

- Distribution: high binding to plasma proteins (90-99%). Vd of 0.1-0.2 l/kg. Ibuprofen diffuses well, passes into synovial fluid and crosses the placental barrier. It has not been detected in milk of lactating women (detection limit 0.5 mcg/ml).

- Metabolism: widely metabolized in the liver by hydroxylation and carboxylation of the isobutyl group, generating several inactive metabolites, of which the majority are 2-[4-(2-hydroxy-2-methyl-propyl)-phenyl] propionic acid and 2-[4-(carboxypropyl)-phenyl] propionic acid

- Elimination: in urine (90%; 50-60% major metabolites and their glucuronides and < 10% unchanged), with minor amounts in feces. The t1/2 is 2-4 hours, and its elimination is complete after 24 hours.

Pharmacokinetics in special situations :

- Children: although the distribution and t1/2 appear similar to those in adults, the CLt of ibuprofen could be affected by age.

- Renal failure: in mild failure (CLcr 60-90 ml/min) there is an increase in the free fraction (3%), an elevation in the AUC and the S/R enantiomer ratio. The elimination of metabolites could be reduced in patients with more severe renal impairment.

- Liver failure: in moderate failure (Child-Pugh class B) the t1/2 was doubled while the ratio of S/R enantiomers was reduced, which would indicate the difficulty of converting the R enantiomer into the active form.

INDICATIONS

- Treatment of mild to moderate [PAIN].

- Symptomatic treatment of [FEVER].

- Treatment of [JUVENILE RHEUMATOID ARTHRITIS].

POSOLOGY

- Adults: 10 ml (400 mg)/8 h. Maximum dose 30 ml (1,200 mg)/24 h.

- Children and adolescents < 18 years: 20-30 mg/kg/24 h, divided into 3-4 doses. The interval between doses should never be less than 4 hours.

* Adolescents from 12 years of age (> 40 kg): 10 ml (400 mg)/8 h. Maximum dose 30 ml (1,200 mg)/24 h.

* Children 10-12 years (30-40 kg): 7.5 ml (300 mg)/8 h. Maximum dose 22.5 ml (900 mg)/24 h.

* Children 7-9 years (21-29 kg): 5 ml (200 mg)/8 h. Maximum dose 15 ml (600 mg)/24 h.

* Children 4-6 years (16-20 kg): 3.75 ml (150 mg)/8 h. Maximum dose 11.25 ml (450 mg)/24 h.

* Children 1-3 years (10-15 kg): 2.5 ml (100 mg)/8 h. Maximum dose 7.5 ml (300 mg)/24 h.

* Children 6-12 months (7.7-9 kg): 1.25 ml (50 mg)/6-8 h. Maximum dose 5 ml (200 mg)/24 h.

* Children 3-6 months (5-7.6 kg): 1.25 ml (50 mg)/8 h. Maximum dose 3.75 ml (150 mg)/24 h.

* Children < 3 months (< 5 kg): safety and efficacy have not been evaluated.

- Elderly: no dosage adjustment required.

Administration with food : administer together with food.

Duration of treatment : consult your doctor and/or pharmacist if symptoms worsen or persist for more than 5 days (pain) or 3 days (fever). In the case of children between 3-5 months, it is advisable to consult with the doctor within 24 hours.

Missed dose : administer the next dose at the usual time. Do not double the next dose.

DOSAGE IN KIDNEY FAILURE

- Mild to moderate renal failure (CLcr 30-90 ml/min): use with caution at the lowest possible dose.

- Severe renal failure (CLcr < 30 ml/min): contraindicated.

DOSAGE IN LIVER FAILURE

- Mild to moderate hepatic impairment (Child-Pugh classes A and B): use with caution at the lowest possible dose.

- Severe hepatic insufficiency (Child-Pugh class C): contraindicated.

RULES FOR CORRECT ADMINISTRATION

Administration with food : administer together with food.

- Oral suspension: shake the container before extracting the necessary dose. The suspension can be taken directly or diluted in water.

ADVICE TO THE PATIENT

- The patient should inform their doctor if they experience skin rashes, symptoms that could be related to a gastroduodenal ulcer (such as epigastric pain or dark stools), visual disturbances, weight gain, edema or prolonged headache.

- The patient should notify the doctor if he or she has had any asthmatic reaction while taking this medication.

CONTRAINDICATIONS

- Hypersensitivity to ibuprofen or any component of the medication. Cases of cross-hypersensitivity reactions have been described with other NSAIDs, so it should not be used in case of [ALLERGY TO SALICYLATE] or [ALLERGY TO NSAID]. These allergic reactions are especially common in patients who are asthmatic, have nasal polyps, or have experienced rhinitis, angioedema, or urticaria while receiving another NSAID or salicylates.

- Active or recurrent [PEPTICA ULCER], active inflammatory bowel disease or any other process that increases the risk of [GASTROINTESTINAL HEMORRHAGE]. Ibuprofen has ulcerogenic effects due to the inhibition of prostaglandin synthesis, which could increase the risk of gastrointestinal bleeding and perforation.

- [COAGULATION ALTERATIONS]. Ibuprofen has antiplatelet effects, although less powerful and long-lasting than those of acetylsalicylic acid. Therefore, it may increase bleeding time, so it should be used with caution in patients with active [HEMORRHAGIC DIATHESIS] or [HEMORRHAGE], as well as in patients with [THROMBOCYTOPENIA].

- Perioperative pain in the context of a coronary bypass.

- Severe renal failure (CLcr < 30 ml/min). Safety and efficacy have not been evaluated, so it is recommended not to use.

- Severe liver failure (Child-Pugh class C). Safety and efficacy have not been evaluated, so it is recommended not to use.

- Severe heart failure (NYHA class III-IV) or uncontrolled high blood pressure. Fluid retention could worsen these pathologies.

- Pregnancy. Its use is contraindicated during the third trimester of pregnancy, and its use for prolonged periods of time in the first two trimesters is not recommended.

PRECAUTIONS

- [RENAL INSUFFICIENCY]. Ibuprofen is eliminated through urine, so in case of kidney failure accumulation could occur, with the risk of poisoning. Furthermore, it could lead to a decrease in renal blood flow with reversible acute renal failure due to the inhibition of the synthesis of vasodilatory prostaglandins, and even cases of nephrotic syndrome and acute interstitial nephritis have been described with prolonged treatments. In patients with mild to moderate insufficiency (CLcr between 30-90 ml/min) it is recommended to start treatment with a lower dose than in patients with normal renal function, carefully monitoring the patient. Use in severe insufficiency (CLcr < 30 ml/min) is contraindicated (See Contraindications).

- [LIVER FAILURE]. Due to its hepatic metabolism, accumulation and intoxication could occur in case of liver failure. In patients with mild to moderate insufficiency (Child-Pugh class A or B), it is recommended to start treatment with a lower dose than in patients with normal liver function, carefully monitoring the patient. Use in severe impairment (Child-Pugh class C) is contraindicated (See Contraindications).

- History of peptic ulcer. The use of an NSAID, including ibuprofen, has led to gastroduodenal ulcers, as well as bleeding and cases of perforation that could be fatal. The risk of ulcer is increased in high-dose treatments or for long periods of time, patients with a history of peptic ulcer, especially if they have already had gastrointestinal bleeding or perforation, as well as in the elderly.

As a general rule, it is advisable to administer any NSAID with food to reduce gastric damage. Furthermore, in risk groups it is advisable to start treatment with the lowest possible dose, and always combine an antiulcer drug (H2 antihistamines or pump inhibitors) whenever possible.

These patients, as well as those who are being treated with drugs that may promote bleeding, such as oral anticoagulants or antiplatelet agents, should be closely monitored.

If symptoms of active ulcer or digestive bleeding appear, treatment will be interrupted. Likewise, treatment with ibuprofen should not be started in people with active peptic ulcer (See Contraindications).

- [INFLAMMATORY BOWEL DISEASE]. NSAIDs could precipitate symptomatic attacks of diseases such as Crohn's disease or ulcerative colitis, so it is advisable to use them with caution, and avoid their use in case of active diseases (See Contraindications).

- Cardiovascular effects. NSAIDs could lead to fluid retention (especially with prolonged use), due to the inhibition of the synthesis of vasodilatory prostaglandins, which could lead to the appearance or worsening of [ARTERIAL HYPERTENSION], especially in cases in which where there is no prior treatment, or in which it has not been able to control the disease.

On the other hand, the administration of high doses of ibuprofen (=/> 2,400 mg/24 h) has been related to a higher risk of arterial thrombosis, similar to that of specific COX-2 inhibitors at therapeutic doses. Therefore, it is recommended to avoid the use of these doses in patients with moderate to severe [HEART FAILURE] (NYHA classes II-IV), [ISCHEMIC HEARTDIOPATHY], [PERIPHERAL ARTERIOPATHY], [STROKE] or [CEREBRAL ISCHEMIA].

Before starting long-term treatment with ibuprofen, and especially if high doses are needed, it would be advisable to evaluate other cardiovascular risk factors such as [DYSLIPEMIA], [DIABETES] or [TOBACCOSM].

The use of reduced doses of ibuprofen (1,200 mg/24 h) and for a limited period of time does not seem to present the same cardiovascular risks. Therefore, as with other NSAIDs, the general recommendation would be to use it at the lowest dose that allows symptoms to be controlled and for the shortest period of time possible.

- Skin reactions. The use of NSAIDs has caused very rare, but potentially fatal, serious adverse reactions, such as exfoliative dermatitis, toxic epidermal necrolysis or Stevens-Johnson syndrome. These adverse reactions usually begin early, in the first month of treatment. If symptoms of hypersensitivity, mucosal lesions or skin erythema are observed, treatment will be suspended.

- Chronic [ASTHMA]. The appearance of hypersensitivity reactions with bronchospasm is especially common in these patients, so extreme precautions are recommended. If worsening of respiratory function is observed, treatment will be suspended.

- [ASEPTIC MENINGITIS]. Rare cases of aseptic meningitis have been reported in patients treated with NSAIDs, probably due to a hypersensitivity reaction, although cross-allergy between NSAIDs has not been found. It has been more frequent in patients with [SYSTEMIC LUPUS ERYTHEMATOSUS] and other [COLAGENOSIS], although it has also been reported in some patients who did not suffer from these pathologies. In patients treated with NSAIDs who develop symptoms of meningitis, the possibility of aseptic meningitis should be considered.

- Ibuprofen lysine is contraindicated in case of infection or suspicion of infection in preterm infants.

PRECAUTIONS RELATING TO EXCIPIENTS

- This medicine contains sodium salts, which should be taken into account in patients on low-sodium diets.

- This medicine contains Allura red as an excipient. It can cause allergic type reactions including [ASTHMA], especially in patients with [ALLERGY TO SALICYLATE].

- This medicine contains sorbitol. Patients with hereditary [FRUCTOSE INTOLERANCE] should not take this medication.

SPECIAL WARNINGS

- Gastrointestinal risk: NSAIDs are associated with an increased risk of gastrointestinal irritation, ulceration, bleeding or gastrointestinal perforation. Lesions can appear at any time during treatment. The elderly are at increased risk of serious gastrointestinal events. During prolonged treatments, possible signs and symptoms of ulceration or bleeding should be monitored. A history of esophagitis, gastritis and/or peptic ulcer should also be sought to ensure complete healing before starting treatment with an NSAID.

- Cardiovascular risk: NSAIDs are associated with an increased risk of cardiovascular events, including myocardial infarction and new cases of hypertension or worsening of existing ones. The risk may increase with the duration of treatment, especially in patients with cardiovascular disease or risk factors for cardiovascular disease. Monitor for possible signs of hydrosaline retention (e.g. formation of edema), especially in patients with hypertension or heart failure.

- Risk of serious skin reactions: severe cases, some of them fatal, such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported rarely in association with the use of NSAIDs. Patients may be at increased risk of these reactions at the beginning of treatment: the onset of such an adverse reaction occurs in most cases during the first month of treatment. Acute generalized exanthematous pustulosis (AGEP) has been reported in association with products containing ibuprofen. Ibuprofen administration should be discontinued at the first signs or symptoms of serious skin reactions, such as skin rash, mucosal lesions or any other sign of hypersensitivity.

INTERACTIONS

"INTERACTIONS RELATED TO IBUPROFEN"

- NSAIDs, including low doses of acetylsalicylic acid: the simultaneous use of more than one NSAID should be avoided due to the risk of adverse effects appearing without increasing therapeutic efficacy. Additionally, ibuprofen may reduce the antiplatelet efficacy of acetylsalicylic acid when administered together. If the administration of both drugs is necessary, it is advisable to space out the doses (administer ibuprofen 8 hours before or 30 minutes after ASA).

- Alcohol: toxicity can be enhanced.

- Aliskiren: possible reduction of the antihypertensive effect of aliskiren (NSAIDs act on the renin-angiotensin system). In patients with compromised kidney function (dehydrated or elderly), deterioration of kidney function may be precipitated (possible acute renal failure, usually reversible). Caution, especially in the elderly, monitoring the antihypertensive effect and renal function.

- Food: food delays Tmax (from ± 2 h on an empty stomach to ± 3 h after eating), although this has no effect on the amount absorbed.

- Quinolonic antibacterials: there are isolated reports of seizures that may have been due to the concomitant use of quinolones and some non-steroidal anti-inflammatory drugs.

- Oral anticoagulants, heparin: possible increase in anticoagulant effect, with risk of bleeding. Periodic controls of coagulation rates are recommended.

- Antidiabetic sulfonylureas (chlorpropamide, glibenclamide, tolbutamide): possible increase in hypoglycemic effects, by reducing renal excretion.

- SSRI antidepressants (fluoxetine, paroxetine, sertraline, citalopram): possible increased risk of bleeding in general, and gastrointestinal bleeding in particular, especially in the elderly and patients with a history of digestive bleeding.

- Antihypertensives (ACEI, Beta-blockers): possible reduction of the antihypertensive effect.

- Oral bisphosphonates (alendronic acid): possible increased risk of esophagitis and gastric ulcer. Described cases with naproxen and alendronate.

- Cyclosporine: the effect of NSAIDs on renal prostaglandins can increase the nephrotoxicity of cyclosporine.

- Antiplatelet agents, including pentoxifylline: there is an increased risk of bleeding in general, and gastrointestinal bleeding in particular. Administer with caution.

- Corticosteroids: possible increase in the incidence of gastric discomfort. However, simultaneous use with glucocorticoids in the treatment of osteoarthritis may provide additional therapeutic benefit and allows the glucocorticoid dosage to be reduced.

- Digitalis (digoxin): possible increase in plasma concentrations of digitalis (in neonates). There is also a risk of worsening heart failure and reduced kidney function.

- Diuretics (thiazides, high-ceiling diuretics): risk of reduction of the natriuretic and diuretic effect. It may reduce the antihypertensive action of thiazide diuretics.

- Potassium-sparing diuretics and aldosterone antagonists: possible increased risk of hyperkalemia. Frequent monitoring of serum potassium levels is advised.

- Glitazones (pioglitazone, rosiglitazone): theoretical risk of increased edema that both glitazones and NSAIDs can cause. Caution and monitor for possible signs of fluid retention and heart failure (swollen ankles, dyspnea).

- Hydralazine: possible decrease in the hypotensive effect.

- Iloprost: possible increased risk of bleeding.

- Lithium, salts: possible increase in the toxicity of lithium due to a reduction in its elimination.

- Methotrexate (administered at doses of 15 mg/week or higher): possible increase in plasma levels of methotrexate, with risk of toxicity, sometimes very serious. The severity depends largely on the doses of methotrexate used. The risk of interaction is reduced with low doses of methotrexate such as those used in psoriasis and rheumatoid arthritis.

- Mifepristone: Non-steroidal anti-inflammatory drugs should not be administered within 8-12 days after the administration of mifepristone as they can reduce its effects.

- Paracetamol: the simultaneous and prolonged use of paracetamol and NSAIDs may cause an increased risk of adverse renal effects.

- Pentoxifylline: In patients receiving treatment with ibuprofen in combination with pentoxifylline, the risk of bleeding may increase, so it is recommended to monitor the bleeding time.

- Potassium supplements: possible increase in potassium levels, with risk of hyperkalemia.

- Ticlopidine: possible increased risk of bleeding.

- Zidovudine: Possible alteration of reticulocytes, with severe anemia appearing one week after the start of administration of the NSAID. Blood values ​​should be monitored, especially at the beginning of treatment.

PREGNANCY

Safety in animals: no teratogenic effects have been recorded, but fetal damage has been reported on significant occasions, as well as impairment of childbirth.

Safety in humans: * First and second trimester of pregnancy.

From the 20th week of pregnancy onwards, ibuprofen can cause oligohydramniosis as a consequence of renal dysfunction in the fetus. This may occur shortly after starting treatment and is usually reversible upon discontinuation. Additionally, cases of ductus arteriosus constriction have been reported following treatment in the second trimester, most of which were reversed after cessation of treatment. Therefore, during the first and second trimesters of pregnancy, ibuprofen should not be administered unless considered strictly necessary. If ibuprofen is used by a woman trying to become pregnant, or during the first and second trimesters of pregnancy, the dose and duration of treatment should be reduced as much as possible. Prenatal monitoring for oligohydramniosis and ductus arteriosus constriction should be considered after exposure to ibuprofen for several days from gestational week 20 onwards. Ibuprofen should be discontinued if oligohydramniosis or ductus arteriosus constriction is found.

2) Third trimester of pregnancy

During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to:

- Cardio-pulmonary toxicity (constriction/premature closure of the ductus arteriosus and pulmonary hypertension)

- Renal dysfunction, which can progress to renal failure with oligo-hydroamniosis.

- Possible prolongation of bleeding time, due to an antiplatelet-type effect that can occur even at very low doses.

- Inhibition of uterine contractions, which can cause delay or prolongation of labor (with a greater tendency to bleeding in the mother and child).

Effects on fertility: Ibuprofen can impair female fertility and is not recommended for women trying to conceive. In women who have difficulty conceiving or who are undergoing fertility investigation, discontinuation of this medication should be considered.

LACTATION

Safety in animals: no data available.

Safety in Humans: Ibuprofen and its metabolites are excreted in low concentrations in breast milk. It does not cause serious adverse reactions in children, which is why it can be used during breastfeeding to treat pain and fever.

CHILDREN

Safety and effectiveness in children under 3 months have not been established, so its use is not recommended. Ibuprofen should not be self-medicated in children under 12 years of age.

ADVANCED AGE

No specific problems have been described in the elderly that require dosage readjustment. Elderly patients suffer a higher incidence of gastrointestinal adverse reactions to NSAIDs, especially bleeding and perforation. Therefore, it should be used with caution.

EFFECTS ON DRIVING

Patients who experience dizziness, vertigo, visual disturbances or other central nervous system disorders while taking ibuprofen should refrain from driving or operating machinery. Generally short treatments do not require special precautions.

ADVERSE REACTIONS

Adverse reactions are more frequent with doses of 3200 mg/day.

- Gastrointestinal: (>10%): [DYSPEPSIA], [DIARRHEA]. (1-10%): [NAUSEA], [VOMITING], [ABDOMINAL PAIN]. (0.1-1%): [GASTROINTESTINAL HEMORRHAGE], [GASTRIC ULCER], [DUODENAL ULCER], [ORAL THRUBS]. (<0.1%): [INTESTINAL PERFORATION], [FLATULENCE], [CONSTIPATION], [ESOPHAGITIS], [ESOPHAGEAL OBSTRUCTION], exacerbation of diverticular disease, nonspecific hemorrhagic colitis, [ULCEROUS COLITIS] or [CROHN'S DISEASE], [MELENA ]. If gastrointestinal bleeding occurs, it could cause anemia and [HEMATEMESIS].

- Dermatological/Hypersensitivity: (1-10%): [EXANTEMATIC ERUPTIONS]. (0.1-1%): [URTICARIA], [PRURITUS], [PURPURA] (including allergic purpura), [ANGIOEDEMA], [RHINITIS], [BRONCHIAL SPASM]. (<0.1%): [ANAPHYLAXIA]. (<0.01%): [ERYTHEMA MULTIFORME], [TOXIC EPIDERMICAL NECROLYSIS], systemic lupus erythematosus, [ALOPEIA], [PHOSENSITIVITY REACTIONS], severe skin reactions such as [STEVENS-JOHNSON SYNDROME], [TOXIC EPIDERMICAL NECROLYSIS] (syndrome Lyell) and allergic [VASCULITIS]; frequency unknown [DRESS SYNDROME] (which may include skin rash, swollen lymph nodes and [EOSINOPHILIA]) and acute generalized exanthematous pustulosis (AGE).  

In most cases in which [ASEPTIC MENINGITIS] has been reported with ibuprofen, the patient suffered from some form of autoimmune disease (such as systemic lupus erythematosus or other collagen diseases), which was a risk factor. It is manifested by intense headache, nausea, vomiting, fever, neck stiffness and a certain obtundation, possibly due to a hypersensitivity reaction. An increase in intrathecal synthesis of IgG has been observed, with the presence of immune complexes in the cerebrospinal fluid.

Anaphylactic or anaphylactoid reactions normally occur in patients with a history of hypersensitivity to acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs. This could also happen in patients who have not previously shown hypersensitivity to these drugs.

In case of severe generalized hypersensitivity reaction, swelling of the face, tongue and larynx, bronchospasm, asthma, tachycardia, hypotension and shock may occur.

- Central nervous system: (1-10%): [ASTHENIA], [SOMNOLENCE], [HEADACHE], [DIZZINESS], [VERTIGO]. (0.1-1%): [INSOMNIA], [ANXIETY]. (<0.1%): reaction of [PSYCHOSIS], [NERVIOSISM], [IRRITABILITY], [DEPRESSION], [CONFUSION] or disorientation.

- Hematological: Bleeding time may be prolonged. The rare observed cases of hematological disorders correspond to [THROMBOCYTOPENIA], [LEUCOPENIA], [GRANULOCYTOPENIA], [PANCITOPENIA], [AGRANULOCYTOSIS], [APLASTIC ANEMIA], [HEMOLYTIC ANEMIA].

- Cardiovascular: There seems to be a greater predisposition on the part of patients with hypertension or kidney disorders to suffer [EDEMA]. [ARTERIAL HYPERTENSION] or [HEART FAILURE] may occur (especially in elderly patients).

- Kidneys: [INCREASE IN UREAIC NITROGEN] and [INCREASE IN SERUM CREATININE]. In exceptional cases, NSAIDs may be responsible for [ACUTE RENAL FAILURE], [INTERSTITIAL NEPHRITIS], [GLOMERULONEPHRITIS], [RENAL MEDULAR NECROSIS] or [NEPHROTIC SYNDROME], [PROTEINURIA], [HYPERKALEMIA], [HYPOKALEMIA] and edema. It has been observed in susceptible patients taking high doses of NSAIDs for prolonged periods of time. Patients at risk are those who have heart, kidney or liver failure, ascites, hyperreninemia, hyperaldosteronemia, shock, sepsis, systemic lupus erythematosus, dehydration, those treated with ACE inhibitors or diuretics and the elderly.

- Hepatic: In rare cases [INCREASE IN TRANSAMINASES], [HEPATITIS] and [JAUNDERY] have been observed.

- Otological: Rarely, [TINNITUS].

- Ophthalmic: Very rarely, optical reactions, such as [BLURRY VISION], decreased visual acuity or changes in color perception ([DYSCHROMATOPSY]) have been observed after the administration of ibuprofen, which resolve spontaneously. Isolated cases of reversible toxic [AMBLYOPIA].

- In very rare cases, inflammation associated with infections could be aggravated.

ADVERSE REACTIONS RELATING TO EXCIPIENTS

- Because it contains Allura red (E-129), it may cause [HYPERSENSITIVITY REACTIONS].

- Because it contains ethyl parahydroxybenzoate, it may cause [HYPERSENSITIVITY REACTIONS] (possibly delayed).

- Because it contains propyl parahydroxybenzoate, it may cause [ALLERGY TO PARABENS], possibly delayed.

OVERDOSE

Symptoms: Ibuprofen can cause toxic effects from doses of 80-100 mg/kg, with symptoms appearing after about 4 hours. In case of a mild overdose, symptoms such as abdominal pain, nausea and vomiting, headache, drowsiness, lethargy, nystagmus, tinnitus and ataxia may appear. More serious symptoms rarely occur, although gastrointestinal bleeding, hypotension, hypothermia, metabolic acidosis, seizures, renal failure, coma, respiratory distress in adults, and transient apnea in children may occur after ingesting large amounts.

Treatment: There is no specific antidote.

In the event of mild overdoses, in doses of up to 50 mg/kg, which are not expected to give rise to symptomatic intoxication, water will be administered to mitigate possible gastrointestinal reactions.

In the case of larger overdoses, and if less than an hour has passed, the elimination of unabsorbed ibuprofen will be promoted through the administration of activated charcoal and forced emesis. Forced emesis is contraindicated in children who have ingested more than 400 mg/kg due to the risk of seizures and aspiration pneumonia. Gastric lavage is only recommended for overdoses that could be potentially fatal.

If more than an hour has passed since the overdose, symptomatic treatment will be instituted, especially for hypotension, digestive bleeding and metabolic acidosis. Forced diuresis with alkalinization of urine can be attempted.

Due to its high binding to plasma proteins, it is not expected that ibuprofen can be eliminated by hemodialysis.

Leaflet Ibudol Pediatric 40 Mg/Ml Oral Suspension 1 Bottle 150 Ml + Oral Syringe