Ibuprofen Eg Children 100mg/5ml Orange Flavor Syrup Without Sugar 150ml

NAME
IBUPROFENE EG CHILDREN 100MG / 5ML ORAL SUSPENSION

PHARMACOTHERAPEUTIC CATEGORY
Non-steroidal anti-inflammatory and antirheumatic drugs.

ACTIVE PRINCIPLES
Ibuprofen.

EXCIPIENTS
Children Strawberry 100mg / 5ml oral suspension strawberry flavor without sugar: citric acid monohydrate, sodium citrate, acesulfame potassium, xanthan gum, sodium benzoate, strawberry flavor, maltitol syrup, glycerin, purified water. Children Orange 100mg / 5ml oral suspension orange flavor without sugar: citric acid monohydrate, sodium citrate, acesulfame potassium, xanthan gum, sodium benzoate, orange flavor, maltitol syrup, glycerin, purified water.

INDICATIONS
Symptomatic treatment of fever and mild to moderate pain.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to ibuprofen or to any of the excipients; children under 3 months of age or weighing less than 5.6 kg; hypersensitivity to acetylsalicylic acid or to other analgesics, antipyretics, non-steroidal anti-inflammatory drugs (NSAIDs), particularly when hypersensitivity is associated with nasal polyposis and asthma; active peptic ulcer; severe renal or hepatic insufficiency; severe heart failure (NYHA class IV); history of gastrointestinal bleeding or perforation related to previous active treatments or history of recurrent peptic ulcer / haemorrhage (two or more distinct episodes of proven ulceration or bleeding); concomitant use of NSAIDs, including specific COX-2 inhibitors; pregnancy and breastfeeding.

DOSAGE
The daily dose is structured according to the weight and age of the patient. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms. In children aged between 3 and 6 months, limit administration to those weighing more than 5.6 kg. Oral administration to infants and children aged between 3 months and 12 years should be done using the dosing syringe supplied with the product. The graduated scale on the body of the syringe highlights the notches for the different dosages; in particular the 2.5 ml mark corresponding to 50 mg of ibuprofen and the 5 ml mark corresponding to 100 mg of ibuprofen. The daily dose of 20-30 mg / kg of body weight, divided 3 times a day at intervals of 6-8 hours, can be administered on the basis of the following scheme. Weight 5.6 -7 Kg (3 - 6 months): 2.5. Weight 7 -10 Kg (6 - 12 months): 2.5 ml. Weight 10 - 15 Kg (1 - 3 years): 5 ml. Weight 15 - 20 Kg (4 - 6 years): 7.5 ml (5 ml + 2.5 ml). Weight 20 - 28 Kg (7 - 9 years): 10 ml. Weight 28 - 43 Kg (10 - 12 years): 15 ml. The maximum number of administration is 3 in 24 hours. In case of post-vaccination fever refer to the dosage indicated above, administering a single dose followed, if necessary, by another dose after 6 hours. Do not administer more than two doses in 24 hours. The product is intended for short-term treatments. If the use of the medicine is necessary for more 'than 3 days in infants and children older than 6 months and adolescents, or in the case of worsening of symptoms, the doctor should be consulted. In infants aged between 3 and 5 months, a doctor should be consulted if symptoms persist for more than 24 hours or if symptoms worsen. Instructions for using the dosing syringe: unscrew the cap by pushing it down and turning it to the left; insert the tip of the syringe fully into the hole of the undercap; shake well; turn the bottle upside down, then, holding the syringe firmly, gently pull the plunger down, letting the suspension flow into the syringe up to the mark corresponding to the desired dose; put the bottle back upright and remove the syringe by twisting it gently; insert the tip of the syringe into the child's mouth, and exert a slight pressure on the plunger to drain the suspension. After use, screw the cap to close the bottle and wash the syringe with warm water. Let it dry, keeping it out of the reach and sight of children.

STORAGE
No particular.

WARNINGS
Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms. The use of the medicinal product should be avoided concomitantly with NSAIDs, including selective COX-2 inhibitors. Analgesics, antipyretics, non-steroidal anti-inflammatory drugs can cause hypersensitivity reactions', potentially serious (anaphylactoid reactions), even in subjects not previously exposed to this type of drug. The risk of hypersensitivity reactions after taking ibuprofen is greater in subjects who have presented these reactions after the use of other analgesics, antipyretics, non-steroidal anti-inflammatory drugs and in subjects with bronchial hyperreactivity (asthma), nasal polyposis or previous episodes. of angioedema. Gastrointestinal bleeding, ulceration and perforation: Gastrointestinal bleeding, ulceration and perforation, which can be fatal, have been reported during treatment with all NSAIDs, at any time, with or without warning symptoms or a previous history of serious gastrointestinal events. Elderly: Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal. In the elderly and in patients with a history of ulcer, particularly if complicated by haemorrhage or perforation, the risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing doses of NSAIDs. These patients should start treatment with the lowest available dose. Concomitant use of protective agents should be considered for these patients and also for patients taking low-dose aspirin or other drugs that may increase the risk of gastrointestinal events. Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment. Caution should be exercised in patients taking concomitant medications that could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as aspirin. When gastrointestinal bleeding or ulceration occurs in patients taking ibuprofen, treatment should be discontinued. NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions can be exacerbated. Serious skin reactions, some of the qualifatal, including exfoliative dermatitis, Stevens-Johns syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs. In the early stages of therapy, patients appear to be at higher risk: the onset of the reaction occurs in most cases within the first month of treatment. Ibuprofen should be discontinued at the first appearance of rash, mucosal lesions or any other signs of hypersensitivity '. Caution is required before starting treatment in patients with a history of hypertension and / or heart failure as fluid retention, hypertension and edema have been reported in association with treatment with NSAIDs. Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg / day), may be associated with a modest increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke). In general, epidemiological studies do not suggest that low doses of ibuprofen (e.g. <= 1200 mg / day) are associated with an increased risk of myocardial infarction. Patients with uncontrolled hypertension, congestive heart failure (NYHA class II-III), established ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease should only be treated with ibuprofen after careful consideration and high doses (2400 mg / day) should be avoided. ). Careful consideration should also be exercised before initiating long-term treatment in patients with risk factors for cardiovascular events, especially if high doses (2400 mg / day) of ibuprofen are required. In dehydrated children and adolescents there is a risk of impaired renal function. The use of ibuprofen, acetylsalicylic diacid or other analgesics, antipyretics, non-steroidal anti-inflammatory drugs, requires particular caution: in case of asthma: possible bronchoconstriction; in the presence of coagulation defects: reduction of coagulability; in the presence of kidney, heart or hypertension diseases: possible critical reduction in renal function (especially in subjects with impaired renal or hepatic function, heart failure or being treated with diuretics), nephrotoxicity or fluid retention; in the presence of liver disease: possible hepatotoxicity; rehydrate the subject before the start and during the course of treatment in case of dehydration (for example due to fever, vomiting or diarrhea). The following precautions are of relevance in the course of prolonged treatments: monitor for signs or symptoms of gastrointestinal ulceration or bleeding; monitor for signs or symptoms of hepatotoxicity; monitor for signs or symptoms of nephrotoxicity; if visual disturbances arise (blurred or reduced vision, scotomas, altered color perception): stop treatment and consult an ophthalmologist; if signs or symptoms of meningitis arise: evaluate the rare possibility that it is due to the use of ibuprofen (aseptic meningitis; more frequent in subjects suffering from systemic lupus erythematosus or other collagenopathies). As ibuprofen contains maltitol, patients with rare hereditary problems of fructose intolerance should not take this medicine. Ibuprofen does not contain sugar and is therefore indicated for those patients who need to control the intake of sugars and calories. Each 2.5 ml dose of suspension contains 4.51 mg (0.20 mmol) of sodium; this should be taken into consideration in cases where a low sodium diet is recommended.

INTERACTIONS
The following interactions are common to ibuprofen, acetylsalicylic acid and other analgesics, antipyretics, non-steroidal anti-inflammatory drugs (NSAIDs): avoid the simultaneous use of two or more analgesics, antipyretics, non-steroidal anti-inflammatory drugs: increased risk of effects unwanted; corticosteroids: increased risk of gastrointestinal ulceration or bleeding; antibacterials: possible increased risk of seizures induced by quinolones; anticoagulants: NSAIDs may increase the effects of anticoagulants, such as warfarin; antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding; antidiabetics: possible increase in the effect of sulfonylureas; antivirals: ritonavir, possible increase in concentration of NSAIDs; cyclosporine: increased risk of nephrotoxicity; cytotoxic: methotrexate, reduced excretion (increased risk of toxicity); lithium: reduced excretion (increased risk of toxicity); tacrolimus: increased risk of nephrotoxicity; uricosurics: probenecid, slows the excretion of NSAIDs (increased plasma concentrations); methotrexate: potential increase in plasma methotrexate concentration; zidovudine: increased risk of haemarthroses and hematomas in HIV (+) haemophiliacs when treated concomitantly with zidovudine and ibuprofen; diuretics, ACE inhibitors and angiotensin II antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. In some patients with impaired renal function (e.g. dehydrated patients or elderly patients with impaired renal function) the co-administration of an ACE inhibitor or angiotensin II antagonist and agents that inhibit the cyclo-oxygenase system may lead to further deterioration of renal function, including possible acute renal failure, usually reversible. These interactions should be considered in patients taking ibuprofen concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be administered with caution, especially in elderly patients. Patients should be adequately hydrated and monitoring of renal function should be considered after initiation of concomitant therapy. Acetylsalicylic acid: Concomitant administration of ibuprofen and acetylsalicylic acid is generally not recommended due to the potential for increased side effects. Experimental data suggest that ibuprofen can competitively inhibit the effect of low-dose acetylsalicylic acid on platelet aggregation when drugs are administered concurrently. Although there are uncertainties regarding the extrapolation of these data to the clinical situation, the possibility cannot be excluded that regular, long-term use of ibuprofen may reduce the cardioprotective effect of low dose acetylsalicylic acid. No relevant clinical effects are considered likely following occasional use of ibuprofen.

SIDE EFFECTS
The side effects observed with ibuprofen are common to other analgesics, antipyretics, non-steroidal anti-inflammatory drugs. Hypersensitivity reactions. Rarely: anaphylactoid reactions (urticaria with or without angioedema), dyspnoea (from laryngeal obstruction or bronchospasm), shock, syndrome characterized by abdominal pain, fever, chills, nausea and vomiting; bronchospasm. Gastrointestinal disorders: the most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, gastrointestinal perforation or bleeding, sometimes fatal, may occur, particularly in the elderly. Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported following administration of ibuprofen. Gastritis has been observed less frequently. Epigastric pain, heartburn. Gastric upset can be reduced by taking the drug on a full stomach. Rarely: hepatitis, jaundice, abnormal liver function tests, pancreatitis, duodenitis, oesophagitis, hepatorenal syndrome, hepatic necrosis, liver failure. Pathologies of the nervous system and sense organs: vertigo, headache, irritability, tinnitus; rarely: depression, insomnia, difficulty concentrating, emotional lability, somnolence, aseptic meningitis, convulsions, auditory and visual disturbances. Respiratory, thoracic and mediastinal disorders. Rarely: bronchospasm, dyspnea, apnea. Skin and subcutaneous tissue disorders: Bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (very rarely). Skin rashes (including maculopapular type), itching. Rarely: vesiculo-bullous eruptions, urticaria, erythema multiforme, alopecia, exfoliative dermatitis, photosensitivity dermatitis. Disorders of the blood and lymphatic system. Very rarely: neutropenia, agranulocytosis, aplastic anemia, haemolytic anemia (possible positive Coombs test), thrombocytopenia (with or without purpura), eosinophilia, decreased hemoglobin and hematocrit, pancytopenia. Metabolism and nutrition disorders: decreased appetite. Cardiac and vascular disorders: Edema, hypertension and heart failure have been reported in association with NSAID treatment. Fluid retention (generally responds promptly to discontinuation of treatment). Very rarely: cerebrovascular accidents, hypotension, congestive heart failure in subjects with impaired cardiac function, palpitations.Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg / day), may be associated with a modest increase in risk of arterial thrombotic events (e.g. myocardial infarction or stroke). Renal and urinary disorders. Very rarely: acute renal failure in subjects with pre-existing significant renal impairment, papillary necrosis, tubular necrosis, glomerulonephritis, renal impairment test, polyuria, cystitis, haematuria. Immune system disorders: Single cases of aseptic meningitis symptoms such as neck tension, headache, nausea, vomiting, fever, disorientation have been reported in patients with pre-existing autoimmune diseases (e.g. systemic lupus erythematosus, connective system diseases). Various. Rarely: dry eyes and mouth, gum ulcers, rhinitis. The reporting of suspected adverse reactions that occur after the authorization of the drug is important, as it allows continuous monitoring of the benefit / risk ratio of the drug.

PREGNANCY AND BREASTFEEDING
It is unlikely that anyone under the age of 12 will become pregnant, or breastfeed. However, in such circumstances the following considerations must be kept in mind. Inhibition of prostaglandin synthesis can negatively affect pregnancy and / or embryo / fetal development. Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and cleft cleft after use of a prostaglandin synthesis inhibitor in early pregnancy. The risk was considered to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre- and post-implantation loss and embryo-fetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular, has been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period. 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 may progress to renal failure with oligo-hydroamnios; the mother and the newborn, at the end of pregnancy, to: possible prolongation of the bleeding time, an antiplatelet effect that can occur even at very low doses; inhibition of uterine contractions resulting in delayed or prolonged labor.