Descrizione Clinica
PAIDOFEN BABY 100 MG/5 ML ORALLY
active ingredients
Each ml of oral suspension contains: Active ingredient: ibuprofene 20 mg. Excipients with known effects: Sodium 2.03 mg, liquid malt 753,30 mg. For the full list of excipients, see paragraph 6.1.Excellent
PAIDOFEN Children 100 mg/5 ml oral suspension Strawberry taste without sugar: Monohydrate citric acid, citrate sodium, potassium acesulphame, xantana gum, benzoate sodium, strawberry aroma, liquid maltitol, glycerin, purified water. PAIDOFEN Children 100 mg/5 ml oral suspension taste orange without sugar: Monohydrate citric acid, citrate sodium, potassium acesulphame, xantana gum, benzoate sodium, orange aroma, liquid maltitol, glycerin, purified water.Therapeutic indications
Symptomatic treatment of mild or moderate fever and pain.Contraindications
• Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. • Children under 3 months or less than 5.6 kg. • Hypersensitivity to acetylsalicylic acid or other analgesic, antipyretic, non-steroidal anti-inflammatory (NSAID), especially when hypersensitivity is associated with nasal and asthma polypoxes. • Active peptic ulcer. • Severe kidney or liver failure. • severe heart failure (IV class NYHA). • History of gastrointestinal hemorrhage or perforation related to previous active treatments or history of hemorrhage / recurrent peptic ulcer (two or more distinct episodes of proven ulceration or bleeding). • Concurrent use of NSAIDs, including specific COX-2 inhibitors. • Pregnancy and nursing (see paragraph 4.6).Population
Population: The daily dose is structured according to the weight and age of the patient. Undesirable effects can be minimized with the use of the effective minimum dose for the shortest possible duration of treatment needed to control symptoms (see paragraph 4.4). In children aged 3 to 6 months limit administration to those weighing more than 5.6 kg. The daily dose of 20-30 mg/kg body weight, divided 3 times daily at intervals of 6-8 hours, can be administered on the basis of the following diagram.| PEOPLE | Age | Single dose in ml | no maximum of SOMMINISTRATIONS/day |
| 5,6 -7 Kg | 3 - 6 months | 2.5 ml | 3 in 24 hours |
| 7 -10 Kg | 6 - 12 months | 2.5 ml | |
| 10 - 15 Kg | 1 - 3 years | 5 ml | |
| 15 - 20 Kg | 4 - 6 years | 7.5 ml (5 ml + 2.5 ml) | |
| 20 - 28 Kg | 7 - 9 years | 10 ml | |
| 28 - 43 Kg | 10 - 12 years | 15 ml |
Conservation
For storage conditions after first opening see paragraph 6.3.Warnings
After three days of treatment without appreciable results consult your doctor. Undesirable effects can be minimized with the use of the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see below paragraphs on gastrointestinal and cardiovascular risks). The use of PAIDOFEN must be avoided in conjunction with FANS, including selective COX-2 inhibitors. Analgesics, antipyretics, non-steroidal anti-inflammatory drugs can cause hypersensitivity reactions, potentially serious (anaphylactoid reactions), even in individuals not previously exposed to this type of medication. The risk of hypersensitivity reactions after taking ibuprofen is greater in individuals who have presented such reactions after the use of other analgesic, antipyretic, nonsteroidal anti-inflammatory drugs and in subjects with bronchial hyperreactivity (asthma), nasal polyposi or previous angioedema episodes (see paragraph 4.2 and paragraph 4.8). Gastrointestinal hemorrhage, ulceration and drilling: during treatment with all NSAIDs, at any time, with or without warning symptoms or previous history of serious gastrointestinal events, gastrointestinal hemorrhage, ulceration and perforation, which may be fatal. Senior patients have an increase in the frequency of adverse reactions to NSAIDs, especially hemorrhages and gastrointestinal perforations, which can be fatal (see paragraph 4.2). In the elderly and in patients with history of ulcer, especially if complicated by hemorrhage or perforation (see paragraph 4.3), the risk of gastrointestinal hemorrhage, ulceration or perforation is higher with increased doses of NSAID. These patients must begin treatment with the lowest dose available. Concurrent use of protective agents (e.g. misoprostol or protonic pump inhibitors) must be considered for these patients and also for patients taking low doses of aspirin or other drugs that may increase the risk of gastrointestinal events (see paragraph 4.5). Patients with history of gastrointestinal toxicity, particularly elderly, must report any unusual gastrointestinal symptoms (especially gastrointestinal hemorrhage) in particular in the early stages of treatment. Caution should be lent to patients taking concomitant drugs that could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or anti-aggregating agents such as aspirin (see paragraph 4.5). When bleeding or gastrointestinal ulceration occurs in patients taking PAIDOFEN, treatment must be suspended. NSAIDs should be given with caution to patients with a history of gastrointestinal disease ( ulcerative colitis, Crohn's disease) since such conditions can be exacerbated (see paragraph 4.8). Severely serious skin reactions have been reported, some of which fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis in association with the use of NSAIDs (see paragraph 4.8). Patients seem to be at higher risk in the early stages of therapy: the onset of the reaction occurs in most cases within the first month of treatment. Acute Pustolosis was reported in general (PEAG) in relation to medicines containing ibuprofen. Hybuprofen should be suspended at the first appearance of signs and symptoms of skin reactions, such as rash, mucosa lesions or any other sign of hypersensitivity. Masking the symptoms of underlying infections: Paidofen can mask the symptoms of infection, which may delay the start of proper treatment and thus worsen the outcome of the infection. This was observed in bacterial pneumonia acquired in communities and bacterial complications of chickenpox. When Paidofen is administered for relief from fever or pain related to infection, it is recommended to monitor the infection. In non-hospital contexts, the patient should contact the doctor if symptoms persist or worsen. Caution is required before starting treatment in patients with positive anamnesiums for hypertension and/or heart failure since retention of fluids, hypertension and edema were found in association with NSAIDs. Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg/die), may be associated with a modest increase in the 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/die) are associated with an increase in the risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (II-III class NYHA), proven ischemic cardiopathy, peripheral arterial disease and/or cerebrovascular disease should be treated with ibuprofen only after careful consideration and should avoid high doses (2400 mg/die). Careful consideration should be exercised even before starting long-term treatment patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, cigarette smoking habit), especially if high doses (2400 mg/die) are required of ibuprofen. The use of ibuprofen, acetylsalicylic acid or other analgesic, antipyretic, non-steroidal anti-inflammatory, requires special caution: • in case of asthma: possible bronchoconstriction; • in the presence of clotting defects: reduction of coagulation; • in the presence of kidney, heart or hypertension diseases: possible critical reduction of kidney function (especially in subjects with impaired kidney or liver function, heart failure or in treatment with diuretics), nephrotoxicity or fluid retention; • in the presence of liver diseases: possible hepatotoxicity; • rehydrate the subject before the start and during the treatment in case of dehydration (e.g. for fever, vomiting or diarrhea); The following precautions are relevant during prolonged treatment: • monitor the signs or symptoms of gastrointestinal ulceration or bleeding; • monitor signs or symptoms of hepatotoxicity; • monitor signs or symptoms of nephrotoxicity; • if visual disturbances arise (unused or reduced view, rhytoms, alteration of color perception): stop treatment and consult the ophthalmologist; • if signs or symptoms of meningitis arise: evaluate the rare possibility that it is due to the use of ibuprofene (aseptic meningitis; more frequent in subjects affected by systemic lupus erythematosus or other collagenopathies). There is a risk of alteration of kidney function in dehydrated children and adolescents. Sodium: This medicine contains 30.45 mg of sodium for each dose of 7.5 ml equivalent to 1.53% of the maximum daily intake recommended by the WHO which corresponds to 2 g of sodium per adult. This should be taken into account in cases a poor sodium diet is recommended. - Benzoate sodium: The benzoate sodium can increase the hetero. The increase in bilirubinemia following its detachment from albumin can increase the neonatal hetero that can evolve in kernittero (deposits of bilirubin not conjugated in the brain tissue). - Liquid maltitol: Patients suffering from rare hereditary problems of fructose intolerance should not take this medicine. PAIDOFEN does not contain sugar and is therefore indicated for patients who need to control the intake of sugar and calories.Interactions
The following interactions are common to ibuprofen, acetylsalicylic acid and other analgesic, antipyretic, non-steroidal anti-inflammatory drugs (NSAID): Contraindicated associations: • avoid the contemporary use of two or more analgesic, antipyretic, non-steroidal anti-inflammatory: increased risk of side effects. • Acetylsalicylic acid: concurrent administration of ibuprofen and acetylicylic acid is not generally recommended due to the potential increase in unwanted effects. Experimental data suggests that ibuprofen can competitively inhibit the effect of acetylsalicylic acid at low doses on platelet aggregation when the two drugs are administered simultaneously. Although there are uncertainties regarding the extrapolation of this data to the clinical situation, the possibility that regular use, long-term of ibuprofen, can reduce the cardioprotective effect of acetylsalicylic acid at low doses. No significant clinical effect is considered likely due to occasional use of ibuprofen (see paragraph 5.1). Associations requiring precautions of use: • corticosteroid: increased risk of gastrointestinal ulceration or hemorrhage (see paragraph 4.4); • antibacterial: possible increase in the risk of convulsions induced by kinolonics; • anticoagulants: NSAIDs can increase the effects of anticoagulants, such as warfarin (see paragraph 4.4); • Serotonin reuptake selective anti-aggregating agents and inhibitors (SSRIs): increased risk of gastrointestinal hemorrhages (see paragraph 4.4); • anti-diabetics: possible increase in sulfaniluree effect; • antivirals: ritonavir, possible increase in concentration of NSAIDs; • cyclosporin: increased risk of nephrotoxicity;• cytotoxic: metotressate, reduction of excretion ( increased risk of toxicity); • lithium: reduction of excretion (increased risk of toxicity); • tacrolimus: increased risk of nephrotoxicity; • uricosurics: probenecid, slows down the excretion of NSAIDs (increasing plasma concentrations); • metotrexate: potential increase in plasma concentration of metotrexate; • zidovudine: increased risk of hemartrosis and hematomas in HIV hemophilics (+) if treated simultaneously with zidovudine and ibuprofen; • diuretics, inhibitors and angiotensin II antagonists: NSAIDs can reduce the effect of diuretics and other antihypertensive drugs. In some patients with impaired kidney function (e.g. dehydrated patients or elderly patients with impaired kidney function) co-administration of an ACE inhibitor or an angiotensin II antagonist and agents inhibiting the cyclo-oxidase system may lead to further deterioration of kidney function, which includes a possible acute kidney failure, generally reversible. These interactions must be considered in patients taking PAIDOFEN in conjunction with ACE inhibitors or antagonists of angiotensin II. Therefore, the combination should be given with caution, especially in elderly patients. Patients should be properly hydrated and monitoring of renal function should be taken into consideration after the start of concomitant therapy.Effects
The side effects observed with ibuprofen are common to other analgesic, antipyretic, non-steroidal anti-inflammatory drugs. Reactions of hypersensitivity: Rarely: anaphylactoid reactions (orticaria with or without angioedema), dispnea (from laryngeal obstruction or bronchospasm), shock, syndrome characterized by abdominal pain, fever, shiver, nausea and vomiting; bronchospasmo (see paragraphs 4.3 and 4.4). Gastrointestinal diseases: The most commonly observed adverse events are gastrointestinal. Peptic ulcers, perforation or gastrointestinal hemorrhage may occur, sometimes fatal, especially in the elderly (see paragraph 4.4). After administration of PAIDOFEN were reported: nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, ematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see paragraph 4.4). Less frequently gastritis were observed. Epigastric pain, gastric pyrosis. Gastric disorders can be reduced by taking the drug on a full stomach. Rarely: hepatitis, jaundice, alteration of liver function tests, pancreatis, duodenitis, esophagitis, liver syndrome, liver necrosis, liver failure. Pathologies of the nervous system and the sense organs: Vertigo, headache, irritability, tinnitus. Rarely: depression, insomnia, difficulty of concentration, emotional lability, drowsiness, aseptic meningitis, seizures, hearing and visual disorders. Respiratory, chest and mediastinic pathologies. Rarely: bronchospasm, dispnea, apnea. Pathologies of skin and subcutaneous tissue: Bollose reactions including Stevens-Johnson syndrome and epidermal toxic necrolysis (very rarely). Skin rashes (also of type maculopapulare), itching. Rarely: bladder-bollose eruptions, hives, multiform erythema, alopecia, exfoliatory dermatitis, photosensitivity reactions, photosensitivity dermatitis, unknown frequency. Drug reaction with heosinophilia and systemic symptoms (DrESS syndrome), Frequency: unknown. Generalized acute exantelosis (PEAG), Frequency: not known. Emolinfopoietic system pathologies. Very rarely: neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia (possible positive Coombs test), piastrinopenia (with or without purple), heosinophilia, hemoglobin reduction and hematocrite, pancytopenia. Disorders of metabolism and nutrition. Reduced appetite. Heart and vascular disease: Edema, hypertension and heart failure have been reported in association with treatment with NSAIDs. Fluid retention (usually responds promptly to the termination of treatment). Very rarely: cerebrovascular accidents, hypotension, congestive heart failure in subjects with compromised heart function, palpitations. Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg/die), may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see paragraph 4.4). Kidney and urinary pathologies. Very rarely: acute kidney failure in subjects with pre-existing significant impairment of kidney function, papillar necrosis, tubular necrosis, glomerulonephritis, alteration of kidney function tests, polyuria, cystitis, hematuria. Immune system disorders: In patients with pre-existing auto-immune diseases (e.g. systemic lupus erythematosus, connective system diseases) individual cases of aseptic meningitis symptoms such as nucan tension, headache, nausea, vomiting, fever, disorientation (see paragraph 4.4) have been reported. Other. Rarely: dry eyes and mouth, gum ulcers, rhinitis. Reporting of suspicious adverse reactions. The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.Overdosing
Toxicity signs and symptoms of toxicity were generally not observed at doses less than 100 mg/kg in children or adults. However, in some cases you may need a support treatment. It has been observed that children manifest signs and symptoms of toxicity after ingestion of ibuprofen at doses of 400 mg/kg or greater. In cases of severe poisoning, it is possible that metabolic acidosis occurs. Synonyms Most patients who have ingested significant quantities of ibuprofen manifest symptoms within 4-6 hours. The most commonly reported overdose symptoms include: nausea, vomiting, abdominal pain, lethargy and drowsiness. The effects on the central nervous system (SNC) include headaches, tunatus, dizziness, seizures and loss of consciousness. Rarely, nistagm, metabolic acidosis, hypothermia, kidney effects, gastrointestinal bleeding, coma, apnea, diarrhea and depression of the SNC and respiratory system were also reported. Disorientation, state of excitement, fainting and cardiovascular toxicity including hypotension, bradycardia and tachycardia have been reported. In cases of significant overdose are possible kidney failure and liver damage. Treatment There is no specific antidote for overdosing ibuprofen. In case of overdose, a symptomatic and support treatment is therefore indicated. Particular attention is given to the control of blood pressure, acid-base balance and gastrointestinal bleeding. Within an hour of the ingestion of a potentially toxic quantity must be considered the administration of activated charcoal. Alternatively, in the adult, within an hour of the ingestion of a potentially dangerous overdose for life, the gastric lavender must be taken into account. An adequate diuresis must be ensured and renal and hepatic functions must be closely monitored. The patient must remain under observation for at least four hours after ingestion of a potentially toxic drug. Any occurrence of frequent or prolonged seizures must be treated with intravenous diazepam. Other support measures may be required in relation to the patient's clinical conditions. For more information, contact the local anti-veleni center.It is unlikely that subjects under 12 years of age will go to pregnancy, or breast breastfeeding. In such circumstances, the following considerations must be taken into account.
Pregnancy
: Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/fetal development. Results of epidemiological studies suggest an increased risk of abortion and cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor in the early stages of pregnancy. The absolute risk of heart failure increased from less than 1% to about 1.5%. It has been considered that the risk increases with dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors showed an increase in the loss of pre- and post-plant and embryo-fetal mortality. In addition, an increase in the incidence of various malformations, including cardiovascular disorders, was reported in animals that had been 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 arterial duct and pulmonary hypertension); • kidney dysfunction that can progress to kidney failure with oligo-idroamnios; the mother and the newborn, at the end of pregnancy, to: • possible prolongation of bleeding time, an anti-aggregating effect that can also be necessary at very low doses; • inhibition of uterine contractions resulting in delay or extension of labor.Source: Farmadati
