NUROFENKID FEBBRE D 24CPS100MG

NUROFENKID FEVER AND PAIN 100 MG, SOFT CHEWABLE CAPSULES

active ingredients

Each chewable soft capsule contains 100 mg of ibuprofen. Excipients with known effect: Glucose, 358,3 mg/ chewable soft capsule Saccarosium, 251,6 mg/ chewable soft capsule Soy Lecithin, 0.01 mg/ chewable soft capsule For the full list of excipients, see paragraph 6.1.

Excellent

Gelatin, Purified Water, Glucose, Liquid, Saccarosium, Fume Acid (E297), Sucralose, Citric Acid (E330), Acesulfame K (E950), Defied Sodium, Glycerine, Orange Aroma, Red Iron oxide (E172), Yellow Iron Oxide (E172). Ink of the capsules: Titanium dioxide (E171), propylene glycol, HPMC 2910/Ipromellosa 3cP (E464). Technological aids: Medium chain triglycerides, Lecithin (derived by soy), stearic acid.

Therapeutic indications

The medicinal product is indicated in children with body weight between 20 kg (7 years) and 40 kg (12 years). Short-term symptomatic treatment of mild to moderate pain such as toothache, headache, and fever and pain associated with the common cold.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. Patients who have already shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or hives) in response to acetylcylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs). In the presence or in the case of history of recurrent peptic ulcer / bleeding (two or more distinct episodes of proven ulceration or bleeding). History of gastrointestinal hemorrhage or perforation linked to a previous therapy with NSAID. Severe heart failure (class NYHA IV), severe kidney failure or severe liver failure (see paragraph 4.4). Last trimester of pregnancy (see paragraph 4.6). This medicine contains soy lecithin. In the presence of peanut allergy or soy, do not use this medicine. Cerebrovascular bleeding or other active bleeding episodes. Unclear disorders of blood formation. Severe dehydration (caused by vomiting, diarrhea or insufficient intake of liquids).

Population

Posology: Only for oral use and for short-term treatments. Undesirable effects can be minimized with the use of the minimum effective dose for the shortest duration of treatment required to control symptoms (see paragraph 4.4). In children, the dose of ibuprofen depends on body weight, usually 5 - 10 mg/kg body weight as a single dose. The maximum daily dosage of Nurofenkid Fever and Pain is 20-30 mg/kg body weight. The recommended daily dose can be obtained as follows:

Body weight of the child (kg)	Age (Anni)	Single dose	Maximum daily dose
20-29	7-9	200 mg of ibuprofen (corresponding to 2 capsules)	600 mg of ibuprofen (corresponding to 6 capsules)
30-40	10-12	300 mg of ibuprofen (corresponding to 3 capsules)	900 mg of ibuprofen (corresponding to 9 capsules)

Doses should be administered every 6 to 8 hours (or at a minimum interval of 6 hours between one dose and the other), if required. Do not use the medicine in children under 7 years of age or with a body weight of less than 20 kg. If the medicinal product is to be administered to the child for more than three days or if the symptoms worsen, the doctor must be consulted. Particular populations of patients. Renal insufficiency: In patients with impairment of mild or moderate renal function a reduction in dose is not required (for patients with severe kidney failure, see paragraph 4.3). Hepatic insufficiency: In patients with impairment of mild or moderate liver function, no dose reduction is required (for patients with severe liver dysfunction, see paragraph 4.3). Method of administration: For oral use. The product must be chewed before swallowing. No water needed.

Conservation

Do not store at temperatures above 25°C.

Warnings

Undesirable effects can be minimized with the use of the minimum effective dose for the shortest duration of treatment, necessary to control symptoms (see gastrointestinal and cardiovascular risks below). Older subjects have a greater frequency of adverse reactions to NSAIDs, especially bleeding and gastrointestinal perforation, which can be fatal. Respiratory system: Bronchospasm may worsen in patients suffering from or with history of bronchial asthma or allergic pathology. Other: The use of ibuprofen in conjunction with other NSAIDs, including selective cyclooxygenase-2 inhibitors, must be avoided (see paragraph 4.5). Systemic erythematous lupus (LES) and mixed connective tissue disease: Patients with Lupus Eritematoso Sistemico (LES) and mixed connective tissue disease may present an increased risk of aseptic meningitis (see paragraph 4.8). Metabolism of porphyrin: Caution is required in patients with congenital disorders of porphyrin metabolism (e.g., intermittent acute porphyria). Renal Compromise: Renal failure in terms of kidney function may be further aggravated (see paragraph 4.3 and paragraph 4.8). There is a risk of kidney failure in dehydrated children. In general terms, the habitual intake of analgesics, in particular in combination with more active substances with a painkiller effect, can lead to permanent kidney damage with the risk of kidney failure (nephropathy from analgesics). Hepatic Comprogation: Hepatic dysfunction (see paragraph 4.3 and paragraph 4.8). Surgical intervention: Caution is required immediately after major surgeries. Allergies: Precaution is required in patients with allergic reactions to other substances, as there is a greater risk of hypersensitivity reactions even after the use of Nurofenkid Fever and Pain. In patients suffering from hay fever, nasal polyps or chronic obstructive respiratory disorders, there is a greater risk of allergic reactions. These may occur in the form of asthma attacks (the so-called analgesic asthma), Quincke edema or hives. Severe acute reactions of hypersensitivity (for example, anaphylactic shock) are observed very rarely. To the first signs of hypersensitivity reactions after using Nurofenkid Febbre and Pain, treatment must be suspended. The measures necessary from the medical point of view, in line with the symptoms, must be undertaken by specialized personnel. Cardiovascular and cerebrovascular effects: It requires caution (consulting the doctor or pharmacist) before starting treatment in patients with a history of hypertension and/or heart failure as water retention, hypertension and edema were reported in association with NSAID therapy. Clinical studies suggest that the use of ibuprofen, especially in high doses (2400 mg per day) may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke). Overall, epidemiological studies do not indicate that low doses of ibuprofen (e.g., ≤ 1200 mg per day) are associated with an increased risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), conclaimed ischemic cardiopathy, peripheral arteriopathy and/or cerebrovascular disease should be treated with ibuprofen only after careful examination and should avoid high doses (2400 mg per day). Particular attention should also be paid before starting long-term treatment in patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, smoking), especially if high doses of ibuprofen are required (2400 mg per day). Comprogation of female fertility: There is a limited evidence that drugs that inhibit the cyclooxygenase/synthesis of prostaglandins can cause a compromise of female fertility by exerting an effect on ovulation. This is reversible after the termination of treatment. Gastrointestinal system: NSAIDs should be given with caution to patients with a history of gastrointestinal pathologies ( ulcerative colitis, Crohn's disease), since these conditions can be exacerbated (see paragraph 4.8). Gastrointestinal bleeding, ulceration or perforation, which may be fatal, have been reported with all NSAIDs at any time during treatment, with or without warning symptoms or previous history of serious gastrointestinal events. The risk of gastrointestinal bleeding, ulceration or perforation is higher with the increase in doses of NSAIDs, in patients with history of ulcer, especially if complicated by hemorrhage or perforation (see paragraph 4.3) and in the elderly. Such patients should start treatment with the lowest dose available. The combined therapy with protective agents (e.g. misoprostol or protonic pump inhibitors) must be taken into account for these patients and, moreover, for patients taking acetylicylic acid at low doses or other drugs that may increase the risk of gastrointestinal events (see below and paragraph 4.5). Patients with history of gastrointestinal toxicity, especially if elderly, must report any unusual abdominal symptoms (especially gastrointestinal bleeding), particularly in the early stages of treatment. Caution should be recommended in patients taking medications 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 acetylsalicylic acid (see paragraph 4.5). When gastrointestinal bleeding or ulceration occurs in patients who are taking ibuprofen, treatment must be stopped. Effects: dermatologic: Severe skin reactions, some of which fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and epidermal toxic necrolysis have been reported very rarely in association with the use of NSAIDs (see paragraph 4.8). Patients seem to be at greater risk of these reactions in the early stages of therapy: in most cases, the onset of the reaction occurred within the first month of treatment. Hybuprofen should be suspended from the first appearance of skin rash, mucosa lesions or any other sign of hypersensitivity. Exceptionally, chickenpox can be the origin of severe infectious complications to the skin and soft tissues. To date, the contribution of NSAIDs cannot be excluded in the worsening of these infections. Therefore, it is recommended to avoid the use of Nurofenkid Fever and Pain in case of chickenpox. Piastrinic function: As they can interfere with the pyastrinic function, NSAIDs must be used with caution in patients with idiopathic thrombocytopenic (PTI) and hemorrhagic diathesis. In case of prolonged administration of Nurofenkid Fever and Pain, periodic verification of hepatitis values, kidney function and hemochrome is required. Prolonged use of any kind of painkiller for headaches can make your symptoms worse. If this situation occurs or is suspected, you should consult your doctor and treatment should be stopped. Diagnosis of drug abuse headache (MOH) must be suspected in patients who experience frequent or daily headaches despite (or due to) regular use of medications for headaches. Undesirable effects related to the active ingredient, especially those with the gastrointestinal tract or the central nervous system, can increase in the case of concomitant alcohol intake during use of NSAIDs. NSAIDs can mask symptoms of infection and fever. This product contains glucose. Patients with rare hereditary problems of glucose-galactose disease should not take this medicine. This product contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose mal absorption or saccarase-isomaltase failure should not take this medicine.

Interactions

Ibuprofen should be avoided in association with: • Other NSAIDs, including selective cycloxygenase-2 inhibitors: Avoid the concomitant use of two or more NSAIDs as this may increase the risk of unwanted effects (see paragraph 4.4). • Acetylsalicylic acid: Concurrent administration of ibuprofen and acetylsalicylic 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 medicines are administered simultaneously. Although there are uncertainties regarding the application of this data to the clinical situation, the possibility of regular long-term use of ibuprofen can reduce the cardioprotective effect of acetylylylethyllic acid at low doses can be excluded. No significant clinical effect is considered likely due to occasional use of ibuprofen (see paragraph 5.1). Ibuprofen should be used with caution in combination with: • Anticoagulants: NSAIDs can increase the effects of anticoagulants, such as warfarin (see paragraph 4.4). • Anti-hypertensives (ACE inhibitors, beta-blockers and antagonists of angiotensin II) and diuretics: NSAIDs can reduce the effect of these medicines. Diuretics can increase the risk of NSAID nephrotoxicity. In some patients with impaired kidney function (e.g. dehydrated patients or elderly patients with impaired kidney function), co-administration of an inhibitor ACE, beta-blocker or an antagonist of angiotensin II and agents inhibiting cyclo-oxidase can cause further worsening of kidney function, including a possible acute kidney failure, usually reversible. Therefore, these associations must be administered with caution especially in elderly patients. Patients should be properly hydrated and renal function monitoring should be taken into account at the beginning of concomitant therapy and subsequently on a periodic basis. In particular, the concomitant use of potassium-saving diuretics can increase the risk of hyperkaliemia. • Courtesy: Increased risk of gastrointestinal ulceration or bleeding (see section 4.4).• Serotonin reuptake selective agents and inhibitors (SSRIs): Increased risk of gastrointestinal bleeding (see paragraph 4.4). • Heart glycosides: NSAIDs can worsen heart failure, reduce glomerular filtration speed and increase plasma levels of glycosides. Concurrent use of Nurofenkid Fever and Pain with digoxin based preparations can increase the seric levels of digoxin. Serum digoxin levels are not normally required if the medicine is used correctly (maximum 3 days). • Lithium and phenytoin: There are evidence of a potential increase in plasma levels of lithium in case of co-administration with ibuprofen. If used correctly, it is not necessary to control plasma concentrations of lithium or phenytoin. • Probenecid and the Finpirazone: Drugs containing probenecid and finpirazone may delay the elimination of ibuprofen. • Methodology: There is the possibility of increased metotrexate in plasma. • Ciclosporine: Increased risk of nephrotoxicity. • Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone administration as they can reduce the effect of mifepristone. • Tacrolimus: Possible increase in the risk of nephrotoxicity when NSAIDs are administered with tacrolimus. • Zidovudina: Increased risk of hematological toxicity in case of concomitant administration of FANS and zidovudine. There is evidence of increased risk of hematrosis and hematomas in HIV-positive hemophilic patients treated simultaneously with zidovudine and ibuprofen. • Chinolonic Antibiotics: Data from animal studies indicate that NSAIDs can increase the risk of seizures associated with the use of chinolonic antibiotics. Patients taking NSAIDs and kinolones may have an increased risk of developing seizures. • Oral hypoglycemic agents: Inhibition of metabolism of drugs containing sulfaniluree, prolonged half-life and increased risk of hypoglycemia. • Aminoglycosides: NSAIDs can reduce aminoglycoside excretion. Children: you should pay attention in case of treatment with ibuprofen and aminoglycosides. • CYP2C9 inhibitors: Concurrent administration of ibuprofen and inhibitors of CYP2C9 may increase exposure to ibuprofen (substrate of CYP2C9). In a study with voriconazole and fluconazole (CYP2C9) inhibitors, an increase in exposure to the S (+)-ibuprofen of about 80 to 100% was demonstrated. A reduction in the dose of ibuprofen should be considered when at the same time powerful CYP2C9 inhibitors are administered, particularly when high doses of ibuprofen are administered with voriconazole or fluconazole.

Effects

The list of side effects listed below refers to all side effects that have occurred during treatment with ibuprofen, including those observed during long-term treatment and high doses in patients with rheumatism. The frequencies reported above very rare cases refer to the short-term use of daily doses up to a maximum of 1200 mg of ibuprofen for the oral dosage form and a maximum of 1800 mg for the assumptions. It should be taken into account that the following side effects are mainly dose-dependent and vary from individual to individual. Adverse reactions associated with the use of ibuprofen are listed below according to the classification for systems and organs and by frequency. The frequencies are defined as follows: Very common (≥ 1/10); Common (from ≥ 1/100 to Classification for Systems and Organs Frequency Undesirable effects Infections and infestations Very rare Increased inflammations related to infections (e.g., development of necrotizing bundles). In exceptional cases, severe skin infections and soft tissue complications may occur during a chickenpox infection. Emolinfopoietic system pathologies Very rare Hematopoiesi disorders (anemia, leucopenia, thrombocytopenia, pancitopenia, agranulocytosis). The first signs can be: fever, sore throat, superficial ulcers of the mouth, flu-like symptoms, severe fatigue, epistaxis, skin bleeding and ecchimosis. In these cases, the patient should be advised to stop taking the drug, to avoid self-medication with analgesics or antipyretics and to consult the doctor. Immune system disorders   Reactions of hypersensitivity characterized by1 Uncommon Orticaria and itching Very rare Severe hypersensitivity reactions. The symptoms may be: swelling of the face, tongue and larynx, dispnea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock). Exacerbation of asthma. Notable Reactivity of the respiratory tract that includes asthma, bronchospasm or dispnea. Psychiatric disorders Very rare Psychic reactions, depression. Diseases of the nervous system Uncommon Central nervous system disorders, such as headaches, dizziness, insomnia, agitation, irritability or fatigue. Very rare Meningitis asettica2 Pathologies of the eye Uncommon Visual disturbances Ear and labyrinth pathologies Rare Tinnitus Heart disease Very rare Heart failure, palpitations and edema, myocardial infarction. Vascular diseases Very rare Hypertension, vasculitis. Gastrointestinal diseases Town Gastrointestinal disorders, such as abdominal pain, nausea and dyspepsia. Diarrhea, flatulence, constipation, heartburn, vomiting, slight blood losses at the gastrointestinal level that in exceptional cases may cause anemia. Uncommon Gastrointestinal ulcer, gastrointestinal perforation or bleeding, ulcerative stomatitis, worsening of the colitis and Crohn's disease (see paragraph 4.4), gastritis. Very rare Esophagitis, formation of symil-diaphragmatic intestinal stenosis, pancreatis. Hepatobiliary diseases Very rare Hepatic dysfunction, liver damage, especially in case of prolonged therapy, liver failure, acute hepatitis. Pathologies of skin and subcutaneous tissue Uncommon Skin rashes of various nature. Very rare Severe forms of skin reactions, such as boiling reactions including Stevens-Johnson syndrome, multiform erythema and epidermal toxic necrolysis, alopecia. Notable Reaction to the drug with heosinophilia and systemic symptoms ( DRESS syndrome). Kidney and urinary pathologies Rare Rarely, renal tissue damage (paint necrosis) and high concentrations of urea in the blood may also be observed; high concentrations of uric acid in the blood. Very rare Edema formation, especially in patients with arterial hypertension or kidney failure, nephrotic syndrome, interstitial nephritis, which can be accompanied by acute kidney failure. Diagnostic examinations Rare Decrease of hemoglobin levels. Description of selected adverse reactions. 1 Hypersensitivity reactions were reported following treatment with ibuprofen. These may include (a) non-specific and anaphylaxis allergic reactions, (b) respiratory reactivity that includes asthma, aggravated asthma, bronchospasm or dispnea, or (c) different skin disorders, including skin rashes of various types, itching, hives, porpora, angioedema and, more rarely, exfoliative and bollose syndrome (. 2 The pathogenic mechanism of aseptic meningitis induced by drugs is not entirely known. However, the available data on aseptic meningitis related to NSAIDs indicate an immune reaction (due to a temporary relationship with the drug intake and the disappearance of symptoms after the drug is suspended). It should be noted that isolated cases of aseptic meningitis symptoms were observed (such as torcicollo, headache, nausea, vomiting, fever or clouding of the state of consciousness) during treatment with ibuprofen in patients with existing autoimmune diseases (such as systemic lupus erythematosus and the mixed disease of connective tissue). 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

In children, doses of ibuprofen higher than 400 mg/kg can cause symptoms of toxicity, while the risk of toxic effects should not be excluded with a dose greater than 100 mg/kg. In adults, the dose-response effect is less clear. The half-life in case of overdose is 1.5-3 hours. Synonyms Most patients who have ingested clinically important quantities of NSAID will develop nothing more than nausea, vomiting, epigastric pain or, more rarely, diarrhea. Tinnitus, headache and gastrointestinal bleeding are also possible. In more severe cases of intoxication, toxicity is observed at the expense of the central nervous system, which is manifested with drowsiness, occasionally excitability and disorientation or coma. Occasionally, patients develop seizures. In case of severe intoxication, metabolic acidosis can occur and protrombine/INR time can be prolonged, probably due to interference with the action of the factors of the coagulation present in the circle. Acute kidney failure and liver damage can occur. Asthma exacerbation is possible in asthmatic subjects. Treatment The treatment must be symptomatic and supportive and must include the maintenance of airway pervity and the monitoring of heart function and vital signs until stabilization. Oral administration of activated carbon should be considered if the patient is within an hour of ingestion of a potentially toxic quantity. Convulsions must be treated with diazepam or lorazepam intravenously if they are frequent or prolonged. Administer bronchodilators for asthma.

Pregnancy:

Inhibition of prostaglandin synthesis can adversely affect pregnancy and/or embryo/fetal development. Results of epidemiological studies indicate an increase in the risk of miscarriage, heart malformation and gastroschisis, after the use of an inhibitor of the synthesis of prostaglandins in the early stages of pregnancy. The absolute risk of cardiovascular malformations had increased from less than 1% to about 1.5%. The risk is believed to increase dose and duration of therapy. In animals, the administration of a prostaglandin synthesis inhibitor showed an increase in pre- and post-system loss and embryo-fetal mortality. In addition, an increase in the incidence of various malformations, including cardiovascular disorders, was reported in animals treated with an inhibitor of the synthesis of prostaglandins during the period of organogenesis. During the first and second quarter of pregnancy, ibuprofen should not be administered if not in strictly necessary cases. If ibuprofen is used by a woman who intends to conceive or during the first and second quarter of pregnancy, the dose must be kept as low as possible and the duration of treatment must be as short as possible. 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, which can worsen up to kidney failure with oligo-hydroamniosis; the mother and the newborn, at the end of pregnancy, to: - possible prolongation of bleeding time, an anti-aggregating effect that can also occur at very low doses; - inhibition of uterine contractions that may result in delay or extension of labor. Consequently, ibuprofen is contraindicated during the third trimester of pregnancy (see paragraph 4.3).

Nursing:

Hybuprofen and its metabolites pass into breast milk only in low concentrations. Since no harmful effects on infants are known today, for a short-term treatment of the recommended dose, breastfeeding should not be interrupted.

Fertility

: There is some evidence that drugs that inhibit the cycle-oxygenase/prostaglandin synthesis can affect female fertility due to ovulation. This effect is reversible after the termination of treatment.

Source: Farmadati