NUROFENKID FEVER D * 24CPS100MG

NUROFENKID FEVER D * 24CPS100MG

Therapeutic indications

The medicine 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.

Dosage and method of use

Dosage:For oral use only and for short-term treatments. Undesirable effects can be minimized by using the lowest effective dose for the shortest duration of treatment needed to control symptoms (see section 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:

Doses should be administered approximately every 6 to 8 hours (or with a minimum interval of 6 hours between doses), if required. Do not use the medicine in children under 7 years of age or weighing less than 20 kg. If the medicine is to be given to the child for more than three days or if symptoms worsen, the doctor should be consulted.Particular patient populations. Renal impairment: No dose reduction is required in patients with mild or moderate renal impairment (for patients with severe renal impairment, see section 4.3). Hepatic impairment: No dose reduction is required in patients with mild or moderate hepatic impairment (for patients with severe hepatic dysfunction, see section 4.3).Method of administration: For oral use. The product must be chewed before swallowing. No water is needed.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients who have already shown hypersensitivity reactions (e.g., asthma, rhinitis, angioedema or urticaria) in response to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs). In the presence or in the case of a history of recurrent peptic ulcer / haemorrhage (two or more distinct episodes of proven ulceration or bleeding). History of gastrointestinal bleeding or perforation related to previous NSAID therapy. Severe heart failure (NYHA class IV), severe renal failure or severe hepatic failure (see section 4.4). Last trimester of pregnancy (see section 4.6). This medicine contains soy lecithin. If you have a peanut or soy allergy, do not use this medicine. Cerebrovascular haemorrhage or other active bleeding episodes. Unclear disorders of blood formation. Severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake).

Side effects

The list of side effects below refers to all side effects that have occurred during treatment with ibuprofen, including those seen during long-term and high-dose treatment in patients with rheumatism. Frequencies reported, which occur with incidence higher than very rare cases, refer to the short-term use of daily doses of up to 1200 mg ibuprofen for the oral dosage form and a maximum of 1800 mg for suppositories. . It should be taken into account that the following undesirable effects are predominantly dose-dependent and vary from individual to individual. Adverse reactions associated with the use of ibuprofen are listed below by system organ class and frequency. Frequencies are defined as follows: Very common (≥ 1/10); Common (≥ 1/100 to

Description of selected adverse reactions

. ¹ Hypersensitivity reactions have been reported following treatment with ibuprofen. These may include (a) non-specific allergic reactions and anaphylaxis, (b) respiratory tract reactivity including asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) various skin disorders, including various skin rashes, itching, urticaria, purpura, angioedema and, more rarely, exfoliative and bullous dermatitis (including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme). ² The pathogenetic mechanism of drug-induced aseptic meningitis is not fully understood. However, available data on NSAID-related aseptic meningitis indicate an immune reaction (due to a temporary relationship with drug intake and disappearance of symptoms after drug discontinuation). It should be noted that isolated cases of symptoms of aseptic meningitis (such as stiff neck, headache, nausea, vomiting, fever or clouded consciousness) have been observed during treatment with ibuprofen in patients with existing autoimmune diseases (such as systemic lupus erythematosus and mixed connective tissue disease). 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 systemhttp://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

Special warnings

Undesirable effects can be minimized by using the lowest effective dose for the shortest duration of treatment needed to control symptoms (see gastrointestinal and cardiovascular risks below). Elderly subjects have a higher frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal.Respiratory system: Bronchospasm may worsen in patients with or with a history of bronchial asthma or allergic disease.Other NSAIDs: The use of ibuprofen concomitantly with other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided (see section 4.5).Systemic lupus erythematosus (SLE) and mixed connective tissue disease: Patients with systemic lupus erythematosus (SLE) and mixed connective tissue disease may be at increased risk for aseptic meningitis (see section 4.8).Porphyrin metabolism: Caution is required in patients with congenital disorders of porphyrin metabolism (eg acute intermittent porphyria).Renal impairment: Renal failure in terms of renal function may be further aggravated (see section 4.3 and section 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 several active substances with a pain-relieving effect, can lead to permanent renal damage with the risk of renal failure (analgesic nephropathy).Hepatic impairment:Hepatic dysfunction (see sections 4.3 and 4.8).Surgical interventions:Caution is required immediately following major surgeries.Allergies:Caution is warranted in patients with allergic reactions to other substances, as there is an increased risk of hypersensitivity reactions occurring even with the use of Nurofenkid Fever and Pain. There is an increased risk of allergic reactions in patients suffering from hay fever, nasal polyps or chronic obstructive breathing disorders. These can present in the form of asthma attacks (so-called analgesic asthma), Quincke's edema or urticaria. Severe acute hypersensitivity reactions (eg anaphylactic shock) are observed very rarely. At the first signs of hypersensitivity reactions after using Nurofenkid Fever and Pain, the treatment should be stopped. Medically necessary measures, in line with symptoms, should be undertaken by trained personnel.Cardiovascular and cerebrovascular effects: Caution is required (consult your doctor or pharmacist) 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 NSAID therapy. Clinical studies suggest that the use of ibuprofen, especially in high doses (2400 mg per day) may be associated with a modest increased risk of arterial thrombotic events (eg, 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), overt ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease should only be treated with ibuprofen after careful consideration and high doses (2400 mg per day) should be avoided. . Particular care should also be taken before initiating long-term treatment in patients with risk factors for cardiovascular events (e.g., hypertension, hyperlipidaemia, diabetes mellitus, smoking), especially if high doses of ibuprofen (2400 mg per day) are required. .Impaired female fertility: There is limited evidence that drugs that inhibit cyclooxygenase / prostaglandin synthesis can cause impairment of female fertility by exerting an effect on ovulation. This is reversible upon discontinuation of treatment.Gastrointestinal system: NSAIDs should be administered with caution to patients with a history of gastrointestinal disorders (ulcerative colitis, Crohn's disease), as these conditions may be exacerbated (see section 4.8). Gastrointestinal bleeding, ulceration or perforation, which can be fatal, have been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events. The risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, especially if complicated with haemorrhage or perforation (see section 4.3) and in the elderly. Such patients should start treatment with the lowest available dose. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients and, in addition, for patients taking concomitantly low dose acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal events (see below and section 4.5). Patients with a history of gastrointestinal toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding), particularly in the early stages of treatment. Caution should be advised in patients taking concomitant medicinal products that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid (see section 4.5). When gastrointestinal bleeding or ulceration occurs in patients taking ibuprofen, treatment should be stopped.Effects: dermatological: Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at increased risk of these reactions in the early stages of therapy: in the majority of cases, the onset of the reaction occurred within the first month of treatment. Ibuprofen should be discontinued at the first appearance of rash, mucosal lesions or any other signs of hypersensitivity. Exceptionally, chickenpox can cause severe infectious skin and soft tissue complications. To date, the contribution of NSAIDs in the worsening of these infections cannot be ruled out. Therefore, it is recommended to avoid the use of Nurofenkid Fever and Pain in case of chickenpox.Platelet function:Because they can interfere with platelet function, NSAIDs should be used with caution in patients with idiopathic thrombocytopenic purpura (ITP) and bleeding diathesis. In case of prolonged administration of Nurofenkid Fever and Pain, a periodic check of liver values, renal function, as well as blood count is necessary. Prolonged use of any type of pain reliever for headaches can worsen the symptoms. If this situation occurs or is suspected, the doctor should be consulted and the treatment stopped. The diagnosis of drug overuse headache (MOH) should be suspected in patients who experience frequent or daily headaches despite (or because of) regular use of headache medications. Undesirable effects related to the active substance, especially those affecting the gastrointestinal tract or the central nervous system, may increase in case of concomitant alcohol intake while using NSAIDs. NSAIDs can mask the symptoms of infection and fever. This product contains glucose. Patients with rare hereditary problems of glucose-galactose malabsorption should not take this medicine. This product contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Pregnancy and breastfeeding

Pregnancy:Inhibition of prostaglandin synthesis can adversely affect pregnancy and / or embryo / fetal development. Results from epidemiological studies indicate an increased risk of spontaneous abortion, cardiac malformations and gastroschisis after the use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiovascular malformations was increased from less than 1% to approximately 1.5%. The risk is believed to increase with increasing dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-fetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular ones, has been reported in animals treated with a prostaglandin synthesis inhibitor during the period of organogenesis. During the first and second trimester of pregnancy, ibuprofen should not be administered except in strictly necessary cases. If ibuprofen is used by a woman intending to conceive or during the first and second trimester of pregnancy, the dose should be kept as low as possible and the duration of treatment should 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 the arterial duct and pulmonary hypertension); - renal dysfunction, which can worsen up to renal failure with oligo-hydroamniosis; the mother and the newborn, at the end of pregnancy, to: - possible prolongation of the bleeding time, an antiplatelet effect which can occur even at very low doses; - inhibition of uterine contractions which can result in a delay or prolongation of labor. Consequently, ibuprofen is contraindicated during the third trimester of pregnancy (see section 4.3).Feeding time:Ibuprofen and its metabolites pass into breast milk only in low concentrations. Since no harmful effects on infants are known to date, it is not necessary to interrupt breastfeeding for short-term treatment at the recommended dose.Fertility: There is some evidence that drugs that inhibit cyclo-oxygenase / prostaglandin synthesis may impair female fertility by effecting ovulation. This effect is reversible after stopping treatment.

Expiry and retention

Do not store at temperatures above 25 ° C.

Interactions with other drugs

Ibuprofen should be avoided in combination with: •Other NSAIDs, including selective cyclooxygenase-2 inhibitors: Avoid concomitant use of two or more NSAIDs as this may increase the risk of undesirable effects (see section 4.4). •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 the two drugs are administered simultaneously. Although there are uncertainties regarding the application 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 (see section 5.1).Ibuprofen should be used with caution in combination with: •Anticoagulants: NSAIDs may enhance the effects of anticoagulants, such as warfarin (see section 4.4). •Antihypertensives (ACE inhibitors, beta-blockers and angiotensin II antagonists) and diuretics: NSAIDs may reduce the effect of these medicines. Diuretics may increase the risk of NSAID nephrotoxicity. In some patients with impaired renal function (e.g., dehydrated patients or elderly patients with impaired renal function), co-administration of an ACE inhibitor, a beta-blocker or an angiotensin II antagonist and agents that inhibit cyclo-oxygenase can lead to further worsening of renal function, including possible acute renal failure, which is usually reversible. Therefore, these combinations should be administered with caution especially in elderly patients. Patients should be adequately hydrated and monitoring of renal function should be considered at initiation of concomitant therapy and on a periodic basis thereafter. In particular, concomitant use of potassium-sparing diuretics may increase the risk of hyperkalaemia. •Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding (see section 4.4). •Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): Increased risk of gastrointestinal bleeding (see section 4.4). •Cardiac glycosides: NSAIDs can worsen heart failure, reduce glomerular filtration rate and increase plasma glycoside levels. Concomitant use of Nurofenkid Fever and Pain with digoxin preparations may increase serum digoxin levels. Monitoring of serum digoxin levels is not normally required if the medicinal product is used correctly (for up to 3 days). •Lithium and phenytoin: There is evidence of a potential increase in plasma lithium levels when co-administered with ibuprofen. When used correctly, it is not necessary to monitor plasma concentrations of lithium or phenytoin. •Probenecid and sulfinpyrazone: Medicines containing probenecid and sulfinpyrazone may delay the elimination of ibuprofen. •Methotrexate: There is a possibility of an increase in plasma methotrexate. •Ciclosporine: Increased risk of nephrotoxicity. •Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone administration as they may reduce the effect of mifepristone. •Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are administered with tacrolimus. •Zidovudine: Increased risk of haematological toxicity in case of concomitant administration of NSAIDs and zidovudine. There is evidence of an increased risk of haemarthrosis and hematoma in HIV-positive haemophilia patients treated concomitantly with zidovudine and ibuprofen. •Quinolone antibiotics: Data from animal studies indicate that NSAIDs may increase the risk of seizures associated with the use of quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing seizures. •Oral hypoglycemic agents: Inhibition of metabolism of sulfonylurea-containing drugs, prolonged half-life and increased risk of hypoglycaemia. •Aminoglycosides: NSAIDs may reduce the excretion of aminoglycosides. Children: Care should be taken in case of concomitant treatment with ibuprofen and aminoglycosides. •CYP2C9 inhibitors: Concomitant administration of ibuprofen and CYP2C9 inhibitors may increase exposure to ibuprofen (CYP2C9 substrate). In a study with voriconazole and fluconazole (CYP2C9 inhibitors), an increase in exposure to S (+) - ibuprofen of approximately 80 - 100% was shown. A dose reduction of ibuprofen should be considered when potent CYP2C9 inhibitors are administered concurrently, particularly when high doses of ibuprofen are administered with voriconazole or fluconazole.

Overdose

In children, ibuprofen doses above 400 mg / kg can cause symptoms of toxicity, while the risk of toxic effects should not be excluded with a dose higher 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. Symptoms Most patients who have ingested clinically significant amounts of NSAIDs 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, central nervous system toxicity is observed, manifesting as drowsiness, occasionally excitability and disorientation or coma. Occasionally, patients develop seizures. In cases of severe intoxication, metabolic acidosis may occur and the prothrombin time / INR may be prolonged, possibly due to interference with the action of circulating coagulation factors. Acute renal failure and liver damage can occur. An exacerbation of asthma is possible in asthmatics.TreatmentTreatment should be symptomatic and supportive and should include maintaining a patent airway and monitoring cardiac function and vital signs until stabilization. Oral administration of activated charcoal should be considered if the patient presents within one hour of ingesting a potentially toxic amount. Seizures should be treated with intravenous diazepam or lorazepam if they are frequent or prolonged. Administer bronchodilators for asthma.

Active principles

Each chewable soft capsule contains 100 mg of ibuprofen.Excipients with known effect: Glucose, 358.3 mg / soft chewable capsule Sucrose, 251.6 mg / soft chewable capsule Soy Lecithin, 0.01 mg / soft chewable capsule For a full list of excipients, see section 6.1.

Excipients

Gelatin, Purified water, Glucose, liquid, Sucrose, Fumaric acid (E297), Sucralose, Citric acid (E330), Acesulfame K (E950), Sodium edetate, Glycerin, Orange flavor, Red iron oxide (E172), Oxide of yellow iron (E172). Ink of the capsules: Titanium dioxide (E171), Propylene glycol, HPMC 2910 / Hypromellose 3cP (E464). Technological adjuvants: Medium chain triglycerides, Lecithin (derived from soy), Stearic acid.