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NUROFEN FEVER D * BB100MG / 5ML A

  • RECKITT BENCKISER H.(IT.) SpA
  • 034102020
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NUROFEN FEVER D * BB100MG / 5ML A

Therapeutic indications

Symptomatic treatment of fever and mild to moderate pain.

Dosage and method of use

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 (see section 4.4). In children between 3 and 6 months of age, limit administration to those weighing more than 5.6 kg. Method of administration: Oral administration to infants and children aged 3 months to 12 years should be done using a measuring syringe or measuring spoon provided with the product. Patients suffering from stomach problems can take the medicine with meals. The daily dose of 20-30 mg / kg body weight, divided 3 times a day at intervals of 6-8 hours, can be administered according to the following scheme (do not exceed the recommended doses). The graduated scale on the body of the syringe highlights the notches for the different dosages; in particular the 2.5 ml notch corresponding to 50 mg of ibuprofen and the 5 ml notch corresponding to 100 mg of ibuprofen. The measuring spoon has two notches for two different dosages: the 2.5 ml notch corresponding to 50 mg of ibuprofen and the 5 ml notch corresponding to 100 mg of ibuprofen.

Weight Indicative age Single dose in ml maximum number of administrations / day
From 5.6 Kg 3 - 6 months 2.5 ml 3 in 24 hours
From 7 Kg 6 - 12 months 2.5 ml
From 10 Kg 13 years 5 ml
From 15 Kg 4 - 6 years 7.5ml (5ml + 2.5ml)
From 20 Kg 7 - 9 years 10 ml
From 28 to 43 Kg 10 - 12 years 15 ml

Special populations: in case of post-vaccination fever refer to the dosage indicated above, it is recommended to administer a single dose (2.5 ml) followed, if necessary, by another dose after 6 hours. Do not administer more than two doses in 24 hours. Consult your doctor if the fever does not subside. The product is intended for short-term treatments. In infants aged 3 to 5 months, a doctor should be consulted if symptoms persist for more than 24 hours or if symptoms worsen. If the use of the medicinal product 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, a doctor should be consulted. Instructions for using the dosing syringe: 1. Unscrew the cap by pushing it down and turning it to the left. 2. Fully insert the tip of the syringe into the hole in the undercap. 3. Shake well. 4. Turn the bottle upside down, then, while holding the syringe firmly, gently pull the plunger down to drain the suspension into the syringe to the mark corresponding to the desired dose. 5. Put the bottle back upright and remove the syringe by twisting it gently. 6. Insert the tip of the syringe into the child's mouth, and exert a slight pressure on the plunger to drain the suspension. 7. 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.

Contraindications

• Hypersensitivity to ibuprofen or to any of the excipients listed in section 6.1. • Children under 3 months of age or weighing less than 5.6 kg. • The medicinal product is contraindicated in patients who show or have previously shown hypersensitivity (eg asthma, rhinitis, angioedema or urticaria) to acetylsalicylic acid or other analgesics, antipyretics, non-steroidal anti-inflammatory drugs (NSAIDs), particularly when hypersensitivity it is associated with nasal polyposis and asthma. • Active peptic ulcer. • Severe renal or hepatic insufficiency (see section 4.4). • Severe heart failure (see section 4.4). • History of gastrointestinal bleeding or perforation, related to previous NSAID-based therapies. History of recurrent peptic bleeding / ulcer (two or more distinct episodes of proven ulceration or bleeding). • Concomitant use of NSAIDs, including specific COX-2 inhibitors. • During the last trimester of pregnancy (see section 4.6).

Side effects

The list of the following undesirable effects includes all those that have been recognized during treatment with ibuprofen for short treatment periods and for daily doses up to a maximum of 1200 mg. In case of treatments for chronic or prolonged high-dose diseases, other undesirable effects may occur. Adverse reactions associated with ibuprofen administration are listed below by system organ class and by frequency. Frequencies are defined as: Very common (1/10); Common (1/100, ≥1 / 1,000, ≥1 / 10,000,

System and organ classification Frequency Adverse reaction
Infections and infestations Rare Cystitis, rhinitis
Very rare Worsening of infection-related inflammation (e.g. development of necrotizing fasciitis), in exceptional cases severe skin infections and soft tissue complications have been found during a chickenpox infection.
Disorders of the blood and lymphatic system Very rare Disorders of hematopoiesis ¹
Disorders of the immune system Uncommon Hypersensitivity reactions manifested by urticaria and itching²
Very rare Severe hypersensitivity reactions including swelling of the face, tongue and larynx, dyspnoea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock).
Metabolism and nutrition disorders Not known Fluid retention and decreased appetite³.
Psychiatric disorders Not known Irritability
Rare Depression, insomnia, difficulty concentrating, emotional lability, visual and auditory disturbances.
Nervous system disorders Uncommon Headache, dizziness, sleepiness, convulsions.
Very rare Aseptic meningitis4
Rare Cerebrovascular haemorrhage
Eye disorders Rare Dry eye
Ear and labyrinth disorders Not known Tinnitus
Cardiac pathologies Not known Heart failure and edema5.
Rare Palpitations
Vascular pathologies Not known Hypertension5 and shock.
Respiratory, thoracic and mediastinal disorders Not known Respiratory tract reactivity including asthma, laryngeal obstruction, bronchospasm or apnea, dyspnoea.
Gastrointestinal disorders Uncommon Abdominal pain, nausea and dyspepsia6.
Rare Diarrhea, flatulence, dry mouth, constipation and vomiting.
Very rare Peptic ulcer, gastrointestinal perforation or bleeding, melaena and haematemesis7. Mouth ulcerations and gastritis.
Not known Exacerbation of colitis and Crohn's disease8, pancreatitis, duodenitis, esophagitis.
Hepatobiliary disorders Very rare Hepatic dysfunction, hepatitis, jaundice, hepatorenal syndrome, hepatic necrosis, hepatic failure.
Skin and subcutaneous tissue disorders Uncommon Various skin rashes²
Very rare Bullous reactions including Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis².
Rare Exfoliative dermatitis, alopecia, photosensitivity dermatitis.
Not known Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome).
Renal and urinary disorders Rare Tubular necrosis, glomerulus nephritis, polyuria, hematuria.
Very rare Acute renal failure9
Diagnostic tests Rare Decrease in hematocrit levels
Very rare Decrease in hemoglobin levels
Description of some adverse reactions.

¹ Haematopoiesis disorders including anemia, aplastic anemia, haemolytic anemia (positive Coombs test), leukopenia, neutropenia, thrombocytopenia (with or without purpura), eosinophilia, pancytopenia and agranulocytosis. The first symptoms may be: fever, sore throat, superficial mouth ulcers, flu-like symptoms, marked fatigue, nosebleeds and bleeding. Rarely, congestive heart failure in patients with impaired heart function. ² Hypersensitivity reactions: These reactions include a) non-specific allergic reactions and anaphylaxis, fever, chills, b) respiratory tract reactivity including asthma, aggravated asthma, bronchospasm (see sections 4.3 and 4.4) or dyspnoea or c) various skin conditions which include various rashes (including maculo-papular in nature), pruritus, urticaria with or without angioedema, purpura, angioedema and very rarely, bullous and exfoliative dermatitis including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme. ³ Decreased appetite: generally resolves rapidly upon discontinuation of treatment (see section 4.4). 4 The pathogenetic mechanism of drug-induced aseptic meningitis is not fully understood. However, the available data on aseptic meningitis related to the administration of NSAIDs suggest an immune reaction (due to a temporal relationship with the drug intake and the disappearance of symptoms after discontinuation of treatment). Of note, single cases of symptoms of aseptic meningitis (such as stiff neck, numb neck, headache, nausea, vomiting, fever and disorientation) have been observed during treatment with ibuprofen in patients with autoimmune disorders (such as systemic lupus erythromatosus, mixed connective tissue disease ).5 Heart failure and edema: Clinical studies and epidemiological data suggest that the use of ibuprofen, especially at high doses (2400 mg / day) and for long-term treatments, may be associated with a modest increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see section 4.4). Congestive heart failure in patients with impaired heart function. 6 The most commonly observed adverse events are gastrointestinal in nature. Gastric upset can be reduced by taking the medicine on a full stomach. 7 Peptic ulcers, gastrointestinal perforation or haemorrhage, melaena and sometimes fatal hematemesis can occur. 8 Exacerbation of colitis and Crohn's disease (see section 4.4). 9 Acute renal failure especially in the case of long-term therapy, associated with increased serum urea levels and edema. Papillary necrosis may occur. 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 system.

Special warnings

Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see below on gastrointestinal and cardiovascular risks). The use of Nurofen Fever and Pain 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 non-subjects. previously exposed to this type of medication. The risk of hypersensitivity reactions after taking ibuprofen is higher in subjects who have experienced such 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 ( see section 4.2 and section 4.8). 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. There is a risk of renal impairment in dehydrated children and adolescents (see sections 4.3 and 4.8). Elderly: Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal (see section 4.2). In the elderly and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), 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 (e.g. misoprostol or proton pump inhibitors) 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 (see section 4.5). 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 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 (aspirin) (see section 4.5). . When gastrointestinal bleeding or ulceration occurs in patients taking Nurofen Fever and Pain, the 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 may be exacerbated (see section 4.8). 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). 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. Nurofen Fever and Pain should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity. Chickenpox can exceptionally cause severe infectious skin and soft tissue complications. To date, the contribution of NSAIDs in the worsening of these infections cannot be excluded, therefore it is advisable to avoid the use of Nurofen Fever and Pain in case of chickenpox. Caution is required (discuss with 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 treatment with NSAIDs. Clinical studies and epidemiological data suggest that the use of ibuprofen, especially at high doses (2400 mg / day) and for long-term treatment, 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, established ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease should only be treated with ibuprofen after careful consideration. Similar considerations should be made before initiating long-term treatment in patients with risk factors for cardiovascular events (eg hypertension, hyperlipidemia, diabetes mellitus, smoking). The use of ibuprofen, acetylsalicylic acid or other analgesics, antipyretics, non-steroidal anti-inflammatory drugs requires particular caution: • in case of asthma or current or previous allergic diseases: possible deterioration of 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 during prolonged treatments: • Watch 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 the treatment and consult the ophthalmologist; • if signs or symptoms of meningitis develop: evaluate the rare possibility that this is due to the use of ibuprofen (aseptic meningitis; more common in subjects with systemic lupus erythematosus and mixed connective tissue disease or other collagen diseases) (see section 4.8) . Since Nurofen Fever and Pain contains maltitol, patients with rare hereditary problems of fructose intolerance should not take this medicine. Nurofen Fever and Pain does not contain sugar and is therefore indicated for those patients who need to control the intake of sugars and calories. This medicinal product contains less than 1 mmol (23 mg) of sodium for doses up to 12 ml, ie essentially “sodium-free” and about 1.2 mmol (about 27.6 mg) of sodium for each 15 ml dose. This is equivalent to 1.4% approximately the maximum recommended daily dietary intake of an adult. NUROFEN FEVER AND PAIN Children 100mg / 5ml oral suspension strawberry flavor without sugar contains 3.3 mg of propylene glycol (present in the strawberry flavor) in 1 ml.

Pregnancy and breastfeeding

People under the age of 12 are unlikely to become pregnant, or breastfeed. However, in such circumstances the following considerations must be kept in mind. Pregnancy: During the first and second trimester of pregnancy, the administration of ibuprofen should be avoided. Ibuprofen is contraindicated during the third trimester of pregnancy. Inhibition of prostaglandin synthesis can adversely affect pregnancy and / or embryo / fetal development. Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations increased by less than 1% up to about 1.5%. The risk was considered to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause increased 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 can 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 which can occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor. Feeding time: There is limited data showing that ibuprofen can pass in low concentrations into breast milk and is unlikely to have adverse effects in newborns.Fertility: Not relevant.

Expiration and retention

No Details.

Interactions with other drugs

Ibuprofen should be avoided in combination with: • Acetylsalicylic acid (aspirin): unless low dose acetylsalicylic acid (no more than 75 mg per day), as per common clinical practice, has not been recommended by your doctor, as it may increase the risk of adverse reactions (see paragraph 4.4). Experimental data indicate that ibuprofen may inhibit the effects of low-dose acetylsalicylic acid on platelet aggregation when the drugs are administered concomitantly. However, the paucity of data and the uncertainties relating to the application of the extrapolated ex vivo data to the clinical situation do not allow definitive conclusions to be drawn on the regular use of ibuprofen; Clinically relevant effects from occasional use of ibuprofen are unlikely (see section 5.1). • Other NSAIDs including selective cyclooxygenase-2 inhibitors: avoid the simultaneous use of two or more analgesics, antipyretics, non-steroidal anti-inflammatory drugs: increased risk of side effects (see section 4.4). Ibuprofen should be used with caution in combination with: • corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see section 4.4); • quinolone antibiotics: data from animal studies indicate that NSAIDs may increase the risk of seizures associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing seizures; • anticoagulants, such as warfarin: NSAIDs may increase the effects of anticoagulants (see section 4.4); • antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4); • antidiabetics: possible increase in the effect of sulfonylureas; • antivirals, such as ritonavir: possible increase in the concentration of NSAIDs; • cyclosporine: increased risk of nephrotoxicity • mifepristone: NSAIDs should not be administered in the 8-12 days after taking mifepristone as they can reduce its effectiveness; • cytotoxic, such as methotrexate: reduced excretion (increased risk of toxicity); • lithium: reduced excretion (increased risk of toxicity); • tacrolimus: increased risk of nephrotoxicity; • uricosurics, such as probenecid: slows down the excretion of NSAIDs (increased plasma concentrations); • methotrexate: potential increase in the plasma concentration of methotrexate; • zidovudine: increased risk of blood toxicity when NSAIDs are used in combination with zidovudine. There is evidence of an 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 Nurofen Fever and Pain 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 and periodically; • cardiac glycosides: NSAIDs can worsen heart failure, reduce VGF (glomerular filtration rate) and increase plasma levels of glycosides.

Overdose

Toxicity Signs and symptoms of toxicity were generally not observed at doses below 100 mg / kg in children or adults. However, supportive treatment may be required in some cases. Children have been observed to exhibit signs and symptoms of toxicity after ingestion of ibuprofen at doses of 400 mg / kg or greater. The half-life of the drug in case of overdose is 1.5-3 hours. Symptoms Most patients who accidentally ingest clinically relevant amounts of ibuprofen will experience symptoms within 4-6 hours. The most commonly reported symptoms of overdose include: nausea, vomiting, abdominal pain, lethargy and somnolence. Effects on the central nervous system (CNS) include headache, tinnitus, dizziness, seizures, and loss of consciousness. Nystagmus, metabolic acidosis, hypothermia, renal effects, gastrointestinal bleeding, coma, apnea, diarrhea and CNS and respiratory depression have also been reported rarely. Disorientation, arousal state, fainting and cardiovascular toxicity including hypotension, bradycardia and tachycardia have been reported. In cases of significant overdose, renal failure and liver damage are possible. In cases of severe poisoning, metabolic acidosis and prolonged prothrombin time (INR) may occur, possibly caused by interference with the action of circulating clotting factors. An exacerbation of the symptoms of the disease may occur in asthmatics. Treatment There is no specific antidote to ibuprofen overdose. In the event of an overdose, symptomatic and supportive treatment is therefore indicated and should include maintenance of a patent airway and monitoring of cardiac function and vital signs until the patient is stabilized. Particular attention is paid to the control of blood pressure, acid-base balance and any gastrointestinal bleeding. Administration of activated charcoal should be considered within one hour of ingesting a potentially toxic amount. Alternatively, gastric lavage should be considered within one hour of ingesting a potentially life-threatening overdose in adults. Adequate diuresis must be ensured and renal and hepatic functions closely monitored. The patient should remain under observation for at least four hours following ingestion of a potentially toxic amount of drug. Any occurrence of frequent or prolonged seizures should be treated with intravenous diazepam or lorazepam. If ibuprofen has already been absorbed, alkaline substances should be administered to promote the excretion of acid ibuprofen in urine. Administer bronchodilators in case of asthma. Depending on the patient's clinical condition, other supportive measures may be necessary. For more information, contact your local poison control center.

Active principles

NUROFEN FEVER AND PAIN Children 100mg / 5ml Oral Suspension. Each ml of oral suspension contains: Active ingredient: ibuprofen 20 mg. Excipients with known effects: maltitol, propylene glycol and sodium. For the full list of excipients, see section 6.1.

Excipients

Nurofen Fever and Pain Children 100mg / 5ml oral suspension orange flavor without sugar: Polysorbate 80, glycerin, maltitol syrup, sodium saccharin, citric acid, sodium citrate, xanthan gum, sodium chloride, orange flavor, domifene bromide, purified water. Nurofen Fever and Pain Children 100mg / 5ml oral suspension strawberry flavor without sugar: Polysorbate 80, glycerin, maltitol syrup, sodium saccharin, citric acid, sodium citrate, xanthan gum, sodium chloride, strawberry flavor, domifene bromide, purified water.

034102020
12 Items