NUROFEN IT'S CALLED A FEVER

NUROFEN FEVER AND PAIN CHILDREN 100 MG/5 ML

active ingredients

NUROFEN FEBRUARY AND DOLORE Children 100mg/5ml Oral Suspension Each ml of oral suspension contains: Active ingredient: ibuprofene 20 mg. Excipients with known effects: liquid maltitol, glycol propylene (present in strawberry aroma), wheat starch (present in orange aroma) and sodium. For the full list of excipients, see paragraph 6.1.

Excellent

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

Therapeutic indications

Symptomatic treatment of mild or moderate fever and pain.

Contraindications

• Hypersensitivity to ibuprofen or any of the excipients listed in the paragraph 6.1. • Children under 3 months or less than 5.6 kg. • The drug is contraindicated in patients who show or have previously shown hypersensitivity (e.g. asthma, rhinitis, angioedema or urticaria) to acetylsalicylic acid or other analgesic, antipyretic, non-steroidal anti-inflammatory drugs (NSAID), especially when hypersensitivity is associated with nasal and asthma polypoxes. • Active peptic ulcer. • Severe kidney or liver failure (see paragraph 4.4). • Severe heart failure (see paragraph 4.4). • History of gastrointestinal hemorrhage or perforation, related to previous therapies based on NSAID 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. • Patients with cerebrovascular bleeding history or other active bleeding. • Patients with unclear disorders of blood formation. • Patients with severe dehydration (caused by vomiting, diarrhea or insufficient liquid intake). • During the last quarter of pregnancy (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 minimum effective dose for the shortest possible treatment duration 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. Method of administration Oral administration to infants and children aged between 3 months and 12 years should take place by means of dosing syringe or dosing spoon provided with the product. Patients suffering from stomach problems can take the medicine during meals. The daily dose of 20-30 mg/kg body weight, divided 3 times a day at intervals of 6-8 hours, can be given on the basis of the following diagram (do not exceed the recommended doses). The graduated scale on the syringe body highlights the heels for different dosages; in particular the 2.5 ml notch corresponding to 50 mg of ibuprofene and the 5 ml notch corresponding to 100 mg of ibuprofene. The dosing teaspoon contains two notches for two different dosages: the 2.5 ml notch corresponding to 50 mg of ibuprofene and the 5 ml notch corresponding to 100 mg of ibuprofene.

Special populations: in the case of post-vaccination fever refer to the above dosage, it is recommended to take a single dose (2.5 ml) followed, if necessary, from another dose after 6 hours. Do not administer more than two doses in 24 hours. Consult the doctor if the fever does not decrease. The product is intended for short-term treatments. In infants between 3 and 5 months, the doctor must be consulted if the symptoms persist for a period of more than 24 hours or in case of symptomatology worsening. In case the use of the medicine is necessary for more than 3 days in infants and children older than 6 months and adolescents, or in case of worsening of symptomatology a doctor must be consulted. Instructions for using the dosing syringe: 1. Unscrew the cap by pushing it down and turning it to the left. 2. Deeply introduce the syringe tip into the trap hole. 3. Shake well. 4. Turn the bottle, then, firmly holding the syringe, gently pull the plunger downwards, causing the suspension to flow into the syringe until the heel corresponding to the desired dose. 5. Put the bottle in vertical position and remove the syringe by turning it gently. 6. Introduce the syringe tip into the baby's mouth, and exert a slight pressure on the plunger to cause the suspension to flow. 7. After use screw the cap to close the bottle and wash the syringe with hot water. Let it dry, keeping it out of reach and sight of children.

Conservation

No Detail.

Warnings

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). Other NSAIDs: the use of Nurofen Fever and Pain should be avoided in conjunction with NSAIDs, 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), hay fever, nasal polypoxes, chronic obstructive respiratory disorders or previous angioedema episodes (see paragraph 4.2 and paragraph 48). Gastrointestinal effects (GI): 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. Caute should be lent to patients taking concomitant medications that could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or anti-aggregating agents such as acetilsalicylic acid (aspirin) (see paragraph 4.5). When hemorrhage or gastrointestinal ulcer occurs in patients taking Nurofen Fever and Pain, treatment should 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). Dermatologic effects: severe skin reactions: severe skin reactions were rarely reported, some of which fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis in association with the use of NSAID (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. Generalized acute urstolosis (PEAG) was reported in relation to medicines containing ibuprofen. Ibuprofen should be suspended at the first appearance of severe skin signs and symptoms such as rash, mucosa lesions or any other sign of hypersensitivity. Masking the symptoms of underlying infections: Nurofen Fever and Pain may 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 Nurofen Fever and Pain 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. The chickenpox can exceptionally be the origin of serious infectious complications to the skin and soft tissues. To date, the contribution of NSAIDs cannot be excluded in the worsening of such infections, therefore it is recommended to avoid the use of Nurofen Fever and Pain in case of chickenpox. Cardiovascular and cerebrovascular effects: Caution is required (discussed with your physician or pharmacist) before starting treatment in patients with positive anamnesis for hypertension and/or heart failure because in association with the treatment with the NSAIDs fluid, hypertension and edema were found. Clinical studies and epidemiological data suggest that the use of ibuprofen, especially at high doses (2400 mg/die) and for long-term treatments, 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 myocardial infarction. Patients with uncontrolled hypertension, congestive heart failure, established ischemic cardiopathy, peripheral arterial disease and/or cerebrovascular disease should be treated with ibuprofen only after careful consideration. Analogue considerations must be made before starting a long-term treatment in patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, smoking). Renal diseases: in general, the usual use of analgesics, especially the combination of different analgesic substances, can cause permanent kidney injury, with risk of kidney failure (nephropathy from analgesics). In dehydrated children and adolescents there is a risk of alteration of kidney function (see paragraph 4.3 and 4.8). In patients with heart failure, kidney or liver failure, in those taking diuretics or having undergone important surgery resulting in dehydration, diuresis and kidney function must be monitored. Other considerations: Prolonged use of any type of analgesic for headaches can make your symptoms worse. If this situation occurs or is suspected, the doctor must be consulted and the treatment must be suspended. Diagnosis of drug abuse headache (medication overuse headache -MOH) must be suspected in patients who experience frequent or daily headaches despite or due to regular use of medicines for headaches Promoted female fertility: see paragraph 4.6. The use of ibuprofen, acetylsalicylic acid or other analgesic, antipyretic, non-steroidal anti-inflammatory, requires special caution: • in case of asthma or allergic diseases in place or in advance: possible deterioration of bronchoconstriction; in the presence of clotting defects as ibuprofen, the active ingredient of Nurofen Fever and Pain, can temporarily inhibit the functionality of platelets (thrombocytic aggregation). Therefore it is recommended to carefully monitor patients with clotting disorders. • 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). • immediately after increased surgery • congenital disorders of porphyrin metabolism (e.g. intermittent acute porphyria). 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 the treatment and consult the ophthalmologist; • if signs or symptoms of meningitis arise: assess the rare possibility that it is due to the use of ibuprofene (aseptic menus; most frequent in subjects suffering from systemic erythematose lupus and mixed disease of connective tissue or other collagenopathies) (see paragraph 4.8). Since Nurofen Fever and Pain contains liquid maltitol, patients with rare hereditary problems of fructose intolerance should not take this medicine. It can have a slight laxative effect. The caloric value of maltitol is 2.3 kcal/g. Nurofen Fever and Pain does not contain sugar and is therefore indicated for those patients who need to control sugar and calorie intake. This medicine contains 9.08 mg of sodium for 5 ml equivalent to 0.45% of the maximum daily intake recommended by the WHO that corresponds to 2 g sodium for an adult. NUROFEN FEBRUARY AND DOLORE Children 100mg/5ml oral suspension Strawberry taste without sugar contains 11,75 mg propylene glycol (present in strawberry aroma) in 5 ml. Co-administration with any dihydrogenase alcohol substrate as ethanol can induce severe adverse effects in infants. NUROFEN FEBRUARY AND DOLORE Children 100mg/5ml oral suspension taste orange without sugar contains only a very small amount of gluten (from thewheat starch present in orange aroma). This medicine is considered > and is very unlikely to cause problems to a celiac patient. A 5 ml dose contains no more than 0.225 micrograms of gluten. If the patient is allergic to wheat (condition other than celiac disease) he should not take this medicine.

Interactions

Ibuprofen should be avoided in association with: • Acetylsalicylic acid: concurrent administration of ibuprofen and acetylicylic acid is not generally recommended due to the potential increase in unwanted effects. Experimental data indicates that ibuprofen can inhibit the effects of acetylsalicylic acid at low dose on pyasternic aggregation when drugs are administered in conjunction. However, data evacuity and uncertainty regarding the application of ex-live data to the clinical situation do not allow to draw definitive conclusions on the regular use of ibuprofen; clinically relevant effects are unlikely due to the occasional use of ibuprofen (see paragraph 5.1). • Other NSAIDs included selective cycloxygenase-2 inhibitors: avoid the contemporary use of two or more analgesic, antipyretic, non-steroidal anti-inflammatory drugs: increased risk of side effects (see paragraph 4.4). Ibuprofen should be used with caution in association with: • corticosteroids: increased risk of gastrointestinal ulceration or hemorrhage (see paragraph 4.4); • chinolonic antibiotics: data from animal studies indicate that NSAIDs can increase the risk of convulsions associated with chinolonic antibiotics. Patients taking NSAIDs and Chinoloni may have an increased risk of developing seizures; • anticoagulants, such as warfarin: NSAIDs can increase the effects of anticoagulants (see paragraph 4.4); • Serotonin reuptake selective anti-aggregating agents and inhibitors (SSRIs): increased risk of gastrointestinal hemorrhages (see paragraph 4.4); • phenytoin: Concurrent use of Nurofen Febbre and Pain with phenytoin can increase the serum levels of these medicines. The correct use of drugs (administrated for a maximum period of 3 days) does not normally require control of the serum levels of phenytoin. • antidiabetics: an increase in the hypoglycemic effect of sulfaniluree is possible. In the case of simultaneous treatment, it is recommended to monitor blood glucose levels. • antivirals, such as ritonavir: possible increase in the concentration of NSAIDs; • cyclosporin: increased risk of nephrotoxicity;• mifepristone: NSAIDs should not be administered in 8-12 days following mifepristone intake because they can reduce its effectiveness; • cytotoxic, such as methorate: reduction of excretion ( increased risk of toxicity); • lithium: reduction of excretion (increased risk of toxicity); • tacrolimus: increased risk of nephrotoxicity; • Uricosuric, as probenecid and finpirazone: slow the excretion of NSAIDs (increasing plasma concentrations); • metotrexate: potential increase in plasma concentration of metotrexate; • zidovudine: increased risk of blood toxicity when NSAIDs are used in association with zidovudine. There are demonstrations of increased risk of hemartrosis and hematomas in HIV hemophilics (+) if treated simultaneously with zidovudine and ibuprofen; • antihypertensives (ACE inhibitors and antagonists of angiotensin II) and diuretics: 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 inhibitor ACE or an angiotensin II antagonist and agents inhibiting the cyclo-oxidase system can lead to further deterioration of kidney function, which includes a possible acute kidney failure, generally reversible. These interactions must be considered in patients taking Nurofen Fever and Pain 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 and periodically. • potassium saving diuretics: Concurrent administration of Nurofen Fever and Pain and potassium-saving diuretics can lead to hyperpotassiemia • CYP2C9 inhibitors: Concurrent administration of ibuprofen and CYP2C9 inhibitors can increase exposure to ibuprofen (substrate of CYP2C9). In a study with voriconazole and fluconazole (CYP2C9) inhibitors, an increased exposure to S(+)-ibuprofen from approximately 80% to 100% was demonstrated. You should consider reducing the dose of ibuprofen when administering strong CYP2C9 inhibitors simultaneously, especially when high doses of ibuprofen are administered with voriconazole or fluconazole. • cardiac glycosides (Digoxin): NSAIDs can worsen heart failure, reduce VGF (glomerular filtration speed) and increase plasma levels of glycosides.

Effects

The list of the following side effects includes all those that were recognized during treatment with ibuprofen for short periods of treatment and for daily doses up to a maximum of 1200 mg. In case of therapies for chronic or prolonged high dose pathologies, other side effects may occur. Adverse reactions associated with the administration of ibuprofen are listed to follow according to the classification for systems and organs and according to the frequency. The frequencies are defined as: Very common (≥1/10); Common (≥1/100,

Description of some adverse reactions ¹ Hematopoiesis disorders including anemia, aplastic anemia, hemolytic anemia (positiveness to the Coombs test), leucopenia, neutropenia, thrombocytopenia (with or without purple), heosinophilia, pancytopenia and agranulocytosis. The first symptoms may be: fever, throat, superficial ulcers of the mouth, flu-like symptoms, marked fatigue, hepistaxes and hemorrhage. In these cases, the patient should immediately stop the medicine, avoid any automedication medication containing analgesics or antipyretics and consult the doctor. Rarely congestive heart failure in patients with compromised heart functions. 2 Reactions of hypersensitivity: these reactions include a) non-specific allergic reactions and anaphylaxis, fever, bruises, b) reactivity of the respiratory tract that includes asthma, aggravated asthma, bronchospasm (see paragraph 4.3 and 4.4) or Stevensomnatus or c) several skin diseases that include various skin rashes (also of maculoedema without papular), itching, or hibernaryocyte. 3 Decrease of appetite: in general it quickly resolves to suspend treatment (see paragraph 4.4). ⁴ The pathogenic mechanism of aseptic meningitis induced by drugs is not completely known. However, the data available on aseptic meningitis related to the administration of NSAIDs induce to think of an immune reaction (due to a temporal relationship with the intake of the drug and the disappearance of symptoms after the suspension of treatment). Note, individual cases of symptoms of aseptic meningitis (such as torquel, numb neck, headache, nausea, vomiting, fever and disorientation) were observed during treatment with ibuprofen in patients with autoimmune diseases (such as systemic erythromatic lupus, mixed connective disease).⁵ Heart failure and edema: Clinical studies and epidemiological data suggest that the use of ibuprofen, especially at high doses (2400 mg/die) and for long-term treatments, may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see paragraph 4.4). Congestive heart failure in patients with impaired heart functions. ⁶ The most commonly observed adverse events are gastrointestinal. Gastric disorders can be reduced by taking the medicine on a full stomach. ⁷ Peptic ulcers, perforation or gastrointestinal hemorrhage, melena and hematogenesis may occur at times fatal. ⁸ Exacerbation of Crohn's colitis and disease (see paragraph 4.4). ⁹ Acute renal insufficiency especially in case of long-lasting therapies, associated with increased uretha levels in serum and edema. Papillary necrosis may occur. 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: https://www.aifa.gov.it/content/segnalazioni-reazioniavverse.

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. The half-life of the drug in case of overdose is 1.5-3 hours. Synonyms Most patients who accidentally ingest clinically relevant amounts of ibuprofen will 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, tinnitus, 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. In cases of severe poisoning, it is possible that metabolic acidosis occurs and an extension of the protrombine time (INR), probably caused by interference with the action of the factors of the coagulation present in the circle. An exacerbation of the symptoms of the disease can occur in asthmatic subjects. Treatment There is no specific antidote for overdosing ibuprofen. In case of overdose, a symptomatic and support treatment is indicated and must include the maintenance of airway pervity and the monitoring of heart function and vital signs until the patient's stabilization. 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, the administration of activated carbon must be taken into account. Alternatively, in the adult, within an hour of the ingestion of a potentially dangerous overdose for life must be taken into account the gastric lavender. 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 diazepam or lorazepam intravenously. If ibuprofen has already been absorbed, alkaline substances must be administered to promote excretion in the urine of acid ibuprofen. Administer bronchodilators in case of asthma. 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. The following considerations must also be taken into account in such circumstances.

Pregnancy

During the first and second quarter of pregnancy, the administration of ibuprofen should be avoided. Ibuprofen is contraindicated during the third trimester of 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 an inhibitor of prostaglandin synthesis 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 the 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.

Food

There are limited data that demonstrates that ibuprofen can go into low concentrations in breast milk and is unlikely to have side effects for infants.

Fertility

There is evidence that medicines that inhibit cycloxygenase/prostaglandine synthesis can cause a female fertility impairment due to ovulation. This effect is reversible after termination of treatment.

Source: Farmadati