FLUIFORT FEBBRE DOL BB150ML FRENCH

FLUIFORT 100 MG/5 ML ORAL SUSPENSION WITHOUT SUGAR

active ingredients

Each ml of oral suspension contains: Active ingredient: ibuprofene 20 mg. Excipients with known effect: 1 ml contains malt syrup 753,30 mg, benzoate sodium 1 mg, citrate sodium 7 mg, glucose (contained in orange aroma) 2,535 mg. For the full list of excipients, see paragraph 6.1.

Excellent

FLUIFORT FEVER AND PAIN Children 100mg/5ml oral suspension strawberry taste without sugar Monohydrate citric acid, citrate sodium, potassium acesulphame, xantana gum, benzoate sodium, strawberry aroma, maltitol syrup, glycerin, purified water FLUIFORT FEVER AND PAIN Children 100mg/5ml oral suspension orange taste without sugar Monohydrate citric acid, citrate sodium, potassium acesulphame, xantana gum, benzoate sodium, orange aroma, maltitol syrup, glycerin, 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. • Hypersensitivity to acetylsalicylic acid or other analgesic, antipyretic, non-steroidal anti-inflammatory (NSAID), especially when hypersensitivity is associated with nasal and asthma polypoxes. • Active peptic ulcer. • Severe kidney or liver failure. • Severe heart failure. • History of gastrointestinal hemorrhage or perforation related to previous active treatments or history of hemorrhage/recurring peptic ulcer (two or more separate episodes of proven ulceration or bleeding). • Concurrent use of NSAIDs, including specific COX-2 inhibitors. • During the last quarter of pregnancy (see paragraph 4.6).

Population

The daily dose is structured according to the weight and age of the patient. The lowest effective dose should be used for the shortest period necessary to relieve symptoms (see paragraph 4.4). Undesirable effects can be minimized with the use of the effective minimum dose for the shortest possible duration of treatment needed to control symptoms (see paragraph 4.4). In children aged 3 to 6 months limit administration to those weighing more than 5.6 kg. Oral administration to infants and children aged between 3 months and 12 years should take place by means of a dose syringe provided with the product. 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 daily dose of 20-30 mg/kg body weight, divided 3 times daily at intervals of 6-8 hours, can be administered on the basis of the following diagram.

PEOPLE	Age	Single dose in ml	no maximum of SOMMINISTRATIONS/day
5,6 -7 Kg	3 - 6 months	2.5 ml	3 in 24 hours
7 -10 Kg	6 - 12 months	2.5 ml
10 - 15 Kg	1 - 3 years	5 ml
15 - 20 Kg	4 - 6 years	7.5 ml (5 ml + 2.5 ml)
20 - 28 Kg	7 - 9 years	10 ml
28 - 43 Kg	10 - 12 years	15 ml

In the case of post-vaccination fever refer to the above dosage, giving a single dose 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. Infants between 3 and 5 months weighing more than 5.6 kg: 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. Infants and children (aged between 6 months and 12 years): In case the use of the medicinal product is necessary for more than 3 days in infants and children older than 6 months, or in case of worsening of symptomatology, the 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 hole of the subfolder. 3 - Act well. 4 - Turn the bottle over, then, holding the syringe firmly, gently pull the plunger downwards, causing the suspension to flow into the syringe until the cup corresponding to the desired dose. 5 - Reject 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 details.

Warnings

After three days of treatment without appreciable results consult your doctor. Undesirable effects can be minimized with the use of the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see below paragraphs on gastrointestinal and cardiovascular risks). The use of FLUIFORT 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), nasal polyposi or previous angioedema episodes (see paragraph 4.2 and paragraph 4.8). Gastrointestinal hemorrhage, ulceration and drilling: during treatment with all NSAIDs, at any time, with or without warning symptoms or previous history of serious gastrointestinal events, gastrointestinal hemorrhage, ulceration and perforation, which may be fatal. In dehydrated children and adolescents there is a risk of alteration of kidney function. 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 acetylsalicylic acid (see paragraph 4.5). When bleeding or gastrointestinal ulcer occurs in patients taking FLUIFORT FEBRUARY AND ONLY, the treatment must be suspended. NSAIDs should be given with caution to patients with a history of gastrointestinal disease ( ulcerative colitis, Crohn's disease) since such conditions can be exacerbated (see paragraph 4.8). Strict skin reactions: Severely serious skin reactions have been reported, some of which fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis in association with the use of NSAIDs (see paragraph 4.8). Patients seem to be at higher risk in the early stages of therapy: the onset of the reaction occurs in most cases within the first month of treatment. 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. FLUIFORT FEVER AND PAIN must be stopped at the first appearance of skin rash, mucosa lesions or any other sign of hypersensitivity. 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 FLUIFORT FEBRUARY AND ONLY in case of chickenpox. Masking the symptoms of underlying infections: FLUIFORT FEBRU AND DOLORE can mask the symptoms of infection, which may delay the start of an adequate treatment and therefore worsen the outcome of the infection. This was observed in bacterial pneumonia acquired in communities and bacterial complications of chickenpox. When FLUIFORT FEBRU AND DOLORE is administered for relief from fever or pain related to infection, it is recommended to monitor the infection. In non-hospital contexts, the patient should contact the doctor if symptoms persist or worsen. Caution is required before starting treatment in patients with positive anamnesiums for hypertension and/or heart failure since retention of fluids, hypertension and edema were found in association with NSAIDs. Clinical studies 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). 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: reduction of coagulation; • in the presence of kidney, heart or hypertension diseases: possible critical reduction of kidney function (especially in subjects with impaired kidney or liver function, heart failure or in treatment with diuretics), nephrotoxicity or fluid retention; • in the presence of liver diseases: possible hepatotoxicity. • rehydrate the subject before the start and during the treatment in case of dehydration (e.g. for fever, vomiting or diarrhea); The following precautions are relevant during prolonged treatment: • monitor the signs or symptoms of gastrointestinal ulceration or bleeding; • monitor signs or symptoms of hepatotoxicity; • monitor signs or symptoms of nephrotoxicity; • if visual disturbances arise (unused or reduced view, rhytoms, alteration of color perception): stop treatment and consult the ophthalmologist; • if signs or symptoms of meningitis arise: assess the rare possibility that it is due to the use of ibuprofene (aseptic mingitis; most frequent in subjects with systemic lupus erythematosus and mixed disease of connective tissue or other collagenopathies). FLUIFORT FEVER AND PAIN contains maltitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine. From the 5 ml dose, taken three times a day, may have a slight laxative effect. The caloric value of maltitol is 2.3 kcal/g. FLUIFORT FEVER AND PAIN contains benzoate sodium. This medicine contains 1 mg of benzoate sodium in each ml of suspension. FLUIFORT FEVER AND PAIN contains sodium. This medicine contains less than 1 mmol (23 mg) of sodium in doses of 2.5 ml, 5 ml, 7.5 ml and 10 ml, i.e. essentially ‘without sodium’. This medicine contains 30.45 mg of sodium in the 15 ml dose equivalent to 1,52% of the maximum daily intake recommended by the WHO which corresponds to 2 g sodium for an adult. FLUIFORT FEVER AND PAIN contains glucose (in orange aroma present in FLUIFORT FEBRUARY AND DOLORE Children 100mg/5ml oral suspension taste orange without sugar). Patients suffering from rare problems of glucose-galactose mal absorption should not take this medicine.

Interactions

Ibuprofen should be avoided in association with: • Acetylsalicylic acid (aspirin): unless acetylsalicylic acid at low dose (no more than 75 mg per day), as for common clinical practice, has not been recommended by the doctor, since it can increase the risk of adverse reactions (see paragraph 4.4). 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 including selective cycloxygenase-2 inhibitors: avoid the contemporary use of two or more analgesic, antipyretic, nonsteroidal anti-inflammatory: 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); • antibacterial: possible increase in the risk of convulsions induced by kinolonics; • anticoagulants: NSAIDs can increase the effects of anticoagulants, such as warfarin and ticlopidine (see paragraph 4.4); • anti-aggregating agents, such as acetylsalicylic acid: increased risk of gastrointestinal hemorrhage (see paragraph 4.4); • Selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see paragraph 4.4); • anti-diabetics: possible increase in sulfaniluree effect; • antivirals: 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 their effectiveness; • cytotoxic: metotressate, reduction of excretion ( increased risk of toxicity) and potential increase in plasma concentration of metotrexate; • lithium: reduction of excretion (increased risk of toxicity); • tacrolimus: increased risk of nephrotoxicity; • uricosurics: probenecid, slows down the excretion of NSAIDs (increasing plasma concentrations); • zidovudine: increased risk of hemartrosis and hematomas in HIV hemophilics (+) if treated simultaneously with zidovudine and ibuprofen; • diuretics, inhibitors and angiotensin II antagonists: NSAIDs can reduce the effect of diuretics and other antihypertensive drugs. In some patients with impaired kidney function (e.g. dehydrated patients or elderly patients with impaired kidney function) the co-administration of an inhibitor ACE or an angiotensin II antagonist and agents that inhibit 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 FLUIFORT FEBRU AND DOLORE 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; • cardiac glycosides: NSAIDs can worsen heart failure, reduce VGF (glomerular filtration speed) and increase plasma levels of glycosides. Experimental data suggests that ibuprofen can inhibit the effects of acetylylethyllic acid at low doses on platelet aggregation when drugs are administered in conjunction. However, the exigity of data and uncertainty regarding their application to the clinical situation does not allow to draw definitive conclusions for the continued use of ibuprofen; it seems that there are no clinically relevant effects from the occasional use of ibuprofen (see paragraph 5.1).

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. The side effects observed with ibuprofen are common to other analgesic, antipyretic, non-steroidal anti-inflammatory drugs. 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, Classification for systems and organs according to MedDRA) Not common Rare Very rare Notable Infections and infestations   Cystitis, rhinitis Increased inflammations related to infections (eg development of necrotizing bundles), in exceptional cases severe skin infections and complications to soft tissues were found during a chickenpox infection.   System pathologies emolinfopoietico     Haematopoiesis disorders including anaemia, aplastic anaemia, haemolytic anaemia (positive Coombs test), leucopenia, neutropenia, thrombocytopenia (with or without purpura), eosinophilia, pancytopenia and agranulocytosis¹   Immune system disorders Reactions of hypersensitivity2   Anaphylaxis, angioedema or severe shock (gravi reactions of hypersensitivity that include swelling of the face, tongue and larynx, dispnea, tachycardia, hypotension).   Disorders of metabolism and of nutrition       Reduced appetite, fluid retention. 3 Psychiatric disorders   Depression, insomnia, difficulty of concentration, emotional lability, disorder of vision and hearing   Reliability Diseases of the nervous system Vertigo, headache, drowsiness, convulsion Exciting cerebrovascular, cerebrovascular hemorrhage Synthetic Meningitis⁴   Pathologies of the eye   Dry eye     Ear and labyrinth pathologies       Tinnitus Heart disease   Palpitation congestive heart failure in subjects with compromised heart function Edema and heart failure ⁵ Vascular diseases     Hypotension Hypertension⁵, shock Respiratory diseases, , chests and medianistic       Reactivity of the respiratory tract that includes asthma, obstruction of the larynx, bronchospasm, dispnea, apnea. Gastrointestinal diseases Nausea, dyspepsia, abdominal pain. ⁶ Vomito, flatulence, constipation, diarrhea, dry mouth, gum ulceration Peptic ulcer, perforation or gastrointestinal bleeding, gastrointestinal hemorrhage, melena, ematemesis.⁷. Mouth burn, gastritis Exacerbation of colitis and Crohn's disease ⁸ pancreatitis, duodenitis, esophagitis Hepatobiliary diseases     Abnormal liver function, hepatitis, jaundice, hepatorenal syndrome, hepatic necrosis, liver failure, evidence of abnormal liver function.   Skin and tissue disorders subcutaneous Various skin rashes2 Exfoliatory dermatitis, alopecia, photosensitivity dermatitis Bollous dermatitis including Stevens-Johnson syndrome, multiform erythema and epidermal toxic necrolysis2. Reaction from drug with heosinophilia and systemic symptoms ( DRESS syndrome), generalized acute exantematic pustolosis (PEAG), photosensitivity reactions Kidney and urinary pathologies   Tubular necrosis, glomerulonefrite, polyuria, hematuria, abnormal kidney function test Acute kidney failure⁹   Diagnostic examinations   Ematocritus decreased Reduced hemoglobin   ¹ The first symptoms may be: fever, throat, superficial ulcers of the mouth, flu-like symptoms, marked fatigue, hepistaxes and hemorrhage. 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. Epigastric pain and gastric pyrosis have also occurred. Gastric disobetics 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 the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Toxicity Signs and symptoms of toxicity have not generally been observed at doses below 100 mg/kg in children or adults.However, supportive treatment may be necessary 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 overdose is 1.5-3 hours. Synonyms Most patients who have ingested significant quantities 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 ibuprofen overdose.Therefore, symptomatic and supportive treatment is indicated in the event of an overdose.Maintain airway patency and monitor cardiac function and vital signs until the patient is stabilized.Particular attention should be paid to monitoring blood pressure, acid-base balance and any gastrointestinal bleeding.Administration of activated charcoal should be considered within one hour of ingestion of a potentially toxic amount.Alternatively, gastric lavage should be considered in adults within one hour of ingestion of a potentially life-threatening overdose.Adequate diuresis should be ensured and renal and hepatic function should be closely monitored.The patient should remain under observation for at least four hours following ingestion of a potentially toxic amount of the drug.Any occurrence of frequent or prolonged convulsions should be treated with intravenous diazepam or lorazepam.If ibuprofen has already been absorbed, alkaline agents should be administered to promote excretion of acidic ibuprofen in the urine.Bronchodilators should be administered in cases of asthma.Other supportive measures may be necessary depending on the patient's clinical condition.For more information, contact your local poison control center.

It is unlikely that subjects under the age of 12 will become pregnant or breastfeed.However, in such circumstances the following considerations should be taken into account.

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 a prostaglandin synthesis inhibitor in the early stages of pregnancy. The absolute risk of heart failure increased from less than 1% to about 1.5%. It has been considered that the risk increases with dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors showed an increase in the loss of pre- and post-plant and embryo-fetal mortality. In addition, an increase in the incidence of various malformations, including cardiovascular disorders, was reported in animals that had been given prostaglandin synthesis inhibitors during the organogenetic period. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to: • cardiopulmonary toxicity (with premature closure of arterial duct and pulmonary hypertension); • kidney dysfunction that can progress to kidney failure with oligo-idroamnios; the mother and the newborn, at the end of pregnancy, to: • possible prolongation of bleeding time, an anti-aggregating effect that can also be necessary at very low doses; • inhibition of uterine contractions resulting in delay or extension of labor.

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

: Not relevant.

Source: Farmadati