Fluifort fever and child pain 100 mg/5ml - strawberry flavored oral suspension - 150 ml

Product Description

Symptomatic treatment of fever and mild to moderate pain.

Therapeutic indications

Symptomatic treatment of fever and mild to moderate pain.

Composition

Each ml of oral suspension contains:

Active ingredient: ibuprofen 20 mg.
Excipients: maltitol syrup 753.30 mg. For the full list of excipients, see section 6.1.
Excipients: Fluifort Fever and Pain Children 100mg/5ml sugar-free strawberry-flavored oral suspension Citric acid monohydrate, sodium citrate, acesulfame potassium, xanthan gum, sodium benzoate, strawberry flavoring, maltitol syrup, glycerin, purified water

Contraindications/Undesirable effects

• Hypersensitivity to ibuprofen or to any of the excipients. • Children under 3 months of age or weighing less than 5.6 kg. • Hypersensitivity to acetylsalicylic acid or other analgesics, antipyretics, nonsteroidal anti-inflammatory drugs (NSAIDs), particularly when hypersensitivity is associated with nasal polyps and asthma. • Active peptic ulcer. • Severe renal or hepatic insufficiency. • Severe heart failure. • History of gastrointestinal bleeding or perforation related to previous active treatments or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). • Concomitant use of NSAIDs, including specific COX-2 inhibitors. • Pregnancy and breastfeeding (see section 4.6).

Dosage

The daily dose is structured according to the weight and age of the patient. Undesirable effects can be minimised by using the lowest effective dose for the shortest duration of treatment necessary to control symptoms (see section 4.4). In children aged between 3 and 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 be done using the measuring syringe provided with the product. The graduated scale on the body of the syringe clearly shows the markings for the different dosages; in particular, the 2.5 ml mark corresponding to 50 mg of ibuprofen and the 5 ml mark corresponding to 100 mg of ibuprofen. The daily dose of 20-30 mg/kg of body weight, divided 3 times a day at intervals of 6-8 hours, can be administered according to the following schedule.

In case of post-vaccination fever, refer to the dosage indicated above, administering a single dose 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 decrease. Infants aged ≥ 3 to ≤ 5 months weighing more than 5 kg: In infants aged 3 to 5 months, a doctor should be consulted if symptoms persist for more than 24 hours or if symptoms worsen. Infants and children (aged ≥ 6 months to < 12 years): If use of the medicine is necessary for more than 3 days in infants and children aged over 6 months, or if symptoms worsen, a doctor should be consulted. Instructions for using the dosing syringe: 1 - Unscrew the cap by pushing it downwards and turning it to the left. 2 - Insert the tip of the syringe fully into the hole in the undercap. 3 - Shake well. 4 - Turn the bottle upside down, then, holding the syringe firmly, gently pull the plunger downwards, allowing the suspension to flow into the syringe up to the mark corresponding to the desired dose. 5 - Return the bottle to an upright position and remove the syringe by gently twisting it. 6 - Insert the tip of the syringe into the child's mouth and apply gentle pressure to the plunger to release the suspension. After use, screw the cap back on the bottle and rinse the syringe with warm water. Leave it to dry, keeping it out of the reach and sight of children.

Storage

No special requirements.

Warnings

Consult your doctor after three days of treatment without noticeable results. Side effects can be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see the sections below 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, and nonsteroidal anti-inflammatory drugs can cause potentially serious hypersensitivity reactions (anaphylactoid reactions), even in subjects not previously exposed to this type of drug. The risk of hypersensitivity reactions after taking ibuprofen is greater in subjects who have shown such reactions after using other analgesics, antipyretics, and nonsteroidal anti-inflammatory drugs and in subjects with bronchial hyperreactivity (asthma), nasal polyps, or previous episodes of angioedema (see sections 4.2 and 4.8). Gastrointestinal bleeding, ulceration, and perforation: Gastrointestinal bleeding, ulceration, and 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. Elderly: Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal (see section 4.2). The risk of gastrointestinal bleeding, ulceration, or perforation is higher with increasing NSAID doses, especially in the elderly and in patients with a history of ulcers, particularly if complicated with haemorrhage or perforation (see section 4.3). These patients should start treatment on 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 when elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal bleeding), particularly in the initial stages of treatment. Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors, or antiplatelet agents such as aspirin (see section 4.5). If gastrointestinal bleeding or ulceration occurs in patients receiving FLUIFORT 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). Patients appear to be at higher risk early in the course of therapy: the onset of the reaction occurs in most cases within the first month of treatment. FLUIFORT FEVER AND PAIN should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Caution is required before initiating 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 treatment. Clinical studies and epidemiological data suggest that the use of ibuprofen, particularly 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). Overall, 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 be treated with ibuprofen only after careful consideration. Similar considerations should be made before initiating 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 analgesics, antipyretics, or nonsteroidal anti-inflammatory drugs requires particular caution: • in case of asthma: possible bronchoconstriction; • in the presence of coagulation defects: reduced coagulability; • in the presence of renal or cardiac disease or hypertension: possible critical reduction in renal function (especially in patients with impaired renal or hepatic function, heart failure, or on diuretic therapy), nephrotoxicity, or fluid retention; • in the presence of liver disease: possible hepatotoxicity. • rehydrate the subject before the start and during treatment in case of dehydration (for example due to fever, vomiting or diarrhoea); The following precautions are important during prolonged treatments: • monitor 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 occur (blurred or reduced vision, scotomas, alteration of colour perception): discontinue treatment and consult an ophthalmologist; • if signs or symptoms of meningitis occur: evaluate the rare possibility that it is due to the use of ibuprofen (aseptic meningitis; more frequent in subjects suffering from systemic lupus erythematosus or other collagen diseases). Since FLUIFORT FEVER AND PAIN contains maltitol, patients with rare hereditary problems of fructose intolerance should not take this medicine. FLUIFORT FEVER AND PAIN is sugar-free and is therefore indicated for patients who need to monitor their sugar and calorie intake. Each 2.5 ml dose of suspension contains 4.51 mg (0.20 mmol) of sodium; this should be taken into consideration if a low-sodium diet is recommended. In dehydrated children and adolescents there is a risk of alteration of renal function.

Interactions

The following interactions are common to ibuprofen, acetylsalicylic acid and other analgesics, antipyretics, non-steroidal anti-inflammatory drugs (NSAIDs): • avoid the simultaneous use of two or more analgesics, antipyretics, non-steroidal anti-inflammatory drugs: increased risk of adverse effects • corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see section 4.4) • antibacterials: possible increased risk of convulsions induced by quinolones • anticoagulants: NSAIDs may increase the effects of anticoagulants, such as warfarin (see section 4.4) • antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4) • antidiabetics: possible increased risk of gastrointestinal bleeding (see section 4.4) of the effect of sulfonylureas • antivirals: ritonavir, possible increase in the concentration of NSAIDs • ciclosporin: increased risk of nephrotoxicity • cytotoxics: methotrexate, reduced excretion (increased risk of toxicity) • lithium: reduced excretion (increased risk of toxicity) • tacrolimus: increased risk of nephrotoxicity • uricosurics: probenecid, slows the excretion of NSAIDs (increase in plasma concentrations) • methotrexate: potential increase in the plasma concentration of methotrexate. • Zidovudine: increased risk of haemarthrosis and haematomas in HIV (+) haemophiliacs if treated simultaneously 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 compromised renal function (e.g., dehydrated patients or elderly patients with compromised renal function), the coadministration of an ACE inhibitor or angiotensin II antagonist and agents that inhibit the cyclooxygenase system may lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible. These interactions should be considered in patients taking FLUIFORT 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 initiating concomitant therapy. Experimental data indicate that ibuprofen may inhibit the effects of low-dose aspirin on platelet aggregation when the drugs are administered concomitantly. However, the limited data and the uncertainties regarding their application to the clinical situation do not allow definitive conclusions to be drawn for the continuous use of ibuprofen; there appears to be no clinically relevant effect from occasional use of ibuprofen (see section 5.1).

Undesirable effects

The undesirable effects observed with ibuprofen are common to other analgesics, antipyretics, and non-steroidal anti-inflammatory drugs. Hypersensitivity reactions Rarely: anaphylactoid reactions (urticaria with or without angioedema), dyspnoea (due to laryngeal obstruction or bronchospasm), shock, syndrome characterized by abdominal pain, fever, chills, nausea and vomiting; bronchospasm (see sections 4.3 and 4.4). Gastrointestinal disorders The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation, or gastrointestinal bleeding, sometimes fatal, particularly in the elderly, may occur (see section 4.4). Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported after administration of FLUIFORT FEVER AND PAIN (see section 4.4). Less frequently, gastritis has been observed. Epigastric pain, heartburn. Gastric disturbances may be reduced by taking the drug with food. Rarely: hepatitis, jaundice, abnormal liver function tests, pancreatitis, duodenitis, esophagitis, hepatorenal syndrome, hepatic necrosis, hepatic failure. Nervous system and sensory organ disorders: Vertigo, headache, irritability, tinnitus. Rarely: Depression, insomnia, difficulty concentrating, emotional lability, somnolence, aseptic meningitis, convulsions, hearing and vision disturbances. Respiratory, thoracic and mediastinal disorders: Rarely: Bronchospasm, dyspnoea, apnoea. Skin and subcutaneous tissue disorders: Bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (very rare). Rash (including maculopapular), pruritus. Rarely: Vesiculobullous eruptions, urticaria, erythema multiforme, alopecia, exfoliative dermatitis, photosensitivity dermatitis. Frequency not known: Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). Blood and lymphatic system disorders: Very rare: Neutropenia, agranulocytosis, aplastic anemia, haemolytic anemia (possibly positive Coombs test), thrombocytopenia (with or without purpura), eosinophilia, decreased haemoglobin and haematocrit, pancytopenia. Metabolism and nutrition disorders: Decreased appetite. Cardiac and vascular disorders: Edema, hypertension, and cardiac failure have been reported in association with NSAID treatment. Fluid retention (usually responds promptly to discontinuation of treatment). Very rare: Cerebrovascular accident, hypotension, congestive heart failure in patients with compromised cardiac function, palpitations. Clinical trial and epidemiological data suggest that use of ibuprofen, particularly at high doses (2400 mg/day) and in long-term treatment, may be associated with a modest increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see section 4.4). Renal and urinary disorders Very rarely: acute renal failure in patients with pre-existing significantly impaired renal function, papillary necrosis, tubular necrosis, glomerulonephritis, abnormal renal function tests, polyuria, cystitis, haematuria. Immune system disorders Single cases of symptoms of aseptic meningitis such as neck tension, headache, nausea, vomiting, fever, disorientation have been reported in patients with pre-existing autoimmune diseases (e.g. systemic lupus erythematosus, connective tissue diseases) (see section 4.4). Various Rarely: dry eyes and mouth, gum ulcers, rhinitis. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important, as it allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-unasospetta-reazione-avversa.

Overdose

Toxicity Signs and symptoms of toxicity have generally not been observed at doses less than 100 mg/kg in children or adults. However, supportive treatment may be necessary in some cases. Children have been observed to show 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. Symptoms: Most patients who have ingested significant amounts of ibuprofen will experience symptoms within 4–6 hours. The most commonly reported symptoms of overdose include nausea, vomiting, abdominal pain, lethargy, and drowsiness. Central nervous system (CNS) effects include headache, tinnitus, dizziness, convulsions, 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, excitation, fainting, and cardiovascular toxicity including hypotension, bradycardia, and tachycardia have been reported. Renal failure and liver damage are possible in cases of significant overdose. In cases of severe poisoning, metabolic acidosis may occur. Treatment: There is no specific antidote for ibuprofen overdose. Therefore, symptomatic and supportive treatment is indicated in the event of an overdose. Maintain a clear airway and monitor cardiac function and vital signs. 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 must be ensured, and renal and hepatic function must be closely monitored. The patient should remain under observation for at least four hours following ingestion of a potentially toxic amount. Frequent or prolonged seizures should be treated with intravenous diazepam. Other supportive measures may be necessary depending on the patient's clinical condition. For further information, contact your local poison control center.

Pregnancy and breastfeeding

Persons under 12 years of age are unlikely to become pregnant or breastfeed. However, in such circumstances, the following considerations should be taken into account. Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/fetal development. Results of epidemiological studies suggest an increased risk of miscarriage, cardiac malformation, and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk is believed to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors 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, has been reported in animals administered prostaglandin synthesis inhibitors during the organogenetic period. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the fetus to: • cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); • renal dysfunction that may progress to renal failure with oligo-hydroamniosis; • the mother and the newborn, at the end of pregnancy, to: • possible prolongation of bleeding time, an antiplatelet effect that may occur even at very low doses; • inhibition of uterine contractions resulting in delayed or prolonged labor.

Format

Oral suspension 150 ml