Active ingredients: Ibuprofen
FLUIBRON FEVER AND PAIN Children 100mg / 5ml oral suspension strawberry flavor without sugar
FLUIBRON FEVER AND PAIN Children 100mg / 5ml oral suspension orange flavor without sugar Ibuprofen.
Indications Why is Fluibron used in fever and pain? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
FLUIBRON FEVER AND PAIN contains Ibuprofen, a non-steroidal anti-inflammatory drug (NSAID) with analgesic, antipyretic and anti-inflammatory activity
THERAPEUTIC INDICATIONS
FLUIBRON FEVER AND PAIN is indicated for the symptomatic treatment of fever and mild or moderate pain.
Contraindications When Fluibron should not be used fever and pain
- Hypersensitivity to the active substance or to any of the excipients;
- Hypersensitivity to acetylsalicylic acid or to other analgesics, antipyretics, non-steroidal anti-inflammatory drugs (NSAIDs), particularly when hypersensitivity is associated with nasal polyposis and asthma;
- Active peptic ulcer;
- Children under 3 months of age or weighing less than 5.6 kg;
- Severe renal or hepatic insufficiency;
- Severe heart failure;
- Pregnancy or breastfeeding;
- 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 intake of other NSAIDs, including selective COX-2 inhibitors.
Precautions for use What you need to know before taking Fluibron fever and pain
Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms.
The use of FLUIBRON FEVER AND PAIN should be avoided in conjunction with NSAIDs, including selective COX-2 inhibitors.
The use of FLUIBRON FEVER AND PAIN, acetylsalicylic acid or other analgesics, antipyretics, non-steroidal anti-inflammatory drugs, requires particular caution:
- in case of previous gastrointestinal ulceration, perforation or bleeding: risk of relapse;
- in case of asthma: possible 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 the elderly or 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;
- in case of dehydration (for example due to fever, vomiting or diarrhea) rehydrate the subject before the start and during the course of treatment;
The following precautions are of relevance in the case of 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 you have visual disturbances (blurred or reduced vision, scotomas, changes in color perception) stop treatment and consult your doctor;
- if signs or symptoms of meningitis develop: there is a rare possibility that it is due to the use of ibuprofen (aseptic meningitis more frequent in subjects with systemic lupus erythematosus or other collagenopathies).
Interactions What medications or foods can change the effect of Fluibron on fever and pain
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even those without a prescription.
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 unwanted effects;
- corticosteroids: increased risk of gastrointestinal ulceration or bleeding;
- antibacterials: possible increased risk of quinolone-induced seizures;
- anticoagulants: NSAIDs can increase the effects of anticoagulants, such as warfarin;
- antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding;
- antidiabetics: possible increase in the effect of sulfonylureas;
- antivirals: ritonavir: possible increase in the concentration of NSAIDs;
- cyclosporine: increased risk of nephrotoxicity;
- cytotoxic: methotrexate: reduced excretion (increased risk of toxicity);
- lithium: reduced excretion (increased risk of toxicity);
- tacrolimus - increased risk of nephrotoxicity;
- uricosurics: probenecid: slows down the excretion of NSAIDs (increase in plasma concentrations);
- methotrexate: potential increase in the plasma concentration of methotrexate;
- zidovudine: 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 FLUIBRON 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. Experimental data indicate that ibuprofen may inhibit the effects of low-dose acetylsalicylic acid on platelet aggregation when drugs they are administered concurrently.
However, the limited data and the uncertainties relating to their application to the clinical situation do not allow definitive conclusions to be drawn for the continued use of ibuprofen; there appears to be no clinically relevant effect from the occasional use of ibuprofen.
Warnings It is important to know that:
Analgesics, antipyretics, non-steroidal anti-inflammatory drugs can cause hypersensitivity reactions, potentially serious (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 experienced such reactions after the use of other analgesics, antipyretics, non-steroidal anti-inflammatory drugs and in subjects with bronchial hyperactivity (asthma), nasal polyposis or previous episodes of angioedema (see "Contraindications" and "Undesirable Effects").
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.
Elderly: Elderly patients have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which can be fatal.
In the elderly and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation, the risk of gastrointestinal bleeding, ulceration or perforation is higher with increased doses of NSAIDs. These patients should start treatment with the lowest available dose.
Concomitant use of protective agents (misoprostol or proton pump inhibitors) should 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.
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 aspirin.
When gastrointestinal bleeding or ulceration occurs in patients taking FLUIBRON 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 "Undesirable effects").
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 "Undesirable effects").
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. FLUIBRON FEVER AND PAIN should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity.
Caution should be exercised in patients with a history of hypertension and / or heart failure as fluid retention and edema have been reported in association with NSAID therapy.
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 (eg 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). There is a risk of impaired renal function in dehydrated children and adolescents.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
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. 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 from less than 1% to approximately 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. In addition, an increased incidence of various malformations, including cardiovascular malformations, has been reported in animals given prostaglandin synthesis inhibitors during the organ genetic 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 oligohydroamnios;
the mother and the newborn, at the end of pregnancy, to:
- possible prolongation of bleeding time, an antiplatelet effect which can occur even at very low doses;
- inhibition of uterine contractions resulting in delayed or prolonged labor.
Important information about some of the ingredients
- FLUIBRON FEVER AND PAIN contains maltitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine;
- FLUIBRON FEVER AND PAIN does not contain sugar and is therefore indicated in patients who must control the intake of sugars and calories;
- Each 2.5 ml dose of suspension contains 4.51 mg of sodium; this should be taken into account in cases where a low-sodium diet is recommended
Dosage and method of use How to use Fluibron fever and pain: Dosage
Always use FLUIBRON FEVER AND PAIN exactly following your doctor's instructions. If in doubt, consult your doctor or pharmacist.
The daily dose is chosen according to the weight and age of the child.
Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms. 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 be done using the measuring syringe provided with the product. 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 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 scheme.
In the 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 .
The product is intended for short-term treatments.
If the use of the medicinal product is necessary for more than 3 days in infants and children over 6 months of age and adolescents, or in the case of worsening of symptoms, the doctor should be consulted.
In infants aged 3 to 5 months, a doctor should be consulted if symptoms persist for more than 24 hours or if symptoms worsen.
Instructions for using the dosing syringe:
- Unscrew the cap by pushing it down and turning it to the left.
- Fully insert the tip of the syringe into the undercap hole.
- Shake well.
- Turn the bottle upside down, then, holding the syringe firmly, gently pull the plunger downward, allowing the suspension to flow into the syringe until it reaches the mark printed on the plunger corresponding to the desired dose.
- Put the bottle back upright and remove the syringe by twisting it gently.
- Insert the tip of the syringe into the child's mouth, and exert a slight pressure on the plunger to drain the suspension.
After use, screw the cap to close the bottle and wash the syringe with hot water. Allow it to dry, keeping it out of the reach and sight of children.
Overdose What to do if you have taken too much Fluibron fever and pain
Symptoms of overdose can occur in children who have taken more than 400 mg / kg. 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 NSAIDs develop at most nausea, vomiting, epigastric pain, or rarely diarrhea. Tinnitus, headache, and gastrointestinal bleeding are also possible. In case of ingestion of more important quantities, toxicity of the central nervous system is observed which manifests itself with drowsiness, occasionally excitement and disorientation or coma, convulsions. In more serious cases, metabolic acidosis, prolongation of prothrombin time (INR) may occur. Kidney failure and liver damage can also occur. In asthmatics there may be an "exacerbation of the symptoms of the disease.
Treatment
There is no antidote to ibuprofen. The treatment is symptomatic and consists of suitable support interventions. Maintenance of the airway patency and monitoring of cardiac function and vital signs. base and any gastrointestinal bleeding.
In case of acute overdose, gastric emptying (vomiting or gastric lavage) is all the more effective the earlier it is implemented; the administration of alkali and the induction of diuresis may also be useful; the ingestion of activated charcoal can help reduce the absorption of the drug.
IF IN ANY DOUBT ABOUT USING FLUIBRON FEVER AND PAIN, SEEK YOUR DOCTOR OR PHARMACIST
Side Effects What are the side effects of Fluibron fever and pain
Like all medicines, FLUIBRON FEVER AND PAIN can cause side effects, although not everybody gets them.
The side effects seen with ibuprofen are generally common to other analgesics, antipyretics, non-steroidal anti-inflammatory drugs.
Hypersensitivity reactions:
Rarely: anaphylactoid reactions (urticaria with or without angioedema), shock, syndrome characterized by abdominal pain, fever, chills, nausea and vomiting, bronchospasm.
Effects on the gastrointestinal system:
The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal, may occur, particularly in the elderly (see section "Special warnings").
After administration of FLUIBRON FEVER AND PAIN have been reported: nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section "Special warnings"). Gastritis has been observed less frequently.
Epigastric pain, heartburn. Gastric upset can be reduced by taking the drug on a full stomach.
Rarely: hepatitis, jaundice, abnormal liver function tests, pancreatitis, duodenitis, oesophagitis, hepatorenal syndrome, hepatic necrosis, liver failure.
Effects on the nervous system and sense organs:
Vertigo, headache, irritability, tinnitus.
Rarely: depression, insomnia, difficulty concentrating, emotional lability, drowsiness, aseptic meningitis, convulsions, auditory and visual disturbances.
Effects on the respiratory system:
Rarely: bronchospasm, dyspnea, apnea.
Effects on skin and appendages:
Bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (very rarely).
Skin rashes (including maculo-papular type), itching.
Rarely: vesiculo-bullous rashes, urticaria, erythema multiforme, alopecia (hair loss), exfoliative dermatitis, photosensitivity dermatitis.
Effects on the blood:
Very rarely: neutropenia, agranulocytosis, aplastic anemia, haemolytic anemia (possible positive Coombs test), thrombocytopenia, (with or without purpura), eosinophilia, decreased hemoglobin and hematocrit, pancytopenia.
Metabolism and nutrition disorders:
Reduction of appetite.
Effects on the cardiovascular system:
Edema, hypertension and heart failure have been reported in association with NSAID treatment.
Fluid retention (generally responds promptly to discontinuation of treatment).
Very rarely: cerebrovascular accidents, hypotension, congestive heart failure in subjects with impaired heart function, palpitations.
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 (eg myocardial infarction or stroke) Effects on the kidneys: Very rarely: acute renal failure in subjects with pre-existing significant renal impairment, papillary necrosis, tubular necrosis, glomerulus nephritis, renal impairment test, polyuria, cystitis, haematuria.
Immune system disorders:
Single cases of aseptic meningitis symptoms such as neck tension, headache, nausea, vomiting, fever, disorientation have been reported in patients with pre-existing autoimmune diseases (eg: systemic lupus erythematosus, connective system diseases).
Various:
Rarely: dry eyes and mouth, gum ulcers, rhinitis.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avversei. By reporting side effects you can help provide more information on safety. of this medicine.
Expiry and Retention
Check the expiration date indicated on the package.
The expiry date refers to the product in intact packaging, correctly stored.
Warning: do not use the medicine after the expiry date shown on the package.
Shelf life after first opening: 6 months.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
Keep this medicine out of the sight and reach of children.
COMPOSITION
FLUIBRON FEVER AND PAIN Children 100mg / 5ml oral suspension orange flavor without sugar
Each ml of suspension contains:
active ingredient: 20 mg of ibuprofen
excipients: Citric acid monohydrate, sodium citrate, acesulfame potassium, xanthan gum, sodium benzoate, orange flavor, maltitol syrup, glycerin, purified water.
FLUIBRON FEVER AND PAIN Children 100mg / 5ml oral suspension strawberry flavor without sugar
Each ml of suspension contains:
active ingredient: 20 mg of ibuprofen
excipients: Citric acid monohydrate, sodium citrate, acesulfame potassium, xanthan gum, sodium benzoate, strawberry flavor, maltitol syrup, glycerin, purified water.
PHARMACEUTICAL FORM AND CONTENT
Oral suspension, 150 ml bottle with dosing syringe.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
FLUIBRON FEVER AND PAIN
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of oral suspension contains:
Active ingredient: ibuprofen 20 mg.
Excipients: 753.30 mg maltitol syrup.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Oral suspension.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Symptomatic treatment of fever and mild or moderate pain.
04.2 Posology and method of administration
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.
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 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 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.
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.
The product is intended for short-term treatments.
If the use of the medicinal product is necessary for more than 3 days in infants and children over 6 months of age and adolescents, or in the case of worsening of symptoms, the doctor should be consulted.
In infants aged 3 to 5 months, a doctor should be consulted if symptoms persist for more than 24 hours or if symptoms worsen.
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 of the undercap.
3 - Shake well.
4 - Invert the bottle, then, holding the syringe firmly, gently pull the plunger down, making the suspension flow into the syringe up to the mark corresponding to the desired dose.
5 - Put the bottle back upright and remove the syringe by twisting it gently.
6 - Introduce the tip of the syringe into the child's mouth, and exert a slight pressure on the plunger to drain the suspension.
After use, screw the cap to close the bottle and wash the syringe with warm water. Allow it to dry, keeping it out of the reach and sight of children.
04.3 Contraindications
• 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 to other analgesics, antipyretics, non-steroidal anti-inflammatory drugs (NSAIDs), particularly when hypersensitivity is associated with nasal polyposis 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 lactation (see section 4.6).
04.4 Special warnings and appropriate precautions for use
After three days of treatment without appreciable results, consult your doctor.
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). Use of FLUIBRON 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 subjects not previously exposed to this type of drug. The risk of hypersensitivity reactions after taking ibuprofen is higher in subjects who have presented these 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.
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 (eg 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 aspirin (see section 4.5).
When gastrointestinal bleeding or ulceration occurs in patients taking
DELIDOR, the treatment must be suspended.
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. FLUIBRON FEVER AND PAIN should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity.
Caution is required 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 treatments, may be associated with a modest increased risk of arterial thrombotic events (eg 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: possible 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 renal or
impaired liver 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);
There is a risk of impaired renal function in dehydrated children and adolescents.
The following precautions are of relevance 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 arise (blurred or reduced vision, scotomas, altered color perception): stop the treatment and consult the ophthalmologist;
• if signs or symptoms of meningitis arise: evaluate the rare possibility that it is due to the use of ibuprofen (aseptic meningitis; more frequent in subjects with systemic lupus erythematosus or other collagenopathies).
Since FLUIBRON FEVER AND PAIN contains maltitol, patients with rare hereditary problems of fructose intolerance should not take this medicine. FLUIBRON FEVER AND PAIN does not contain sugar and is therefore indicated for those patients who need to control the intake of sugars and calories.
Each 2.5 ml dose of suspension contains 4.51 mg (0.20 mmol) of sodium; this should be taken into account in cases where a low sodium diet is recommended.
04.5 Interactions with other medicinal products and other forms of interaction
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 corticosteroid side effects: increased risk of gastrointestinal ulceration or bleeding (see section 4.4)
• antibacterials: possible increased risk of seizures induced by anticoagulant quinolones: 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 increase in the effect of sulfonylureas
• antivirals: ritonavir, possible increase in the concentration of NSAIDs ciclosporin: increased risk of nephrotoxicity
• cytotoxic: methotrexate, reduced excretion (increased risk of toxicity)
• lithium: reduced excretion (increased risk of toxicity)
• tacrolimus: increased risk of nephrotoxicity
• uricosurics: probenecid, slows down the excretion of NSAIDs (increase in plasma concentrations)
• methotrexate: potential increase in the plasma concentration of methotrexate.
• Zidovudine: 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) 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 FLUIBRON 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.
Experimental data indicate that ibuprofen can inhibit the effects of low-dose acetylsalicylic acid on platelet aggregation when drugs are administered concomitantly. firm conclusions for continued use of ibuprofen; there appears to be no clinically relevant effect from occasional use of ibuprofen (see section 5.1).
04.6 Pregnancy and lactation
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.
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 from less than 1% to approximately 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.
In addition, 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 may progress to renal failure with oligo-hydroamnios;
the mother and the newborn, at the end of pregnancy, to:
• possible prolongation of bleeding time, an antiplatelet effect which can occur even at very low doses;
• inhibition of uterine contractions resulting in delayed or prolonged labor.
04.7 Effects on ability to drive and use machines
Not relevant, given the patient's age.
04.8 Undesirable effects
The side effects observed with ibuprofen are common to other analgesics, antipyretics, non-steroidal anti-inflammatory drugs.
Hypersensitivity reactions
Rarely: anaphylactoid reactions (urticaria with or without angioedema), dyspnoea (from 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, gastrointestinal perforation or haemorrhage, sometimes fatal, may occur, particularly in the elderly (see section 4.4).
After administration of FLUIBRON FEVER AND PAIN have been reported: nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section 4.4). Gastritis has been observed less frequently.
Epigastric pain, heartburn. Gastric upset can be reduced by taking the drug on a full stomach.
Rarely: hepatitis, jaundice, abnormal liver function tests, pancreatitis, duodenitis, oesophagitis, hepatorenal syndrome, hepatic necrosis, liver failure.
Pathologies of the nervous system and sense organs
Vertigo, headache, irritability, tinnitus.
Rarely: depression, insomnia, difficulty concentrating, emotional lability, drowsiness, aseptic meningitis, convulsions, auditory and visual disturbances.
Respiratory, thoracic and mediastinal disorders
Rarely: bronchospasm, dyspnea, apnea.
Skin and subcutaneous tissue disorders
Bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (very rarely).
Skin rashes (including maculopapular type), itching.
Rarely: vesiculo-bullous eruptions, urticaria, erythema multiforme, alopecia, exfoliative dermatitis, photosensitivity dermatitis.
Disorders of the blood and lymphatic system
Very rarely: neutropenia, agranulocytosis, aplastic anemia, haemolytic anemia (possible positive Coombs test), thrombocytopenia (with or without purpura), eosinophilia, decreased hemoglobin and hematocrit, pancytopenia.
Metabolism and nutrition disorders
Reduction of appetite.
Cardiac and vascular diseases
Edema, hypertension and heart failure have been reported in association with NSAID treatment.
Fluid retention (generally responds promptly to discontinuation of treatment).
Very rarely: cerebrovascular accidents, hypotension, congestive heart failure in subjects with impaired heart function, palpitations.
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 (eg myocardial infarction or stroke. ) (see section 4.4).
Renal and urinary disorders
Very rarely: acute renal failure in subjects with pre-existing significant renal impairment, papillary necrosis, tubular necrosis, glomerulonephritis, renal impairment test, polyuria, cystitis, haematuria.
Disorders of the immune system
Single cases of aseptic meningitis symptoms 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 system diseases) (see section 4.4).
Various
Rarely: dry eyes and mouth, gum ulcers, rhinitis.
"Reporting of suspected adverse reactions.
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous 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. "address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse".
04.9 Overdose
Symptoms of overdose can occur in children who have taken more than 400 mg / kg. 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 NSAIDs develop at most nausea, vomiting, epigastric pain, or rarely diarrhea. Tinnitus, headache, and gastrointestinal bleeding are also possible. In case of ingestion of more important quantities, toxicity of the central nervous system is observed which manifests itself with drowsiness, occasionally excitement and disorientation or coma, convulsions. In more serious cases, metabolic acidosis, prolongation of prothrombin time (INR) may occur. Kidney failure and liver damage can also occur. In asthmatics there may be an "exacerbation of the symptoms of the disease.
Treatment
There is no antidote to ibuprofen. The treatment is symptomatic and consists of suitable support interventions. Maintenance of the airway patency and monitoring of cardiac function and vital signs. base and any gastrointestinal bleeding.
In case of acute overdose, gastric emptying (vomiting or gastric lavage) is all the more effective the earlier it is implemented; the administration of alkali and the induction of diuresis may also be useful; the ingestion of activated charcoal can help reduce the absorption of the drug.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: non-steroidal anti-inflammatory / antirheumatic drugs, derivatives of propionic acid.
ATC code: M01AE01.
Ibuprofen is a synthetic analgesic-anti-inflammatory, with a marked antipyretic activity. Chemically it is the progenitor of phenyl-propionic derivatives. The analgesic activity is non-narcotic. Ibuprofen is a potent inhibitor of prostaglandin synthesis and exerts its activity by inhibiting its synthesis peripherally.
Experimental data indicate that ibuprofen may inhibit the effects of low-dose acetylsalicylic acid on platelet aggregation when the drugs are administered concomitantly. In one study, following administration of a single 400 mg dose of ibuprofen, taken within 8 hours before or 30 minutes after the administration of acetylsalicylic acid (81 mg), there was a decrease in the effect of acetylsalicylic acid on thromboxane formation and platelet aggregation. However, the limited data and the uncertainties relating to their application to the clinical situation do not allow definitive conclusions to be drawn for the continued use of ibuprofen; there appears to be no clinically relevant effect from the occasional use of ibuprofen.
05.2 Pharmacokinetic properties
Ibuprofen is well absorbed after oral administration and is rapidly distributed throughout the body. When taken on an empty stomach, maximum serum levels are reached after approximately 45 minutes. When taken concomitantly with food, maximum blood levels are reached between one "hour and a half and 3 hours. Ibuprofen binds to a large extent to plasma proteins, is distributed in the tissue and in the synovial fluid. The plasma half-life of the molecule is approximately two hours. Ibuprofen is metabolised in the liver to two inactive metabolites and these, together with unchanged ibuprofen, are excreted by the kidney both as such and conjugated. Elimination by the kidney is rapid and complete. Ibuprofen is excreted in milk in very high concentrations. low.
05.3 Preclinical safety data
There is no further information on preclinical data other than that already reported elsewhere in this Summary of Product Characteristics (see section 4.6).
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
FLUIBRON FEVER AND PAIN Children 100mg / 5ml oral suspension strawberry flavor without sugar
Citric acid monohydrate, sodium citrate, acesulfame potassium, xanthan gum, sodium benzoate, strawberry flavor, maltitol syrup, glycerin, purified water
FLUIBRON FEVER AND PAIN Children 100mg / 5ml oral suspension orange flavor without sugar
Citric acid monohydrate, sodium citrate, acesulfame potassium, xanthan gum, sodium benzoate, orange flavor, maltitol syrup, glycerin, purified water
06.2 Incompatibility
Not relevant.
06.3 Period of validity
FLUIBRON FEVER AND PAIN Children 100mg / 5ml oral suspension strawberry flavor without sugar
36 months.
Shelf life after first opening: 6 months.
FLUIBRON FEVER AND PAIN Children 100mg / 5ml oral suspension orange flavor without sugar
36 months.
Shelf life after first opening: 6 months.
06.4 Special precautions for storage
No particular.
06.5 Nature of the immediate packaging and contents of the package
FLUIBRON FEVER AND PAIN Children 100mg / 5ml strawberry flavor oral suspension unsweetened
Amber colored polyethylene terephthalate (PET) bottle with polyethylene cap and undercap with child resistant closure.
Dosing syringe with body and plunger in polyethylene.
FLUIBRON FEVER AND PAIN Children 100mg / 5ml oral suspension orange flavor unsweetened
Amber colored polyethylene terephthalate (PET) bottle with polyethylene cap and undercap with child resistant closure.
Dosing syringe with body and plunger in polyethylene.
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
A.I.C owner: Chiesi Farmaceutici S.p.A. - Via Palermo, 26 / A - 43122 Parma (PR)
08.0 MARKETING AUTHORIZATION NUMBER
FLUIBRON FEVER AND PAIN Children 100mg / 5ml oral suspension strawberry flavor without sugar - 150 ml bottle with dosing syringe: AIC n. 043188010
FLUIBRON FEVER AND PAIN Children 100mg / 5ml oral suspension orange flavor without sugar - 150 ml bottle with dosing syringe: AIC n. 043188022
