FEVRALT BB OS SOSP 100MG/5ML

FEVRALT CHILDREN 100 MG/5 ML

active ingredients

5 ml oral suspension contain as an active ingredient: Ibuprofen 100 mg Excipients with known effect: 5 ml oral suspension contain 2000 mg of liquid maltitol, 15 mg benzoate sodium (E211) and 0.05 mg of ethanol For the full list of excipients, see paragraph 6.1.

Excellent

Purified water Maltitol Liquid Glycerol Gomma Xantana Sodium Benzoate (E 211) Sodium Ciclamato Citric Acid (to correct pH) Orange aroma (preparation flavoring, natural flavoring identical, ethyl alcohol) Acesulfame Polysorbate 80 Sodium Edetate

Therapeutic indications

Reduced fever (including post-vaccination fever). Attenuation of symptoms from cooling and flu. Attenuation of mild and moderate pain, such as teething pain, sore throat, toothache, earache, headache. For the symptomatic treatment of the Reumatoid Youth Arthritis. Fevralt is indicated in infants (with a weight of more than 5 kg) and in children up to 12 years.

Contraindications

- Patients under the age of 3 months or under the weight of 5 kg - Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1 in particular when hypersensitivity is associated with nasal and asthma polypoxes - Hypersensitivity to aspirin or other similar medicines (FANS) and in particular when hypersensitivity is associated with asthma, rhinitis, hivery. - History of gastrointestinal bleeding or drilling related to a previous episode or history of bleeding / recurrent peptic ulcer (two or more separate episodes of proven ulcer or bleeding) - severe heart failure (IV class NYHA) - Pregnancy and nursing

Population

Fevralt is for oral use and only to be taken for a short period. Undesirable effects can be minimized with the use of the minimum effective dose for the shortest possible duration of treatment needed to control symptoms (see paragraph 4.4) The lowest effective dose should be used for the shortest period necessary to relieve symptoms (see paragraph 4.4). Population For fever and mild to moderate pain : Fevralt can be administered to infants from 3 months of age and weighing more than 5 kg. The usual daily dose is 20-30 mg/kg body weight divided into 3-4 fractional doses to be administered with the dosage spoon enclosed by 2.5 ml and 5 ml (see the following table). Normally the dose should be given every about 6-8 hours. This time can be reduced to 4 hours, if necessary, without exceeding the maximum daily dose of 30 mg/kg body weight.

Age	Weight (Kg)	posiology
3-5 months	5,6 - 7,7	2.5 ml corresponding to 50 mg	3 times a day	(150 mg) in 24 hours
6-12 months	7,8 - 10	2.5 ml corresponding to 50 mg	3-4 times a day	(150-200 mg) in 24 hours
>1-≤3 years	11 -15	5 ml corresponding to 100 mg	3 times a day	(300 mg) in 24 hours
4-6 years	16 - 20	7.5 ml corresponding to 150 mg	3 times a day	(450 mg) in 24 hours
7-9 years	21 - 28	10 ml corresponding to 200 mg	3 times a day	(600 mg) in 24 hours
10-12 years	29 - 40	15 ml corresponding to 300 mg	3 times a day	(900 mg) in 24 hours

• For infants aged between ≥3 and ≤ 5 months weighing more than 5 Kg In infants between 3 and 5 months must be consulted by the doctor if symptoms persist for a period of more than 24 hours or in case of symptomatic deterioration • In infants and children (aged between ≥ 6 months to 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 should be consulted the doctor For post vaccination fever Fevralt can be used in infants under the age of 6 months only after careful medical evaluation. The usual dose is 2.5 ml corresponding to 50 mg. Only if necessary can be administered another 2.5 ml corresponding to 50 mg, 6 hours later Do not administer more than 5 ml, corresponding to 100 mg, in 24 hours. If the fever persists after the second dose, the doctor must be consulted. For symptomatic treatment of Young Reumatoid Arthritis The usual daily dose is 30 to 40 mg/Kg divided into 3 to 4 doses. How to administer the bottle well before use For instructions before administration, see paragraph 6.6

Conservation

Do not refrigerate or freeze

Warnings

Undesirable effects can be minimized with the use of the lowest effective dose for the shortest duration of treatment required to control symptoms (see paragraph 4.2 and gastrointestinal and cardiovascular risks below). Masking the symptoms of underlying infections Fevralt can mask the symptoms of infection, which could delay the start of proper treatment and thus worsen the outcome of the infection. This was observed in bacterial pneumonia acquired in communities and bacterial complications of chickenpox. When Fevralt is administered for relief from fever or pain related to infection, it is recommended to monitor the infection. In non-hospital contexts, please contact your doctor if the symptoms of your infant/child persist or worsen. In patients with pre-existing asthma not sensitive to aspirin or other NSAIDs or with pre-existing allergic pathology. In patients with Systemic Lupus Erythematosus, there is an increase in the risk of aseptic meningitis. In patients with symptoms and/or signs that suggest liver, intestinal, or kidney dysfunction. In patients who are taking other NSAIDs or a low dose of aspirin (less than 75 mg/die). NSAIDs, including Fevralt, can cause serious gastrointestinal-type adverse events that include bleeding, ulceration and perforation. These serious adverse events may occur at any time during treatment with or without warning symptoms. NSAIDs must be prescribed with caution in the elderly and in those who have a positive anamnesi of peptic ulcer or gastrointestinal bleeding. The risk is higher with increasing doses of NSAIDs. It is recommended to start treatment with the lowest effective dose. The co-prescription of protective agents must also be taken into account for patients taking low doses of aspirin or other NSAIDs (see paragraph 4.5). Adequate monitoring and instructions are recommended for patients with positive anamnesis of hypertension and/or mild to moderate congestive heart failure since fluid and edema retention were reported in association with NSAID therapy. Clinical studies suggest that the use of ibuprofen especially at high doses (2400 mg/die) 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 arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (II-III class NYHA), proven ischemic cardiopathy, peripheral arterial disease and/or cerebrovascular disease should be treated with ibuprofen only after careful consideration and should avoid high doses (2400 mg/die). Careful consideration should be exercised even before starting long-term treatment patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, cigarette smoking habit), especially if high doses (2400 mg/die) are required of ibuprofen. In patients there are limited evidence that drugs that inhibit cyclooxygenase/prostaglandine synthesis (NSAID) can cause fertility problems through an ovulation effect. This effect is reversible with the interruption of treatment. Patients with rare hereditary problems of fructose intolerance should not take this medicine. The use of ibuprofen, acetylsalicylic acid or other analgesic, antipyretic, non-steroidal anti-inflammatory drugs requires special caution: • In case of ulcer, perforation or gastrointestinal bleeding priors: • In case of asthma: possible bronchoconstriction • In the presence of clotting defects: • In case of kidney disease, heart disease or hypertension: critical reduction of kidney function (especially in elderly individuals with reduced liver or kidney function, heart failure, or under treatment with diuretics), nephrotoxicity or water retention. • In case of liver disease: possible hepatotoxicity In addition, the use of ibuprofen, acetylsalicylic acid or other analgesic, antipyretic, nonsteroidal anti-inflammatory drugs requires adequate precautions: • Rehydrate patients before start and during treatment in case of dehydration (for example: fever, vomiting or diarrhea) In dehydrated children and adolescents there is the risk of alteration of kidney function (the following precautions are important during a long-term treatment) • Monitoring signs or symptoms of ulcers or gastrointestinal bleeding • monitoring signs or symptoms of hepatotoxicity • monitoring signs or symptoms of nephrotoxicity • if vision disorders occur (annebbiated or reduced vision, scotoma, altered perception) stop treatment and consult an ophthalmologist; • in case of development of signs or symptoms of meningitis: assess the possibility that may be caused by the use of ibuprofen (asetic meningitis, more common in patients with systemic lupus erythematosus or other collagen pathologies). Severe skin reactions Serious skin reactions have been reported, some of which fatal, including exfoliatory 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. This medicine contains the following excipients: • Liquid Maltitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine. • Sodium This medicine contains less than 1 mmole of sodium (23 mg) for 2.5 ml, 5 ml, 7.5 ml, 10 ml and 15 ml oral suspension, i.e. essentially without sodium. • Sodium Benzoato (E211) This medicine contains 15 mg of sodium benzoate for dose of 5 ml oral suspension which is equivalent to 3 mg/ml. Benzoate sodium can increase jaundice (skin and eyes) in infants up to four weeks of age. • Ethanol (ethyl alcohol) This medicine contains 0.05 mg of alcohol (ethanol) in each dose of 5 ml oral suspension which is equivalent to 0.01 mg/ml. The amount in each dose of 5 ml oral suspension is equivalent to 0.001 ml of beer and to 0.0005 ml of wine. The small amount of alcohol in this medicine will not produce significant effects.

Interactions

The following interactions are generally associated with ibuprofen, acetylsalicylic acid, and other Non-Spyrogen Anti-inflammatory drugs (NSAIDs). Fevralt should be used with caution in association with:

Antiagulants / Anti-platelet	Possible enhancement of the anticoagulant effects such as Warfarin. Increased gastrointestinal bleeding Acetyl acid: Concurrent administration of Ibuprofen and acetylsalicylic acid is not generally recommended due to the potential increase in unwanted effects. Experimental data suggests that Ibuprofen can competitively inhibit the effect of acetylsalicylic acid at low doses on platelet aggregation when the two drugs are administered simultaneously. Although there are uncertainties regarding the extrapolation of these data to the clinical situation, it cannot be ruled out the possibility that long-term regular use of Ibuprofen can reduce the cardioprotective effect of acetylsalicylic acid at low doses. No significant clinical effect is considered likely due to occasional use of Ibuprofene (see paragraph 5.1).
Selective Serotonin Reuptake inhibitors (SSRIs)	Increased gastrointestinal bleeding
Antihypertensives	Reduction of hypotensive effect
Diuretics	Reduced hypotensive effect. Increased risk of nephrotoxicity. Possible increase in the risk of hyperkaliemia (induced by potassium-saving diuretics)
ACE-Inhibitions	Reduced hypotensive effect. Possible increase in the risk of nephrotoxicity and hyperkaliemia
Chinolonic (Antibacterial)	Possible increase in the risk of seizures
Sulphonluree (Antidiabetics)	Possible increase in the hypoglycemic effect
Courtesy	Possible increase in the risk of gastrointestinal adverse reactions
Litio	Increased lithium plasma levels
Metotrexate (Cytotoxic)	Increased plasma levels of metotrexate
Antivirals such as Ritonavir	Possible increase in liver concentrations of NSAIDs and increased risk of adverse reactions
Zidovudine	Increased risk of hematoma and hematoma in HIV positive hemophiliacs
Ciclosporin	Increased risk of nephrotoxicity
Tacrolimus	Increased risk of nephrotoxicity
Cardioactive glycosides	NSAIDs can exacerbate heart failure, reduce glomerular filtration speed (GFR) and increase plasma levels of cardioactive glucosides.
Resurrection	Probenecid: reduction of NSAID excretion (increasing plasma concentrations)

Effects

Within each frequency class the unwanted effects are reported in decreasing order of gravity. The frequency is defined as follows: very common (> 1/10), common (>1/100, 1/1,000, 1/10,000, Reactions of hypersensitivity Raro: Anaphylactoid reactions that include: • hives with or without angioedema; • dispnea due to obstruction of larynx or bronchospasm; • collapse; • abdominal pain; • fever and chills, nausea and vomiting. Emolinfopoietic system pathologies Raro: Neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia with possible tests Coombs positive, piastrinopenia with or without purple, eosinophilia, reduction of hemoglobin and heatocritus, pancitopenia. Disorders of metabolism and nutrition Not common: Reduced appetite Psychiatric disorders and pathologies of the nervous system City: Cephalea, irritability. Raro: Depression, insomnia, difficulty of concentration, emotional fragility, drowsiness, aseptic meningitis, seizures. Pathologies of the eye Raro: Visual disturbances. Eye dryness Ear and labyrinth pathologies City: Tinnitus. Vertigo Vascular pathologies and heart disease Not common: Edema, fluid retention, hypertension and heart failure were observed in some patients taking NSAIDs. Raro: Damn cerebrovascular, hypotension, congestive heart failure in patients with partial heart function. Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg/die) may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke) - (see paragraph 4.4). Edema, hypertension and heart failure were reported in association with treatment with NSAIDs.

Respiratory, chest and mediastinic pathologies
Not common:	Broncospasmo, dispnea
Raro:	Apnea, reiterate.
Gastrointestinal pathologies
City:	Gastric ulcer with or without bleeding and/or perforation that can be fatal especially in the elderly. Nausea, vomiting, ematemesis, diarrhea, melena, flatulence, constipation, dyspepsia, abdominal pain. Stomatitis, exacerbation of colitis and Crohn's disease.
Not common:	Gastritis and epigastric pain, gastric burning.
Raro:	Pancreatis, duodenitis, esophagitis. Dry mouth.
Hepatobiliary diseases
Raro:	Hepatitis, jaundice, alterations of liver function, liver necrosis, kidney hepato syndrome, liver failure.
Pathologies of skin and subcutaneous tissue
Raro:	Skin rashes, itching, hives, bladder-bollose eruptions, multiform erythema, alopecia, exfoliatory dermatitis, photosensitivity.
Very rare:	Skin reactions like Stevens-Johnson syndrome, toxic epidermal necrolysis.
Frequency: not known	Drug reactions with heosinophilia and systemic symptoms (DrESS syndrome) General acute acute acute acute (PEAG)
Kidney and urinary pathologies
Raro:	Chrosis of papillary/tubular cells, glomerulonephritis, alterations of kidney function tests, polyuria, cystitis, hematuria. Acute kidney failure in patients with pre-existing significant impairment of kidney function.
Diagnostic examinations
- Interference on liver function test
- Interference on renal function test

Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions occurring after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Toxicity Signs and symptoms of toxicity were generally not observed at doses less than 100 mg/kg in children or adults. However, in some cases you may need a support treatment. It has been observed that children manifest signs and symptoms of toxicity after ingestion of ibuprofen at doses of 400 mg/kg or greater. Synonyms Most patients who have ingested significant quantities of ibuprofen will manifest symptoms within 4-6 hours. The most commonly reported overdose symptoms include: abdominal pain, nausea, vomiting, drowsiness and lethargy. The effects on the central nervous system (SNC) include headaches, tinnitus, dizziness, seizures and loss of consciousness. In cases of severe poisoning it is possible that metabolic acidosis occurs Rarely were also reported nistagm, hypothermia, kidney effects, intestinal gastro bleeding, diarrhea, depression of the central nervous system and respiratory system, coma and especially in very small children, apnea. Disorientation, state of excitement, fainting and cardiovascular toxicity including hypotension, bradycardia, tachycardia and atrial fibrillation have also been reported. In cases of significant overdose are possible kidney failure and liver damage Treatment There is no specific antidote for overdosing ibuprofen. In case of overdose, a symptomatic and support treatment is therefore indicated. Particular attention is given to the control of blood pressure, acid-base balance and any gastro-intestinal bleeding. Within an hour of ingestion of a potentially toxic quantity, it must be considered the administration of activated carbon. Alternatively, in the adult within an hour of the ingestion of a potentially dangerous overdose for life must be taken into account the gastric lavender. Adequate diuresis must be ensured and kidney and liver functions must be closely monitored. The patient must remain under observation for at least 4 hours after ingestion of a potentially toxic drug. Any occurrence of frequent or prolonged seizures must be treated with intravenous diazepam. Other support measures may be required in relation to the patient's clinical conditions. For more information contact the local anti-veleni center.

Fevralt should not be used in pregnant women, during pregnancy and nursing.

Source: Farmadati