DECAFLOW FEVER PAIN

DECAFLU FEVER AND PAIN CHILDREN 100 MG/5 ML

active ingredients

Each ml of oral suspension contains: Active ingredient: ibuprofene 20 mg. Excipients: malt syrup 753,30 mg For full list of excipients, see paragraph 6.1.

Excellent

Decaflu FEBBRE AND DOLORE 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 Decaflu FEBBRE and DOLORE 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. • Pregnancy and nursing (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). 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. max. of SOMMINISTRAZONI/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. The product is intended for short-term treatments. In case the use of the medicinal product is necessary for more than 3 days in infants and children older than 6 months and in adolescents, or in case of worsening of symptomatology, the doctor must be consulted. 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. 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. 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). Masking the symptoms of underlying infections Decaflu FEBBRE AND DOLORE can mask the symptoms of infection, which may delay the start of proper treatment and thus worsen the outcome of the infection. This was observed in bacterial pneumonia acquired in communities and bacterial complications of chickenpox. When Decaflu FEBBRE 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. The use of Decaflu FEBBRE and DOLORE must 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. Seniors: elderly 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, especially elderly, must report any unusual gastrointestinal symptoms (especially gastrointestinal hemorrhage) in particular in the early stages of treatment. Caution should be lent to patients taking concomitant drugs 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 aspirin (see paragraph 4.5). When bleeding or gastrointestinal ulceration occurs in patients taking Decaflu FEBBRE and DOLORE, 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). Severe 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 (PEAG) exantelosis has been reported in relation to products containing ibuprofen. Ibuprofen should be suspended at the first appearance of signs and symptoms of severe skin reactions, such as rash, mucosa lesions or any other sign of hypersensitivity. Drug reactions with heosinophilia and systemic symptoms (DrESS syndrome) were observed with unknown frequency (see paragraph 4.8). 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. In cases of severe poisoning, it is possible that metabolic acidosis occurs (see paragraph 4.9). 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: possible 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); In dehydrated children and adolescents there is a risk of alteration of kidney function. 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: evaluate the rare possibility that it is due to the use of ibuprofene (aseptic meningitis; more frequent in subjects affected by systemic lupus erythematosus or other collagenopathies). This medicine contains maltitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine. This medicine contains: • 0.025mg of benzoate sodium for each dose of 2,5 ml suspension; • 0.05mg of benzoate sodium for each dose of 5 ml suspension; • 0.075mg of benzoate sodium for each dose of 7.5 ml suspension; • 0.1mg of benzoate sodium for each dose of 10 ml suspension; • 0.15mg benzoate sodium for each dose of 15 ml suspension. Benzoate sodium can increase jaundice (skin and eyes) in infants (up to 4 weeks). This medicine contains less than 1mmol (23) mg sodium per dose i.e. essentially ‘without sodium’: - 4,51 mg of sodium for each 2.5 ml dose of suspension; - 9.02 mg sodium per dose of 5 ml suspension; - 13,53 mg sodium per dose of 7.5 ml suspension; - 18,04 mg sodium for each dose of 10 ml suspension; For doses of 15 ml of suspension this medicine contains 27.06 mg of sodium which is 1.35% of the maximum daily intake recommended by the WHO which corresponds to 2 g of sodium for an adult. Decaflu FEBBRE And DOLORE does not contain sugar and is therefore indicated for those patients who need to control the intake of sugars and calories.

Interactions

The following interactions are common to ibuprofen, acetylsalicylic acid and other analgesic, antipyretic, non-steroidal anti-inflammatory drugs (NSAID): • avoid the contemporary use of two or more analgesic, antipyretic, non-steroidal anti-inflammatory drugs: increased risk of side effects • 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 (see paragraph 4.4) • anti-aggregant agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal hemorrhage (see paragraph 4.4) • antidiabetics: possible increase in sulphanluree effect • antiviral: ritonavir, possible increase in concentration of NSAIDs • cyclosporin: increased risk of nephrotoxicity • cytotoxic: metotressate, reduction of excretion (increased risk of toxicity) • lithium: reduction of excretion (increased risk of toxicity) • tacrolimus: increased risk of nephrotoxicity • uricosury: probenecid, slows the excretion of NSAIDs (increasing plasma concentrations) • metotrexate: potential increase in plasma concentration. • Zidovudine: increased risk of hemorrhosis 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) co-administration of an ACE inhibitor or an angiotensin II antagonist and agents inhibiting the cyclooxygenase 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 Decaflu FEBBRE 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. Experimental data indicates that ibuprofen can inhibit the effects of acetylsalicylic 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 side effects observed with ibuprofen are common to other analgesic, antipyretic, non-steroidal anti-inflammatory drugs. Reactions of hypersensitivity Rarely: anaphylactoid reactions (orticaria with or without angioedema), dispnea (from laryngeal obstruction or bronchospasm), shock, syndrome characterized by abdominal pain, fever, shivers, nausea and vomiting; bronchospasmo (see paragraphs 4.3 and 4.4). Gastrointestinal diseases The most commonly observed adverse events are gastrointestinal. Peptic ulcers, perforation or gastrointestinal hemorrhage may occur, sometimes fatal, especially in the elderly (see paragraph 4.4). After administration of Decaflu FEBBRE and DOLORE were reported: nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, ematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see paragraph 4.4). Less frequently gastritis were observed. Epigastric pain, gastric pyrosis. Gastric disorders can be reduced by taking the drug on a full stomach. Rarely: hepatitis, jaundice, alteration of liver function tests, pancreatis, duodenitis, esophagitis, liver syndrome, liver necrosis, liver failure. Pathologies of the nervous system and the sense organs Vertigo, headache, irritability, tinnitus. Rarely: depression, insomnia, difficulty of concentration, emotional lability, drowsiness, aseptic meningitis, seizures, hearing and visual disorders. Respiratory, chest and mediastinic pathologies Rarely: bronchospasm, dispnea, apnea. Pathologies of skin and subcutaneous tissue Drug reaction with heosinophilia and systemic symptoms (DrESS syndrome) (unknown frequency), bollose reactions including Stevens-Johnson syndrome and epidermal toxic necrolysis (very rarely). Skin rashes (also of type maculopapulare), itching. Rarely: bladder-bollose eruptions, hives, multiform erythema, alopecia, exfoliatory dermatitis, photosensitivity dermatitis. Frequency not noted: Generalized acute exantelosis (PEAG) Emolinfopoietic system pathologies Very rarely: neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia (possible positive Coombs test), piastrinopenia (with or without purple), heosinophilia, hemoglobin reduction and hematocrite, pancytopenia. Metabolism and nutrition disorders Reduced appetite. Heart and vascular disease Edema, hypertension and heart failure were reported in association with NSAID treatment. Fluid retention (usually responds promptly to the termination of treatment). Very rarely: cerebrovascular accidents, hypotension, congestive heart failure in subjects with compromised heart function, palpitations. 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). Kidney and urinary pathologies Very rarely: acute kidney failure in subjects with pre-existing significant impairment of kidney function, papillar necrosis, tubular necrosis, glomerulonephritis, alteration of kidney function tests, polyuria, cystitis, hematuria. Immune system disorders In patients with pre-existing auto-immune diseases (e.g. systemic lupus erythematosus, connective system diseases) individual cases of aseptic meningitis symptoms such as nucan tension, headache, nausea, vomiting, fever, disorientation (see paragraph 4.4) have been reported. Other Rarely: dry eyes and mouth, gum ulcers, rhinitis. 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

Overdose symptoms 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. Synonyms Most patients who accidentally ingest clinically relevant amounts of NSAIDs develop more nausea, vomiting, epigastric pain or rarely diarrhea. Tinnitus, headache and gastrointestinal bleeding are also possible. In the case of ingestion of more important quantities, we see the toxicity of the central nervous system manifested with drowsiness, occasionally excitation and disorientation or coma, seizures. In cases of severe poisoning, it is possible that metabolic acidosis occurs and prolonged protrombine time (INR). Renal failure and liver damage can also be manifested. An exacerbation of the symptoms of the disease can occur in asthmatic subjects.Treatment There is no ibuprofen antidote. The treatment is symptomatic and consists of suitable support. Maintaining airway pervity and heart function monitoring and vital signs. Particular attention is given to the control of blood pressure, acid-base balance and gastrointestinal bleeding. In case of acute overdose, gastric emptiness (vomite or gastric lavender) is both more effective as early as it is implemented; alkali administration and diuresis induction may also be useful; active carbon ingestion can help reduce the absorption of the drug.

It is unlikely that subjects under 12 years of age will go to pregnancy, or breast breastfeeding. The following considerations must also be taken into account in such circumstances. 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 disease, 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.

Source: Farmadati