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€10.39

Decaflu fever and pain strawberry taste - syrup for children 150 ml

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Product Description

Drug for the symptomatic treatment of fever and mild to moderate pain.

Indications

Decaflu fever and pain strawberry-flavored oral suspension is a symptomatic treatment of fever and mild to moderate pain.

Composition

Active ingredients

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

Citric acid monohydrate, sodium citrate, acesulfame potassium, xanthan gum, sodium benzoate, strawberry flavoring, maltitol syrup, glycerin, purified water.

Directions for use and dosage

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 section 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 3 months to 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 notches for the different dosages; in particular, the 2.5 ml mark corresponds to 50 mg of ibuprofen and the 5 ml mark corresponds 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.

Weight Age Single dose in ml n° Maximum number of administrations/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 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 use of the medicine is necessary for more than one year, consult your doctor. 3 days in infants and children over 6 months of age and in adolescents, or in case of worsening of symptoms, a doctor must be consulted. In infants aged between 3 and 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 downwards and turning it to the left.
  • Insert the tip of the syringe fully into the hole in the undercap.
  • Shake well.
  • Invert the bottle, 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.
  • Return the bottle to an upright position and remove the syringe by gently twisting it.
  • Insert the tip of the syringe into the child's mouth and apply gentle pressure to the plunger to allow the suspension to flow out. After use, screw the cap on the bottle and rinse the syringe with hot water. Leave it to dry, keeping it out of the reach and sight of children.

Warnings

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 duration necessary to control symptoms (see paragraphs below on gastrointestinal and cardiovascular risks). Masking of symptoms of underlying infections Decaflu Fever and Pain may mask the symptoms of infection, which could delay the initiation of adequate treatment and therefore worsen the outcome of the infection. This has been observed in community-acquired bacterial pneumonia and in bacterial complications of chickenpox. When Decaflu Fever and Pain is administered for the relief of infection-related fever or pain, monitoring for the infection is recommended. In non-hospital settings, the patient should consult a doctor if symptoms persist or worsen. The use of Decaflu 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 these types of drugs. The risk of hypersensitivity reactions after taking ibuprofen is greater in subjects who have experienced 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 anytime 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 can be fatal (see section 4.2). The risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing NSAID doses, 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, as well as for patients taking low-dose aspirin or other drugs likely to 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 exercised in patients taking 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 taking Decaflu 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: Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at highest risk early in the course of therapy, with the onset of the reaction occurring in the majority of cases within the first month of treatment. Acute generalized exanthematous pustulosis (AGEP) has been reported in connection with products containing ibuprofen. Ibuprofen should be discontinued at the first appearance of signs and symptoms of serious skin reactions, such as rash, mucosal lesions, or any other sign of hypersensitivity. Drug reactions with eosinophilia and systemic symptoms (DRESS syndrome) have been observed with unknown frequency (see section 4.8). Caution is advised 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 therapy. 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 small 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. In cases of severe poisoning, metabolic acidosis may occur (see section 4.9). 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 consideration 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, 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 renal, cardiac or hypertension diseases: possible critical reduction of renal function (especially in subjects with impaired renal or hepatic function, heart failure or treated with diuretics), nephrotoxicity or fluid retention;
  • in the presence of liver diseases: possible hepatotoxicity;
  • rehydrate the subject before the start and during treatment in case of dehydration (for example due to fever, vomiting or diarrhea);

In dehydrated children and adolescents there is a risk of alteration of renal function. The following precautions are important during prolonged treatment:

  • 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 color perception): discontinue treatment and consult an ophthalmologist;
  • if signs or symptoms of meningitis occur: consider 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). This medicine contains maltitol.

Patients with rare hereditary problems of fructose intolerance should not take this medicine. This medicine contains:

  • 0.025 mg sodium benzoate per 2.5 ml dose of suspension;
  • 0.05 mg sodium benzoate per 5 ml dose of suspension;
  • 0.075 mg sodium benzoate per 7.5 ml dose of suspension;
  • 0.1 mg sodium benzoate per 10 ml dose of suspension;
  • 0.15 mg sodium benzoate per 15 ml dose of suspension. Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks). This medicine contains less than 1 mmol (23) mg sodium per dose, i.e. essentially 'sodium-free': - 4.51 mg sodium per 2.5 ml dose of suspension; - 9.02 mg of sodium per 5 ml dose of suspension; - 13.53 mg of sodium per 7.5 ml dose of suspension; - 18.04 mg of sodium per 10 ml dose of suspension; For 15 ml doses of suspension, this medicine contains 27.06 mg of sodium, equivalent to 1.35% of the WHO recommended maximum daily intake of 2 g of sodium for an adult. Decaflu Fever and Pain does not contain sugar and is therefore indicated for those patients who need to control their sugar and calorie intake.

Contraindications

Hypersensitivity to ibuprofen or to any of the excipients listed in section 6.1. 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 cardiac insufficiency.
  • 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).

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 quinolone-induced convulsions
  • 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 increase in the effect of sulfonylureas
  • antivirals: ritonavir, possible increase in the concentration of NSAIDs
  • ciclosporin: increased risk of nephrotoxicity
  • cytotoxics: methotrexate, decreased 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 plasma concentrations of methotrexate
  • Zidovudine: increased risk of haemarthrosis and haematomas in HIV (+) haemophiliacs if 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 compromised renal function (e.g., dehydrated patients or elderly patients with compromised renal function), the co-administration of an ACE inhibitor or an 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 Decaflu 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 acetylsalicylic acid 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 haemorrhage, sometimes fatal, particularly in the elderly, may occur (see section 4.4). After administration of Decaflu Fever and Pain, the following have been reported: nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section 4.4). Less frequently, gastritis has been observed. Epigastric pain, heartburn. Gastric disturbances can be reduced by taking the drug with food. Rarely: hepatitis, jaundice, abnormal liver function tests, pancreatitis, duodenitis, esophagitis, hepatorenal syndrome, liver necrosis, liver failure.

Nervous system and sensory 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

Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) (frequency not known), bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (very rare). Skin rashes (including maculopapular), pruritus. Rarely: vesiculobullous eruptions, urticaria, erythema multiforme, alopecia, exfoliative dermatitis, photosensitivity dermatitis. Frequency not known: Acute generalized exanthematous pustulosis (AGEP)

Blood and lymphatic system disorders

Very rarely: 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: Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment. Fluid retention (usually responds promptly to discontinuation of treatment). Very rarely: cerebrovascular accident, hypotension, congestive heart failure in patients with compromised cardiac 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 modestly 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 subjects with pre-existing significantly impaired renal function, papillary necrosis, tubular necrosis, glomerulonephritis, abnormal renal function tests, polyuria, cystitis, haematuria.

Immune system disorders

In patients with pre-existing autoimmune diseases (e.g. systemic lupus erythematosus, connective tissue diseases), single cases of symptoms of aseptic meningitis such as neck tension, headache, nausea, vomiting, fever, disorientation have been reported (see section 4.4). Various Rarely: dry eyes and mouth, gum ulcers, rhinitis.

Overdose

Symptoms of overdose may 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 larger quantities, central nervous system toxicity is observed, manifested by drowsiness, occasionally excitation and disorientation or coma, and convulsions. In cases of severe poisoning, metabolic acidosis and prolongation of the prothrombin time (INR) may occur. Renal failure and liver damage may also occur. Asthmatics may experience exacerbation of disease symptoms. Treatment: There is no antidote to ibuprofen. Treatment is symptomatic and consists of appropriate supportive measures. Maintain airway patency and monitor cardiac function and vital signs. Particular attention is paid to blood pressure, acid-base balance, and any gastrointestinal bleeding. In cases of acute overdose, gastric emptying (vomiting or gastric lavage) is more effective the earlier it is performed; administration of alkali and induction of diuresis may also be useful; ingestion of activated charcoal may help reduce drug absorption.

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 embryonic/fetal development. 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. Additionally, 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 neonate, at the end of pregnancy, to: possible prolongation of bleeding time, an anti-aggregating effect that may occur even at very low doses; inhibition of uterine contractions resulting in delayed or prolonged labor.

Format

150 ml with measuring syringe.

Product Code:FRCM080723

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