Algopirina fever and pain children 100 mg/5 ml - sugar-free orange flavored oral suspension - 150 ml

Product Description

Treatment for fever and pain.

Indications

Algopirina Febbre E Dolore Bambini 100mg/5ml Oral Suspension, symptomatic treatment of fever and mild to moderate pain.

Orange flavor.

Composition

Active ingredients

Each ml of oral suspension contains: ibuprofen 20 mg.

Excipients

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

Directions for use and Dosage

The daily dose is 100 mg. structured according to the weight and age of the patient.
In children aged between 3 and 6 months, limit administration to those weighing more than 5.6 kg.
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.

Warnings

After three days of treatment without appreciable results, consult your doctor.

The use of ALGOPIRINA FEBBRE E DOLORE should be avoided in conjunction with NSAIDs, including selective COX-2 inhibitors. Analgesics, antipyretics, and nonsteroidal anti-inflammatory drugs can cause hypersensitivity reactions, potentially serious (anaphylactoid reactions), even in subjects not previously exposed to this type of drug. 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 GI events.
Elderly: 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 increasing NSAID doses. These patients should start treatment on the lowest dose available. Concomitant use of protective agents (e.g., misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients taking low-dose aspirin or other drugs known to increase gastrointestinal risk. Patients with a history of NSAID toxicity should be monitored closely. Patients with gastrointestinal problems, particularly the elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal bleeding), particularly in the initial stages of treatment. If gastrointestinal bleeding or ulceration occurs in patients receiving Algopirina Febbre E Dolore, 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. 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. 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. Algopirina Fever and Pain should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Caution is required before initiating treatment in patients with a history of hypertension and/or heart failure, as fluid retention, hypertension, and edema have been reported in association with NSAID treatment. Clinical studies suggest that use of ibuprofen, particularly at high doses (2400 mg/day), 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 arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (NYHA class II-III), established ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should be treated with ibuprofen only after careful consideration, and high doses (2400 mg/day) should be avoided. Careful consideration should also be exercised before initiating long-term treatment in patients with risk factors for cardiovascular events (e.g., hypertension, hyperlipidemia, diabetes mellitus, smoking), especially if high doses (2400 mg/day) of ibuprofen are required. The use of ibuprofen, acetylsalicylic acid or other analgesics, antipyretics, nonsteroidal 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: evaluate the rare possibility that it is due to the use of ibuprofen (aseptic meningitis; more frequent in subjects suffering from systemic lupus erythematosus or other collagen diseases).

Since Algopirina Febbre E Dolore contains maltitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Algopirina Febbre E Dolore does not contain sugar and is therefore indicated for those patients who need to control their sugar and calorie intake.
Each 2.5 ml dose of suspension contains 4.51 mg (0.20 mmol) of sodium; this should be taken into consideration if a low-sodium diet is recommended.

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 ibuprofen or to any of the excipients. Children under 3 months of age or weighing less than 5.6 kg. Hypersensitivity to ibuprofen or to any of the excipients. 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 (NYHA class IV). History of gastrointestinal bleeding or perforation related to previous active treatments or history of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding). Concomitant use of NSAIDs, including specific COX-2 inhibitors. Pregnancy and breastfeeding.

Undesirable effects

The undesirable effects observed with ibuprofen are common to other analgesics, antipyretics, and nonsteroidal anti-inflammatory drugs. Hypersensitivity reactions Rarely: anaphylactoid reactions (urticaria with or without angioedema), dyspnea (due to laryngeal obstruction or bronchospasm), shock, syndrome characterized by abdominal pain, fever, chills, nausea and vomiting; bronchospasm. 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. Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported after administration of Algopirina Febbre E Dolore. Less frequently, gastritis has been observed. Epigastric pain, heartburn. Gastric disturbances can be reduced by taking the drug on a full stomach. Rarely: Hepatitis, jaundice, abnormal liver function tests, pancreatitis, duodenitis, esophagitis, hepatorenal syndrome, liver necrosis, liver failure. Nervous system and sensory organ disorders: Vertigo, headache, irritability, tinnitus. Rarely: Depression, insomnia, difficulty concentrating, emotional lability, somnolence, aseptic meningitis, convulsions, hearing and vision disturbances. Respiratory, thoracic and mediastinal disorders: Rarely: Bronchospasm, dyspnoea, apnoea. Skin and subcutaneous tissue disorders: Bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (very rare). Skin rashes (including maculopapular rash), pruritus. Rarely: vesiculobullous eruptions, urticaria, erythema multiforme, alopecia, exfoliative dermatitis, photosensitivity dermatitis. Not known: Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). Blood and lymphatic system disorders: Very rare: neutropenia, agranulocytosis, aplastic anemia, haemolytic anemia (possibly positive Coombs test), thrombocytopenia (with or without purpura), eosinophilia, decreased haemoglobin and haematocrit, pancytopenia. Metabolism and nutrition disorders: Decreased appetite. Cardiac and vascular disorders: Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment. Fluid retention (usually responds promptly to discontinuation of treatment). Very rare: cerebrovascular accidents, hypotension, congestive heart failure in patients with compromised cardiac function, palpitations. Clinical studies suggest that the use of ibuprofen, particularly at high doses (2400 mg/day), may be associated with a modest increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke). Renal and urinary disorders Very rare: acute renal failure in patients with pre-existing significant renal impairment, papillary necrosis, tubular necrosis, glomerulonephritis, abnormal renal function tests, polyuria, cystitis, hematuria. Immune system disorders: Individual cases of symptoms of aseptic meningitis such as neck tension, headache, nausea, vomiting, fever, and disorientation have been reported in patients with pre-existing autoimmune diseases (e.g. systemic lupus erythematosus, connective tissue diseases). Various Rarely: dry eyes and mouth, gum ulcers, rhinitis. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important, as it allows continued monitoring of the benefit/risk balance of the medicinal product.

Overdose

Toxicity Signs and symptoms of toxicity have generally not been observed at doses below 100 mg/kg in children and adults. However, supportive treatment may be necessary in some cases. Children have been observed to show signs and symptoms of toxicity after ingestion of ibuprofen at doses of 400 mg/kg or greater. The half-life of the drug in case of overdose is 1.5-3 hours. Symptoms Most patients who have ingested significant amounts of ibuprofen will experience symptoms within 4 to 6 hours. The most commonly reported symptoms of overdose include nausea, vomiting, abdominal pain, lethargy, and drowsiness. Central nervous system (CNS) effects include headache, tinnitus, dizziness, convulsions, and loss of consciousness. Nystagmus, metabolic acidosis, hypothermia, renal effects, gastrointestinal bleeding, coma, apnea, diarrhea, and CNS and respiratory depression have also been reported rarely. Disorientation, excitation, fainting, and cardiovascular toxicity including hypotension, bradycardia, and tachycardia have been reported. Renal failure and liver damage are possible in cases of significant overdose. In cases of severe poisoning, metabolic acidosis may occur. Treatment: There is no specific antidote for ibuprofen overdose. Therefore, supportive symptomatic treatment is indicated in the event of an overdose. Particular attention should be paid to monitoring blood pressure, acid-base balance, and any gastrointestinal bleeding. Administration of activated charcoal should be considered within one hour of ingestion of a potentially toxic amount. Alternatively, gastric lavage should be considered in adults within one hour of ingestion of a potentially life-threatening overdose. Adequate diuresis must be ensured, and renal and hepatic function must be closely monitored. The patient should remain under observation for at least four hours following ingestion of a potentially toxic amount of the drug. Any occurrence of frequent or prolonged convulsions should be treated with intravenous diazepam. Other supportive measures may be necessary depending on the patient's clinical condition. For further information, contact your local poison control center.

Pregnancy and breastfeeding

Pregnancy It is unlikely that individuals under 12 years of age will become pregnant or breastfeed. However, in such circumstances, the following considerations should be taken into account. Inhibition of prostaglandin synthesis may adversely affect the 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 is believed to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to result in increased pre- and post-implantation loss and embryo-fetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular, has been reported in animals administered prostaglandin synthesis inhibitors during the organogenetic period.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the fetus to:

• cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);
• renal dysfunction that may progress to renal failure with oligo-hydroamniosis; the mother and the newborn, at the end of pregnancy, to:
• possible prolongation of bleeding time, an anti-aggregating effect that may occur even at very low doses;
• inhibition of uterine contractions resulting in delayed or prolonged labor.

Storage

No particulars.

Format

150 ml bottle with measuring syringe