Nurofen fever & pain children 100 mg/5 ml - strawberry taste 150 ml

Product Description

Syrup for fever and pain in children.

Indications

Nurofen Fever and Pain Children 100 mg/5ml Oral Suspension is a medicine indicated for the symptomatic treatment of fever and mild to moderate pain in children.

Flavor: Strawberry
Sugar Free.

Composition

Active ingredient for each ml: ibuprofen 20 mg.
Excipients: Polysorbate 80, glycerin, maltitol syrup, sodium saccharin, citric acid, sodium citrate, xanthan gum, sodium chloride, strawberry flavoring, domiphene bromide, purified water.

How to use and Dosage

Dosage
The daily dose is structured according to the weight and age of the patient.
Undesirable effects can be minimised by using the lowest effective dose for the shortest duration of treatment necessary to control symptoms.
In children aged between 3 and 6 months, limit administration to those weighing more than 5.6 kg.
Method of administration
Oral administration to infants and children aged between 3 months and 12 years should be done using the measuring syringe or measuring spoon provided with the product.
Patients who suffer from stomach problems can take the medicine during meals.
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. (Do not exceed the recommended doses)
The graduated scale on the body of the syringe clearly shows the notches for the different dosages; in particular, the 2.5 ml mark corresponding to 50 mg of ibuprofen and the 5 ml mark corresponding to 100 mg of ibuprofen.
The measuring spoon has two notches for two different dosages: the 2.5 ml mark corresponding to 50 mg of ibuprofen and the 5 ml mark corresponding to 100 mg of ibuprofen.

Special populations: in case of post-vaccination fever, refer to the dosage indicated above. It is recommended to administer a single dose (2.5 ml) followed, if necessary, by another dose after 6 hours.
Do not administer more than 2.5 ml. of two doses in 24 hours.
Consult your doctor if the fever does not decrease.
The product is intended for short-term treatment.
In infants between 3 and 5 months of age, your doctor should be consulted if symptoms persist for more than 24 hours or if symptoms worsen.
If the use of the medicine is necessary for more than 24 hours, 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.

Instructions for using the dosing syringe:

1. Unscrew the cap by pushing it downwards and turning it to the left.
2. Insert the tip of the syringe fully into the hole in the undercap.
3. Shake well.
4. 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.
5. Return the bottle to an upright position and remove the syringe by gently twisting it.
6. Insert the tip of the syringe into the child's mouth and apply gentle pressure on the plunger to allow the suspension to flow out.
7. After use Screw the cap to close the bottle and wash the syringe with hot water.
   Let it dry, keeping it out of the reach and sight of children.

Warnings

The use of Nurofen Fever and Pain should be avoided in conjunction with NSAIDs, including selective COX-2 inhibitors.
Analgesics, antipyretics, and non-steroidal anti-inflammatory drugs can cause potentially serious hypersensitivity reactions (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, and non-steroidal anti-inflammatory drugs and in subjects with bronchial hyperreactivity (asthma), nasal polyps or previous episodes of angioedema.
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.
There is a risk of impaired renal function in dehydrated children and adolescents.
Elderly: Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal.
The risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing NSAID doses, in the elderly and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation.
These patients should initiate treatment with the most appropriate dose. low 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 likely to increase the risk of gastrointestinal events.
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 advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or anti-platelet agents such as acetylsalicylic acid (aspirin).
When gastrointestinal bleeding or ulceration occurs in patients receiving Nurofen Fever and Pain, the treatment should be withdrawn.
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: the onset of the reaction occurs in the majority of cases within the first month of treatment.
Nurofen Fever and Pain should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Caution is advised (discuss with your doctor or pharmacist) before initiating treatment in patients with a history of hypertension and/or heart failure as these conditions may be exacerbated. 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 treatment, may be associated with a modest 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.
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 consideration should be made before initiating long-term treatment in patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking).
The use of ibuprofen, acetylsalicylic acid, or other analgesics, antipyretics, and nonsteroidal anti-inflammatory drugs requires particular caution:

• in case of asthma or allergic diseases, current or previous: possible deterioration of 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);

The following precautions are relevant during prolonged treatments:

• monitor for signs or symptoms of gastrointestinal ulceration or bleeding;
• monitor for signs or symptoms of hepatotoxicity;
• monitor signs or symptoms of nephrotoxicity;
• if visual disturbances occur (blurred or reduced vision, scotomas, alteration of color perception):
  stop 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 with systemic lupus erythematosus and mixed connective tissue disease or other collagen diseases).

Since Nurofen Fever and Pain contains maltitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Nurofen Fever and Pain does not contain sugar and is therefore suitable for those patients who need to control their sugar and calorie intake.
Each 2.5 ml dose of suspension contains 4.63 mg (0.20 mmol) of sodium; this should be taken into consideration if a controlled 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.
• The medicinal product is contraindicated in patients who show or have previously shown hypersensitivity (e.g. asthma, rhinitis, angioedema, or urticaria) to acetylsalicylic acid or other analgesics, antipyretics, nonsteroidal 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 NSAID therapy; 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.
• During the last trimester of pregnancy.

Interactions

Ibuprofen should be avoided in combination with:

• Acetylsalicylic acid (aspirin): Unless low dose acetylsalicylic acid (not more than 75 mg daily), as is common clinical practice, has been advised by your doctor, as it may increase the risk of serious side effects. increase the risk of adverse reactions.
  Experimental data indicate that ibuprofen may inhibit the effects of low-dose aspirin on platelet aggregation when the drugs are administered concomitantly.
  However, the limited data and the uncertainties relating to the application of ex vivo data to the clinical situation do not allow definitive conclusions to be drawn on the regular use of ibuprofen;
  Clinically relevant effects from occasional use of ibuprofen are unlikely.
• Other NSAIDs including selective cyclooxygenase inhibitors -2: Avoid the concomitant use of two or more NSAIDs. Analgesics, antipyretics, nonsteroidal anti-inflammatory drugs: increased risk of adverse effects.

Ibuprofen should be used with caution in combination with:

• Corticosteroids: increased risk of gastrointestinal ulceration or bleeding.
• Quinolone antibiotics: data from animal studies indicate that NSAIDs may increase the risk of convulsions associated with quinolone antibiotics.
  Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions.
• Anticoagulants, such as warfarin: NSAIDs may enhance the effects of anticoagulants.
• Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding.
• Antidiabetics: possible increased effect of sulfonylureas
• Antivirals, such as ritonavir: possible increase in the concentration of NSAIDs.
• Cyclosporin: increased risk of nephrotoxicity.
• Mefepristone: NSAIDs should not be administered within 8–12 days of taking mefepristone since may reduce its effectiveness.
• Cytotoxics, such as methotrexate: reduced excretion (increased risk of toxicity).
• Lithium: reduced excretion (increased risk of toxicity)
• Tacrolimus: increased risk of nephrotoxicity.
• Uricosurics, such as probenecid: slows the excretion of NSAIDs (increase in plasma concentrations).
• Methotrexate: potential increase in plasma concentrations of methotrexate.
• Zidovudine: increased risk of haematological toxicity when NSAIDs are used in combination with zidovudine.
  There is evidence of an increased risk of haemarthrosis and haematomas in HIV (+) haemophiliacs when treated simultaneously with zidovudine and ibuprofen.
• Diuretics, ACE inhibitors and Antagonists Angiotensin II: 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 increase the risk of serious complications. lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible.
  These interactions should be considered in patients taking Nurofen 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 consideration should be given to monitoring renal function after initiation of concomitant therapy and periodically thereafter.
• Cardiac glycosides: NSAIDs may worsen heart failure, reduce GFR (glomerular filtration rate) and increase plasma glycoside levels.

Undesirable effects

The list of the following undesirable effects includes all those that have been recognized during treatment with ibuprofen for short periods of treatment and for daily doses of up to 1200 mg.
/>In case of high-dose therapy for chronic or prolonged conditions, other undesirable effects may occur.
Adverse reactions associated with the administration of ibuprofen are listed below according to system organ class and frequency.
The frequencies are defined as:

• Very common (1/10);
• Common (1/100, <1/10);
• Uncommon (1/1,000, <1/100);
• Rare (1/10,000, <1/1,000);
• Very rare (<1/10,000);
• Not known (frequency cannot be estimated from the available data);

Within each frequency grouping, undesirable effects are presented in decreasing order of gravity.

Description of selected adverse reactions

1. Haematopoiesis disorders including anaemia, aplastic anaemia, haemolytic anaemia (Coombs test positive), leukopenia, Neutropenia, thrombocytopenia (with or without purpura), eosinophilia, pancytopenia and agranulocytosis.
   The first symptoms may be: fever, sore throat, superficial mouth ulcers, flu-like symptoms, marked fatigue, epistaxis and haemorrhage.
   Rarely, congestive heart failure in patients with impaired cardiac function.
2. Hypersensitivity reactions: These reactions include:
   
   • non-specific allergic reactions and anaphylaxis, fever, chills,
   • respiratory tract reactivity including asthma, aggravated asthma, bronchospasm or dyspnoea
   • various skin conditions including various rashes (including maculopapular in nature), pruritus, urticaria with or without angioedema, purpura, angioedema and very rarely, bullous and exfoliative dermatitis including necrolysis toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme.
3. Decreased appetite: generally resolves rapidly upon discontinuation of treatment.
4. The pathogenetic mechanism of drug-induced aseptic meningitis is not fully understood.
   However, available data on aseptic meningitis related to the administration of NSAIDs suggest an immune reaction (due to a temporal relationship with drug intake and the disappearance of symptoms after discontinuation of treatment).
   Of note, single cases of symptoms of aseptic meningitis (such as stiff neck, numbness, headache, nausea, vomiting, fever and disorientation) have been observed during treatment with ibuprofen in patients with autoimmune diseases (such as systemic lupus erythromatosus, mixed connective tissue disease).
5. Cardiac failure and oedema: Clinical studies and epidemiological data suggest that The use of ibuprofen, particularly at high doses (2400 mg/day) and in long-term treatment, may be associated with a modest increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke).
   Congestive heart failure in patients with compromised cardiac function
6. The most commonly observed adverse events are gastrointestinal in nature.
   Gastric disturbances can be reduced by taking the medicine with food.
7. Peptic ulcers, perforation or gastrointestinal bleeding, melaena and haematemesis, sometimes fatal, may occur.
8. Exacerbation of colitis and Crohn's disease.
9. Acute renal failure, especially in case of long-term therapy, associated with increased serum urea levels and edema.
   May Papillary necrosis may occur.

Overdose

Toxicity
Signs and symptoms of toxicity have not generally been observed at doses below 100 mg/kg in children or 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 overdose is 1.5–3 hours.
Symptoms
Most patients who accidentally ingest clinically relevant amounts of ibuprofen will experience symptoms within 4–6 hours.
The most common symptoms of overdose are: Commonly reported side effects include nausea, vomiting, abdominal pain, lethargy, and somnolence.
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 more serious cases, prolongation of prothrombin time (INR) may occur, probably caused by interference with the action of circulating coagulation factors.
In asthmatic subjects, anaphylaxis may be necessary. check for an exacerbation of the symptoms of the disease.
Treatment
There is no specific antidote for ibuprofen overdose.
In case of overdose, symptomatic and supportive treatment is therefore indicated and should include maintaining a patent airway and monitoring cardiac function and vital signs until the patient is stabilized.
Particular attention is due to the control of 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, in adults, gastric lavage should be considered 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 frequent or prolonged convulsions should be treated with intravenous diazepam or lorazepam.
If ibuprofen has already been absorbed, alkaline substances should be administered to promote excretion of the acidic ibuprofen in the urine.
Administer bronchodilators in cases of asthma.
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

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.
Pregnancy
During the first and second trimester of pregnancy, ibuprofen administration should be be avoided.
Ibuprofen is contraindicated during the third trimester of pregnancy.
Inhibition of prostaglandin synthesis may may adversely affect pregnancy and/or embryo/fetal development.
Results from 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%, up 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 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 given prostaglandin synthesis inhibitors during the organogenetic period.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors Prostaglandins may expose the fetus to:

• cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);
• renal dysfunction which 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 which may may occur even at very low doses;
• inhibition of uterine contractions resulting in delayed or prolonged labor.

Breastfeeding
There are limited data demonstrating that ibuprofen can pass into breast milk in low concentrations and is unlikely to have any adverse effects on infants.

Format

150 ml bottle