Nurofen fever and pain children 100 mg/5 ml 150 ml sugar-free oral suspension strawberry flavour

Nurofen fever and pain children 100 mg / 5 ml 150 ml sugar-free oral suspension strawberry flavour is a syrup specifically formulated for the symptomatic treatment of fever and pain in children . Thanks to its active ingredient, ibuprofen , it acts effectively as an antipyretic, analgesic and anti-inflammatory , offering rapid relief from symptoms such as headache, toothache, sore throat, earache and fever, including post-vaccination fever. The oral suspension is sugar-free, ideal for children who need to control their calorie intake or who follow special diets, and has a pleasant strawberry flavour that makes it easy to take even in the little ones.

The 150 ml format is equipped with a dosing syringe that allows you to administer the correct dose based on the weight and age of the child, ensuring practicality and precision. Nurofen children is indicated for pediatric use starting from 3 months of age (with a weight greater than 5.6 kg) up to 12 years, ensuring a prolonged action of up to 8 hours. Its sugar-free formulation and the presence of strawberry flavor make it particularly suitable even for the most demanding children.

By choosing Nurofen fever and pain children 100 mg / 5 ml sugar-free oral suspension strawberry flavor , you offer your child an effective and safe treatment for fever and pain , with the guarantee of a product designed for the needs of the little ones. Ideal for the symptomatic treatment of fever and mild to moderate pain , this syrup represents a reliable and easy-to-administer solution for the daily well-being of children.

ACTIVE INGREDIENTS

Active ingredients in Nurofen fever and pain children 100 mg/5 ml 150 ml sugar-free oral suspension strawberry flavour - What is the active ingredient in Nurofen fever and pain children 100 mg/5 ml 150 ml sugar-free oral suspension strawberry flavour?

NUROFEN FEVER AND PAIN Children 100mg/5ml Oral Suspension Each ml of oral suspension contains: Active ingredient: ibuprofen 20 mg. Excipients with known effect: liquid maltitol, propylene glycol (present in the strawberry flavour), wheat starch (present in the orange flavour) and sodium. For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Nurofen fever and pain children 100 mg/5 ml 150 ml sugar-free oral suspension strawberry flavour - What does Nurofen fever and pain children 100 mg/5 ml 150 ml sugar-free oral suspension strawberry flavour contain?

Nurofen Fever and Pain Children 100mg/5ml sugar-free orange flavoured oral suspension Polysorbate 80, glycerin, maltitol syrup, sodium saccharin, citric acid, sodium citrate, xanthan gum, sodium chloride, orange flavouring, domiphene bromide, purified water. Nurofen Fever and Pain Children 100mg/5ml sugar-free strawberry flavoured oral suspension Polysorbate 80, glycerin, maltitol syrup, sodium saccharin, citric acid, sodium citrate, xanthan gum, sodium chloride, strawberry flavouring, domiphene bromide, purified water.

DIRECTIONS

Therapeutic indications Nurofen fever and pain children 100 mg/5 ml 150 ml sugar-free oral suspension strawberry flavour - Why is Nurofen fever and pain children 100 mg/5 ml 150 ml sugar-free oral suspension strawberry flavour used? What is it used for?

Symptomatic treatment of fever, including post-vaccination fever, and mild to moderate pain (such as headache, toothache, sore throat, earache).

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Nurofen fever and pain children 100 mg/5 ml 150 ml sugar-free oral suspension strawberry flavour - When should Nurofen fever and pain children 100 mg/5 ml 150 ml sugar-free oral suspension strawberry flavour not be used?

• 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. • 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 (see section 4.4). • Severe cardiac insufficiency (see section 4.4). • 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. • Patients with a history of cerebrovascular bleeding or other active bleeding. • Patients with unexplained blood formation disorders. • Patients with severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake). • During the last trimester of pregnancy (see section 4.6).

DOSAGE

Quantity and method of taking Nurofen fever and pain children 100 mg/5 ml 150 ml sugar-free oral suspension strawberry flavour - How do you take Nurofen fever and pain children 100 mg/5 ml 150 ml sugar-free oral suspension strawberry flavour?

Dosage The daily dose is structured according to the weight and age of the patient. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration of treatment necessary to control symptoms (see section 4.4). 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 dosing syringe or measuring spoon provided with the product. Patients who suffer from stomach problems may 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 scheme (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 marks 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.

Weight	Approximate age	Single dose in ml	Maximum number of administrations/day
From 5.6 kg	3 - 6 months	2.5 ml	3 in 24 hours
From 7 Kg	6 - 12 months	2.5 ml
From 10 Kg	1 - 3 years	5 ml
From 15 Kg	4 - 6 years	7.5ml (5ml + 2.5ml)
From 20 Kg	7 - 9 years	10 ml
From 28 to 43 Kg	10 - 12 years	15 ml

In case of post-vaccination fever, refer to the daily dosage recommended in the table above. The product is intended for short-term treatments. In infants aged between 3 and 5 months, a doctor should be consulted if the symptoms persist for more than 24 hours or if the symptoms worsen. If the use of the medicine is necessary for more than 3 days in infants and children over 6 months and in adolescents, or if the symptoms worsen, a doctor should 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. Turn the bottle upside down, 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 gently press the plunger to release the suspension. 7. After use, screw the cap on the bottle and wash the syringe with hot water. Leave it to dry, keeping it out of the reach and sight of children.

CONSERVATION

Storage Nurofen fever and pain children 100 mg/5 ml 150 ml sugar-free oral suspension strawberry flavour - How do you store Nurofen fever and pain children 100 mg/5 ml 150 ml sugar-free oral suspension strawberry flavour?

None in particular.

WARNINGS

Warnings Nurofen fever and pain children 100 mg/5 ml 150 ml sugar-free oral suspension strawberry flavour - About Nurofen fever and pain children 100 mg/5 ml 150 ml sugar-free oral suspension strawberry flavour it is important to know that:

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see sections below on gastrointestinal and cardiovascular risks). Other NSAIDs: the use of Nurofen Fever and Pain should be avoided in conjunction with NSAIDs, including selective COX-2 inhibitors. Analgesics, antipyretics, non-steroidal anti-inflammatory drugs may cause hypersensitivity reactions, potentially serious (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, non-steroidal anti-inflammatory drugs and in subjects with bronchial hyperreactivity (asthma), hay fever, nasal polyps, chronic obstructive respiratory disease or previous episodes of angioedema (see sections 4.2 and 4.8). Gastrointestinal (GI) effects: GI bleeding, ulceration and perforation: GI 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: Elderly patients have an increased frequency of adverse reactions to NSAIDs especially GI bleeding and perforation, which may be fatal (see section 4.2). The risk of GI 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 (see section 4.3). 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 likely to increase gastrointestinal risk (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 advised 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 anti-platelet agents such as acetylsalicylic acid (aspirin) (see section 4.5). 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 (see section 4.8). Dermatological effects: Severe 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: the onset of the reaction occurring in the majority of cases within the first month of treatment. Acute generalised exanthematous pustulosis (AGEP) has been reported in connection with medicinal products containing ibuprofen. Ibuprofen should be discontinued at the first appearance of signs and symptoms of severe skin reactions, such as rash, mucosal lesions, or any other sign of hypersensitivity. Masking of symptoms of underlying infections: Nurofen Fever and Pain may mask the symptoms of infection, which may 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 Nurofen Fever and Pain is administered for the relief of infection-related fever or pain, monitoring of the infection is advised. In non-hospital settings, the patient should seek medical advice if symptoms persist or worsen. Chickenpox may exceptionally cause serious infectious complications of the skin and soft tissue. To date, the contribution of NSAIDs to the worsening of such infections cannot be excluded, therefore it is recommended to avoid the use of Nurofen Fever and Pain in case of chickenpox. Cardiovascular and cerebrovascular effects : Caution is advised (discuss with your doctor or pharmacist) before initiating treatment in patients with a history of hypertension and/or heart failure since fluid retention, hypertension and oedema have been reported in association with NSAID treatment. 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. Patients with uncontrolled hypertension, congestive heart failure, established ischaemic 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). Renal disorders : In general, the habitual use of analgesics, especially the combination of different analgesic substances, may cause permanent renal damage, with risk of renal failure (analgesic nephropathy). In dehydrated children and adolescents there is a risk of impaired renal function (see sections 4.3 and 4.8). Monitoring of urine output and renal function should be considered in patients with heart failure, renal or hepatic failure, in those taking diuretics or in those who have undergone major surgery resulting in dehydration. Other considerations: Prolonged use of any type of analgesic for headache may worsen the symptoms. If this situation occurs or is suspected, a doctor should be consulted and treatment should be discontinued. The diagnosis of medication overuse headache (MOH) should be suspected in patients who experience frequent or daily headaches despite or because of the regular use of headache medications. Impaired female fertility : see section 4.6. The use of ibuprofen, acetylsalicylic acid or other analgesics, antipyretics, non-steroidal anti-inflammatory drugs requires particular caution: • in case of asthma or allergic diseases present or in history: possible deterioration of bronchoconstriction; in the presence of coagulation defects as ibuprofen, the active ingredient of Nurofen Fever and Pain, can temporarily inhibit platelet function (thrombocyte aggregation). Therefore, it is recommended to carefully monitor patients with coagulation disorders; • in the presence of renal, cardiac or hypertension disease: possible critical reduction of renal function (especially in subjects with impaired renal or hepatic function, heart failure or in treatment with diuretics), nephrotoxicity or fluid retention; • in the presence of liver disease: possible hepatotoxicity; • rehydrate the subject before the start and during treatment in case of dehydration (for example due to fever, vomiting or diarrhoea); • immediately after major surgery; • congenital disorders of porphyrin metabolism (for example, acute intermittent porphyria). The following precautions are relevant 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 colour 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 with systemic lupus erythematosus and mixed connective tissue disease or other collagen diseases) (see section 4.8). Since Nurofen Fever and Pain contains liquid maltitol , patients with rare hereditary problems of fructose intolerance should not take this medicine. It may have a mild laxative effect. The caloric value of maltitol is 2.3 kcal/g. Nurofen Fever and Pain does not contain sugar and is therefore indicated for those patients who need to control their sugar and calorie intake. This medicinal product contains 9.08 mg sodium per 5 ml equivalent to 0.45% of the maximum daily intake recommended by the WHO which corresponds to 2 g sodium for an adult. NUROFEN FEVER AND PAIN Children 100mg/5ml sugar-free strawberry flavoured oral suspension contains 11.75 mg propylene glycol (present in the strawberry flavour) in 5 ml. Co-administration with any substrate of alcohol dehydrogenase such as ethanol may lead to serious adverse effects in neonates. NUROFEN FEVER AND PAIN Children 100mg/5ml sugar-free orange flavoured oral suspension contains only a very small amount of gluten (from the wheat starch present in the orange flavour). This medicine is considered (gluten-free) and is very unlikely to cause problems for a patient with coeliac disease. One 5 ml dose contains no more than 0.225 micrograms of gluten. If the patient is allergic to wheat (other than coeliac disease) they should not take this medicine.

INTERACTIONS

Interactions Nurofen fever and pain children 100 mg/5 ml 150 ml sugar-free oral suspension strawberry flavour - Which medicines or foods can modify the effect of Nurofen fever and pain children 100 mg/5 ml 150 ml sugar-free oral suspension strawberry flavour?

Ibuprofen should be avoided in combination with : • Acetylsalicylic acid: Concomitant administration of ibuprofen and acetylsalicylic acid is not generally recommended due to the potential for increased adverse effects. 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 the application of ex vivo data to the clinical situation do not allow definitive conclusions to be drawn on regular use of ibuprofen; clinically relevant effects from occasional use of ibuprofen are unlikely (see section 5.1). • Other NSAIDs including cyclooxygenase-2 selective inhibitors : avoid the concomitant use of two or more analgesics, antipyretics, nonsteroidal anti-inflammatory drugs: increased risk of adverse effects (see section 4.4). Ibuprofen should be used with caution in combination with: • corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see section 4.4); • 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 increase the effects of anticoagulants (see section 4.4); • antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4); • phenytoin: Concomitant use of Nurofen Fever and Pain with phenytoin may increase the serum levels of these medicines. Correct use of the drugs (administered for a maximum period of 3 days) does not normally require monitoring of serum phenytoin levels. • antidiabetics: an increase in the hypoglycaemic effect of sulphonylureas is possible. In the case of simultaneous treatment, monitoring of blood glucose levels is recommended. • antivirals, such as ritonavir: possible increase in the concentration of NSAIDs; • ciclosporin: increased risk of nephrotoxicity; • mifepristone: NSAIDs must not be administered in the 8-12 days following mifepristone intake as they may reduce its efficacy; • 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 and sulfinpyrazone: slow the excretion of NSAIDs (increase in plasma concentrations); • methotrexate: potential increase in plasma concentrations of methotrexate; • zidovudine: increased risk of haematotoxicity when NSAIDs are used in combination with zidovudine. There is evidence of an increased risk of haemarthrosis and haematomas in HIV (+) haemophiliacs if treated simultaneously with zidovudine and ibuprofen; • antihypertensives (ACE inhibitors and angiotensin II antagonists) and diuretics: 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 cyclo-oxygenase 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 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. • potassium-sparing diuretics: Concomitant administration of Nurofen Fever and Pain and potassium-sparing diuretics may lead to hyperkalaemia • CYP2C9 inhibitors: Concomitant administration of ibuprofen and CYP2C9 inhibitors may increase the exposure to ibuprofen (CYP2C9 substrate). In a study with voriconazole and fluconazole (CYP2C9 inhibitors), an increased exposure to S(+)-ibuprofen of approximately 80% to 100% was demonstrated. Consideration should be given to reducing the ibuprofen dose when strong CYP2C9 inhibitors are administered concomitantly, particularly when high doses of ibuprofen are administered with voriconazole or fluconazole. • cardiac glycosides (Digoxin): NSAIDs may worsen heart failure, reduce GFR (glomerular filtration rate) and increase plasma glycoside levels.

SIDE EFFECTS

Like all medicines, Nurofen fever and pain children 100 mg/5 ml 150 ml sugar-free oral suspension strawberry flavour can cause side effects - What are the side effects of Nurofen fever and pain children 100 mg/5 ml 150 ml sugar-free oral suspension strawberry flavour?

The following list of undesirable effects includes all those that have been recognized during treatment with ibuprofen for short periods of treatment and for daily doses up to a maximum of 1200 mg. In case of therapies for chronic or prolonged diseases at high doses, other undesirable effects may occur. The adverse reactions associated with the administration of ibuprofen are listed below according to the system organ class and by 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 (the frequency cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in decreasing order of seriousness.

Classification by systems and organs	Frequency	Adverse reaction
Infections and infestations	Rare	Cystitis, rhinitis
	Very rare	Worsening of infection-related inflammation (e.g. development of necrotizing fasciitis), in exceptional cases severe skin infections and soft tissue complications have been reported during chickenpox infection.
Pathologies of the haemolymphopoietic system	Very rare	Disorders of hematopoiesis ¹
Immune system disorders	Uncommon	Hypersensitivity reactions manifested by urticaria and itching²
	Very rare	severe hypersensitivity reactions including swelling of the face, tongue and larynx, dyspnoea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock). Exacerbation of asthma.
Metabolism and nutrition disorders	Not known	Fluid retention and decreased appetite³.
Psychiatric disorders	Not known	Irritability
	Rare	Depression, insomnia, difficulty concentrating, emotional lability, hearing disorders.
Nervous system disorders	Uncommon	Headache, dizziness, drowsiness, convulsions, agitation, tiredness
	Very rare	Aseptic meningitis 4
	Rare	Cerebrovascular hemorrhage
Eye pathologies	Rare	Dry eyes
	Uncommon	Visual disturbances
Ear and labyrinth pathologies	Not known	Tinnitus
Heart disease	Very rare	Myocardial infarction
	Not known	Heart failure and edema 5 .
	Rare	Palpitations
Vascular pathologies	Not known	Hypertension 5 and shock.
Respiratory, thoracic and mediastinal pathologies	Not known	Respiratory tract reactivity including asthma, laryngeal obstruction, bronchospasm or apnea, dyspnea.
Gastrointestinal disorders	Uncommon	Abdominal pain, nausea and dyspepsia 6 .
	Rare	Diarrhea, flatulence, dry mouth, constipation and vomiting.
	Very rare	Peptic ulcer, perforation or gastrointestinal bleeding, melena and haematemesis 7 . Mouth ulcerations and gastritis.
	Not known	Exacerbation of colitis and Crohn's disease 8 , pancreatitis, duodenitis, esophagitis.
Hepatobiliary pathologies	Very rare	Liver dysfunction, hepatitis, jaundice, hepatorenal syndrome, hepatic necrosis, hepatic failure.
Skin and subcutaneous tissue disorders	Uncommon	Various skin rashes²
	Very rare	Bullous reactions including Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis².
	Rare	Exfoliative dermatitis, alopecia, photosensitivity reactions.
	Not known	Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), acute generalized exanthematous pustulosis (AGEP).
Kidney and urinary disorders	Rare	Tubular necrosis, glomerular nephritis, polyuria, hematuria.
	Very rare	Acute renal failure 9
Diagnostic tests	Rare	Decrease in hematocrit levels
	Very rare	Decrease in hemoglobin levels

Description of selected adverse reactions ¹ Haematopoietic disorders including anaemia, aplastic anaemia, haemolytic anaemia (positive Coombs test), leucopenia, neutropenia, thrombocytopenia (with or without purpura), eosinophilia, pancytopenia and agranulocytosis. Early symptoms may include fever, sore throat, superficial mouth ulcers, flu-like symptoms, marked fatigue, epistaxis and haemorrhage. In these cases, the patient should be advised to immediately stop the medicinal product, avoid any over-the-counter medicinal products containing analgesics or antipyretics and consult a doctor. Rarely, congestive heart failure in patients with impaired cardiac function. ² Hypersensitivity reactions: These reactions include a) non-specific allergic reactions and anaphylaxis, fever, chills, b) respiratory tract reactivity including asthma, aggravated asthma, bronchospasm (see sections 4.3 and 4.4) or dyspnoea or c) various skin disorders including various rashes (including maculopapular in nature), pruritus, urticaria with or without angioedema, purpura, angioedema and very rarely, bullous and exfoliative dermatitis including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme. ³ Decreased appetite: Generally resolves rapidly upon discontinuation of treatment (see section 4.4). ⁴ The pathogenetic mechanism of drug-induced aseptic meningitis is not fully understood. However, available data on aseptic meningitis related to NSAID administration suggest an immune reaction (due to a temporal relationship with drug intake and the disappearance of symptoms after treatment discontinuation). Of note, single cases of aseptic meningitis symptoms (such as stiff neck, numbness in the neck, 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 Heart failure and oedema: 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 (for example myocardial infarction or stroke) (see section 4.4). Congestive heart failure in patients with compromised cardiac function. ⁶ The most commonly observed adverse events are gastrointestinal in nature. Gastric disturbances may be reduced by taking the medicinal product with food. ⁷ Peptic ulcers, perforation or gastrointestinal bleeding, melaena and haematemesis, sometimes fatal, may occur. ⁸ Exacerbation of colitis and Crohn's disease (see section 4.4). ⁹ Acute renal failure, especially in case of long-term therapy, associated with increased serum urea levels and oedema. Papillary necrosis may occur. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioniavverse .

OVERDOSE

Overdose Nurofen fever and pain children 100 mg/5 ml 150 ml sugar-free oral suspension strawberry flavour - What are the risks of Nurofen fever and pain children 100 mg/5 ml 150 ml sugar-free oral suspension strawberry flavour in case of overdose?

Toxicity Signs and symptoms of toxicity have not generally been observed at doses below 100 mg/kg in children or adults. However, in some cases supportive treatment may be necessary. 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 following 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 commonly reported symptoms of overdose 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, excitement, 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 and prolongation of prothrombin time (INR) may occur, probably due to interference with the action of circulating clotting factors. In asthmatic subjects, exacerbation of symptoms of the disease may occur. Treatment There is no specific antidote for ibuprofen overdose. Therefore, symptomatic and supportive treatment is indicated in the event of overdose and should include maintaining a patent airway and monitoring cardiac function and vital signs until the patient is stabilized. 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 within one hour of ingestion of a potentially life-threatening overdose in adults. Adequate diuresis should be ensured and renal and hepatic function should be closely monitored. The patient should remain under observation for at least four hours following ingestion of a potentially toxic amount. Any occurrence of 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. Bronchodilators should be administered in cases of asthma. Other supportive measures may be necessary depending on the clinical condition of the patient. For more information, contact your local poison control center.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Nurofen fever and pain children 100 mg/5 ml 150 ml sugar-free oral suspension strawberry flavour

It is unlikely that subjects under the age of 12 years will become pregnant or breast-feed. However, in such circumstances the following considerations should be taken into account. Pregnancy Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or embryo/foetal development. Results of epidemiological studies suggest an increased risk of miscarriage and of 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 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-foetal mortality. In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period. From the 20th ^week of pregnancy onwards, the use of ibuprofen may cause oligohydramnios resulting from fetal renal dysfunction. This condition may be encountered soon after initiation of treatment and is usually reversible upon discontinuation of treatment. In addition, cases of constriction of the ductus arteriosus have been reported following treatment in the second trimester, most of which resolved after discontinuation of treatment. Therefore, during the first and second trimesters of pregnancy, ibuprofen should not be given unless clearly necessary. If ibuprofen is used by a woman planning to become pregnant, or during the first and second trimester of pregnancy, the lowest possible dose should be used for the shortest possible duration. Following exposure to ibuprofen for several days from the 20th ^week of gestation onwards, antenatal monitoring for oligohydramnios and constriction of the ductus arteriosus should be considered. If oligohydramnios or constriction of the ductus arteriosus occurs, treatment with ibuprofen should be discontinued. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to: - cardiopulmonary toxicity (premature constriction/closure of the ductus arteriosus and pulmonary hypertension); - renal dysfunction (see above); the mother and the neonate, at the end of pregnancy, to: - possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labour. Consequently, Nurofen Fever and Pain is contraindicated during the third trimester of pregnancy (see sections 4.3 and 5.3). Breastfeeding There are limited data showing that ibuprofen may pass into breast milk in low concentrations and is unlikely to have any adverse effects on the infant. Fertility There is evidence that medicinal products that inhibit cyclooxygenase/prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This effect is reversible after discontinuation of treatment.

DRIVING AND USE OF MACHINERY

Taking Nurofen fever and pain children 100 mg/5 ml 150 ml sugar-free oral suspension strawberry flavour before driving or using machines - Does Nurofen fever and pain children 100 mg/5 ml 150 ml sugar-free oral suspension strawberry flavour affect driving or using machines?

Not relevant, considering the patient's age.