Nurofen for fever and pain

Package leaflet: Information for the patient

Nurofen Fever and Pain 200mg/5ml oral suspension, orange flavour sugar-free, strawberry flavour sugar-free

Ibuprofen
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

• Keep this leaflet. You may need to read it again.
• If you need more advice or information, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after: 3 days.

Contents of this leaflet:

1. What Nurofen Fever and Pain is and what it is used for
2. What you need to know before using Nurofen Fever and Pain
3. How to use Nurofen Fever and Pain
4. Possible side effects
5. How to store Nurofen Fever and Pain
6. Contents of the pack and other information

1. What Nurofen Fever and Pain is and what it is used for

Nurofen Fever and Pain contains ibuprofen, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These medicines help reduce pain, fever, and inflammation.
Nurofen Fever and Pain is indicated in children from 2 to 12 years of age, adolescents, and adults for the symptomatic treatment of fever, including post-vaccination fever, and mild to moderate pain (such as headache, toothache, sore throat, earache, muscle pain), whether or not associated with influenza and cold.

2. What you need to know before using Nurofen Fever and Pain

Allergic reactions to ibuprofen have been reported, including
breathing difficulties, swelling of the face and neck area (angioedema), and chest pain.
Stop taking Nurofen Fever and Pain immediately and contact your doctor or emergency medical services right away if you notice any of these signs.
Do not use Nurofen Fever and Pain if:

• you are allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6);
• you have experienced or previously experienced allergic reactions such as shortness of breath, rhinitis (runny nose), swelling of the face, lips, and throat (angioedema), or hives, particularly if associated with nasal polyps and asthma, after taking other painkillers, other antipyretics, acetylsalicylic acid, or other non-steroidal anti-inflammatory drugs (NSAIDs);
• you suffer from severe kidney or liver disease (renal or hepatic failure);
• you suffer from severe heart disease (heart failure);
• you are currently suffering or have previously suffered from gastrointestinal bleeding and/or intestinal perforation following previous treatments with NSAIDs;
• you are currently suffering or have previously suffered from gastric/duodenal ulcers (peptic ulcers) or recurrent or active bleeding (at least two distinct episodes of proven ulceration or bleeding);
• you are taking other non-steroidal anti-inflammatory drugs (NSAIDs, including selective COX-2 inhibitors) (see section “Other medicines and Nurofen Fever and Pain”);
• the child is under 2 years of age;
• you are in the last trimester of pregnancy (see section “Pregnancy, breastfeeding and fertility”).

Warnings and precautions
Talk to your doctor or pharmacist before using Nurofen Fever and Pain if:

• you suffer or have previously suffered from allergies to medicines used to treat fever, pain, and inflammation (non-steroidal anti-inflammatory drugs), and if you have breathing difficulties (asthma), nasal polyps, or swelling of the face, lips, and throat (angioedema);
• you are taking other medicines used to treat pain, reduce fever, and/or treat inflammation (non-steroidal anti-inflammatory drugs, NSAIDs, including COX-2 inhibitors) (see section “Other medicines and Nurofen Fever and Pain”);
• you have previously suffered from stomach or intestinal disorders (history of ulcers), especially if complicated by bleeding or perforation, as this may increase the risk of gastrointestinal bleeding and perforation. In such cases, your doctor may advise starting treatment with the lowest available dose and possibly using concomitant medicines that protect the stomach (misoprostol or proton pump inhibitors). This should also be considered if you are taking low-dose aspirin or other medicines that may increase the risk of stomach and intestinal disorders (see section “Other medicines and Nurofen Fever and Pain”). During treatment with all NSAIDs, at any time and with or without warning symptoms or previous history of serious gastrointestinal events, gastrointestinal bleeding, ulceration, and perforation may occur, which can be fatal. Therefore, inform your doctor of any unusual gastrointestinal symptoms (especially gastrointestinal bleeding), particularly during the initial stages of treatment. If gastrointestinal bleeding or ulceration occurs, discontinue treatment with Nurofen Fever and Pain and contact your doctor;
• you suffer or have previously suffered from inflammatory bowel disease (ulcerative colitis, Crohn’s disease), as these conditions may worsen (see section “Possible side effects”);
• you are taking medicines that may increase the risk of ulceration or bleeding, such as medicines used to treat inflammation and certain immune system disorders (oral corticosteroids), anticoagulants such as warfarin, medicines with antiplatelet effects such as aspirin, or medicines used to treat depression (selective serotonin reuptake inhibitors) (see section “Other medicines and Nurofen Fever and Pain”);
• you have heart conditions (uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease) or have previously suffered from reduced blood flow to the brain (stroke), or if you think you or the child may be at risk for these conditions (e.g., if you have high blood pressure, elevated blood sugar levels (diabetes), high blood lipid levels, or if you smoke). Medicines like Nurofen Fever and Pain may be associated with a slight increase in the risk of heart attack or stroke: this risk is more likely at high doses and with prolonged treatment. Do not exceed the recommended dose or duration of treatment;
• you suffer or have previously suffered from high blood pressure and/or severe heart disease (heart failure), as fluid retention, high blood pressure, and swelling (edema) have been reported in association with NSAID therapy;
• you have an infection (see section “Infections” below);
• you have chickenpox, as use of Nurofen Fever and Pain should be avoided in this case.

Use of Nurofen Fever and Pain requires adequate precautions, especially if:

• you suffer or have previously suffered from asthma, as breathing difficulties may worsen;
• you have blood clotting disorders;
• you have kidney, heart, liver disease, or hypertension;
• the child or adolescent is dehydrated (e.g., due to fever, vomiting, or diarrhea); in this case, rehydrate before and during treatment to avoid the risk of impaired kidney function.

During prolonged treatment with Nurofen Fever and Pain, you should pay particular attention and inform your doctor immediately if any of the following occur:

• signs or symptoms of stomach or intestinal ulcers or bleeding (e.g., black, foul-smelling stools, vomiting blood);
• signs or symptoms of liver damage (e.g., hepatitis, jaundice);
• signs or symptoms of kidney damage (e.g., increased urine production, blood in urine);
• visual disturbances (blurred or reduced vision, areas of complete or partial blindness, altered color perception);
• symptoms such as headache, disorientation, nausea, vomiting, neck stiffness, and fever, as these may be symptoms of aseptic meningitis (more frequent in patients with systemic lupus erythematosus or other collagen diseases).

Skin reactions
Serious skin reactions have been reported with ibuprofen treatment, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). Stop using Nurofen Fever and Pain and contact your doctor immediately if you notice any symptoms related to these serious skin reactions described in section 4.
Infections
Nurofen Fever and Pain may mask symptoms of infections such as fever and pain. Therefore, Nurofen Fever and Pain may delay appropriate treatment of the infection, potentially increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult your doctor immediately.
Children and adolescents
In dehydrated children and adolescents, there is a risk of impaired kidney function.
Other medicines and Nurofen Fever and Pain
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
Nurofen Fever and Pain may affect or be affected by other medicines, particularly inform your doctor or pharmacist if you are taking:

• other medicines used to treat pain, reduce fever, and/or treat inflammation (non-steroidal anti-inflammatory drugs, NSAIDs, including COX-2 inhibitors or acetylsalicylic acid). In such cases, these combinations should be avoided as they increase the risk of adverse effects;
• medicines used to treat inflammation and certain immune system disorders (corticosteroids);
• medicines used to treat bacterial infections (quinolone antibiotics);
• anticoagulant medicines (i.e., substances that thin the blood and prevent clot formation, e.g., aspirin/acetylsalicylic acid, warfarin, ticlopidine);
• medicines used to treat depression such as selective serotonin reuptake inhibitors;
• antidiabetic medicines for treating high blood sugar levels (sulfonylureas);
• a medicine used to treat viral infections (ritonavir);
• medicines that modulate the immune response (tacrolimus and cyclosporine);
• a medicine used in the treatment of cancer and rheumatism (methotrexate);
• a medicine used for mental disorders (lithium);
• a medicine used for terminating pregnancy (mifepristone): do not take NSAIDs within 8–10 days after taking mifepristone;
• a medicine used to treat gout (probenecid);
• medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan) and diuretics;
• medicines used to treat heart conditions (cardiac glycosides).

Nurofen Fever and Pain with food and drinks
This medicine can be taken with or without food.
Any possible stomach-related side effects, if present, may be reduced by taking the medicine with food.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
It is unlikely that girls under 12 years of age will become pregnant or breastfeed.
Do not take Nurofen Fever and Pain during the last three months of pregnancy, as it may harm the fetus or cause problems during childbirth.
It may cause kidney and heart problems in the fetus. It may affect the tendency of the mother and child to bleed and delay or prolong labor. You should not take Nurofen Fever and Pain during the first six months of pregnancy unless absolutely necessary and under medical advice. If treatment is required during this period or during attempts to conceive, the lowest effective dose for the shortest possible duration should be used. From the 20th week of pregnancy, Nurofen Fever and Pain may cause kidney problems in the fetus if taken for more than a few days, thereby reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) or causing constriction of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment is required for more than a few days, your doctor may recommend additional monitoring.
Breastfeeding
This medicine passes into breast milk in small amounts. It may be used during breastfeeding if taken at the recommended doses and for short periods.
Fertility
Avoid taking this medicine if you are trying to become pregnant, as it may affect ovulation. This effect reverses upon discontinuation of treatment.
Nurofen Fever and Pain contains:

• Maltitol liquid: if your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine. It may have a mild laxative effect. The caloric value of maltitol is 2.3 kcal/g;
• Sodium: this medicine contains less than 1 mmol (23 mg) of sodium per doses up to 12 ml, i.e., essentially “sodium-free”. This medicine contains approximately 27.6 mg of sodium per 15 ml dose, equivalent to about 1.4% of the maximum daily recommended dietary intake for an adult;
• Propylene glycol (present in the strawberry flavor): this medicine contains 16.45 mg of propylene glycol per 5 ml;
• Wheat starch (present in the orange flavor): this medicine contains only a very small amount of gluten (from wheat starch). This medicine is considered “gluten-free” and is very unlikely to cause problems if you have celiac disease. A 5 ml dose contains no more than 0.315 micrograms of gluten. If you are allergic to wheat (a condition different from celiac disease), do not take this medicine.

3. How to take Nurofen Fever and Pain

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Adults and adolescents over 12 years of age (≥ 43 kg body weight):
200–400 mg of ibuprofen (equivalent to 5 – 10 ml of oral suspension), 2–3 times daily.
The interval between doses must not be less than 4 hours. Do not exceed the maximum daily dose of 1200 mg (30 ml) within 24 hours.
Use in adults is particularly indicated in patients presenting with dysphagia.
Use in the elderly:
No dose adjustment is required.
Children aged 2–12 years (10–43 kg body weight)
The daily dose of 20–30 mg/kg body weight, divided into 3 doses administered at 6–8 hour intervals, may be given according to the following dosing schedule (calculate the dose to be administered based on the weight shown in the table and the child's age).

The daily oral dose can be administered using the oral syringe or dosing spoon provided with the product.
The graduated scale on the syringe clearly indicates markings for different doses: the 2.5 ml mark corresponds to 100 mg of ibuprofen, the 3.75 ml mark corresponds to 150 mg of ibuprofen, and the 5 ml mark corresponds to 200 mg of ibuprofen.
The dosing spoon has two concave ends for different dosages: the 1.25 ml mark corresponds to 50 mg of ibuprofen, the 2.5 ml mark corresponds to 100 mg of ibuprofen, and the 5 ml mark corresponds to 200 mg of ibuprofen.
If you suffer from stomach problems, take Nurofen Fever and Pain preferably during meals.
In the case of post-vaccination fever, refer to the recommended daily dosage shown in the table above.
Nurofen Fever and Pain should be administered only for short-term treatment.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used. If you have an infection, consult your doctor immediately if symptoms (e.g., fever and pain) persist or worsen (see section 2).
Consult your doctor if you do not notice improvement or if symptoms worsen after:
3 days.

Instructions for using the dosing syringe

1. Unscrew the cap by pressing down and turning it to the left.
2. Insert the tip of the syringe fully into the opening in the inner cap.
3. Shake well.
4. Invert the bottle, then, holding the syringe firmly, gently pull the plunger downward to draw the suspension 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 rotating it.
6. Insert the tip of the syringe into the mouth and gently press the plunger to dispense the suspension.
7. After use, screw the cap back on to close the bottle and wash the syringe with warm water. Allow it to dry, and store it out of sight and reach of children.

If you take more Nurofen Fever and Pain than you should
If you have taken more Nurofen Fever and Pain than you should, or if your child has accidentally taken this medicine, always contact a doctor or the nearest hospital for advice on potential risks and the necessary actions to take.
Symptoms of overdose may include: nausea, stomach ache, vomiting (possibly with traces of blood), deep drowsiness with reduced response to normal stimuli (lethargy), headache, ringing in the ears, confusion, and uncontrolled eye movements. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, blood in the urine, low blood potassium levels, feeling cold, and breathing difficulties may occur.
Symptoms of overdose may appear within 4–6 hours after taking ibuprofen.
Other possible symptoms include: increased acid levels in the blood (metabolic acidosis), lowered body temperature (hypothermia), kidney problems, bleeding in the stomach and intestines, deep loss of consciousness (coma), temporary cessation of breathing (apnea), diarrhea, reduced activity of the nervous and respiratory systems, disorientation, agitation, fainting, low blood pressure (hypotension), decreased or increased heart rate (bradycardia or tachycardia). Additionally, reduced blood clotting (prolonged prothrombin time) may occur.
If significantly high doses of ibuprofen are taken, severe kidney and liver damage may occur. In patients with asthma, the condition may worsen.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
If you experience any of the following side effects, STOP treatment with Nurofen Fever and Pain and consult your doctor immediately:

• allergic reactions, even severe ones, which may include: hives, itching, purpura, swelling of the face, mouth and throat (angioedema), difficulty breathing (bronchospasm or dyspnea), irregular heartbeat (tachycardia), low blood pressure (hypotension), anaphylaxis, shock, and worsening of asthma;
• aseptic meningitis with symptoms such as confusion, headache, nausea, vomiting, neck stiffness and fever (more likely if you have systemic lupus erythematosus or other collagen diseases);
• flat, red, target-shaped or circular rashes on the trunk, often with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals and eyes. These serious skin reactions may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis];
• widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome);
• widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually occur early in treatment (generalized acute exanthematous pustulosis).

Other side effects include:
Uncommon ( may affect up to 1 in 100 people ):

• headache, dizziness, drowsiness and convulsions;
• stomach pain, nausea and indigestion (dyspepsia);
• skin rashes.

Rare ( may affect up to 1 in 1,000 people ):

• cystitis, rhinitis;
• depression, insomnia, difficulty concentrating, mood instability, disturbances in hearing and vision;
• cerebral haemorrhage;
• dry eyes;
• awareness of your heartbeat (palpitations);
• diarrhoea, flatulence, dry mouth, constipation and vomiting;
• hair loss (alopecia);
• skin becomes sensitive to light;
• serious kidney disorders including tubular necrosis, glomerulonephritis, presence of blood in urine, and increased urine production;
• decreased haematocrit levels.

Very rare ( may affect up to 1 in 10,000 people ):

• reduction in blood cell counts (anaemia, leucopenia, thrombocytopenia, eosinophilia, pancytopenia, agranulocytosis) – early signs include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds and bleeding;
• signs or symptoms of stomach or intestinal ulcers or bleeding, black and foul-smelling stools, vomiting blood;
• bleeding sores in the mouth, stomach burning (gastritis);
• simultaneous kidney and liver disease (hepatorenal syndrome), death of some liver cells (hepatic necrosis), liver disease (liver failure, hepatic dysfunction, hepatitis, jaundice);
• serious kidney disorders (acute renal failure, papillary necrosis), particularly after long-term treatment, associated with increased blood urea concentration and swelling (oedema);
• decreased haemoglobin levels in the blood;
• severe skin infections and soft tissue complications during chickenpox infection;
• worsening of infections-related inflammation (e.g. necrotizing fasciitis) associated with the use of certain non-steroidal anti-inflammatory drugs (NSAIDs). If signs of infection appear or worsen, seek immediate medical advice to determine whether anti-infective/antibiotic therapy is needed.

Not known ( frequency cannot be estimated from the available data ):

• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome;
• irritability;
• fluid retention and loss of appetite;
• abnormal perception of sounds such as ringing, buzzing or whooshing noises (tinnitus);
• serious heart disease (heart failure) and swelling (oedema);
• increased blood pressure (hypertension) and reduced blood flow to the body (shock);
• respiratory tract disorders including asthma, laryngeal obstruction, laboured breathing (bronchospasm), temporary cessation of breathing (apnoea), and difficulty breathing (dyspnoea);
• worsening of inflammatory bowel diseases (colitis and Crohn’s disease), inflammation of the pancreas (pancreatitis), inflammation of the duodenum (duodenitis), inflammation of the oesophagus (oesophagitis);
• a severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: skin rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cell);
• a widespread, red, scaly rash with pustules forming under the skin and blisters, mainly affecting skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (generalized acute exanthematous pustulosis). Stop using Nurofen Fever and Pain if you develop these symptoms and contact your doctor immediately. See also section 2.

The use of ibuprofen, especially at high doses (2400 mg/day), may be associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke.
Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nurofen Fever and Pain

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Exp.
The expiry date refers to the last day of that month. Do not store this medicine above 30°C.
After opening the bottle, store for a maximum of: 6 months.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What NUROFEN FEVER AND PAIN 200mg/5ml oral suspension, orange flavour, sugar-free contains

• The active substance is ibuprofen. Each ml of oral suspension contains 40 mg of ibuprofen.
• The other components are polysorbate 80, glycerol, maltitol syrup, sodium saccharin, sodium citrate, sodium chloride, xanthan gum, citric acid, orange flavour (containing wheat starch), domiphen bromide, purified water.

What NUROFEN FEVER AND PAIN 200mg/5ml oral suspension, strawberry flavour, sugar-free contains

• The active substance is ibuprofen. Each ml of oral suspension contains 40 mg of ibuprofen.
• The other components are polysorbate 80, glycerol, maltitol syrup, sodium saccharin, sodium citrate, sodium chloride, xanthan gum, citric acid, strawberry flavour (containing propylene glycol), domiphen bromide, purified water.

Description of the appearance of Nurofen Fever and Pain and contents of the pack
Oral suspension in 100 ml or 150 ml bottles with dosing syringe or dosing spoon and child-resistant cap.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Reckitt Benckiser Healthcare (Italia) S.p.A., via G. Spadolini 7, 20141 Milan, Italy
Manufacturer
RB NL Brands B.V., Schiphol Boulevard 207, Schiphol 1118BH, The Netherlands

Patient information leaflet

Nurofen Fever and Pain Children 100mg/5ml oral suspension orange flavour sugar-free, strawberry flavour sugar-free

Ibuprofen
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice improvement or if you experience worsening of symptoms after:
• 24 hours in infants aged 2 to 5 months;
• 3 days in infants and children over 6 months of age and in adolescents.

Contents of this leaflet:

1. What Nurofen Fever and Pain is and what it is used for
2. What you need to know before using Nurofen Fever and Pain
3. How to use Nurofen Fever and Pain
4. Possible side effects
5. How to store Nurofen Fever and Pain
6. Package contents and other information

1. What Nurofen Fever and Pain is and what it is used for

Nurofen Fever and Pain contains ibuprofen, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These act to reduce pain, fever, and inflammation.
Nurofen Fever and Pain is indicated in children weighing at least 5 kg for the symptomatic treatment of fever, including post-vaccination fever, and mild to moderate pain (such as headache, toothache, sore throat, earache, muscle pain), even when associated with influenza and colds (see section “How to use Nurofen Fever and Pain”).

2. What you need to know before using Nurofen Fever and Pain

Allergic reactions to ibuprofen have been reported, including
breathing difficulties, swelling of the face and neck area (angioedema), and chest pain.
Stop using Nurofen Fever and Pain immediately and contact your doctor or emergency medical services
immediately if you notice any of these signs.
Do not use Nurofen Fever and Pain if the child

• is allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6);
• has had or currently has allergic reactions such as shortness of breath, rhinitis (runny nose), swelling of the face, lips, and throat (angioedema), or hives, especially if associated with nasal polyps and asthma, after taking other painkillers, antipyretics, acetylsalicylic acid, or other non-steroidal anti-inflammatory drugs (NSAIDs);
• suffers from a severe kidney or liver disease (renal or hepatic failure);
• suffers from a severe heart condition (heart failure);
• has had or currently has gastrointestinal bleeding and/or perforation following previous treatment with NSAIDs;
• has had or currently has gastric/duodenal ulcers (peptic ulcers) or active or recurrent bleeding (at least two distinct episodes of proven ulceration or bleeding);
• is currently taking other non-steroidal anti-inflammatory drugs (NSAIDs, including selective COX-2 inhibitors) (see section “Other medicines and Nurofen Fever and Pain”);
• has any disease that increases the risk of bleeding;
• has unexplained blood disorders;
• is in a severe state of dehydration, for example, has experienced severe episodes of vomiting, diarrhoea, or drinks very little;
• is under 3 months of age, except for the treatment of post-vaccination fever (see section “How to use Nurofen Fever and Pain”);
• weighs less than 5 kg;
• is in the last trimester of pregnancy (see section “Pregnancy, breastfeeding and fertility”).

Warnings and precautions
Talk to your doctor or pharmacist before using Nurofen Fever and Pain if the child:

• has had or currently has allergies to medicines used to treat fever, pain, and inflammation (non-steroidal anti-inflammatory drugs), and if the child suffers from breathing difficulties (asthma), seasonal allergies (hay fever), nasal polyps, or has serious respiratory or chest problems, e.g., chronic obstructive pulmonary disease, or swelling of the face, lips, and throat (angioedema);
• is taking other medicines used to treat pain, reduce fever, and/or treat inflammation (non-steroidal anti-inflammatory drugs, NSAIDs, including COX-2 inhibitors) (see section “Other medicines and Nurofen Fever and Pain”);
• has had stomach or intestinal problems (history of ulcers), especially if complicated by bleeding or perforation, as there may be an increased risk of gastrointestinal bleeding and perforation. In such cases, your doctor may advise starting treatment with the lowest available dose and possibly using concomitant medicines that protect the stomach (misoprostol or proton pump inhibitors). This should also be considered if taking low-dose aspirin or other medicines that may increase the risk of stomach and intestinal diseases (see section “Other medicines and Nurofen Fever and Pain”). During treatment with any NSAID, at any time, with or without warning symptoms or previous history of serious gastrointestinal events, gastrointestinal bleeding, ulceration, and perforation may occur, which can be fatal. Therefore, inform your doctor of any unusual gastrointestinal symptoms (especially gastrointestinal bleeding), particularly in the early stages of treatment. If gastrointestinal bleeding or ulceration occurs, stop treatment with Nurofen Fever and Pain and contact your doctor;
• has had or currently suffers from inflammatory bowel disease (ulcerative colitis, Crohn’s disease), as these conditions may worsen (see section “Possible side effects”);
• is taking medicines that could increase the risk of ulcer or bleeding, such as medicines used to treat inflammation and certain immune system disorders (oral corticosteroids), anticoagulants such as warfarin, medicines with antiplatelet effects like aspirin, or medicines used to treat depression (selective serotonin reuptake inhibitors) (see section “Other medicines and Nurofen Fever and Pain”);
• has heart conditions (uncontrolled hypertension, congestive heart failure, confirmed ischemic heart disease, peripheral arterial disease) or has had reduced blood flow to the brain (stroke), or if you think the child may be at risk for these conditions (e.g., if the child has high blood pressure, elevated blood sugar levels (diabetes), high blood lipid levels, or smokes). Medicines like Nurofen Fever and Pain may be associated with a slight increase in the risk of heart attack or reduced blood flow to the brain: the risk is more likely at high doses and with prolonged treatment. Do not exceed the recommended dose or duration of treatment;
• has high blood pressure and/or severe heart disease (heart failure), as fluid retention, high blood pressure, and swelling (edema) have been reported in association with NSAID therapy;
• has an infection (see section “Infections” below);
• has chickenpox, as use of Nurofen Fever and Pain should be avoided in this case.

The use of Nurofen Fever and Pain requires adequate precautions, especially if the child:

• has had or currently has asthma, as breathing difficulties may worsen;
• has blood clotting disorders or hypertension;
• has kidney, heart, or liver disease and is taking medicines that increase urine production (diuretics), or has undergone major surgery resulting in fluid loss, as your doctor may recommend periodic blood and urine tests for the child;
• has undergone major surgery;
• suffers from certain congenital conditions affecting blood formation (e.g., acute intermittent porphyria); is dehydrated (e.g., due to fever, vomiting, or diarrhoea); in this case, rehydrate the child before and during treatment to avoid the risk of impaired kidney function.

During prolonged treatment with Nurofen Fever and Pain, you should pay particular attention
and immediately inform the doctor if any of the following occur:

• signs or symptoms of stomach or intestinal ulceration or bleeding (e.g., black, tarry, foul-smelling stools, vomiting blood);
• signs or symptoms of liver damage (e.g., hepatitis, jaundice);
• signs or symptoms of kidney damage (e.g., increased urine production, blood in urine);
• visual disturbances (blurred or reduced vision, areas of complete or partial blindness, altered colour perception);
• symptoms such as frequent or daily headaches despite regular use of headache medicines, which could be caused by excessive use of these medicines;
• symptoms such as headache, disorientation, nausea, vomiting, neck stiffness, and fever, as these could indicate aseptic meningitis (more common if the child has systemic lupus erythematosus or other collagenoses).

Skin reactions
Serious skin reactions have been reported with ibuprofen treatment, including exfoliative dermatitis,
erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with
eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP).
Stop using Nurofen Fever and Pain and contact your doctor immediately if you notice any symptoms
related to these serious skin reactions described in section 4.
Infections
Nurofen Fever and Pain may mask symptoms of infections such as fever and pain. Therefore, Nurofen
Fever and Pain may delay appropriate treatment of the infection, increasing the risk of complications.
This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox.
If you take this medicine while having an infection and infection symptoms persist or worsen, contact
your doctor immediately.
Children and adolescents
In dehydrated children and adolescents, there is a risk of impaired kidney function.
Other medicines and Nurofen Fever and Pain
Inform your doctor or pharmacist if the child is taking, has recently taken, or might take any other
medicine.
Nurofen Fever and Pain may affect or be affected by other medicines, particularly, inform your doctor or
pharmacist if the child is taking:

• other medicines used to treat pain, reduce fever, and/or treat inflammation (non-steroidal anti-inflammatory drugs, NSAIDs, including COX-2 inhibitors or acetylsalicylic acid). In such cases, these combinations should be avoided as they increase the risk of possible side effects;
• medicines used to treat inflammation and certain immune system disorders (corticosteroids);
• medicines used to treat bacterial infections (quinolone antibiotics);
• medicines with anticoagulant effects (i.e., substances that thin the blood and prevent clot formation, e.g., acetylsalicylic acid, warfarin, ticlopidine);
• medicines used to treat depression such as selective serotonin reuptake inhibitors;
• a medicine used to treat seizures (phenytoin);
• antidiabetic medicines to treat high blood sugar levels (sulfonylureas);
• a medicine used to treat viral infections (ritonavir);
• medicines that modulate the immune response (tacrolimus and cyclosporine);
• a medicine used in the treatment of cancer and rheumatism (methotrexate);
• a medicine used for mental illness (lithium);
• a medicine used to terminate pregnancy (mifepristone): do not take NSAIDs within 8–12 days after taking mifepristone;
• a medicine used to treat gout (probenecid and sulfinpyrazone);
• medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II antagonists such as losartan) and diuretics;
• potassium-sparing diuretics;
• CYP2C9 inhibitors (e.g., voriconazole, fluconazole), as concomitant administration of ibuprofen and CYP2C9 inhibitors may slow down the elimination of ibuprofen (a CYP2C9 substrate), leading to increased exposure to ibuprofen;
• medicines used to treat heart conditions (cardiac glycosides such as digoxin);
• zidovudine (a medicine for the treatment of HIV/AIDS).

Nurofen Fever and Pain with food and drinks
The medicine can be taken with or without food.
Possible stomach-related side effects, if present, may be reduced by taking the medicine with food.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
consult your doctor or pharmacist before taking this medicine.
Pregnancy
It is unlikely that girls under 12 years of age will become pregnant or breastfeed.
Do not take Nurofen Fever and Pain during the last 3 months of pregnancy, as it may harm the fetus or
cause problems during childbirth.
It may cause kidney and heart problems in the fetus. It may affect the tendency of both mother and
child to bleed and delay or prolong labour. You should not take Nurofen Fever and Pain during the first
6 months of pregnancy unless absolutely necessary and under medical advice. If treatment is needed
during this period or during attempts to conceive, the lowest effective dose for the shortest possible time
should be used. From the 20th week of pregnancy, Nurofen Fever and Pain may cause kidney problems
in the fetus if taken for more than a few days, thereby reducing the levels of amniotic fluid surrounding
the baby (oligohydramnios) or causing narrowing of a blood vessel (ductus arteriosus) in the baby’s
heart. If treatment is needed for more than a few days, your doctor may recommend additional
monitoring.
Breastfeeding
This medicine passes into breast milk in small amounts. It can be used during breastfeeding if taken at
the recommended doses and for short periods.
Fertility
This medicine belongs to a group of medicines (NSAIDs) that may impair fertility in women. This effect
is reversible upon discontinuation of the medicine.
Nurofen Fever and Pain contains:

• Maltitol liquid: if your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine. It may have a mild laxative effect. The caloric value of maltitol is 2.3 kcal/g;
• Sodium: this medicine contains 9.08 mg of sodium (a main component of table salt) per 5 ml, equivalent to 0.45% of the maximum daily recommended dietary intake for an adult;
• Wheat starch (present in the orange flavour): this medicine contains only a very small amount of gluten (from wheat starch). This medicine is considered "gluten-free" and it is very unlikely to cause problems if you have coeliac disease. A 5 ml dose contains no more than 0.225 micrograms of gluten. If you are allergic to wheat (a condition different from coeliac disease), do not take this medicine;
• Propylene glycol (present in the strawberry flavour): this medicine contains 11.75 mg of propylene glycol per 5 ml. If the child is less than 4 weeks old, talk to your doctor or pharmacist before administering this medicine, especially if the child is taking other medicines containing propylene glycol or alcohol.

3. How to use Nurofen Fever and Pain

Use this medicine exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

• In infants aged between 3 and 6 months, limit administration to those weighing more than 5 kg.
• The daily oral dose for infants and children aged between 3 months and 12 years can be administered using the dosing syringe or dosing spoon provided with the product.

The daily dose of 20–30 mg/kg body weight, divided into 3 doses per day at intervals of 6–8 hours, may be administered according to the following scheme (calculate the dose to be administered based on the weight shown in the table and the child's age).

The graduated scale on the syringe clearly shows markings for 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 dosing spoon has two markings 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.
If your child suffers from stomach upset, administer Nurofen Fever and Pain preferably during meals.
In case of post-vaccination fever, use the medicine as follows:

• in children aged between 2 and 3 months, weighing at least 5 kg, under medical advice, administer a single dose of 2.5 ml, followed, if necessary, by another dose of 2.5 ml after 6–8 hours. If fever persists, consult your doctor;
• in children over 3 months of age, refer to the recommended daily dosage shown in the table above.

Nurofen Fever and Pain should be administered only for short-term treatment.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used. If you have an infection, contact your doctor immediately if symptoms (e.g. fever and pain) persist or worsen (see section 2).
Contact your doctor if you do not notice improvement or if you observe worsening of symptoms after:

• 24 hours in infants aged between 2 and 5 months;
• 3 days in infants and children over 6 months of age and in adolescents.

Instructions for using the dosing syringe

1. Unscrew the cap by pushing down and turning it to the left.
2. Insert the tip of the syringe fully into the opening of the inner cap.
3. Shake well.
4. Invert the bottle, then, holding the syringe firmly, gently pull the plunger down to draw the suspension 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 rotating it.
6. Insert the tip of the syringe into the child’s mouth, and gently press the plunger to dispense the suspension.
7. After use, screw the cap back on to close the bottle, and wash the syringe with warm water. Allow it to dry, and store it out of sight and reach of children.

If you take more Nurofen Fever and Pain than you should
If you have taken more Nurofen Fever and Pain than recommended, or if your child has accidentally taken this medicine, always contact a doctor or the nearest hospital for advice on potential risks and actions to take.
Symptoms of overdose may include: nausea, stomach ache, vomiting (possibly with traces of blood), deep drowsiness with reduced response to normal stimuli (lethargy), headache, ringing in the ears, confusion, and uncontrolled eye movements. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, blood in the urine, low blood potassium levels, feeling cold, and breathing difficulties may occur.
Symptoms of overdose may appear within 4–6 hours after taking ibuprofen.
You may also experience: increased acid levels in the blood (metabolic acidosis), lowering of body temperature (hypothermia), kidney effects, bleeding of the stomach and intestines, deep loss of consciousness (coma), temporary cessation of breathing (apnea), diarrhea, reduced activity of the central nervous system and respiratory depression, disorientation, agitation, fainting, low blood pressure (hypotension), decreased or increased heart rate (bradycardia or tachycardia). In addition, reduced blood clotting (prolonged prothrombin time) may occur.
If significantly high doses of ibuprofen are taken, severe kidney and liver damage may occur. In asthmatic patients, the condition may worsen.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
STOP treatment with Nurofen Fever and Pain and consult a doctor if the child experiences any of the following side effects:

• allergic reactions, even severe ones, which may include: hives, itching, purpura, swelling of the face, mouth and throat (angioedema), breathing difficulties (bronchospasm or dyspnea), irregular heartbeat (tachycardia), low blood pressure (hypotension), anaphylaxis, severe shock, and worsening of asthma;
• aseptic meningitis with symptoms such as confusion, headache, nausea, vomiting, neck stiffness and fever (more frequent if the child has systemic lupus erythematosus or other collagen diseases);
• flat, red, target-shaped or circular rashes on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital and eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis];
• widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome);
• widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized pustular eruption).

Other side effects include:
Uncommon (may affect up to 1 in 100 people):

• headache, dizziness, drowsiness and convulsions;
• stomach pain, nausea and indigestion (dyspepsia);
• skin rashes;
• vision disturbances.

Rare (may affect up to 1 in 1,000 people):

• cystitis, rhinitis;
• depression, insomnia, difficulty concentrating, mood instability, hearing disturbances;
• cerebral haemorrhage;
• dry eyes;
• awareness of heartbeat (palpitations);
• diarrhoea, flatulence, dry mouth, constipation and vomiting;
• hair loss (alopecia);
• skin becomes sensitive to light;
• serious kidney diseases including tubular necrosis, glomerulonephritis, presence of blood in urine and increased urine production;
• decreased haematocrit levels.

Very rare (may affect up to 1 in 10,000 people):

• reduction in blood cell counts (anaemia, leucopenia, thrombocytopenia, eosinophilia, pancytopenia, agranulocytosis) – early signs include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds and bleeding;
• signs or symptoms of stomach or intestinal ulcers or bleeding, black and foul-smelling stools, vomiting blood;
• bleeding lesions in the mouth, stomach burning (gastritis);
• simultaneous kidney and liver disease (hepatorenal syndrome), death of some liver cells (hepatic necrosis), liver disease (liver failure, liver dysfunction, hepatitis, jaundice);
• serious kidney diseases (acute renal failure, papillary necrosis), particularly after long-term treatment, associated with increased blood urea concentration and swelling (oedema);
• decreased haemoglobin levels in the blood;
• heart attack (myocardial infarction);
• severe skin infections and soft tissue complications during chickenpox infection;
• worsening of inflammation associated with infections (e.g. necrotizing fasciitis) associated with the use of certain non-steroidal anti-inflammatory drugs (NSAIDs). If signs of infection appear or worsen, consult a doctor immediately to determine whether anti-infective/antibiotic therapy is needed.

Not known (frequency cannot be estimated from the available data):

• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome;
• irritability;
• fluid retention and decreased appetite;
• abnormal perception of noises such as ringing, buzzing or hissing (tinnitus);
• severe heart disease (heart failure) and swelling (oedema);
• increased blood pressure (hypertension) and reduced blood flow to the body (shock);
• respiratory tract disorders including asthma, laryngeal obstruction, laboured breathing (bronchospasm), temporary cessation of breathing (apnoea), and difficulty breathing (dyspnoea);
• worsening of inflammatory bowel diseases (colitis and Crohn's disease), inflammation of the pancreas (pancreatitis), inflammation of the duodenum (duodenitis), inflammation of the oesophagus (oesophagitis);
• a severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: skin rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cells);
• a widespread, red, scaly rash with pustules under the skin and blisters, mainly affecting skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (generalized pustular eruption). Stop using Nurofen Fever and Pain if you develop these symptoms and contact your doctor immediately. See also section 2.

The use of ibuprofen, especially at high doses (2400 mg/day), may be associated with a modest increase in the risk of heart attack (myocardial infarction) or stroke.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Nurofen Fever and Pain

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Exp..
The expiry date refers to the last day of that month. This medicine does not require
any special storage conditions.
After opening the bottle, keep for no longer than: 6 months.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Pack contents and other information

What NUROFEN FEVER AND PAIN Children 100mg/5ml Oral Suspension, Orange sugar-free flavour contains

• The active substance is ibuprofen. Each ml of oral suspension contains 20 mg of ibuprofen.
• The other ingredients are polysorbate 80, glycerol, maltitol syrup, sodium saccharin, sodium citrate, sodium chloride, xanthan gum, citric acid, orange flavour (containing wheat starch), domiphen bromide, purified water.

What NUROFEN FEVER AND PAIN Children 100mg/5ml Oral Suspension, Strawberry sugar-free flavour contains

• The active substance is ibuprofen. Each ml of oral suspension contains 20 mg of ibuprofen.
• The other ingredients are polysorbate 80, glycerol, maltitol syrup, sodium saccharin, sodium citrate, sodium chloride, xanthan gum, citric acid, strawberry flavour (containing propylene glycol), domiphen bromide, purified water.

Description of the appearance of Nurofen Fever and Pain and pack contents
Oral suspension in bottles of 100 ml or 150 ml with dosing syringe or dosing spoon and child-resistant cap.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Reckitt Benckiser Healthcare (Italia) S.p.A., via G. Spadolini 7, 20141 Milano, Italy

Manufacturer
RB NL Brands B.V., Schiphol Boulevard 207, Schiphol 1118BH, The Netherlands