NUROFEN FEVER D*BB100MG/5ML F

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

What it 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) whose action reduces pain, fever, and inflammation.
Nurofen Fever and Pain is indicated in children aged 3 months to 12 years for the symptomatic treatment of fever, including post-vaccination fever, and mild to moderate pain (such as headache, toothache, sore throat, earache).

What you need to know before taking the medicine
Signs of an allergic reaction to this medicine, including breathing problems, swelling of the face and neck (angioedema), and chest pain, have been reported with ibuprofen.
Immediately stop Nurofen Fever and Pain and contact your doctor or emergency medical service immediately if you notice any of these signs.

Do not use Nurofen Fever and Pain if the child
- is allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
- has or has had allergic reactions such as wheezing, rhinitis (runny nose), swelling of the face, lips and throat (angioedema) or urticaria, especially if associated with nasal polyps and asthma, after taking other analgesics, other antipyretics, acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs);
- suffers from severe kidney or liver disease (renal or hepatic insufficiency);
- suffers from severe heart disease (heart failure);
- suffers or has suffered from stomach and/or intestinal bleeding (gastrointestinal hemorrhage) or perforation following previous NSAID treatments;
- suffers or has suffered from gastric/duodenal ulcers (peptic ulcers) or ongoing or recurrent bleeding (at least two distinct episodes of demonstrated ulceration or bleeding);
- is 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;
- in case of unexplained blood disorders;
- is in a severe state of dehydration, for example, has had severe episodes of vomiting, diarrhea or drinks very little;
- is under 3 months of age or weighs less than 5.6 kg;
- is in the last trimester of pregnancy (see section Pregnancy and breastfeeding).

Warnings and precautions
Talk to your doctor or pharmacist before using Nurofen Fever and Pain if the child:
• suffers or has suffered from allergies to medicines used to treat fever, pain and inflammation (non-steroidal anti-inflammatory drugs) and if they suffer from breathing difficulties (asthma), seasonal allergies (hay fever), nasal polyps, severe respiratory or chest problems, e.g. chronic obstructive pulmonary disease, 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 suffered from stomach and intestinal disorders (history of ulcer), especially if complicated by bleeding or perforation as an increase in gastrointestinal hemorrhages and perforations may occur. In these cases, the doctor will advise you to start treatment with the lowest available dose and possibly the concomitant use of medicines that protect the stomach (misoprostol or proton pump inhibitors). This should also be considered if low doses of aspirin or other drugs that may increase the risk of stomach and intestinal diseases are taken (see section Other medicines and Nurofen Fever and Pain). During treatment with all NSAIDs, at any time, with or without warning symptoms or previous history of serious gastrointestinal events, bleeding, ulceration and perforation of the stomach or intestine may occur, which can be fatal. Therefore, inform your doctor of any unusual gastrointestinal symptoms (especially gastrointestinal bleeding) especially in the early stages of treatment. If gastrointestinal bleeding or ulceration occurs, stop treatment with Nurofen Fever and Pain and contact your doctor;
• suffers or has suffered from inflammatory bowel disease (ulcerative colitis, Crohn's disease) as these diseases may worsen (see section Possible side effects);
• if you are taking medicines that could increase the risk of ulcer or bleeding, such as medicines used to treat inflammation and certain immune system diseases (oral corticosteroids), anticoagulants such as warfarin, medicines that may have an antiplatelet effect such as aspirin, medicines to treat depression (selective serotonin reuptake inhibitors) (see section Other medicines and Nurofen Fever and Pain);
• has heart disease (uncontrolled hypertension, congestive heart failure, confirmed ischemic heart disease, peripheral arterial disease) or has suffered from reduced blood flow to the brain (stroke), or if you think the child may be at risk for these conditions (for example if they have high blood pressure, if they have high sugar levels (diabetes) or fats in the blood or if they smoke). Medicines such as 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 therapies. Do not exceed the recommended dose or duration of treatment;
• suffers or has 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;
• has an infection (see section Infections below);
• has chickenpox, in which case it is advisable to avoid the use of Nurofen Fever and Pain.

The use of Nurofen Fever and Pain requires adequate precautions, especially if the child:
• suffers or has suffered from asthma because breathing difficulties could worsen;
• suffers from coagulation problems or hypertension;
• suffers from kidney, heart, liver diseases if taking drugs that increase urine production (diuretics), or if he has undergone major surgery with consequent fluid loss, as in these cases his doctor will advise him to perform periodic blood and urine tests on the child;
• has undergone major surgery;
• suffers from certain congenital diseases affecting blood formation (e.g. acute intermittent porphyria); is dehydrated (e.g. due to fever, vomiting or diarrhea), in this case rehydrate him before starting and during treatment to avoid the risk of impaired kidney function.

During prolonged treatments with Nurofen Fever and Pain, you must pay particular attention and immediately inform your doctor if:
• signs or symptoms of ulcerations or bleeding of the stomach and intestine (e.g. black and foul-smelling stools, vomiting with blood) appear;
• signs or symptoms of liver damage (e.g. hepatitis and jaundice) appear;
• signs or symptoms of kidney damage (e.g. increased urine production, blood in the urine) appear;
• visual disturbances (blurred or reduced vision, areas of complete or partial blindness, altered color perception) appear;
• symptoms such as frequent or daily headaches despite regular use of headache medicines, as these could be caused by excessive use of these medicines, appear;
• symptoms such as headache, disorientation, nausea, vomiting, stiff neck and fever appear, as these could be symptoms due to aseptic meningitis (more frequent if the child suffers from systemic lupus erythematosus or other collagenopathies).

Skin reactions
Severe skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP) have been reported in association with ibuprofen treatment. Stop using Nurofen Fever and Pain and contact your doctor immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Infections
Nurofen Fever and Pain may mask the symptoms of infections such as fever and pain. It is therefore possible that Nurofen Fever and Pain may delay adequate treatment of the infection, which could increase the risk of complications. This has been observed in pneumonia caused by bacteria and in bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and the symptoms of the infection persist or worsen, consult your doctor immediately.

Children and adolescents
In dehydrated children and adolescents there is a risk of altered kidney function.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.

If the child experiences any of the following side effects, STOP treatment with Nurofen Fever and Pain and contact your doctor:
• allergic reactions, including severe ones, which may include: urticaria, itching, purpura, swelling of the face, mouth and throat (angioedema), difficulty breathing (bronchospasm or dyspnea), altered heart rate (tachycardia), low blood pressure (hypotension), anaphylaxis, severe shock and worsening of asthma;
• aseptic meningitis with symptoms such as disorientation, headache, nausea, vomiting, stiff neck and fever (more frequent if the child suffers from systemic lupus erythematosus or other collagenopathies);
• reddish non-raised, target-shaped or circular patches on the trunk, often with central blisters, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes. These severe 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 enlarged lymph nodes (DRESS syndrome);
• widespread, red and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Further side effects include:

Uncommon (may affect up to 1 in 100 people):
• headache, dizziness, drowsiness and seizures;
• stomach pain, nausea and indigestion (dyspepsia);
• skin rashes;
• visual disturbances.

Rare (may affect up to 1 in 1,000 people):
• cystitis, rhinitis;
• depression, insomnia, difficulty concentrating, unstable mood, hearing disorders;
• cerebrovascular hemorrhage;
• dry eyes;
• awareness of one's own heartbeat (palpitations);
• diarrhea, flatulence, dry mouth, constipation and vomiting;
• hair loss (alopecia);
• skin becomes sensitive to light;
• severe kidney diseases including tubular necrosis, glomerulonephritis, blood in the urine and increased urine production;
• decreased hematocrit levels.

Very rare (may affect up to 1 in 10,000 people):
• reduction in the number of blood cells (anemia, leukopenia, thrombocytopenia, eosinophilia, pancytopenia, agranulocytosis) - the first signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds and hemorrhages;
• signs or symptoms of ulcerations or bleeding of the stomach and intestine, black and foul-smelling stools, vomiting with blood;
• lesions with bleeding of the mouth, heartburn (gastritis);
• simultaneous kidney and liver disease (hepatorenal syndrome), death of some liver cells (hepatic necrosis), liver disease (hepatic insufficiency, hepatic dysfunction, hepatitis, jaundice);
• severe kidney diseases (acute renal failure, papillary necrosis) particularly following long-term treatments, associated with an increase in urea concentration in the blood and swelling (edema);
• decrease in hemoglobin levels in the blood;
• heart attack (myocardial infarction);
• severe skin infections and soft tissue complications during chickenpox infection;
• worsening of infection-related inflammation (e.g. necrotizing fasciitis) associated with the use of certain non-steroidal anti-inflammatory drugs (NSAIDs). If signs of an infection appear or worsen, you should consult your doctor immediately to assess whether anti-infective/antibiotic therapy is necessary.

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, tinkling or rustling (tinnitus);
• severe heart disease (heart failure) and swelling (edema);
• increased blood pressure (hypertension) and reduced blood flow to the body (shock);
• respiratory tract disorders including asthma, laryngeal obstruction, wheezing (bronchospasm), temporary cessation of breathing (apnea) and difficulty breathing (dyspnea);
• worsening of inflammatory bowel diseases (colitis and Crohn's disease), inflammation of the pancreas (pancreatitis), inflammation of the duodenum (duodenitis), inflammation of the esophagus (esophagitis);
• a severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cell);
• a widespread, red and scaly rash, with pustules forming under the skin and blisters located mainly on the skin folds, on the trunk and upper limbs accompanied by fever at the beginning of treatment (acute generalized 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 modest increase in the risk of heart attack (myocardial infarction) or stroke.

Reporting side effects
If you get 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/segnalazionireazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.