NUROFEN FEVER D*BB100MG/5ML A

NUROFEN FEBBRE E DOLORE CHILDREN 100mg/5ml oral suspension orange flavor sugar-free
Ibuprofen

What it is and what it is used for
Nurofen Febbre e Dolore contains ibuprofen, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) whose action helps to reduce pain, fever and inflammation.
Nurofen Febbre e Dolore is indicated in children aged 3 months to 12 years for the symptomatic treatment of fever and mild to moderate pain.

What you need to know before taking the medicine
Do not use Nurofen Febbre e Dolore if your child
- is allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
- experiences or has experienced in the past allergic reactions such as shortness of breath, rhinitis (runny nose), swelling of the face, lips and throat (angioedema) or urticaria, particularly 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 bleeding of the stomach and/or intestine (gastrointestinal hemorrhage) or perforation following previous NSAID treatments;
- suffers or has suffered from gastric/duodenal ulcers (peptic ulcers) or active or recurrent bleeding (at least two distinct episodes of confirmed ulceration or bleeding);
- is taking other non-steroidal anti-inflammatory drugs (NSAIDs, including selective COX-2 inhibitors) (see section "Other medicines and Nurofen Febbre e Dolore");
- has any condition that increases the risk of bleeding;
- in case of unexplained blood disorders;
- is severely dehydrated, 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 Febbre e Dolore if your 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), nasal polyps, swelling of the face, lips and throat (angioedema);
- is taking other medicines used to treat pain, to lower fever and/or to treat inflammation (non-steroidal anti-inflammatory drugs, including COX-2 inhibitors) (see section "Other medicines and Nurofen Febbre e Dolore");
- has suffered from stomach and intestinal disorders (history of ulcer), especially if complicated by bleeding or perforation, as there may be an increased risk of gastrointestinal bleeding and perforation. In these cases, your 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 can increase the risk of stomach and intestinal diseases are taken (see section "Other medicines and Nurofen Febbre e Dolore"). 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) particularly in the initial stages of treatment. If gastrointestinal bleeding or ulceration occurs, discontinue treatment with Nurofen Febbre e Dolore and contact your doctor;
- suffers or has suffered from an inflammatory bowel disease (ulcerative colitis, Crohn's disease) as these diseases 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 some 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 Febbre e Dolore");
- has heart conditions (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, high blood sugar (diabetes) or high blood fats or if they smoke). Medicines like Nurofen Febbre e Dolore 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) since, in association with NSAID therapy, fluid retention, high blood pressure and swelling (edema) have been reported;
- has an infection (see section "Infections" below);
- has chickenpox, in which case, it is advisable to avoid the use of Nurofen Febbre e Dolore.

The use of Nurofen Febbre e Dolore requires adequate precautions, particularly if your child:
- suffers or has suffered from asthma as breathing difficulties may worsen;
- suffers from coagulation problems;
- suffers from kidney, heart, liver diseases, if they are taking drugs that increase urine production (diuretics), or if they have undergone major surgery with consequent fluid loss, as in these cases your doctor will advise you 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 them before and during treatment to avoid the risk of impaired kidney function.

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

Skin reactions
Severe skin reactions have been reported in association with Nurofen Febbre e Dolore treatment. Stop taking Nurofen Febbre e Dolore and consult your doctor immediately if you experience a rash, mucosal lesions, blisters or other signs of allergy, as these may be the first signs of a very severe skin reaction. See section 4.

Infections
Nurofen Febbre e Dolore can mask the symptoms of infections such as fever and pain. It is therefore possible that Nurofen Febbre e Dolore may delay appropriate 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 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.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If your child experiences any of the following side effects, STOP treatment with Nurofen Febbre e Dolore and consult your doctor:
- severe skin and mucous membrane alterations characterized by rashes, redness, itching and blisters (bullous and exfoliative dermatitis including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis);
- allergic reactions, even severe, which may include: urticaria, itching, purpura, swelling of the face, mouth and throat (angioedema), difficulty breathing (bronchospasm or dyspnea), altered heartbeats (tachycardia), low blood pressure (hypotension), anaphylaxis, shock and worsening of asthma;
- aseptic meningitis with symptoms such as disorientation, headache, nausea, vomiting, stiff neck and fever (more frequent if the child has systemic lupus erythematosus or other collagenopathies).

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, unstable mood, hearing and vision disturbances
- cerebrovascular hemorrhage
- dry eyes
- awareness of one's own heartbeat (palpitations)
- diarrhea, flatulence, dry mouth, constipation and vomiting
- hair loss (alopecia), skin reaction caused by exposure to sunlight (photosensitivity dermatitis)
- severe kidney diseases including tubular necrosis, glomerulonephritis, appearance of 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, nose bleeding and hemorrhages
- signs or symptoms of stomach and intestinal ulceration or bleeding, black and foul-smelling stools, vomiting with blood
- bleeding lesions of the mouth, heartburn (gastritis)
- concurrent 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 treatment, associated with an increase in blood urea concentration and swelling (edema)
- decreased hemoglobin levels in the blood
- severe skin infections and soft tissue complications during chickenpox infection
- worsening of infection-related inflammations (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 immediately consult your doctor to assess whether anti-infective/antibiotic therapy is necessary
Not known (frequency cannot be estimated from the available data):
- irritability
- fluid retention and decreased appetite
- abnormal perception of sounds such as buzzing, ringing 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, shortness of breath (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, swelling of the lymph nodes and an increase in eosinophils (a type of white blood cell)
- a widespread, red, scaly rash, with pustules under the skin and blisters located mainly on the skin folds, trunk and upper limbs accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop using Nurofen Febbre e Dolore 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 increased risk of heart attack (myocardial infarction) or stroke.

Reporting of side effects
If you get any side effects, including any 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.