NUROFEN FEVER D*BB100MG/5ML A

NUROFEN Fever and Pain Children 100mg/5ml oral suspension orange flavour sugar-free
NUROFEN Fever and Pain Children 100mg/5ml oral suspension strawberry flavour 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 helps reduce 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 have been reported with ibuprofen, including breathing problems, swelling of the face and neck (angioedema), and chest pain. Stop taking Nurofen Fever and Pain immediately and contact your doctor or emergency services 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);
- experiences or has experienced in the past allergic reactions such as wheezing, rhinitis (runny nose), swelling of the face, lips and throat (angioedema) or hives, 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 stomach and/or intestinal bleeding (gastrointestinal haemorrhage) 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 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);
- 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
Consult your doctor or pharmacist before using Nurofen Fever and Pain if the child:
• suffers or has suffered from an allergy 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, lower 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 bleeding and perforations may occur. 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 medicines 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) particularly in the initial stages of treatment. If gastrointestinal bleeding or ulceration occurs, discontinue Nurofen Fever and Pain treatment 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 Fever and Pain);
• has heart conditions (uncontrolled hypertension, congestive heart failure, confirmed ischaemic 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 fat levels in the blood, or if they smoke). 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 therapy. 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, in association with NSAID therapy, fluid retention, high blood pressure and swelling (oedema) have been reported;
• 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, particularly if the child:
• suffers or has suffered from asthma because breathing difficulties could worsen;
• suffers from clotting problems;
• suffers from kidney, heart, liver diseases and hypertension;
• is dehydrated (e.g., due to fever, vomiting or diarrhoea), in this case rehydrate them before 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 notify your doctor if:
• signs or symptoms of ulcerations or bleeding of the stomach and intestine appear (e.g., black and foul-smelling stools, vomiting with blood);
• signs or symptoms of liver damage appear (e.g., hepatitis and jaundice);
• signs or symptoms of kidney damage appear (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 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
Serious skin reactions, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalised 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 serious skin reactions described in section 4.

Infections
Nurofen Fever and Pain can mask the symptoms of infections such as fever and pain. Therefore, Nurofen Fever and Pain 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 the child experiences any of the following side effects, STOP treatment with Nurofen Fever and Pain and consult your doctor:
• allergic reactions, including severe ones, which may include: hives, itching, purpura, swelling of the face, mouth and throat (angioedema), difficulty breathing (bronchospasm or dyspnoea), altered heart beat (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);
• red, non-raised, target-shaped or circular patches on the trunk, often with central blisters, peeling skin, ulcers of the mouth, throat, nose, genitals and eyes. These severe 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 generalised exanthematous pustulosis).

Additional 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 disorders;
• cerebrovascular haemorrhage;
• dry eyes;
• sensation of one's own heartbeat (palpitations);
• diarrhoea, flatulence, dry mouth, constipation and vomiting;
• hair loss (alopecia);
• skin becomes sensitive to light;
• severe kidney diseases including tubular necrosis, glomerulonephritis, appearance of blood in urine and increased urine production;
• decrease in haematocrit levels.

Very rare (may affect up to 1 in 10,000 people):
• reduction in the number of blood cells (anaemia, leucopenia, thrombocytopenia, eosinophilia, pancytopenia, agranulocytosis) - the first signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds and haemorrhages;
• signs or symptoms of ulcerations or bleeding of the stomach and intestine, black and foul-smelling stools, vomiting with blood;
• bleeding lesions in the mouth, heartburn (gastritis);
• concomitant 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 blood urea concentration and swelling (oedema);
• decrease in haemoglobin levels in the blood;
• severe skin infections and soft tissue complications during chickenpox infection;
• worsening of infection-related inflammations (e.g., necrotising fasciitis) associated with the use of some 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):
• chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome;
• irritability;
• fluid retention and decreased appetite;
• abnormal perception of noises such as buzzing, ringing or rustling (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, wheezing (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: rash, fever, swelling of lymph nodes and increased eosinophils (a type of white blood cell);
• a widespread, red and scaly rash, with the formation of pustules under the skin and blisters mainly located on skin folds, trunk and upper limbs accompanied by fever at the beginning of treatment (acute generalised exanthematous pustulosis). Stop using Nurofen Fever and Pain if these symptoms develop 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, tell 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.