NUROFEN FEVER D*200MG/5ML ARA

Nurofen Fever and Pain 200mg/5ml oral suspension orange flavor sugar-free
Nurofen Fever and Pain 200mg/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 helps reduce pain, fever, and inflammation.
Nurofen Fever and Pain is indicated for children aged 2 to 12 years, adolescents, and adults for the symptomatic treatment of fever, including post-vaccination fever, and mild or 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 region (angioedema), and chest pain.
Stop Nurofen Fever and Pain immediately and contact your doctor or emergency medical service immediately if you notice any of these signs.

Do not use Nurofen Fever and Pain if:
- you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in paragraph 6);
- you experience or have experienced allergic reactions in the past 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);
- you suffer from severe kidney or liver disease (renal or hepatic insufficiency);
- you suffer from severe heart disease (heart failure);
- you suffer or have suffered from stomach and/or intestinal bleeding (gastrointestinal hemorrhage) or perforation following previous NSAID treatments;
- you suffer or have suffered from gastric/duodenal ulcers (peptic ulcers) or active or recurrent bleeding (at least two distinct episodes of demonstrated ulceration or bleeding);
- you are taking other non-steroidal anti-inflammatory drugs (NSAIDs, including selective COX-2 inhibitors) (see paragraph Other medicines and Nurofen Fever and Pain);
- the child is under 2 years of age;
- you are in the last trimester of pregnancy (see paragraph Pregnancy, breastfeeding, and fertility).

Warnings and precautions
Consult your doctor or pharmacist before using Nurofen Fever and Pain if:
• you suffer or have suffered from allergy to medicines used to treat fever, pain, and inflammation (non-steroidal anti-inflammatory drugs) and if you suffer from breathing difficulties (asthma), nasal polyps, swelling of the face, lips, and throat (angioedema);
• you are taking other medicines used for the treatment of pain, to lower fever and/or to treat inflammation (non-steroidal anti-inflammatory drugs, NSAIDs including COX-2 inhibitors) (see paragraph Other medicines and Nurofen Fever and Pain);
• you have 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 you are taking low doses of aspirin or other medicines that may increase the risk of stomach and intestinal diseases (see paragraph Other medicines and Nurofen Fever and Pain). During treatment with all NSAIDs, at any time, with or without warning symptoms or a 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 at the beginning of treatment. If gastrointestinal bleeding or ulceration occurs, stop treatment with Nurofen Fever and Pain and contact your doctor;
• you suffer or have suffered from inflammatory bowel disease (ulcerative colitis, Crohn's disease) as these diseases may worsen (see paragraph Possible side effects);
• 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 paragraph Other medicines and Nurofen Fever and Pain);
• you have heart disease (uncontrolled hypertension, congestive heart failure, confirmed ischemic heart disease, peripheral arterial disease) or have suffered from reduced blood flow to the brain (stroke), or if you think you or the child may be at risk for these conditions (for example if you have high blood pressure, if you have high sugar levels (diabetes) or fat in the blood, or if you 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 in prolonged therapies. Do not exceed the recommended dose or duration of treatment;
• you suffer or have 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;
• you have an infection (see paragraph Infections below);
• you have chickenpox, as, in that 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:
• you suffer or have suffered from asthma because breathing difficulties could worsen;
• you suffer from coagulation problems;
• you suffer from kidney, heart, liver diseases, and hypertension;
• the child or adolescent is dehydrated (for example due to fever, vomiting, or diarrhea), in this case, rehydrate them before the start 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 appear (e.g., black and foul-smelling stools, vomiting 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 headache, disorientation, nausea, vomiting, stiff neck, and fever, as these could be symptoms due to aseptic meningitis (more frequent if you suffer from systemic lupus erythematosus or other collagen diseases).

Skin reactions
Severe skin reactions have been reported in association with ibuprofen treatment, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP). 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 paragraph 4.

Infections
Nurofen Fever and Pain can mask the symptoms of infections such as fever and pain. Therefore, it is 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, contact 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 you experience any of the following side effects, STOP treatment with Nurofen Fever and Pain and consult your doctor:
• allergic reactions, even severe ones, which may include: hives, itching, purpura, swelling of the face, mouth, and throat (angioedema), breathing difficulties (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 you suffer from systemic lupus erythematosus or other collagen diseases);
• non-raised, target-shaped or circular reddish 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).

Additional side effects include:

Uncommon (may affect up to 1 in 100 people):
• headache, dizziness, drowsiness, and convulsions;
• stomach pain, nausea, and difficulty digesting (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;
• feeling your 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 blood;
• bleeding lesions of 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 (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):
• 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 (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 breathing difficulties (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 pus-filled blisters under the skin and blisters located mainly on skin folds, 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 paragraph 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 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.