BRUFENKIDS FEB DOL*OS 150ML

BRUFENKIDS FEBBRE E DOLORE 20 mg/ml oral suspension
Ibuprofen

What it is and what it is used for
BRUFENKIDS FEBBRE E DOLORE contains ibuprofen, an active ingredient belonging to a group of medicines called NSAIDs (non-steroidal anti-inflammatory drugs). NSAIDs are drugs for pain, fever and inflammation.

BRUFENKIDS FEBBRE E DOLORE is used to treat:
• fever;
• mild to moderate pain.

BRUFENKIDS FEBBRE E DOLORE can be used in infants and children aged between 3 months and 12 years.

What you need to know before taking the medicine
Do not take BRUFENKIDS FEBBRE E DOLORE:
• if you are allergic to the active ingredient or any of the other ingredients of this medicine (listed in paragraph 6);
• if you have had allergic symptoms (e.g., breathing difficulties, nasal congestion, skin rashes) after taking aspirin or other anti-inflammatory drugs, particularly if associated with nasal polyps, facial swelling (angioedema) and/or asthma;
• if you have a stomach or duodenal ulcer;
• if you have had even one episode of stomach or intestinal ulcer, perforation or bleeding (including blood in vomit or during bowel movements or black and tarry stools) caused by taking medication;
• if you have had two or more distinct episodes of stomach or intestinal ulcer or bleeding (including blood in vomit or during bowel movements or black and tarry stools);
• if you have severe liver or kidney problems;
• if you suffer from severe heart failure;
• if you have any disease that increases the risk of bleeding;
• if you are severely dehydrated, for example, have had severe episodes of vomiting, diarrhea or drink very little;
• during the third trimester of pregnancy.

Do not use BRUFENKIDS FEBBRE E DOLORE in children under 3 months of age or weighing less than 5 kg.

Warnings and precautions
Talk to your doctor before taking BRUFENKIDS FEBBRE E DOLORE if:
• you suffer from systemic lupus erythematosus (SLE, also known as lupus) or mixed connective tissue disease, illnesses that affect connective tissue causing joint or muscle pain, skin changes, and problems in other organs;
• you have had stomach or intestinal disorders, e.g., ulcer, Crohn's disease, ulcerative colitis;
• you have reduced kidney function;
• you have liver problems;
• you have blood clotting problems;
• you have or have had allergies (e.g., hay fever);
• you have nasal inflammation (chronic rhinitis) or nasal polyps;
• you are elderly, as you have a higher likelihood of developing adverse events to this medicine;
• you have chickenpox, as pain relievers and anti-inflammatory drugs (NSAIDs) can worsen the severity of skin lesions caused by it. In such cases, your doctor may advise you not to use this medicine;
• you suffer from asthma or long-term (chronic) respiratory diseases;
• if you are a child or adolescent or elderly and are dehydrated, as you have a higher likelihood of kidney problems;
• you have an infection - see Infections section below.

Heart attack and stroke
Anti-inflammatory/pain relief medicines like ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when given in high doses. Do not exceed the recommended dose or duration of treatment.
You should discuss your treatment with your doctor or pharmacist before taking BRUFENKIDS FEBBRE E DOLORE if you have:
• heart problems including heart attack, angina (chest pain) or if you have a history of heart attack, coronary bypass surgery, peripheral arterial disease (poor circulation in the legs or feet due to narrowing or blockage of the arteries) or any type of stroke (including mini-stroke or TIA, transient ischemic attack);
• high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.

Signs of an allergic reaction to this medicine have been reported with ibuprofen, including breathing problems, swelling in the face and neck area (angioedema), and chest pain. Stop taking BRUFENKIDS FEBBRE E DOLORE immediately and contact your doctor or emergency medical service immediately if you notice any of these signs.

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 BRUFENKIDS FEBBRE E DOLORE and contact your doctor immediately if you notice any of the symptoms related to these severe skin reactions described in paragraph 4.

Infections
BRUFENKIDS FEBBRE E DOLORE can mask the symptoms of infections such as fever and pain. Therefore, it is possible that BRUFENKIDS 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 symptoms of the infection persist or worsen, contact your doctor immediately.

PAY ATTENTION, as during treatment with all pain and anti-inflammatory drugs (NSAIDs):
• at any time, with or without warning symptoms, even in patients without previous severe stomach or intestinal (gastrointestinal) problems, bleeding, ulceration or perforation of the stomach or intestine have been reported, which can be fatal;
• although very rarely, severe skin reactions, some of which fatal, have been reported, manifesting as redness, blistering and exfoliation (e.g., exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis). In the early stages of therapy, patients seem to be at higher risk: such reactions occur in most cases within the first month of treatment;
• eye changes may occur if BRUFENKIDS FEBBRE E DOLORE is used for prolonged treatments. Periodic eye checks are necessary during therapy;
• especially if used for prolonged periods and at high doses, headaches may occur; in this case, do not increase the dose of BRUFENKIDS FEBBRE E DOLORE to relieve the pain.

The risk of side effects can be reduced by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms. Do not exceed the dose of BRUFENKIDS FEBBRE E DOLORE and do not take it for long periods; always carefully follow your doctor's instructions.

STOP treatment and contact your doctor if:
• you notice any stomach or intestinal (gastrointestinal) symptoms, especially if it is bleeding;
• a skin rash, mucosal lesions or any other sign of an allergic reaction appears (e.g., redness, itching, swelling of the face and throat, sudden drop in blood pressure).

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

Serious side effects
Stop taking BRUFENKIDS FEBBRE E DOLORE and contact your doctor immediately if you experience any of the following conditions:
• severe stomach problems, heartburn or abdominal pain due to stomach or duodenal ulcer (peptic ulcers), sudden and severe pain in the pit of the stomach or abdomen (gastrointestinal perforation). These side effects are uncommon;
• vomiting containing blood (hematemesis) or black stools (melena), associated with stomach or intestinal bleeding (gastrointestinal hemorrhage) or unusual fatigue with reduced urine output (due to invisible bleeding). These conditions are common side effects;
• allergic reactions, even severe ones, manifesting as more or less sudden appearance of skin lesions, e.g., spotted or widespread color changes (rash, purpura), urticaria, itching, swelling (angioedema) of the face, eyes, lips, swelling of the tongue and throat with possible difficulty breathing and swallowing. An increase in heart rate and a sudden drop in blood pressure may also occur (anaphylactic reaction, anaphylaxis or severe shock);
• severe skin rashes with redness, peeling and/or blistering (e.g., erythema multiforme, Stevens-Johnson Syndrome, toxic epidermal necrolysis, exfoliative and bullous dermatitis). Such conditions occur very rarely;
• difficulty breathing (asthma, bronchospasm, dyspnea or apnea). These conditions are uncommon side effects;
• systemic lupus erythematosus (SLE, known as lupus), a disease that affects connective tissue causing joint or muscle pain, skin changes, and problems in other organs. This condition occurs rarely;
• worsening of infections such as the appearance of necrotizing fasciitis, which manifests as fever, chills, weakness, sweating, diarrhea, vomiting, redness, pain, swelling, bruising in an area of the body due to tissue necrosis (death of tissue cells);
• inflammation of the meninges (aseptic meningitis) which manifests as: very high fever, sudden headache, inability to flex the head, nausea, vomiting, confusion, drowsiness and discomfort to light. This condition occurs rarely;
• severe skin reaction known as DRESS syndrome. Symptoms of DRESS include: rash, fever, swollen lymph nodes and an increase in eosinophils (a type of white blood cell);
• a widespread, red and scaly rash, with pustules under the skin and vesicles located mainly on the skin folds, on the trunk and on the upper limbs accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop using BRUFENKIDS FEBBRE E DOLORE if you develop these symptoms and contact your doctor immediately. See also paragraph 2;
• flat, reddish, target-shaped or circular patches on the trunk, often with central vesicles, skin peeling, ulcers in 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];
• chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome.

Other side effects
Tell your doctor if you notice:

Common side effects (may affect up to 1 in 10 people)
• nausea, vomiting, diarrhea, intestinal gas (flatulence), difficulty defecating (constipation), indigestion (dyspepsia), abdominal pain;
• headache, dizziness;
• fatigue;
• rash.

Uncommon side effects (may affect up to 1 in 100 people)
• nasal inflammation (rhinitis);
• gastritis, mouth ulcers;
• vertigo, drowsiness, difficulty sleeping (insomnia), anxiety, altered sensation (paresthesia);
• ringing in the ears (tinnitus), impaired hearing, visual disturbances;
• appearance of skin lesions following sun exposure (photosensitivity);
• altered liver function, yellowish discoloration of the eyes or skin (jaundice), dark urine, pale stools, itching or abdominal pain, possible signs of liver inflammation (hepatitis);
• hypersensitivity reactions (urticaria, itching);
• kidney problems such as nephrotic syndrome, kidney inflammation (tubulointerstitial nephritis), altered function (renal insufficiency).

Rare side effects (may affect up to 1 in 1,000 people)
• decrease in the number of white blood cells (leukopenia) or certain types of white blood cells (neutropenia, agranulocytosis), decrease in the number of platelets (thrombocytopenia), decrease in the number of red blood cells due to destruction (hemolytic anemia) or bone marrow problems (aplastic anemia);
• depression, confusion;
• vision alteration due to, for example, inflammation of the optic nerve (optic neuritis) or toxic optic neuropathy;
• swelling (edema).

Very rare side effects (may affect up to 1 in 10,000 people)
• reduced liver function, inflammation of the pancreas (pancreatitis);
• sensation of heart palpitations, heart attack, reduced function (insufficiency) of the heart, high blood pressure (hypertension);
• breathing problems due to edema in the lungs;
• kidney damage (acute renal failure, papillary necrosis).

Other side effects with unknown frequency (frequency cannot be estimated from the available data)
• burning sensation in the mouth or throat, pain or burning (heartburn) in the pit of the stomach, inflammation of the oral mucosa with ulcers (ulcerative stomatitis), worsening of colon inflammation (colitis) or Crohn's disease;
• worsening of skin infections caused by chickenpox;
• stroke;
• hallucinations, malaise, reduced appetite.

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.