BRUFENKIDS FEB DOL 20 MG/ML ORAL SUSPENSION 150 ML BOTTLE WITH DOSING SYRINGE

Name
BRUFENKIDS FEVER AND PAIN 20 mg/ml oral suspension
Ibuprofen


What is it and what is it for?
BRUFENKIDS FEVER AND PAIN contains ibuprofen, an active ingredient belonging to a group of medicines called NSAIDs (nonsteroidal anti-inflammatory drugs). NSAIDs are medicines used to treat pain, fever, and inflammation.

BRUFENKIDS FEVER AND PAIN is used to treat:
• fever;
• mild to moderate pain.

BRUFENKIDS FEVER AND PAIN 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 FEVER AND PAIN:
• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if you have had allergic symptoms (e.g. difficulty breathing, nasal congestion, skin rashes) after taking aspirin or other anti-inflammatory medicines, particularly if associated with nasal polyps, swelling of the face (angioedema) and/or asthma;
• if you have a stomach or duodenal ulcer;
• if you have had even one episode of ulcer, perforation or bleeding in the stomach or intestine (including blood in vomiting or during bowel movements or black, tarry stools) caused by taking medicines;
• if you have had two or more distinct episodes of ulcers or bleeding in your stomach or intestines (including blood in your vomit or during bowel movements or black, 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 if you have had severe vomiting, diarrhoea or if you drink very little;
• during the third trimester of pregnancy.

Do not use BRUFENKIDS FEVER AND PAIN in children under 3 months of age or weighing less than 5 kg.


Warnings and precautions
Talk to your doctor before taking BRUFENKIDS FEVER AND PAIN if:
• have systemic lupus erythematosus (SLE, known as lupus) or mixed connective tissue disease, diseases that affect the connective tissue causing joint or muscle pain, skin changes, and problems with other organs;
• have had stomach or intestinal diseases, such as ulcers, Crohn's disease, ulcerative colitis;
• has reduced kidney function;
• has liver problems;
• has blood clotting problems;
• have or have had allergies (e.g. hay fever);
• has inflammation of the nose (chronic rhinitis) or nasal polyps;
• is elderly, as he or she is more likely to develop adverse events from this medicine;
• have chickenpox, as pain and inflammation medications (NSAIDs) can worsen the severity of the skin lesions caused by it. In such cases, your doctor may advise you not to use this medicine;
• suffers from asthma or respiratory diseases that have lasted for a long time (chronic);
• if you are a child or adolescent or elderly and are dehydrated as you are more likely to have kidney problems.
• have an infection – see section “Infections” below.

Heart attack and stroke
Anti-inflammatory/painkiller medications such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when taken 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 FEVER AND PAIN if you have:
• heart problems including heart attack, angina (chest pain) or if you have had a heart attack, coronary artery bypass surgery, peripheral artery 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, family history of heart disease or stroke, or if you are a smoker.

Signs of an allergic reaction to ibuprofen have been reported, including breathing problems, swelling of the face and neck (angioedema), and chest pain. Stop taking BRUFENKIDS FEVER AND PAIN immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.

Skin reactions
Serious skin reactions, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Stop using BRUFENKIDS 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
BRUFENKIDS FEVER AND PAIN may hide the symptoms of infections such as fever and pain. Therefore, BRUFENKIDS 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 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.

PLEASE NOTE , as during treatment with all pain and inflammation medicines (NSAIDs):
• bleeding, ulceration or perforation of the stomach or intestine, which can be fatal, has been reported at any time, with or without warning symptoms, even in patients with no previous serious stomach or intestinal (gastrointestinal) problems;
• Although very rare, serious skin reactions, some of them fatal, manifesting as redness, blistering and peeling (e.g. exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis) have been reported. Patients appear to be at highest risk in the early stages of therapy: these reactions occur in most cases within the first month of treatment;
• eye changes may occur if BRUFENKIDS FEVER AND PAIN is used for prolonged treatments. Periodic eye checks are necessary during therapy;
• especially if used for prolonged periods and at high doses, headache may occur; in this case, do not increase the dose of BRUFENKIDS FEVER AND PAIN to relieve the pain.

The risk of side effects can be reduced by using the lowest effective dose and for the shortest duration necessary to control symptoms. Do not exceed the recommended dose of BRUFENKIDS FEVER AND PAIN or take it for long periods; always follow your doctor's instructions carefully.

STOP treatment and contact your doctor if:
• note any symptoms affecting your stomach and intestines (gastrointestinal), especially if they involve 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 FEVER AND PAIN and contact your doctor immediately if you experience any of the following conditions:
• severe stomach problems, heartburn or abdominal pain due to a stomach or duodenal ulcer (peptic ulcers), sudden, severe pain in the pit of the stomach or belly (gastrointestinal perforation). These side effects are uncommon;
• vomiting blood (hematemesis) or black stools (melena), associated with bleeding from the stomach or intestines (gastrointestinal bleeding) or abnormal tiredness with reduced urine output (due to invisible bleeding). These conditions are common side effects;
• allergic reactions, including serious ones, which manifest themselves with the more or less sudden appearance of skin lesions, for example, blotchy or widespread discoloration (rash, purpura), hives, 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, dyspnoea or apnoea). These conditions are uncommon side effects;
• systemic lupus erythematosus (SLE, commonly known as lupus), a disease that affects connective tissue, causing joint or muscle pain, skin changes, and problems with other organs. This condition occurs rarely;
• worsening of infections such as the onset of necrotizing fasciitis which manifests itself with 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) manifested by: very high fever, sudden headache, inability to bend the head, nausea, vomiting, confusion, drowsiness, and sensitivity to light. This condition occurs rarely;
• serious skin reaction known as DRESS syndrome. Symptoms of DRESS include: rash, fever, swollen lymph nodes, and increased eosinophils (a type of white blood cell);
• a widespread, red, scaly rash with pustules under the skin and blisters, mainly located in the skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop using BRUFENKIDS FEVER AND PAIN if you develop these symptoms and contact your doctor immediately.
See also paragraph 2;
• flat, target-shaped or circular reddish spots on the trunk, often with central vesicles, peeling skin, 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];
• chest pain, which may 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, diarrhoea, intestinal gas (flatulence), difficulty in evacuating bowel movements (constipation), indigestion (dyspepsia), abdominal pain;
• headache, dizziness;
• fatigue;
• rash.

Uncommon side effects (may affect up to 1 in 100 people)
• inflammation of the nose (rhinitis);
• gastritis, mouth ulcers;
• dizziness, drowsiness, difficulty falling asleep (insomnia), anxiety, changes in sensation (paraesthesia);
• ringing in the ears (tinnitus), impaired hearing, vision disturbances;
• appearance of skin lesions following exposure to the sun (photosensitivity);
• changes in liver function, yellowing of the eyes or skin (jaundice), dark urine, pale stools, itching or pain in the abdomen, possible signs of inflammation of the liver (hepatitis);
• hypersensitivity reactions (hives, itching);
• kidney problems such as nephrotic syndrome, inflammation of the kidney (tubulointerstitial nephritis), changes in function (renal failure).

Rare side effects (may affect up to 1 in 1,000 people)
• decrease in the number of white blood cells (leukopenia) or of 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 problems with the bone marrow (aplastic anemia);
• depression, confusion;
• alteration of vision due for example to inflammation of the optic nerve (optic neuritis) or to 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);
• feeling of heart in the throat (palpitations), heart attack, reduced heart function (failure), high blood pressure (hypertension);
• breathing problems due to swelling 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 lining of the mouth with ulcers (ulcerative stomatitis), worsening of inflammation of the colon (colitis) or Crohn's disease;
• worsening of skin infections caused by chickenpox;
• stroke;
• hallucinations, malaise, reduced appetite.

Reporting of side effects
If you experience 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.