DECAFLU FEBBRE DOLORE*ORAL LIQUID

Decaflu Febbre e Dolore Bambini 100 mg/5 ml oral suspension orange flavor sugar-free
Decaflu Febbre e Dolore Bambini 100 mg/5 ml oral suspension strawberry flavor sugar-free
Ibuprofen

What it is and what it is used for
Decaflu 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.
Decaflu Febbre e Dolore is indicated in children from 3 months to 12 years of age, adolescents and adults for the symptomatic treatment of fever, including post-vaccination fever, and mild or moderate pain (such as headache, sore throat, earache).

What you need to know before taking the medicine
Do not use Decaflu Febbre e Dolore if the child:
• is allergic to ibuprofen, or to any of the other ingredients of this medicine (listed in paragraph 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 (severe renal or hepatic insufficiency);
• suffers from severe heart disease (severe 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 demonstrated ulceration or bleeding);
• is taking other non-steroidal anti-inflammatory drugs (NSAIDs, including COX-2 inhibitors) (see paragraph Other medicines and Decaflu 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;
• in the last trimester of pregnancy (see paragraph Pregnancy, breastfeeding and fertility).

Warnings and precautions
Talk to your doctor or pharmacist before using Decaflu Febbre e Dolore if the child:
• suffers or has suffered from allergy to medicines used to treat fever, pain and inflammation (non-steroidal anti-inflammatory drugs) and if they suffer from difficulty breathing (asthma), nasal polyps, swelling of the face, lips and throat (angioedema);
• is taking other medicines used for the treatment of pain, to lower fever and/or to treat inflammation (non-steroidal anti-inflammatory drugs, including COX-2 inhibitors) (see paragraph Other medicines and Decaflu Febbre e Dolore);
• 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 drugs that may increase the risk of stomach and intestinal diseases are taken (see paragraph Other medicines and Decaflu Febbre e Dolore). 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 in the initial stages of treatment. If gastrointestinal bleeding or ulceration occurs, discontinue treatment with Decaflu Febbre e Dolore Bambini and contact your doctor;
• suffers or has suffered from inflammatory bowel disease (ulcerative colitis, Crohn's disease) as these diseases may worsen (see paragraph 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 paragraph Other medicines and Decaflu 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 you or the child may be at risk for these conditions (for example, if you have high blood pressure, high blood sugar (diabetes) or high blood fat levels, or if you smoke). Medicines like Decaflu 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 with high doses and 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 (edema) have been reported;
• has an infection (see paragraph Infections below).
• has chickenpox, in which case it is advisable to avoid the use of Decaflu Febbre e Dolore.

The use of Decaflu Febbre e Dolore requires adequate precautions, especially if:
• suffers or has suffered from asthma because breathing difficulties could worsen;
• suffers from clotting problems or hypertension;
• suffers from kidney, heart, liver diseases if taking 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 Decaflu Febbre e Dolore, you must pay particular attention and immediately notify your doctor if:
• signs or symptoms of stomach and intestinal ulcerations 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
Serious skin reactions have been reported in association with Decaflu Febbre e Dolore treatment.
Discontinue treatment with Decaflu Febbre e Dolore and consult your doctor immediately if a rash, mucosal lesions, blisters or other signs of allergy appear, as these may be the first signs of a very serious skin reaction. See paragraph 4.

Infections
Decaflu Febbre e Dolore can mask symptoms of infections such as fever and pain. It is therefore possible that Decaflu Febbre e Dolore could 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 infection symptoms persist or worsen, contact your doctor immediately.

Children and adolescents
In dehydrated children and adolescents there is a risk of impaired renal function.

Possible side effects
Like all medicines, Decaflu Febbre e Dolore can cause side effects, although not everyone experiences them.

If you experience any of the following side effects, STOP treatment with Decaflu Febbre e Dolore and contact your doctor:
• severe skin and mucosal changes characterized by eruptions, redness, itching and blisters (bullous and exfoliative dermatitis including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis);
• allergic reactions, including severe ones, which may include: urticaria, itching, purpura, swelling of the face, mouth and throat (angioedema), difficulty breathing (bronchospasm or dyspnea), altered heart rate (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 have systemic lupus erythematosus or other collagenopathies).

Further side effects include:

Uncommon (may affect up to 1 in 100 people):
• headache, dizziness, drowsiness and seizures;
• stomach pains, nausea and indigestion (dyspepsia);
• skin rashes;
• visual disturbances.

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;
• perception of one's 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 stomach and intestinal ulcerations or bleeding, black and foul-smelling stools, vomiting with blood;
• lesions with bleeding of the mouth, heartburn (gastritis);
• simultaneous 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;
• heart attack (myocardial infarction);
• severe skin infections and soft tissue complications during chickenpox infection;
• worsening of infection-related inflammation (e.g., necrotizing fasciitis) associated with the use of some non-steroidal anti-inflammatory drugs (NSAIDs). If signs of an infection appear or worsen, you should immediately contact 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 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 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 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 the skin folds, trunk and upper limbs accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop using Decaflu Febbre e Dolore 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 increase in the risk of heart attack (myocardial infarction) or stroke.