IBUPROFEN EG*BB 150ML ORANGE

IBUPROFENE EG Children 100 mg/5 ml oral suspension strawberry flavor sugar-free
IBUPROFENE EG Children 100 mg/5 ml oral suspension orange flavor sugar-free
Ibuprofen
Generic medicine

What it is and what it is used for
Ibuprofen EG contains ibuprofen, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) whose action reduces pain, fever, and inflammation.

Ibuprofen EG 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
Do not give Ibuprofen EG to your child
- if they are allergic to the active ingredient (ibuprofen) or any of the other ingredients of this medicine (listed in paragraph 6);
- if they experience or have 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);
- if they suffer from severe kidney or liver disease (renal or hepatic insufficiency);
- if they suffer from severe heart problems (severe heart failure);
- if they suffer or have suffered from stomach and/or intestinal bleeding (gastrointestinal hemorrhage) or perforation following previous NSAID treatments;
- if they suffer or have suffered from gastric/duodenal ulcers (peptic ulcers) or active or recurrent bleeding (at least two distinct episodes of proven ulceration or bleeding);
- if they are taking other non-steroidal anti-inflammatory drugs (NSAIDs, including selective COX-2 inhibitors) (see paragraph Other medicines and Ibuprofen EG);
- if they have any disease that increases the risk of bleeding;
- in case of unexplained blood disorders;
- if they are in a severe state of dehydration, for example, have had severe episodes of vomiting, diarrhea, or drink very little;
- if they are under 3 months of age or weigh less than 5.6 kg.

Do not take Ibuprofen EG in the last trimester of pregnancy (see Pregnancy and breastfeeding).

Warnings and precautions
Talk to your doctor or pharmacist before using Ibuprofen EG if the child:
• suffers or has suffered from allergies to medicines used to treat fever, pain, and inflammation (non-steroidal anti-inflammatory drugs) and if they suffer from breathing difficulties (asthma), seasonal allergies (hay fever), nasal polyps, if they have severe respiratory or chest problems, e.g., chronic obstructive pulmonary disease, swelling of the face, lips, and throat (angioedema);
• is taking other medicines used for the treatment of pain, to reduce fever and/or to treat inflammation (non-steroidal anti-inflammatory drugs, NSAIDs including COX-2 inhibitors) (see paragraph Other medicines and Ibuprofen EG);
• 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, the doctor will advise starting 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 Ibuprofen EG). 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, which can be fatal, may occur. Therefore, inform your doctor of any unusual gastrointestinal symptoms (especially gastrointestinal bleeding) particularly in the early stages of treatment. If gastrointestinal bleeding or ulceration occurs, stop treatment with Ibuprofen EG and contact your doctor;
• suffers or has suffered from an 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 Ibuprofen EG);
• has heart diseases (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 the child may be at risk for these conditions (for example, if they have high blood pressure, high sugar levels (diabetes) or fats in the blood, or if they smoke). Medicines like Ibuprofen EG 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 therapies. 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) because, in association with NSAID therapy, fluid retention, high blood pressure, and swelling (edema) have been reported;
• has an infection (see section Infections below);
• has chickenpox, in which case it is advisable to avoid the use of Ibuprofen EG.
The use of Ibuprofen EG requires adequate precautions, especially if the child:
• suffers or has suffered from asthma because breathing difficulties could worsen;
• suffers from clotting problems or hypertension;
• suffers from kidney, heart, or liver diseases if taking drugs that increase urine production (diuretics), or if they have undergone major surgery with consequent fluid loss, as in these cases your doctor will advise you to have periodic blood and urine tests for the child;
• has undergone major surgery;
• suffers from certain congenital diseases affecting blood formation (for example, acute intermittent porphyria); 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 altered kidney function.

During prolonged treatments with Ibuprofen EG, you must pay particular attention and immediately notify the doctor if:
• signs or symptoms of ulceration 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 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 the 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).

Signs of an allergic reaction to this medicine, including breathing problems, swelling of the face and neck area (angioedema), and chest pain, have been reported with ibuprofen. Stop Ibuprofen EG 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 Ibuprofen EG and contact your doctor immediately if you notice any of the symptoms related to these severe skin reactions described in paragraph 4.

Infections
Ibuprofen EG can mask symptoms of infections such as fever and pain. It is therefore possible that Ibuprofen EG 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 infection symptoms 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 the child experiences any of the following side effects, STOP treatment with Ibuprofen EG and contact your doctor:
• chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome;
• reddish, non-raised, target-shaped or circular 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);
• allergic reactions, even severe, which may include: hives, 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 the child has systemic lupus erythematosus or other collagenopathies).

Further 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;
• visual disturbances.

Rare (may affect up to 1 in 1,000 people):
• cystitis, rhinitis;
• depression, insomnia, difficulty concentrating, unstable mood, hearing disturbances;
• cerebrovascular hemorrhage;
• dry eyes;
• sensation of one's 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, presence of 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 ulceration or bleeding of the stomach and intestine, 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 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):
• 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, swollen lymph nodes, and an increase in eosinophils (a type of white blood cell);
• a widespread, red, and scaly rash, with pustules forming under the skin and blisters mainly located on skin folds, trunk, and upper limbs accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop using Ibuprofen EG 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 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.