BENATIA*BB 150ML 100MG/5ML ARA

BENATIA Children 100mg/5ml oral suspension strawberry flavour sugar-free
BENATIA Children 100mg/5ml oral suspension orange flavour sugar-free
Ibuprofen

What it is and what it is used for
BENATIA contains ibuprofen, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) whose action reduces pain, fever, and inflammation. BENATIA is indicated in children from 3 months to 12 years of age 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 BENATIA to your child:
- if they are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
- if they experience or have experienced in the past allergic reactions such as shortness of breath, rhinitis (runny nose), swelling of the face, lips and throat (angioedema) or urticaria, especially 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 a severe kidney or liver disease (renal or hepatic insufficiency);
- if they suffer from a severe heart disease (heart failure);
- if they suffer or have suffered from stomach and/or intestinal bleeding (gastrointestinal haemorrhage) or perforation following previous treatments with NSAIDs;
- if they suffer or have suffered from gastric/duodenal ulcers (peptic ulcers) or active or recurrent bleeding (at least two distinct episodes of confirmed ulceration or bleeding);
- if they are taking other non-steroidal anti-inflammatory drugs (NSAIDs, including selective COX-2 inhibitors) (see section Other medicines and BENATIA);
- if they have any disease that increases the risk of bleeding;
- in case of unexplained blood disorders;
- if they are severely dehydrated, for example, have had severe episodes of vomiting, diarrhoea, or drink very little;
- if they are under 3 months of age or weigh less than 5.6 kg;
- if they are in the last trimester of pregnancy (see section Pregnancy and breastfeeding).

Warnings and precautions
Talk to your doctor or pharmacist before giving BENATIA to your child.
• if they suffer or have suffered from an allergy 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);
• if they are taking other medicines used to treat pain, to lower fever and/or to treat inflammation (non-steroidal anti-inflammatory drugs, NSAIDs including COX-2 inhibitors) (see section Other medicines and BENATIA);
• if they 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 low doses of aspirin or other drugs that may increase the risk of stomach and intestinal diseases are taken (see section Other medicines and BENATIA). 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, stop treatment with BENATIA and contact your doctor;
• if they suffer or have suffered from an inflammatory bowel disease (ulcerative colitis, Crohn's disease) as these diseases may worsen (see section Possible side effects);
• if they are 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 section Other medicines and BENATIA);
• if they have heart diseases (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 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 such as BENATIA 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;
• if they suffer or have 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 (oedema) have been reported;
• if they have an infection (see section Infections below);
• if they have chickenpox, in which case, it is advisable to avoid the use of BENATIA.

The use of BENATIA requires adequate precautions, especially if the child:
• suffers or has suffered from asthma because breathing difficulties could worsen;
• suffers from coagulation problems or hypertension;
• suffers from kidney, heart, or liver diseases, if they are taking drugs that increase urine production (diuretics), or if they have undergone major surgery with consequent fluid loss, since 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 (for example, acute intermittent porphyria); is dehydrated (for example due to fever, vomiting, or diarrhoea), in which case rehydrate them before and during treatment to avoid the risk of kidney function alteration.

During prolonged treatments with BENATIA, you must pay particular attention and immediately inform your doctor if:
• signs or symptoms of stomach and intestinal ulceration or bleeding appear (e.g., black and foul-smelling stools, bloody vomit);
• 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 colour 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 suffers from systemic lupus erythematosus or other collagenopathies).

Skin reactions
Serious skin reactions have been reported in association with BENATIA treatment. Stop taking BENATIA 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 section 4.

Infections
BENATIA can mask the symptoms of infections such as fever and pain. It is therefore possible that BENATIA 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 renal function.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
If your child experiences any of the following serious side effects, stop administering the tablets and immediately inform your doctor or go to the nearest hospital:
• severe skin and mucosal alterations characterized by rashes, 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 dyspnoea), altered heartbeats (tachycardia), low blood pressure (hypotension), anaphylaxis, severe shock, and worsening of asthma;
• aseptic meningitis with symptoms such as disorientation, headache, nausea, vomiting, stiff neck, and fever (more frequent if the child suffers from systemic lupus erythematosus or other collagenopathies). Additional 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;
• vision disturbances.

Rare (may affect up to 1 in 1,000 people):
• cystitis, rhinitis;
• depression, insomnia, difficulty concentrating, unstable mood, hearing disorders;
• cerebrovascular haemorrhage;
• dry eyes;
• perception of one's own heartbeat (palpitations);
• diarrhoea, 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 haematocrit levels.

Very rare (may affect up to 1 in 10,000 people):
• reduction in the number of blood cells (anaemia, leucopenia, thrombocytopenia, eosinophilia, pancytopenia, agranulocytosis) - the first signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds, and haemorrhages;
• signs or symptoms of stomach and intestinal ulceration or bleeding, black and foul-smelling stools, bloody vomit;
• lesions with bleeding from 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 (oedema);
• decreased haemoglobin 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., necrotising fasciitis) associated with the use of some 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 ringing, buzzing, or rustling (tinnitus);
• severe heart disease (heart failure) and swelling (oedema);
• increased blood pressure (hypertension) and reduced blood flow to the body (shock);
• respiratory tract disorders including asthma, laryngeal obstruction, shortness of breath (bronchospasm), temporary cessation of breathing (apnoea), and difficulty breathing (dyspnoea);
• worsening of inflammatory bowel diseases (colitis and Crohn's disease), inflammation of the pancreas (pancreatitis), inflammation of the duodenum (duodenitis), inflammation of the oesophagus (oesophagitis);
• a severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: rash, fever, swelling of lymph nodes, and an increase in eosinophils (a type of white blood cell);
• a widespread, red and scaly rash, with the formation of pustules under the skin and blisters located mainly on the skin folds, on the trunk and upper limbs accompanied by fever at the beginning of treatment (acute generalised exanthematous pustulosis);
• skin becomes sensitive to light.

Stop using BENATIA if these symptoms develop and contact your doctor immediately.
See also section 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, 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.