DOLIBLOC*BB SUSP 150ML S/Z ARA

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

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

DOLIBLOC is indicated in children aged 3 months to 12 years for the treatment of fever and mild to moderate pain.

What you need to know before taking the medicine
Do not use DOLIBLOC if your child
- is allergic to ibuprofen or any of the other ingredients of this medicine, listed in section 6;
- experiences or has experienced in the past allergic reactions such as shortness of breath, rhinitis (runny nose), swelling of the face, lips and throat (angioedema) or urticaria, 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 (renal or hepatic insufficiency);
- suffers from severe heart disease (heart failure);
- suffers or has suffered from stomach and/or intestinal bleeding (gastrointestinal haemorrhage) 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 selective COX-2 inhibitors) (see section Other medicines and Dolibloc);
- has any condition that increases the risk of bleeding;
- has unexplained blood disorders;
- is severely dehydrated, for example has had severe episodes of vomiting, diarrhoea or drinks very little;
- is under 3 months of age or weighs less than 5.6 kg;
- is in the last trimester of pregnancy (see section Pregnancy and breastfeeding).

Warnings and precautions
Talk to your doctor or pharmacist before using DOLIBLOC if your 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 breathing difficulties (asthma), seasonal allergies (hay fever), nasal polyps, 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 lower fever and/or to treat inflammation (non-steroidal anti-inflammatory drugs, NSAIDs including COX-2 inhibitors) (see section Other medicines and Dolibloc);
- 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 medicines that may increase the risk of stomach and intestinal diseases are taken (see section Other medicines and Dolibloc). 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 early stages of treatment. If gastrointestinal bleeding or ulceration occurs, discontinue treatment with Dolibloc and contact your doctor;
- suffers or has suffered from an inflammatory bowel disease (ulcerative colitis, Crohn's disease) as such diseases may worsen (see section 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 section Other medicines and Dolibloc);
- has heart disease (uncontrolled hypertension, congestive heart failure, confirmed ischaemic 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 Dolibloc 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) since, in association with NSAID therapy, fluid retention, high blood pressure and swelling (oedema) have been reported;
- has chickenpox, in which case it is advisable to avoid the use of Dolibloc;
- has an infection - see section Infections below.

Infections
Dolibloc can mask the symptoms of infections such as fever and pain. Therefore, it is possible that Dolibloc 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.

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

Be especially careful with Dolibloc:
Severe skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalised exanthematous pustulosis (AGEP) have been reported in association with ibuprofen treatment.
Stop using Dolibloc and contact your doctor immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Severe skin reactions have been reported in association with Dolibloc treatment. Stop taking Dolibloc 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 severe skin reaction. See section 4. The use of Dolibloc requires adequate precautions, particularly if the child:
- suffers or has suffered from asthma because breathing difficulties could worsen;
- suffers from coagulation problems;
- suffers from kidney, heart, liver diseases, if taking medicines that increase urine production (diuretics), or if they have undergone major surgery with consequent fluid loss, as in these cases the doctor will advise you to have periodic blood and urine tests performed 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 diarrhoea), in this case rehydrate them first;
- before and during treatment to avoid the risk of impaired kidney function.

During prolonged treatments with Dolibloc, you must pay particular attention and immediately inform 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 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 colour perception);
- symptoms such as frequent or daily headaches despite regular use of medicines for headache, 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).

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 everybody gets them.

Stop using ibuprofen and consult your doctor immediately if you notice that your child experiences any of the following symptoms:
- red patches, not raised, target-shaped or circular on the trunk, often with central blisters, peeling skin, ulcers of the mouth, throat, nose, genitals and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (bullous dermatitis, 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, including severe ones, which may include: urticaria, itching, purpura, swelling of the face, mouth and throat (angioedema), difficulty breathing (bronchospasm or dyspnoea), 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 suffers from 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
- vision disturbances

Rare (may affect up to 1 in 1,000 people):
- cystitis, rhinitis
- depression, insomnia, difficulty concentrating, unstable mood, hearing disturbances
- cerebrovascular haemorrhage
- dry eyes
- perception of one's own heartbeat (palpitations)
- diarrhoea, flatulence, dry mouth, constipation and vomiting
- hair loss (alopecia), skin reaction caused by exposure to sunlight (photosensitivity dermatitis)
- 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, leukopenia, 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 ulcerations or bleeding of the stomach and intestine, black and foul-smelling stools, vomiting with blood
- lesions with bleeding of the mouth, heartburn (gastritis)
- concomitant 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 treatment, 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 certain non-steroidal anti-inflammatory drugs (NSAIDs). If signs of an infection occur or worsen, you should consult your doctor immediately 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, tinkling or rustling (tinnitus)
- severe heart disease (heart failure) and swelling (oedema), chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome
- 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 (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 widespread, red and scaly rash, with pustules forming under the skin and blisters located mainly on the skin folds, trunk and upper limbs accompanied by fever at the beginning of treatment (acute generalised exanthematous pustulosis). Stop using Dolibloc if you develop these symptoms and contact your doctor immediately. See also section 2
- A severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: rash, fever, swelling of the lymph nodes and an increase in eosinophils (a type of white blood cell)
- The skin becomes sensitive to light

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.