IBUPROFENE DOC*BB FL 150ML FR

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

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

What you need to know before taking the medicine
Do not use PAVIK if your child
- you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
- 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 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);
- suffer from severe kidney or liver disease (renal or liver failure);
- suffer from a serious heart disease (heart failure);
- suffer or have suffered from stomach and/or intestinal bleeding (gastrointestinal haemorrhage) or perforation following previous NSAID-based treatments;
- suffers or has suffered from gastric/duodenal ulcers (peptic ulcers) or current or recurrent bleeding (at least two distinct episodes of proven ulceration or bleeding);
- you are taking other non-steroidal anti-inflammatory drugs (NSAIDs, including selective COX-2 inhibitors) (see paragraph “Other medicines and PAVIK);
- is less than 3 months old or weighs less than 5.6 kg;
- is in the last trimester of pregnancy (see paragraph “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before using PAVIK if your child:
- you suffer or have suffered from an allergy to medicines used to treat fever, pain and inflammation (non-steroidal anti-inflammatories) and if you suffer from difficulty breathing (asthma), seasonal allergies (hay fever), polyps in the nose, if you have severe breathing or chest problems, e.g. chronic obstructive pulmonary disease, swelling of the face, lips and throat (angioedema);
- you are taking other medicines used to treat pain, to reduce fever and/or to treat inflammation (non-steroidal anti-inflammatories, NSAIDs including COX-2 inhibitors) (see paragraph “Other medicines and PAVIK”);
- have suffered from stomach and intestinal disorders (history of ulcer), especially if complicated by bleeding or perforation as an increase in gastrointestinal bleeding and perforation may occur. In these cases, your doctor will advise you to start treatment with the lowest dose available and possibly the concomitant use of medicines that protect the stomach (misoprostol or proton pump inhibitors). This should also be considered if you take low doses of aspirin or other medicines which may increase the risk of stomach and intestinal diseases (see paragraph “Other medicines and PAVIK”).
During treatment with all NSAIDs, bleeding, ulceration, and perforation of the stomach or intestine, which may be fatal, may occur at any time, with or without warning symptoms or previous history of serious gastrointestinal events. Therefore tell your doctor about any uncommon gastrointestinal symptoms (especially gastrointestinal bleeding), particularly in the early stages of treatment. If gastrointestinal bleeding or ulceration occurs, stop taking PAVIK and contact your doctor;
- suffer or have suffered from an inflammatory bowel disease (ulcerative colitis, Crohn's disease) as these diseases can worsen (see paragraph “Possible side effects”);
- if you are taking medicines that may increase the risk of ulcers 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 anti-platelet effect such as aspirin , medicines to treat depression (selective serotonin reuptake inhibitors) (see paragraph “Other medicines and PAVIK”);
- have heart disease (uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease) or have suffered from reduced blood supply to the brain (stroke), or if you think your child may be at risk for these conditions ( for example if you have high blood pressure, if you have high levels of sugar (diabetes) or fat in your blood or if you smoke). Medicines such as PAVIK 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 at high doses and with prolonged therapy. Do not exceed the recommended dose or duration of treatment;
- suffer or have suffered from high blood pressure and/or severe heart disease (heart failure) since, in association with NSAID therapy, water retention, high blood pressure and swelling (edema) have been reported;
- have chickenpox, since, in this case, it is advisable to avoid the use of PAVIK;
- you have an infection – see “infections” paragraph below.

Infections
PAVIK can hide the symptoms of infections such as fever and pain. It is therefore possible that PAVIK 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 symptoms of the infection persist or get worse, contact your doctor immediately.

Serious skin reactions have been reported in association with PAVIK treatment. Stop taking PAVIK and contact your doctor immediately if you experience a skin rash, mucosal lesions, blisters or other signs of allergy, as these may be the first signs of a very serious skin reaction. See paragraph 4.

The use of PAVIK requires adequate precautions, particularly if the child:
- suffer or have suffered from asthma because it could worsen breathing difficulties;
- suffer from clotting problems;
- you suffer from kidney, heart or liver diseases, if you take drugs that increase urine production (diuretics), or if you have undergone major surgery resulting in loss of fluids, since in these cases your doctor will advise you to perform periodic blood and urine tests on the child;
- has undergone major surgical operations;
- suffer from some congenital diseases that affect blood formation (for example acute intermittent porphyria);
- he is dehydrated (for example due to fever, vomiting or diarrhoea), in this case rehydrate him before starting and during the treatment to avoid the risk of altering the function of the kidneys.

During prolonged treatments with PAVIK, you must pay particular attention and immediately notify your doctor if:
- signs or symptoms of ulceration or bleeding of the stomach and intestines (e.g. black, foul-smelling stools, bloody vomiting);
- signs or symptoms of liver damage (for example hepatitis and jaundice);
- signs or symptoms of kidney damage (for example increased urine output, blood in the urine);
- visual disturbances (blurred or reduced vision, areas of complete or partial blindness, alteration of color perception);
- symptoms such as frequent or daily headaches despite regular use of headache medicines, as they may 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 is affected by systemic lupus erythematosus or other collagenopathies).

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 your child experiences any of the following side effects STOP treatment with PAVIK and contact your doctor:
- severe alterations of the skin and mucous membranes characterized by eruptions, redness, itching and blisters (bullous and exfoliative dermatitis including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis);
- allergic reactions, even serious, which may include: hives, itching, purpura, swelling of the face, mouth and throat (angioedema), difficulty breathing (bronchospasm or dyspnoea), altered heart beats (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 is affected by 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 difficulty digesting (dyspepsia)
- skin rashes
- vision disorders

Rare (may affect up to 1 in 1,000 people):
- cystitis, rhinitis - depression, insomnia, difficulty concentrating, unstable mood, hearing disorders
- cerebrovascular hemorrhage
- dry eyes
- perception of your own heartbeat (palpitations)
- diarrhoea, flatulence, dry mouth, constipation and vomiting
- hair loss (alopecia), skin reaction caused by exposure to sunlight (photosensitivity dermatitis)
- serious kidney diseases including tubular necrosis, glomerular nephritis, appearance of blood in the urine and increased urine production
- decrease in hematocrit 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 tiredness, nose and throat bleeding hemorrhages
- signs or symptoms of ulceration or bleeding of the stomach and intestines, black and smelly stools, bloody vomiting
- lesions with bleeding from the mouth, heartburn (gastritis)
- simultaneous disease of the kidneys and liver (hepatorenal syndrome), death of some liver cells (hepatic necrosis), liver disease (liver failure, liver dysfunction, hepatitis, jaundice)
- severe kidney diseases (acute renal failure, papillary necrosis) particularly following long-term treatment, associated with an increase in the concentration of urea in the blood and swelling (edema)
- decrease in hemoglobin levels in the blood
- heart attack (myocardial infarction)
- serious skin infections and soft tissue complications during chickenpox infection
- worsening of inflammation related to infections (for example necrotizing fasciitis) associated with the use of some non-steroidal anti-inflammatory drugs (NSAIDs). If signs of an infection appear or worsen, you should contact 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 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, obstruction of the larynx, shortness of breath (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 widespread, red and scaly rash, with the formation of pustules under the skin and vesicles located mainly on the skin folds, trunk and upper limbs accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop using PAVIK if you develop these symptoms and contact your doctor immediately. See also paragraph 2.
- You may experience a 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).
- The skin becomes sensitive to light.

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.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist, including any not listed in this leaflet. 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.