ALGOPIRINA FEBBRE DOL*150ML FR

ALGOPIRINA FEBBRE E DOLORE Children 100mg/5ml oral suspension strawberry flavour sugar-free
ALGOPIRINA FEBBRE E DOLORE Children 100mg/5ml oral suspension orange flavour sugar-free
Ibuprofen
Equivalent medicinal product

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

Algopirina Febbre e Dolore is indicated in children from 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 use Algopirina Febbre e Dolore if:
- you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in paragraph 6);
- you 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);
- you suffer from severe kidney or liver disease (renal or hepatic insufficiency);
- you suffer from severe heart problems (severe heart failure);
- you suffer or have suffered from stomach and/or intestinal bleeding (gastrointestinal haemorrhage) or perforation following previous NSAID treatments;
- you suffer or have suffered from gastric/duodenal ulcers (peptic ulcers) or ongoing or recurrent bleeding (at least two distinct episodes of ulceration or bleeding);
- you are simultaneously using other medicines from the same family of non-steroidal anti-inflammatory drugs (NSAIDs), including those that selectively inhibit the action of an enzyme called COX-2 (see paragraph Other medicines and Algopirina Febbre e Dolore);
- you have any condition that increases the risk of bleeding;
- in case of unexplained blood disorders;
- you are in a severe state of dehydration, for example, you have had severe episodes of vomiting, diarrhoea or drink very little;
- you are under 3 months of age or weigh less than 5.6 kg;
- you are in the last trimester of pregnancy (see Pregnancy and breastfeeding).

Warnings and precautions
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 Algopirina Febbre e Dolore and contact your doctor immediately if you notice any of the symptoms related to these severe skin reactions described in paragraph 4.

Consult your doctor or pharmacist before using Algopirina Febbre e Dolore if:
- you suffer or have suffered from allergy to medicines used to treat fever, pain and inflammation (non-steroidal anti-inflammatory drugs) and if you suffer from breathing difficulties (asthma), seasonal allergies (hay fever), nasal polyps, if you have severe respiratory 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, reduce fever and/or treat inflammation (non-steroidal anti-inflammatory drugs (NSAIDs)), including those that selectively inhibit the action of an enzyme called COX-2 (see Other medicines and Algopirina Febbre e Dolore);
- you 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 you are taking low doses of aspirin or other medicines that may increase the risk of stomach and intestinal diseases (see paragraph Other medicines and Algopirina Febbre e Dolore). During treatment with all NSAIDs, at any time, with or without warning symptoms or 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 Algopirina Febbre e Dolore and contact your doctor;
- you suffer or have suffered from gastrointestinal diseases such as Crohn's disease or ulcerative colitis, inform your doctor because the use of NSAIDs could intensify these diseases (see paragraph 4 Possible side effects);
- you are taking medicines that could increase the risk of ulcer or bleeding, such as medicines used to treat inflammation and certain 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 Algopirina Febbre e Dolore);
- you have heart disease (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 blood sugar (diabetes) or fat levels in the blood, or if they smoke). Medicines such as Algopirina 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 at high doses and during prolonged therapy. Do not exceed the recommended dose or duration of treatment;
- you suffer or have suffered from high blood pressure and/or severe heart disease (heart failure) because fluid retention, high blood pressure and swelling (oedema) have been reported in association with NSAID therapy;
- you have an infection - see paragraph Infections below.
- you have chickenpox, in which case it is advisable to avoid the use of Algopirina Febbre e Dolore.

The use of Algopirina Febbre e Dolore requires adequate precautions, especially if the child:
- suffers or has suffered from asthma because it could worsen breathing difficulties;
- suffers from coagulation problems or hypertension;
- suffers from kidney, heart or liver disease;
- takes medicines 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 the child undergo periodic blood and urine tests;
- has undergone major surgery;
- suffers from certain congenital diseases affecting blood formation (e.g., acute intermittent porphyria);
- is dehydrated due to fever, vomiting or diarrhoea, your doctor will advise you to restore hydration status both before and during treatment to avoid the risk of kidney function impairment.

Anti-inflammatory/pain relief medicines such as ibuprofen may be associated with a modest increased risk of heart attack or stroke, especially when administered in high doses. Do not exceed the recommended dose or duration of treatment.
You should discuss therapy with your doctor or pharmacist before using Algopirina Febbre e Dolore if the child has:
- heart problems including heart attack, angina (chest pain) or if they have a history of heart attack, coronary bypass surgery, peripheral arterial disease (poor circulation in the legs or feet due to narrowing or obstruction of the arteries) or any type of stroke (including mini-stroke or TIA, transient ischemic attack);
- high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if they are a smoker.

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 treatment with Algopirina Febbre e Dolore immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.
During prolonged treatments with Algopirina Febbre e Dolore, you must pay particular attention and immediately notify your doctor if:
- signs or symptoms of lesions (ulcerations) or bleeding of the stomach and intestines appear (e.g., black and foul-smelling stools, vomiting with blood);
- signs and symptoms of liver damage (e.g., hepatitis and jaundice);
- signs and symptoms of kidney damage (e.g., increased urine production, blood in urine);
- visual disturbances such as blurred or reduced vision, partial or complete blindness (scotomas), altered colour perception: in this case, immediately stop treatment and consult an ophthalmologist;
- 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 ibuprofen treatment. Stop taking Algopirina 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
Algopirina Febbre e Dolore may mask the symptoms of infections such as fever and pain. It is therefore possible that Algopirina Febbre e Dolore 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, consult your doctor immediately.

To reduce the possible side effects mentioned above, the lowest effective dose should be used for the shortest time necessary to control symptoms.
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 everyone experiences them.

If the child experiences any of the following side effects, STOP treatment with Algopirina
Febbre e Dolore and contact your doctor immediately:
• severe skin and mucous membrane alterations characterised by rashes, redness, itching and blisters (bullous and exfoliative dermatoses including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis);
• allergic reactions, including severe ones, which may include: hives, 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 has systemic lupus erythematosus or other collagenopathies);
• non-raised, target-shaped or circular reddish 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, elevated 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 generalised exanthematous pustulosis).

Further side effects include:

Uncommon (may affect up to 1 in 100 people):
• headache, dizziness, drowsiness and seizures;
• stomach pains, nausea and difficulty digesting (dyspepsia);
• skin rashes;
• visual 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;
• awareness 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, appearance of 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 ulceration or bleeding of the stomach and intestines, black and foul-smelling stools, vomiting with blood;
• bleeding lesions 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 urea concentration in the blood 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 inflammation (e.g., necrotising fasciitis);
• associated with the use of certain 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 (oedema);
• 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 severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: rash, fever, swollen lymph nodes and increased 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, trunk and upper limbs, accompanied by fever at the beginning of treatment (acute generalised exanthematous pustulosis). Stop using Algopirina Febbre e Dolore if you develop these symptoms and contact your doctor immediately. Also see paragraph 2;
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

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.