VICKS VAPORUB*INHAL OINT 50G

Nurofen Fever and Pain for Children 100mg/5ml oral suspension, strawberry flavour, sugar-free
Nurofen Fever and Pain for Children 100mg/5ml oral suspension, orange flavour, sugar-free
Ibuprofen

What it is and what it is used for
Nurofen Fever and Pain contains ibuprofen, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) whose action reduces pain, fever and inflammation.
Nurofen Fever and Pain is indicated for 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
Signs of an allergic reaction to this medicine have been reported with ibuprofen, including breathing problems, swelling of the face and neck (angioedema), and chest pain.
Stop Nurofen Fever and Pain immediately and contact your doctor or emergency medical service immediately if you notice any of these signs.

Warnings and precautions
Do not use Nurofen Fever and Pain if the 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 confirmed ulceration or bleeding);
- is taking other non-steroidal anti-inflammatory drugs (NSAIDs, including selective COX-2 inhibitors) (see section Other medicines and Nurofen Fever and Pain);
- has any disease that increases the risk of bleeding;
- in case of unexplained blood disorders;
- is in a severe state of dehydration, 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).

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 Nurofen Fever and Pain and contact your doctor:
• 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, 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);
• non-raised, target-shaped or circular reddish spots 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).

Additional side effects include:

Uncommon (may affect up to 1 in 100 people):
• headache, dizziness, drowsiness and seizures;
• 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, vomiting with blood;
• bleeding lesions in 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 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 inflammation (e.g. necrotising fasciitis) associated with the use of certain non-steroidal anti-inflammatory drugs (NSAIDs). If signs of 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):
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome;
• 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, 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, 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 localized mainly on the skin folds, trunk and upper limbs accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop using Nurofen Fever and Pain if you develop these symptoms 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.