VICKS VAPORUB OINTMENT FOR INHALATION USE 50 G JAR

Name
Nurofen Fever and Pain Children 100mg/5ml sugar-free strawberry-flavored oral suspension
Nurofen Fever and Pain Children 100mg/5ml sugar-free orange-flavored oral suspension
Ibuprofen


What is it and what is it for?
Nurofen Fever and Pain contains ibuprofen, which belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs), which work by reducing pain, fever, and inflammation.
Nurofen Fever and Pain is indicated in 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, earaches).


What you need to know before taking the medicine
Signs of an allergic reaction to ibuprofen, including breathing problems, swelling of the face and neck area (angioedema), and chest pain, have been reported with ibuprofen.
Stop taking Nurofen Fever and Pain immediately and contact your doctor or emergency services immediately if you notice any of these signs.


Warnings and precautions
Do not use Nurofen Fever and Pain if the child
- are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
- you 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 hepatic failure);
- suffers from a serious heart disease (heart failure);
- suffer or have suffered from bleeding in the stomach and/or intestine (gastrointestinal haemorrhage) or perforation following previous treatments with NSAIDs;
- you suffer or have suffered from active or recurrent gastric/duodenal ulcers (peptic ulcers) or bleeding (at least two distinct episodes of proven ulceration or bleeding);
- if you are taking other non-steroidal anti-inflammatory drugs (NSAIDs, including selective COX-2 inhibitors) (see section "Other medicines and Nurofen Fever and Pain");
- if you have any disease that increases the risk of bleeding;
- in case of unclear blood disorders;
- if you are severely dehydrated, for example if you have had severe vomiting, diarrhoea or if you drink very little;
- is less than 3 months old 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 your child experiences any of the following side effects, STOP taking Nurofen Fever and Pain and contact your doctor:
• allergic reactions, including serious ones, which may include: hives, itching, purpura, swelling of the face, mouth and throat (angioedema), difficulty breathing (bronchospasm or dyspnoea), abnormal heartbeat (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 collagen diseases);
• flat, target-shaped or circular reddish spots on the trunk, often with central blisters, peeling skin, and ulcers of the mouth, throat, nose, genitals, and eyes. These severe rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis];
• widespread skin rash, high body temperature and swollen lymph nodes (DRESS syndrome);
• widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

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, mood swings, hearing problems;
• cerebrovascular hemorrhage;
• dry eyes;
• perception of one's heartbeat (palpitations);
• diarrhea, flatulence, dry mouth, constipation and vomiting;
• hair loss (alopecia);
• the skin becomes sensitive to light;
• severe kidney disease including tubular necrosis, glomerular nephritis, blood in the urine and increased urine output;
• decrease in hematocrit levels.

Very rare (may affect up to 1 in 10,000 people):
• reduction in the number of blood cells (anemia, leukopenia, thrombocytopenia, eosinophilia, pancytopenia, agranulocytosis) - the first signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe tiredness, nosebleeds and hemorrhages;
• signs or symptoms of ulceration or bleeding of the stomach and intestines, black and foul-smelling stools, vomiting blood;
• lesions with bleeding from the mouth, heartburn (gastritis);
• simultaneous kidney and liver disease (hepatorenal syndrome), death of some liver cells (liver necrosis), liver disease (liver failure, liver dysfunction, hepatitis, jaundice);
• severe kidney disease (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 infection-related inflammation (e.g., necrotizing fasciitis) associated with the use of some nonsteroidal 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):
• 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 (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 (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 esophagus (esophagitis);
• a serious skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: rash, fever, swollen lymph nodes, and an increase in eosinophils (a type of white blood cell);
• a widespread, red, scaly rash with pustules under the skin and blisters, mainly located in the skin folds, trunk, and upper limbs, accompanied by fever at the start 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.

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 experience 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.