NUROFENKID FEBBRE D*24CPS100MG

Nurofenkid Fever and Pain 100 mg, chewable soft capsules
Ibuprofen

What it is and what it is used for
The active ingredient (which makes this medicine effective) is ibuprofen, which is a non-steroidal anti-inflammatory drug (NSAID).

Nurofenkid Fever and Pain is indicated in children weighing between 20 kg (7 years) and 40 kg (12 years) for the short-term symptomatic treatment of mild to moderate pain such as toothache, headache, and fever and pain associated with the common cold.
Consult your doctor if you do not feel better or if you feel worse after 3 days.

What you need to know before taking the medicine
Do not use this medicine if your child:
• is allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
• has previously experienced hypersensitivity reactions (e.g. asthma, runny nose, hives, swelling of the face, tongue, lips or throat) after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);
• is allergic to peanuts or soy as this medicine contains soy lecithin;
• suffers (or has suffered) from recurrent gastric/duodenal ulcers (peptic ulcers) or bleeding (at least two episodes of proven ulceration and bleeding);
• has suffered from gastrointestinal bleeding or perforation related to previous NSAID treatments;
• suffers from severe heart failure;
• suffers from severe kidney or liver failure;
• suffers from cerebral hemorrhage (cerebrovascular bleeding) or other active bleeding;
• suffers from unexplained blood formation disorders;
• suffers from severe dehydration (e.g. caused by vomiting, diarrhea or insufficient fluid intake).

Do not take Nurofenkid Fever and Pain in the last 3 months of pregnancy.

Warnings and precautions
Talk to your doctor or pharmacist before using Nurofenkid Fever and Pain if your child:
• has an infection - see section Infections below;
• suffers from asthma or an allergic disease because they might experience shortness of breath;
• suffers from hay fever, nasal polyps or chronic obstructive respiratory disorders, there is an increased risk of allergic reactions. Allergic reactions can manifest as asthma attacks (so-called analgesic asthma), Quincke's edema or hives;
• has reduced kidney function;
• suffers from liver disorders. With prolonged administration of Nurofenkid Fever and Pain, regular monitoring of liver values, kidney function and blood count is necessary;
• caution is advised if the child is taking other medicines that could increase the risk of ulceration or bleeding, such as oral corticosteroids (e.g. prednisolone), anticoagulants (such as warfarin), selective serotonin reuptake inhibitors (a medicine for depression) or antiplatelet agents (such as acetylsalicylic acid);
• is taking another NSAID (including COX-2 inhibitors such as celecoxib or etoricoxib) as concomitant use should be avoided;
• suffers from SLE (Systemic Lupus Erythematosus, an immune system disease affecting connective tissue resulting in joint pain, skin changes and disorders of other organs) or mixed connective tissue disease;
• suffers from a hereditary blood formation disorder (e.g. acute intermittent porphyria);
• suffers from coagulation disorders;
• suffers from chronic inflammatory bowel diseases such as Crohn's disease or ulcerative colitis;
• is dehydrated, as there is a risk of kidney impairment in dehydrated children;
• has undergone major surgery;
• has chickenpox, as it is advisable to avoid the use of Nurofenkid Fever and Pain during the infection period.

Infections
Nurofenkid Fever and Pain can mask the symptoms of infections such as fever and pain. It is therefore possible that Nurofenkid Fever and Pain may 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 worsen, consult your doctor immediately.

Skin reactions
Severe skin reactions have been reported in association with Nurofenkid Fever and Pain treatment. Stop taking Nurofenkid Fever and Pain and consult your doctor immediately if you experience rash, mucosal lesions, blisters or other signs of allergy, as these may be the first signs of a very severe skin reaction. See section 4.

Side effects can be minimized by using the lowest effective dose for the shortest treatment duration necessary to control symptoms.

Gastrointestinal bleeding, ulceration or perforation, which can be fatal, have been reported during treatment with all NSAIDs, at any time, with or without warning symptoms or previous history of serious gastrointestinal events. In case of gastrointestinal bleeding or ulceration, treatment must be stopped immediately. The risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing doses of NSAIDs, in patients with a history of ulcer, especially if complicated with bleeding or perforation (see section 2 Do not use Nurofenkid Fever and Pain) and in the elderly. Such patients should start treatment with the lowest available dose. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients and for patients requiring concomitant administration of low-dose acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal damage.

In general, the habitual use of (different types of) analgesics can lead to serious persistent kidney problems with the risk of kidney failure (analgesic nephropathy).

Anti-inflammatory/pain relief medicines such as ibuprofen may be associated with a modest increased risk of heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment.
Therapy should be evaluated with your doctor or pharmacist before taking Nurofenkid Fever and Pain if you have:
- heart problems, including heart failure, angina pectoris (chest pain), or a history of heart attack, bypass surgery, peripheral artery disease (circulation problems in the legs or feet due to narrowing or blockage of arteries), or any type of stroke (including mini-stroke or transient ischemic attack TIA);
- high blood pressure (hypertension), diabetes, high cholesterol (hypercholesterolemia), family history of heart disease or stroke, or if you are a smoker.

While taking Nurofenkid Fever and Pain, before your child undergoes surgery, the doctor or dentist should be consulted or informed, respectively.

Prolonged use of any type of painkiller for headache can worsen its symptoms. If this situation occurs or is suspected, a doctor should be consulted and treatment should be discontinued. The diagnosis of medication-overuse headache (MOH) should be suspected in patients who experience frequent or daily headaches despite (or because of) regular use of headache medicines.

Patients who report ocular disorders during ibuprofen treatment must discontinue therapy and undergo ophthalmological examinations.

Elderly patients
Elderly subjects have a higher risk of adverse reactions to NSAIDs, especially in the stomach and intestines.

Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding), especially in the initial stages of treatment.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects can be minimized by taking the lowest dose for the shortest time necessary to relieve symptoms. Your child may experience any of the known side effects of NSAIDs (see below). In this case, or if you have any doubts, stop administering the medicine to your child and consult your doctor as soon as possible. Elderly people who use this medicine have a higher risk of experiencing problems associated with side effects.

STOP administering this medicine and contact your doctor immediately if your child experiences:
• signs of gastrointestinal bleeding such as: severe abdominal pain, dark stools, vomiting with blood or dark particles resembling coffee grounds;
• signs of rare but severe allergic reactions such as worsening asthma, unexplained wheezing or shortness of breath, swelling of the face, tongue or throat, difficulty breathing, rapid heartbeat, drop in blood pressure leading to shock. These symptoms can also occur with the first use of this medicine. If any of these symptoms appear, contact a doctor immediately;
• severe skin reactions such as widespread rash, cracked skin, blisters or peeling skin.

Contact your doctor if your child experiences any of the following side effects, if you notice a worsening of these effects, or if you notice any effects not listed.

Common (may affect up to 1 in 10 people)
• Gastric and intestinal disorders such as heartburn, stomach pain and nausea, indigestion, diarrhea, vomiting, flatulence (wind) and constipation and slight blood loss in the stomach and/or intestines which in exceptional cases can cause anemia.

Uncommon (may affect up to 1 in 100 people)
• gastrointestinal ulcer, perforation or bleeding, inflammation of the oral mucosa with ulcerations, worsening of existing intestinal disorders (colitis or Crohn's disease), gastritis
• headache, dizziness, insomnia, agitation, irritability and fatigue
• visual disturbances
• various types of skin rashes
• hypersensitivity reactions with urticaria and itching

Rare (may affect up to 1 in 1000 people)
• tinnitus (ringing in the ears), hearing loss
• increased blood urea concentrations, flank and/or abdominal pain, blood in the urine and fever which may be signs of kidney damage (papillary necrosis)
• increased blood uric acid concentrations
• decreased hemoglobin levels

Very rare (may affect up to 1 in 10,000 people)
• inflammation of the esophagus, pancreatitis and formation of diaphragm-like intestinal strictures
• heart failure, heart attack
• reduced amount of urine compared to normal and swelling (especially in patients with high blood pressure or reduced kidney function), swelling (edema) and cloudy urine (nephrotic syndrome); inflammatory kidney disease (interstitial nephritis) which can lead to acute kidney failure. If any of the above symptoms occur or in case of general malaise, stop taking Nurofenkid Fever and Pain and consult your doctor immediately, as these could be the first signs of kidney damage or kidney failure
• psychotic reactions, depression
• high blood pressure, vasculitis
• palpitations
• liver dysfunction, liver damage (the first signs may be skin discoloration), particularly in long-term treatment, liver failure, acute inflammation of the liver (hepatitis)
• problems in blood cell production - the first signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, nose and skin bleeding and unexplained bruising. In these cases, you must stop therapy immediately and consult a doctor. Any self-medication treatment with painkillers or medicines that reduce fever (antipyretic medicines) should be avoided
• severe skin infections and soft tissue complications during chickenpox infection
• a worsening of infection-related inflammations (e.g. necrotizing fasciitis) associated with the use of some analgesics (NSAIDs) has been described. If signs of an infection appear or worsen, you should immediately go to the doctor who will assess whether anti-infective/antibiotic therapy is necessary
• symptoms of aseptic meningitis with stiff neck, headache, nausea, vomiting, fever or clouding of consciousness have been observed during ibuprofen use. Patients with autoimmune disorders (SLE, mixed connective tissue disease) may be more easily affected. Contact a doctor immediately if these symptoms occur
• severe forms of skin reactions such as rash with redness and blisters (e.g. Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis / Lyell's syndrome), hair loss (alopecia)

Not known (frequency cannot be estimated from the available data)
• Airway hyperreactivity including asthma, bronchospasm or dyspnoea.
• A severe 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 and scaly rash, with 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 generalized exanthematous pustulosis). Stop using Nurofenkid Fever and Pain if you develop these symptoms and contact your doctor immediately. See also section 2.
• Skin becomes sensitive to light.

Medicines like Nurofenkid Fever and Pain 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.