NUROFENKID FEVER D 100 MG SOFT CHEWABLE CAPSULES 24 CAPSULES IN PVC/PE/PVDC/AL BLISTER

Name
Nurofenkid Fever and Pain 100 mg, chewable soft capsules
Ibuprofen


What is it and what is it for?
The active ingredient (which makes this medicine effective) is ibuprofen, which is a nonsteroidal 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.
Contact 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:
• are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
• have ever had hypersensitivity reactions (e.g. asthma, runny nose, hives, swelling of the face, tongue, lips or throat) after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs);
• are allergic to peanuts or soya as this medicine contains soya lecithin;
• suffer (or have 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;
• suffer from severe kidney or liver failure;
• have a brain haemorrhage (cerebrovascular bleeding) or other active bleeding;
• suffers from unexplained blood formation disorders;
• suffers from severe dehydration (e.g. caused by vomiting, diarrhoea 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:
• have an infection – see section “Infections” below;
• suffer from asthma or an allergic disease because he or she may experience shortness of breath;
• suffer from hay fever, nasal polyps, or chronic obstructive pulmonary disease, there is an increased risk of allergic reactions. Allergic reactions may present as asthma attacks (so-called analgesic asthma), Quincke's edema, or urticaria;
• has reduced kidney function;
• suffers from liver problems. During prolonged administration of Nurofenkid Fever and Pain, regular monitoring of liver values, kidney function and blood count is necessary;
• caution should be exercised if the child is taking other medicines which could increase the risk of ulceration or bleeding, such as oral corticosteroids (e.g. prednisolone), antiplatelet drugs (such as warfarin), selective serotonin reuptake inhibitors (a medicine for depression) or antiplatelet agents (such as acetylsalicylic acid);
• are taking another NSAID (including COX-2 inhibitors such as celecoxib or etoricoxib) as concomitant use should be avoided;
• suffer from SLE (Systemic Lupus Erythematosus, a disease of the immune system that affects the connective tissue resulting in joint pain, skin changes and disorders of other organs) or mixed connective tissue disease;
• suffer 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 renal impairment in dehydrated children;
• has undergone major surgery;
• has chickenpox, as it is advisable to avoid using Nurofenkid Fever and Pain during the period of infection.

Infections
Nurofenkid Fever and Pain may mask the symptoms of infections such as fever and pain. Therefore, 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 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, contact your doctor immediately.

Skin reactions
Serious skin reactions, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Stop using Nurofenkid Fever and Pain and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.

Gastrointestinal bleeding, ulceration, or perforation, which can be fatal, has been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events. If gastrointestinal bleeding or ulceration occurs, treatment should be discontinued immediately. The risk of gastrointestinal bleeding, ulceration, or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 2 Do not use Nurofenkid Fever and Pain), and in the elderly. These patients should start treatment on 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 low-dose aspirin or other drugs likely to increase the risk of gastrointestinal damage.

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

Anti-inflammatory/painkiller medications 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.
Treatment should be discussed with your doctor or pharmacist before taking Nurofenkid Fever and Pain in case of:
- heart problems, including heart failure, angina (chest pain), or if you have a history of heart attack, bypass surgery, peripheral arterial disease (circulation problems in the legs or feet due to narrowed or blocked arteries), or any type of stroke (including a "mini-stroke" or a transient ischemic attack "TIA");
- high blood pressure (hypertension), diabetes, high cholesterol (cholesterolemia), family history of heart disease or stroke, or if you smoke.

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 taking Nurofenkid Fever and Pain immediately and contact your doctor or emergency services immediately if you notice any of these signs.

While taking Nurofenkid Fever and Pain, before your child undergoes surgery, your doctor or dentist should be consulted or informed, respectively.
Prolonged use of any type of painkiller for headaches can worsen symptoms. If this occurs or is suspected, consult a doctor and discontinue treatment. The diagnosis of medication-overuse headache (MOH) should be suspected in patients who experience frequent or daily headaches despite (or because of) the regular use of headache medications.

Patients who experience ocular disturbances during treatment with ibuprofen should discontinue therapy and undergo ophthalmological examinations.

Elderly patients
Elderly individuals are at greater 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 duration necessary to relieve symptoms. Your child may experience one of the known side effects of NSAIDs (see below). If this happens, or if you have any concerns, stop giving your child the medicine and contact your doctor as soon as possible. Elderly people using this medicine are at greater risk of developing problems associated with side effects.

STOP taking this medicine and contact your doctor immediately if your child experiences:
• signs of gastrointestinal bleeding such as: severe abdominal pain, dark stools, vomiting blood or dark particles resembling coffee grounds;
• signs of rare but serious allergic reactions such as worsening of asthma, unexplained wheezing or shortness of breath, swelling of the face, tongue, or throat, difficulty breathing, rapid heartbeat, or low blood pressure resulting in shock. These symptoms may occur even when you first use this medicine. If any of these symptoms occur, contact a doctor immediately;
• 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] [very rare - may affect up to 1 in 10,000 users];
• widespread skin rash, high body temperature, swollen lymph nodes and increased eosinophils (a type of white blood cell) (DRESS syndrome) [not known - frequency cannot be estimated from the available data];
• widespread, red, scaly rash with bumps under the skin and blisters, mainly located in the skin folds, on the trunk and upper limbs, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis) [not known - frequency cannot be estimated from the available data].

Talk to your doctor if your child experiences any of the following side effects, if you notice any 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, diarrhoea, vomiting, flatulence (aerophagia) and constipation and slight blood loss in the stomach and/or intestines which in exceptional cases can cause anaemia.

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

Rare (may affect up to 1 in 1,000 people):
• tinnitus (ringing in the ears), hearing loss;
• increased concentrations of urea in the blood, pain in the flanks and/or abdomen, blood in the urine and fever which may be signs of kidney damage (papillary necrosis);
• increased concentrations of uric acid in the blood;
• decrease in hemoglobin levels.

Very rare (may affect up to 1 in 10,000 people):
• inflammation of the esophagus, pancreatitis and formation of diaphragmatic-like intestinal stenosis;
• heart failure, heart attack;
• less urine than 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 if you feel generally unwell, stop taking Nurofenkid Fever and Pain and consult your doctor immediately, as these may be the first signs of kidney damage or kidney failure;
• psychotic reactions, depression;
• high blood pressure, vasculitis;
• palpitations;
• liver dysfunction, liver damage (first signs may be skin discoloration), particularly in long-term treatment, liver failure, acute inflammation of the liver (hepatitis);
• Problems with blood cell production – the first signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nose and skin bleeding, and unexplained bruising. In these cases, you should stop treatment immediately and consult a doctor. Any self-medication with painkillers or fever-reducing medications (antipyretics) should be avoided;
• serious skin infections and soft tissue complications during chickenpox infection;
• worsening of inflammation related to an infection (e.g. necrotizing fasciitis) has been described in association with the use of some analgesics (NSAIDs). If signs of an infection appear or worsen, you should see your doctor immediately who will assess whether anti-infective/antibiotic therapy is necessary;
• Symptoms of aseptic meningitis, including stiff neck, headache, nausea, vomiting, fever, or blurred consciousness, have been observed during ibuprofen use. Patients with autoimmune disorders (SLE, mixed connective tissue disease) may be more likely to be affected. Contact a doctor immediately if these symptoms occur.
• hair loss (alopecia).

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;
• airway reactivity including asthma, bronchospasm or dyspnea;
• the skin becomes sensitive to light.

Medicines such as Nurofenkid Fever and Pain may be associated with a small 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.