NUROFENTEEN 200 MG ORODISPERSIBLE TABLETS 12 ORODISPERSIBLE LEMON TABLETS IN PVC/AL/POLYAMIDE/AL BLISTER

Name
NUROFENTEEN 200 mg orodispersible tablets lemon
Ibuprofen


What is it and what is it used for?
NUROFENTEEN contains 200 mg of ibuprofen. Ibuprofen belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). These medicines work by changing the body's response to pain, swelling, and high temperature.

NUROFENTEEN is used for:
• relieve mild to moderate pain symptoms such as headaches, toothaches and menstrual cramps;
• reduce fever.

Talk to your doctor if you do not feel better or if you feel worse after 3 days in adolescents, or after 3 days in case of fever or after 4 days for pain treatment in adults.


What you need to know before taking the medicine
Do not take NUROFENTEEN if:
• are allergic (hypersensitive) to ibuprofen or any of the other ingredients of NUROFENTEEN (listed in section 6);
• have suffered from breathing difficulties, asthma, rhinitis, swelling of the face and/or hands or hives after taking ibuprofen, acetylsalicylic acid or other similar painkillers (NSAIDs);
• suffer from severe liver failure, severe kidney failure or severe heart failure;
• have or have had two or more episodes of stomach ulcer or stomach bleeding;
• has had gastrointestinal bleeding or perforation following previous treatment with NSAIDs;
• has a cerebrovascular hemorrhage or other types of active bleeding;
• suffers from unexplained blood formation disorders;
• suffers from severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake);
• is in the last 3 months of pregnancy (see below).


Warnings and precautions
Talk to your doctor or pharmacist before taking NUROFENTEEN:
• if you have an infection – see section “Infections” below;
• if you suffer from certain skin diseases (systemic lupus erythematosus (SLE) or mixed connective tissue disease);
• if you suffer from a hereditary blood formation disorder (acute intermittent porphyria);
• if you have blood clotting problems;
• if you suffer or have suffered from gastrointestinal tract disorders (ulcerative colitis or Crohn's disease);
• if you suffer from reduced kidney function;
• if you suffer from liver disorders;
• if you are planning a pregnancy;
• if you suffer or have suffered from asthma or allergic diseases, as you may experience shortness of breath;
• if you suffer from hay fever, nasal polyps, or chronic obstructive pulmonary disease, as there is an increased risk of developing allergic reactions. Allergic reactions may manifest themselves in the form of asthma attacks (so-called analgesic asthma), swelling of the skin (Quincke's edema), or hives;
• it is advisable to avoid taking NUROFENTEEN if you have chickenpox;
• if you take NUROFENTEEN for long periods of time, you will need to have regular tests to assess your liver function and kidney function, and to carry out blood cell counts;
• undesirable effects can be minimised by using the lowest effective dose for the shortest possible time;
• older people are at greater risk of developing adverse reactions;
• In general, the habitual use of (different types of) painkillers can lead to serious, permanent kidney problems. This risk may increase with physical exertion associated with salt loss and dehydration. Therefore, it should be avoided;
• Prolonged use of any type of painkiller for headaches may worsen the symptoms. If this occurs or is suspected, you should stop taking NUROFENTEEN and consult your doctor. The diagnosis of medication-overuse headache (MOH) should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of painkillers;
• taking it in combination with other NSAIDs, including cyclooxygenase-2 selective inhibitors, may increase the risk of side effects and should be avoided (see section "Other medicines and NUROFENTEEN");
• in dehydrated adolescents there is a risk of renal impairment;
• particular attention is required if you have recently undergone major surgery;
• anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used in high doses.
Do not exceed the recommended dose or duration of treatment.

You should discuss your treatment with your doctor or pharmacist before taking NUROFENTEEN if you have:
- heart problems including heart attack, angina (chest pain), or if you have had a heart attack, coronary artery bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrowing or blockage of the arteries), or any type of stroke (including a "mini-stroke" or "TIA" - transient ischemic attack);
- high blood pressure, diabetes, high cholesterol, family history of heart disease or stroke, or if you are a smoker.

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

Infections
NUROFENTEEN may hide the symptoms of infections such as fever and pain. It is therefore possible that NUROFENTEEN 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 NUROFENTEEN and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.


Possible side effects
Like all medicines, NUROFENTEEN can cause side effects, although not everybody gets them.
Undesirable effects can be minimized by using the lowest effective dose for the shortest duration possible for symptom relief.
You may experience one of the known side effects of NSAIDs (see below). If this happens, or if you are concerned, stop taking this medicine and tell your doctor as soon as possible. Elderly people taking this medicine are at greater risk of developing problems associated with side effects.

Stop taking this medicine and see your doctor immediately if you experience:
• signs of intestinal bleeding such as: severe abdominal pain, dark stools, vomiting blood or dark particles resembling coffee grounds;
• signs of very 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 a drop in blood pressure leading to shock. These symptoms may occur even when you first use this medicine;
• 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].

Consult your doctor if you experience any of the following adverse reactions

Common (may affect up to 1 in 10 users)
• gastrointestinal problems, such as heartburn, abdominal pain and nausea, indigestion, diarrhoea, vomiting, flatulence (wind) and constipation and slight bleeding in the stomach and/or intestine which in exceptional cases may cause anaemia.

Uncommon (may affect up to 1 in 100 people)
• gastrointestinal ulcers, bleeding and perforation, inflammation of the oral mucosa with ulceration, worsening of existing intestinal disorders (ulcerative colitis or Crohn's disease), gastritis;
• central nervous system disorders such as headache, dizziness, insomnia, agitation, irritability or tiredness;
• vision disorders;
• various skin rashes;
• hypersensitivity reactions with urticaria and itching.

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

Very rare (may affect up to 1 in 10,000 users)
• esophagitis, pancreatitis, formation of membranous strictures in the intestine (diaphragmatic-like intestinal strictures);
• heart failure, heart attack and swelling of the face and hands (edema);
• decreased urine output 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 may lead to acute kidney failure. If you experience any of the above symptoms or if you feel generally unwell, stop taking NUROFENTEEN and consult your doctor immediately as these may be the first signs of kidney damage or kidney failure;
• psychotic reactions and depression;
• high blood pressure and vasculitis;
• palpitations;
• liver dysfunction, liver damage (first sign may be skin discoloration), especially with long periods of treatment, liver failure, acute inflammation of the liver (hepatitis);
• problems with blood cell production – early signs include fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe tiredness, nose and skin bleeding, and unexplained bruising. In these cases, you should stop taking NUROFENTEEN and consult your doctor immediately. Do not self-medicate with painkillers or medicines to reduce fever (antipyretics).
• serious skin infections and soft tissue complications have been reported during chickenpox infection;
• worsening of infection-related inflammation (e.g. necrotizing fasciitis) has been described in association with the use of some analgesics (NSAIDs). If signs of an infection appear or worsen, contact your doctor immediately to assess whether anti-infective/antibiotic therapy is necessary;
• Symptoms of aseptic meningitis with neck stiffness, headache, nausea, vomiting, fever, or disorientation have been observed during ibuprofen use. Patients with autoimmune diseases (SLE, mixed connective tissue disease) may be more susceptible.
Contact your 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;
• respiratory tract reactivity including asthma, bronchospasm and dyspnea;
• the skin becomes sensitive to light.
Medicines such as NUROFENTEEN 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.