NUROFENTEEN*12ORO TAB 200MG LI

NUROFENTEEN 200 mg orodispersible lemon tablets
Ibuprofen

What it is and what it is 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:
• relieving symptoms of mild to moderate pain such as headache, toothache, and menstrual pain
• reducing fever

Consult 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:
• you are allergic (hypersensitive) to ibuprofen or any of the other ingredients of NUROFENTEEN (listed in section 6)
• you have suffered from breathing difficulties, asthma, rhinitis, swelling of the face and/or hands, or hives after taking ibuprofen, acetylsalicylic acid, or other similar analgesics (NSAIDs)
• you suffer from severe liver failure, severe kidney failure, or severe heart failure
• you have (or have had) two or more episodes of stomach ulcer or stomach bleeding
• you have experienced gastrointestinal bleeding or perforation following previous NSAID treatments
• you have cerebrovascular hemorrhage or other types of active bleeding
• you suffer from unexplained blood formation disorders
• you suffer from severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake)
• you are in the last 3 months of pregnancy (see below).

Warnings and precautions
Consult 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 respiratory diseases, as there is an increased risk of developing allergic reactions. Allergic reactions can manifest as asthma attacks (so-called analgesic asthma), skin swelling (Quincke's edema) or hives
• it is advisable to avoid taking NUROFENTEEN if you have chickenpox
• if NUROFENTEEN is taken for long periods of time, regular tests to evaluate liver and kidney function, and blood cell count should be performed
• undesirable effects can be minimized by using the lowest effective dose for the shortest possible time
• elderly people are at higher risk of developing adverse reactions
• in general, habitual use of (different types of) analgesics can lead to serious permanent kidney problems. This risk may increase in case of physical exertion associated with salt loss and dehydration. Therefore, it should be avoided.
• prolonged use of any type of analgesic for headaches can worsen the symptoms. If this occurs or this situation 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 analgesic medicines
• concomitant use with other NSAIDs, including selective cyclooxygenase 2 inhibitors, may increase the risk of undesirable effects and should be avoided (see section Taking with other medicines)
• in dehydrated adolescents, there is a risk of kidney impairment
• particular caution is required if you have recently undergone major surgery
• anti-inflammatory/pain relief medicines such as ibuprofen may be associated with a modest increased risk of heart attack or stroke, especially if administered 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 a history of heart attack, coronary artery bypass surgery, peripheral arterial disease (poor circulation in the legs or feet due to narrowing or obstruction of the arteries) or any type of stroke (including '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.

Infections
NUROFENTEEN can hide symptoms of infections such as fever and pain. Therefore, NUROFENTEEN may delay appropriate treatment of an 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 infection symptoms persist or worsen, consult your doctor immediately.

Skin reactions
Serious skin reactions have been reported in association with NUROFENTEEN treatment. Stop taking NUROFENTEEN and consult your doctor immediately if you experience a rash, mucosal lesions, blisters, or other signs of allergy as these may be the first signs of a very serious skin reaction. See 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 possible time for symptom relief.
You may experience one of the known side effects of NSAIDs (see below). If this happens, or if you have concerns about it, stop taking this medicine and inform your doctor as soon as possible. Elderly people taking this medicine are more at risk of developing problems associated with side effects.

Stop taking this medicine and consult your doctor immediately if you experience:
• signs of intestinal bleeding such as: severe abdominal pain, dark stools, vomiting with 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, breathing difficulties, accelerated heartbeat, drop in blood pressure leading to shock. These symptoms can also occur with the first use of this medicine;
• severe skin reactions such as rashes all over the body, peeling, blistering or flaking of the skin.

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

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

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 fatigue
• Vision disorders
• Various skin rashes
• Hypersensitivity reactions with hives and itching

Rare (may affect up to 1 in 1,000 people)
• Tinnitus (ringing in the ears)
• Increased uric acid levels in the blood, flank and/or abdominal pain, blood in the urine and fever may be signs of kidney damage (papillary necrosis).
• Decreased hemoglobin levels

Very rare (may affect up to 1 in 10,000 people)
• esophagitis, pancreatitis, formation of membranous strictures in the intestine (diaphragm-like intestinal strictures)
• heart failure, heart attack and swelling of the face and hands (edema)
• reduced 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 can lead to acute kidney failure. If any of the above symptoms occur or if you have a general feeling of ill health, stop taking NUROFENTEEN and consult your doctor immediately as these could 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 for long periods of treatment, liver failure, acute inflammation of the liver (hepatitis).
• problems in blood cell production - first signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, bleeding from the nose and skin and unexplained bruising. In these cases, you should stop taking NUROFENTEEN and consult your doctor immediately. No self-medication treatment with analgesics and fever-reducing drugs (antipyretic medicines) should be carried out
• severe skin infections and soft tissue complications have been observed during a chickenpox infection
• the worsening of inflammation related to infections (e.g. necrotizing fasciitis) associated with the use of some analgesics (NSAIDs) has been described. 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 stiff neck, headache, nausea, vomiting, fever or disorientation have been observed during the use of ibuprofen. Patients with autoimmune diseases (SLE, mixed connective tissue disease) may be more susceptible. Contact your doctor immediately if these symptoms occur.
• severe forms of skin reactions such as skin rashes with redness and blistering (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis/Lyell's syndrome), hair loss (alopecia)

Not known (frequency cannot be estimated from the available data):
• Respiratory tract reactivity including asthma, bronchospasm and dyspnea
• A severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: skin rash, fever, swollen lymph nodes and an increase in eosinophils (a type of white blood cell).
• A widespread, red, scaly rash with bumps 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 NUROFENTEEN if you develop these symptoms and contact your doctor immediately. See also section 2.
• The skin becomes sensitive to light;

Medicines such as NUROFENTEEN may be associated with a slight 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.