NUROFENTEEN*12ORO DISINT. TAB 200MG M

NUROFENTEEN 200 mg mint orodispersible 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 to:
• relieve symptoms of mild to moderate pain such as headache, toothache, and menstrual pain;
• reduce fever.

Consult your doctor if you do not feel better or if you feel worse after 3 days in adolescents, or after 3 days for 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 paragraph 6);
• you have suffered from breathing difficulties, asthma, rhinitis, swelling of the face and/or hands, or urticaria 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 had gastrointestinal bleeding or perforation following previous NSAID treatments;
• you have cerebrovascular haemorrhage or other types of active bleeding;
• you suffer from unexplained blood formation disorders;
• you suffer from severe dehydration (caused by vomiting, diarrhoea 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 the Infections section 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 oedema) or urticaria;
• it is advisable to avoid taking NUROFENTEEN if you have chickenpox;
• if NUROFENTEEN is taken for long periods, regular tests must be carried out to evaluate liver and kidney function, and blood cell counts;
• undesirable effects can be minimised by using the lowest effective dose for the shortest possible time;
• the elderly have a 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 headache can worsen its 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) 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 attention 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 therapy 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 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, a family history of heart disease or stroke, or if you are a smoker.

Signs of an allergic reaction to this medicine, including respiratory problems, swelling of the face and neck region (angioedema), chest pain, have been reported with ibuprofen. Stop NUROFENTEEN immediately and contact your doctor or emergency medical service immediately if you notice any of these signs.

Infections
NUROFENTEEN can mask 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 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
Severe skin reactions, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalised 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 severe skin reactions described in paragraph 4.

Possible side effects
Like all medicines, NUROFENTEEN can cause side effects, although not everybody gets them.

Side effects can be minimised by using the lowest effective dose for the shortest possible time to relieve symptoms.
You may experience one of the known side effects of NSAIDs (see below). If this happens, or if you have any concerns, stop taking this medicine and tell your doctor as soon as possible. Elderly people taking this medicine are at higher 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 similar to 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, drop in blood pressure leading to shock. These symptoms can also occur on the first use of this medicine;
• reddish, non-raised, target-shaped or circular spots on the trunk, often with central blisters, skin peeling, 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 rash, high body temperature, enlarged 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 and scaly rash, with bumps under the skin and blisters, mainly located on the skin folds, trunk and upper limbs, accompanied by fever. Symptoms usually appear at the beginning 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 blood loss in the stomach and/or intestines which in exceptional cases can cause anaemia.

Uncommon (may affect up to 1 in 100 users)
• 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 disturbances
• various skin rashes
• hypersensitivity reactions with urticaria and itching

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

Very rare (may affect up to 1 in 10,000 users)
• oesophagitis, pancreatitis, formation of membranous constrictions in the intestine (diaphragm-like intestinal constrictions)
• heart failure, heart attack and swelling of the face and hands (oedema)
• reduced urine output and swelling (especially in patients with high blood pressure or reduced kidney function); swelling (oedema) 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 malaise, 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 could be changes in skin colour), especially for long periods of treatment, liver failure, acute inflammation of the liver (hepatitis)
• problems in the production of blood cells - 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 must stop taking NUROFENTEEN and consult your doctor immediately. No self-medication treatment with analgesics and medicines to reduce fever (antipyretic medicines) should be carried out
• severe skin infections and soft tissue complications have been observed during a chickenpox infection
• worsening of infection-related inflammations (e.g. necrotising fasciitis) associated with the use of some analgesics (NSAIDs) has been described. If signs of an infection appear or worsen, consult 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.
• hair loss (alopecia).

Not known (frequency cannot be estimated from the available data)
• Chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome
• respiratory tract reactivity including asthma, bronchospasm and dyspnoea
• 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.