NUROFENXS*20 SOFT CAPSULES 400MG

NUROFENXS 400 mg soft capsules
Ibuprofen

What it is and what it is used for
Ibuprofen belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). These medicines provide relief by changing the body's response to pain and fever.

NUROFENXS is used in adults and adolescents weighing 40 kg or more (from 12 years of age).

NUROFENXS is used for the short-term symptomatic treatment of mild to moderate pain, such as headache, toothache, menstrual pain, and fever and pain associated with the common cold.

In adolescents aged 12 years and over and in adults, 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 take NUROFENXS:
• if you are allergic to ibuprofen, Ponceau 4R (E124), peanuts or soya, or any of the other ingredients of this medicine (listed in section 6);
• if you have ever suffered from breathing difficulties, asthma, runny nose, swelling of the face and/or hands or hives after taking ibuprofen, acetylsalicylic acid or other similar analgesics (NSAIDs);
• if you have (or have had two or more separate episodes of) stomach or duodenal ulcers (peptic ulcer) or bleeding;
• if you have a history of gastrointestinal bleeding or perforation following previous NSAID treatments;
• if you suffer from severe liver, kidney or heart failure;
• if you suffer from unexplained blood formation disorders;
• if you are in the last three months of pregnancy (see section Pregnancy, breastfeeding and fertility);
• if you suffer from severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake);
• if you suffer from brain bleeding (cerebrovascular bleeding) or other active bleeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking NUROFENXS if:
• you have an infection - see section Infections below;
• you suffer from certain skin diseases (systemic lupus erythematosus (SLE)) or mixed connective tissue disease (immune system conditions that cause joint pain, skin rashes and fever);
• you suffer from a certain hereditary blood formation disorder (e.g. acute intermittent porphyria) or have blood clotting problems;
• you have or have had intestinal diseases (ulcerative colitis or Crohn's disease);
• you have reduced kidney function;
• you have liver problems. If this medicine is administered for a prolonged period, regular monitoring of liver values, kidney function and blood count is required;
• you have recently undergone major surgery;
• you are trying to become pregnant;
• you suffer or have suffered from asthma or allergy, as you may experience shortness of breath;
• you suffer from hay fever, nasal polyps or chronic obstructive respiratory disorders, as there is an increased risk of developing allergic reactions. Allergic reactions can manifest as asthma attacks (so-called analgesic asthma), acute swelling (Quincke's oedema) or skin rash (hives);
• you are taking other medicines that may increase the risk of ulceration or bleeding such as oral corticosteroids, blood thinners (like warfarin), selective serotonin reuptake inhibitors (medicines for depression) or antiplatelet agents such as acetylsalicylic acid;
• you are taking other NSAID-based medicines, including specific cyclooxygenase-2 (COX-2) inhibitors, as these may increase the risk of undesirable effects and should be avoided (see section Other medicines below);
• you have chickenpox. It is advisable to avoid using this medicine.

Side effects can be minimised by using the lowest effective dose for the shortest possible time.

Prolonged use of any type of analgesic for headaches can worsen symptoms. If this occurs or is suspected, you should stop taking this medicine 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 headache medication.

In general, habitual use of (different types of) analgesics can lead to serious, long-lasting kidney problems and should be avoided. This risk can be further increased by physical exertion associated with salt loss and dehydration. Therefore, it should be avoided.

In dehydrated adolescents, there is a risk of kidney impairment.

Anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a slight increase in the risk of heart attack or stroke, particularly if used at high doses. Do not exceed the recommended dose or duration of treatment.

You should discuss your treatment with your doctor or pharmacist before taking NUROFENXS if:
• you have heart problems including heart attack, angina pectoris (chest pain) or if you have had a 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 transient ischaemic attack TIA);
• you have 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 breathing problems, swelling of the face and neck area (angioedema) and chest pain, have been reported with ibuprofen. Stop NUROFENXS immediately and contact your doctor or emergency medical service immediately if you notice any of these signs.

Infections
This medicine can mask the symptoms of infections such as fever and pain. Therefore, this medicine may delay appropriate 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.

Severe 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 this medicine and contact your doctor immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Elderly patients
Elderly patients are at higher risk of side effects.

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

Side effects can be minimised by using the lowest 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 about it, stop taking this medicine and tell your doctor as soon as possible. Elderly patients taking this medicine are at greater 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 blood or dark particles resembling coffee grounds;
• signs of very rare but severe allergic reactions such as worsening asthma, unexplained wheezing or shortness of breath, swelling of the face, tongue or throat, breathing difficulties, fast heartbeat, drop in blood pressure leading to shock. These symptoms can also occur on first use of this medicine;
• reddish, non-raised, target-shaped or circular patches 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 people];
• widespread rash, high body temperature, enlarged lymph nodes and an increase in eosinophils (a type of white blood cell) (DRESS syndrome) [frequency unknown - 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 generalised exanthematous pustulosis) [frequency unknown - cannot be estimated from the available data].

Consult your doctor if you experience any of the following side effects, if they worsen or if you notice any other effect not listed.

Common (may affect up to 1 in 10 people):
• stomach upset such as heartburn, stomach pain, feeling unwell and nausea, indigestion, diarrhoea, vomiting, flatulence and constipation, and slight blood loss in the stomach and/or intestine which in exceptional cases can cause anaemia.

Uncommon (may affect up to 1 in 100 people):
• gastrointestinal ulcers, sometimes with bleeding and perforation, inflammation of the oral mucosa with ulceration (ulcerative stomatitis), inflammation of the stomach (gastritis), worsening of colitis and Crohn's disease;
• central nervous system disorders such as headache, dizziness, insomnia, agitation, irritability or fatigue;
• visual disturbances;
• allergic reactions, such as skin rashes, itching and asthma attacks. You must stop taking this medicine and inform your doctor immediately;
• various skin rashes.

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

Very rare (may affect up to 1 in 10,000 people):
• inflammation of the oesophagus (oesophagitis) or pancreas (pancreatitis) and formation of membranous strictures in the small and large intestine (intestinal strictures, similar to diaphragmatic strictures);
• severe skin infections and soft tissue complications have been found during a chickenpox infection;
• high blood pressure, palpitations, heart failure, heart attack, inflammation of blood vessels (vasculitis) and swelling (oedema);
• reduced urine output compared to normal 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 being unwell, stop taking this medicine and consult your doctor immediately as these could be the first signs of kidney damage or kidney failure;
• liver dysfunction, liver damage (the first signs could be skin discolouration), especially for long-term treatment, liver failure, acute inflammation of the liver (hepatitis);
• problems in the production of blood cells - the first signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, nosebleeds and skin bleeding and unexplained bruising. In these cases, you must stop treatment immediately and consult your doctor. Do not treat these symptoms with analgesics or medicines that reduce fever (antipyretic medicines);
• psychotic reactions and depression;
• 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 during the use of this medicine, you must go to the doctor immediately to assess whether anti-infective/antibiotic therapy is necessary;
• symptoms of aseptic meningitis with neck stiffness, headache, feeling unwell, nausea, vomiting, fever or reduced level of consciousness have been observed during the use of ibuprofen. Patients with autoimmune disorders (SLE, mixed connective tissue disease) may be more susceptible. Contact a doctor immediately if these symptoms occur;
• hair loss (alopecia);
• severe generalised hypersensitivity reactions;
• worsening of asthma and bronchospasm.

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

This medicine contains Ponceau 4R (E124) which may cause allergic reactions.

Medicines such as this may be associated with a slight increase in the 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.