NUROFENCAPS*10 SOFT CAPSULES 400MG

Nurofencaps 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.

Nurofencaps is used in adults and adolescents weighing over 40 kg (from 12 years of age) for the short-term symptomatic treatment of:
• mild to moderate pain such as headache, menstrual pain and toothache;
• fever and pain associated with the common cold.
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 and 4 days for pain treatment in adults.

What you need to know before taking the medicine
Do not take Nurofencaps if:
• you are allergic to the active ingredient or any of the other ingredients of this medicine (listed in section 6)
• you have ever suffered from breathing difficulties, asthma, runny nose, swelling or hives after taking acetylsalicylic acid or similar analgesics (NSAIDs)
• you have (or have had two or more separate episodes of) stomach/duodenal ulcer (peptic ulcer) or stomach bleeding
• you have had gastrointestinal bleeding or perforation following previous treatment with NSAIDs (non-steroidal anti-inflammatory drugs)
• you suffer from unexplained blood formation disorders
• you suffer from severe liver, kidney or heart failure
• you are in the last 3 months of pregnancy (see section Pregnancy and breastfeeding)
• you suffer from severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake)
• you suffer from bleeding in the brain (cerebrovascular bleeding) or other active bleeding.

Do not administer to adolescents weighing less than 40 kg or children under 12 years of age.

Warnings and precautions
Consult your doctor or pharmacist before taking Nurofencaps if:
• you have an infection - see section Infections below.
• you suffer from systemic lupus erythematosus (SLE) or mixed connective tissue disease (immune system conditions causing 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.
• you have recently undergone major surgery.
• 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 may manifest as asthma attacks (so-called analgesic asthma), acute swelling (Quincke's edema) or skin rash.
• you are taking other medicines that could 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.

Other warnings

• Prolonged use of analgesics for headaches can worsen the symptoms. If this occurs or is suspected, you should stop taking Nurofencaps and consult your doctor.
• You should avoid taking Nurofencaps if you have chickenpox.
• If Nurofencaps is taken for long periods of time, regular blood tests and regular liver and kidney checks are necessary.
• Taking Nurofencaps in combination with other NSAIDs, including selective cyclooxygenase 2 inhibitors, may increase the risk of adverse effects and should be avoided (see section Other medicines and Nurofencaps).
• In general, the habitual use of (different types of) analgesics can lead to severe lasting kidney problems and should be avoided. The risk is further increased by salt loss and dehydration.
• In dehydrated adolescents, there is a risk of impaired kidney function.

Infections
Nurofencaps can mask the symptoms of infections such as fever and pain. Therefore, it is possible that Nurofencaps 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 infection symptoms persist or worsen, consult your doctor immediately.

Skin reactions
Serious skin reactions have been reported in association with Nurofencaps treatment. Stop taking Nurofencaps and consult your doctor immediately if you develop 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.

Anti-inflammatory/pain relief medicines such as ibuprofen may be associated with a modest increased risk of heart attack or stroke, especially when given in high doses. Do not exceed the recommended dose or duration of treatment.

You should discuss your therapy with your doctor or pharmacist before taking Nurofencaps 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 blockage of arteries) or any type of stroke (including mini-stroke or TIA, transient ischaemic attack);
- high blood pressure, diabetes, high cholesterol, family history of heart disease or stroke, or if you are a smoker.

Side effects can be minimized by using the lowest effective dose for the shortest period of time. Elderly people are more at risk of experiencing side effects.

Consult your doctor before taking Nurofencaps if any of the above conditions concern you.

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

Side effects can be minimized 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 about it, 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 consult your doctor immediately if you experience:

• signs of intestinal bleeding such as: severe abdominal pain, dark stools, vomiting blood or dark particles similar to 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, rapid heartbeat, drop in blood pressure leading to shock. These symptoms may also occur on first use of this medicine;
• severe skin reactions such as skin rashes all over the body, peeling, blistering or flaking of the skin.

Consult your doctor if you experience any of the following adverse reactions, if they become severe or if you notice any adverse reaction not listed in the leaflet.

Common (may affect up to 1 in 10 people)
• Gastrointestinal disorders such as heartburn, abdominal pain, nausea, and indigestion, vomiting, flatulence, diarrhoea, constipation and mild blood loss in the stomach and/or intestines which in exceptional cases can cause anaemia.

Uncommon (may affect up to 1 in 100 people)
• Gastric or intestinal 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 should stop taking Nurofencaps and consult your doctor immediately
• Various skin rashes

Rare (may affect up to 1 in 1,000 people)
• Tinnitus (ringing in the ears)
• Kidney damage (papillary necrosis) and high uric acid concentrations in the blood
• Impaired hearing
• Increased urea concentration in the blood
• Reduced haemoglobin levels

Very rare (may affect up to 1 in 10,000 people)
• Swelling (oedema), high blood pressure (hypertension) and heart failure have been reported in association with NSAID treatment
• Inflammation of the oesophagus or pancreas, formation of membranous strictures in the small and large intestine (diaphragm-like intestinal strictures).
• Severe skin infections and soft tissue complications have been observed during a chickenpox infection.
• 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 may lead to acute kidney failure. If any of the above symptoms occur or if you have a general feeling of being unwell, stop taking Nurofencaps and consult your doctor immediately as these could be the first signs of kidney damage or kidney failure.
• Blood cell production disorders. The first signs are: fever, sore throat, superficial ulcers of the oral cavity, flu-like symptoms, severe exhaustion, nose and skin bleeding. In these cases, you must stop treatment immediately and consult your doctor. Do not treat these symptoms with analgesics or medicines that reduce fever (antipyretics).
• Psychotic reactions and depression.
• Worsening of infection-related inflammation (e.g. necrotising fasciitis) has been described in association with the use of certain analgesics (NSAIDs). If signs of an infection appear or worsen while using Nurofencaps, consult your doctor immediately to assess whether anti-infective/antibiotic therapy is necessary.
• High blood pressure, palpitations, heart failure, myocardial infarction.
• Liver dysfunction, liver damage, especially for long periods of treatment, liver failure, acute inflammation of the liver (hepatitis).
• Symptoms of aseptic meningitis with neck stiffness, headache, feeling unwell, nausea, fever or disorientation have been observed during the use of ibuprofen. Patients with autoimmune disorders (SLE, mixed connective tissue disease) may be more susceptible. Contact your doctor immediately if these symptoms occur.
• Severe forms of skin reactions such as rashes with redness and blistering (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis/Lyell's syndrome), hair loss (alopecia).
• Severe generalized hypersensitivity reactions.
• Worsening of asthma and bronchospasm.
• Inflammation of blood vessels (vasculitis).

Not known (frequency cannot be estimated from the available data)
• 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 extremities accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop using Nurofencaps if you develop these symptoms and contact your doctor immediately. See also section 2.
• the skin becomes sensitive to light.

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

Medicines such as Nurofencaps 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.