NUROFENCAPS 400 MG SOFT CAPSULES 10 CAPSULES IN PVC/PVDC/AL BLISTER

Name
Nurofencaps 400 mg soft capsules
Ibuprofen


What is it and what is it for?
Ibuprofen belongs to a group of medications called nonsteroidal anti-inflammatory drugs (NSAIDs). These medications provide relief by altering the body's response to pain and fever.

Nurofencaps is used in adults and adolescents weighing more than 40 kg (from 12 years of age) for the short-term symptomatic treatment of:
• mild to moderate pain such as headache, menstrual cramps and toothache;
• fever and pain associated with the common cold.
Talk to 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:
• are allergic to the active substance, ponceau 4R (E124) or to any of the other ingredients of this medicine (listed in section 6);
• have ever suffered from breathing difficulties, asthma, runny nose, swelling or hives after taking acetylsalicylic acid or other similar pain relievers (NSAIDs);
• have (or have had two or more distinct episodes of) gastric/duodenal ulcer (peptic ulcer) or stomach bleeding;
• have had gastrointestinal bleeding or perforation following previous treatment with NSAIDs (nonsteroidal anti-inflammatory drugs);
• suffers from unexplained blood formation disorders;
• suffer from severe liver, kidney or heart failure;
• is in the last 3 months of pregnancy (see section "Pregnancy and breastfeeding");
• suffers from severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake);
• have bleeding in the brain (cerebrovascular bleeding) or other active bleeding.

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


Warnings and precautions
Talk to your doctor or pharmacist before taking Nurofencaps if:
• have an infection – see section “Infections” below;
• have systemic lupus erythematosus (SLE) or mixed connective tissue disease (immune system conditions that cause joint pain, skin rashes, and fever);
• suffer from a certain hereditary disorder of blood formation (e.g. acute intermittent porphyria) or have problems with blood clotting;
• have or have had intestinal diseases (ulcerative colitis or Crohn's disease);
• has reduced kidney function;
• has liver problems;
• has recently undergone major surgery;
• suffer or have suffered from asthma or allergies, as you may experience shortness of breath;
• 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), acute swelling (Quincke's edema), or skin rash;
• if you are taking other medicines that may increase the risk of ulceration or bleeding such as oral corticosteroids, medicines to thin the blood (such as warfarin), selective serotonin reuptake inhibitors (medicines for depression) or antiplatelet agents such as acetylsalicylic acid.

Other warnings
• Prolonged use of painkillers for headaches can worsen symptoms. If this occurs or you suspect this, you should stop taking Nurofencaps and consult your doctor.
• You should avoid taking Nurofencaps if you have chickenpox.
• If you take Nurofencaps for long periods of time, you need to have regular blood tests and have your liver and kidneys checked regularly.
• Taking Nurofencaps 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 Nurofencaps").
• Generally, the habitual use of (different types of) painkillers can lead to serious, long-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 altered renal function.

Infections
Nurofencaps may mask the symptoms of infections, such as fever and pain. Therefore, Nurofencaps may delay adequate treatment of the infection, which could increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and the symptoms 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 Nurofencaps and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Anti-inflammatory/painkiller medications such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when taken 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 Nurofencaps 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 (angioedema), and chest pain. Stop taking Nurofencaps immediately and contact your doctor or emergency services immediately if you notice any of these signs. 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.

Talk to your doctor before taking Nurofencaps if any of the above conditions worry you.


Possible side effects
Like all medicines, Nurofencaps 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 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 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 vesicles, peeling skin, ulcers of the mouth, throat, nose, genitals and eyes.
These serious skin 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 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, if they become serious, or if you notice any adverse reactions not listed in the package leaflet.

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

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 tiredness;
• Vision 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 concentrations of uric acid in the blood;
• Hearing impairment;
• Increased concentration of urea in the blood;
• Reduction in hemoglobin levels.

Very rare (may affect up to 1 in 10,000 people)
• Swelling (edema), high blood pressure (hypertension), and heart failure have been reported in association with NSAID treatment;
• Inflammation of the esophagus or pancreas, formation of membranous strictures in the small and large intestine (diaphragmatic-like intestinal strictures);
• Serious skin infections and soft tissue complications have been reported during chickenpox infection;
• 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 Nurofencaps and consult your doctor immediately, as these may be the first signs of kidney damage or kidney failure.
• Disturbances in blood cell production. The first signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds, and skin bleeding. In these cases, you should stop treatment immediately and consult your doctor. Do not treat these symptoms with painkillers or fever-reducing medications (antipyretics);
• Psychotic reactions and depression;
• Worsening of infection-related inflammation (e.g. necrotising fasciitis) has been described in association with the use of some analgesics (NSAIDs). If signs of an infection appear or worsen while using Nurofencaps, contact 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 with long periods of treatment, liver failure, acute inflammation of the liver (hepatitis);
• Symptoms of aseptic meningitis, including stiff neck, headache, malaise, nausea, fever, or disorientation, have been observed during ibuprofen use. Patients with autoimmune disorders (SLE, mixed connective tissue disease) may be more susceptible. Contact your doctor immediately if these symptoms occur;
• 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)
• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome;
• 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 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.