BRUFEN ANALGES*12FC TAB 400MG

BRUFEN ANALGESICO 200 mg film-coated tablets
BRUFEN ANALGESICO 400 mg film-coated tablets
Ibuprofen (as lysine salt)

What it is and what it is used for
BRUFEN ANALGESICO contains the active substance ibuprofen. It belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs provide relief by modifying the body's response to pain and fever.

BRUFEN ANALGESICO tablets are used for the symptomatic treatment of mild to moderate pain, such as headache, dental pain, menstrual pain, and pain and fever associated with the common cold.

What you need to know before taking the medicine
Do not take BRUFEN ANALGESICO:
• if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in paragraph 6);
• if you have suffered an allergic reaction, such as asthma, difficulty breathing, swelling of the face, tongue or throat, hives, runny and itchy nose, caused by acetylsalicylic acid (ASA) or other NSAIDs;
• if you have (or have had two or more episodes of) stomach ulcer or bleeding;
• if you have had gastrointestinal perforation or bleeding while using NSAIDs;
• if you suffer from cerebrovascular bleeding or other active bleeding;
• if you suffer from blood formation disorders of unknown nature;
• if you have severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake);
• if you suffer from severe liver, kidney or heart failure;
• if you are in the last 3 months of pregnancy.

Warnings and precautions
Talk to your doctor or pharmacist before taking BRUFEN ANALGESICO:
• if you have recently undergone major surgery;
• if you suffer or have suffered from asthma or an allergic disease, as difficulty breathing may occur;
• if you suffer from hay fever, nasal polyps or chronic obstructive respiratory disease, as there is an increased risk of allergic reactions. Allergic reactions can occur as asthma attacks (so-called analgesic asthma), Quincke's oedema or hives;
• if you suffer from heart problems;
• if you have a history of gastrointestinal diseases (such as ulcerative colitis, Crohn's disease);
• if you suffer from systemic lupus erythematosus or mixed connective tissue disease (a disease affecting the skin, joints and kidneys);
• if you suffer from certain hereditary blood formation disorders (e.g. acute intermittent porphyria);
• if you suffer from blood clotting disorders;
• if you are taking other NSAIDs. Concomitant use with other NSAIDs, including specific cyclo-oxygenase-2 inhibitors, increases the risk of adverse reactions (see section Other medicines and BRUFEN ANALGESICO, below) and should be avoided;
• if you have chickenpox, it is advisable to avoid using BRUFEN ANALGESICO;
• if you are elderly;
• if you have an infection - see paragraph Infections below.

Patients with kidney or liver problems should consult a doctor before taking ibuprofen tablets.

Anti-inflammatories such as ibuprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke, particularly if given in high doses.
Do not exceed the recommended dose or duration of treatment (see paragraph 3).

You should discuss treatment with your doctor or pharmacist before taking BRUFEN ANALGESICO if:
• you have heart problems, including heart failure, angina (chest pain), or a history of heart attack, bypass surgery, peripheral artery disease (circulation problems in the legs or feet due to narrowing or blockage of the arteries), or any type of stroke (including mini-stroke or transient ischaemic attack, TIA);
• you suffer from high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or are a smoker.

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

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 BRUFEN ANALGESICO and contact your doctor immediately if you notice any of the symptoms related to these severe skin reactions described in paragraph 4.

Infections
BRUFEN ANALGESICO can hide the symptoms of infections such as fever and pain. It is therefore possible that BRUFEN ANALGESICO could 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 symptoms of the infection persist or worsen, contact your doctor immediately.
Undesirable effects can be minimised by using the lowest effective dose for the shortest period of time. Elderly people have an increased risk of undesirable effects.

In general, habitual use of analgesics (even of different types) can lead to serious and persistent kidney problems. This risk can increase during physical exercise associated with salt loss and dehydration. Therefore, it should be avoided. There is a risk of impaired kidney function in dehydrated children and adolescents.

Prolonged use of any type of analgesic for headache can make it worse. If such a situation is present or suspected, medical advice should be sought and treatment should be stopped. The diagnosis of headache from overuse of medicines should be suspected in patients who have headaches despite (or because of) regular use of headache medicines.

During prolonged administration of BRUFEN ANALGESICO, regular checks of the liver, kidney function and blood cell count are required. Your doctor may ask you to undergo blood tests during treatment.

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

Side effects can be minimised by taking the lowest dose for the shortest period of time necessary to relieve symptoms. Elderly people using this product have a higher risk of developing problems associated with side effects.

Medicines such as BRUFEN ANALGESICO may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

Some of the side effects listed below are less frequent when the maximum daily dose is 1200 mg compared to high-dose therapy in rheumatic patients.

If you think you have any of the following side effects or symptoms, stop taking this medicine and seek immediate medical attention:
• stomach or intestinal ulcers, sometimes with bleeding and perforation, blood vomiting or tarry black stools (common: may affect up to 1 in 10 people)
• kidney disorders with blood in the urine that may be associated with kidney failure (uncommon: may affect up to 1 in 100 people)
• severe allergic reactions (very rare: may affect up to 1 in 10,000 people) such as:
- difficulty breathing or unexplained wheezing
- dizziness or fast heartbeat
- drop in blood pressure causing shock
- swelling of the face, tongue and throat.
• 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 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)
• severe skin condition that can affect the mouth and other parts of the body with symptoms including red patches, often itchy, similar to measles rash, starting on the limbs and sometimes on the face and rest of the body. The spots can swell or can progress to form raised, red, pale-centred spots. Affected patients may have fever, sore throat, headache and/or diarrhoea (very rare: may affect up to 1 in 10,000 people)
• severe peeling or flaking of the skin (very rare: may affect up to 1 in 10,000 people)
• Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome) (not known: frequency cannot be estimated from the available data).
• inflammation of the pancreas with severe epigastric pain, often with nausea and vomiting (very rare: may affect up to 1 in 10,000 people)
• nausea, vomiting, loss of appetite, general feeling of ill health, fever, itching, yellowing of the skin and eyes, light-coloured stools, dark-coloured urine, which may be signs of hepatitis or liver failure (very rare: may affect up to 1 in 10,000 people)
• heart disorder with shortness of breath and swelling of the feet or legs due to fluid retention (heart failure) (not known: frequency cannot be estimated from the available data)
• aseptic meningitis (infection around the brain or spinal cord, with symptoms including: fever, nausea, vomiting, headache, stiff neck and extreme sensitivity to bright light and clouded mental state such that you are not fully aware of your surroundings (very rare: may affect up to 1 in 10,000 people)
• heart attack (myocardial infarction, very rare: may affect up to 1 in 10,000 people) or stroke (frequency not known: cannot be estimated from the available data)
• severe kidney damage (papillary necrosis, particularly with long-term use (rare: may affect up to 1 in 1,000 people)
• worsening of infection-related inflammation (e.g. development of flesh-eating bacteria syndrome) particularly with the use of other NSAIDs (very rare: may affect up to 1 in 10,000 people)
• Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome (not known: frequency cannot be estimated from the available data)

Stop taking the medicine and tell your doctor if the following occur:
Very common: (may affect more than 1 in 10 people)
• indigestion or heartburn
• abdominal pain (stomach pain) or other stomach abnormalities

Not known (frequency cannot be estimated from the available data)
• visual disturbances
• a widespread, red, scaly rash, with pustules 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 BRUFEN ANALGESICO if you develop these symptoms and contact your doctor immediately. See also paragraph 2.

Tell your doctor if any of the following side effects occur:
Very common (may affect more than 1 in 10 people)
• nausea, flatulence, diarrhoea, constipation, vomiting

Common (may affect up to 1 in 10 people)
• headache, drowsiness, dizziness, spinning sensation, tiredness, agitation, inability to sleep, irritability
• stomach and duodenal ulcers, sometimes with bleeding and perforation, occult blood loss which can lead to anaemia, a condition in which there is a decrease in red blood cells (symptoms include tiredness, headache, shortness of breath during exercise, dizziness and pallor), tarry black stools, vomiting with blood, mouth ulcers and herpes, inflammation of the colon (symptoms include diarrhoea, usually with blood and mucus, stomach pain and fever), worsening of inflammatory bowel disease, inflammation of the intestinal wall

Uncommon (may affect up to 1 in 100 people)
• hives, itching, unusual bleeding or bruising under the skin, rash, asthma attack (sometimes with hypotension)
• runny or blocked nose, sneezing, facial pain or pressure, difficulty breathing
• inflammation of the stomach (symptoms include: pain, nausea, vomiting, blood vomiting, blood in stools)
• increased skin sensitivity to the sun
• swelling of the face, lips, mouth, tongue or throat, which may cause difficulty swallowing or breathing, sometimes with high blood pressure
• fluid retention in body tissues, especially in patients with high blood pressure or kidney problems

Rare (may affect up to 1 in 1,000 people)
• a disease affecting the skin, joints and kidneys (lupus erythematosus syndrome)
• depression, confusion, hallucinations, mental illness with strange or disturbing thoughts or mood
• ringing, hissing, whistling, sounds or other persistent noises in the ears
• increased urea nitrogen, transaminases and alkaline phosphatase, decreased haemoglobin and haematocrit values, inhibition of platelet aggregation, prolonged bleeding time, decreased serum calcium, increased serum uric acid, all observed with a blood test
• loss of visual capacity

Very rare (may affect up to 1 in 10,000 people)
• rapid or irregular heartbeat (palpitations)
• increased fluid in body tissues
• inflammation of the oesophagus, narrowing of the intestine
• liver disorders, liver damage (especially with long-term use), liver failure, yellowing of the skin and/or eyes, also called jaundice
• severe skin infections, with soft tissue complications, may occur if you have chickenpox
• fluid accumulation in the lungs, symptoms include shortness of breath, which can be very severe and usually worsens when lying down

Not known (frequency cannot be estimated from the available data)
• worsening of an inflammatory disease that can affect any part of the gastrointestinal tract (symptoms include pain, fever, diarrhoea and weight loss), worsening of inflammation of the colon (symptoms: diarrhoea, usually with blood and mucus, stomach pain, fever)
• high blood pressure
• unusual hair loss or incipient baldness
• menstrual disorders

Reporting of side effects
If you get any side effects, including those 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.