IBUPROFEN ARI*12FC TAB 400MG

Ibuprofen Aristo 400 mg film-coated tablets
Equivalent medicinal product

What it is and what it is used for
Ibuprofen Aristo contains the active substance ibuprofen.
Ibuprofen is a medicine that reduces fever and relieves pain (non-steroidal anti-inflammatory drugs, NSAIDs).

In adults and adolescents weighing 40 kg or more (aged 12 years or older), it is used for the short-term symptomatic treatment of mild to moderate pain and/or fever.

Consult your doctor if you do not feel better or if you feel worse after 3 days, if you have a fever, or 4 days if you are taking this medicine for pain.
Consult your doctor after 3 days if your adolescent child does not feel better or worsens after 3 days.

What you need to know before taking the medicine
Do not take Ibuprofen Aristo if
- you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in paragraph 6). Symptoms of an allergic reaction may include swelling of the eyelids, lips, tongue or throat;
- you have ever had an allergic reaction [such as bronchospasm (tightening of the muscles in the lungs which can cause wheezing)], asthma, runny, itchy and inflamed nose with sneezing, hives (an itchy rash) or angioedema (swelling under the skin) when taking ibuprofen, acetylsalicylic acid or similar analgesics (NSAIDs);
- you suffer from unknown blood formation disorders;
- you have or have had recurrent stomach/duodenal ulcers (peptic ulcers) or bleeding (at least 2 different episodes of confirmed ulcers or bleeding);
- you have had gastrointestinal bleeding or perforation associated with previous NSAID treatment;
- you have bleeding in the brain (cerebrovascular bleeding) or other active bleeding;
- you suffer from severe liver, kidney or heart failure;
- you have severe dehydration (e.g., caused by vomiting, diarrhoea or insufficient fluid intake);
- you are in the last three months of pregnancy.

Warnings and precautions
Undesirable effects can be minimised by using the lowest effective dose for the shortest period of time necessary to control symptoms.

Discuss treatment with your doctor or pharmacist before taking Ibuprofen Aristo if:
- you suffer from systemic lupus erythematosus (SLE, sometimes known as lupus) or a connective tissue disease (autoimmune diseases affecting connective tissue)
- you have or have had gastrointestinal diseases (ulcerative colitis, Crohn's disease), as your condition may worsen
- you suffer from hereditary blood formation disorders (e.g., acute intermittent porphyria)
- you suffer from reduced liver or kidney function
- you have recently undergone major surgery
- you are sensitive (allergic) to other substances
- you suffer from hay fever, nasal polyps or chronic obstructive respiratory disease, because you are at higher risk of developing allergic reactions. Allergic reactions can occur as asthma attacks (so-called analgesic asthma), sudden swelling (Quincke's oedema) or hives
- you are dehydrated
- you have an infection - see Infections section below.

Effects on the gastrointestinal tract
The combined use of Ibuprofen Aristo with other non-steroidal anti-inflammatory drugs (NSAIDs), including so-called COX-2 inhibitors (cyclooxygenase-2 inhibitors), should be avoided.

Gastrointestinal bleeding, ulcers and perforation
Gastrointestinal bleeding, ulcers and perforation, sometimes with fatal outcome, have been reported with all NSAIDs. These have occurred at any time during therapy, with or without previous warning symptoms or previous history of serious gastrointestinal events.

In patients with a history of ulcer, especially if complicated by bleeding or perforation (see paragraph 2 DO NOT take Ibuprofen Aristo), and in elderly patients, the risk of gastrointestinal bleeding, ulceration or perforation is greater with increasing dose of NSAIDs. These patients should start treatment with the lowest available dose.
Concomitant use of protective medicines (e.g., misoprostol or proton pump inhibitors) should be considered for these patients and for patients taking low doses of acetylsalicylic acid or other medicines that may increase the risk of gastrointestinal events concomitantly.

If you have suffered from undesirable effects affecting the gastrointestinal tract - especially if you are elderly - you must report any unusual gastrointestinal symptoms (especially gastrointestinal bleeding) to your doctor, particularly in the initial stages of treatment.

Caution is advised if you are also taking other medicines that may increase the risk of ulcers or bleeding, such as oral corticosteroids, anticoagulants (blood thinners) such as warfarin, selective serotonin reuptake inhibitors (used to treat psychiatric disorders including depression) or antiplatelet agents such as acetylsalicylic acid (see paragraph 2 Other medicines and Ibuprofen Aristo).

Treatment must be discontinued and you must consult a doctor if gastrointestinal bleeding or ulceration occurs during the use of Ibuprofen Aristo.

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

You should discuss treatment with your doctor or pharmacist before taking Ibuprofen Aristo if:
- you suffer from heart problems, including heart failure and angina pectoris (chest pain) or if you have had a heart attack, bypass surgery, peripheral arterial disease (blood circulation problems in your 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 or high cholesterol, have a family history of heart disease or stroke, or if you smoke.

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 treatment with Ibuprofen Aristo immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.

Skin reactions
Severe skin reactions have been reported in association with ibuprofen treatment, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalised exanthematous pustulosis (AGEP). Stop using Ibuprofen Aristo and contact your doctor immediately if you notice any of the symptoms related to these severe skin reactions described in paragraph 4.

It is advisable to avoid using Ibuprofen Aristo during chickenpox infection.

Infections
Ibuprofen Aristo can mask the symptoms of infections such as fever and pain. It is therefore possible that Ibuprofen Aristo could 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.

Other warnings
Very rarely, severe acute hypersensitivity reactions (e.g., anaphylactic shock) have been observed. At the first signs of a hypersensitivity reaction after taking Ibuprofen Aristo, treatment should be discontinued and a doctor consulted. Any medical procedure appropriate to the symptoms should be performed by medical personnel.

Ibuprofen can temporarily inhibit platelet function (blood platelet aggregation). Therefore, patients with blood clotting disorders should be carefully monitored.

During prolonged use of Ibuprofen Aristo, regular checks of liver function parameters, kidney function and blood cell count are required.

If you use analgesics for a long time, this can cause headaches, which should not be treated with other analgesics. If you think this is your case, talk to your doctor.

In general, the habitual use of analgesics, particularly the combination of different types of analgesics, can lead to permanent kidney damage. This risk may increase during physical exercise associated with salt loss and dehydration. Therefore it should be avoided.

The risk of kidney failure is increased in dehydrated patients, in the elderly and in those taking diuretics and ACE inhibitors.

If you experience visual disturbances, contact your doctor.

Elderly patients
Elderly patients should be aware of their increased risk of adverse events, particularly gastrointestinal bleeding and perforation, which can be fatal (also refer to the warning regarding bleeding at the beginning of paragraph 2).

Adolescents
In dehydrated adolescents, there is a risk of impaired kidney function.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.

The most commonly observed side effects are related to the digestive tract. Stomach/duodenal ulcers (peptic ulcers), perforation, or bleeding, sometimes fatal, may occur, especially in elderly patients (see section 2: Warnings and precautions). After use, nausea, vomiting, diarrhoea, flatulence, constipation, indigestion, abdominal pain, black tarry stools, bloody vomit, sores (ulceration) in the mouth and throat area (ulcerative stomatitis), worsening of colitis and Crohn's disease have been reported (see section 2: Warnings and precautions). Less commonly, inflammation of the stomach lining (gastritis) has been observed. In particular, the risk of developing gastrointestinal bleeding depends on the dosage and duration of treatment.

In association with NSAID treatment, fluid retention (oedema), hypertension and heart failure have been reported.

More serious side effects • Stop taking Ibuprofene Aristo and contact a doctor immediately if you experience severe general allergic reactions (hypersensitivity), a very rare side effect (may affect up to 1 in 10,000 people):
It can manifest as:
- swelling of the face (facial oedema), tongue or throat (laryngeal swelling with airway constriction)
- difficulty breathing
- rapid heartbeat
- drop in blood pressure leading to shock
- chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome [frequency not known (frequency cannot be estimated from available data)]
• You should consult a doctor immediately if you experience an infection with symptoms such as fever and severe worsening of your general condition, or fever with symptoms of local infection such as sore throat/pharynx/mouth or urinary problems. Ibuprofene Aristo can cause a reduction in the number of white blood cells [agranulocytosis, a very rare side effect (may affect up to 1 in 10,000 people)] which causes reduced resistance to infections. It is important to inform your doctor about the medicine you are taking.
• Stop treatment with ibuprofen and consult your doctor immediately if you notice any of the following symptoms:
- non-raised, target-shaped or circular reddish 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] [a very rare side effect (may affect up to 1 in 10,000 people)].
- In addition, a severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cell) [frequency not known (frequency cannot be defined from available data)].
- skin rash or mucous membrane lesions. Severe skin rashes may include blistering on the skin, particularly on the legs, arms, hands and feet, which may also involve the face and lips. This can worsen, if the blisters enlarge and spread and parts of the skin can peel off (toxic epidermal necrolysis) [a very rare side effect (may affect up to 1 in 10,000 people)].
- widespread, red and scaly rash, with lumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalised exanthematous pustulosis) [frequency not known (frequency cannot be estimated from available data)].
• Stop taking Ibuprofene Aristo and inform your doctor immediately if you experience relatively severe upper abdominal pain, bloody vomit, bloody and/or dark stools.
- Fluid retention (oedema), particularly in patients with high blood pressure (hypertension) or kidney problems, nephrotic syndrome, interstitial nephritis which may be accompanied by acute renal failure (kidney failure) [a very rare side effect (may affect up to 1 in 10,000 people)]. Reduced urine production, fluid retention within the body (oedema) and malaise (general feeling of being unwell) may be signs of kidney failure.

If any of the listed symptoms occur or worsen, you should stop taking Ibuprofene Aristo and contact your doctor immediately.

Other side effects
Common (may affect up to 1 in 10 people)
- Gastrointestinal disorders, e.g. heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhoea, constipation, indigestion and mild gastrointestinal blood loss, which, in exceptional cases, can cause anaemia.

Uncommon (may affect up to 1 in 100 people)
- Central nervous system disorders, such as headache, dizziness, insomnia, agitation, irritability or fatigue
- Vision disturbances. In this case, you should stop using ibuprofen and inform your doctor.
- Stomach/intestinal ulcers (peptic ulcers) may occur, sometimes with bleeding and perforation (rupture in the wall of the digestive tract), which can be fatal, especially in elderly patients, ulcerative stomatitis (inflammation of the oral mucosa with ulceration), worsening of colitis or Crohn's disease (inflammation of the colon).
- Inflammation of the inner lining of the stomach (gastritis)
- Hypersensitivity reactions such as skin rash and itching, as well as asthma attacks (sometimes accompanied by a drop in blood pressure).
In such cases, you should immediately inform your doctor and stop taking Ibuprofene Aristo.

Rare side effects (may affect up to 1 in 1,000 people)
- Ringing in the ears (tinnitus)
- Hearing loss
- Kidney tissue damage (papillary necrosis), increased uric acid concentration in the blood, high urea concentration in the blood.

Very rare side effects (may affect up to 1 in 10,000 people)
- Blood cell formation disorders, such as a decrease in the amount of red blood cells or haemoglobin (anaemia), white blood cells (leucopenia) or platelets (thrombocytopenia); and other blood disorders (pancytopenia, agranulocytosis, eosinophilia, coagulopathy, neutropenia, aplastic anaemia or haemolytic anaemia). The first symptoms may be fever, sore throat, superficial mouth sores, flu-like symptoms, severe fatigue, nasal and skin bleeding.
- In temporal association with the use of some anti-inflammatory agents (non-steroidal anti-inflammatory drugs; which also include Ibuprofene Aristo), a worsening of infection-related inflammation (e.g. development of necrotising fasciitis) has been reported.
If signs of infection appear or worsen during the use of Ibuprofene Aristo (e.g. redness, swelling, heat, pain, fever), consult a doctor immediately. The doctor will assess whether you need antibiotic therapy.
- During the use of ibuprofen, symptoms of aseptic meningitis (inflammation without infection of the membranes lining the brain) have been observed, such as severe headache, nausea, vomiting, fever, stiff neck or blurred consciousness. The risk appears to be higher in patients already suffering from certain autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease).
- Low blood sugar (hypoglycaemia)
- Low blood sodium (hyponatraemia)
- Palpitations, weak heart muscle (heart failure), heart attack
- High blood pressure (hypertension)
- Vascular inflammation (vasculitis)
- Inflammation of the oesophagus or pancreas (pancreatitis), narrowing of the intestine (intestinal diaphragm stenosis)
- Psychotic reactions, hallucinations, confusion, depression and anxiety
- Asthma, difficulty breathing (dyspnoea), bronchospasm
- Yellowing of the eyes and/or skin (jaundice), liver dysfunction, liver damage, especially during long-term therapy, liver failure, acute inflammation of the liver (hepatitis).
- Hair loss (alopecia), red or purple patches on the skin (purpura) or photosensitivity reactions (triggered by sunlight).
- In exceptional cases, if you have chickenpox, severe skin infections and soft tissue complications (chickenpox infection) may occur.

Frequency not known (frequency cannot be defined from available data)
- Inflammation of the nasal mucosa (rhinitis)
- Pins and needles sensation (paresthesia) and inflammation of the optic nerve (optic neuritis)
- Kidney malfunction

Medicines such as Ibuprofene Aristo may be associated with a small 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, tell 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.