IBUPROFEN AUR*10 SOFTGEL 400MG

Ibuprofen Aurobindo Pharma 400 mg soft capsules
Equivalent medicinal product

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

Ibuprofen Aurobindo Pharma is indicated in adults and adolescents weighing 40 kg or more (aged 12 years and over), for the short-term symptomatic treatment of mild to moderate pain such as headache, flu symptoms, toothache, muscle pain, painful periods and fever.

Ibuprofen Aurobindo Pharma is also indicated in adults for the treatment of mild to moderate pain during migraine, with or without aura.

You must consult a doctor if you do not feel better or if you experience a worsening after 3 days in adolescents; after 3 days in case of fever or migraine and after 5 days in case of pain in adults.

What you need to know before taking the medicine
Do not take Ibuprofen Aurobindo Pharma:
- if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
- if you have suffered an allergic reaction, such as asthma, difficulty breathing, swelling of the face, tongue or throat, hives, itchy and runny nose, caused by acetylsalicylic acid (ASA) or other NSAIDs;
- if you have (or have had two or more episodes of) stomach or intestinal ulcer or bleeding;
- if you have had gastrointestinal perforation or bleeding during NSAID use;
- 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 Ibuprofen Aurobindo Pharma:
• if you have recently undergone major surgery;
• if you suffer or have suffered from asthma or an allergic disease, as shortness of breath 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 present as asthma attacks (so-called analgesic asthma), Quincke's oedema or urticaria;
• if you have suffered from gastrointestinal ulcers (see also the section Do not take Ibuprofen Aurobindo Pharma);
• 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 diseases (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 cyclooxygenase-2 inhibitors, increases the risk of adverse reactions (see the section Other medicines and Ibuprofen Aurobindo Pharma below) and should be avoided;
• if you have chickenpox, it is advisable to avoid using this medicine;
• if you are elderly;
• if you suffer from kidney or liver problems;
• if you have an infection - please see the Infections section below;
• signs of an allergic reaction to this medicine, including breathing problems, swelling of the face and neck (angioedema) and chest pain, have been reported with ibuprofen.
Stop this medicine immediately and contact your doctor or emergency medical service immediately if you notice any of these signs;
• 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 Ibuprofen Aurobindo Pharma and contact your doctor immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Infections
• Ibuprofen Aurobindo Pharma can mask symptoms of infections such as fever and pain. It is therefore possible that Ibuprofen Aurobindo Pharma 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, contact your doctor immediately.

Start treatment with the lowest available dose if you have ever had gastrointestinal ulcers, are elderly or require concomitant administration of low-dose acetylsalicylic acid or other medicines that may increase gastrointestinal risk (see Other medicines and Ibuprofen Aurobindo Pharma below). Your doctor may also add therapy with medicines that protect the gastric mucosa (e.g. misoprostol or proton pump inhibitors). Inform your doctor if unusual stomach symptoms occur, particularly signs of bleeding such as vomiting blood or black tar-like stools (see also section 4, Possible side effects).

Anti-inflammatory/painkillers such as ibuprofen may be associated with a small increased risk of myocardial infarction or stroke, particularly when given at high doses. Do not exceed the recommended dose or duration of treatment (see section 3).

You should discuss treatment with your doctor or pharmacist before taking Ibuprofen Aurobindo Pharma if:
• you suffer from heart problems, including heart failure, angina (chest pain), or if you have a history of heart attack, bypass surgery, peripheral arterial disease (circulation problems 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 suffer from high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or are a smoker. Very rare reports of potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with ibuprofen use. Patients are at greater risk of such reactions during the first month of therapy. Stop taking this medicine and contact your doctor or pharmacist if you notice a rash, mucosal lesions or any other signs of allergic reactions (see section 4).

Undesirable effects can be minimised by using the lowest effective dose for the shortest possible time. Elderly people have an increased risk of undesirable effects.

Skin reactions
Severe skin reactions have been reported in association with Ibuprofen Aurobindo Pharma treatment. Stop taking Ibuprofen Aurobindo Pharma 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 severe skin reaction. See section 4.

In general, habitual use of analgesics (even of different types) can lead to severe and persistent kidney problems. This risk can increase during physical exercise associated with salt loss and dehydration. Therefore, it should be avoided.

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

In prolonged administration of Ibuprofen Aurobindo Pharma, regular checks of liver function, kidney function and blood cell count are required. Your doctor may ask you to undergo blood tests during treatment.

Children and adolescents
There is a risk of kidney failure in dehydrated children and adolescents.
Ibuprofen Aurobindo Pharma is not indicated for use in adolescents weighing less than 40 kg and in children under 12 years of age.

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

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

Medicines such as Ibuprofen Aurobindo Pharma may be associated with a small increased risk of a heart attack (myocardial infarction) or stroke (see section 2, Warnings and precautions).

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, vomiting blood or black tar-like 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 rapid heartbeat;
- drop in blood pressure causing shock;
- swelling of the face, tongue and throat;
• potentially life-threatening skin rashes, with the formation of severe blisters and bleeding of the lips, eyes, mouth, throat, nose and genitals or severe skin reactions that begin with painful red areas, then with large blisters and finally detachment of the skin layers. This is accompanied by fever and chills, muscle pain and general malaise (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis) (very rare: may affect up to 1 in 10,000 people);
• a widespread red and scaly rash with subcutaneous bumps and blisters mainly on the skin folds, trunk and upper limbs accompanied by fever at the beginning of treatment (acute generalised exanthematous pustulosis). See also section 2 (frequency not known: cannot be estimated from the available data);
• severe skin condition that can affect the mouth and other parts of the body with symptoms including red patches, often itchy, similar to a measles rash, starting on the limbs and sometimes on the face and the rest of the body. The spots may swell or may 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 flaking or peeling of the skin (very rare: may affect up to 1 in 10,000 people);
• 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 unwellness, 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) (frequency not known: 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 blurred mental state such that you are not fully in touch with the environment) (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);
• problems in the production of blood cells - the first signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, bleeding from the nose and skin (very rare: may affect up to 1 in 10,000 people);
• a severe skin reaction known as DRESS syndrome may occur. DRESS syndrome includes: rash, fever, swelling of the lymph nodes and an increase in eosinophils (a type of blood cell) (frequency not known: cannot be estimated from the available data).

Other side effects:

Very common (may affect more than 1 in 10 people):
• nausea, heartburn, flatulence, diarrhoea, constipation, vomiting, abdominal pain.

Common (may affect up to 1 in 10 people):
• headache, drowsiness, dizziness, feeling lightheaded, tiredness, agitation, inability to sleep, irritability;
• occult blood loss which can lead to a condition where there is a reduced number of red blood cells (symptoms include fatigue, headache, shortness of breath during exercise, dizziness and paleness), mouth ulcers and cold sores, inflammation of the colon (symptoms include diarrhoea, usually with blood and mucus, stomach pain, 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 attacks (sometimes with hypotension);
• runny or blocked nose, sneezing, facial pressure or pain, difficulty breathing;
• inflammation of the stomach (symptoms include pain, nausea, vomiting, vomiting blood, blood in bowel movements);
• fluid accumulation in body tissues, especially in patients with high blood pressure or kidney problems;
• visual disturbances.

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 illnesses with strange or disturbing thoughts or moods;
• ringing, whistling, hissing, sounds or other persistent noises in the ears;
• increased blood urea nitrogen, serum transaminases and alkaline phosphatase, decreased haemoglobin and haematocrit values, inhibition of platelet aggregation, prolonged bleeding time, decreased serum calcium, increased serum uric acid, all detected with a blood test;
• vision loss.

Very rare (may affect up to 1 in 10,000 people):
• fast or irregular heartbeat (palpitations);
• fluid accumulation in body tissues;
• high blood pressure;
• inflammation of the alimentary canal, narrowing of the intestine;
• unusual hair loss or thinning;
• in case of chickenpox, severe skin infections with soft tissue complications may occur;
• menstrual cycle disorders.

Not known (frequency cannot be estimated from the available data):
• light-sensitive skin;
• chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.

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.