Name
SUBITENE 200 mg film-coated tablets
Ibuprofen
Equivalent medicine


What it is and what it is used for
SUBITENE contains ibuprofen, which belongs to a class of medicines called NSAIDs (nonsteroidal anti-inflammatory drugs). These medicines work by reducing the pain and swelling caused by inflammation and fever.
SUBITENE is used to treat pain of various origins and natures: headache, toothache, neuralgia, muscle and bone pain (muscular and osteoarticular), menstrual pain. SUBITENE is also indicated as an adjuvant in the treatment of symptoms of fever and influenza.

Talk to your doctor if you do not feel better or if you feel worse after a short time of treatment.


What you need to know before taking the medicine
Do not take SUBITENE:
- if you are allergic to ibuprofen, to other similar anti-inflammatory medicines (e.g. acetylsalicylic acid) or to any of the other ingredients of this medicine (listed in section 6);
- if you have suffered from ulcers or bleeding in the stomach or intestine (active gastroduodenal ulcers) or if you suffer from other stomach problems (gastropathies);
- if you have suffered in the past from stomach and intestinal disorders associated with bleeding (gastrointestinal bleeding, perforation related to previous active treatments or history of bleeding, recurrent peptic ulcer, with two or more distinct episodes of proven ulceration or bleeding);
- if you suffer from severe liver or kidney problems (severe hepatic or renal insufficiency);
- if you suffer from severe heart problems (severe heart failure);
- if you are in the last three months of pregnancy or if you are breast-feeding (See section "Pregnancy and breast-feeding");
- if you have significant dehydration (caused by vomiting, diarrhea or insufficient fluid intake);
- if the person who is to take the medicine is a child under 12 years of age.


Warnings and precautions
Talk to your doctor or pharmacist before taking SUBITENE.

Take this medicine with caution and after consulting your doctor in the following situations:
• if you suffer from chronic inflammatory bowel diseases such as inflammation of the colon with ulcers (ulcerative colitis), inflammation of the digestive tract (Crohn's disease);
• if you suffer from problems with your normal blood clotting mechanism. SUBITENE may prolong bleeding time;
• if you have previously experienced breathing difficulties due to narrowing of the airways (bronchospasm) following the taking of medicines used to treat inflammation (non-steroidal anti-inflammatory drugs);
• if you suffer from breathing problems (asthma), chronic rhinitis or current or previous allergic diseases;
• if you suffer from liver, kidney, heart problems or high blood pressure;
• if you are taking other anti-inflammatory medicines (including selective COX-2 inhibitors);
• if the patient is an adolescent and is dehydrated;
• if you have an infection (see section "Infections" below).

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 taking Subitene immediately and contact your doctor or emergency services immediately if you notice any of these signs.

Inform your doctor in the following cases:
- if you experience any unusual symptoms in your abdomen , particularly if these symptoms occur at the beginning of treatment. In fact, the risk of bleeding or ulceration of the digestive tract is higher in this case, especially if you are elderly, if you take high doses of this medicine and if you take other medicines (see section "Other medicines and SUBITENE"). If bleeding or ulceration of the digestive tract occurs, treatment must be stopped because they can be fatal. You must be particularly careful if you have had a gastric or intestinal ulcer, particularly if it was complicated by perforation or accompanied by bleeding;
- if you suffer from heart problems , have had a stroke or think you may be at risk of developing these conditions (for example if you have high blood pressure, diabetes or high cholesterol or are a smoker). This medicine may increase the risk of heart attack (myocardial infarction) or stroke especially if you take high doses or for long periods. Never exceed the recommended dose or duration of treatment. Take special care if you take this medicine at high doses (2400 mg daily) and for long-term treatment, as it may increase the risk of heart problems (stroke and heart attack);
- if you are undergoing prolonged treatment with this medicine or suffer from diffuse lupus erythematosus, your doctor will have to periodically check your kidneys;
- if you experience swelling in your legs (oedema), heart problems (heart failure) or high blood pressure which may be symptoms of kidney problems . SUBITENE can in fact cause kidney problems especially in elderly people or those who already have kidney, heart, liver problems or who take diuretics or ACE inhibitors. Stop treatment if kidney problems occur.

This medicine may cause :
- eye problems. If you take this medicine for long periods, have your eyes checked regularly;
- brain problems (aseptic meningitis) on rare occasions. This may occur mainly in people suffering from diseases such as systemic lupus erythematosus and related connective tissue diseases, but has also been observed in patients without concomitant chronic diseases;
- permanent damage to your kidneys, with risk of kidney failure. This may happen to you if you regularly take this medicine;
- allergic reactions (hypersensitivity reactions), even serious ones (anaphylactoid reactions). The risk increases if you have suffered from these problems in the past after taking an anti-inflammatory medicine (analgesics, antipyretics, NSAIDs) or if you suffer from asthma, rhinitis, hay fever or other disorders (nasal polyposis, chronic obstructive respiratory disease, angioedema, see the section "Do not take SUBITENE"). Allergic reactions may be in the form of breathing crises (analgesic asthma) or may manifest themselves as skin rashes (urticaria, Quincke's edema). Stop treatment at the first signs of onset.

Infections
Subitene may hide the symptoms of infections such as fever and pain. It is therefore possible that Subitene may 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 get worse, contact your doctor immediately.

Take special care with Subitene
Serious skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP) have been reported in association with ibuprofen treatment. Stop using Subitene and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Children and adolescents
This medicine is not recommended for children under 12 years of age.
Kidney damage may occur in dehydrated children and adolescents.

Elderly people
If you are elderly, you may be more susceptible to side effects, particularly bleeding and perforation of the digestive tract, which can be fatal.


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

Stop treatment with SUBITENE and contact your doctor immediately if the following side effects occur:
- formation of lesions in the stomach or intestines (peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal), especially in elderly people;
- feeling of heaviness in the stomach, nausea, vomiting, diarrhoea, flatulence, constipation, digestive disorders (dyspepsia), abdominal pain, presence of blood in the stool (melena) and in vomit (haematemesis);
- infection of the mouth with the formation of lesions (ulcerative stomatitis);
- worsening of some intestinal disorders (colitis and Crohn's disease);
- increased risk of heart problems (stroke and heart attack), especially if you take this medicine in high doses and for prolonged treatment;
- exacerbation of infection-related inflammation has been described (e.g. development of necrotizing fasciitis);
- 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 rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis];
- extensive skin rash, high body temperature and swollen lymph nodes (DRESS syndrome);
- extensive, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis);
- chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Common (may affect up to 1 in 10 people):
malaise, dizziness, fatigue.

Uncommon (may affect up to 1 in 100 people):
• increased stomach acidity (gastritis);
• hypersensitivity reactions, such as skin rashes, urticaria, purpura, exanthema, pruritus, angioedema, asthma attacks, bronchospasm, dyspnoea (sometimes accompanied by low blood pressure);
• insomnia, drowsiness;
• anxiety;
• reduced sensation in the legs and arms (paraesthesia);
• respiratory congestion, cold (rhinitis);
• breathing disorders (bronchospasm, dyspnea, apnea);
• vision disorders;
• ringing in the ears, impaired hearing, dizziness;
• liver disorders (hepatitis, jaundice, impaired liver function);
• skin sensitivity to light (photosensitivity);
• kidney problems (impaired kidney function and toxic nephropathy in various forms, including interstitial nephritis, nephrotic syndrome and renal failure).

Rare (may affect up to 1 in 1,000 people):
• vision problems (optic neuritis, ocular alteration resulting in visual disturbances, toxic optic neuropathy);
• depression, confusion, hallucinations;
• lupus erythematosus syndrome;
• reduction in the levels of platelets (thrombocytopenia), white blood cells (leukopenia, neutropenia, agranulocytosis), red blood cells (haemolytic anaemia), reduction in the levels of all blood components (aplastic anaemia);
• inflammation of the brain membrane in the absence of bacterial infection (aseptic meningitis), especially if you have suffered from immune system disorders in the past (such as systemic lupus erythematosus or mixed connective tissue disease); may manifest itself with symptoms such as headache, stiff neck, nausea, vomiting, fever, disorientation;
• swelling due to fluid accumulation (edema).

Very rare (may affect up to 1 in 10,000 people):
• severe rash with blisters on the skin, especially on the legs, arms, hands and feet, which may spread to the face and lips (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis). severe hypersensitivity reactions. Symptoms may include: facial swelling, swelling of the tongue, swelling of the internal larynx with constriction of the airways, dyspnoea, tachycardia, anaphylaxis, exfoliative and bullous dermatitis;
• bothersome awareness of heartbeat (palpitations), heart failure, heart attack or high blood pressure, acute pulmonary edema, edema;
• pancreatic disorders (pancreatitis);
• liver failure.

Not known (frequency cannot be estimated from the available data)
• a widespread, red, scaly rash with pustules under the skin and blisters mainly located in the skin folds, trunk and upper limbs accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop using Subitene if you develop these symptoms and contact your doctor immediately. See also section 2;
• Kounis syndrome.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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.