IBUPROFENE DOC*12FC TAB 400MG

IBUPROFEN DOC 400 mg film-coated tablets
Equivalent medicine

What it is and what it is used for
IBUPROFEN DOC contains ibuprofen, an active ingredient belonging to a group of medicines called NSAIDs (non-steroidal anti-inflammatory drugs). NSAIDs are drugs for pain, fever and inflammation.

IBUPROFEN DOC is used:
• to treat pain of various kinds, due to toothache (for example, after extraction or dental and oral surgery), menstrual pain, headache, muscle, joint (osteoarticular) and nerve (neuralgia) pain;
• together with other medicines, to treat symptoms due to flu or feverish conditions.

IBUPROFEN DOC can be used by adults and children over 12 years of age.

What you need to know before taking the medicine
Do not take IBUPROFEN DOC:
• if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in paragraph 6);
• if you have had allergic reactions after taking aspirin (acetylsalicylic acid), other pain relievers, fever reducers, or other non-steroidal anti-inflammatory drugs (NSAIDs), particularly if associated with nasal polyps, facial swelling (angioedema) and/or asthma;
• if you have a severe or active ulcer of the stomach or intestinal wall;
• if you have a history of perforation or bleeding in the stomach or intestines caused by taking medicines;
• if you have had two or more distinct episodes of bleeding or injury to the stomach or intestinal wall (recurrent peptic ulcer);
• if you have severe liver or kidney problems;
• if you suffer from severe heart problems (severe heart failure);
• if you have any disease that increases the risk of bleeding;
• if you are severely dehydrated, for example, you have had severe vomiting, diarrhoea, or drink very little;
• after the sixth month of pregnancy.

Do not use IBUPROFEN DOC in children under 12 years of age.

Warnings and precautions
Talk to your doctor before taking IBUPROFEN DOC if:
• you suffer from systemic lupus erythematosus (SLE) or mixed connective tissue disease, diseases that affect connective tissue causing joint or muscle pain, skin changes, and problems with other organs;
• you have had stomach or intestinal problems, e.g. ulcer, Crohn's disease, ulcerative colitis (see the section below "PAY ATTENTION to gastrointestinal risks" and "Do not take IBUPROFEN DOC");
• you have reduced kidney function;
• you have liver problems;
• you have blood clotting problems;
• you have or have had allergies (e.g. hay fever);
• you have nasal inflammation (chronic rhinitis) or nasal polyps;
• you suffer from asthma or long-term (chronic) respiratory diseases;
• you have had swelling of the face, throat, lips or other parts of the body (angioedema) in the past;
• you are elderly, as you have a higher probability of developing adverse events to this medicine, particularly life-threatening bleeding and perforations of the stomach and intestines (see the section below "PAY ATTENTION to gastrointestinal risks");
• you have chickenpox, as pain relievers and anti-inflammatory drugs (NSAIDs) could worsen the severity of skin lesions caused by it. In such cases, your doctor may advise against using this medicine;
• if you are a dehydrated adolescent or elderly person, as you have a higher probability of having kidney problems;
• you have an infection - see section Infections below.

Heart attack and stroke
Anti-inflammatory/pain relief medicines such as ibuprofen may be associated with a modest increased risk of heart attack or stroke, especially if administered 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 IBUPROFEN DOC if you have:
• heart problems including heart attack, angina (chest pain) or if you have a history of heart attack, coronary bypass surgery, peripheral arterial disease (poor circulation to the legs or feet due to narrowing or obstruction of the arteries) or any type of stroke (including mini-stroke or TIA, transient ischemic attack);
• high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.

Skin reactions
Severe skin reactions have been reported in association with IBUPROFEN DOC treatment.
Stop taking IBUPROFEN DOC and consult your doctor immediately if you experience rash, mucosal lesions, blisters or other signs of allergy, as these may be the first signs of a very serious skin reaction. See paragraph 4.

Infections
IBUPROFEN DOC can mask the symptoms of infections such as fever and pain. Therefore, it is possible that IBUPROFEN DOC 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 infection symptoms persist or worsen, consult your doctor immediately.

PAY ATTENTION, as during treatment with all non-steroidal anti-inflammatory drugs for pain and inflammation (NSAIDs):
• at any time, with or without warning symptoms, even in patients without previous serious stomach or intestinal (gastrointestinal) problems, bleeding, ulceration or perforation of the stomach or intestines have been reported, which can be life-threatening (see paragraph "Do not take IBUPROFEN DOC"). If you are elderly or have had this type of problem in the past, the risk of these events occurring will be higher if you take higher doses of the medicine. In this case, your doctor will tell you to start treatment with the lowest available dose, and may also prescribe a medicine to protect your stomach (gastroprotectors such as misoprostol or proton pump inhibitors) to be taken together with IBUPROFEN DOC;
• severe 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 DOC treatment. Stop using IBUPROFEN DOC and contact your doctor immediately if you notice any of the symptoms related to these severe skin reactions described in paragraph 4;
• severe allergic reactions (anaphylactoid reactions, up to anaphylactic shock) may occur;
• eye changes may occur if IBUPROFEN DOC is used. During therapy, periodic eye examinations are necessary, especially for prolonged treatments;
• especially if used for prolonged periods and at high doses, headache may occur; in this case, do not increase the dose of IBUPROFEN DOC to relieve the pain.

If you have reduced heart, liver or kidney function (especially if you suffer from systemic lupus erythematosus), your doctor will prescribe periodic specific tests, particularly in the case of prolonged treatments, and will prescribe the lowest effective dose and for the shortest possible duration of treatment needed to control symptoms.

The risk of side effects can be reduced by using the lowest effective dose and for the shortest possible duration of treatment needed to control symptoms. Do not exceed the dose of IBUPROFEN DOC and do not take it for long periods; always carefully follow your doctor's instructions.

STOP treatment and contact your doctor if:
• you notice any symptoms affecting the stomach and intestines (gastrointestinal), especially if it involves bleeding, particularly if this occurs in the early stages of treatment, if you are an elderly patient or if you have had gastrointestinal problems in the past;
• a skin rash, mucosal lesions or any other sign of an allergic reaction appears (e.g. redness, itching, swelling of the face and throat, sudden drop in blood pressure);
• you experience vision problems;
• you experience liver problems;
• signs of an allergic reaction to this medicine have been reported with ibuprofen, including breathing problems, swelling of the face and neck area (angioedema) and chest pain. Stop IBUPROFEN DOC immediately and contact your doctor or emergency medical service immediately if you notice any of these signs.

Children
Do not use IBUPROFEN DOC in children under 12 years of age. If necessary, ask your doctor for advice, as specific (lower) dosages are available for such patients.

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

Serious side effects
Stop taking IBUPROFEN DOC and seek immediate medical attention if you experience any of the following conditions:
• severe stomach problems, heartburn or abdominal pain due to lesions of the stomach or intestines (peptic ulcers), violent and sudden pain in the pit of the stomach or abdomen (gastrointestinal perforation). These side effects are uncommon;
• blood in vomit (hematemesis) or black stools (melena), bleeding from the stomach or intestines (gastrointestinal haemorrhages). These conditions are common side effects;
• allergic reactions, even severe, that manifest with a more or less sudden appearance of skin lesions, for example with widespread or patchy redness (rash, purpura), urticaria, itching, swelling of the face, eyes, lips, oedema of the throat with possible difficulty breathing and swallowing (angioedema). These conditions occur uncommonly. Rarely, a severe allergic reaction, which can be life-threatening, may also occur, characterized by an increase in heart rate and a sudden drop in blood pressure (anaphylactic reaction, anaphylaxis);
• reddish non-raised spots, target-shaped or circular 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];
• difficulty breathing (even severe asthma, bronchospasm or dyspnoea). These conditions are uncommon side effects;
• systemic lupus erythematosus (SLE), a disease that affects connective tissue causing joint or muscle pain, skin changes, and problems with other organs. This condition occurs rarely;
• worsening of infections such as the appearance of necrotizing fasciitis which manifests with fever, chills, weakness, sweating, diarrhoea, vomiting, redness, pain, swelling, bruises in an area of the body due to tissue necrosis (death of tissue cells);
• inflammation of the meninges (aseptic meningitis) which manifests with: very high fever, sudden headache, inability to flex the head, nausea, vomiting, confusion, drowsiness and light sensitivity. This condition occurs rarely;
• widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome). DRESS symptoms also include an increase in eosinophils (a type of white blood cell);
• widespread, red and scaly rash, with bumps under the skin and blisters located mainly on skin folds, trunk and upper limbs, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalised exanthematous pustulosis).

Other side effects
Tell your doctor if you notice:

Common side effects (may affect up to 1 in 10 people)
• nausea, vomiting, diarrhoea, intestinal gas (flatulence), constipation, indigestion (dyspepsia), abdominal pain;
• headache, dizziness;
• fatigue.

Uncommon side effects (may affect up to 1 in 100 people)
• inflammation of the nose (rhinitis);
• stomach inflammation (gastritis), mouth ulcers;
• vertigo, drowsiness, difficulty falling asleep (insomnia), anxiety, altered sensation (paresthesia);
• impaired hearing, ringing in the ears (tinnitus), visual disturbances;
• skin reactions following sun exposure (photosensitivity);
• altered liver function, yellowish discolouration of the eyes or skin (jaundice), dark urine, pale stools, itching or abdominal pain, inflammation of the liver (hepatitis);
• kidney problems such as nephrotic syndrome, inflammation of the kidney (tubulointerstitial nephritis), altered function (renal insufficiency).

Rare side effects (may affect up to 1 in 1,000 people)
• decreased number of white blood cells (leukopenia) or certain types of white blood cells (neutropenia, agranulocytosis), decreased number of platelets (thrombocytopenia), decreased number of red blood cells due to destruction (haemolytic anaemia) or bone marrow problems (aplastic anaemia);
• depression, confusion;
• altered vision due to, for example, inflammation of the optic nerve (optic neuritis) or toxic optic neuropathy;
• swelling (oedema).

Very rare side effects (may affect up to 1 in 10,000 people)
• reduced liver function, inflammation of the pancreas (pancreatitis);
• feeling of heart in throat (palpitations), heart attack (myocardial infarction), reduced heart function (insufficiency), high blood pressure (hypertension);
• breathing problems due to oedema in the lungs.

Other side effects
• pain or burning (heartburn) in the pit of the stomach, inflammation of the oral mucosa with ulcers (ulcerative stomatitis);
• worsening of colon inflammation (colitis) or Crohn's disease;
• worsening of skin infections caused by chickenpox;
• stroke;
• hallucinations, malaise;
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

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.