IBUPROFENE DOC 400 MG FILM-COATED TABLETS 12 TABLETS IN PVC/AL BLISTER

Name
IBUPROFENE DOC 400 mg film-coated tablets
Equivalent medicine


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

IBUPROFENE 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 pain (nervralgia);
• together with other medicines, to treat symptoms due to flu or fever.

IBUPROFENE 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 IBUPROFENE DOC:
• if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
• if you have had allergic reactions after taking aspirin (acetylsalicylic acid), other medicines for pain, fever, or other non-steroidal anti-inflammatory drugs (NSAIDs), particularly if associated with nasal polyps, swelling of the face (angioedema) and/or asthma;
• if you have a lesion of the stomach or intestinal wall (severe or active peptic ulcer);
• if you have had a history of perforation or bleeding in the stomach or intestine caused by taking medicines;
• if you have had two or more distinct episodes of bleeding or injury to the wall of your stomach or intestine (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 if you have had severe vomiting, diarrhoea or drink very little;
• after the sixth month of pregnancy.

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


Warnings and precautions
Talk to your doctor before taking IBUPROFENE DOC if:
• suffer from systemic lupus erythematosus (SLE) or mixed connective tissue disease, diseases that affect the connective tissue causing joint or muscle pain, skin changes and problems with other organs;
• have had stomach or intestinal problems, for example ulcer, Crohn's disease, ulcerative colitis (see paragraph below "WARNING" on gastrointestinal risks and "Do not take IBUPROFENE DOC");
• has reduced kidney function;
• has liver problems;
• has blood clotting problems;
• have or have had allergies (e.g. hay fever);
• has inflammation of the nose (chronic rhinitis) or nasal polyps;
• suffers from asthma or respiratory diseases that have lasted for a long time (chronic);
• have had swelling of the face, throat, lips or other parts of the body (angioedema) in the past;
• are elderly, as they are more likely to develop adverse events from this medicine, particularly bleeding and perforations of the stomach and intestines which may be life-threatening (see section below BE CAREFUL about gastrointestinal risks);
• have chickenpox, as pain and inflammation medicines (NSAIDs) may make the skin lesions caused by it worse. In such cases your doctor may advise you not to use this medicine;
• if you are a dehydrated teenager or elderly as they are more likely to have kidney problems;
• have an infection – see section “Infections” below.

Heart attack and stroke
Anti-inflammatory/pain-relieving drugs such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when taken 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 IBUPROFENE DOC if you have:
• heart problems including heart attack, angina (chest pain) or if you have had a heart attack, coronary artery bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrowing or blockage of the arteries) or any type of stroke (including 'mini stroke' or 'TIA', transient ischaemic 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 treatment with IBUPROFENE DOC.
Stop taking IBUPROFENE DOC and consult your doctor immediately if you experience a skin rash, mucosal lesions, blisters or other signs of allergy, as these may be the first signs of a very serious skin reaction. See section 4.

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

PLEASE NOTE , as during treatment with all nonsteroidal 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 intestine, which may be life-threatening, has been reported (see section "Do not take IBUPROFENE DOC"). If you are elderly or have had these types of problems in the past, the risk of experiencing these events 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 IBUPROFENE DOC;
• 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 treatment with IBUPROFENE DOC. Stop using IBUPROFENE DOC and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4;
• serious allergic reactions (anaphylactoid reactions, up to anaphylactic shock) may occur;
• eye changes may occur if IBUPROFENE DOC is used. During therapy it is necessary to carry out periodic eye checks, 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 IBUPROFENE DOC to relieve the pain.

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

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

STOP treatment and contact your doctor if:
• note any symptoms affecting your stomach and intestines (gastrointestinal), especially bleeding, particularly if this occurs early in 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);
• exhibits vision problems;
• has liver problems;
• 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 IBUPROFENE DOC immediately and contact your doctor or emergency services immediately if you notice any of these signs.

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


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

Serious side effects
Stop taking IBUPROFENE DOC and contact your doctor immediately if you experience any of the following conditions:
• severe stomach problems, heartburn or abdominal pain due to lesions in the stomach or intestine (peptic ulcers), sudden severe pain in the pit of the stomach or belly (gastrointestinal perforation). These side effects are uncommon;
• vomiting containing blood (haematemesis) or black stools (melena), bleeding from the stomach or intestines (gastrointestinal haemorrhages). These conditions are common side effects;
• allergic reactions, even serious ones, which manifest themselves with the more or less sudden appearance of skin lesions, for example with widespread or blotchy redness (rash, purpura), hives, itching, swelling of the face, eyes, lips, swelling of the throat with possible difficulty in breathing and swallowing (angioedema). These conditions occur with uncommon frequency. Rarely, a serious allergic reaction may also occur, which can be life-threatening, characterised by an increase in heart rate and a sudden drop in blood pressure (anaphylactic reactions, anaphylaxis);
• flat, target-shaped or circular reddish spots on the trunk, often with central blisters, peeling skin, and 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];
• 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 onset of necrotizing fasciitis which manifests itself with fever, chills, weakness, sweating, diarrhoea, vomiting, redness, pain, swelling, bruising in an area of ​​the body due to tissue necrosis (death of tissue cells);
• inflammation of the meninges (aseptic meningitis) which manifests itself with: very high fever, sudden headache, inability to bend the head, nausea, vomiting, confusion, drowsiness and sensitivity to light. This condition occurs rarely;
• widespread skin rash, high body temperature and swollen lymph nodes (DRESS syndrome). Symptoms of DRESS also include increased eosinophils (a type of white blood cell);
• widespread, red, scaly rash with bumps under the skin and blisters located mainly in the skin folds, trunk and upper limbs, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized 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;
• dizziness, drowsiness, difficulty falling asleep (insomnia), anxiety, changes in sensation (paraesthesia);
• impaired hearing, ringing in the ears (tinnitus), vision disturbances;
• skin reactions following exposure to the sun (photosensitivity);
• changes in liver function, yellowing of the eyes or skin (jaundice), dark urine, pale stools, itching or pain in the abdomen, inflammation of the liver (hepatitis);
• kidney problems such as nephrotic syndrome, inflammation of the kidney (tubulointerstitial nephritis), changes in function (renal failure).

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

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 the throat (palpitations), heart attack (myocardial infarction), reduced heart function (failure), high blood pressure (hypertension);
• problems breathing due to swelling in the lungs.

Other side effects
• pain or burning (heartburn) in the pit of the stomach, inflammation of the mucosa of the mouth with ulcers (ulcerative stomatitis);
• worsening of inflammation of the colon (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, 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.