Description Ibutrixen Fast is a medicinal product belonging to the NSAID group, with analgesic, antipyretic, and anti-inflammatory effects. Ibutrixen Fast can be used for pain of various origins, from headaches and migraines, to joint and bone pain, as well as pain associated with colds, flu, and fever. Composition The active substance is ibuprofen ( Ibuprofenum ). Each soft capsule contains 400 mg of ibuprofen ( Ibuprofenum ). Excipients: Capsule fill: Macrogol 600 (E 1521); Potassium hydroxide (E 525); Purified water. Capsule shell: Purified water; Sorbitol, liquid, partly dehydrated (E 420); Gelatin (E 441); Hydrolysed gelatin; Erythrosine (E127); Soya lecithin; Triglycerides, medium chain; Macrogol 600. Dosage Always use this medicine exactly as described in the package leaflet or as directed by your doctor or pharmacist. If you have any further questions, ask your doctor or pharmacist. Ibutrixen Fast is taken orally. The medicine is intended for short-term use. Adults and adolescents over 12 years of age (weighing at least 40 kg): 1 tablet (400 mg). If necessary, the dose can be repeated after 4 hours (but not sooner). The maximum daily dose of IIbutrixen Fast is 3 tablets (1200 mg). Coated tablets are taken after a meal with a sufficient amount of water. The medicinal product should not be used for more than 3 days without consulting a doctor. Action Ibutrixen Fast contains an active ingredient from the NSAID group of drugs—nonsteroidal anti-inflammatory drugs. Ibuprofen has analgesic, antipyretic, and anti-inflammatory effects. This medication relieves pain and lowers fever. Indications Ibutrixen Fast is used to treat: pain of various origins of mild to moderate intensity: headache, migraine, toothache, tension pain, muscle, joint and bone pain, pain associated with flu and colds, neuralgia; fever of various origins (including flu, colds or other infectious diseases); painful menstruation. Contraindications Do not use Ibutrixen Fast if: you are allergic (hypersensitive) to ibuprofen or any of the other ingredients of Ibutrixen Fast ; you have taken acetylsalicylic acid or other non-steroidal anti-inflammatory drugs; you have ever had allergy symptoms such as a runny nose, hives, swelling or asthma; you have or have had a stomach and/or duodenal ulcer, perforation (hole) or gastrointestinal bleeding (two or more episodes), also related to previous NSAID treatment; you have severe liver or kidney failure; you have severe heart failure; you have had cerebrovascular bleeding or other active bleeding; you are taking other non-steroidal anti-inflammatory drugs (including so-called COX-2 inhibitors) at the same time, as there is an increased risk of side effects; you are in the last trimester of pregnancy; you have a bleeding diathesis (tendency to bleed). Side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Accumulation of fluid in tissues (edema), high blood pressure and heart failure have been reported in association with NSAID treatment. Chest pain, which may be a symptom of a potentially severe allergic reaction called Kounis syndrome. The most commonly observed side effects involve the gastrointestinal tract. Ulcers of the stomach and/or duodenum (peptic ulcer), perforation, or bleeding may occur, sometimes fatal, particularly in elderly patients. The following have been reported after use: nausea, vomiting, diarrhea, flatulence, constipation, digestive problems, abdominal pain, tarry stools, vomiting blood, sores (ulcers) in the mouth and throat (ulcerative stomatitis), exacerbation of colitis and Crohns disease. Inflammation of the stomach lining (gastritis) has been reported less frequently. In particular, the risk of gastrointestinal bleeding depends on the dose and duration of treatment. Stop taking Ibutrixen Fast and contact your doctor immediately if you experience any of the following symptoms: severe stomach pain, especially after starting Ibutrixen Fast (uncommon: may affect up to 1 in 100 people); black stools, diarrhea containing blood, or vomiting blood (uncommon: may affect up to 1 in 100 people); skin rash, severe peeling or blistering of the skin, lesions of the mucous membranes (very rare: may affect up to 1 in 10,000 people) or any signs of hypersensitivity (uncommon: may affect up to 1 in 100 people); fever, sore throat and mouth, flu-like symptoms, feeling tired, nosebleeds and skin bleeding. These may be caused by a decrease in the number of white blood cells in your body (agranulocytosis) (very rare: may affect up to 1 in 10,000 people). - severe or persistent headache (very rare: may affect up to 1 in 10,000 people); blisters on the hands and feet (Stevens-Johnson syndrome) (very rare: may affect up to 1 in 10,000 people); A serious skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, fever, swollen lymph nodes and an increase in eosinophils (a type of white blood cell) (not known: frequency cannot be estimated from the available data); A red, scaly, widespread rash with bumps under the skin and blisters mainly located in skin folds, on the trunk and upper limbs, accompanied by fever at the beginning of treatment (acute generalised exanthematous pustulosis). If these symptoms occur, stop taking Ibutrixen Fast and seek medical help immediately; Red, non-raised, target-like or circular spots on the trunk, often with central blisters, peeling skin, and ulcers in 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); a widespread rash with high temperature and enlarged lymph nodes (DRESS); a 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). Other side effects that may occur: Common: may affect up to 1 in 10 people: gastrointestinal complaints such as heartburn, abdominal pain and nausea, diarrhoea, vomiting, flatulence (wind) and constipation; minor gastrointestinal bleeding, which in exceptional cases may lead to anaemia. Uncommon: may affect up to 1 in 100 people: gastrointestinal ulceration, potentially with bleeding and perforation, ulcerative stomatitis, worsening of existing bowel disease (colitis or Crohns disease), gastritis; hypersensitivity reactions with skin rash and itching, as well as asthma attacks (possibly with a drop in blood pressure); central nervous system disorders such as headache, dizziness, insomnia, agitation, irritability and fatigue; visual disturbances. Rare: may affect up to 1 in 1,000 people: tinnitus, hearing loss; Pain on the side and/or in the upper abdomen, blood in the urine and fever may be symptoms of kidney damage (papillary necrosis); Increased uric acid levels in the blood, increased urea levels in the blood. Very rare: may affect up to 1 in 10,000 people: If symptoms of an infection occur or worsen while taking Ibutrixen Fast, consult a doctor immediately. Anti-infective and/or antibiotic therapy should be investigated. Symptoms of aseptic meningitis with stiff neck, headache, nausea, vomiting, fever, or impaired consciousness have been observed after ibuprofen administration. Patients with autoimmune disorders (systemic lupus erythematosus (SLE), mixed connective tissue disease) seem to be predisposed; problems with blood cell production (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis); first symptoms include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, nosebleeds, and skin bleeding. In such cases, treatment should be stopped immediately and a doctor should be consulted. Do not self-medicate with painkillers or fever-reducing medications (antipyretics); severe general allergic reactions (hypersensitivity reactions) – symptoms may include: swelling of the face, tongue, and throat, shortness of breath, rapid heartbeat, drop in blood pressure, or life-threatening shock. If any of these symptoms occur, which can happen even on the first use, immediate medical attention is necessary; psychotic reactions, depression – palpitations, heart failure, myocardial infarction, edema, hypertension, and heart failure have been reported in connection with treatment with high doses of NSAIDs; hypertension, vasculitis; asthma, shortness of breath, bronchospasm – esophagitis, pancreatitis, formation of diaphragm-like strictures of the small intestine. If relatively severe epigastric pain, vomiting blood, or black stools occur, treatment should be discontinued and a doctor consulted; Liver damage (first signs may be skin discoloration), especially with long-term therapy, liver failure, acute hepatitis, impaired liver function; passing less urine than usual and swelling (especially in patients with high blood pressure or reduced kidney function); swelling (edema) and cloudy urine (nephrotic syndrome); inflammatory kidney disease (interstitial nephritis), which may lead to acute kidney failure. If you experience any of the above-mentioned symptoms or feel generally unwell, stop taking Ibutrixen Fast and contact your doctor immediately, as these may be the first signs of kidney damage or kidney failure; severe forms of skin reactions, including rash with redness and blisters, Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyells syndrome), hair loss (alopecia). Frequency not known (frequency cannot be estimated from the available data): The skin becomes sensitive to light. Warnings and precautions Caution should be exercised in patients with or who have had: connective tissue diseases, intestinal diseases (e.g. Crohns disease, ulcerative colitis), high blood pressure, impaired renal/liver function, surgical procedures, bronchial asthma, chickenpox. You should take into account other medications you are taking, such as corticosteroids. Store at room temperature. Keep out of the reach and sight of children. Use of other medications Please tell your doctor or pharmacist about all the medicines you are taking, have recently taken or might take, including medicines obtained without a prescription. Ibutrixen Fast may interact with: anticoagulants; blood pressure lowering drugs; other NSAIDs; digoxin; diuretics; lithium, methotrexate; corticosteroids; antidiabetic drugs derived from sulfonylureas; quinolone antibiotics. Pregnancy and breastfeeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. The use of this drug in the third trimester of pregnancy is contraindicated. Ibuprofen passes into breast milk. Use of the drug in children and adolescents The medicine is not intended for persons under 12 years of age.