Ibufen 600

/ Dexcel

Undesirable effects may be minimized by using the lowest effective dose for the shortest possible duration to control symptoms.
Rheumatic disorders: The ibuprofen dose depends on age and/or body weight. The recommended daily dose for adults is 1,200 mg in divided doses. In severe or acute conditions, it can be advantageous to increase the dosage to 1600 mg daily; in divided doses. The maximum single dose for adults should not exceed 800 mg ibuprofen.
Special populations:
Elderly patients: No special dose adjustment is necessary. Due to the possible adverse event profile, elderly patients should be carefully monitored.
Impaired kidney function: In patients with mild to moderate renal function impairments, no dose reduction is necessary.
Impaired liver function: In patients with mild to moderate hepatic function impairments, no dose reduction is necessary.
Children and adolescents: The recommended daily dose for children and adolescents is up to 30mg/kg in divided doses, and up to 10mg/kg in a single dose. Children and adolescents below 12 years of age must not take this drug mg, as the active ingredient content is too high. For this age group, there are other ibuprofen preparations with lower concentrations of the active ingredient.
Method of administration and duration of treatment: The drug should be swallowed whole (not chewed) with adequate intake of liquid and not on an empty stomach. Patients with a sensitive stomach should take the drug  with food. The duration of treatment is determined by the attending physician. In rheumatic disorders, the use of Ibuprofen mg may be necessary over a longer period of time.               

For the relief of mild to moderate pain such as headache, toothache, primary dysmenorrhea, backache, muscular pain. Anti-inflammatory and analgesic in arthritis and osteo arthritis.

Hypersensitivity to the active ingredient or to any of the excipients. Known hypersensitivity reactions (e.g. bronchospasm, asthma, rhinitis or urticaria) after taking aspirin (acetylsalicylic acid) or other nonsteroidal anti-inflammatory drugs (NSAIDs) in the past. Unexplained blood disorders. Active or history of recurrent peptic ulcer or haemorrhage (at least 2 distinct episodes of confirmed ulceration or bleeding). History of gastrointestinal bleeding or perforation related to previous NSAID therapy. Cerebrovascular or other active bleeding. Severe liver or kidney impairment. Severe congestive heart failure (NYHA class IV). Last trimester of pregnancy.

Gastrointestinal safety: Concomitant administration of Ibuprofen with NSAIDs, including cyclo-oxygenase-2 specific inhibitors, should be avoided. Undesirable effects may be minimized by using the lowest effective dose for the shortest possible duration to control symptoms.
Children and adolescents: For use in children and adolescents, see Posology.
Elderly patients: With NSAID therapy, the elderly are at increased risk of adverse reactions, especially gastrointestinal bleeding and perforation, which may be fatal.
Gastrointestinal bleeding, ulceration and perforation: Gastrointestinal bleeding, ulceration or perforation, also with fatal outcome, have been reported with all NSAIDs. They have occurred at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal effects. The risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation, and in the elderly. These patients should commence treatment on the lowest dose available. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant low dose aspirin, or other drugs likely to increase gastrointestinal risk. Patients with a history of gastrointestinal toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment. Caution should be advised in patients receiving concomitant medications which could increase the risk of ulcers or haemorrhage, such as oral corticosteroids, anticoagulants such as warfarin; selective serotonin re-uptake inhibitors or anti-platelet agents such as aspirin. When gastrointestinal bleeding or ulceration occurs in patients receiving Ibuprofen, the treatment should be withdrawn. NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn’s disease) as these conditions may be exacerbated.
Cardiovascular and cerebrovascular effects: Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate decompensated heart failure as fluid retention and oedema have been reported in association with NSAID therapy. Clinical trials suggest that use of ibuprofen, particularly at high doses (2,400 mg daily) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low doses of ibuprofen (e.g. ≤ 1,200 mg daily) are associated with an increased risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with ibuprofen after careful consideration, and high doses (2,400 mg daily) should be avoided. Similar considerations should be made before initiating longer-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), especially if high doses of ibuprofen (2,400 mg daily) are required.
Dermatological effects: Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis (Lyell’s syndrome), have been reported very rarely in association with the use of NSAIDs. Patients appear to be at highest risk of these reactions early in the course of therapy, with the onset of the reaction occurring within the first month of treatment in the majority of cases. This drug should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. There have been exceptional cases of severe skin infections and soft tissue complications during varicella infection. NSAID contribution to an exacerbation of these infections could not be ruled out. It is thus advisable to avoid Ibuprofen therapy during varicella infection.
Also note: This  must only be used after careful weighing of the benefit-risk-ratio: With congenital impaired porphyrin metabolism (e.g. acute intermittent porphyria). With systemic lupus erythematosus (SLE) and mixed connective tissue disease.
An especially careful medical supervision is necessary: With a history of gastrointestinal disorders or with chronic inflammatory intestinal disorders (ulcerative colitis, Crohn’s disease). With hypertension or congestive heart failure. With impaired renal function. With impaired hepatic function. Directly after major surgical procedures. With patients suffering from hay fever, nasal polyps or chronic obstructive respiratory diseases, as they are at increased risk of allergic reactions. These may be asthma attacks (so-called analgesic-induced asthma), Quincke’s oedema or urticaria. With patients with allergic reactions to other substances, as they are also at higher risk of hypersensitivity reactions when using  Ibuprofen. Severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been reported very rarely. Ibuprofen.must be discontinued at the first appearance of hypersensitivity reactions after ingestion/administration. Adequate therapeutic measures have to be taken by professionals. Ibuprofen, the active ingredient of Ibuprofen, may temporarily inhibit platelet function (platelet aggregation). Patients with coagulation disorders should therefore be monitored closely. In long-term use of Ibuprofen, liver function, kidney function and blood count should be checked regularly. During prolonged use of painkillers, headaches may occur, which must not be treated by increasing the medicine dose. In general, habitual intake of painkillers, especially a combination of several analgesic active ingredients, may permanently harm the kidneys with the risk of renal failure (analgesic nephropathy). Concomitant use of NSAIDs and alcohol may worsen undesirable effects related to the active ingredient, especially those affecting the gastrointestinal tract or the central nervous system (CNS). Regarding female fertility, see section Fertility, pregnancy and Lactation.
See prescribing information for full details. 

The assessment of undesirable effects is based on the following frequencies: Very common: ≥ 1/10, Common: ≥ 1/100 – < 1/10, Uncommon: ≥ 1/1,000 – < 1/100, Rare: ≥ 1/10,000 – < 1/1,000, Very rare: < 1/10,000.
Not known: frequency cannot be estimated from the available data.
The following undesirable effects depend mainly on the dose and may vary individually; this has to be taken into account.
The most commonly observed undesirable effects are gastrointestinal in nature. Peptic ulcers, perforation or haemorrhage, sometimes fatal, particularly in the elderly, may occur. Nausea, vomiting, diarrhoea, flatulence, constipation, digestive problems, abdominal pain, melena, hematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn’s disease have been reported following administration. Less frequently, gastritis has been observed. Especially the risk of gastrointestinal bleeding depends on the dose and the duration of treatment.
Oedema, hypertension and congestive heart failure have been reported in connection with NSAID therapy.
Clinical trials suggest that use of ibuprofen, particularly at high doses (2,400 mg daily) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke).
Cardiac disorders: Very rare: palpitations, oedema, cardiac insufficiency, cardiac infarction.
Blood and lymphatic system disorders: Very rare: abnormal blood formation (anaemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). Early signs may be: fever, sore throat, superficial lesions in the mouth, flue-like symptoms, strong exhaustion, nosebleed and ecchymosis. In long-term therapy, the blood count should be checked regularly.
Nervous system disorders: Common: disturbances of the central nervous system such as headache, dizziness, insomnia, excitation, irritability or fatigue.
Eye disorders: Uncommon: visual impairment.
Disorders of the ear and the labyrinth: Very rare: tinnitus.
Gastrointestinal disorders: Very common: gastrointestinal complaints like heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhoea, constipation and low gastrointestinal blood losses, which may cause anaemia in exceptional cases. Common: gastrointestinal ulcers, possibly with bleeding and perforation, ulcerative stomatitis, exacerbation of colitis and Crohn’s disease. Uncommon: gastritis. Very rare: esophagitis, pancreatitis.
The patient must be instructed to stop taking the medication and to immediately consult a doctor if strong pain in the upper abdomen occurs or in case of melena or hematemesis. Very rare: formation of intestinal, diaphragm-like strictures.
Renal and urinary disorders: Uncommon: formation of oedema, especially in patients with arterial hypertension or renal insufficiency, nephrotic syndrome; interstitial nephritis, which can accompany an acute renal failure. Very rare: renal tissue lesions (papillary necrosis) and elevated uric acid concentration in the blood. Renal function should be checked regularly.
Skin and subcutaneous tissue disorders: Very rare: bullous skin reactions like Stevens–Johnson syndrome and toxic epidermal necrolysis (Lyell’s syndrome), alopecia. There have been exceptional cases of severe skin infections and soft tissue complications during varicella infection.
Infections and parasitic diseases: Very rare: there is a correlation of systemic treatment with NSAIDs and exacerbation of infection-related inflammations (e.g. development of necrotizing fasciitis). This may be connected to the effect mechanism of NSAIDs. If during the treatment with Ibufen 600 new infection signs occur or worsen, it is recommended that the patient consult a doctor immediately. It has to be verified whether a therapy with anti-infectives/antibiotics is indicated. Very rare: symptoms of aseptic meningitis with stiff neck, headache, nausea, vomiting, fever or disorientation. Patients with autoimmune disorders (SLE, mixed connective tissue disease) seem to be at increased risk.
Vascular disorders: Very rare: arterial hypertension.
Immune system disorders: Uncommon: hypersensitivity reactions with skin rash and itching skin as well as asthma attacks (possibly with drop in blood pressure). The patient must be instructed to immediately consult a doctor and to stop taking Ibufen 600 in this case. Very rare: severe general hypersensitivity reactions. They may be expressed as: facial oedema, tongue swelling, internal swelling of the larynx with restriction of the airways, difficulty in breathing, tachycardia, drop in blood pressure and even life-threatening shock. With any of these signs, which can already appear at first intake of the medication, immediate medical attention is required.
Hepato-biliary disorders: Very rare: liver dysfunction, liver damage, especially in long-term therapy, liver failure, acute hepatitis. In long-term treatment, hepatic parameters should be checked regularly.
Psychiatric disorders: Very rare: psychotic reactions, depression.

Ibuprofen (like other NSAIDs) should be used with caution in combination with:
Other NSAIDs including salicylates: Concomitant administration of several NSAIDs may increase the risk of gastrointestinal ulceration and haemorrhage due to synergistic effects. Therefore, concomitant use of ibuprofen with other NSAIDs should be avoided.
Digoxin, phenytoin, lithium: Concomitant use of this drug with digoxin, phenytoin or lithium preparations may increase the serum level of these medicines. Surveillance of the serum lithium level is necessary, surveillance of the serum digoxin level and the serum phenytoin level is recommended.
Diuretics, ACE inhibitors, beta-adrenergic antagonists and angiotensin II receptor antagonists: NSAIDs may diminish the effect of diuretics and antihypertensive drugs. In patients with impaired renal function (e.g. patients suffering from dehydration or elderly patients with impaired renal function), concomitant use of an ACE inhibitor, a beta-blocker or an angiotensin II receptor antagonist with a cyclooxygenase inhibitor may lead to further deterioration of the renal function, including a possibly acute renal failure, which is usually reversible. This combination should thus be chosen only with great caution, especially in elderly patients. Patients must be encouraged to an adequate intake of fluid and regular surveillance of renal parameters should be considered after initiation of a combination therapy. Concomitant administration of Ibuprofen potassium-sparing diuretics may cause hyperkalaemia.
Glucocorticoids: Increased risk of gastrointestinal ulceration or bleeding.
Anti-platelet agents and selective serotonin re-uptake inhibitors (SSRIs): Increased risk of gastrointestinal bleeding.
Aspirin (acetylsalicylic acid): Due to the potential for increased undesirable effects, concomitant use of ibuprofen with aspirin is generally not recommended. Experimental data suggest that ibuprofen may competitively inhibit the effect of low dose aspirin on platelet aggregation when they are administered concomitantly. Although there are uncertainties regarding extrapolation of these data to the clinical situation, it cannot be ruled out that regular long-term ibuprofen use can diminish the cardioprotective effect of low doses of aspirin. No clinically relevant effect is considered to be likely for occasional ibuprofen use.
Methotrexate: Administration of Ibuprofen within 24 hours before or after administration of methotrexate may lead to an increased methotrexate concentration and to an increase of its toxic effect.
Ciclosporin: Increased risk of nephrotoxicity of ciclosporin in concomitant use with certain NSAIDs. This effect cannot be ruled out either for a combination of ciclosporin with ibuprofen.
Anticoagulants: NSAIDs may enhance the effects of anticoagulants such as warfarin.
Sulfonylurea: Clinical trials have shown interaction between NSAIDs and oral anti-diabetic medication (sulfonylurea). Although interaction between ibuprofen and sulfonylurea has not been reported yet, surveillance of blood glucose levels is recommended as a precaution in concomitant therapy.
Tacrolimus: Increased risk of nephrotoxicity when ibuprofen is administered with tacrolimus.
Zidovudine: There is evidence of an increased risk of haemarthroses and haematoma in HIV positive haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.
Probenecid and sulfinpyrazone: Medicinal products containing probenecid or sulfinpyrazone may retard ibuprofen excretion.
Quinolone antibiotics: Animal data indicate that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions.
Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effect of mifepristone.
Children and adolescents: Research on interaction with other medication was conducted with adults only.

Pregnancy: Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor in early pregnancy. It is assumed that the risk increases with increased dose and duration of therapy. In animals, the administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation losses and embryo/foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period. During the first and second trimester of pregnancy, ibuprofen should not be given unless absolutely necessary. If ibuprofen is taken by a woman attempting to conceive, or during the first or second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors:
Can expose the foetus to the following risks:
– cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension)
– renal dysfunction, which may progress to renal failure with oligohydramnios
Can expose the mother and the neonate at the end of pregnancy to the following risks:
– possible prolongation of bleeding time, an anti-platelet aggregation effect, which can occur even with very low doses
– inhibition of uterine contractions, which may result in delayed or prolonged labour.
Consequently, ibuprofen is contraindicated during the third trimester of pregnancy.
Lactation: The active ingredient ibuprofen and its metabolites pass into breast milk in low concentrations only. As adverse effects for the infant are not known, an interruption in lactation is usually not indicated during short-time use of ibuprofen. However, if a longer duration of treatment or higher doses are prescribed, early ablactation should be considered.
Fertility: The use of this drug  may impair female fertility, like other medicines, known to inhibit cyclooxygenase/prostaglandin synthesis, and is thus not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of this drug should be considered.     

Symptoms of intoxication: Possible symptoms are disturbances of the central nervous system such as headaches, dizziness, drowsiness and unconsciousness (in children also myoclonic seizures) as well as abdominal pain, nausea and vomiting. Furthermore, gastrointestinal bleeding and liver or kidneys impairment are possible. Hypotension, respiratory depression and cyanosis have also been reported.
Treatment of intoxication: There is no specific antidote.

Take with food.