Gastrointestinal bleeding, ulcer and perforation
Brufen CP should be used with caution in patients with a pentinal ulcer and other gastrointestinal diseases in the history, as possible exacerbation of these conditions.
With the use of all NSAIDs, any cases of gastrointestinal bleeding, ulcers, or perforations have been reported at any time. These adverse events can be life-threatening and can occur if there are / or no warning signs or serious gastrointestinal illnesses in the anamnesis. The risk of gastrointestinal bleeding, ulceration, or perforation increases with an increase in the dose of the drug Brufen CP in patients with peptic ulcer disease, especially complicated by bleeding or perforation in the history, and in elderly patients. In these patients, treatment should be started with the lowest dose. In this group of patients, as well as in patients requiring concomitant low-dose acetylsalicylic acid therapy or other drugs that may increase the risk of gastrointestinal disease, combination therapy with gastroprotectors (eg misoprostol or proton pump inhibitors) should be considered.
Avoid simultaneous use of Brufen CP and other NSAIDs, including selective cyclooxygenase-2 (COX-2) inhibitors, due to an increased risk of ulceration or bleeding (see "Interactions with Other Drugs").
In the initial phase of treatment, patients with gastro-intestinal diseases in history, especially elderly patients, should report the occurrence of any unusual symptoms in the abdomen (especially gastrointestinal bleeding).
Should be used with caution Brufen CP patients concomitantly receiving drugs that may increase the risk of ulceration or bleeding, such as steroids for oral anticoagulants (including
warfarin), Selective serotonin reuptake inhibitors or antiplatelet drugs, including
acetylsalicylic acid (see section "Interaction with other drugs").
In the event of gastrointestinal bleeding or ulceration therapy with CP Brufen it should be discontinued.
Respiratory disorders
Caution must be exercised when using the drug Brufen CP patients with bronchial asthma, chronic rhinitis or allergic diseases, including history, as reported instances of bronchospasm, urticaria or angioedema when applying Brufen CP in this group of patients.
Heart failure, renal and hepatic impairment
Care should be taken when using the drug Brufen CP in patients with renal, hepatic or heart failure, since the use of NSAIDs may lead to impaired renal function. Simultaneous therapy with several analgesics further increases this risk. In patients with renal, hepatic or heart failure, the minimum effective dose should be administered within the shortest period of time and monitor renal function, especially with prolonged treatment.
Cardiovascular and cerebrovascular disorders
Care should be taken to use the drug Brufen CP in patients with heart failure or hypertension in the anamnesis, since ibuprofen has been reported on cases of edema.
Data from epidemiological studies indicate that the use of ibuprofen at a high dose (2,400 mg per day) and with long-term treatment may be associated with a slight increase in the risk of developing arterial thrombotic complications, including myocardial infarction or stroke.In the course of epidemiological studies, it has not been proven that the use of ibuprofen in a low dose (<1200 mg / day) is associated with an increased risk of developing arterial thrombotic complications, in particular myocardial infarction.
Therapy with Brufen CP in patients with uncontrolled hypertension, heart failure, ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease should be performed only after a thorough assessment of the benefit / risk. Such an assessment should also be made before the appointment of long-term treatment to patients with risk factors for developing cardiovascular diseases (such as hypertension, hyperlipidemia, diabetes, smoking).
Dermatological disorders
When using NSAIDs, very rare cases of serious skin reactions, including life-threatening ones, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported. At the initial stage of therapy, patients are most at risk of developing these reactions. In most cases, the reaction develops during the first month of treatment.At the first appearance of skin rash, lesions of the mucosa or any other signs of hypersensitivity, the use of the drug Brufen CP should be discontinued.
Renal impairment
Care should be taken to begin therapy with Brufen CP in patients with significant dehydration. There is a risk of developing kidney failure, especially in children and adolescents with dehydration.
Prolonged use of ibuprofen, like other NSAIDs, led to the development of medullary necrosis of the kidney and other pathological changes in the kidneys. Renal toxicity was also observed in patients with renal prostaglandins playing a compensatory role in maintaining renal perfusion. The use of NSAIDs in this group of patients can lead to a dose-related decrease in prostaglandin production and, in a secondary way, renal blood flow, which can cause renal failure. Patients with impaired renal function, heart failure, impaired liver function, taking diuretics, ACE inhibitors, and elderly patients are at increased risk of this reaction.After the abolition of NSAIDs, as a rule, the condition is restored before the start of treatment.
Hematologic disorders
Brufen CP, like other NSAIDs, can inhibit platelet aggregation and increase bleeding time in healthy patients.
Aseptic meningitis
In rare cases, the development of aseptic meningitis has been observed in patients receiving ibuprofen therapy. Although the emergence of aseptic meningitis is most likely in patients with systemic lupus erythematosus and associated connective tissue diseases, there have been reports of aseptic meningitis in patients who do not have this chronic disease.
Elderly patients
In elderly patients, the use of NSAIDs may be accompanied by an increased incidence of adverse reactions, especially perforation and gastrointestinal bleeding, which can be life threatening.