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Special warnings when using the drug: Concomitant use of ibuprofen with other NSAIDs, including selective cyclooxygenase 2 (COX-2) inhibitors, should be avoided because the risk of adverse effects may be increased.
Undesirable effects may be limited by using the lowest effective dose for the shortest duration necessary to ensure symptom control.
Patients with asthma and chronic rhinitis, chronic sinusitis and/or nasal polyps are at increased risk of allergic reactions when taking NSAIDs and/or aspirin.
The drug may cause asthma attacks, especially in some subjects allergic to NSAIDs or aspirin.
Gastrointestinal effects: Gastrointestinal bleeding, ulceration or perforation may occur at any time during NSAID treatment. These adverse events can be fatal and may occur with or without warning symptoms or a history of serious gastrointestinal events.
The risk of gastrointestinal bleeding, ulceration or perforation is higher in elderly patients or with increasing doses or in patients with complications of bleeding or perforation. Initiation of treatment with the lowest possible dose, combined with gastrointestinal protective agents (e.g. misoprostol or proton pump inhibitors) should be considered in these patients and in patients requiring concomitant low-dose aspirin or other drugs likely to increase the risk of gastrointestinal adverse events.
Patients with a history of gastrointestinal disease, especially the elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) early in treatment.
Caution should be exercised when ibuprofen is used concomitantly with drugs that may increase the risk of ulceration or bleeding, such as oral corticosteroids, oral anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as aspirin.
If symptoms of gastrointestinal bleeding or ulceration occur in a patient taking ibuprofen, treatment should be discontinued immediately.
NSAIDs should be used with caution and with close monitoring in patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease), due to the risk of aggravation of symptoms.
Cardiovascular and cerebrovascular effects: Risk of cardiovascular thrombosis: Systemic non-aspirin non-steroidal anti-inflammatory drugs (NSAIDs) may increase the risk of cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur as early as the first few weeks of treatment and may increase with duration of treatment. The risk of cardiovascular thrombosis has been observed mainly at high doses.
Physicians should periodically assess the occurrence of cardiovascular events, even in the absence of previous cardiovascular symptoms. Patients should be warned about the symptoms of serious cardiovascular events and should seek medical attention immediately if these symptoms occur.
To minimize the risk of adverse events, Momentact Analgesico should be used at the lowest effective daily dose for the shortest possible duration.
Patients with a history of hypertension and/or mild to moderate heart failure should be closely monitored, as fluid retention and edema have been reported in association with NSAID therapy.
Clinical studies have shown that the use of ibuprofen, especially at high doses (2400 mg daily), may increase the risk of arterial thrombotic events (e.g. myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low doses of ibuprofen (≤ 1200 mg daily) are associated with an increased risk of arterial thrombotic events.
Patients with uncontrolled hypertension, congestive heart failure (grade II, III), myocardial ischemia, peripheral arterial disease and/or stroke should only be treated with ibuprofen after careful consideration and high doses (2400 mg daily) should be avoided.
Careful consideration should be given before initiating long-term treatment in patients with risk factors for cardiovascular disease (e.g. hypertension, hyperlipidemia, diabetes mellitus, smoking), especially at high doses of 2400 mg daily.
Conceals the symptoms of the underlying infection: The drug may mask symptoms of infection, delaying adequate treatment and thus worsening the progression of the disease. This has been observed in cases of community-acquired pneumonia and complications of bacterial varicella.
When ibuprofen is used to reduce fever or relieve pain due to infection, the infection should be carefully monitored. If symptoms persist or worsen, a doctor should be consulted.
Skin effects: Serious, potentially fatal skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome and Lyell syndrome, have been reported very rarely with NSAID therapy.
The risk of skin reactions is usually early, and may appear early in the course of ibuprofen use, in most cases within the first month of treatment. Cases of acute generalized exanthematous pustulosis (AGEP) have been reported with ibuprofen. Discontinue ibuprofen at the first sign of rash, mucosal lesions or any other sign of skin reactions.
Varicella can be a cause of serious infectious complications of the skin and soft tissues. The effect of NSAIDs in exacerbating these infections cannot be excluded at this time. Therefore, ibuprofen should be avoided in chickenpox.
Functional renal failure: NSAIDs, by inhibiting the vasodilating action of renal prostaglandins, are likely to cause functional renal failure by reducing glomerular filtration. This side effect is dose dependent.
At the start of treatment or after increasing the dose, monitoring of diuresis and renal function is recommended in patients with the following risk factors: elderly subjects; associated medications such as: ACE inhibitors, sartans, diuretics (see Interactions); hypovolaemia whatever the cause; heart failure, chronic renal failure; nephrotic syndrome; lupus nephropathy; decompensated hepatic cirrhosis.
Tubular acidosis and hypokalemia may occur after acute overdose and in patients who take ibuprofen for a long time at high doses (usually more than 4 weeks), including doses in excess of the recommended daily dose.
Water and sodium retention: Water and sodium retention with possibility of edema, hypertension or increase in hypertension, worsening of heart failure. Clinical monitoring is necessary from the start of treatment in the event of hypertension or heart failure. A decrease in the effect of antihypertensives is possible.
Hyperkalaemia: Hyperkalaemia favored by diabetes or concomitant treatment with hyperkalaemic medicinal products.
Regular monitoring of serum potassium should be performed in these circumstances.
Taking this medicine should be avoided in case of treatment with another nonsteroidal anti-inflammatory drug, with an oral anticoagulant, with lithium, with acetylsalicylic acid at analgesic, antipyretic or anti-inflammatory doses, with methotrexate at doses greater than 20 mg per week, with low molecular weight and related heparins and unfractionated heparins (at curative doses and/or in the elderly), with pemetrexed, in patients with weak to moderate renal function.
Precautions for use: Ibuprofen, like any drug that inhibits the synthesis of cyclooxygenases and prostaglandins, can impair fertility via an effect on ovulation. This effect is reversible upon discontinuation of treatment. The use of ibuprofen is not recommended in women who wish to conceive a child.
Caution is advised in patients with coagulation disorders.
Particular care should be taken when initiating treatment with ibuprofen in severely dehydrated patients.
Regular and prolonged use of analgesics carries a risk of headache and analgesic nephropathy.
Bronchospasm can be triggered in patients suffering from or having a history of bronchial asthma or allergic pathology.
Ibuprofen can mask objective and subjective signs of infection. In isolated cases, worsening of infectious inflammation (eg. development of necrotizing fasciitis) has been described temporally related to the use of NSAIDs. Ibuprofen should therefore be used with caution in patients with an infection.
Caution should be exercised in patients with collagen diseases other than systemic lupus erythematosus.
In the event of visual disturbances appearing during treatment, a complete ophthalmological examination should be carried out.
During prolonged treatments, it is recommended to check the blood count, hepatic and renal functions.
Warnings regarding excipients: This medicinal product contains 44.56 mg sodium per sachet, equivalent to 2.23% of the maximum recommended daily intake of sodium for adults of 2 g.
This medicinal product contains 81.9 mg potassium per sachet. This should be taken into account in patients with impaired renal function or in patients on a controlled potassium supplement.
This medicinal product contains 2.148 g sucrose per sachet. If the patient have been diagnosed with intolerance to certain sugars, consult the doctor before taking this medicinal product. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency should not take this medicinal product.
This medicinal product contains 20 mg aspartame per sachet. Aspartame is hydrolysed in the gastrointestinal tract when taken orally. One of the main hydrolysis products is phenylalanine. Therefore, it may be dangerous for people with phenylketonuria (PKU).
There is no nonclinical or clinical evidence to evaluate the use of aspartame in children under 12 weeks of age.
Effects on the Ability to Drive and Use Machines: Patients should be warned that adverse effects such as dizziness and visual disturbances may occur after taking NSAIDs. Single or short-term use is unlikely to affect the ability to drive or use machines.
Use in Children: Children (age ≥12 years and <18 years): There is a risk of kidney damage in dehydrated children/adolescents.
Use in the Elderly: Older adults are at increased risk of adverse effects from NSAIDs, especially gastrointestinal bleeding and gastric perforation, which can be fatal.
