Nimill Special Precautions

Caution should be taken in administering NIMILL to patients with a history of hemorrhages, with upper gastro-intestinal tract diseases and in subjects treated with anticoagulants or platelet aggregation inhibitors. Since the drug is mainly excreted by the renal route, it is necessary to reduce the posology in patients affected by renal failure, according to the glomerular filtration rate. The product should not be administered to patients with severe renal failure.
The drug can cause water retention. Therefore particular a caution should be adopted when treating hypertensive patients, together with those affected by a reduced heart function. Patients who require particular alertness should exercise caution if drowsiness or dizziness is observed during the therapy. Since cases of ocular alterations with other non-steroidal anti-inflammatory drugs have been reported, in case of vision disorders the treatment should be interrupted and an ophthalmological exam should be performed.
Caution: This product should only be used for pain-killing and not for fever lowering. The maximum duration of a treatment course with the product is 15 days. There is risk of liver toxicity in patients taking this product. It should not be used at the same time with other medicines that can also cause liver damage or in patients whose liver is already damaged.
The product is used as a second line treatment in pain killing and inflammation, after failed treatment with at least one non-steroidal anti-inflammatory drug.
The maximum single dose should not be more than 100 mg.
In order to reduce undesirable effect, the minimum effective dose and the shortest duration of treatment should be used after taking consideration of the clinical condition of the patient.
Cardiovascular Risk: NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
Gastrointestinal Risk: NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.
Renal Effects: Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of a NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.
Advanced Renal Disease: No information is available from controlled clinical studies regarding the use of NIMILL in patients with advanced renal disease. Therefore, treatment with NIMILL is not recommended in these patients with advanced renal disease. If therapy must be initiated, close monitoring of the patients renal function is advisable.
Use in Pregnancy & Lactation: See USE IN PREGNANCY & LACTATION section for further information.