Nimill

Each tablet contains: Nimesulide 100 mg.

Second line treatment of acute pain and primary dysmenorrhoea.

Orally administration.
Adult: 100 mg twice daily.
NIMILL should be used at the lowest effective dose for shortest possible time.

In case of overdosage, symptomatic treatment should be adopted (gastric lavage and activated charcoal administration).

Established individual hypersensitivity to nimesulide, to acetylsalicylic acid or to other non-steroidal anti-inflammatory drugs, gastrointestinal hemorrhage in progress or active gastro-duodenal ulcer, asthma, severe renal impairment, moderate of severe hepatic impairment. Nimesulide must not be administered to patients with a history of presence of hepatic disease. NIMILL should not be given to patients who have demonstrated allergic-type reaction to sulfonamides.
The third trimester of pregnancy, because of risks of premature closure of the ductus arteriosus, and prolonged parturition.
Contraindicated in children under 12 years of age.
NIMILL is also contraindicated in patients with severe heart failure and for the treatment of peri-operative pain in the setting of coronary artery bypass graft surgery.
History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy; active, or history of recurrent peptic ulcer/haemorrhage.

In rare cases, Nimesulide has been associated with serious liver injury.
Elderly Patients: Particular care should be taken when administering the drug to elderly patients.

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.

Pregnant Women: NIMILL are contraindicated for use during the third trimester of pregnancy because of risks of premature closure of the ductus arteriosus and the potential to prolong parturition. Caution is recommended in prescribing NIMILL during the first and second trimesters of pregnancy, particularly from the middle to end of the second trimester of pregnancy (onset at approximately 20 weeks) due to possible fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment or failure.
NIMILL should not be used during the first two trimesters of pregnancy unless the expected benefits to the mother outweigh the risks to the fetus.
Published studies and postmarketing reports describe maternal Non-Steroidal Anti-Inflammatory Drug (NSAID) use at approximately 20 weeks gestation or later in pregnancy associated with fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment or failure. NSAIDS were shown to cause significant reduction in fetal urine production prior to reduction of amniotic fluid volume. There have also been a limited number of case reports of maternal NSAID use and neonatal renal dysfunction and renal impairment without oligohydramnios, some of which were irreversible, even after treatment discontinuation.
These adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after NSAID initiation.
Complications of prolonged oligohydramnios may for example, include limb contractures and delayed lung maturation. In some postmarketing cases of impaired neonatal renal function, invasive procedures such as exchange transfusion or dialysis were required.
If after careful consideration of the benefit-risk, NSAID treatment is considered necessary to be administered anywhere from the middle (onset at approximately 20 weeks) to the end of the second trimester of pregnancy, the use should be limited to the lowest effective dose and shortest duration possible. It is also recommended that ultrasound monitoring of amniotic fluid be considered if NIMILL treatment extends beyond 48 hours and that NSAIDS treatment be discontinued if oligohydramnios occurs, followed by appropriate medical follow up.
Use during lactation: It is not known whether nimesulide is excreted with the milk, thus the administration during lactation is not advised.

Occasionally, the onset of side effects affecting the gastroenteric system has been observed i.e. pyrosis, nausea and gastralgia, usually mild and transitory. Allergic reactions are relatively frequent usually erythematous or urticarioid skin rashes. CNS symptoms are reported, such as headache, dizziness, and drowsiness.
Other rarely observed side effects are oliguria, with or without water retention and localized or diffused oedema, melena (probably correlated with possible gastro-intestinal ulcers and haemorrhages), petacchiae and purpura especially in the lower limbs, associated with thrombocytopenia. Even if no case has been reported for nimesulide, it should be remembered that as in the case of other non-steroidal anti-inflammatory drugs, the product can trigger severe hypersensitivity reactions, e.g., Steven-Johnson syndrome. Lyell syndrome, anaphylactic reactions and possibly risk of stomatitis.

Caution should be taken in administering NIMILL to patients treated with anticoagulants or platelet aggregation inhibitors.

Store below 30°C.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

M01AX17 - nimesulide ; Belongs to the class of other non-steroidal antiinflammatory and antirheumatic products.

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