As with other NSAIDs, caution should be exercised when treating patients with a history of upper gastrointestinal disease and in patients receiving treatment with anticoagulants. MOVIX^® should be withdrawn if peptic ulceration or gastrointestinal bleeding occurs.

Special attention should be paid in patients reporting mucocutaneous adverse events and consideration given to discontinuing MOVIX^®.

NSAIDs inhibit the synthesis of renal prostaglandins which play a supportive role in the maintenance of renal perfusion. In patients whose renal blood flow and blood volume are decreased, administration of an NSAID may precipitate overt renal decompensation which is typically followed by recovery to pre-treatment state upon discontinuation of nonsteroidal anti-inflammatory therapy. Patients at greatest risk of such a reaction are dehydrated patients, those with congestive heart failure, liver cirrhosis, nephrotic syndrome and overt renal disease, those receiving a diuretic or those having undergone major surgical procedures which led to hypovolaemia. In such patients, the volume of diuresis and the renal function should be carefully monitored at the beginning of therapy. In rare instances, NSAIDs may be the cause of interstitial nephritis, glomerulonephritis, renal medularry necrosis or nephrotic syndrome.

The dose of MOVIX^® in patients with end-stage renal failure on haemodialysis should not be higher than 7.5 mg. No dose reduction is required in patients with mild or moderate renal impairment (ie, in patients with a creatinine clearance of>25 mL/min).

As with most other NSAIDs, occasional elevations of serum transaminases or other parameters of liver function have been reported. In most cases, these have been small and transient increases above the normal range. If the abnormality is significantor persistent, MOVIX^® should be stopped and follow-up tests carried out.

Frail or debilitated patients may tolerate side effects less well and such patients should be carefully supervised. As with other NSAIDs, caution should be used in the treatment of elderly patients who are more likely to be suffering from impaired renal, hepatic or cardiac function.
MOVIX^® suppositories should not be used in patients with any inflammatory lesions of the rectum or anus, or in patients with a recent history of rectal or anal bleeding.

Effects on the Ability of Drive or Operate Machinery: There are no specific studies about effects on the ability to drive vehicles and to use machinery. However, when adverse effects eg, vertigo and drowsiness occur, it is advisable to refrain from these activities.

Use in pregnancy & lactation: In animals, lethal effects on the embryo have been reported at doses higher than those used clinically. (See Contraindications).

The following adverse events which may be causally related with the administration of MOVIX^® have been reported. The following frequencies are based on corresponding occurrences in clinical trials, regardless of any causal relationship.

The information is based on clinical trials involving 3750 patients who have been treated with daily oral doses of 7.5 – 15 mg MOVIX^® tablets over a period of up to 18 months (mean duration of treatment: 127 days).

Gastrointestinal: More frequent than 1%.: Dyspepsia, nausea, vomiting, abdominal pain, constipation, flatulence, diarrhea. Between 0.1% & 1%: Disturbances of blood count, including differential white cell count, leucopenia and thrombocytopenia. Concomitant administration of a potentially myelotoxic drug, in particular methotrexate, appears to be a predisposing factor to the onset of a cytopenia.

Dermatological: More frequent than 1%: Pruritus, skin rash. Between 0.1% and 1%: Stomatitis, urticaria. Less frequent than 0.1%: Photosensitisation.

Respiratory: Less frequent than 0.1%: Onset of acute asthma has been reported in certain individuals following the administration of aspirin or other NSAIDs, including MOVIX^®.

Central Nervous System: More frequent than 1%: Lightheadedness, headache. Between 0.1% and 1%: Increase in blood pressure, palpitations, flushes.

Genitourinary: Between 0.1% and 1%: Abnormal renal function parameters (increased serum creatinine and/or serum urea).

Liver Function: Raised transaminases or bilirubin.

Other NSAIDs (including salicylates in high doses): Concomitant administration of more than one NSAID may increase the risk of gastrointestinal ulceration and bleeding through synergistic action.
Oral Anticoagulants, Ticlopidine, Systemically Administered Heparin, Thrombolytics: Increased risk of bleeding. If such co-prescribing cannot be avoided, close monitoring of the effectsof anticoagulants is required.

Lithium: NSAIDs have been reported to increase lithium plasma levels. It is recommended that plasma lithium levels be monitored when initiating, adjusting and discontinuing MOVIX^®.

Methotrexate: As other NSAIDs, MOVIX^® may increase the haematologic toxicity of methotrexate. In this situation, strict monitoring of blood cell count is recommended.

Contraception: NSAIDs have been reported to decrease the efficacy of intrauterine devices.

Diuretics: Treatment with NSAIDs is associated with the potential for acute renal insufficiency in patients who are dehydrated. Patients receiving MOVIX^® and diuretics should be adequately hydrated and be monitored for renal function prior to initiating treatment.

Antihypertensives (eg, ?-blockers, ACE inhibitors, vasodilator, diuretics): A reduced effect of the antihypertensive drug by inhibition of vasodilating prostaglandins has been reported during treatment with NSAIDs.
Cholestyramine binds meloxicam in the gastrointestinal tract leading to a faster elimination of meloxicam.
Nephrotoxicity of cyclosporine may be enhanced by NSAIDs via renal prostaglandin-mediated effects. During combined treatment, renal function is to be measured.
No relevant pharmacokinetic drug-drug interactions were detected with respect to the concomitant administration of antacids, cimetidine, digoxin and furosemide.

Interactions with oral antidiabetics cannot be excluded.