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Mebilax 15

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Anti-inflammatory analgesic
Barcode: 8935206094565
Description

MEBILAX 15

 

Keep out of reach of children.

Read the directions carefully before use.

For prescription only.

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Active ingredient: Meloxicam....................... 15 mg

Excipients: Lactose, kollidon CL-M, magnesium stearate, PVP K30.

PHARMACEUTICAL FORM: Tablet.

Product description: A light yellow tablet, plain on both sides and intact edges.

THERAPEUTIC INDICATIONS:

Symptomatic treatment of chronic pains in the following cases:

  • Osteoarthritis (joint failure, degenerative joint disease)
  • Rheumatoid arthritis
  • Ankylosing spondylitis

POSOLOGY AND METHOD OF ADMINISTRATION:

Rheumatoid arthritis, ankylosing spondylitis: 15 mg (1 tablet/day). According to the therapeutic response, the dose may be reduced to 7.5 mg daily.

Acute course of joint degeneration: 7.5 mg daily. If necessary, the dose may be increased to 15 mg daily (1 tablet daily).

In patients with increased risks for adverse reactions and elderly patients, the starting dose should be 7.5 mg daily.

In renal-failure patients on dialysis, the dose should not exceed 7.5 mg daily. Meloxicam should not be given to patients who have severe renal failure.

Meloxicam’s  safety and efficacy in children and adolescents below 18 years have not been determined.

Or as directed by the physician.

CONTRAINDICATIONS:

Allergy to any ingredients of the drug.

Meloxicam should not be given to patients who are allergic to aspirin and other NSAIDs.

Bronchial asthma, nasal polyps, angioneurotic oedema, Quincke’s edema, urticaria following the administration of aspirin or other NSAIDs, progressive gastro-duodenal ulcer, gastrorrhagia, cerebral hemorrhage. Severe hepatic impairment. Non-dialysed severe renal failure.

Pregnant women and breast-feeding mothers.

SPECIAL WARNINGS AND PRECAUTIONS FOR USE:

Caution should be exercised in patients with a history of upper gastrointestinal disease or in patients receiving treatment anticoagulants. Meloxicam should be discontinued if gastro-duodenal or gastrointestinal bleeding occurs.

Meloxicam should not be used in patients with severe hepatic failure, bleeding disorders or severe renal failure. The dose of meloxicam in patients with end-stage renal failure should not be higher than 7.5 mg per day. No dose reduction is required in patients with mild or moderate renal impairment. Meloxicam should be discontinued and follow-up tests undertaken if elevations of serum transaminases or other parameters of liver function have been reported.

Cardiovascular thrombotic events: Non-steroidal anti-inflammatory drugs (NSAIDs), non-aspirin, by systemic route, have shown an increased risk of cardiovascular thrombosis including myocardial infarction and stroke which can be fatal. This risk may occur early in the first few weeks of treatment and may increase with duration of use. The risk of cardiovascular thrombosis has been observed most consistently at higher doses.

In order to minimize the potential risk for an adverse cardiovascular event in Mebilax 15-treated patients, use the lowest effective dose for the shortest duration possible.

Relating to lactose excipient: Patients with rare hereditary problems of galactose intolerance, lapp lactase deficiency or glucose - galactose malabsorption should not take this medicine.

USE IN PREGNANCY AND LACTATION:

There is no adequate evidence that meloxicam causes monstrosity. However, meloxicam is not recommended for use in pregnant women, particularly during the third trimester of pregnancy.

Administration should not be used in mothers who are breastfeeding.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:

The drug may cause certain undesirable effects e.g., dizziness, drowsiness; therefore, it is best not to take meloxicam while participating in these activities.

INTERACTIONS:

The concomitant use of meloxicam and other NSAIDs increases the risk of gastrointestinal ulceration or bleeding. The concomitant administration of meloxicam and anticoagulants, thrombolytics have an increased risk of bleeding.

Meloxicam has produced elevations in lithium plasma levels, may increase the risk of methotrexate toxicity, and may increase nephrotoxicity of ciclosporin. The co-administration of meloxicam and diuretics may increase the potential for renal failure in patients with dehydration.

Meloxicam reduces the effects of antihypertensive drugs.

UNDESIRABLE EFFECTS:

Common: gastrointestinal disorders e.g., nausea, vomiting, abdominal pain, constipation, dyspepsia, diarrhea, anemia, pruritus, skin rash, headache, and edema.

Uncommon: mild elevations of transaminase and bilirubin, eructation, esophagitis, gastroduodenal ulcer, occult gastrointestinal haemorrhage, leukopenia, thrombocytopenia, stomatitis, urticaria, hypertension, palpitations, face flushing, increased levels of creatinine and blood urea, dizziness, tinnitus, and drowsiness.

Rare: colitis, gastroduodenal ulcer, hepatitis, gastritis, photosensitivity reaction, erythema, Stevens-Johnson syndrome, Lyell's syndrome, bronchial asthma, angioneurotic edema, anaphylactic shock.

Cardiovascular thrombotic events (see Special warnings and precautions for use).

Please inform your doctor of all undesirable effects upon drug administration.

OVERDOSE:

In case of overdose, the standard measures for first-aid should be carried out. There is no known specific antidote at present. Accelerated removal of meloxicam by cholestyramine was demonstrated in a clinical trial. Severe injuries on the gastrointestinal tract can be treated by antacids or H2-antihistamines.

PHARMACODYNAMIC PROPERTIES:

ATC code: M01AC06

Mebilax 15 contains meloxicam which is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam family, with anti-inflammatory, analgesic and antipyretic properties. A common mechanism for the mentioned effects is the ability to inhibit biosynthesis of prostaglandins of meloxicam, known mediators of inflammation, pain and fever.

PHARMACOKINETIC PROPERTIES:

Meloxicam is well absorbed from the gastrointestinal tract, which is reflected by an average bioavailability of 89% following oral administration. Meloxicam is very strongly bound to plasma proteins, essentially albumin. Meloxicam is strongly metabolized at liver, occurs to equal extents in urine and faeces. The mean elimination half-life is about 20 hours.

PRESENTATION: Box of 2 blisters x 10 tablets.

SHELF-LIFE: 36 months from the manufacturing date.

STORAGE CONDITIONS: Store in dry places, not exceeding 30oC, protect from light.

SPECIFICATIONS: Manufacturer’s.

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