Mebilax 7.5

Print
Non steroidal anti-inflammatory, analgesics
Barcode: 8935206094381
Description

MEBILAX 7,5

COMPOSITION:

Meloxicam .......................................................7.5 mg

Excipients q.s.................................................. 1 tablet

(Lactose, kollidon CL-M, magnesium stearate, PVP K30)

DOSAGE FORM: Tablet.

PRESENTATION: Box of 2 blisters x 10 tablets.

PHARMACODYNAMICS:

Mebilax containing meloxicam containing meloxicam 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.

PHARMACOKINETICS:

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.

INDICATIONS:

Symptomatic treatment of chronic pains in:

- Painful osteoarthritis (arthrosis, degenerative joint disease).

- Rheumatoid arthritis.

- Ankylosing spondylitis.

CONTRAINDICATIONS:

Hypersensitivity to any of the excipients of the drug.

Meloxicam should not be given to patients who have allergic reactions with aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs).

Asthma, nasal polyps, angioneurotic oedema, Quincke’s edema, urticaria following the administration of aspirin or other NSAIDs, progressive peptic ulcer, gastrointestinal bleeding, cerebrovascular bleeding. Severely impaired liver function. Non-dialysed severe renal failure.

Pregnant women and breast-feeding mothers.

WARNINGS AND PRECAUTIONS:

Caution should be exercised in patients with upper gastrointestinal disease or in patients receiving concomitant medication with anticoagulants. Mebilax should be discontinued if peptic ulcer or gastrointestinal bleeding occurs.

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. The administration of meloxicam should be discontinued and appropriate investigations undertaken if having occasional increases in serum transaminase levels or other liver function parameters.

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

Physicians should remain alert for the development of such events, even in the absence of previous cardiovascular symptoms. Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur.

To minimize the potential risk for an adverse cardiovascular event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible.

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 is not recommended in women who are breastfeeding.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:

The drug may cause undesirable effects such as dizziness, drowsiness, so it is best not to take meloxicam while participating in these activities.

INTERACTIONS:

Combination with other NSAIDS drugs increases the risk of gastrointestinal gastrointestinal ulceration or bleeding. The concomitant use with anticoagulants, thrombolytic drugs increases risk of bleeding.

Meloxicam has been reported to increase blood lithium levels, hematological toxicity of methotrexate and nephrotoxicity of cyclosporine. The co-administration of meloxicam and diuretics may result in possible acute renal failure in dehydrated patients.

Meloxicam reduces the effects of antihypertensive drugs.

ADVERSE EFFECTS:

Gastrointestinal disturbances e.g diarrhea, stomachache, dyspepsia, nausea, flatulence. Vertigo, headache, dizziness, tinnitus. Pruritus, skin rash, urticaria.

Rare: anemia, blood count disorders, gastrointestinal ulceration or haemorrhage.

Cardiovascular thrombotic events (see Warnings and precautions).

Inform your physician about any adverse effects occur during the treatment.

OVERDOSAGE:

In case of overdose, the standard measures for first-aid should be carried out. There is no known specific antidote at present. It has been shown in a clinical trial that cholestyramine accelerates the elimination of meloxicam.

Severe injuries on the gastrointestinal tract can be treated by antacid drugs or H2-antihistamine agents.

DOSAGE & ADMINISTRATION:

Rheumatoid arthritis, ankylosing spondylitis: 15 mg (2 tablets once daily). According to the therapeutic response, the dose may be reduced to 7.5 mg (1 tablet per day).

Exacerbations of osteoarthritis: 7.5 mg per day (1 tablet per day). If necessary, the dose may be increased to 15 mg per day (2 tablets per day).

Patients with increased risks for adverse reactions and elderly patients should start treatment with 7.5 mg per day (1 tablet per day).

In dialysis patients with renal failure, the dose should not exceed 7.5 mg (1 tablet per day). Meloxicam should not be given to patients who have severe renal failure.

Meloxicam is not recommended for use in children and adolescents below 18 years due to insufficient data on safety and efficacy.

Or as directed by the physician.

Read the directions carefully before use.         

Consult the physician for more information.             

This drug is for prescriptions only.

Shelf-life: 36 months from the manufacturing date.

Storage conditions: Store in dry places, not exceeding 30oC, protect from light.

Specifications: Manufacturer's.

Reviews

There are yet no reviews for this product.