MELOX Tablet Ref.[28337] Active ingredients: Meloxicam

Source: Υπουργείο Υγείας (CY)  Revision Year: 2020  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Product name and form

Melox 7.5mg tablets.

Melox 15mg tablets.

Pharmaceutical Form

Tablet.

For oral administration.

Melox 7.5mg tablets: Light yellow, round, flat, scored on one side, 7mm diameter tablets. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Melox 15mg tablets: Light yellow, round, flat, scored on one side, 10.5mm diameter tablets. The tablet can be divided into equal halves doses.

Qualitative and quantitative composition

Each Melox 7.5mg Tablet contains 7.5mg meloxicam.

Each Melox 15mg Tablet contains 15mg meloxicam.

Excipient with known effect: lactose monohydrate.

One 7.5 mg tablet contains 18.75 mg lactose monohydrate.

One 15 mg tablet contains 37.5 mg lactose monohydrate.

For the full list of excipients see section 6.1.

Active Ingredient Description
Meloxicam

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam family, with anti-inflammatory, analgesic and antipyretic properties. The anti-inflammatory activity of meloxicam has been proven in classical models of inflammation. As with other NSAID, its precise mechanism of action remains unknown. However, there is at least one common mode of action shared by all NSAID (including meloxicam): inhibition of the biosynthesis of prostaglandins, known inflammation mediators.

List of Excipients

Melox 7.5 mg tablets also contain sodium citrate dehydrate, lactose monohydrate, microcrystaline cellulose, anhydrous silica, povidone K-25, crospovidone and magnesium stearate.

Melox 15 mg tablets also contain sodium citrate dehydrate, lactose monohydrate, microcrystaline cellulose, anhydrous silica, povidone K-25, crospovidone and magnesium stearate.

Pack sizes and marketing

Tablets are packaged in Polyvinyl chloride/Poyvinynylidene chloride film-aluminium foil blisters with a patient in packs of 10, 20 and 30 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Marketing authorization dates and numbers

Melox 7.5mg Tablets – 17762
Melox 15mg Tablets – 17763

Date of first authorisation:

Melox 7.5mg Tablets – 27.05.1998
Melox 15mg Tablets – 27.05.1998

Date of latest renewal:

Melox 7.5mg Tablets – 12.10.2009
Melox 15mg Tablets – 12.10.2009

Drugs

Drug Countries
MELOX Cyprus, Estonia, Hong Kong, Lithuania, Malta, Romania, Singapore, Turkey

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