MELOXICAM Orodispersible tablet Ref.[7314] Active ingredients: Meloxicam

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2017  Publisher: Alpex Pharma (UK) Limited, Warren Plantation Church End, Haynes, Bedford, MK45 3RJ, UK Contact address: PO BOX 849, Bedford, MK45 9EG

Product name and form

Meloxicam 7.5 mg Orodispersible Tablets.

Pharmaceutical Form

Orodispersible Tablet.

Round light yellow, flat tablet embossed with AX6 on one side.

Qualitative and quantitative composition

Meloxicam 7.5 mg.

Excipients:

E421: Mannitol 126.3 mg
E420: Sorbitol 20 mg
E951: Aspartame 4 mg

For other Excipients See 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

E421: Mannitol
E421: Mannitol pregranulated
E420: Sorbitol
E1201: Povidone Cl
E330: Citric acid anhydrous
E951: Aspartame
E553: Talc
E572: Magnesium stearate
E1202: Povidone K30
E572: Sodium lauryl sulphate
Yoghurt flavour
Forest fruit flavour

Pack sizes and marketing

Boxes containing 2 Alu/PA-Alu-PVC blister packs of 10 tablet each.

Boxes containing 3 Alu/PA-Alu-PVC blister packs of 10 tablet each.

Boxes with one polyethylene bottle with polypropylene child-resistant tamper evident screw cap with desiccant containing 30 tablets each.

Boxes with one polyethylene bottle with polypropylene child-resistant tamper evident screw cap with desiccant containing 200 tablets each.

Marketing authorization holder

Alpex Pharma (UK) Limited, Warren Plantation – Church End, Haynes, Bedford, MK45 3RJ, UK

Contact address: PO BOX 849, Bedford, MK45 9EG

Marketing authorization dates and numbers

PL 31388/0003

07/08/2009

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