LOXIFLAM Tablet Ref.[115325] Active ingredients: Meloxicam

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2023  Publisher: PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead 2191

Product name and form

LOXIFLAM 7,5 mg tablets.

LOXIFLAM 15 mg tablets.

Pharmaceutical Form

Tablets.

LOXIFLAM 7,5 mg tablet is a round, pale yellow, flat bevelled tablet, bisected on one side.

LOXIFLAM 15 mg tablet is a round, pale yellow, biconvex tablet.

Qualitative and quantitative composition

Each tablet of LOXIFLAM 7,5 mg contains 7,5 mg meloxicam.

Contains sugar: Lactose monohydrate 163,5 mg

Each tablet of LOXIFLAM 15 mg contains 15 mg meloxicam.

Contains sugar: Lactose monohydrate 156,0 mg

For full list of excipients, see section 6.1.

Active Ingredient

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

LOXIFLAM 7,5 tablets:

Croscarmellose sodium
Lactose monohydrate
Povidone K25
Sodium stearyl fumarate
Trisodium citrate dihydrate

LOXIFLAM 15 mg tablets:

Croscarmellose sodium
Lactose monohydrate
Povidone K25
Sodium stearyl fumarate
Trisodium citrate dihydrate

Pack sizes and marketing

LOXIFLAM 7,5 mg: 30 tablets are packed in a clear or red polyvinyl chloride, polyvinylidene chloride or a clear polyvinyl chloride, polyethylene, polyvinylidene chloride film sealed with an aluminium foil backing. The blister strips are packed into an outer cardboard carton together with a leaflet.

LOXIFLAM 15 mg: 10 or 30 tablets are packed in a polyvinyl chloride, polyethylene, polyvinylidene chloride or red polyvinyl chloride, polyvinylidene chloride film sealed with an aluminium foil backing. The blister strips are packed into an outer cardboard carton together with a leaflet.

Not all packs and pack sizes may be marketed.

Marketing authorization holder

PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead 2191

Marketing authorization dates and numbers

LOXIFLAM 7,5 mg: 36/3.1/0101
LOXIFLAM 15 mg: 36/3.1/0102

05 September 2003

Drugs

Drug Countries
LOXIFLAM South Africa

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