PONSTAN FORTE Film-coated tablet Ref.[7310] Active ingredients: Mefenamic acid

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Chemidex Pharma Limited, Chemidex House, Egham Business Village, Crabtree Road, Egham, Surrey TW20 8RB, United Kingdom

Product name and form

Ponstan Forte Tablets 500 mg.

Pharmaceutical Form

Film-coated tablet.

Yellow, biconvex elliptical film coated tablet, inscribed ‘Ponstan Forte’ on one side.

Qualitative and quantitative composition

Each tablet contains 500 mg mefenamic acid.

Excipients with known effect: Each tablet contains 22.73 mg lactose monohydrate, and 0.067 mg sunset yellow (E110).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Mefenamic acid

Mefenamic acid is a non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic and antipyretic properties.

List of Excipients

Tablet core:

Lactose monohydrate
Pregelatinized starch
Maize starch
Povidone
Colloidal anhydrous silica
Talc
Magnesium stearate
Croscarmellose sodium type A
Sodium laurilsulfate

Coating (Opadry OY-LS-22808):

Hypromellose
Lactose
Macrogol 4000
Vanillin
Quinoline yellow (E104)
Sunset yellow (E110)
Titanium dioxide (E171)

Polish: (Opaglos AG7350):

Beeswax, white
Carnauba wax, yellow
Polysorbate 20
Sorbic acid (E200)

Pack sizes and marketing

a) Aluminium foil/pvc blister pack in cardboard carton. Pack sizes: 28 and 100 tablets.

b) HDPE DUMA and polypropylene container. Pack sizes: 100 and 500 tablets.

c) Amber polystyrene bottle with a high density polyethene anti-arthritic closure. Pack sizes: 6, 12, 84, 100 and 500 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Chemidex Pharma Limited, Chemidex House, Egham Business Village, Crabtree Road, Egham, Surrey TW20 8RB, United Kingdom

Marketing authorization dates and numbers

PL 17736/0007

10/10/2005

Drugs

Drug Countries
PONSTAN Australia, Brazil, Cyprus, Hong Kong, Ireland, Mexico, Nigeria, New Zealand, Turkey, United Kingdom, South Africa

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