Suspension Ref.[50221] Active ingredients: Mefenamic acid

Source: Health Products Regulatory Authority (ZA) Revision Year: 2021 Publisher: Adcock lngram Limited, Address, 1 New Road, Erand Gardens, Midrand, 1685 P.O. Box Private Bag X69 Bryanston 2021

Product name and form

PONSTEL 250, 250 mg capsules.

PONSTEL FORTE, 500 mg tablets.

PONSTEL S, 50 mg/5 mL suspension.

Pharmaceutical Form
PONSTEL 250: Capsules. Size ‘1’ hard gelatin capsules with an ivory opaque body and cap containing a white to slightly offwhite powder. PONSTEL FORTE: Tablets. Buff-coloured, round, biconvex tablets. PONSTEL S: Suspension. A creamy, light caramel coloured, uniform suspension with a butter toffee and anise mint odour and taste.

Qualitative and quantitative composition

PONSTEL 250

Each capsule contains: Mefenamic acid 250 mg.

Excipients with known effect:

Contains sugar (lactose monohydrate): 60 mg.

For full list of excipients, see section 6.1.

PONSTEL FORTE

Each tablet contains: Mefenamic acid 500 mg.

Sugar free.

For full list of excipients, see section 6.1.

PONSTEL S

Each 5 mL suspension contains: Mefenamic acid 50 mg.

Excipients with known effect:

Preservative (sodium benzoate): 0,5% m/v.
Contains ethanol 96,5%: 0,025 mL.
Contains sugar (sucrose): 1,0 g.
Contains sugar (sorbitol 70% solution): 970 mg.

For 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
PONSTEL 250: D & C yellow No. 10 (CI 47005) FD & C red No. 3 (CI 45430) Gelatin Lactose monohydrate Titanium dioxide (CI 77891) PONSTEL FORTE: Calcium stearate Colloidal anhydrous silica (silicon dioxide) Hydroxypropyl cellulose Microcrystalline cellulose Starch corn (maize starch) Sodium lauryl sulphate Spectracol quinoline (PLK0013) (Colour D & C yellow No. 10 lake (CI 47005) Spectracol erythrosine lake (805005) FD &C red No.3 lake (CI 45430) PONSTEL S: Caramel 48000 (clarkes) Carboxymethylcellulose sodium 7MF Ethanol 96,5% Flavor anise mint LR3072A Flavor butter toffee 78185-33 Glucono delta lactone Hydrochloric acid AR 37% Povidone K29-32 Purified water Sodium benzoate Sodium hydroxide B.P Sorbitol 70% solution (non-crystallising) Sugar granulated (sucrose) Veegum HV

Pack sizes and marketing

PONSTEL 250:

250 mg capsules in containers of 100’s and 250’s, and blister packs of 20’s.

100’s pack: White cylindrically shaped polypropylene securitainer (49 × 75 mm) with a round white LDPE closure.
250’s pack: White cylindrically shaped polypropylene securitainer (62 × 152 mm) with a round white LDPE Closure.
250’s pack: White cylindrical shaped high-density polyethylene (HDPE) container (475 mL, 53 × 450 cc) with screw cap with an inside wad seal.
20’s pack: Clear, transparent, non-toxic well thermo formable, food grade PVC film on printed aluminium foil with VMCH coating (dull side printing).

PONSTEL FORTE:

500 mg tablets in containers of 50’s.

50’s Blister pack: Clear, transparent, non-toxic, well thermo formable, food grade PVC film on aluminium foil with VMCH coating on bright side (dull side printing).

50’s Securitainer pack: White or grey polypropylene securitainer (0205), 49 mm LDPE closure and cotton wool balls as wadding.
50’s HDPE container: 160mL (35 × 150) white colour cylindrical screw type high density polyethylene (HDPE) container with a white colour HDPE screw cap with induction seal Wad.

PONSTEL S:

Suspension in bottles of 100 ml, 200 ml and 2,5 L.

PONSTEL S, is packed using the following packaging materials:

100 mL or 200 mL amber glass bottles with a 28 mm white polypropylene cap with liner.
2,5 L rectangular amber HDPE bottle with a utility thread finish with a 3,15 mm white polypropylene cap with liner.

Not all pack sizes may be marketed.

Marketing authorization holder

Adcock lngram Limited, Address, 1 New Road, Erand Gardens, Midrand, 1685
P.O. Box
Private Bag X69
Bryanston 2021

Marketing authorization dates and numbers

PONSTEL 250: 28/2.7/0703

PONSTEL FORTE: 28/2.7/0548

PONSTEL S: 28/2.7/0704

PONSTEL 250: 28 October 1994

PONSTEL FORTE: 30 March 1994

PONSTEL S: 15 August 1994

Drugs

Drug	Countries
PONSTEL	Hong Kong, South Africa

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