AMDOCIN Capsule Ref.[115178] Active ingredients: Indometacin

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2024  Publisher: Innovata Pharmaceuticals (Pty) Ltd, Crownwood Office Park, Block D, Ground Floor, 100 Northern Parkway, Ormonde, Johannesburg, 2091, South Africa

Product name and form

AMDOCIN (capsules).

Pharmaceutical Form

AMDOCIN capsules are yellow gelatin capsules containing white to off-white powder.

Qualitative and quantitative composition

Each AMDOCIN capsule tablet contains Indomethacin 25 mg.

For full list of excipients, see section 6.1.

Active Ingredient

Indometacin has anti-inflammatory, antipyretic, and analgesic effects, it is an inhibitor of prostaglandin synthetase.

List of Excipients

Lactose
Maize starch
Microcrystalline cellulose
Sodium starch glycolate

Hard gelatin capsule, with a yellow cap and body:

Quinoline yellow
Sunset yellow
Titanium dioxide

Pack sizes and marketing

Aluminium foil/PVC film blister strip of 15 capsules and a package insert in a printed carton.

4 Aluminium foil/PVC film blister strip of 21 capsules and a package insert in a printed carton.

Bottles containing 100, 500 and 1 000 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Innovata Pharmaceuticals (Pty) Ltd, Crownwood Office Park, Block D, Ground Floor, 100 Northern Parkway, Ormonde, Johannesburg, 2091, South Africa

Marketing authorization dates and numbers

A 27/3.1/0169

21 December 1992

Drugs

Drug Countries
AMDOCIN South Africa

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