INDOREM Hard capsule Ref.[51164] Active ingredients: Indometacin

Source: Υπουργείο Υγείας (CY)  Revision Year: 2022  Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Product name and form

Indorem 25 mg hard capsules.

Pharmaceutical Form

Hard capsules.

Ivory/Ivory hard capsules.

Qualitative and quantitative composition

Each hard capsule contains 25 mg indometacin.

Excipient(s) with known effect: This product contains 88.5 mg lactose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Indometacin

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

Hard capsule content:

Povidone
Lactose monohydrate
Maize starch
Starch, pregelatinised
Sodium laurilsulfate
Silica, colloidal anhydrous
Magnesium stearate
Talc

Hard capsule shell:

Body:

Quinoline yellow
Erythrosin-FD & C Red 3
Titanium dioxide
Gelatin

Cap:

Quinoline yellow
Erythrosin-FD & C Red 3
Titanium dioxide
Gelatin

Pack sizes and marketing

PVC/Aluminium blisters. Pack sizes of 30 and 100 hard capsules.

PP containers with PE closure. Pack size of 1000 hard capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Marketing authorization dates and numbers

7732

Date of first authorization: 02/02/1981
Date of latest renewal: 10/09/2012

Drugs

Drug Countries
INDOREM Cyprus, Malta
 
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