SOTILEN Capsule Ref.[28272] Active ingredients: Piroxicam

Source: Υπουργείο Υγείας (CY)  Revision Year: 2021  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Product name and form

Sotilen 10mg capsules.

Pharmaceutical Form

Capsule.

Sotilen 10mg capsules are brown-green hard gelatin capsules of size “2” printed “Medochemie” or unprinted according to market specific requirement, for oral administration.

Qualitative and quantitative composition

Each capsule contains piroxicam 10mg.

Excipients with known effect: lactose monohydrate, carmoisine.

Each capsule contains 287 mg lactose monohydrate and 0.1333% w/w carmoisine.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Piroxicam

Piroxicam is a non-steroidal anti-inflammatory agent with analgesic and antipyretic activity. It is effective regardless of the aetiology of the inflammation.

List of Excipients

Lactose monohydrate
Croscarmellose sodium
Sodium lauryl sulphate
Magnesium stearate

The capsule shell consists of:

Gelatin
Titanium dioxide (E171)
Brilliant blue FCF (E133)
Quinoline yellow (E104)
Carmoisine (E122)
Erythrosine (E127)

Pack sizes and marketing

PVC-Al blisters. Carton packs of 20, 30 and 100 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Marketing authorization dates and numbers

19898

Date of first authorisation: 28/12/2005
Date of Renewal: 16/05/2012

Drugs

Drug Countries
SOTILEN Cyprus, Hong Kong

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