DOLENIO Film-coated tablets Ref.[6845] Active ingredients: Glucosamine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Blue Bio Pharmaceuticals Ltd., 5<sup>th</sup> Floor, Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland

Product name and form

Dolenio 500 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

White to off white, oval shaped, bi-convex film-coated tablets.

Qualitative and quantitative composition

One film-coated tablet contains 628.2 mg of Glucosamine sulphate sodium chloride equivalent to 500 mg Glucosamine sulphate or 393 mg glucosamine.

Excipient with known effect: One tablet contains Sodium 51.538 mg.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Glucosamine

Glucosamine is an endogenous substance, a normal constituent of the polysaccharide chains of cartilage matrix and synovial fluid glucosaminoglycans. In vitro and in vivo studies have shown glucosamine stimulates the synthesis of physiological glycosaminoglycans and proteoglycans by chondrocytes and of hyaluronic acid by synoviocytes.

List of Excipients

Core tablet:

Povidone K30
Macrogol 4000
Magnesium Stearate

Film-Coating:

Hypromellose
Titanium Dioxide (E171)
Talc
Propylene glycol
Polysorbate 80

Pack sizes and marketing

Alu/PVC/PVDC Blister packs.

Pack-sizes: 90, 180, 270 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Blue Bio Pharmaceuticals Ltd., 5th Floor, Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland

Marketing authorization dates and numbers

PL 33831/0002

01/03/2012

Drugs

Drug Countries
DOLENIO Cyprus, Estonia, France, Ireland, Lithuania, Malta, Netherlands, Poland, United Kingdom

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.