OSVAREN Film-coated tablet Ref.[10708] Active ingredients: Calcium acetate Magnesium carbonate

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2017  Publisher: Fresenius Medical Care Nephrologica Deutschland GmbH, Else-Kröner-Straße 1, 61352 Bad Homburg v.d.H., Germany

Product name and form

Osvaren 435 mg/235 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

White to yellowish, oblong film-coated tablet with a single score line.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Qualitative and quantitative composition

Each film-coated tablet contains: Calcium acetate, 435 mg equivalent to 110 mg calcium and Magnesium carbonate, heavy 235 mg equivalent to 60 mg magnesium.

Excipients with known effect: Each film-coated tablet contains 5.6 mg sodium and 50 mg sucrose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Calcium acetate

Calcium is an endogenous ion of the body essential for the maintenance of a number of physiologic processes. It participates as an integral factor in the maintenance of the functional integrity of the nervous system, in the contractile mechanisms of muscle tissue, in the clotting of blood, and in the formation of the major structural material of the skeleton. Soluble calcium salts are commonly used in the treatment of calcium deficiency.

Magnesium carbonate

Magnesium carbonate, MgCO3 (archaic name magnesia alba), is an inorganic salt. The most common magnesium carbonate forms are the anhydrous salt called magnesite (MgCO3) and the di, tri, and pentahydrates known as barringtonite (MgCO3·2 H2O), nesquehonite (MgCO3·3 H2O), and lansfordite (MgCO3·5 H2O), respectively. The primary use of magnesium carbonate is the production of magnesium oxide by calcining.

List of Excipients

Tablet core:

Starch, pregelatinised, from maize
Maize starch
Sucrose
Gelatin
Croscarmellose sodium
Magnesium stearate

Film coating:

Castor oil, refined
Hypromellose

Pack sizes and marketing

HDPE container with LDPE cap: Pack size of 180 film-coated tablets.

Marketing authorization holder

Fresenius Medical Care Nephrologica Deutschland GmbH, Else-Kröner-Straße 1, 61352 Bad Homburg v.d.H., Germany

Marketing authorization dates and numbers

PL 29386/0005

Date of first authorisation: 11.03.2008
Date of latest renewal: 03.01.2011

Drugs

Drug Countries
OSVAREN Austria, Estonia, Spain, France, Croatia, Lithuania, Netherlands, Romania, United Kingdom, South Africa

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