PHOSEX Tablet Ref.[49966] Active ingredients: Calcium acetate

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2011  Publisher: Pharmacosmos A/S, Roervangsvej 30, DK-4300 Holbaek, Denmark

Product name and form

Phosex 1000 mg tablet.

Pharmaceutical Form

Tablet.

Oval yellow tablet embossed “PHOS-EX” on one side with a score-line on the reverse.

Qualitative and quantitative composition

1 tablet contains.

Calcium Acetate 1000 mg (calcium acetate anhydrous 986.36 mg) equivalent to 250 mg calcium.

For a 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.

List of Excipients

Macrogol 8000
Sodium starch glycolate (type A)
Calcium stearate
Lemon meringue flavour containing lemon oil, citral, aldehyde C-9, lime oil, orange oil, vanillin, ethyl vanillin, malto-dextrin, tricalcium phosphate
Yellow iron oxide (E172)

Pack sizes and marketing

White HDPE bottles with polypropylene caps.

Package size: bottle with 50, 100, 180, 200, 500 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Pharmacosmos A/S, Roervangsvej 30, DK-4300 Holbaek, Denmark

Marketing authorization dates and numbers

PL 18380/0003

Date of first authorisation: 29 June 2001
Date of last renewal: 22 December 2007

Drugs

Drug Countries
PHOSEX Ireland, United Kingdom

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