RENACET Film-coated tablet Ref.[49790] Active ingredients: Calcium acetate

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2010  Publisher: RenaCare NephroMed GmbH, Werrastr. 1 a, 35625 Hรผttenberg, Germany Phone: +49 (0) 64 03 9 21 60 Fax: +49 (0) 64 03 9 21 63 E-mail: mail@renacare.com

Product name and form

Renacet 475 mg, film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

white, round, convex film-coated tablets.

Qualitative and quantitative composition

Active substance: Calcium acetate.

Each film-coated tablet contains:

475 mg calcium acetate (anhydrous) equivalent to 120.25 mg calcium.

Excipients: Contains sucrose, see section 4.4.

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

Tablet core:

Maize starch
Sucrose
Gelatin
Sodium starch glycolate (Type A)
Croscarmellose sodium
Magnesium stearate

Film coat:

Hypromellose
Refined castor oil
Saccharin sodium
Talc
Orange flavour

Pack sizes and marketing

Pack sizes:

100 film-coated tablets
200 film-coated tablets

PVDC-coated PVC/aluminium foil blisters

Marketing authorization holder

RenaCare NephroMed GmbH, Werrastr. 1 a, 35625 Hรผttenberg, Germany
Phone: +49 (0) 64 03 9 21 60
Fax: +49 (0) 64 03 9 21 63
E-mail: mail@renacare.com

Marketing authorization dates and numbers

PL 36032/0001

30/06/2010

Drugs

Drug Countries
RENACET Germany, United Kingdom

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