CALTRATE Film-coated tablet Ref.[49835] Active ingredients: Calcium carbonate

Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: GlaxoSmithKline Consumer Healthcare (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Product name and form

Caltrate 600 mg/400 IU, Film-coated Tablets.

Pharmaceutical Form
Film-coated tablet. Capsule-shaped grey/beige tablets. One side is scored and engraved with “D” on the left and “600” on the right of the score. The other side is engraved with “Caltrate”. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Qualitative and quantitative composition

Each tablet contains:

600 mg of calcium (as calcium carbonate)

10 micrograms of cholecalciferol (equivalent to 400 I.U. vitamin D₃)

Excipients with known effect: sucrose, partially hydrogenated soya bean oil.

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Calcium carbonate	Calcium carbonate releases, in a pH-dependent manner, calcium ions in the stomach. Calcium carbonate is widely used as antacid and extensively used as a dietary supplement.

List of Excipients
Tablet core: Microcrystalline cellulose Povidone Crospovidone type A Sodium laurilsulfate Sodium croscarmellose Magnesium stearate DL-α-tocopherol Partially hydrogenated soya bean oil Sucrose Bovine gelatin hydrolyzed Corn starch Silicon dioxide Tablet coat: Light liquid paraffin Talc OPADRY OY-S-27203: Methylhydroxypropylcellulose Titanium dioxide (E171) Light liquid paraffin Sodium laurilsulfate Red iron oxide (E172) Black iron oxide (E172) Yellow iron oxide (E172)

Pack sizes and marketing

Opaque white high density polyethylene bottles with a polypropylene cap and induction sealed foil liner.

Bottles contain 20, 30, 60, 90 or 180 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

GlaxoSmithKline Consumer Healthcare (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Marketing authorization dates and numbers

PA0678/156/001

Date of first authorisation: 24^th April 2009
Date of last renewal: 1^st August 2013

Drugs

Drug	Countries
CALTRATE	France, Hong Kong, Ireland

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