ATACAND Tablet Ref.[50796] Active ingredients: Candesartan

Source: Health Products Regulatory Authority (IE)  Revision Year: 2023  Publisher: CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489, Greifswald, Germany

Product name and form

Atacand 4 mg tablets.

Pharmaceutical Form

Tablet.

Round (diameter 7 mm), white tablets with a score and marked A/CF on one side and marked 004 on the other side.

The tablet can be divided into equal doses.

Qualitative and quantitative composition

Each tablet contains 4 mg candesartan cilexetil.

Excipient with known effect: Each tablet contains 93.4 mg lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Candesartan

Candesartan is an AIIRA, selective for AT1 receptors, with tight binding to and slow dissociation from the receptor. It has no agonist activity. The antagonism of the angiotensin II (AT1) receptors results in dose related increases in plasma renin levels, angiotensin I and angiotensin II levels, and a decrease in plasma aldosterone concentration.
List of Excipients

Carmellose calcium
Hydroxypropylcellulose
Lactose monohydrate
Magnesium stearate
Maize starch
Macrogol

Pack sizes and marketing

PVC/PVDC blister packs of 7, 14, 28, 30, 56, 90 and 98 tablets.

HDPE bottles of 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489, Greifswald, Germany

Marketing authorization dates and numbers

PA2239/010/001

Date of first authorisation: 23 January 1998
Date of last renewal: 29 April 2007

Drugs

Drug Countries
ATACAND Austria, Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Ireland, Israel, Lithuania, Malta, Mexico, Nigeria, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United States, South Africa
 
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