CANDESARTAN CILEXETIL Tablet Ref.[51457] Active ingredients: Candesartan

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2023  Publisher: Milpharm Limited, Ares Block, Odyssey Business Park, West End Road, Ruislip HA4 6QD, United Kingdom

Product name and form

Candesartan cilexetil 16 mg tablets.

Pharmaceutical Form

Tablet.

Yellow, biconvex, uncoated, round shaped [diameter 7.3 mm] tablets debossed with “CN” and “16” separated by scoreline on one side and plain on other side. The tablet can be divided into equal doses.

Qualitative and quantitative composition

Each tablet contains 16 mg candesartan cilexetil.

Excipient with known effect: Lactose monohydrate.

Each tablet contains 125.60 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

Lactose monohydrate
Hydroxypropyl cellulose
Carmellose calcium
Magnesium aluminometasilicate
Propylene glycol
Magnesium stearate
Iron oxide yellow

Pack sizes and marketing

Candesartan Cilexetil tablets are available in PVC/PVdC – Aluminium foil blister pack and HDPE container pack with polypropylene closure.

Pack sizes:

Blister pack: 7, 28, 30, 56, 90, 98 & 500 tablets.

HDPE pack: 30, 90 & 500 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Milpharm Limited, Ares Block, Odyssey Business Park, West End Road, Ruislip HA4 6QD, United Kingdom

Marketing authorization dates and numbers

PL 16363/0381

12/07/2013 / 11/10/2023

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