AMIAS Tablet Ref.[6490] Active ingredients: Candesartan

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Neon Healthcare Limited, 8 The Chase, John Tate Road, Hertford, SG13 7NN, United Kingdom

Product name and form

Amias 2 mg Tablets.
Amias 4 mg Tablets.
Amias 8 mg Tablets.
Amias 16 mg Tablets.
Amias 32 mg Tablets.

Pharmaceutical Form

Tablet.

Amias 2 mg Tablets are round white tablets.

Amias 4 mg Tablets are round white tablets with a single score line on both sides.

The tablet can be divided into equal doses.

Amias 8 mg Tablets are round pale pink tablets with a single score line on both sides.

The tablet can be divided into equal doses.

Amias 16 mg Tablets are round light pink tablets with one convex side and one scored flat side, embossing 16 on convex side.

The tablet can be divided into equal doses.

Amias 32 mg Tablets are round light pink tablets with convex faces, debossed 32 on one face and scored on the other face.

The tablet can be divided into equal doses.

Qualitative and quantitative composition

Each tablet contains 2 mg candesartan cilexetil.
Each tablet contains 95.4 mg lactose monohydrate.

Each tablet contains 4 mg candesartan cilexetil.
Each tablet contains 93.4 mg lactose monohydrate.

Each tablet contains 8 mg candesartan cilexetil.
Each tablet contains 89.4 mg lactose monohydrate.

Each tablet contains 16 mg candesartan cilexetil.
Each tablet contains 81.3 mg lactose monohydrate.

Each tablet contains 32 mg candesartan cilexetil.
Each tablet contains 162.7 mg lactose monohydrate.

For a 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
Hydroxypropyl cellulose
Iron oxide red (E172) (8, 16 and 32 mg tablets only)
Lactose monohydrate
Magnesium stearate
Maize starch
Macrogol

Pack sizes and marketing

Polypropylene blisters (7, 10 or 14 tablets/blister).

2 mg tablets: Blister packs of 7 and 14 tablets.

4 mg, 8 mg and 16 mg tablets: Blister packs of 7, 14, 20, 28, 50, 56, 98, 98x1 (single dose unit), 100 or 300 tablets.

32 mg tablets: Blister packs of 7, 10, 14, 20, 28, 50, 56, 98, 100 or 300 tablets. PVC/PVDC/Alu blister

4mg Tablets: Blister packs of 14, 28, 30, 56, 84, 90, 91, 98, 140 or 280 tablets.

8 mg Tablets: Blister packs of 14, 28, 30, 56, 84, 90, 91, 98, 140 or 280 tablets.

16 mg Tablets: Blister packs of 14, 28, 30, 56, 84, 90, 91, 98, 140 or 280 tablets.

32 mg Tablets: Blister packs of 7, 14, 20, 28, 30, 50, 56, 84, 90, 91, 98, 100, 140, 280 or 300 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Neon Healthcare Limited, 8 The Chase, John Tate Road, Hertford, SG13 7NN, United Kingdom

Marketing authorization dates and numbers

PL 45043/0077
PL 45043/0078
PL 45043/0079
PL 45043/0080
PL 45043/0081

Date of first authorisation: 15 December 1998
Date of latest renewal: 29 April 2002

Drugs

Drug Countries
AMIAS United Kingdom

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