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AMIAS Tablets (2018)

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.

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.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Takeda UK Limited, Building 3, Glory Park, Glory Park Avenue, Wooburn Green, BUCKS HP10 0DF, United Kingdom

Date of first authorisation: 15 December 1998

Date of latest renewal: 29 April 2002

Marketing authorization number:

PL 16189/0001
PL 16189/0002
PL 16189/0003
PL 16189/0004
PL 16189/0007