Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Herts, EN11 9BU
Cozaar 12.5 mg film-coated tablets.
Cozaar 25 mg film-coated tablets.
Cozaar 50 mg film-coated tablets.
Cozaar 100 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablets. COZAAR 12.5 mg tablet: Blue, oval film-coated tablets marked 11 on one side and plain on the other. COZAAR 25 mg tablet: White, oval unscored film-coated tablets marked 951 on one side and plain on the other. COZAAR 50 mg tablet: White, oval film-coated tablets marked 952 on one side and scored on the other. The score line is not intended for breaking the tablet. COZAAR 100 mg tablet: White, teardrop-shaped film-coated tablets marked 960 on one side and plain on the other. |
Each COZAAR 12.5 mg tablet contains 12.5 mg of losartan potassium.
Each COZAAR 25 mg tablet contains 25 mg of losartan potassium.
Each COZAAR 50 mg tablet contains 50 mg of losartan potassium.
Each COZAAR 100 mg tablet contains 100 mg of losartan potassium.
Each COZAAR 12.5 mg tablet contains 25.25 mg lactose monohydrate.
Each COZAAR 25 mg tablet contains 12.75 mg lactose monohydrate.
Each COZAAR 50 mg tablet contains 25.5 mg lactose monohydrate.
Each COZAAR 100 mg tablet contains 51.0 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Losartan |
Losartan is a synthetic oral angiotensin-II receptor (type AT1) antagonist. Antihypertensive activity and suppression of plasma aldosterone concentration are maintained, indicating effective angiotensin II receptor blockade. |
| List of Excipients |
|---|
|
Microcrystalline cellulose (E460) |
COZAAR 12.5 mg: PVC/PE/PVDC blister packages with aluminum foil lidding in cartons containing 7, 14, 21, 28, 50, 98, 210 or 500 tablets and a unit-dose package of 28 tablets for hospital use. HDPE bottles of 100 tablets.
COZAAR 25 mg: PVC/PE/PVDC blister packages with aluminum foil lidding in cartons containing 7 or 28 tablets.
COZAAR 50 mg: PVC/PE/PVDC blister packages with aluminum foil lidding in cartons containing 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 280 or 500 tablets and unit-dose packages of 28, 56 and 98 tablets for hospital use. HDPE bottles of 100 or 300 tablets.
COZAAR 100 mg: PVC/PE/PVDC blister packages with aluminum foil lidding in cartons containing 7, 10, 14, 15, 20, 28, 30, 50, 56, 84, 90, 98 or 280 tablets and unit-dose packages of 28, 56 and 98 tablets for hospital use. HDPE bottles of 100 tablets.
Not all pack sizes may be marketed.
Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Herts, EN11 9BU
12.5 mg: PL 0025/0515
25 mg: PL 0025/0336
50 mg: PL 0025/0324
100 mg: PL 0025/0416
12.5 mg: 6 January 2009/22 December 2009
25 mg: 15 December 1994/27 August 2009
50 mg: 15 December 1994/22 December 2009
100 mg: 28 November 2001/22 December 2009
| Drug | Countries | |
|---|---|---|
| COZAAR | Brazil, Canada, Cyprus, Germany, Ecuador, Spain, Finland, France, Hong Kong, Croatia, Ireland, Mexico, Netherlands, Poland, Singapore, Turkey, United Kingdom, United States, South Africa |
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