Source: Medicines Authority (MT) Revision Year: 2022 Publisher: Les Laboratoires Servier, 50, rue Carnot, 92284 Suresnes cedex, France
Coveram 5mg/5mg tablets.
[Coveram 5mg/10mg tablets]
[Coveram 10mg/5mg tablets]
[Coveram 10mg/10mg tablets]
| Pharmaceutical Form |
|---|
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Tablet. White, rod-shaped tablet, 8.5 mm long and 4.5 mm wide, engraved with 5/5 on one face and [White, square-shaped tablet, 8 mm long and 8 mm wide, engraved with 5/10 on one face and [White, triangular-shaped tablet, 9.5 mm x 8.8 mm x 8.8 mm, engraved with 10/5 on one face and [White, round tablet, 8.5 mm diameter, engraved with 10/10 on one face and |
One tablet contains 3.395 mg perindopril equivalent to 5 mg perindopril arginine and 6.935 mg amlodipine besilate equivalent to 5 mg amlodipine.
[One tablet contains 3.395 mg perindopril equivalent to 5 mg perindopril arginine and 13.870 mg amlodipine besilate equivalent to 10 mg amlodipine]
[One tablet contains 6.790 mg perindopril equivalent to 10 mg perindopril arginine and 6.935 mg amlodipine besilate equivalent to 5 mg amlodipine]
[One tablet contains 6.790 mg perindopril equivalent to 10 mg perindopril arginine and 13.870 mg amlodipine besilate equivalent to 10 mg amlodipine]
Excipient with known effect: lactose monohydrate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Amlodipine |
Amlodipine is a calcium ion influx inhibitor of the dihydropyridine group (slow channel blocker or calcium ion antagonist) and inhibits the transmembrane influx of calcium ions into cardiac and vascular smooth muscle. |
|
| Perindopril |
Perindopril is an inhibitor of the enzyme that converts angiotensin I into angiotensin II (Angiotensin Converting Enzyme ACE). The converting enzyme, or kinase, is an exopeptidase that allows conversion of angiotensin I into the vasoconstrictor angiotensin II as well as causing the degradation of the vasodilator bradykinin into an inactive heptapeptide. Inhibition of ACE results in a reduction of angiotensin II in the plasma, which leads to increased plasma renin activity (by inhibition of the negative feedback of renin release) and reduced secretion of aldosterone. Since ACE inactivates bradykinin, inhibition of ACE also results in an increased activity of circulating and local kallikrein-kinin systems (and thus also activation of the prostaglandin system). |
|
| Perindopril and Amlodipine |
Perindopril is an inhibitor of the enzyme that converts angiotensin I into angiotensin II (Angiotensin Converting Enzyme ACE). Perindopril is active in all grades of hypertension: mild, moderate, severe; a reduction in systolic and diastolic blood pressures in both supine and standing positions is observed. Amlodipine is a calcium ion influx inhibitor of the dihydropyridine group and inhibits the transmembrane influx of calcium ions into cardiac and vascular smooth muscle. The mechanism of the antihypertensive action of amlodipine is due to a direct relaxant effect on vascular smooth muscle. |
| List of Excipients |
|---|
|
Lactose monohydrate |
5, 7, 10, 14, 20, 28, 30 or 50 tablets in polypropylene container equipped with a low density polyethylene flow reducer and a low density polyethylene stopper containing a desiccant gel.
Box of 1 container of 5, 7, 10, 14, 20, 28, 30 or 50 tablets.
Box of 2 containers of 28, 30 or 50 tablets.
Box of 3 containers of 28 tablets
Box of 3 containers of 30 tablets.
Box of 4 containers of 30 tablets.
Box of 10 containers of 50 tablets.
Not all pack sizes may be marketed.
Les Laboratoires Servier, 50, rue Carnot, 92284 Suresnes cedex, France
MA 066/01501
MA 066/01502
MA 066/01503
MA 066/01504
Date of first registration: 05/12/2008
Date of renewal: 01/06/2018
| Drug | Countries | |
|---|---|---|
| COVERAM | Australia, Cyprus, Ecuador, Estonia, Finland, France, Malta, Nigeria, Netherlands, Singapore, Tunisia, Turkey, South Africa |
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on the other face.